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11/3/2021
Good afternoon and welcome to Super News Pharmaceuticals 3rd Quarter 2021 Financial Results Conference Call. At this time, all participants are in the 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 Bozzo of Westwick Investor Relations Representative for Super News Pharmaceuticals. You may begin.
Thank you, Nika. Good afternoon, everyone, and thank you for joining us today for Sopernos Pharmaceuticals' third quarter 2021 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 Sopernos' Chief Executive Officer, Jack Kattar, 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.sopernos.com. Following remarks by management, we will open the call to questions. 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 Sopernos' 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 November 3, 2021. 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. Sopernos declares any obligation to update these forward-looking statements except as required by applicable securities laws. I will now turn the call over to Jack.
Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us as we discuss our 2021 third quarter results and recent developments. During the third quarter, we continue to execute on our long-term growth strategy and the 2023 Trochendi XR transition, as highlighted by the announcement in October of the proposed acquisition of Adamus Pharmaceuticals. This acquisition represents a significant step in further building a strong and diverse Parkinson's disease portfolio and aligns with our focus of acquiring value-enhancing, clinically differentiated products to treat CNS diseases. The acquisition will increase our revenue base and cash flow and reduce our dependency on TrochanDxR. The transaction is also expected to be accretive in 2022. Regarding Calvary, the launch is progressing well in line with our forecast. As expected, prescription growth accelerated as we entered the back-to-school season. For the month of September, total prescriptions were 7,132, an increase of 37% compared to the month of August, and an increase of 118% compared to the monthly average during the three-month period prior to September. In addition, the latest weekly prescriptions data shows total prescriptions of 2,248, an increase of 51% compared to the weekly average over the prior 12-week period. We also saw a significant increase of 340% in Calvary's base of prescribers during the third quarter of 2021 compared to the second quarter of 2021, with more than 3,470 physicians prescribing the product. On the managed care front, we've made great progress by securing coverage with one of the key PBMs and advancing discussions with the others. Also in Medicaid, Calvary is now covered as Tier 2 or better for 48% of all Medicaid lives versus 7% in the second quarter. During the third quarter, we received acknowledgement by the FDA that they received our supplemental NDA for Calvary to treat adult ADHD patients and that they have assigned a PDUFA date of April 29, 2022. We continue to make progress on the apomorphine infusion pump, or SPNA-30, and expect to file the NDA in this month. For SPNA-20, the IND was filed in September 2021, and the Phase II clinical study for treatment-resistant depression remains on track for initiation by the end of 2021. We are also pleased by our progress on SPN817 with the Phase II program now targeted to start in the first half of 2022 for the treatment of focal seizures in adults. Recall that SPN817 represents a novel mechanism of action for an anticonvulsant and utilizes synthetic form of fuprazine A, which is a potent acetylcholinesterase inhibitor with pharmacological activities in CNS conditions such as epilepsy. In addition to the above, we have achieved significant milestones with our internal research program. The program focuses on generating our own new chemical entities that target various CNS conditions. Recently, two new chemical entities, SPN443 and SPN446, were nominated for further development after successfully completing initial preclinical screening and lead optimization activities. Additional novel molecules are also undergoing further optimization before being nominated for further development. Moving on to the commercial products, we continue to be pleased with the performance of Trucandy XR and Oxtelar XR despite declines in prescriptions and the reduced promotional efforts by the company. Since the launch of Calvary, the products have been promoted by a much smaller neurology sales force that is focusing its efforts on supporting the current prescriber base. For the first nine months of 2021, the two products combined delivered net product sales of $314 million, essentially flat compared to $317 million in the same period last year. On APICAN, the year-over-year decline in net product sales was due partially to a higher level of channel inventory in the same quarter last year, as well as the lingering effects of competitive dynamics that have prevailed for the last 12 months. Finally, in addition to the significant corporate development activities over the past last year and a half, we continue to be active in 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 third quarter and year-to-date results, please refer to today's press release. Total revenue for the third quarter of 2021 was $148.5 million, a 4% decrease compared to $155.1 million in the same quarter last year. Total revenue in the current period was comprised of net product sales of $145.5 million and royalty revenue of $2.9 million. The decrease in net product sales in the third quarter was due to a decrease in net product sales of APICON and Terkendi XR. This decrease was partially offset by an increase in net product sales from our other products. Calvary was launched in late May of this year and we are very happy to report 2.4 million of net product sales in the first quarter of launch. Calvary net sales include a temporary Temporarily high commercial co-pay deduction as we support patients during the early launch period while we continue our commercial contracting efforts to establish access for patients. For SG&A, third quarter 2021, expenses were $72 million compared to $54.5 million in the same period last year. This increase was primarily due to activities to support the launch of Calgary. Research and development expenses were $19.7 million for the third quarter of 2021 compared to $16.8 million in the same period last year. The increase was due to higher regulatory costs related to the acquired products and costs associated with MyBlock post-market commitment studies. Operating earnings were $32.6 million for the third quarter of 2021 compared to $56.1 million in the same period last year. Net earnings were $21.6 million for the third quarter of 2021, or $0.40 per diluted share, compared to $40 million, or $0.74 per diluted share, in the same period last year. For the first nine months of 2021, total revenue was $420.7 million, a 12 percent increase over $376.8 million in the same period last year. Total revenue was comprised of net product sales of $412.5 million and royalty revenue of $8.2 million. The increase in net product sales in the first nine months of 2021 was due to the acquisition of the CNX products from U.S. World Meds in June 2020. Cost of goods sold for the first nine months of 2021 was $58.1 million as compared to $33.9 million for the same period last year. The increase was primarily due to royalties associated with the acquired products and costs for rejected myoblock inventory. SG&A expenses in the first nine months of 2021 was $203 million compared to $144.2 million in the same period last year. This increase is primarily due to activities to support the launch of Calgary. Research and development expenses in the first nine months of 2021 were $69.4 million compared to $58 million in the same period last year. The increase is primarily due to the $15 million accounting charge for the Navitur corporate restructuring. The contingent consideration gain for the first nine months of 2021 was $7.7 million. This reflects the charge to the purchase price milestones we expect to pay to U.S. World Meds. For the first nine months of 2021, operating earnings were $79.9 million compared to $130.7 million in the same period last year. Net earnings were $51 million for the first nine months of 2021, or $0.94 per diluted share, compared to $96.2 million, or $1.79 per diluted share, in the same period last year. As of September 30, 2021, the company has 849 $0.3 million in cash, cash equivalents, and marketable securities compared to $772.9 million as of December 31, 2020. For the full year 2021, the company is adjusting its financial guidance. Please note that no transaction costs associated with the Adamas acquisition are reflected in this new guidance. We are lowering the top end of our revenue guidance range. This range is now $550 to $570 million from $550 to $580 million previously. For the full year 2021, we are lowering our combined R&D and SVNA expenses to a range of $370 to $400 million from a range of $380 to $410 million previously. In addition, we are increasing our expectations for operating earnings to a range of $90 to $95 million from a range of 70 to 90 million previously. Continue to expect full year 2021 amortization of intangible assets of approximately 24 million and a full year 2021 effective tax rate of 28 to 31 percent. Given the magnitude and growing number of product acquisition related items, starting in 2022, we will be adding non-GAAP financial measures to our quarterly earnings press release as we believe they provide greater transparency and can assist in understanding and assessing Sopernos' business, as well as reflect how we manage the business internally and set operational goals. The non-GAAP financial measures that will adjust our GAAP results will be amortization of intangibles, depreciation, stock-based compensation, transaction cost, and the income tax effect of those charges. With that, I will now turn the call back to the operator for Q&A.
As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question or if your question has been answered, press the pound or hash key. Your first question comes from the line of David Steinberg from Jefferies. Your line is now open.
Thanks. Good afternoon. I have a couple questions. Just generally, Jack, first off, how is – Calvary doing versus your expectations during the all-important back-to-school assessment season? And then just a little granularity on some of the metrics you might use in terms of sampling, payer access. I know that, for example, in sampling you indicated that you're putting 25,000 samples into the field. Is that still the same? Have they been used up? Have you put in any more samples? and where are you in coverage? And then I have a follow-up after that. Thanks.
Yeah, sure. As we mentioned, and we said the same thing basically last quarter, it is actually tracking exactly per our forecast, even on shipments and prescriptions. So, so far we're pretty pleased with the performance of the launch. Specifically regarding sampling, yes, we continue to sample, and that will be and will continue to be an ongoing activity for us. Of course, at the beginning of the launch, and we are still in a launch mode, obviously, you know, that will continue to be on the heavier side. But as time goes on, you know, on an ongoing basis, it will become more measured, you know, in line with obviously the uptake and the physician's activities. As far as the payer access, as I mentioned in my remarks, we're really pleased with the progress that we've made in the last quarter. We've signed up one of the very important key PBMs, so they're on board and the product is now covered, and we're already seeing tremendous traction because of that. And also, we've made similar progress on the Medicaid, so we have now about 50% of the Medicaid lives, approximately, with a Tier 2 or even better coverage. So we're pretty pleased with that. It's taking time, but we expected that, and that's why, obviously, for this year, our guidance on Calvary is where it is as far as the net sales. But, again, back to the initial question you had, I mean, gross sales are tracking exactly as we expected at this time in the launch.
And then just to follow up on the sampling, you mentioned, Jack, it's heavy. So, therefore, the actual scripts are understated. At what point in time in the coming months or quarters do you think we'll be able to get a more accurate read on true demand, i.e., what we see script-wise is what you're seeing in actual usage by patients? And then just secondly, you mentioned that the adult approval is expected in next April. I'm just curious. Are you seeing any off-label use? And I guess we would see that in the pill size. You know, it's about $300 WAC for the 100 to 200 milligram dose, but above 200 milligram, which I assume would be all the adults or older children, it's almost $600 WAC. So what are you seeing in terms of the percent of the pills that are the 100 to 200 mg versus above 200 mg? Thanks. Thanks.
Yeah, on the conversion, I mean, this is more of a rule of thumb. You would expect maybe a quarter to 50% of the samples to work themselves through in the first six months or so. It's a little bit slower than we expected initially with the conversion, so we're really watching it very closely. And then regarding the activity as time goes on, again, it really depends on how quickly the physicians are going with the samples. Now, obviously, what a lot of times screws up the tracking and these numbers is physicians giving more than one sample to the same patient or giving it either at the same time or a few times in a row. And you do have that kind of behavior. We don't want necessarily to discourage physicians from using the samples. especially with the coverage. As coverage is coming online, we want to make sure patients continue to be on the medication until the coverage comes online. So we try to be sensitive from that perspective, and therefore the numbers are not always clean as far as reading the exact conversion rate for the samples. Regarding your question on the adults, we're not seeing really too much at all because Clearly, we don't call on adult psychiatrists, so we are completely focused on child psychiatry and the pediatricians. So other than some folks hearing about it, we might get one or two requests here or there, so it's really minimum at this point if there is anything. And the dose, regarding your question on the daily dose, it is still a little bit on the lower side than we think it will end up. We have published data from our open label extension, and we saw the dose actually with the children and the adolescent, you know, creeping up over time somewhere between the 300 and 400 milligrams. So we expect that over time it will go up to the higher, you know, total daily dose. But initially, you know, you will expect physicians to take, you know, be cautious with it, see how kids respond. Because even the 100 milligram, I mean, was fairly effective if you remember from our phase three clinical study. So we're seeing very good response from the product on the clinical side. But that will take time for them to migrate a little bit more towards the higher doses. And certainly as the adult comes on board, hopefully next year, we expect, again, that to be more in the probably 400 milligram range and maybe closer to the 600 because we did test all the way up to 600 milligram.
Okay, and just a final quick question. You've given us your target long-term growth to net. Could you help us with what the growth to net will shake out in the next couple quarters?
Yeah, I mean, we said that we would love to be where we are today with our current portfolio, right? So we'll be pretty happy if we end up somewhere in the 45 to 55, give or take, growth to net. Actually, we've moved pretty well in the third quarter. From the second quarter, we've moved about 10 points, and we hope to move another 10 to 20 points. It's a little bit hard for me to give you a target date as to when I'm going to hit the 50% or the 55%, but definitely in the first half of next year, we sure hope to get there. And we're working pretty hard to get there as early as possible. Obviously, that's probably the best way of putting it.
Okay, thank you.
Your next question comes from the line of Ken Kakshiyadathor from Cowen. Your line is now open.
Hey, Jack. Just a couple questions. You've had now a little bit of experience with Quelbrey, and you've seen quite a bit of products and how they've launched, and you've been able to get feedback on those launches from clinicians and understand the experience so as you kind of are getting this initial experience with quelbury can you frame for us um your conviction and and kind of the ultimate size do you think this could be bigger than stratera which was around a half a billion maybe bigger than internet can you try to give us some kind of comparison as you take all these different disparate data points that you're getting and try to help us understand, frame out what you see and what you think in terms of, you know, the direction it's going. And then on the apomorphine pump, you've been, you know, very conservative in how you talk about it, which is understandable given, you know, the regulatory process has to play out. But when we have discussions with our clinician consultants, they're real enthusiastic and talk about the need and these late stage patients obviously could get good pricing. So could you help us understand a little bit of you know, your little bit of cautious optimism versus their more enthusiasm and what we should be thinking about that. And then lastly, just would love it if you would touch upon, you know, BD and whether it's a great deal that you're doing with Adamas, whether you're going to be able to reload and be in a position to do something like that again in the short term. And if there's things that you see that maybe we don't see that could be acted upon a little bit quicker than we think. Thanks so much.
Yeah, sure. Regarding the first question, as far as Calgary, you may recall, and some folks on the call might recall, when Stratera first launched, they actually reached up to about 19%, if I'm not mistaken, market share penetration of the whole ADHD market. And they did that fairly quickly because they were the first non-stimulant product to ever enter the marketplace. Before that, it was all with stimulants and the only products available, the controlled substances. But then the changes in the label came on board. People started getting also a little bit disappointment as far as the performance of the product, how quickly it works, and so forth. And the product settled somewhere from a market share perspective, somewhere around the 7%, 6%, give or take. That's where it really ended up settling. Intuniv, also when they launched, they peaked somewhere in the 4% to 5%. And that's why actually the whole category ended up being around the 10% of the ADHD market. What we hope to accomplish with Calvary is hopefully perform way better than where Stratera and Intuniv settled as far as a market share. And we're starting to see some of the early signs, actually, that Calvary is not being reserved only for use for people who are dissatisfied with non-stimulants. Actually, some physicians are using it on a lot of patients who are on stimulants and dissatisfied with the stimulants or where the parents don't want to give their kids stimulants or controlled substances or products that could be abused. And we're very encouraged with that, especially early on. because, of course, the easy positioning that physicians could see this or the perception would be, well, let me see, I'll just put patients who are on non-stimulants today and they're not happy, we'll let them try Calvary. That is not what's happening in the marketplace, so it's very encouraging, the initial size that we're seeing as far as the patient profile on which the product is being used and adopted. So that will tell us that eventually if our strategy is successful and the product continues to perform, there is no reason for the market to be split up 90% stimulants and 10% non-stimulants. Because I'm always a believer and I always talk about the fact and I talk about it from our experience in the category, but also as a parent myself. There is no reason for a parent to put their kid on a stimulant, on a controlled substance, if they have another option that really works, works well, works early, and is safe and tolerable. And to me, as a parent, that's a no-brainer. I mean, that's a decision I will make every day and, you know, give my kid the chance to take a non-stimulant that could work really quickly, which we're seeing in the marketplace in line with what we saw in our phase three in the clinical data. safe, tolerable. I mean, discontinuation rates in our phase three studies are in the two to three percent, and very tolerable drug, and very easy to take. It's easy for the parents with the refills and all these issues, and it's also easier for the physicians. If you really think about these physicians who prescribe heavily, for them it's a huge amount of work for them to do the refills every single month for every patient they have, you know, on these stimulant medications. So all in all, I sure hope and we definitely are targeting to be much bigger than what Stratera did. On the second question regarding the pump, I mean, as far as, You know, some people sensing that we are a little bit more conservative regarding the potential of the pump. I mean, we did mention that in Europe, for example, on a unit basis, the pump sells about, you know, it's a multiple fold of what the apricot pen, you know, sells in Europe. So certainly there is an example where the pump could outperform, you know, the injection, single injection pens. But every market is different, clearly. The reimbursement, the coverage here in the U.S. is a little bit different than in Europe. And that's why we took a little bit more conservative stance on it. And when we made the acquisition, we mentioned somewhere about 125 to 175 as peak sales. Is there a possibility we could easily beat these numbers? Absolutely. I mean, that is a possibility. We believe that could be easily achieved. But again, we need to see the label. We need to see where the product ends up as far as the actual indication. And therefore, from there, how can we position the pump? Because the need is there, no question about it. The big question is how wide of a window is it going to be? In other words, is it going to be applicable to patients who are only severe patients, patients who are moderate and severe, and therefore, you know, is it across stage four and five of the disease, or is it across stage three, four, and five, and so forth. So it heavily depends on the label and where we end up with the product. So that's why we've taken so far a more cautious approach. It's a great product, and that's one of the major reasons why we made the acquisition is because we believe that's a great growth driver for us in the future. And then the last question on the business development, absolutely. As I made a remark in my prepared remarks, we continue to look at different opportunities. We will reload the balance sheet, so to speak. The business on its own will continue to generate even more cash flows next year, reloading our balance sheet. And therefore, we will continue to look at opportunities, whether it's on the licensing side or product acquisitions or company acquisitions. I mean, for the appropriate opportunity, we could also potentially raise more money to do the right transaction. Thank you.
Your next question comes from the line of David Amsalem from Piper Sandler. Your line is now open.
Thanks. So I just have a few. I wanted to come back to Calgary. And regarding the PBM win, can you talk about the formulary tiering for that product? Is it totally unrestricted? And Then secondly, more broadly, regarding the payer landscape for Calgary, are you seeing or are you negotiating, I should say, with payers such that you can eliminate any step-throughs or at least avoid a non-stimulant step-through? Just talk about philosophically what you're trying to accomplish with your contracting discussions. And then I also had a question on APAkin with the decline in sales. I'm assuming a lot of that is the availability of Kinmobi. I guess the question there is, do you expect further pressure or do you see sort of a bottoming out of that product anytime soon? Thanks.
Yeah. Yeah, on the coverage, I mean, in line with a lot of the comments we've made historically on clearly getting complete open access. A lot of the PBMs and a lot of the plans, they come to you with ridiculous high rebates that they're looking for as far as what would it take to give you open access. So what takes the time in these negotiations is clearly something that is more reasonable. that we could work with them to make sure, first of all, patients get access to this, you know, what we believe is an incredible treatment option for a lot of patients out there, but with reasonable rebates that we can work with to give us the right coverage. So ideally, yes, of course, you know, you want these patients to get access to this medication without a lot of these step edits, but realistically, there'll probably be some step edits that We're trying to work our way through those step edits through our negotiations and continued discussions. We've made a lot of progress there and that's why we're pleased with at least landing the first contract here and improving the coverage on the product. As far as You know, where do we land? I mean, it is conceivable that you're going to land in different plans, different status or different tiers or different coverage. I mean, there is no one way that this product is going to be covered across all the plans. So there will be a variety of step-throughs or PAs or whatever the case might be, you know, that different plans will put in place. And we expected that even from the beginning. I mean, we knew that would end up being the case in this category especially, and we're seeing that in a lot of other categories, not just in ADHD. Regarding APRICAN, I mean, we had the third quarter last year, as briefly I mentioned in my remarks. We had a little bit unusually a high third quarter last year, so that's why this quarter was a tough comparison, so to speak. I think if you remember in the second quarter, we did about $27 million, if I'm not mistaken, on net sales. So this quarter was about $25 million. I mean, we see the product settling somewhere in the mid-20s, probably on a quarterly basis. That's where we hope to be. Now, the competitive pressures continue. You know, Whitkin & Moby has been in the market for about a year now. So we've seen that pressure. We continue to see some of those pressures on it as well. And like every category, also you see pressures on the managed care and continued pressure on the managed care, because the more activity in any category, you start seeing more pressures on the managed care as well. So we're seeing some signs of that also. Thank you.
Once again, if you would like to ask a question, please press TAR1 on your telephone or touch-tone key. Your next question comes from the line of Annabelle Samini from Stifel. Your line is now open.
Hi. Thanks for taking my question. Just to go back to the restrictions that you're seeing on the coverage side as far as step-throughs, are they requesting that patients step through stimulants or just the non-stimulants? So I guess that's the first question. And do you have a sense of what percent of the population or the prescriptions are from switching from stimulants or other stimulants versus patients who are new to treatment? And then I guess on the conversion rate of patients going from the starter kits to actual prescriptions. Can you just remind us how large the starter kits are? Is it just a couple weeks of treatment? And if that's the case, then I guess why does it take six months to see what a true conversion rate is from starter kit to actual prescription? Thanks.
Yeah, regarding the step-throughs, it's really a mix, as I mentioned earlier. I mean, the different plans will have different coverage, different schemes, so to speak, you know, some through a non-stimulant, some through stimulants. So it's really a mixed bag, so to speak. As far as the percent of patients who are coming from non-stimulants or stimulants, the only thing I can point to is, you know, we recently completed a survey as far as to where these patients among our prescribers as to where these patients are coming from or what type of patients, you know, physicians are starting Calvary on. And we're really encouraged, as I mentioned earlier to the earlier question on the potential of Calvary eventually. We're very encouraged with the early signs that actually a good portion of these patients are coming from the stimulant side. They're dissatisfied with the stimulants and their side effects and tolerability issues and so forth. Another good chunk of patients is coming from current non-stimulants and And also, interestingly, a good portion, about a quarter of the patients, physicians reported, are putting really patients who have what they characterize as complex ADHD as well. So ADHD with a lot of other comorbidities. Because as many of you may know, stimulants also are not contraindicated in a lot of areas where you might have mood disorders or other conditions associated with ADHD. So So it's really a mixed bag, but we're seeing a good healthy number that is coming from the stimulant side. As far as the starter kit, it's initially two weeks sample size, and therefore that's why we're seeing potentially in a lot of ways we're seeing physicians giving more than one starter kit and therefore pushing out a little bit the conversion into real prescriptions. So, we continue to monitor that. I mean, we have our reps. Obviously, they do monitor how quickly physicians go through samples, but also at the same time, how many prescriptions they've written or not written. So, we can tell in a way, but at the same time, as I mentioned earlier, we're trying to strike a balance here. We want people to be happy and trying to use the product and encourage them and enthusiastic about it. We'll try to manage that in as smooth a manner as possible without disrupting, you know, physicians' excitement about the product and so forth. Okay.
And if I could just ask one more question on treatment. Is it strictly Kenmobi or is it still the COVID restrictions mixed with Kenmobi being a very easy access type of treatment?
I mean, access to physicians, and I'm sure you're probably hearing that from a lot of companies, hasn't gone back to what it used to be pre-COVID. So there is no question about that as far as access reach to physicians is impacting and has impacted everyone's business, including us, including even the Calvary launch, including the Apokin business as well. But yes, I mean, the impact on Apokin is a combined effect of many things, including, yes, COVID, including the increased competition from Kenmobi.
Yeah. I guess my point was they need a nurse to be able to start them with the treatment. So is that the rate-limiting step for you? And at some point, Kenmobi's got, I guess, some high levels of irritation. So is there a point where patients wash through Kenmobi and then they move on to, say, go back to apokine or move on to apokine, or do they just move on to the next level of care, whatever that drug is?
We've seen and we've heard about examples, you know, across all these examples, so to speak, all these categories. So we've heard about patients who have tried kinmobi, haven't been satisfied, different efficacy profile, and physicians put them back on apokine. We've heard people who says, well, Kenmobi is more convenient, so I can just take a sublingual tablet instead of an injection. So, I mean, you're going to see a lot of flow of patients back and forth across these products until they settle with the product that is most suitable for them. Yes, in our case, of course, it's a little bit more complicated, the initiation, because you have the nurse, the involvement of the nurse, and training the patient on using the injectable, you know, the pen itself, the titration, all that. But that's also part of the service that we offer our patients. I mean, some patients actually like that. You know, they like that, you know, hand-holding, the training, a nurse who really follows up with them, see how they're doing on the medication, the compliance. and also reporting back to their physician. So it's really part of what we call our circle, you know, of care for the patient. It's not just here is a prescription and good luck with it and see what happens to you. No, we like to really service these patients and help them, and that's part of it, yeah, as far as the whole APOCAN experience.
Okay, great. Thank you. There are no further questions at this time. I'll turn it over back to Jakathar.
Thank you. We remain focused on the launch of Calgary and look forward to closing the acquisition of Adamas by the end of this year or early 2022. In addition, we look forward to submitting the NDA for SPN 830 this month and get back on the regulatory path towards potential approval next year. With the Adamas acquisition, Calgary's growth and the launch of SPN 830, our dependency on Trochendi XR will be much reduced by the time generics enter the market. We look forward to updating you on our progress and thanks again for joining us today.
This concludes today's conference call. Thank you for participating. You may now disconnect.