Q1 2021 Supernus Pharmaceuticals Inc Earnings Call
Okay.
Good afternoon, and welcome to see Paradise Pharmaceuticals, first quarter 2000 on 'twenty, One financial results conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
Operator: Good afternoon, and welcome to Supernus Pharmaceuticals' first quarter 2021 financial results conference call. At this time, all participants are in a listen only mode.
Operator: 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 Vozzo of Westwick Investor Relations, a representative of Supernus Pharmaceuticals. Thank you, Jurgen.
As a reminder, this conference call is being recorded.
I would now like to turn the conference over to Peter Bozzo.
Smith Investor Relations representative for Super Nice Pharmaceuticals, you may begin.
Peter Vozzo: Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' first 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 Supernus' Chief Executive Officer, Jack Khattar, and Jim Kelly, Chief Financial Officer.
Thank you here again, good afternoon, everyone and thank you for joining us today for <unk> Pharmaceuticals first 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 supremacist Chief Executive Officer, Jackatar, and Jim Kelly Chief Financial Officer today's call.
Peter Vozzo: Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.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 Supernus' 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.
All is being made available via the Investor Relations section of the company's website at IR. That's the Pernis Dot 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 reflects the furnaces current perspective.
Active 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 actual results may differ materially from those projected in these forward looking statements for the benefit of those who.
Peter Vozzo: However, actual results may differ materially from those projected in these forward-looking statements. For the benefit of those who may be listening to the replay, this call was held and recorded on May 5, 2021, at approximately 4.30 p.m. Eastern Time.
Maybe listening to the replay this call is being held and recorded on May five 2021 at approximately 430 P M Eastern time.
Peter Vozzo: 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 does not assume 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.
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. So pernice declines 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 first quarter results.
Jack A. Khattar: And thanks for taking the time to join us as we discuss our 2021 first quarter results. Since the beginning of 2021, we have made significant regulatory, operational, and commercial progress on a number of fronts. First, in April, we received FDA approval for Calvary for the treatment of ADHD in pediatric patients 6 to 17 years of age.
Since the beginning of 2021 we have made significant regulatory operational and commercial progress on a number of fronts first in April we received FDA approval for a calibrated for the treatment of ADHD in pediatric patients six to 17 years of age.
Jack A. Khattar: We are actively preparing for the launch of the product in the U.S., starting later in the second quarter, and are excited by the opportunity to provide this treatment as an important option for patients. Our commercial launch activities include engagement with both physicians and patient groups who have expressed great interest in this unique new alternative for the treatment of ADHD. We will be launching Kelbree with more than 175 sales representatives who have strong expertise in CNS.
We are actively preparing for the launch of the product in the U S. Starting later in the second quarter and are excited by the opportunity to provide this treatment as an important option for patients.
Our commercial launch activities are ongoing and include engagements with both physicians and patient groups, who have expressed great interest in this unique no alternative for the treatment of ADHD.
We will be launching category with more than 175 sales representatives, who have strong expertise on CNS, we are leveraging our heritage in the ADHD space, having created more ADHD products than any other company in the world over the past two decades, so partner scientists created four different.
Jack A. Khattar: We are leveraging our heritage in the ADHD space, having created more ADHD products than any other company in the world over the past two decades. Supernus scientists have created four different ADHD products using our technologies and expertise in the field.
<unk> ADHD products, using our technologies and expertise in the field.
Jack A. Khattar: Our leadership in ADHD product development and commitment to the ADHD community is second to none. We are excited about the considerable level of attention Calgary has received since its approval from physicians, patient advocacy groups, and the media because of its unique profile as the first novel, non-controlled substance to be approved in over a decade. We will conduct post-marketing commitment studies, including a new study of Kelby in preschool-aged children with ADHD, 4 to 5 years of age.
Our leadership in ADHD product development and commitment to the ADHD community is second to none.
We are excited about the considerable level of attention caliber has received since its approval from physicians patient advocacy groups and the media because of its unique profile as the first novel non controlled substance to be approved in over a decade.
We will conduct a post marketing commitment studies, including a new study for scale debris and preschool aged children with ADHD for two five years of age.
Completion of these studies is in response to a written request by the FDA and should therefore result in the FDA granting an additional six months of market exclusivity.
Jack A. Khattar: The completion of these studies is in response to a written request by the FDA and should therefore result in the FDA granting an additional six months of market exclusivity. Regarding the adult population, we are on track to submit a supplemental NDA to the FDA for CalBRI for the treatment of ADHD in adult patients in the third quarter of this year. The adult indication is important to help expand the use of CalBRI as adults represent approximately half of the total ADHD market in the U.S.
Regarding the adult population, we are on track to submit a supplemental NDA to the FDA.
<unk> for the treatment of ADHD in adult patients in the third quarter of this year. The adult indication is important to help expand the use of Calgary as adults represent approximately half of the total ADHD market in the U S.
Turning now to the NDA for the April morphine infusion pump or SPN 830, we recently met with the FDA to discuss the contents of the November 'twenty 'twenty, a refusal to file letter and the requirements for Resubmission.
Based on those discussions we now plan to resubmit the SPN 830, NDA in the second half of 2021.
Jack A. Khattar: Turning now to the NDA for the Apomorphine Infusion Pump, or SPN 830. We recently met with the FDA to discuss the contents of the November 2020 refusal to file letter and the requirements for resubmission. Based on those discussions, we now plan to resubmit the SPNA 30 NDA in the second half of 2021. Since the last update we gave, we have made good progress on the additional device testing that the FDA has asked for, and we are now focused on completing all the remaining activities to have a complete file for resubmission later this year.
Since the last update we gave we have made good progress on the additional device testing that the FDA has asked for and we are now focused on completing all remaining activities to have a complete file for Resubmission later this year.
Regarding SPN eight 'twenty, our first in class orally active <unk> activator, we have advanced it towards a phase II clinical program in treatment resistant depression. Following the successful completion of a multiple ascending dose study in healthy volunteers in the Mad study SPN 820 exhibited a favorable.
<unk> safety and Tolerability profile across a broad range of potentially therapeutic doses.
We remain on track to initiate a randomized phase two clinical study in treatment resistant depression by the end of 2021.
Moving on to the commercial products, we saw familiar first quarter dynamics, such as insurance pressure that impacted our brand's performance compared to the fourth quarter of 'twenty 'twenty four.
Jack A. Khattar: Regarding SPNA20, our first-in-class orally active mTORC1 activator, we have advanced SPNA-20 towards a Phase II clinical program in treatment-resistant depression following the successful completion of a multiple ascending-dose study in healthy volunteers. In the MAT study, SPNA-20 exhibited a favorable safety and tolerability profile across a broad range of potentially therapeutic doses.
For April can net sales were also impacted by competitive headwinds for the brand that were initially seen in the fourth quarter of last year, while still early in the second quarter. We believe we are starting to see stabilization in the business and look forward to improving the trend for the remainder of the year.
Compared to last year net sales of Trokendi XR increased 5% in the first quarter of 2021 while net sales have accelerated our grew by 14%.
These products continue to report healthy net sales gains. Despite the continued challenges from the pandemic. The typical first quarter market dynamics and the fact that they have now been on the market for nearly eight years.
Jack A. Khattar: We remain on track to initiate a randomized Phase II clinical study in treatment-resistant depression by the end of 2021. Moving on to the commercial products, we saw familiar first-quarter dynamics such as insurance pressure that impacted our brand's performance compared to the fourth quarter of 2020. For Apokin, net sales were also impacted by competitive headwinds for the brand that were initially seen in the fourth quarter of last year.
First quarter 2021 prescriptions as reported by Ikea and on on an extended unit basis were flat for Selinexor as compared to the first quarter of 2020, while Trokendi XR first quarter extended unit prescriptions went down 13% as compared to the first quarter of 2020.
Yeah.
Finally regarding corporate development, we continue to be active and 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 Jim.
Jack A. Khattar: While still early in the second quarter, we believe we are starting to see stabilization in the business and look forward to improving the trend for the remainder of the year. Compared to last year, net sales of Shokendi XR increased 5% in the first quarter of 2021, while net sales of Oxfeller XR grew by 14%. These products continue to report healthy net sales gains despite the continued challenges from the pandemic, the typical first quarter market dynamics, and the fact that they have now been on the market for nearly eight years.
Thank you Jack and good afternoon.
As I review, our first quarter results. Please refer to today's press release.
I'll begin with our revenue earnings and a discussion of some unique items in the period and then turn to discuss operating expenses.
In summary, our results keep us on track with our 2021 plans. Our team is well prepared for the launch of Calgary as an important new treatment option for ADHD.
Pediatric patients and our cash balance of 808 million maintains our strategic flexibility to in license or acquire new products.
Jack A. Khattar: First quarter 2021 prescriptions as reported by IQVIA and on an extended unit basis were flat for Oxteller XR as compared to the first quarter of 2020, while Trukendi XR first quarter extended unit prescriptions were down 13% as compared to the first quarter of 2020. Finally, regarding corporate development, 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 Jim. Thank you, Jack, and good afternoon.
Total revenue for the first quarter of 2021 was $130 9 million, an increase of 38% over $95 million in the same same quarter last year.
Total revenue was comprised of net product sales of $128 4 million and royalty revenue of $2 6 million.
Net product sales for the first quarter of 'twenty 'twenty. One included $99 2 million from Trokendi, XR and ex stellar XR, reflecting 7% growth versus the first quarter 2020.
And $29 2 million from a per can sit dargo and myobloc.
Of note the continued strength of Trokendi XR and our stellar XR was offset by <unk>, which saw declines in demand linked to market and payer pressures.
Jim Kelly: As I review our first quarter results, please refer to today's press release. I'll begin with our revenue earnings and a discussion of some unique items in the period, and then turn to discuss operating expenses. In summary, our results keep us on track with our 2021 plans, our team is well prepared for the launch of CalBRI as an important new treatment option for ADHD and pediatric patients, and our cash balance of $808 million maintains our strategic flexibility to in-license or acquire new products.
Regarding inventory levels, we saw some moderate destocking across the portfolio equal to approximately $1 million compared to the fourth quarter of 2020.
Operating earnings were $13 2 million for the first quarter of 2021 as compared to $29 million in the same period the prior year.
Of note in the first quarter of 2021, we recorded a number of noncash items that were the primary driver of this decline.
Jim Kelly: Total revenue for the first quarter of 2021 was $130.9 million, an increase of 38 percent over $95 million in the same quarter last year. Total revenue was comprised of net product sales of $128.4 million and royalty revenue of $2.6 million.
We recorded a noncash in process R&D expense of $15 million related to the equity investment in avatar.
And noncash contingent consideration expense of $1 million associated with the 2020 U S World net acquisition.
On the Navistar related 15 million noncash expense as a result of the accounting impact of the March 2021 Napa tour corporate restructuring whereby we expense our investment as an inquired acquired in process R&D asset in the period.
Jim Kelly: Net product sales for the first quarter of 2021 included $99.2 million from Tricandi XR and Extellar XR, reflecting 7% growth versus the first quarter of 2020, and $29.2 million from Apikin, Zadaga, and Myable. Of note, the continued strength of Trikendi XR and Oxteller XR was offset by APIC-M, which saw declines in demand linked to market-im Regarding inventory levels, we saw some moderate destocking across the portfolio, equal to approximately a million units compared to the fourth quarter of 2020.
In addition, amortization expense for intangible assets was $6 million for the first quarter of 2021, a $4 7 million.
The increase compared to the same period the prior year.
Net earnings were $5 7 million for the first quarter of 2021 or 11 cents per diluted share compared to $21 5 million per 40 cents per diluted share in the same period the previous year.
Given the magnitude and growing number of the product acquisition related items were considering adding non-GAAP financial measures to future company earnings press releases as we believe they provide greater transparency and can assist investors.
Jim Kelly: Operating earnings were $13.2 million for the first quarter of 2021, as compared to $29 million in the same period the prior year. Of note, in the first quarter of 2021, we recorded a number of non-cash items that were the primary driver of this decline.
In understanding and assessing ongoing economics of <unk> business and reflect how we manage the business internally and set operational goals more.
Jim Kelly: We recorded a non-cash, in-process R&D expense of $15 million related to the equity investment in Navitrol and a non-cash contingent consideration expense of $1 million associated with the 2020 U.S. World Med acquisition. The Navator related $15 million non-cash expense is the result of the accounting impact of the March 2021 Navator corporate restructuring, whereby we expensed our investment as an acquired in-process R&D asset In addition, amortization expense for intangible assets was $6 million for the first quarter of 2021, a $4.7 million increase compared to the same period the prior year.
More to come on that topic on our future earnings calls.
As of March 31, 2021, the company had $807 7 million in cash cash equivalent marketable securities and long term marketable securities compared to $772 9 million as of December 31, 2020.
I will now provide some more detail related to operating expenses.
For SG&A first quarter of 2021 expenses were $61 5 million compared to $41 6 million in the same period last year.
This increase was primarily due to expenses associated.
With commercialization efforts for <unk> Z, Doggo, and Myobloc as well as sales marketing and launch activities related to Calgary.
With the launch of <unk> in the second quarter of 2021, we expect a step up of at least $15 million and our quarterly SG&A run rate when compared to the first quarter of 2021.
Jim Kelly: Net earnings were $5.7 million for the first quarter of 2021, or $0.11 per diluted share, compared to $21.5 million or $0.40 per diluted share in the same period the previous year. Given the magnitude and growing number of product acquisition-related items, we're considering adding non-GAAP financial measures to future company earnings press releases as we believe they provide greater transparency and can assist investors in understanding and assessing the ongoing economics of Supernus's business and reflect how we manage the business internally and set operational goals.
Research and development expenses were $34 3 million for the first quarter of 2021 compared to $18 9 million in the same period last year.
Excluding the impact of the previously mentioned 15 million noncash item associated with our <unk> investment R&D.
R&D expenses in the period were approximately flat year over year.
Turning now to financial guidance for the full year 2021, we continue to expect revenues to range from $550 million to $580 million comprised of net product sales and royalty revenue and including approximately $10 million of net product sales of Calvary base.
Jim Kelly: More to come on that topic on our future earnings calls. As of March 31, 2021, the company had $807.7 million in cash, cash equivalents, marketable securities, and long-term marketable securities, compared to $772.9 million as of December 31, 2020.
On the launch.
In the second quarter of 2021.
For full year 2021 we continue to expect combined R&D and SG&A expenses in the range of 380 million to $410 million and operating earnings between $65 million and $90 million.
In addition, we expect full year 2021 amortization of intangible assets of approximately $24 million.
Jim Kelly: I will now provide some more detail related to operating expenses. For SG&A, the first quarter of 2021 expenses were $61.5 million compared to $41.6 million in the same period last year. This increase was primarily due to expenses associated with commercialization efforts for Apikin, Zadago, and Myoblock, as well as sales, marketing, and launch activities related to Kelberg. With the launch of CalBRI in the second quarter of 2021, we expect a step-up of at least $15 million in our quarterly SG&A run rate when compared to the first quarter of 2021.
New this quarter to our guidance as the full year 2021 effective tax rate of 28% to 31%.
This range is above our normally expected effective tax range for this period of 26% to 28% due to a number of discrete tax items in the year.
With that I now turn the call back over to our operator for Q&A.
Thank you Sir.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound or hash key.
Please standby, while we compile the Q&A roster.
Okay.
Our first question on queue comes from the line of Ken Cacciatore from Cowen and co.
Your line is now open Ken.
Thanks, So much for the question Jack surprised on a really positive guidance here around the income working pump can you provide.
Provide any additional context I know you indicated device testing just trying to better understand what you need to do and it sounds like you don't need to address any additional clinical data and then on the Cobra.
Jim Kelly: Research and development expenses were $34.3 million for the first quarter of 2021, compared to $18.9 million in the same period last year. Excluding the impact of the previously mentioned $15 million non-cash item associated with our Navitore investment, revenues in the period were approximately flat year over year.
Help relaunch little bit managed care has changed even though the environment has changed even since you launched trokendi and ex Telerik, sorry, So just any thoughts around progress there or we cannot be subject to the automatic locks or could we see some maybe initial wins, maybe any update on progress you're making thanks so much.
Jim Kelly: Turning now to financial guidance for the full year 2021, we continue to expect revenues to range from 550 to 580 million, comprised of net product sales and royalty revenue, and including approximately 10 million of net product sales of Calbary, based on the launch in the second quarter of 2021. For full year 2021, we continue to expect combined R&D and SG&A expenses in the range of $380 million to $410 million and operating earnings between $65 million and $90 million.
Yes sure.
Regarding the pump we have.
While we were discussing with the FDA and trying to clarify some of these requirements in parallel as we were trying to complete some of the environmental testing that we had referred to in previous earnings calls.
So those tests have been really progressing very well so we're happy with the timing of those steps because with COVID-19 and so forth, where there were a lot of unknowns as to the timing and whether the suppliers will be able to complete the testing on time and so forth.
So we feel a little bit better about the timeline overall right now as to where do we stand.
And the meeting in March helped us tremendously in clarifying with day after the a exactly the specific items they were looking for.
Jim Kelly: In addition, we expect full year 2021 amortization of intangible assets of approximately 24 million. New this quarter to our guidance is the full year 2021 effective tax rate of 28 to 31 percent. This range is above our normally expected effective tax range for this period of 26 to 28 percent due to a number of discrete tax items in the. With that, I now turn the call back over to our 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, press the pound or hash key.
And therefore.
We feel very good about the timing.
We said the second half of this year, we're working pretty hard to do it as soon as we can and in the in the second half so as we get closer to hopefully we can give people a little bit more clarity within that second half as we get closer to filing but we feel good about it at this point as to where do we stand and yes, I mean, as we mentioned earlier there were Nordic why.
<unk> for any new.
Clinical data behind the product.
Regarding managed care, we continue to talk to managed care I mean, this is an ongoing discussion as everyone knows sometimes it's all the way till the last minute.
Four things to materialize, one way or the other we are clearly trying to avoid any new market in a block type of policies as we all have seen in a lot of the newer market launches.
Operator: Please stand by while we compile. Our first question in queue comes from the line of Ken Kashatori from Coven & Co. Your line is now open.
But we're not going to let that stop us. This is a product that is so unique in the excitement behind it the requests we're getting from the field from patterns from physicians about the product when can you come and talk to me about it I mean, the N O G. The momentum we're seeing in the market place is incredible.
Ken Kashatori: Thanks so much for the question. Jack, I am surprised by the really positive guidance here around the Acomorphine pump. Can you provide any additional context? I know you indicated device testing; just trying to better understand what you need to do.
We're going to let people try this product we're going to sample. It we're going to give it to them, we're going to let you know utilization and demand really drive the success of this product and we hope everyone will partner with US eventually in a reasonable manner as far as managed care is concerned to help everybody get access to this really.
Jack A. Khattar: And it sounds like you don't need to address any additional clinical data. And then on the Kelbree launch, a little bit, managed care has changed, you know, the environment has changed even since you launched for Kendi and Xtel or XR. So just any thoughts around progress there? Are we going to be subject to automatic locks? Or could we see some, maybe, initial wins, maybe any update on progress you're making? Thanks so much.
Great option treatment.
Thank you.
Your next question comes from the line of David Steinberg from Jefferies.
Your line is now open.
Okay. Thanks, and good morning, I have a few questions on on the <unk> launch Jack you indicated you're going to be sampling aggressively so just curious.
Jack A. Khattar: Yeah, sure. Regarding the pump, we have, you know, while we were talking with the FDA and trying to clarify some of these requirements, in parallel, we were trying to complete some of the environmental testing that we had referred to in previous earnings calls. So those, you know, tests have been progressing very well. So we are happy with the timing of those tests, because with COVID and so forth, there were a lot of unknowns as to the timing and whether the suppliers would be able to complete the testing on time and so forth.
I assume that the actual scripts will be understated for some period of time, because the samples will not be included in the paid scripts.
What do you think is a reasonable timeframe.
After the sampling so that the.
Actual scripts would correspond to what youre seeing in the marketplace.
Secondly in terms of target physicians I guess, how many calls do you think you'd make to the high decile docs before the action really starts for the back to school season.
And then.
Are you targeting is there a difference in the decile between.
Jack A. Khattar: So we feel a little bit better about the timeline overall right now as to where we stand. And the meeting in March helped us tremendously in clarifying with the FDA exactly the specific items they were looking for. And therefore, you know, we feel very good about the timing. We said in the second half of this year, and we're working pretty hard to do it as soon as we can in the second half.
Docs that write the most scripts in ADHD and also the docs that right. The most scripts specifically for non stimulants.
And then.
The final. The final question is you get asked this a lot because there are a lot of different analogs.
Ranging from the nearest re formulation of methylphenidate to survive and switch does over $2 billion in sales. What do you think is the best analog to look at for your launch of quell brie. Thanks.
Jack A. Khattar: So as we get closer, hopefully, we can give people a little bit more clarity in the second half, you know, as we get closer to filing. But we feel good about it at this point as to where we stand.
Okay.
I'll see and I'll make sure I'll cover everything.
Starting with the first question about sampling and when would you expect to really start reading real prescriptions and so forth I mean.
On the obvious reasons, we're not going to divulge and disclose completely the full details of our sampling program and for how long or and so forth, so, but clearly as far as prescriptions Youre right.
Jack A. Khattar: And yes, I mean, as we mentioned earlier, there were no requirements for any new, you know, clinical data behind the product. Regarding managed care, we continue to talk to managed care. I mean, this is an ongoing discussion, as everyone knows. Sometimes it's all the way till the last minute for things to materialize one way or the other.
Samples are not picked up by IMS as prescriptions.
When you start seeing IMS prescriptions at east will be a real real demand real prescriptions, you know behind the product.
Hopefully during that period one there.
There is enough enough data that people would like to see we will try to provide folks with some other metrics at least that give people a good feel as to how the launch is going the adoption in the marketplace physicians coming.
Jack A. Khattar: We are clearly trying to avoid any new market, you know, block type of policies as we all have seen in a lot of new market launches. But we're not going to let that stop us. This is a product that is so unique and the excitement behind it. The requests we're getting from the field, from parents, from physicians about the product. When can you come and talk to me about it?
Coming on board or not coming on board and so forth. So I will try to introduce other metrics that hopefully.
Give people at least a good feel as to how the launches is coming up and on the first at least two or three months and so forth until things.
Become much clearer.
As far as Florida, getting physicians I mean, as you know and you've known us in this space I mean, that's really one of the things, we do extremely well and we execute on extremely well.
Jack A. Khattar: I mean, the energy and momentum we're seeing in the marketplace is incredible, and we're going to let people try this product. We're going to sample it. We're going to give it to them.
So you can bet on the fact that we will definitely be targeting physicians very precisely as precisely as possible using really good data sources are here and go after the physicians who are high prescribers on both ends. This is not a product that is just suited for people who use.
David Steinberg: We're going to let, you know, utilization and demand really drive the success of this product. And, you know, we hope everyone will partner with us eventually in a reasonable manner as far as managed care is concerned to help everybody get access to this, you know, really great option treatment. Thank you. Your next question comes from the line of David Steinberg from Jeffries. Your line is now open.
Stimulants or people, who use non stimulus there was a product that is suited for every patient out there. So we're going to go after the physicians who are high volume prescribers and those physicians are across a wide span of different.
Physician type you know from starting with Pediatricians child, psychiatry, and so forth as far as.
Jack A. Khattar: Okay, thanks and good morning. I have a few questions about the QLB launch. Jack, you indicated you're going to be sampling aggressively, so just curious. I assume that the actual scripts will be understated for some period of time because the samples will not be included in the paid script. What do you think is a reasonable time frame after the sampling so that the... You know, actual scripts would correspond to what you're seeing in the marketplace?
The ADHD and of course back to school as we all know.
That's really the.
The big season for a lot of patient initiations.
On somewhere around the 40% of prescriptions are initiated during that back to school season. So we're going to be that we're going to be part of the conversation.
When the physician and the parent and then make sure to calibrate as one of the options that will be presented to the patients and to parents and again back to the profile of caliber and really the exciting clinical profile that we have with this product.
Jack A. Khattar: Secondly, in terms of target physicians, I guess, how many calls do you think you'd make to the high-decile docs before the action really starts for the back-to-school season? And then, are you targeting, is there a difference in the decile between... Docs that write the most scripts for ADHD and also the docs that write the most scripts specifically for non-stimulants? And then the final question is, we get asked this a lot because there are a lot of different analogs, ranging from, you know, the NEOS reformulation and methylphenidate to Vyvanse, which What do you think is the best analog to look at for your launch of Quelvary?
You have a product that is so easy to use you may not even need titration or very minimal titration and it's not dependent on weight on Norway or any of that.
It is a sprinkle option it can work as early as the first week it walks in both attention and hyperactivity and inattention and hyperactivity, It beautiful safety and Tolerability profile.
I know this is just my opinion of why in the world any parent will put their child on a stimulant or any other products, so and we're going to give them a sample to try it and try it for free initially.
So the downside we believe is extremely low obviously, so that's why we feel pretty good about being part of that conversation when it occurs during the back to school season, and we have a good shot that.
Jack A. Khattar: Okay, I'll see and I'll make sure I cover everything. Starting with the first question about sampling and when you expect to really start reading real prescriptions and so forth. For obvious reasons, we're not going to divulge and disclose completely the full details of our sampling program and for how long and so forth. But clearly, as far as prescriptions are concerned, you're right. Samples are not picked up by IMS as prescriptions.
Most parents will probably give us a shot.
Trying the product.
And then the last question if I remember was more is there a difference between those who are prescribed stimulants or non stimulants are the only really.
The overall general rule of thumb on this is all about generalizing here not really.
But as far as kids, if you look at the market about 23% is non stimulants.
Jack A. Khattar: So when you start seeing IMS prescriptions, this will be real demand, real prescriptions behind the product. And only during that period when there isn't enough data that people would like to see, will we try to provide folks with some other metrics, at least to give people a good feel as to how the launch is going, the adoption in the marketplace, physicians coming on board or not coming on board, and so forth. So we'll try to introduce other metrics that hopefully could give people at least a good feel as to how the launch is coming along in the first at least two, three months. And so, as far as targeting physicians, I mean, as you know and you've known us in this space, I mean, that's really one of the things we do extremely well and we execute on extremely well.
In adults the usage of non stimulant is much lower as a percent of the market place. So you would expect with them.
The kids.
Kids usage physicians, who are treating kids they.
They are more likely to use non stimulants vs physicians, who treat adults.
Hey, Jack actually there's one other question I asked I know I asked a lot on which is what what do you think is the correct analog there are lots and lots of different launches in ADHD.
Ranging from highly successful ones to does what.
What would you point to as the number one on number two analog that you would use price to look at.
There's really no good analogs because this is the first real new chemical entity to be introduced on over a decade. So if youre looking forward on analog that is a recent analog.
There is really no such thing in the current environment because most of the products introduced in the last 10 years or so on all three formulations of the same thing methylphenidate on amphetamines.
Jack A. Khattar: So you can bet on the fact that we will definitely be targeting physicians very precisely, as precisely as possible, using really good data sources here, and going after the physicians who are high prescribers on both ends. This is not a product that is just suited for people who use stimulants or people who use non-stimulants.
And the philosophy and is truly unique on its own.
As far as you know its place in the therapy and also the GAAP, it's really fills the gap that we've been waiting for for years and years and as you know we've been in this market for 25 plus years in the ADHD market, we know it extremely well so.
There is really no one I can point to to of course threat. There at that time also was a new chemical entity, but it was a long time ago and it also wasn't the first non stimulant ever.
Jack A. Khattar: This is a product that is suited for every patient out there, so we're going to go after physicians who are high volume prescribers, and those physicians are across a wide span of different physician types, starting with pediatricians, child psychiatry, and so forth, as far as ADHD. And of course, back to school, as we all know, that's really the big season for a lot of patient initiations, you know, somewhere around 40% of prescriptions are initiated during that back to school season. So we're going to be there.
Now if he can take that as an analog and if youre looking for a solar get as to what the pent up demand can be for a real non stimulant that actually works works quickly within a reasonable timeframe has a good safety and tolerability.
You probably should look at the first six months of threat data when they first launched.
And as you know in those days, we went back a child defending against the theater with Adderall XR and so forth and we saw the penetration and it went up very very quickly on I believe if I'm not mistaken it reached a market share up from 19% of the total ADHD market. So that should give you at least probably a good measure.
Jack A. Khattar: We're going to be part of the conversation between the physician and the parent and make sure Calvary is one of the options that will be presented to patients and to parents. And again, back to the profile of Calvary and the really exciting clinical profile we have with this product. You have a product that is so easy to use, you may not even need titration or very minimal titration, and it's not dependent on weight or no weight or any of that. It has a sprinkle option.
As to how deep and strong that demand could be for a real good non stimulant.
Unfortunately for a lot of patients at that time the products started disappointing a little bit then had other issues on the label and so forth, but that 19% maybe is a good measure as to the pent up demand, but also again I'll qualify all led by saying that was the first non stimulant ever to be in.
Traduce at that time.
Hopefully I think California, yes.
Thank you.
Yeah.
Your next question comes from the line of COVID-19 Amsterdam from Piper Sandler.
Jack A. Khattar: It can work as early as the first week. It works in both inattention and hyperactivity, a beautiful safety and tolerability profile. I don't know. This is just my opinion.
Your line is open.
Thanks, Hey, just a couple so first on business development you have this.
Jack A. Khattar: In the world, any parent will put their child on a stimulant or any other product, and we're going to give them a sample to try it and try it for free initially. So the downside, we believe, is extremely low. So that's why we feel pretty good about being part of that conversation when it occurs during the back-to-school season and that we have a good shot that most parents will probably give us a shot at trying the product.
Fairly large commercial infrastructure focused on the psychiatry setting I know you are focused on Calgary and getting that launched right, but how big of a priority is it for you to bring in an asset where you can leverage.
Or psychiatry focused.
Commercial infrastructure.
So that's number one and that's also bearing in mind that youre going to be focused on the adult setting in ADHD in due course, so again thats number one and then secondly.
And I apologize if you already have address this can you just talk about how youre thinking about steady state gross to net.
Jack A. Khattar: And then the last question, if I remember correctly, was more about whether there is a difference between those who prescribe stimulants or non-stimulants? The only really general rule of thumb, and this is overgeneralizing here, not really, but as far as kids, if you look at the market, about 23% are non-stimulants. In adults, the usage of non-stimulants is much lower as a percent of the marketplace.
For free.
Calgary.
Obviously, theres, some things like sampling and co pay assistance.
You are fairly aggressive or that on that early in the launch but with contracting in place looking out say two to three years.
What does that look like thank you.
Sure regarding the first question as far as a priority.
Jack A. Khattar: So you would expect within, you know, kids' usage, physicians who are treating kids are more likely to use non-stimulants versus physicians who treat adults. Hey, Jack, actually, there's one other question I asked. I know I asked a lot of them, which is, what do you think is the correct analog?
And in in BD as we all know availability is always half the battle.
We are looking on for our commercial assets in both areas neurology psychiatry, and we will figure out a way.
If it is in psychiatry and it all depends on the timing of course is the one that asset comes on board, we will figure out a way how to give the right attention and also on up to take away from the caliber to get launched.
Jack A. Khattar: There have been lots of different launches in ADHD, ranging from highly successful ones to duds. What would you point to as the number one or number two analog that you would use for us to look at? There is really no good analog because this is the first real new chemical entity to be introduced in over a decade. So if you're looking for an analog that is a recent invention, there is really no such thing in the current environment because most of the products introduced in the last 10 years or so are all reformulations of the same thing.
Clearly the caliber he launched no question by far is our top top priority as a company at this time and then followed later on by the pump, which was extremely important for us as well.
So anything we bring and depending.
Depending on the timing of that acquisition, if we are lucky and fortunate to be able to in Orlando really good assets.
And we will figure it out and we'll staff it and give it the right resources to do a good job with the new assets as well, so I wouldn't limit ourselves by saying that we're very busy and we don't have the time for something else absolutely not.
Jack A. Khattar: Methylphenidate and amphetamines, and valoxacine is truly unique on its own as far as its place in therapy and also the gap it really fills here, a gap that we've been waiting for for years and years. As you know, we've been in this market for 25 plus years in the ADHD market. There is really no one I can point to. Of course, Stratera at that time was also a new chemical entity, but it was a long time ago, and it was also the first non-stimulant ever.
We are fully engaged on the BD side and it will continue to be a priority for us to employ the balance sheet and put it on the right place to give us future growth for the company.
As far as the question on gross to net than steady state I mean, we've all seen all the horrible gross to net levels at a lot of products have been launching with <unk> and so forth.
We would hope and we will be trying to work pretty hard to be much lower than the <unk> on the 70% gross to net.
Jack A. Khattar: Now, if you can take that as an analog and if you're looking for a surrogate as to what the pent-up demand can be for a real non-stimulant that actually works, works quickly, you know, within a reasonable timeframe, and has good safety and tolerability, you probably should look at the first six months of Stratera when it first launched. As you know, in those days, we were back defending against Stratera with Adderall XR and so forth, and we saw the penetration, and it went up very, very quickly, and I believe, if I'm not mistaken, it reached a market share of 19% of the total ADHD market.
I don't think that's a very viable long term strategy for a lot of products to continue with that kind of.
Trends, so we should hope there'll be much lower than that.
But it's really hard for us to Omega.
Have you a specific number given that we haven't finished all our contracts or the contracts and so forth. So we will need a few.
A year or so in the marketplace obviously.
Get a good feel as to where long term wise steady state wise, we may able to settle at what level.
Okay, great. Thanks, Jack.
Yes.
Yeah.
Your next question comes from the line of Annabel Sammy from Stifel. Your line is now open.
Jack A. Khattar: That should give you at least a good measure as to how deep and strong that demand could be for a real good non-stimulant. Unfortunately, for a lot of patients at that time, the product started disappointing a little bit and had other issues on the label and so forth, but that 19% maybe is a good measure as to the pent-up demand, but also again, I'll qualify all that by saying that it was the first non-stimulant ever to be introduced at that time. Hopefully, that's helpful. Yep, thank you. Your next question comes from the line of David Amsellem from Piper Sendler. Eurominus, Thanks. Hey, just a couple.
Hi, everyone. This is Nick rubino on for Annabel, Thanks for taking our questions.
From a.
First.
How are you guys currently engaging with physicians in kind of this I guess soft launch.
So you're currently in and then how are things going to change once you have the product in hand.
I know you mentioned kind of sampling programs.
As being a large part of that.
And kind of how are you integrating that with physicians and how should we see physicians kind of utilizing that program.
And second on pricing.
You guys are at kind of the low end of the range of options.
Net facilitating payer conversations and lastly.
David A. Amsellem: So first on business development, you have this fairly large commercial infrastructure focused on the psychiatric setting. I know you are focused on Calgary and getting that launch right, but how big of a priority is it for you to bring in an asset where you can leverage your psychiatric-focused commercial infrastructure? So that's number one. And bear in mind that you're going to be focused on the adult setting and ADHD in due course. So again, that's number one.
Can you just remind us quickly about.
Bill Oxazine IP in the U S.
We know it's in CE, but kind of what the broad.
Patent portfolio strength like thank you.
Sure.
I mean, the first question as far as to how the conversation on what kind of conversation you have with physicians. Initially when you have a soft launch so to speak on.
Or when actually the product becomes available clearly.
At the beginning we don't want to jump the gun.
We don't want to disappoint physicians they stopped writing prescriptions on the product is not available. So the timing is very delicate to make sure that those conversations are happening at the right time with the physicians or those conversations meaning detailed conversations about the benefits of the product the unique profile of the product the type of patients that the product can help you.
Jack A. Khattar: And then secondly, and I apologize if you already have addressed this, can you just talk about how you're thinking about steady state gross to net for Fort Calgary? Obviously, there are some things like sampling and copay assistance, and you're fairly aggressive on that early in the launch. But with contracting in place, looking out, say, two to three years, what does that look like? Regarding the first question as far as priority goes, in NBD, as we all know, availability is always half the battle.
And so forth those conversations will be more closer to when we know for sure that the product is going to be at the shelf available. So that when the patient walks out of the physician's office with a prescription they can actually fulfill and get that prescription.
So clearly that's always a delicate part of their initial launch share between getting the supply getting the product in the in.
Jack A. Khattar: We are looking for a commercial asset in both areas, neurology, and psychiatry, and we will figure out a way. If it is in psychiatry, and it all depends on the timing, of course, as to when that asset comes on board, we will figure out a way to give it the right attention and also not take away from the Calvary launch. Clearly, the Calvary launch, no question, by far is our top, top priority as a company at this time, followed later on by the pump, which is extremely important for us as well.
And the pipeline on the distribution channel and making it available and then our sales force at the same time doing.
Building the awareness around the product building excitement around the product and when we get closer if theyre, having the product available to have the real real conversation and selling the product that physicians and showing them the benefits of caliber.
As far as the pricing I mean.
I can't really make any specific comments other than what everybody and on our our pricing. We always said, we are going to be a reasonable and pricing our product. It is price to make sure we have access and give access to people.
Oh for the product.
One question came up a couple of times I mean, we don't know what the total daily dose is going to end up landing it could be much higher than 100 or 200 milligrams. So that remains to be seen obviously as physicians start using the product on.
Jack A. Khattar: So anything we bring in, depending on the timing of that acquisition, if we're lucky and fortunate to be able to land a really good asset, then we'll figure it out, and we'll staff it, and give it the right resources to do a good job with the new asset as well. So I wouldn't limit ourselves by saying now that we're very busy, and we don't have the time for something else. Absolutely not.
On a mass scale and try and get to see where the total daily dose will end up being on an average.
And then finally regarding the locks are seeing on the IP in the U S. We have several families of.
Of patents here.
Surrounding the API synthesis surrounding the formulation as well as surrounding the marvell the use of the locks are seen in ADHD.
Jack A. Khattar: We're fully engaged on the BD side, and it will continue to be a priority for us to manage the balance sheet and put it in the right place to give us future growth for the company. As far as the question on gross net and steady state, I mean, we've all seen all the horrible gross net levels that a lot of products have been launching with and so forth. I sure hope, and we will be trying pretty hard to be much lower than the 60s and the 70s percent gross net.
And the bad then sort of on the 20th 29 to 2033 timeframe as far as exploration.
Great. Thank you very much.
Right.
Once again, if you wish to ask a question. Please press star one on your telephone.
You have a follow up question from the line of David Steinberg from Jefferies. Your line is now open.
Okay. Thanks.
Two follow ups on that.
Yes.
On.
Hum on.
Jack A. Khattar: I don't think that's a very viable long-term strategy for a lot of products to continue with that kind of trend. So we sure hope to be much lower than that. But it's really hard for us to give you a specific number given that we haven't finished all our contracts or the negotiations and so forth. We will need a few.
<unk> on the pricing the pricing came out and I think you just alluded to this with a WAC price.
For the 100 152 milligram.
Given that like half the scripts now on ATC are almost or adult.
And if you look at the $2 99 to sort of 600, ranging from the 100 Meg up to you.
Jack A. Khattar: A year or so in the marketplace, obviously, to get a good feel as to where, long term, steady state wise, you know, we may be able to settle at what level. Okay, great. Thanks, Jack. Your next question comes from the line of Annabel Samimy from Staple. Your line is now open. Hi, everyone. This is Nick Rubino on behalf of Annabel.
No more than 200 mix, where do you think.
The average sort of blended WAC price might be would it be over $400. If you assume are well over $400. If you assume that.
That 50% of the users are going to be to be adult.
And then Jim you called out I just wanted some clarification on this <unk>.
Jonathan Rubin: Thanks for taking our questions. Here are a few from us. First, how are you guys currently engaging with physicians in kind of this like a soft launch that you're currently in? And then how are things going to change once you have the product? I know you mentioned kind of sampling programs being a large part of that, and kind of how are you integrating that with physicians, and how should we see physicians kind of utilizing that program? Then second on pricing. You guys are at kind of the low end of the range of options.
It came in quite a bit lower or a decent amount lower than you thought in the first quarter and you called out market and payer pressures could you give us some more clarification on what those pressures are and why you think there.
Got it.
Get it under control and I think Jack said.
Get to sort of a normalized situation. Thanks.
Yes.
On the TV pricing again, the point I was trying to make is clearly.
We will need some time to see where physicians and up in the experience that they see themselves in the marketplace as far as where the total daily dose will land in our clinical studies as everybody knows we started with 100 milligram for the young children as a starting dose and then for other lesson with 200 milligram and they could go on.
Jack A. Khattar: How is that facilitating pair conversations? And lastly, can you just remind us quickly about Voloxazine IP in the US? We know it's an NCE, but kind of what's the broad patent portfolio strength like? Thank you. Yeah, sure. The first question as far as how the conversation and what kind of conversation you have with physicians initially when you have a soft launch, so to speak, or when the product actually becomes available is, clearly, at the beginning, we don't want to jump the gun because we don't want to disappoint physicians.
All the way up to 400 milligram.
Of course with adults.
We did the study and we started with 200 going all the way up to 600 milligrams. So clearly.
As the actual usage.
Gets in the four to 600 milligrams, so clearly that's going to bring your.
Weighted average WAC in the higher range from a pricing point of view and similarly, even an adolescent because they at Edison study went up from 200 to 400 milligrams. So clearly the 400 milligram is going to carry a much higher price price point.
For that prescription.
Jack A. Khattar: They start writing prescriptions, and the product is not available. So the timing is very delicate to make sure that those conversations are happening at the right time with the physicians. Those conversations, meaning detailed conversations about the benefits of the product, the unique profile of the product, the type of patient that the product can help, you know, and so forth, those conversations will be closer to when we know for sure that the product is going to be on the shelf available so that when the patient walks out of the physician's office with a prescription, they can actually fill, you know, and get that prescription.
So all in all that's why we said the total daily those we see it probably trending upward as time goes on for these reasons as people get more experience with the product and as we get also the adult indication on board as well.
It would be and also 400.
Probably I mean, if you run the math pretty quickly as some are you know certain mix you probably will end up somewhere in.
In that range are higher than the 400.
But for a 30 day prescription.
On a book and I can jump on very quickly on on Jim can add I mean, the market pressures that we talked about it's really the same that I mentioned in my comments, which is really the market dynamics with a competitive like can mobi in region on other products in that sector on demand.
It appears that we've seen some competitive dynamics there.
Jack A. Khattar: So clearly, that's always the delicate part of the initial launch between getting the supply, getting the product in the pipeline, and the distribution channel, making it available, and then our sales force at the same time building the awareness around the product, building the excitement around the product, and when we get closer to having the product available, having the real, real conversation and selling the product to physicians and showing them, you know, the benefits of Calibri. As far as the pricing is concerned, I mean, I can't really make any specific comments other than what everybody knows. Our pricing, we always said we were going to be reasonable in pricing our product. It is priced to make sure we have access to and give access to people for the product.
COVID-19 continue to a certain extent continues to hurt that specific patient population because it is Parkinson's initiation. This is an injection and injection that requires a nurse visit.
So there is more to it than just prescribing it pill. Obviously, so so that continues however, as I mentioned in my remarks, we're starting to see an easing off of that and we started seeing that moderate a little bit at the end of the first quarter into the second quarter. So we're encourage it a little bit with the improvement on patient initiations and so forth.
And then regarding payout thresholds that's really the comment is more related then Jim can jump in but it's really more related to the insurance issues that you typically see in the first quarter and that's exactly right you see it across all products and.
With a specialty product like keep it can.
Potentially a little more than others, just based on the price point.
Reset of insurance and co pays.
Got it okay. So multiply on the first quarter by four it would be on the low side for the year then right.
Jack A. Khattar: One question came up a couple of times. I mean, we don't know where the total daily dose is going to end up landing. It could be much higher than 100 or 200 milligrams. So that remains to be seen obviously as physicians start using the product on a mass scale and trying it to see where the total daily dose will end up being on an average. And then finally, regarding Veloxacine and the IP in the U.S., we have several families of patents here surrounding the API synthesis, surrounding the formulation, as well as surrounding the novel use of Veloxacine in ADHD.
Hopefully yes.
Yeah, I mean, we expect improvement through the year.
Thank you.
Hopefully COVID-19, even gets better and better as time goes on which I think that will be the case. So we are encouraged with what we are starting to see across different states reopening and so forth. So we're very encouraged with that.
Once again, if you wish to ask a question. Please press star one on your telephone and wait for your name to be announced.
A follow up question from the line of Annabel Sammy from Stifel. Your line is now open.
Hi, Thanks again for the extra question here, we did get a.
Question on our end.
Jack A. Khattar: And the patents are in the 2029 to 2033 timeframe as far as expiration. Great, thank you very much. Once again, if you wish to ask a question, please press star 1 in your. You have a follow-up question from the line of David Stainberg from Jefferies. Your line is now open.
Sure.
So with the Trokendi U T Rx was down 13% year over year, we're seeing a big.
Jump in revenue and we're seeing the same dynamic in OXXO as well with.
Flat U T, our axes and increases in our revenues, but with.
Pricing kind of flat to down.
David Steinberg: Okay, thanks. I have two follow-ups. The first is, on Quilby and the pricing. The pricing came out, and I think you just alluded to this, with a WAC price for the 100, 150, 200 milligrams. You know, given that like half the script. Now in the 80s, she is almost an adult.
Where is that delta and how should we think about that.
On that kind of discrepancy.
Mhm.
So why don't I start.
Checking on mine I'll jump in here on you know when you when you look at our stellar.
You look at for example, the prior year some of the ups and downs that we saw in <unk>.
Jack A. Khattar: And if you look at the $299 to sort of $600 ranging from 100 Mbps up to, you know, more than 200 Mbps, where do you think the average sort of blended WAC price might be? Would it be over $400 if you assume, or well over $400 if you assume that 50% of the users are going to be adults? And then, Jim, you called out, I just wanted some clarification on this, apokine came in quite a bit lower or a decent amount lower than you thought in the first quarter, and you called out market and payer pressures.
2020 from for example, Q1, two and three you'll see that the Q3 number of about $28 4 million is in line with where we are now but it shouldered by numbers of about $23 24, and so what we are witnessing is we definitely notice.
That there was some ups and downs in I'll call it the retail.
Channel Holdings of inventory as COVID-19 was happening last year.
We think Thats evening out just based on what we're seeing in the data we use to do our accruals Inc.
So it is creating some year over year comparison issues, primarily from Q4 into Q1.
Jack A. Khattar: Could you give us a little more clarification on what those pressures are and why you think they're going to... get under control? And I think Jack said, you know, get to a sort of a normalized situation. Regarding Calbee pricing, again, the point I was trying to make is clearly we will need some time to see where physicians end up and the experience they see themselves in the marketplace as far as where the total daily dose will land.
That said when you look at the year over year on.
Ex teller itself.
We're looking at.
About 9% year over year.
And we took price of about 8%.
So don't get me wrong sequentially.
The journey from Q1 last year day, now has some ups and downs, but when you look at just the pricing we've taken in a fairly <unk>.
Stable gross to net.
It falls in line with the expectation.
Jack A. Khattar: In our clinical studies, as everybody knows, we started with 100 mg for young children as a starting dose and then for adolescents, 200 mg, and they could go all the way up to 400 mg. Of course, with adults, we did the study, and we started with 200 mg and went all the way up to 600 milligrams.
When you look at Trokendi, you get a year over year.
Let me get my numbers correct here.
Excuse me this is about 14% year over year on stellar with pricing and then a slight improvement in our gross to net in Q1 when.
When you look at there.
Jack A. Khattar: So clearly, as the actual usage in adults gets in the 4 to 600 milligrams, so clearly that's going to bring your, you know, weighted average WAC into the higher range from a pricing point of view. And similarly, even in adolescents because the adolescent study went up from 200 to 400 milligrams. Clearly, the 400 milligram is going to carry a much higher price point for that prescription. So all in all, that's why, you know, we said the total daily dose, we see it probably trending upward as time goes on for these reasons, as people get more experience with the product, and as we get the adult indication on board as well. Could it be north of 400?
On trokendi year over year of about 5% and you compare that to the extended units being down about 12, and so we are certainly making up some benefit there on gross to net as well.
Okay great.
Very helpful. Thank you.
Sure.
There are no further questions in queue I will.
I'll now turn the call over back to Jack.
Thank you.
We remain focused on the launch of calibrating a treatment option that is like no. Other ADHD product on the market I would like to thank all our employees, who have been committed for years to develop the category and to make it available to the millions of patients who can benefit from its unique clinical profile in <unk>.
Additionally, we continue to advance SPN 830, along its regulatory path towards potential approval.
Jack A. Khattar: Probably. I mean, if you run the math pretty quickly, assume, you know, a certain mix, you probably will end up somewhere in that range, higher than $400 for a 30-day prescription. On APOCN, I can jump in very quickly and Jim can add, I mean, the market pressures we talked about are really the same that I mentioned in my comments, which is really the market dynamics with the competition, like Mobi and Bregia and other products in that sector on-demand therapies that we've seen some competitive dynamics there.
It'll be an SPN 830 represent important growth drivers for our company and we are committed to progressing them towards commercialization and market success. Thanks again for joining us today and we look forward to updating you on our progress throughout the year.
Thank you presenters.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Yes.
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Jack A. Khattar: COVID, to a certain extent, continues to hurt that specific patient population because it is Parkinson's initiator. This is an injection that requires a nurse visit, so there is more to it than just prescribing a pill, obviously.
Okay.
Okay.
On a year.
Yeah.
Okay.
Okay.
Jack A. Khattar: So that continues. However, as I mentioned in my remarks, we're starting to see an easing of that, and we start seeing that more a little bit at the end of the first quarter and into the second quarter. So we're encouraged a little bit by the improvement in patient initiations and so forth. And then regarding payer pressures, the comment is more related, and Jim can jump in, but it's really more related to the insurance issues that you typically see in the first quarter.
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Non-GAAP.
Sure.
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Jack A. Khattar: And that's exactly right. You see it across all products, and with a specialty product like Apokin, potentially a little more than others, just based on the price point, the reset of insurance, and co-pays. Got it. Okay. So multiplying the first quarter by four, which should be on the low side for the year. Hopefully, yes.
Revenue.
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Jack A. Khattar: Yeah. Yeah, I mean, we expect improvement through the Thank you. And hopefully COVID even gets better and better as time goes on, which I think that will be the case.
Yes.
Non-GAAP.
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Jack A. Khattar: So we're encouraged with what we are starting to see across different states, reopenings, and so forth. So we're very encouraged by that. Once again, if you wish to ask a question, please press star one on your telephone and wait for your answer.
Yes.
Okay.
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Annabel Eva Samimy: A follow-up question from the line of Annabel Samimy from Stifel. Your line is: Hi, thanks again for the extra question here. We did get an extra question on our end. So, with the Turkendie EUTRX is down 13% year over year, you know, we're seeing a big jump in revenue, and we're seeing the same dynamic in Oxteller as well, with flat EUTRXs and increases in revenues. But with pricing kind of flat to down, where is that delta? And what should we think about?
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Moving forward.
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Jim Kelly: That kind of discrepancy is unacceptable. Thank you. So why don't I start, if Jackie doesn't mind, I'll jump in here on, you know, when you look at Oxteller and you look at, for example, the prior year, some of the ups and downs that we saw in 2020, from, for example, Q1, Q2, and Q3, you'll see that the Q3 number of about 28.4 million is in line with where we are now. But it's backed by numbers of about, you know, 2324.
Okay.
Yeah.
Yeah.
Okay.
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On a normal.
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Jim Kelly: And so what we're witnessing is, we definitely noticed that there were some ups and downs, and I'll call it the retail channel holdings of inventory, as COVID was happening last year. But we think that's evening out just based on what we're seeing in the data we use to do our accruals. And so it is creating some year-over-year comparison issues, primarily from Q4 into Q1. That said, when you look at the year-over-year on Oxteller itself, we're looking at, you know, about 9% year-over-year, and we took prices about 8%.
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Yeah.
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Jim Kelly: So don't get me wrong, sequentially, the journey from Q1 last year to now has had some ups and downs. But when you look at just the pricing we've taken and a fairly stable gross to net, it falls in line with the expectation. When you look at Trikendi, you get a year-over-year, Let me get my numbers correct here. Excuse me, it's about 14% year over year on Oxteller with the pricing and then a slight improvement in our gross net in Q1. When you look at the Trikendi year over year growth of about 5%, you compare that to the extended units being down about 12.
And so on.
And then momentum.
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Jim Kelly: And so we are certainly making up some benefit there on Grist and that as well. Okay, great. That's very helpful. Thank you. There are no further questions in queue.
Operator: I will now turn the call over to you. Thank you. We remain focused on the launch of Kelbree, a treatment option that is like no other ADHD product on the market. I would like to thank all our employees who have been committed for years to developing Kelbree and making it available to the millions of patients who can benefit from its unique clinical profile. In addition, we continue to advance SPNA30 along its regulatory path toward potential approval.
Okay.
Yes.
Thanks.
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Operator: Kelbree and SPNA30 represent important growth drivers for our company, and we are committed to progressing them towards commercialization and market success. Thanks again for joining us today, and we look forward to updating you on our progress throughout the year. This concludes. Thank you for participating.
Okay.
Moving on.
And then.
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