Q3 2019 Earnings Call
Good morning, ladies and gentlemen, and welcome to Supernus Pharmaceuticals third quarter 2019.
Operator: Good morning, ladies and gentlemen, and welcome to Supernus Pharmaceuticals' third quarter 2019 financial results conference call. At this time, all participants are in a listen-only mode.
Actual results conference call.
At this time all participants are in listen only mode. Later, we'll conduct a question and answer session instructions will follow at that time.
Operator: Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference is being recorded. I would now like to turn the conference over to Peter Vozzo of Westwick Investor Relations, a representative of Supernus Pharmaceuticals. Sir, you may begin.
As a reminder, this conference is being recorded.
I'd now like to turn the conference over to be Basel with Investor Relations Representative for Supernus Pharmaceuticals, Sir you may begin.
Peter Vozzo: Thank you, Tawanda. Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals' third quarter 2019 financial results conference call. Yesterday, 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 Chief Financial Officer, Greg Patrick. Today's call is being made available via the investor relations section of the company's website at ir.supernus.com. Following remarks from 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 and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intend, or, in other words, a similar meaning.
He towanda good morning, everyone and thank you for joining us today for Supernus Pharmaceuticals third quarter 2019 financial results Conference call yesterday after the close in the market. The company issued a press release announcing these results on the coffee to their Supernus is chief Executive Officer check, Qatar and Chief Financial Officer grip Patrick.
Today's call is being made available via the Investor Relations section of the company's website that.
Gotcha furnished dotcom following remarks management will open the call the 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 surprises current perspective on existing trends information you can be identified by such worthless expect.
Plan as well maybe dissipate believes should intend in other words of similar meeting any such forward looking statements are not guarantees of future performance in about risks and uncertainties, including those noted in the risk factor section of the company's 2018 annual report on form 10, K. actual results may differ materially from those projected in these forward looking statements.
Peter Vozzo: 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 2018 annual report on Form 10-K. 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 6, 2019, at approximately 9 a.m. Eastern time. Since then, the company may have made additional announcements related to the topics discussed. Please refer to the company's most recent press releases and current filings with the SEC. Supernus declined any application to update these four linking statements, except as required by applicable securities laws. I will now turn the call over to Jack.
For the benefit of those who maybe listening to the replay of this call is being held and recorded on November six 2019 at approximately 90 and eastern time. Since then the company may have made additional announcements relate to the topics discussed. Please reference the company's most recent press releases and kind of filing can be FCC supernus declines any obligation.
These forward looking statements, except as required by applicable securities laws.
I'll now turn the call over to Jeff.
Jack A. Khattar: Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us as we discuss our 2019 third quarter results. In our press release yesterday, we announced the results of the P301 first phase 3 study for SVN810 for the treatment of impulsive aggression in ADHD patients 6 to 11 years old. The study was a randomized, double-blind, placebo-controlled, multi-centered parallel group clinical trial in patients diagnosed with ADHD. Patients receiving SPNA 1036 mg showed a median percent reduction of 58.6% in the average weekly frequency of impulsive regression episodes from the baseline, but that was not statistically significant with a p-value of 0.092 compared to placebo. These results are based on the combined analysis of data from Stages 1 and 2 in the study.
Thank you Peter good morning, everyone and thanks for taking the time to join US as we discussed our 2019 Cook order results.
In our press release yesterday, we announced the results of the peace cereal one first phase three study for SP on eight then for the treatment off impulsive aggression in eight each for the patients six to 11 years old.
The study you want to randomized double blind placebo controlled multicenter parallel group clinical trial in patients diagnosed with 80 HD.
Patients receiving a span eight then 36 milligram show the median four cents reduction, 58.6% and the average weekly frequencies talking to folks regression episodes from the baseline that was not statistically significant with a P value offer 0.0 on line two compared to placebo.
These results are based on the combined analysis of data from stages, one and two in the study and stage, one which was at this stage right before the interim analysis, the medium percent reduction with 60%, which was statistically significant with a P value of 0.0 twonine compared to placebo.
Jack A. Khattar: In stage 1, which was the stage right before the interim analysis, the median percent reduction was 60%, which was statistically significant with a p-value of 0.029 compared to placebo. However, after the interim analysis in stage 2 of the study, the increase in variability in the 36 mg treatment arm seems to have adversely impacted the results in the combined analysis. Clearly, we are disappointed with the lack of statistical significance given that the magnitude of reduction in the frequency of episodes we believe is a clinically meaningful reduction for many patients. In addition, the median percent reduction in frequency of IA behavior in this Phase III study is consistent with the range of 58 to 62 percent improvement in the retrospective modified aggression scale that we saw in the two treatment arms that were statistically significant versus placebo in the Phase IIb study.
However, post the interim analysis in stage two off the study the increase in variability in the 36 milligram treatment arms seems that adversely impacted the results and the combined analysis.
Clearly we are disappointed with the lack of statistical significance given that the magnitude of reduction in the frequency of episodes. We believe it's clinically meaningful reduction for many patients. In addition, the medium percent reduction in frequency of already a behavior and this phase three study as can assist.
And with the range of 58% to 62% improvement and a retrospective modified aggression scale that we saw in the tool treatment arms that port statistically significant versus placebo in the phase Twob study.
Jack A. Khattar: The company will continue its analysis of the results to better understand the reasons behind the increased variability in the 36 mg treatment arm in the P301 phase 3 study. Overall, the trial exhibited favorable tolerability and safety profiles with low incidence of adverse events across all doses. AEs were mild, leading to low discontinuation rates of 0%, 7%, and 5% for the 18mg, 36mg, and both treatment arms combined, respectively.
The company will continue at your analysis of the results to better understand the reasons behind the increase variability in the 36 milligram treatment arm and the piece video one phase three study.
Overall, the trial exhibit it's favorable tolerability and safety profiles with low incidence of adverse events across the whole dozers.
He is worth more out leading to a low discontinuation rates of zero percent, 7%, 5% for the 18 milligram 36 milligram and both treatment arms combined respectively.
And enrollment in the second phase three piece are you able to trial in patients six to 11 years old is at about 98% of the target.
Jack A. Khattar: Enrollment in the second phase 3 P302 trial in patients 6 to 11 years old is at about 98% of the target. The company will stop enrollment and analyze the data, which are expected to be available by the end of 2019. In the meantime, enrollment in the 503 phase 3 trial for adolescent patients will be on hold until data from the 302 study are available and a final decision is reached regarding the SBNA 10 program for impulsive aggression. Regarding SPNA 12, we expect to submit the NDA this month. Our plans and preparations for a potential launch of SPNA 12 in the second half of 2020, if approved by the FDA, continue to progress well. In addition, a phase three program in adult patients with SPNA 12 was initiated during the third quarter. For SPM 604 for the treatment of bipolar disorder, we will commence a phase 3 monotherapy study in the fourth quarter of 2019.
The company will stopped enrollment and analyze the data which are expected to be available why the end of 2019.
In the meantime enrollment in the five all three phase three trials before adolescent patients will be on hold until data from the critical to study are available and a final decision is reach regarding the SP. An eight then program in impulsive aggression.
Regarding ESPN a 12, we expect to submit the end D.A. This month, our plans and preparations for a potential launch that's been a 12 in the second half of 2020, if approved by the FDA continued to progress well.
Additional phase three program in adult patients with ESPN Eighttwo was initiated during the third quarter.
For SPM six so for for the treatment of bipolar disorder, we commence the phase three monotherapy study and the fourth quarter of 2019.
Jack A. Khattar: Moving on to the existing neurology business, total prescriptions for trochandiaxor and oxalatexor in the third quarter of 2019, as reported by IMS, increased to 215,033 prescriptions, representing a 6% increase over the same period last year. For Chikendi XR, prescriptions in the third quarter of 2019 were 172,981, which is a 5% increase over the third quarter last year. For the first nine months of 2019, prescriptions for Chikendi XR increased 7% over the same period last year. Despite this volume growth, as well as the price increase in early 2019, net product sales for Token DXR were essentially flat over both time periods due to continued pressure from gross net sales deductions. For Oxalir-XR, prescriptions in the third quarter were 42,052 prescriptions, representing an increase of 12% over the same period last year.
Moving onto the existing urology business total prescriptions for Trokendi, XR and Oxtellar XR in the third quarter of 2019 as reported by RMS increased to 215033 prescriptions.
Presenting a 6% increase over the same period last year.
For Trokendi XR prescriptions in the third quarter of 2019 were 172981, which is a 5% increase over the third quarter last year.
For the first nine months of 2019 prescriptions for Trokendi XR increased 7% over the same period last year.
Despite this volume growth as well as the price increase in early 2019 net product sales for Trokendi XR were essentially flat over the ball dying periods. You. The continued pressure from gross to net sales deductions.
Oxtellar XR prescriptions in the third quarter were 42052 prescriptions, representing an increase of 12% over the same period last year.
Jack A. Khattar: And year-to-date prescriptions increased 12% year-over-year. Net product sales for Oxfeller XR increased 11% in the third quarter and 10% in the first nine months of 2019 compared to the same periods in 2018. Going forward, given the continued pressure from gross to net deductions and that prescription growth for Trocandex R is trending in the single digits, we expect net sales growth to be essentially flat. As a result, we are revising full year 2019 guidance for net product sales and, to a lesser extent, operating earnings as we are able to continue to leverage our infrastructure and manage our operating expenses. Finally, our activity in corporate development continues in 2019 as we look for neurology and psychiatry assets that represent a strategic fit with our current portfolio. I will now turn the call over to Greg, who will provide more details on our third quarter financial performance.
And year to date prescriptions increased 12% year over year net product sales for Oxtellar XR increased 11% on the third quarter and 10% in the first nine months of 2019 compared to the same periods in 2018.
Going forward given the continued pressure from gross to net deductions and that prescription growth for Trokendi XR is trending in the single digits, we expect net sales growth to be essentially flat.
As a result, we are revising full year 2019 guidance will net product sales and to a lesser extent operating earnings as we were able to continue to leverage our infrastructure and manage our operating expenses.
Finally, our activity in corporate development continues in 2019, as we look forward neurology and psychiatry assets at the present, a strategic fit with our current portfolio I'll now turn the call over to Greg who will provide more details on our third quarter financial performance.
Thank you and good morning, everyone as I'll review, our third quarter 2019 financial results remind listeners to refer to the third quarter results issued in yesterday's press release after the market close.
Greg Patrick: Thank you and good morning everyone. As I review our third quarter 2019 financial results, I remind listeners to refer to the third quarter results issued in yesterday's press release after the market closed. Total revenue for the third quarter of 2019 was $102 million, essentially unchanged from $103 million in the third quarter of 2018. That product sold for Tricondi XR for $77 million in the third quarter of 2019, modestly down from $80 million in the third quarter of 2018. Year-over-year growth in prescriptions of 5% and the year-over-year impact of price increases will be offset by higher gross net deduction. Net product sales for Architello XR in the third quarter of 2019 were $22.7 million, an 11.3% increase as compared to the third quarter of 2018.
Total revenue for the third quarter of 2019 was $102 million essentially unchanged from $103 million and the third quarter of 28, Ken.
Net product sales for Trokendi XR for the third quarter of 29 chain for $77 million modestly down from $80 million in the third quarter 2018.
Year over year growth and prescriptions of 5% and year over year impact of price increase will offset by higher gross to net deductions.
Net product sales for Oxtellar, XR, and the third quarter of 2019 or $22.7 billion, and 11.3% increase as compared to third quarter of 2018.
Growth in prescriptions of 12% and a year over year impact of price increases were partially mitigated by the impact of higher gross to net deductions.
Total revenue for the third quarter of 29 chain was comprised of net product sales of $100 million and royalty revenue of $2.1 billion as compared to net product sales of $100.2 million and royalty revenue of $2.8 million and the third quarter of 28.
Greg Patrick: Growth in prescriptions of 12% and the year-over-year impact of price increases were partially mitigated by the impact of higher gross-to-net deductions. Total revenue for the third quarter of 2019 was comprised of net product sales of $100 million and royalty revenue of $2.1 million, as compared to net product sales of $100.2 million and royalty revenue of $2.8 million in the third quarter of 2018. Turning now to expenses, research and development expenses were $17 million in the third quarter of 2019, modestly lower than $20 million in the same quarter of the prior year. This decrease is primarily attributable to the completion of the four phase three clinical trials for SPN812 in late 2018 and early 2019, partially offset by the cost to manufacture SBNA-12 to support our NDA filing. Selling general and administrative expenses were $41 million in the third quarter of 2019, essentially unchanged from For the third quarter of 2019, operating earnings totaled $40 million, a 6% increase over $37.5 million in the same period last year. This improvement was primarily driven by lower R&D expenses.
Okay.
Turning now to expenses research and development expenses were $17 million in the third quarter 2019 modestly lower than $20 million in the same quarter of the prior year.
This decrease is primarily attributable to the completion of the for phase three clinical trials for SPM 812 in late 2018, an early 29 chain.
Partially offset by the costs to manufacture espionage trial to support our NGL filing.
Selling general and administrative expenses in the third quarter of 2019 $41 million essentially unchanged from the same quarter last year.
For the third quarter of 29, King operating earnings totaled $40 million, a 6% increase over $37.5 million and the same period last year.
This improvement was primarily driven by lower R&D expenses.
The company continues to demonstrate its ability to astutely manage operating expenses as SGN, a remained virtually unchanged compared to the same quarter last year as well as to the second quarter of 29 chain.
Net earnings for the third quarter of 2019 or $28.9 million or 54 cents per diluted share as compared to $28 million or 52 cents per diluted share in the same period last year.
Greg Patrick: The company continues to demonstrate its ability to astutely manage operating expenses as SG&A remained virtually unchanged compared to the same quarter last year as well as to the second quarter of 2019. Net earnings for the third quarter of 2019 were $28.9 million, or $0.54 per diluted share, compared to $28 million, or $0.52 per diluted share, in the same period last year. Growth in operating earnings was offset by a modestly higher effective tax rate in the third quarter of 2019. Specifically, the tax rate increased from 23% in 2018 to 27.1% in 2019.
Gross and operating earnings was offset by a modestly higher effective tax rate in the third quarter of 20 non chain.
Specifically the tax rate increased from 23% and 2018% to 27.1% and 29 chain.
As a result net earnings and third quarter of 29 chain were comparable to net earnings in the third quarter of 2018.
The third quarter ended with $893.1 million in cash cash equivalents marketable securities and long term marketable securities an increase of $118.3 million as compared to $774.8 million as of December 31st.
2018.
Turning to financial guidance for full year 29, Jane we're revising our guidance for net product sales R&D expenses and operating earnings while reaffirming expectations for the effective tax rate.
Greg Patrick: As a result, net earnings in the third quarter of 2019 were comparable to net earnings in the third quarter of 2018. The third quarter ended with $893.1 million in cash, cash equivalents, marketable securities, and long-term marketable securities, an increase of $118.3 million as compared to $774.8 million as of December 31, 2018. Turning to financial guidance for full year 2019, we are revising our guidance for net product sales, R&D expenses, and operating earnings while reaffirming expectations for the effective tax rate. We now expect their product sales to range from $390 million to $395 million, as compared to the previously expected range of $400 million to $410 million. We expect R&D expenses of approximately $70 million compared to the previously expected range of $70 million to $80 million.
We now expect net product sales range from $390 million to $395 million as compared to the previously expected range of $400 million to foreign to $410 million.
We expect R&D expenses of approximately $70 million compared to the previously expected range of $70 million $80 million.
Now expect operating earnings to range from $150 million to $155 million as compared to the previously expected range of $150 million to $160 million.
Looking forward to 2020, we anticipate that the combined impact of product unit volume growth and price increases will be offset by continued pressure and product related gross to net sales deductions.
In addition, as we prepare for the launch of SP in a 12 and the second half of 2020, we anticipate that SGN a expenses will exceed $200 million next year, driven by pre launch and launch marketing expenses.
Greg Patrick: Now expect operating earnings to range from $150 million to $155 million as compared to the previously expected range of $150 million to $160 million. Looking forward to 2020, we anticipate that the combined impact of product unit volume growth and price increases will be offset by continued pressure and product-related gross net sales deductions. In addition, as we prepare for the launch of SPNA 812 in the second half of 2020, we anticipate that SG&A expenses will exceed $200 million next year, driven by pre-launch and launch marketing expenses, as well as the impact of fielding the psychiatry sales force in the second half of 2020. Finally, R&D expenses in 2020 are expected to be comparable to the level in 2019.
Well to impact the fielding the psychiatry salesforce and the second half of next year.
Finally, R&D expenses in 2020 are expected to be comparable to the level and 29 King.
I'll now turn the call back to the operator for questions. Thank you.
Thank you, ladies and gentlemen to ask the question you would need to press Star then one on your telephone.
And the interest this time, we ask that you limit yourself to one question and one follow up.
Feel free to rejoin the queue for additional question.
Again that star one to ask the question to withdraw your question. Please press the pound.
Please standby won't be compiled the Q on a roster.
Our first question comes from a lot of can territory with Cowen Your line is open.
Hey, guys started here the news on 810, Jack over the last couple of years, you've been incredibly prudent on BD.
Operator: I will now turn the call back to the operator for questions. Thank you. Ladies and gentlemen, to ask a question, you will need to press star then 1 on your telephone.
Really the only done early stage asset you do have plenty of cash and obviously built very profitable. So can you just talk about.
Operator: In the interest of time, we ask that you limit yourself to one question and one follow-up. Feel free to rejoin the queue for additional questions. Again, that's star one to ask the question. To withdraw your question, please press the pound. Please stand by while we compile the Q&A roster. Hey guys, sorry to hear the news on 810. Jack, over the last couple of years you've been incredibly prudent on BD, really only doing an early stage asset. You do have plenty of cash, and it's obviously still very profitable.
Business development now that you've had this 810 setback and does it change things and then on aged 12 on a 12, just maybe your view again on the market opportunity. How this product could be positioned there clearly is a big debate on the street about.
Effectiveness in the need for it so maybe give you another chance that just talk about how you think it will fit into the treatment paradigm. Thank you.
Yes, sure starting with.
Jack A. Khattar: So can you just talk about business development now that you've had this 810 setback and how it changes things? And then on H12, on 812, just maybe your view again on the market opportunity and how this product could be positioned. There clearly is a big debate on the street about its effectiveness and the need for it. So maybe I will give you another chance to just talk about how you think it will fit into the treatment paradigm. Thank you.
Business development as far as our strategy.
Really not much if it changes regarding our priorities the assets that kind of assets were looking forward in neurology and psychiatry.
And the quality of the assets that we have been looking forward as well.
So this doesn't really change.
As much because we have been aggressive all these years, we have been intensely and while in the BD side.
Jack A. Khattar: Starting with business development, as far as our strategy is concerned, there's really not much of a change regarding our priorities, the assets, the kind of assets we're looking for in neurology and psychiatry, and the quality of the assets that we have been looking for as well. So this doesn't really change as much because we have been aggressive all these years. We have been intensely involved in the BD side, and the only reason we haven't done anything from a commercial point of view or from a late-stage point of view is because we haven't found anything that we believe at that time when we assess those kind of assets, they actually fit or that they actually add and create value to our story and our shareholders. So everything we've been doing in BD will continue to be consistent as it has been
And the only reason we haven't done anything from a commercial point of view or late stage point of view as because we haven't found anything that we believe at that time, when we assess those kind of assets that they actually fit or that they actually add and create value for our story our shareholder. So so every.
Thing we've been doing NBD, we'll we'll continue to be consistent as it has been over the years.
And one important thing that I would like to remind folks because I get this question all environment people say or not but added on some people's knowledge that we've been saying we want to do something for the last several years and we haven't done anything.
Well.
An important point us to remind people is that we actually became profitable in 2015.
And we havent been sitting on on $800 million in cash since 2015, so our cash position and 16 and 17 was still building up over the years and only until the next last year that we actually raised 400 million a convertible debt deal that got us the disposition.
Jack A. Khattar: And one important thing that I would like to remind folks, because I get this question all the time, and people say, and I've read it in some people's notes, that we've been saying we want to do something for the last several years, and we haven't done anything. Well, an important point to remind people is that we actually became profitable in 2015. And we haven't been sitting on $800 million in cash since 2015. So our cash position in 16 and 17 was, you know, still building up over the years, and only last year did we actually raise $400 million in a convertible debt deal that got us to this position. So it's not like we have been sitting on a pile of cash for three, four years, and we haven't been active doing anything.
So it's not like we have been sitting on a pile of cash for three four years and we haven't been active doing anything and the other important thing as I'm sure everybody remembers in the last two three years, especially the 16 17 18 period.
A lot of our appears in the space where.
Very aggressive in business development, and we saw what happened to them and we saw what happened to their balance sheets on how they over leverage and many of them today are struggling with the heavy depth that they put on their balance sheets and order with assets that didn't turn out to be as good as everybody else goal.
So the key message I guess I'm trying to communicate here as we've been very active in business development and we'll continue to be one of our top priorities in the company.
Jack A. Khattar: And the other important thing is, I'm sure everybody remembers that in the last two, three years, especially the 16, 17, 18 period, a lot of our peers in this space were very aggressive in business development, and we saw what happened to them, and we saw what happened to their balance sheets and how they were over leveraged, and many of them today are struggling with the heavy debt that they put on their balance sheets or with assets that didn't turn out to be So the key message I guess I'm trying to communicate here is that we've been very active in business development. It will continue to be one of our top priorities in the company, but it doesn't mean we're going to all of a sudden reduce the quality of assets that we will be looking at or we're going to, you know, exorbitantly go and pay and overpay for assets that are not really a good fit for the company. Again, our priorities all continue to be the same as far as neurology is concerned. If we can find something that is commercial, that is the late stage, absolutely. If not... We will continue to look at Phase 2 or Phase 1S. Regarding a 12...
But it doesn't mean, we're going to all of the southern reduce the quality of asset said, we were looking at or would again, you know exorbitant legal and pay and overpay for assets that are not really good fit for the company.
Again, our priority is all continue to be the same as far as in urology. If we can find something that is commercial that as late stage absolutely if not.
We will continue to also look at phase two or four phase one assets.
Regarding a 12.
Nothing really has changed in the story and actually the more research we do the more we believe in the product and the market opportunity that is really in front of us.
This is a very large market with about 75 million prescriptions a year.
And as small penetration into this market of 5% to 10% at peak will represent a huge market opportunity or product opportunity for us.
The data that is behind this product continues to resonate extremely well with K AOL and physicians.
Jack A. Khattar: Nothing really has changed in the story, and actually, the more research we do, the more we believe in the product and the market opportunity that is really in front of us. This is a very large market with about 75 million prescriptions a year, and a small penetration into this market of 5% to 10% at peak will represent a huge market opportunity or product opportunity for us. The data that is behind this product continues to resonate extremely well with KOL and physicians, specifically the efficacy and, on top of that, the flexibility in the dosing range, giving patients and physicians a fairly wide range of doses that they can use where they can titrate even to high doses without much sacrifice tolerability or safety. As we all saw, the safety and tolerability profile of this product is really nice and clean, especially in this space.
Specifically, the efficacy and on top of that the flexibility in the dozing range.
Giving patients and physicians fairly wide range of those is that they can use where they can tights rate even for high those is without much sacrifice on the tolerability and the safety as we all saw the safety and Tolerability profile for this product is really a nice and clean.
Especially in the space. So we continue to believe especially in today's environment that and non controlled substance and non stimulant with good efficacy and a very good safety and Tolerability profile is very much needed in today's market. It will be a great treatment options for a lot of our.
Since and specifically for those who want to actually try and non stimulant that could work pretty quickly and they will know very quickly whether its work sort it doesn't work instead of having to wait for five or six weeks to know whether it actually works or doesn't work and then they have to start again, if it didn't work for them.
Jack A. Khattar: So we continue to believe, especially in today's environment, that a non-controlled substance and non-stimulant with good efficacy and a very good safety and tolerability profile is very much needed in today's market. It will be a great treatment option for a lot of our patients, and specifically for those who need to know whether it actually works or doesn't work, and then they have to start again if it doesn't work So this is a very easy product to use.
So this is a very easy product to use it.
It doesn't even perhaps need nitration put a lot of patients because the hundred milligram from week. One we know when the basin will know into parents will know whether it would work for them or not so the downside for Ed pattern, So given the child and non stimulant and non controlled substance.
Is really nothing here because in a week there was no that it will walk or not and the safety and Tolerability is really a nice and clean.
Jack A. Khattar: It doesn't even perhaps need titration for a lot of patients because 100 milligrams from week one, we will know, and the patient will know, and the parents will know whether it will work for them or not. So the downside for a parent to give their child a non-stimulant, a non-controlled substance? [inaudible] And finally, of course, we believe that the broad spectrum nature of SPNA-12, that it works as well for attention and hyperactivity, also seems to be a really big plus for the product given that the current non-stimulants, one of them works on one versus the other. So overall, in totality, we think we have a very well-rounded product with very beneficial advantages for the patient as well as the physician and with very good comparable efficacy.
And similarly for the physicians also it is very easy for them to prescribe and it will be very easy for them to manage the patient case as they progress for the treatment.
And finally of course, we believe that the broad spectrum nature of our CNH wells that it works as well and attention and hyper activity also seems to be.
The loss for the product given that the current and non stimulants one of them either works on a one versus the other.
So overall in totality, we think we have a very well rounded product with very.
Beneficial advantages to the station as well as the physician.
Jack A. Khattar: So we're very excited and continue to be excited about the product. It does represent a novel mechanism of action. This is an innovative therapy for ADHD that we haven't seen in the last probably 10 to 15 years coming into this category. And it will be coming into a category that is not necessarily overcrowded with only four molecules that are today used to treat ADHD. So I'm sure it will be a welcome option by a lot of patients who are not satisfied with the current.
And with the with a very good compatible efficacy. So so we're very excited and continue to be excited about the product. It does represent a novel mechanism of action. This is the.
Innovative therapy and Eightyish, the though we haven't seen anything in the last probably 10 to 15 years coming into this category and it will be coming into the category that is not necessarily overcrowded with only four molecules that up today used to treat HD. So I'm sure. It will be a welcome option by a lot of patients while I'm not.
Satisfied with the current treatments.
Operator: Great, thank you. Thank you. Our next question comes from the line of Annabel Samimy with CFL. Your line is open. Hi guys, thanks for taking my questions. I have a couple.
Great. Thank you.
Thank you.
Next question comes from.
And.
The Mimi.
Your line is open.
Hi, guys. Thanks for taking my questions I have.
A couple.
Jack A. Khattar: First on 810, sorry to see that outcome. I guess my question is, what is the logic in ending enrollment at 98%? Should we assume that the extra 2% enrollment would not have provided any further statistical benefit? And what are your suspicions regarding the variability?
First on.
Sorry to see that outcome I.
I guess my question is.
The logic and ending enrollment at 98% should we assume that the extra 2% enrollment would not have provided any further statistical benefit and what are your suspicions regarding the variability is there anything.
Jack A. Khattar: Is there anything you can do to address that in 302 at this point?
Yes.
Right.
Yes regarding the our decision on the three or two study to was stopped enrollment at this point as as all of you will narrow and we know it pretty well it was pretty slow as far as recruitment in these studies in general so for us even to finish the other 2% as you remember our timeline.
Jack A. Khattar: Yeah, regarding our decision on the 302 study to stop enrollment at this point, as all of you know, and we know it pretty well, it was pretty slow as far as recruitment in these studies in general. So for us even to finish the other 2%, as you remember, our timeline was to get data basically in the first quarter of next year. So we don't think that an extra 2% or 3% enrollment is going to change the picture for us, and especially because what we saw in the 301 is that more patients didn't really help the case for some reason, and we are trying to obviously understand the reasons behind it. So, therefore, we are pretty comfortable that whether you are at 98% or 100% as far as enrollment, the picture doesn't really change much.
Just to get data basically in the first quarter of next year. So we don't thing that to except 2% or 3% enrollment is going to change the extra for us.
And specially that what we saw in the city a one is up more patients to help the case for some reason on which we are planning for obviously understand the reasons behind it.
So therefore, we're pretty comfortable that whether youre at 98% or 100% as far as enrollment the picture of doesn't really change much but we would rather to get the data or Leo and therefore, if we stop it now stopping enrollment and open up the data and analyze it as quickly as we can we should be able to have an understanding.
Jack A. Khattar: We would rather get the data earlier, and therefore, if we stop it now, stop enrollment, and open up the data and analyze it as quickly as we can, we should be able to have an understanding of the project overall and what it means for the program moving forward. So we chose to make that decision at this point so that we can get the data earlier rather than wait another 5 or 6 months for it to come in because we have to enroll another 5 or 6 patients. As far as the variability itself is concerned, it is really very surprising given that it doesn't look like there is no variability or similar variability in the placebo arm. So it is very puzzling for us, it is very surprising, and it is one of the main factors that obviously impacted the statistical analysis and calculations yielding a p-value of 0.09.
The project overall and what it means for the program moving forward. So we chose to make that decision of this volume.
So that we can get the data earlier kind of waiting another five or six months for it to come in because we have to enroll another five or six patients.
As far as the variability itself.
Is really very surprising.
Given that it doesn't look like there is and there is no variability or similar variability in the placebo arm. So it is very positive for US is very surprising. It is one of the main factors Odyssey that impacted the statistical analysis and calculations, yielding a P value 0.09.
Jack A. Khattar: So clearly, you would expect us at this point to be digging very deep into the data to understand what is behind such variability only in the treatment arm, the 36 mg arm, which we find to be very, very unusual to occur because, typically, if you have a variability that is due to the sites or the staff or the way the study is being conducted, it should really apply to all the treatment arms, whether placebo or treatment arms. But for the variability to go from 34%, which is similar to what is in the 18 mg in the placebo, to go all the way up to about 43% in stage 2 on the 36 mg, something really must have happened, and that's why this has been very surprising for us to see that kind of jump in the variability.
So clearly you would expect us at this point, we will be digging very deep into the data understand what is behind such variability only in the treatment arm the 36 milligram on.
Which we find to be very very unusual.
Because typically if you have a variability that is due to the sites or the staff or the way. The study is being conducted it should really apply for all the treatment are all the arms whether to placebo treatment arm. So for the variability to go from 34%, which was similar to what is end to 18 Miller.
And the placebo to go all the way up to about 43% in stage two on the 36 milligram something really must have happened and Thats. Why this has been very surprising for all the C.
I've kind of jump in the variability.
Jack A. Khattar: So I wish we had all the answers at this point; obviously, this data is very fresh, very new; we needed to obviously share it with everybody, and as we gain more insight as to what's behind it, clearly, that will help us also in the analysis of the 302 study, and then we will look collectively at the whole package as to what we have with both studies. The key question, I'm sure, on everybody's mind and ours as well, is it likely that the 302 study will be positive, or is it likely to be negative? I wish I could really predict.
I wish we have all the answers at this point obviously this data is very fresh very new but we needed to obviously schaddick with everybody and as we gain more insight as to what's behind that.
Clearly that would help US also in the analysis under three you'll to study and would then we would look at the whole collectively as a whole package as to what we have with both studies so.
The key question onshore on everybody's mind on our mine as well as it's likely that reopened study will be positive order that likely to be negative I wish I can really predict.
This is psychiatry, the CNS development and.
Jack A. Khattar: This is psychiatry, this is CNS development, and a lot of products on the market today actually do 3 phase 3 studies to get 2 positive, or some of them even have done 5 phase 3 studies to get 2 positive studies. So we all have seen this dynamic, especially in psychiatry. So is it likely that 3 or 2 studies will be needed? Yes, there is a possibility. What is really the probability there? We really don't know for sure, but that's why we want to get the data as quick as possible.
A lot of products on the market today actually a lot of them would do for the phase three studies to get to positive or some of them even have done a five phase three studies, but get to a positive studies. So we all have seen thus.
You know dynamics, especially in psychiatry so.
Is it likely that three auto study, yes, there is a possibility what is really the probability there do we really don't know for sure, but that's why we want to get the data split as possible.
Have a follow up.
Jack A. Khattar: Okay, and if I could have a follow-up. There's a picture in the payer landscape, there's clearly a lot of changes going on in reimbursement, and I don't think it's necessarily unique to you, but it does seem unique to products that are that are, you know, maybe reformulations or in well-served markets. So is there anything you can point to in terms of key systemic issues going on that are directly impacting you? And what does that mean for the possibility of successfully launching 812, not from the clinical side, but more from the reimbursement side? I think that's where there's a lot of concern. Thanks.
Sure.
In apparel landscape is clearly a lot of changes going on in reimbursement and I don't think of necessarily any Q, but it does team unique to products that are.
That or you know, maybe reformulations or in well served market.
Is there anything you can point to in terms of systemic issues going on that are directly impacting you.
And what does that mean for the possibilities Duffy launching.
Not from the clinical side, but more from the reimbursement side, I think thats, where there's a lot of concern. Thanks.
Yes, generally speaking what we're seeing on the Bayer side is not really.
Jack A. Khattar: Yeah, generally speaking, what we're seeing on the payer side is not really peculiar to Supernus or Supernus products per se. Now, SPN812 is not just a reformulation; it's actually a whole new chemical entity. It doesn't exist in the United States on the market, so there is no immediate release of eloxifene. So clearly, just by that, it will be a very different scenario versus a reformulation of an existing molecule in an existing generic market. So there is no generic market for eloxifene. And the other thing, as I mentioned, is a completely, totally novel mechanism of action as well, not just the new molecule, but also the mechanism within which we believe it treats ADHD is also very different from Spatera and any other drug in the marketplace that is prescribed for ADHD.
Peculiar to supporting Us where supernus products per se now SDN 812, as not just the reformulation, it's actually a whole new chemical entity. It doesn't exist in the United States in the market. So there is no immediate release of accessing so clearly just by the avidly we are very different scenario.
So as every formulation of an existing molecule in an existing generic market. So there isn't on generic market over the loxo same.
The thing as I mentioned as a completely pulmonary novel mechanism of action as well not just in your molecule, but also the mechanism within which.
We believe it treats 80 HD is also very defendants right there and any other walk in the marketplace that as prescribed for HD.
So so we think it should be a little bit different but as far as what we know today.
Jack A. Khattar: So we think it should be a little bit different, but as far as what we know today, we believe it will be welcome because a lot of folks, what they've seen in the last decade or so, is exactly what you are mentioning and referring to as just reformulations of amphetamines or methylphenidates and so forth. So we think that this will be given a very different, new, fresh look and examined and looked at and the value it brings to the category as far as a novel and totally new mechanism of action in treating this condition.
We believe it will be welcome because a lot of folks what they've seen in the last decade also as exactly what you are mentioning and reporting through our just reformulations amphetamines methylphenidate, some four or so.
We think that this will be given and ready for the from new fresh look and examine and looking at it and the value. It brings to the category as far as a novel and totally new mechanism of action and treating this condition.
Okay.
Thank you.
Our next question comes from the line of David.
With Jefferies. Your line is open.
Thanks.
Operator: Our next question comes from the line of David Steinberg with Jeff. A lot of folks.
Jack A. Khattar: Thanks. A couple questions. I'm not sure you correctly predicted that, you know, the launch should be very measured. And I think scripts are growing about 10, 11, 12% year-over-year, which is a modest increase from prior to the launch. I was curious, do you expect this sort of game to continue, or will you start to see an acceleration for monotherapy in the next year or two? Jack, I think you indicated that you expect to launch the NDA, file the NDA for 8-12 just this month. What would be a realistic actual launch date for A12, assuming approval?
Well are you correct correctly predicted that you know the lots to be very managers.
And I see scripts are growing about 10, 11, 12% year over year basis, which is a modest increase from prior to the launch the recent launch.
I was curious do you expect this sort of games to continue or would you start to see an acceleration from monotherapy in the next year too and then secondly.
I can think you indicated you expect to launch in the.
File the NDA for 812 just.
Six months, what would be a realistic axle launch date.
For eight wells assuming approval.
Okay.
Yeah on.
Jack A. Khattar: Yeah, on. On Oxtheller XR and monotherapy, as you said, we have said and will continue to expect that to be the case as far as measured growth is concerned behind Oxtheller XR and the monotherapy indication. We think it's actually a major reason why the franchise is doing pretty good, we believe, given that it's already six years old and will be seven coming up in February this coming February, as far as the brand and in its life cycle. So we've been very excited about it, and we'll continue to be excited about it. It is epilepsy; epilepsy is always a much slower, steady kind of buildup and growth.
On Oxtellar XR and the amount of therapy.
As you said I mean, we we have said and we'll continue to expect that could be the case as far as measured growth behind Oxtellar XR and the monotherapy indication and we think it's actually a major reason why the franchise is doing pretty good we believe given that it's already six years old.
Then we'll be seven coming up in February of this coming February as far as a brand and its lifecycle. So so we're we've been very excited about it will continue to be excited about it. It is epilepsy epilepsy is all isn't much slower steady kind of build and growth. So certainly we would hope to be able to confirm.
Jack A. Khattar: So certainly, we would hope to be able to continue to achieve 11 to 12%; that is our goal, that's our target or even more than that. So this is a product that we have until 2027, as far as the patent expiry date is concerned. So we're very excited about it, and we will continue to view it as a growth asset for us, no question about that. As far as the 8-12, the NDA this month, it really all depends on the PDUFA date that the FDA will assign to the submission and also whether they will end up reviewing it within 10 months or 12 months. So that is still to be determined. So we clearly won't know until the end whether they're going to take 10 months or they're going to take 12 months. So depending on that, obviously, our launch date will be correlated.
You bet chief 11% to 12% that is our goal does our target or even more than that so this was a product that we have built 2027.
As the patent expiry. So we're very excited about it and we will continue to view it as a growth asset for US no question about that as far as the Hey, 12, and the a this month, it's really all depends on the PDUFA date that the FDA little assigned to the submission and also whether they will end up really.
Dealing it within 10 months or 12 months so.
That is still to be determined so we clearly want to know till the end you know whether they're going to take 10 months or going to take 12 months. So depending on that obviously, our launch date will be correlated with that.
Thank you.
Jack A. Khattar: Our next question comes from the line of Patrick DiCiccio with Berenberg Capital Markets. The line is open. Patrick, check to see if your phone is on. Sorry about that. Good morning. So just first, a follow up question for Kendi. With the understanding that there's some incremental pressure from payers, I'm wondering if we should expect a new step down in price next year or if you feel comfortable with the visibility that you have for the business that, sort of, the outlook as you see it now is going to be consistent next year.
Our next question comes from.
Okay.
With their capital markets.
Thank you.
Yes.
<unk>.
Sorry about that good morning.
So just first a follow up question on Trokendi.
With the understanding that there's some incremental pressure from payers.
Im wondering if we should expect a new step down in price next year or if you feel comfortable with the visibility that you have sort of business.
That.
Sort of the outlook as you see it now is going to be consistent next year.
Well I mean.
Jack A. Khattar: Well, I mean, it's really what we communicated in the press release as far as, you know, the growth in net product sales. We expect it to be more on the flat side because any price increases we take, if we take any next year, you know, we don't make comments on the future pricing strategy. But any price increases we've taken, especially this year, and unit growth have been pretty much offset by a wider spread on the gross net deductions. So we think that at this point, you know, that's the only thing we can go by.
It's really to what we communicated in the press release as far as the.
Growth in the net product sales, we expect it could be more on the flip side.
Because any price increases we paid if we take any next year, we don't make comments on the future pricing strategy.
But any price increases we've taken in the especially this year and unit growth has been pretty much offset with a wider spread on the gross to net deductions.
So we think that at this point, but thats. The only thing we can go by and we will assume that will probably what will prevail next year as well and Thats why we gave.
Jack A. Khattar: And we will assume that this will probably prevail next year as well. And that's why we gave, you know, a kind of draft guidance, so to speak, regarding 2020 and what to expect as far as net sales growth is concerned, moving forward on to Candix. Or, really, what's happening there is that when the unit growth becomes more in the single digits, as I mentioned earlier in my comments, it becomes difficult for the overall volume to really overcome the fluctuations and the increase in the spread on the gross net deduction. That's basically an issue that we clearly didn't face as much last year because we grew last year by 29%. So when you are growing at double-digit rates, you're still able to weather some of these fluctuations, some of these increases in gross to net deductions.
A year.
Kind of a draft guidance so to speak regarding 2020, and what to expect as far as net sales growth moving forward it onto candidates or.
I mean really what's happening there is one the unit growth becomes more in the single digit as I mentioned earlier in my comments it becomes difficult for the overall volume so really overcome the fluctuations and increase in the spread on the gross to net deductions and Thats basically an issue.
Clearly we did in face as much off last year, because we grew last year by 29%. So when you ought to growing into double digit.
You are still able to whether some of these fluctuations some of these increases in the gross than that.
Deductions and many of you have assets discretion on gross to net for many years actually and we always said it never gets better at all is gets worse.
Jack A. Khattar: And many of you have asked us this question on gross to net for many years now, and we have always said it never gets better, it always gets worse. And as time goes on, it will always increase because managed care is always asking for more rebates, more admin fees, more this and more that. And that's a phenomenon again that is peculiar or special to Supernus; it's an environment we're all living in. And therefore, as these unit growths become more in the single-digits, as the case of Trocandex is, it will become very hard to show higher net sales growth. And actually, you have another example in our case with Accelerator; it is still growing at double-digit rates, and we still continue to manage to grow net sales so far given that it is growing at 11 to 12%. Payor coverage for Stellar XR to Appendix R really doesn't vary that much. So a lot of the contracts we have are very similar, give or take, you know, on both products.
And as time goes on it will always increase because managed care is always asking for more rebates more admin fees more diverse and more of that and thats, a phenomena again, not as peculiar or or special discipline assets, if the environment or living.
And therefore as these units will become more in the single digit as the case Trokendi XR. It will become very hard to show in Ohio net sales growth and actually you have another example in our case with Oxtellar XR. It is still growing into double digit and we still continue to manage to grow the net sales so far.
Given that it is growing in the 11% to 12%.
The.
Payer coverage for Oxtellar XR Trokendi XR, we you don't vary that much. So a lot of the contracts. We have had a very similar to give or take on both products.
And then I just have if I may have few follow ups on SPM eat 12. So just first when should we anticipate the ramp up in sales and marketing and building the sales force in 2020.
Jack A. Khattar: And then I just have, if I may, a few follow-ups on SPN 812. So first, when should we anticipate the ramp-up in sales and marketing and building the sales force in 2020? And then secondly, can you provide some context around the payer environment in terms of what we should be anticipating from a price perspective compared to other branded products on the market, and how we should anticipate 812 positioning versus generics, both on the stimulant and on the non-stimulant side? And then, just lastly, if I could, is there an update on the potential for an international collaboration partner on 812? Thanks.
Then secondly.
Can you provide some context around the payer environment in terms of what we should be anticipating from a price perspective compared to other branded products in the market and how we should anticipate.
12 positioning versus generics both on the stimulant and on the non stimulant side and then just just lastly, if I could is there an update on the potential for in international collaboration partner on 12. Thanks.
Jack A. Khattar: Yeah, okay, let me start with the first one. As far as the ramp up on Salesforce and the commercial infrastructure behind 812. Specifically, the sales force, we typically get the sales force up and running right after the approval and around the launch time, so that's going to be obviously in the second half of next year. When exactly and in which quarter, it's still a little bit hard for us to predict at this point until we have better visibility on the PDUFA date and the expected launch date. But given that we're filing in November, obviously, I don't believe it will be like late in the second quarter or early third quarter; probably a little bit later than that.
[laughter].
Yes, okay.
Okay, Let me start with the first one as far as the ramp up on Salesforce.
Commercial.
Our infrastructure behind a 12.
Specifically this all four we typically get the salesforce up and running right. After they approval and add on the last five so that's going to be obviously in the second half of next year again, when exactly I mean, which quarter it sort of its still a little bit hall for us to predict at this point until we have a better.
Visibility on the PDUFA date and expected launch date so.
But given that we're filing in November obviously, I don't believe it will be like.
In late second quarter or early fourth quarter of probably be a little bit later than that.
And that's when we will build the salesforce for the psychiatry and to launch SP on a 12 again, we've said so far our plans or somewhere around 120, 550 reps as far as launching SPX flow.
Jack A. Khattar: And that's when we will build the sales force for psychiatry and launch SPNA-12. Again, we've set so far, you know, our plans are somewhere around 125, 150 reps as far as launching SPNA-12 are concerned. Regarding payer coverage, as I said earlier in my previous comments, I mean, we expect the product to have decent coverage. We're working pretty hard right now and starting to discuss with the payers and sharing with them our data and so forth and the positioning of the product and the additional benefits it brings to the patients versus genetics or even branded stimulants and non-stimulants. So that is still in the works as we speak and will continue through 2020. So we really don't have a final position, obviously, and we won't know right before the launch as to where we stand on the formula.
Regarding the payer coverage as I said earlier in my previous comments I mean, we expect the product to have a decent coveted we're working pretty hard right now and starting to discuss with the payers and sharing with them, our data and so forth and and the positioning of the product and the additional benefits it brings to the patients versus.
Genetics, or even branded stimulants and non stimulant. So that is still in the works as we speak and will continue through 2020, So where do you don't have a final.
Position, obviously, and we want to know underfunded right before the launch as to what we stand on the former there.
Jack A. Khattar: And similarly with the pricing, the specific pricing of the product, I think all we did and gave you at the investor day was basically the America price bracket. And then finally, I think your question about international. Our strategy so far has been to out-license our products internationally, so that applies to the existing products as well as the pipeline. So we'll continue to look for potential partners overseas for A12, for our pipeline, and for the existing products.
Similarly, with the pricing specific pricing of the product I think what we all we did give you at Investor day was basically the bracket.
Prices for the branded products in both segments non stimulant and stimulants again, we will not make comments on the specific last August we will be launching a product that this war.
And then finally I think your question on international.
Our strategy so far has been to out license our products internationally, so that applies to the existing products as well as the pipeline.
We continue to look for potential partners overseas for a 12 for our pipeline and for the existing bar.
Thank you.
Thank you.
Jack A. Khattar: Our next question comes from the line of David Amsellem with Pipeline. The line is open. Thanks.
Next question comes from.
Hello.
Great.
Your line is open.
Thanks, So I wanted to get a sense for me and maybe some more specific.
Jack A. Khattar: So I wanted to get a sense from you and maybe some more specifics on the extent to which the landscape for both Trekendi and Oxteller is restrictive. For example, how difficult is it to get a prescription filled? How difficult or onerous is the documentation, step-throughs? So I know you've talked a lot about the gross to nets, but what I'm getting at here is, you know, the extent to which doctors may just not want to write prescriptions because of headaches, or patients may not want to fill the scripts because of hurdles on their end. So if you can talk to him about that, that would be helpful. Thanks.
On the extent to it the.
Landscape for both.
Andy and Oxtellar is restrictive how difficult is it to get a prescription filled how difficult or onerous is the documentation.
Stepped through so I know you've talked a lot about the gross to nets, but what I'm getting at here is.
The extent to which doctors may does not want to write it because of headaches or patients may not want to fill the scripts.
Because of hurdles on there and so if you can talk to that that would be helpful. Thanks.
Jack A. Khattar: Yeah, sure. The hurdles that we have today are the same hurdles we've had before as far as whether a physician might not be willing to be aggressive and push for the patient and fight for prior authorization or a step through or whatever. So there is really nothing new in that situation versus what we faced last year or the year before and so forth. We continue to have the same programs for assisting the physicians and going through PAs or any of this paperwork and so forth. So there is really nothing meaningful that has changed as far as mechanistically trying to get the prescription through from the time a physician writes it or if they're willing to write it until the patient gets the prescription.
Yeah sure.
The hurdles that we have today are the same hurdles, we they had before as far as you know, whether if physician might not be willing to the aggressive and push for the patient and fight for a prior authorization cannot have stepped through or whatever so there's really nothing new.
In that situation versus what we face last year over year before and so forth and we continue to have the same programs and assisting the physicians and going through he a's or any of this paper work and so forth.
So there's really nothing meaningfully that has changed as far as mechanistically trying to get the prescription through from the final physician rights it or if they are willing to write it until you know the patient gets the prescription.
Jack A. Khattar: A lot of the gross to net issues are more, whether it's higher rebates, the enriched co-pay program that we have to do in Q1 or a lot of the factors that go into the gross to net reductions that have impacted the wider spread that we are talking about. So as far as the physician dynamics, the patient dynamics, as far as the story around the two products and the benefits that they bring to patients, there is really no fundamental change here with both products. So it's not like we're facing additional hurdles from that perspective.
A lot of the gross to net issues are more whether it's a higher rebates and rich co pay program that we have to do in Q1 or or or a lot of the factors that go into the gross to net.
The reductions that have impacted the wider spread that we are talking about.
So as far as the.
Physician dynamics the basin dynamics as far as the story around the two products and the benefits are they bring to the patients that is really no fundamental change here on both products.
So it's not like we're facing additional hurdles from that perspective, yes. David This is Greg if I can just add on to Jack's comments.
Greg Patrick: David, this is Greg. If I can just add to Jack's comments,
Greg Patrick: The overwhelming dynamic in terms of getting a script authorized is really driven by an automated process that can be adjudicated at the pharmacy. And for both products, it largely rests on their having been on generic topiramate or generic oxcarbazepine beforehand. There is a minimum, I would say almost no paperwork required.
The overwhelming.
Dynamic in terms of getting at a scrip authorizes right.
Driven by automated process.
That can be adjudicated, the pharmacy and for both products and largely rest on their having.
Then on generic topiramate or generic Oxcarbazepine beforehand.
There is a minimum I would say almost no people work required and add is that mentioned all this can be adjudicated at the pharmacy in an automated fashion.
Greg Patrick: And as I mentioned, all this can be adjudicated at the pharmacy in an automated fashion. Okay, do you think that that, Unknown Speaker 1. Unknown Speaker 2, going forward, particularly in migraine where there is more competition? I mean, if you look to 2020 and even beyond, do you expect the largely the status quo as you described, or do you think that there could be meaningful change?
Okay do you think that that mechanistically any of that could.
Change going forward, particularly in migraine, where there there is more competition I mean, if you look just wanted to Tony and even beyond I mean do you expect largely status goes you described or do you think.
There could be meaningful change.
Jack A. Khattar: It could change. I mean, we really don't know for sure.
It could change I mean related I know for sure it could change and that's why we're trying to be cautious and trying to give people as to what 2020 or the things we could face.
Jack A. Khattar: It could change, and that's why we're trying to be cautious in trying to give people as to what 2020 or the things we could face. 2020 will also see potentially oral CGRPs, so even that environment might change on all the CGRPs and how they are treated by payers. So there is a lot in 2020 that could really keep the environment fluid overall, so it's really very hard for us to predict how that will pan out.
2020, we'll also see potentially oral CG ought to be so even that environment might change on all this EG RPM out they are treated by payer. So so there's a lot in 2020 that could really keep the environment fluid.
Overall, so it's really very hard for us to predict.
You know how will that pan out.
Yes, Thats right, David that being said I'm not aware of anything specifically regarding additional mechanistic hurdles that we would have to go through that have presented themselves for next year.
Greg Patrick: That's right, David. That being said, I'm not aware of anything specifically regarding additional mechanistic hurdles that we have to go through that have presented themselves for next year.
Okay. Thanks, that's helpful.
Greg Patrick: Okay, thanks, that's helpful. You're welcome. Thank you. Ladies and gentlemen, we have time for one more. Our final question comes from the line of Esther Hong with Janie, your line, Hi, thanks for taking my question. So my question is on SPN 812. So, assuming approval, what are expectations around a launch trajectory? Can we expect a quicker uptake and launch based on the quicker onset of action and the fact that it's a non-stimulant? And, of course, taking into account that reimbursement will play a role. Thanks.
You're welcome.
Thank you, ladies and gentlemen, we have time for one more question.
Final question comes from the line up.
With Janney your line.
Hi, Thanks for taking my question. So my question is on ESPN 812.
So a pretty assuming approval.
What our expectations around a launch trajectory can we expect a quicker I've taken launch.
Based on the quicker onset of action in the fact that it to non stimulant and of course, taking into account that reimbursement will play a role. Thanks.
Yes, I mean, I mean at this point.
Jack A. Khattar: Yeah, I mean, at this point, what I would say, you know, expect launches to be consistent with a lot of the launches you've seen. So it's not going to be a hockey stick. I don't think it will be a hockey stick kind of effect. So we will expect it to be very commensurate with other launches in this space.
What I would say you expect launch to be consistent with a lot of the launch as you've seen so it's not going to be hockey stick I don't think it will be a hot the hockey stick kind of in effect.
So we will expected to be very commensurate with other launches in this space.
Jack A. Khattar: The good news here, obviously, this is a non-stimulant, so there are also other ways for us that we have at our disposal where we can get patients to really start on this product and get the experience with it through sampling, where, on the other hand, if it were a stimulant, you couldn't really sample stimulants. So we have at least a lot of tactics that we can employ to get patients on the product, let them try it, let them really see for themselves that this could work within a week, you know, given the data we have seen so far, and hopefully that will translate, and it should translate into the marketplace with real experience. And then, maybe the uptake will be very quick. So it remains to be seen, but at this point, we will just be a little bit cautious and try not to model this really too crazy as far as the hockey stick kind of effect in general, so we have the right expectations out there.
The good news here. Obviously this is a non stimulant still there is also other ways for us that we have at our disposal, where we can get patients story to start on this product and get the experience with it so sampling.
Wed on other hand, if it were stimulant you can three samples stimulants. So so we have at least a lot of stack fix if we can employ to get patients on the product let them try it let them really see for themselves of this could work within a week you know given the data we have seen so far and hopefully that will translate and that should translate into the marketplace.
With real experience and then maybe the uptake will be very quick so that remains to be saying, but at this point.
We will just be a little bit cautious and cry enough to model. This really too crazy as far as the hockey stick kind of effect in general.
So we have the right expectations out there.
Thank you.
Jack A. Khattar: Thank you.
Thank you.
Operator: I will now like to turn
Jack A. Khattar: I would now like to turn the call over to Jack Khattar for closing remarks.
I would now like to turn the call over to Jack talked for closing remarks.
Thank you, while we're disappointed with the topline results from the first phase three study we look forward to conducting further analysis on the data and to getting the results from the second study.
Jack A. Khattar: Thank you. While we are disappointed with the top-line results from the first phase 3 study, we look forward to conducting further analysis on the data and to getting the results from the second study. In the meantime, we are working diligently towards the submission of the NDA for SPNA-12, which we expect to happen soon. For the remainder of 2019 and into 2020, we are preparing to launch SPNA-12, if approved, in the second half of 2020. Thanks again for joining us this morning.
In the meantime, we're working diligently though as the submission of the NDA for SPX 12, which we expect to have been shown for the remainder of 2019 and aim to 2020 , we're preparing to launch SP any 12, if approved in the second half of 2020.
Thanks again for joining us this morning.
Ladies and gentlemen that concludes today's conference. Thank you for participating you may now disconnect everyone have a wonderful day.
Operator: Ladies and gentlemen, Jack Khattar. Thank you. Conference. Thank you for participating. You may now disconnect at, BF-WATCH TV 2021