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2/27/2024
Good afternoon, and welcome to the Sopranos Pharmaceuticals fourth 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. I would now like to turn the conference over to Peter Vazzo of ICR Westwick, Investor Relations Representative for Sopranos Pharmaceuticals. You may begin.
Thank you, Rivka. Good afternoon, everyone, and thank you for joining us today for Sopranos Pharmaceuticals' fourth quarter and full year 2023 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Sopranos' Chief Executive Officer, Jack Katar, 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.sopranos.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 Sopranos' 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 factor section of the company's latest SEC filings. Actual 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 September, February 27th, 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 FTC. So, please decline any obligation to update these forward-looking statements, except as required by applicable securities laws. I will now send a call over to Jack.
Thank 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 Trependi XR. Excluding Trependi XR, Sopernos delivered strong growth of 26% in total revenues in 2023 compared to 2022. Specifically, our growth products, Calvary and GoCovery, delivered robust 57% growth in combined net sales compared to last year. In addition, combined full-year 2023 net sales for Calvary and GoCovery reached approximately $260 million, which significantly exceeded the $167 million decline in net sales of Tocandy Exhaust. As a result of our emphasis on growing the rest of our portfolio throughout 2023, Trocan DXR closed the year, representing only 13% of total revenues in the last quarter of 2023. Regarding Calgary, the year 2023 was the first full year with both pediatric and adult indications. For the full year, Calgary'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. Moreover, Calgary finished the year with a strong fourth quarter, reaching net sales of $46.4 million. That represents a 97% increase over the fourth quarter of 2022, and a 25% sequential quarter-to-quarter increase from the third quarter of 2023. In the fourth quarter, prescriptions grew by 47% compared to 2022, and we exceeded our goal of lowering the gross to net deductions to the 50 to 55% range. Actual gross to net for the fourth quarter 2023 was 49.5%, resulting in an average net price per prescription of $268 compared to 61% and $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, Calgary also expanded its base of prescribers, ending the fourth quarter with approximately 25,938 prescribers, up from 16,822 in the fourth quarter of 2022. We continue to be encouraged by the high level of satisfaction by Calvary's prescribers. Satisfaction with Calvary among the heavy prescribers is as high as their satisfaction with extended release stimulants and is significantly higher than their satisfaction with strep error. In 2024, we will be placing more emphasis on the adult segment that represents approximately 67% of the total ADHD market. we expect the ADHD market to have a nominal prescription growth rate in line with the 3% growth rate it had in 2023, when it reached an all-time high of 93.4 million annual prescriptions. Switching now to recovery for full year 2023, prescriptions increased by 10% compared to 2022, and net sales increased by 15%, reaching a record of 120 million. We continue to be pleased with the performance of the brand based on its unique position in the marketplace, treating both off-episodes and this can be easier. The 2023 fourth quarter net sales were $32 million, up 10% compared to last year, and flat compared to the third quarter as they were impacted by the timing of orders at year end. Switching to our legacy products, Oxtel XR net sales were $113 million for full year 2023, essentially stable compared to 2022. In September 2024, we expect the introduction of the first generic Oxtel XR. For Tukendi XR, full year net sales were $94 million down by 64% from the $261 million in 2022. In 2024, we don't expect an increase in the number of genetic players in the market, but expect further erosion in Trochendi XR sales. We anticipate combined net sales of Trochendi XR and Oxtella XR in 2024 to be in the range of $125 million to $135 million. Regarding SPN 830, the FDA has scheduled a pre-approval 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. Assuming FDA approval, the company plans to launch SPN 830 in the second half of 2024, 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 four 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 2025. Second, the company also initiated a phase two open label study with SPNA 20 in approximately 40 subjects with major depressive disorders. This study has the potential of providing data on this first-in-class molecule by the end of this year. Third, our ongoing Phase IIb multicenter randomized double-blind placebo control study of SPNA20 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 2025. The company expects to report interim results from approximately one-half of the targeted randomized patients from its Phase IIa study on SPN817 in treatment-resistant seizures in May 2024. This study is examining the safety, tolerability, and efficacy of SPN817 as adjunctive therapy in adult patients with treatment-resistant seizures. Top line results for the full study are expected in the second half of 2024. Fifth, the initiation of a Phase IIb placebo-controlled study with SPN817 in patients with treatment-resistant focal seizures in the second half of this year. And finally, initiation of a Phase I single-dose study of SPN443 in healthy adults following the submission of an IND. SPM 443 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. With that, I will now turn the call over to Tim.
thank you jack good afternoon everyone as i review our fourth quarter and full year 2023 results please refer to today's press release and 10k that was filed earlier today total revenue for the fourth quarter of 2023 was 164.3 million compared to 167.3 million in the prior year quarter Total revenue in the fourth quarter of 2023 was comprised of net product sales of $156 million and royalty and licensing revenues of $8.3 million. The $7.8 million decrease in net product sales was primarily due to a $37.6 million decline in net product sales of Drakendi XR, partially offset by a $25.6 million increase and net product sales of our growth products, KELDRI and GoCovery. Excluding net product sales of Trekendi XR in both periods, total revenues for the fourth quarter of 2023 increased 31% compared to the prior year quarter. For the fourth quarter of 2023, combined R&D and SG&A expenses were 104.6 million as compared to 91.7 million for the same period in 2022. The increase was primarily due to R&D spend associated with the clinical programs for SBN 817 and SBN 820 as we continue to progress our pipeline. And an increase in selling and marketing expenses due to the increase in the ADHD sales personnel and other CalVie marketing initiatives. During the fourth quarter of 2023, we booked a $20.2 million intangible asset impairment charge mainly related to Zadagno. This non-cash charge reflects the forthcoming loss of explosivity of Zadagno in December of 2027. As a result of the impairment charge, operating loss for the fourth quarter of 2023 was approximately $1 million. as compared to operating earnings of 34.3 million for the same period in 2022. Income tax benefit in the fourth quarter of 2023 was 185,000 as compared to income tax expense of 9.7 million in the same period of 2022. Net earnings was 1.79 for the fourth quarter of 2023, or earnings per diluted share of 2 cents. compared to net earnings of 25.5 million, or earnings per diluted share of 43 cents in the same prior year quarter. On a non-GAAP basis, which excludes amortization of intangibles, impairment charges, share-based compensation, contention consideration, and depreciation, adjusted operating earnings for the fourth quarter of 2023 was 47.1 million, compared to 57.6 million in the same quarter of 2022. Total revenue for the full year of 2023 was $607.5 million compared to $667.2 million in 2022. Total revenue was comprised in net product sales of $573.9 million and royalty and licensing revenues of $33.6 million. The $75.5 million decrease in net product sales was primarily due to $166.9 million decline in net product sales of Trekendi XR, partially offset by a $94.1 million increase in net product sales for growth products, Calvary and GoCovery. Excluding net product sales for Trekendi XR in both periods, total revenues for full 2023 increased 26% compared to full year 2022. Combined R&D and SG&A expenses for the full year of 2023 was $428 million as compared to $451.8 million 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&D expenses associated with the clinical programs SBN 817 and SBN 820 as we continue to progress our pipeline. In addition to the items above, full year 2023 include the aforementioned non-cash impairment charge of $20.2 million, resulting in an operating loss for full year 2023 of $5.3 million as compared to operating earnings of $46.1 million for the prior year. Income tax expense for full year 2023 was $1.5 million, as compared to income tax expense of $32,000 for full year 2022. Net earnings were $1.3 million for the full year 2023, or two cents per diluted share, compared to $60.7 million, or $1.04 per diluted share, for the full year 2022. On a non-GAAP basis, adjusted operating earnings was $125.1 million for the full year 2023 compared to $148.8 million the prior year. As of December 31, 2023, the company had approximately $271.5 million in cash, cash equivalents, and marketable securities. compared to $555.2 million as of December 31, 2022. The decrease was due to the repayment of the conferrable security notes due 2023, offset by approximately $120 million of cash generated from operations. The company has a strong balance sheet and significant financial flexibility for potential M&A and other value-creating opportunities. Now turning to guidance. For four-year 2024, we expect total revenue to range from $580 million to $620 million, comprised of net product sales and royalty and licensing revenues. Note that total revenue guidance for four-year 2024 assumes approximately $125 million to $135 million of combined net sales of Tripendi XR and Xtellar 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 Trikendi XR and Oxtelra XR. For the full year 2024, we expect combined R&D and SG&A expenses to range from $430 million to $460 million. This reflects an increased level of R&D spend in 2024 as our pipeline progresses, especially for the phase two programs for SBN 817 and SBN 820. Overall, we expect full year 2024 operating loss in the range of $30 million to break even. And finally, we expect non-GAAP operating earnings to range from $80 million to $110 million. 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 under Kendi XR and Xtellar 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&A.
Thank you. At this time, we will conduct the question and answer session. To ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andrew Tsai of Jefferies. Your line is now open.
Hey, 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. And secondly, if we backed out the individual products other than Calgary from your total revenue guidance for 2024, is it reasonable to assume your guidance might imply Calgary sales could come in above consensus of around 210 currently? Thanks.
Hi, Andrew. This is Jack.
I mean, when we try to build the guidance, we try to accomplish a couple things. First, to help folks with the trochanter XR, oxalate XR situation and the potential impact of the genetics. So that's why we try to isolate these two components. What's really left is, of course, as the main drivers are GoCoverry and Calvary. So with GoCoverry, if you try to assume growth rates that are 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 Apigen and the other products. So yes, I mean, Calvary, could Calvary be in the 200 to 220 or somewhere in that range? I mean, that is a possibility, and it's not, you know, out of reach or an unreasonable level. So hopefully that will address both questions.
Perfect. Thanks. And then maybe a follow-up question is the SPN817 epilepsy. top line interim data, phase two data coming up. Will that be a distinct press release in May, or will that be shared in conjunction with your Q1 EPS? And 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.
Yeah, the plan is, and hopefully all the data will be available for that timing, is to really issue the data due, you know, with our earnings call. So the earnings call typically is like the first week or early second 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? Certainly, it will include efficacy, you know, seizure reductions, you know, some of the key endpoints that we're looking at in the study, as well as, of course, safety, AEs, and so forth. So, yeah, absolutely. I mean, we're trying to give as much of a full picture as possible for the first 50% of the patients, you know, which is the target by May. And then, ideally, I know we did say on the call that, you know, 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 would be great if we can do that. But for now, until we know the flow of the data, you know, 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 point.
Great. Thanks for the caller. Appreciate the updates.
One moment for our next question. Our next question comes from the line of David Anselm of Piper Sandler. Your line is now open.
Hey, thanks. So I wanted to dig a little deeper on on Calgary. So looking at the prescription trends recently and also in the fourth quarter, 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 copay assistance. I think, Jack, you had mentioned recently that you were paring back some of that copay assistance. So how should we think about the impact there? And what does that mean for the prescription directory of Calgary 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 that. what you may or may not have on that product as it relates to the overall top-line guidance. Thank you.
Yes, well, I'll take the second one first. I mean, the pump or SPNA-30 really don't have much in the guidance or nothing meaningful, so the guidance doesn't include really much there. As far as your question on Calgary, so I'll start by going back to really the third quarter, back to school season. Some of you may remember, you know, at that time and throughout the year, we kept saying our target for gross net is 50 to 55%. And we obviously didn't want to do anything significant as far as any changes in the copay card and the features of the copay 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 prescription growth during that very important season for the brand. And therefore, we instituted a lot of these changes more at the tail end of the third quarter and beginning during the fourth quarter. And that's why actually, you know, we've been able to achieve our goal or even surpass that goal by getting around 49.5% gross to net Now, clearly that always comes at the cost or, you know, sacrificing certain things on the prescription trends. I mean, 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 order moving forward, but when you first make these changes on the copay, you're going to get that biggest impact from a prescription trend perspective and momentum and that's why you know alluding to your question yes in the fourth quarter we saw a sequential growth of about if i'm not mistaken five or six percent and then in one queue of 2024 it is a little bit even softer because of course in one queue you always have the additional pressures of high deductibles insurance resets and so forth so all these Factors are converging as far as one cue 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, you know, the trending. So we're very happy that this is behind us more or less. You know, this is behind us, meaning the major changes in the copay are now behind us. I think we've been able to really manage it extremely well. The team's done an amazing job in the fourth quarter, despite the pressures on the prescriptions and so forth. From a net sales perspective, you know, we had a very, very strong quarter despite the pressure on the prescriptions. And as I mentioned in my prepared remarks, you know, the average net price went up to $268. So that's a very healthy increase and improvement, clearly with the value of the prescription. And we'll continue to do that, you know, throughout 2024. Any 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 happy with the performance of Calvary. The survey that I referenced a little bit in my remarks, I mean, prescribers who actually use Calvary, especially heavy prescribers, their satisfaction level with Calvary is equivalent to their satisfaction level with stimulants. pause for a second and think about that. I mean, that is truly remarkable for a non-stimulant to be, you know, delivering and really, you know, performing in physicians' minds as well as extended release stimulants. Because extended release stimulants are the gold standard in treating ADHD. And for Calvary 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. I mean, we have still so much room to grow in a 93 million 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 Salesforce, clearly, which started around mid last year. So 2024 should have that impact with extent 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're very much looking forward to another strong year for Calgary in 2024.
That'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?
Yeah, 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, you know, 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. It looks like, you know, that is really good, you know, 40%, but also that could mean initially that 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, you know, a creep up in the daily dose into what should be the total daily dose for adults. So as time goes on, we'll see them building up to the right levels, which should be in the 400 to 500 milligram total daily dose in adults. 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. And 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. Okay.
Very helpful. Thank you.
One moment for our next question. Our next question comes from the line of Stacey Koo of T.G. Callen. Your line is now open.
Thanks 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 CalBRI. And related to that, what do you think will be a gross net this year? Are you providing any guidance for how it might settle over the year? I'm just curious, since you're saying right now the adult doses, is it touched 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.
Yeah, regarding the payout access, We have contracts now with two major PBMs out of the three major ones. So, I mean, we'll continue. The door is always open. We always are talking to everybody all the time. And within the states, we continue to, you know, 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, you know, as time goes on. We're pretty happy with the commercial coverage as well as the Medicaid coverage on Calgary 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 on Candixor and Oxtelixor. So we're very happy there, but there's always room for improvement, of course, as different cycles come up. and renewal of certain contracts. And therefore, leading to the gross net question, as we mentioned, I mean, the target will still be in the 50 to 55%. But of course, you're going to have the fluctuations that you typically see in the quarterly, one 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 second quarter, improve a little bit better in the third quarter, and then will be the best one in the fourth quarter. So you're going to follow the same natural trend that we've seen with Trakendi XR or Oxtel XR as time goes on. But at this point, it looks like the 50 to 55 is still a good target and will stay. We'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. Got it. And then finally, I'm sorry, go ahead.
Go ahead. I can follow up with my third question.
Go ahead. No, 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, you know, typically expect with a new product still in its, you know, embryonic kind of stages of with the launch. It's only been two and a half or three years. It takes time, you know, 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. And the target daily dose for kids is in the 300 milligram range, and for the adults is in the 400 to 500 milligram range.
Perfect. You just answered my last question. Thank you.
As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. One moment for our next question. Our next question comes from the line of Annabel Samini of Cycle. Your line is now open.
Hi, this is Jack. I'm 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 that the ADHD market might be normalizing to pre-COVID levels. Have you already kind of seen a rebound there, or is Calgary just performing particularly well in relation to a weaker market?
Yeah, 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. And the 2021, 2022, even a little bit in the 2020 timeframe. And then in 2023, it took a little breather and started to normalize. And that's what, 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 33%. 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. Now, 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.
Great, 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 to promotion, so is there any way that you can kind of take advantage of that further?
Yeah, 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. I mean, people don't sit in front of TV and watch Prime TV anymore as they used to a 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, you know, patient advocacy groups, you know, patient programs. We have significant amount of programs to get to the patients from an education perspective, as well as even within the office, you know, the physician's office and so forth. So we have several programs and many efforts in the digital space, which are all DTC programs. We also have, you know, different influencers who are as well as folks, people who, you know, speak on behalf of the product because they have direct experience with the product and they have a strong influence among consumers as well.
Great. Helpful. Thank you.
I am showing no further questions at this time. I would now like to turn it back to Jack Katar for closing remarks.
In 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 Calgary and GoCoverty 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 three key strategic areas. First, driving significant growth with Calvary and GoCovery, and together with the rest of the portfolio, generating strong cash flow, allowing us to continue our investments in our pipeline. Excluding our legacy products, Stropendi XR and Oxteller XR, Our guidance for 2024 represents a healthy growth rate of approximately 22% in net sales. Second, the potential launch of a third growth product in our portfolio, assuming the FDA approval of SPNA 30 NDA in April. And third, advancing our innovative R&D portfolio of differentiated first-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. We look forward to updating you on our next call.
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.