Supernus Pharmaceuticals Inc

NASDAQ:SUPN

Earnings Call Transcript 2019-Q2

[Operator]

Good day. Good morning, ladies and gentlemen, and welcome to the Supernus Pharmaceuticals Second Quarter 2019 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. As a reminder, this call is being recorded.

I would now like to turn the call over to Peter Vozzo of Westwicke, Investor Relations for Supernus Pharmaceuticals. You may begin.

[Peter Vozzo, Managing Director, Westwicke Partners]

Thank you, Sara. Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals second 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. Following remarks by management, we’ll open the call to questions.

During the course of this call, management may make certain forward-looking statements regarding the 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, believes, should, intend, and other words of similar meaning. 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 2018 Annual Report on Form 10-K. Actual results may differ materially from these 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 August 7, 2019 at 9:00 A.M. Eastern time. Since then, the company may have made additional announcements relating to the topics discussed. Please reference the company’s most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements except as required by applicable securities laws.

I will now turn the call over to Jack.

[Jack Khattar, President and Chief Executive Officer]

Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us as we discuss our 2019 second quarter results. Product prescriptions for Trokendi XR and Oxtellar XR in the second quarter of 2019, as reported by IMS, increased to 209,066 prescriptions, a 7.4% increase over the same period last year.

For Trokendi XR, prescriptions in the second quarter of 2019 were 168,682, which was a 6.4% increase over the same quarter last year. Sequential quarterly growth in prescriptions for Trokendi XR improved in the second quarter to 4.8%, following the first quarter sequential quarterly decline of 5.7%.

However, this rebound in sequential growth was not enough and as not as fast as we expected to recover from first, the seasonal weakness we experienced in the first quarter of 2019; and second, the softness in the overall topiramate market in the first six months of 2019.

Similarly, recovery from the first quarter seasonal impact on market share of the total topiramate market prescriptions this year was slower than in previous years. For example, based on IMS monthly market share data in 2018, Trokendi XR had recovered from the typical first quarter seasonal decline in market share by the end of the quarter in March.

This year, on the other hand, and based on data available only through June, the product is expected to have recovered in July for the 5.13% market share that we had before the first quarter seasonal decline.

In addition, sales deductions have not improved as we had expected in the second quarter of 2019 relative to the first quarter of 2019, and instead have remained relatively flat. Because of these factors, we are revising the 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.

For Oxtellar XR, the launch of the indication of monotherapy for partial seizures continues to go well. In the second quarter, Oxtellar XR prescriptions were 40,384, representing an increase of 12% over the same period last year. The increased level of focus by our sales force in the first six months of the year is supporting a healthy prescription trend on Oxtellar XR. We look forward to continuing this momentum behind the brand.

Moving now to our pipeline. In July, we completed our pre-NDA clinical meeting with the FDA for SPN-812, our novel treatment for ADHD and remain on track to submit the NDA in the second-half of this year. Our plans and preparations for a potential launch of SPN-812 in the second-half of 2020, if approved by the FDA, continue to progress well. In addition, we plan to start a Phase III program in adult patients with SPN-812 in the fourth quarter of this year.

For SPN-810, our novel treatment of impulsive aggression in patients with ADHD, enrollment in the Phase III 301 study pediatric trial is complete. We expect data from its trial in the fourth quarter of this year. Enrollment in the Phase III 302 trial continues with data expected in the first quarter of 2020.

This change is not expected to impact the filing of submission of the NDA for SPN-810. We continue to expect to submit an NDA for SPN-810 in the second-half of 2020 and to launch the drug pending approval by the FDA in the second-half of 2021. Regarding SPN-604 for the treatment of bipolar disorder, we expect to commence the Phase III program in the fourth quarter of this year.

Finally, our activity on the corporate development side continues, as we look for neurology and psychiatry assets that represent a strategic fit with our current portfolio.

I’ll now turn the call over to Greg, who will provide more details on our second quarter financial performance.

[Gregory Patrick, Chief Financial Officer]

Thanks, Jack, and good morning, everyone. As I review our second quarter 2019 financial results, I remind listeners to refer to the second quarter results issued in yesterday’s press release after the market closed.

Total revenue for the second quarter of 2019 was $104.7 million, which is 5.2% higher than the $99.5 million recorded in the second quarter of 2018. Net product sales for Trokendi XR for the second quarter of 2019 were $79 million, an increase of 3.3% versus the second quarter of 2018. For Oxtellar XR, net product sales in the second quarter of 2019 were $23.4 million, a 13.8% increase, as compared to the second quarter of 2018.

Total revenue for the second quarter of 2019 was comprised of net product sales of $102.4 million and royalty revenue of $2.3 million, as compared to net product sales of $97 million, royalty revenue of $1.8 million and licensing revenue of $0.8 million in the second quarter of 2018.

Turning now to expenses. Research and development expenses were $17 million in the second quarter of 2019, as compared to $20 million in the same quarter the prior year. This decrease is primarily attributable to the completion of the four Phase III clinical trials for SPN-812 in late 2018 and in early 2019, partially offset by the costs to manufacture SPN-812 to support our upcoming NDA filing.

Selling, general and administrative expenses in the second quarter of 2019 were $41 million, essentially equivalent to the $40.1 million in the same quarter last year. For the second quarter of 2019, operating earnings totaled $42 million, a 19.3% increase over $35.7 million in the same period last year.

Operating earnings increased faster than net product sales, which grew by 5.5%, demonstrating the company’s ability to manage operating expenses and leverage our established infrastructure. This constitutes a record for the company. In fact, this is the first quarter in which our earnings have exceeded $40 million.

Net earnings in the second quarter of 2019 were $32.7 million, or $0.61 per diluted share, as compared to $30.7 million, or $0.57 per diluted share in the same period last year. Growth in net earnings was driven primarily by higher operating earnings, partially offset by the higher effective tax rate in the second quarter of 2019, compared to the year earlier period.

The effective tax rate in the second quarter of last year benefited from employees exercising stock options, and the rate was materially lower than the rate in the second quarter of this year.

We ended the second quarter of 2019 with $852.3 million in cash, cash equivalents, marketable securities and long-term marketable securities, an increase of $77.5 million, as compared to $774.8 million as of December 31, 2018.

Turning to financial guidance for full-year 2019. As Jack mentioned, we’re revising our guidance for net product sales and operating earnings, while reaffirming expectations for R&D expenses and the effective tax rate. We now expect net product sales to range from $400 million to $410 million, as compared to the previously expected range of $435 million to $455 million.

We continue to expect R&D expenses to range from $70 million to $80 million. We now expect operating earnings to range from $150 million to $160 million, as compared to the previously expected range of $160 million to $180 million. Guidance for the effective tax rate 23% to 25% remains unchanged.

I’ll now turn the call back to the operator for questions.

[Operator]

Thank you. [Operator Instructions] We request that you please limit yourself to one question and one follow-up and then feel free to reenter the queue if you have further questions. Our first question comes from the line of Ken Cacciatore with Cowen and Company. Your line is now open.

[Ken Cacciatore, Cowen and Company]

Hey, guys, thanks for taking the question. Just wanted to look into 2020 from both potentially positive and then a preparation from a modeling perspective. So, obviously, we’re hopeful that we could have 812 on the market, but with flattening Trokendi and Oxtellar growth to a certain extent and spending likely coming up. Can you just prepare us from a P&L perspective of what we could be generally speaking next year, as we think about augmenting the portfolio with 812?

And then on BD, Jack, you touched on it. But can you just talk to us a little bit more, there seems to be a lot of corrective evaluations out there in the marketplace. And so wondering, if the environments improving for you and then as you look at some of the companies that have launched products and have kind of maybe experienced the failed launches, is a way to rehabilitate assets like that, or should we just think some of those assets are gone and by the wayside for a company like you? Thank you.

[Gregory Patrick, Chief Financial Officer]

Okay. Hi, Ken, this is Greg Patrick speaking. With respect to next year, when we talk about expenses to start off, and then we can circle back and talk about net product sales.

From an expense standpoint, this is clearly going to be a launch year for Supernus for SPN-812, we’re very excited about that. Anticipation ought to be that, we will build out our sales force consistent in a manner that we described with our – at our Investor Relations or Investor Day earlier this year, with a sales force somewhere around 150 sales reps, and marketing expenses, which will be commensurate with that.

So from an expense standpoint, it will clearly be a year in which we’re going to launch the product in a way that it needs to be launched and ought to be launched, and with the strong effort that we have been speaking about since we’ve been talking about the launch.

As regards to net product sales, I would say, that SPN-812, since it will be launched towards the back end of the year, one would expect that the contribution from SPN-812 will be there, but it will not be material for the company’s results. And we’ll think about that a little bit more as we get closer. This is going to be very much timing-driven, quite frankly, also be heavily driven by where we stand with respect to managed care in terms of reimbursement and coverage. And that’s something we’ll update investors on as we go forward.

With respect to our existing products, I think a way to frame this year and last year to look forward to next year is to remove the $10 million inventory build-up from 2018 to results of 2018, if you’re correct, for the $10 million inventory build-up in the fourth quarter would be closer to $390 million. And if you made the same adjustment in 2019’s guidance, our guidance has been $400 million to $410 million. So I’ll just bump that up by $10 million, let’s say, to $410 million to $420 million.

So if you look at that trajectory, it’s really kind of $390 million, if I pick the midpoint of the range to $415 million. And I think we would expect next year sales progression to be in line with that. It’s too early to really speculate, but something, which I think would not be too inconsistent with that trend – with that corrected trend.

[Jack Khattar, President and Chief Executive Officer]

Yes, and let me add. I mean, as far as Oxtellar XR, clearly, that continues to show healthy growth trends. Trokendi XR is also a growing product. It’s not a declining product, but the growth is slowing down. So clearly, when you look at year-to-date, prescriptions are up 9% for the first six months of the year versus last year. I mean, that’s actually pretty good for a product that is seven years old and facing the competition that it is facing.

We also, as I mentioned in my prepared remarks, we had a much deeper hole decline in the second quarter because of the steep decline we had in the first quarter this year versus previous years the first quarter results didn’t decline as steeply as they did this year. So we had a much deeper hole to come out of and recover from in the second quarter than we had in previous years.

So in general, to keep it in perspective, and I think quarter-to-date in the third quarter, I mean, Trokendi XR also showing some growth in the 1% to 2%, which I’m sure listeners on this call will remember several previous quarterly transcripts where people asked us how would you expect Trokendi XR to grow in the future? I said, between the 1% to 2% quarter-to-quarter, we’ll be happy with something like this. So if we go back to that norm, I think, Trokendi XR will be fine as well.

As far as business development, Ken, obviously, we’re all seeing the corrections and certain evaluations. I agree there has been some corrections out there in some of the companies some launches, yes, have not gone as well as probably people have expected. So I don’t want to be really too specific and too particular on names or anything like this, but the answer is yes. We do see the environment improving from that perspective and we are very intensely involved in situations and we continue to be looking at it very diligently.

[Ken Cacciatore, Cowen and Company]

Thanks so much.

[Operator]

Thank you. Our next question comes from the line of Annabel Samimy with Stifel. Your line is now open.

[Annabel Samimy, Stifel, Nicolaus & Co.]

Hi. Thanks for taking my question. So just to get a little more granularity on Trokendi and understand your trajectory going forward. You mentioned higher deductions in rebates, as well as topiramate market contracting. So on the first point, how much of it is the hole that you’re climbing out of versus increased rebates that could essentially continue going forward and maybe into the next years?

And with contraction in the topiramate market, I guess, part of the wonders why that should matter, given that you’re still only single-digit penetrated of that molecule regardless of how big that market? Does that mean that you’ve essentially tapped out on conversion of that molecule?

And then if I could just switch one more question to SPN-810. I guess, I’m a little curious on the enrollment and why you’re still struggling to complete enrollment. I would think that after one trial is completed, you’d see more of an acceleration rather than continuation to enroll in the second trial. And on the first trial, that’s complete, I guess, why not release it now? Why wait until the fourth quarter? It was presumably finished, though. I guess, that’s a lot of questions, but if we can get a little more understanding around that? Thank you.

[Jack Khattar, President and Chief Executive Officer]

Yes, sure. Let me start with the deductions, the rebates just to clarify, we said it’s basically flat versus the 1Q that didn’t go up versus 1Q. Now, typically, we would have expected it to actually taper off a little bit in the second quarter, it didn’t happen to the same extent, we would like it. And there were other factors other than just rebates that occurred within the gross to net that caused it to be flat. So it wasn’t really rebates that were the major, major issue here. We do expect it to improve slightly for the rest of the year. I mean, that’s the normal pattern we’ve always had.

As far as the contraction of the market, you’re absolutely right. And we have said that numerous times that our market share of topiramate is still fairly slow, small and we still – and we continue to believe we have a lot of business out there that we could convert.

But the reason I cited it in my comments is the fact that actually our forecast was a 1% growth in the market. And when it declined by 2%, we have a 3 point difference in the market. And if you only take our market share of 5% and translate that into net sales, that is not a small number. And just by the fact that the market went down, naturally, our business shrunk a little bit with the market. That’s the only reason I was citing that just to keep people aware of it.

But you’re you’re correct, and we continue to believe that the market is fairly stable in relative terms of minus 2%, or plus 1%, that is still stable. But when it comes to the numbers themselves, the small percentages, they do translate to a meaningful change in the net sales numbers for us.

So we continue to believe we can still convert immediate release prescriptions to Trokendi XR, nothing has changed here as far as the fundamentals behind the product itself and the benefits of the product delivers even compared to CGRPs. But a lot of things will have time – will take time to play out, even the market expansion that we have talked about beyond topiramate as far as migraine sufferers coming into the market. We continue to believe this will eventually will benefit us as well, but maybe it’s not coming as fast as we would have hoped or we would like ourselves.

As far as SPN-810, let me just clarify to take you back to what happened six months ago and what are we doing right now? 810, the 301 trial has actually achieved its original enrollment dates about five, six months ago. And we have said at that time, we’re going to continue to keep it open for enrollment, so that the 302 trial can catch up with it.

And the 302 trial was about few months behind the 301 trial that was just the start of the trials was about that time period difference between the two. And also each of these trials have different sites. So it happens that the 301 study has better sites or sites have enrolled a little bit faster, we don’t control that as much. And we were hoping the 302 trial will actually catch up, but the 302 trial continues to trail behind the 301.

So we made the decision, we said, “You know, what, let’s just stop the 301, we’re done with the enrollment and we need to get the data as soon as we can.” Because we have also other operational decisions that we have to make as a company as far as preparing for production or during API on what have you.

So as the data continues to lack or we don’t have that data in front of us, it makes these decisions a little bit more difficult. So that’s why we made the decision to open up the 301 trial. And you can only open up the trial until the last patient is out of this trial, you lock the database, you clean it up, and that’s why the data will come in, in the fourth quarter of this year, we don’t have it right now.

And therefore, the 302 trial, which is actually not too far from completion, it’s probably somewhere around the 10 to 15 patients, we still have left. I mean, we’re not talking about we need another 40 or 50 patients here. I mean, we’re really getting there, and we could potentially finish enrollment this year, and maybe get the results early next year. I mean, we’ll be a little bit more specific. But we’ve had some months where we have six patients enrolled, another months, we have zero patients enrolled.

So we really don’t control the pattern. We’re trying to be a little bit cautious here. But even if we do get the data as we did, for example, this year on 812 on the last study, we got it in the first quarter. So if we get the 302 data on SPN-810 also in the first quarter of next year, we will be able to still submit the NDA in the second-half of 2020. So that’s really the progress or the sequence of events that occurred and why we made the decision we did recently and opening up the 301 trial and get the data out there.

[Annabel Samimy, Stifel, Nicolaus & Co.]

Great. Thank you.

[Operator]

Thank you. Our next question comes from the line of Irina Koffler with Mizuho. Your line is now open.

[Irina Koffler, Mizuho Securities USA Inc]

Hi. Thanks for taking my questions. I wanted to focus on SPN-810. Can you help us understand, again, how severe these patients were? How long they’ve been treated with stimulants before enrolling in your study? And did they have any anti-psychotic utilization before they came in to your trial, or are these kids ones are fairly naive to anti-psychotics?

[Jack Khattar, President and Chief Executive Officer]

Yes. I mean, the simple answer is, yes. These patients, as is the market today, actually, a lot of these patients brought on things a lot of used off-label. These things that are off-label for impulsive aggression are even the stimulants themselves that are to treat the ADHD.

So what physicians initially tried to do is titrate and play around with the dose of the stimulant to try to tamper down the aggression and behavior, that could work in some patients with a lot of patients that doesn’t work with them. And also if it does work, it’s only – is very temporary.

And therefore, as a second step, they resolve to things like anti-psychotics, and so forth. So the answer is yes. Our trials do have these patients who have been on anti-psychotics, sedatives antidepressants, I mean, people use all kind of agents site to control the aggression.

And that’s why part of the enrollment actually and the screening period is to watch out these patients from all these medications, except their ADHD medication, which is required to keep their ADHD symptoms control, because SPN-810 is not designed to treat ADHD, it’s designed to be an add-on to the ADHD treatment to treat the impulsive aggressive component of the behavior.

[Irina Koffler, Mizuho Securities USA Inc]

Okay, that’s helpful. Also, you have this adolescent study that’s going on, which on clinicaltrials.gov, it looks like it’s expected to read out at the end of the year. Can you update us on the timing of that study? And is it possible that if one of your two 301 or 302 doesn’t work, would you be able to supplement your NDA with the adolescent study?

[Jack Khattar, President and Chief Executive Officer]

Yes, sure. The 503 study that you’re referring to is for the adolescent, and we have started this trial last year. It is – it continues to enroll. We expect that actually to continue enrollment through next year. So enough data for next year, unless it surprise us and it really the recruitment is way faster than we’ve had experienced before with the pediatric.

Now, that trial regarding our NDA, and this is the approach we’re taking at this point with the FDA and so forth, as we will be submitting the NDA for pediatric indication, not the adolescent indication. And therefore, we look at the 503 clinical trial in adolescence, as supportive from a safety, tolerability perspective. So we will include as part of our NDA submission for the pediatric is whatever we’ve learned and observed in the 503 study just from a safety and tolerability. So that the FDA has some data and they use in the adolescent population.

And later on, we could seek an indication for the treatment of adolescent later on as the trial completes and we really submit it later on as an sNDA. So that’s the strategy we’re taking at this point. So that’s why we don’t believe it should really delay our NDA submission for the pediatric population.

[Irina Koffler, Mizuho Securities USA Inc]

Okay. Thank you very much.

[Operator]

Thank you. Our next question comes from the line of David Steinberg with Jefferies. Your line is now open.

[David Steinberg, Jefferies]

Thanks. Three questions. First, I know you said you use copay assistance in Q1. I was wondering if you rolled it back in Q2, or whether you use that in the second quarter?

Secondly, could you give us a little more granularity, Jack, on the timing of the NDA for 812? I know you said second-half of the year, that’s pretty wide window. And I’ll think of the other one after you answer this question.

[Gregory Patrick, Chief Financial Officer]

Hi, David, this is Greg. With respect to the question about the copay program, that has actually rolled back during the first quarter. It’s got a higher reimbursement level for the first month or two. And then in – no later than in February, early March, it’s actually rolled back to the levels that it continues on for the rest of the year.

What has happened in both the first quarter and second quarter is that, plus the fact that the utilization of the overall program has run a bit higher than our past history indicated and our expectations would have indicated. So the program is actually where it has been from March on forward, but from a utilization standpoint, a little bit heavier than we have seen historically, and that’s a little bit heavier than we expected.

[Jack Khattar, President and Chief Executive Officer]

Yes, and regarding the timing for the 812 NDA, as you would expect us, I mean, we’re working pretty hard to get it as early as we can in the fourth quarter of this year. So we’re not looking at December here. We – we’re looking at earlier in the quarter. And clearly, we will make an announcement when we do make the filing, because, of course, we’re also trying to launch the product. Ideally, you want to launch it around the school year, next year. So that’s why we’re working pretty hard to have it as early as possible in the fourth quarter.

[David Steinberg, Jefferies]

Right. And my third question is on your cash balance. You keep building up cash. You’ve been fairly reluctant to buy anything. I know that valuations have been high, but that’s the prudent thing to do. I’m just curious, how – would you think about perhaps share buybacks? I know, growth companies typically don’t do that. On the other hand, given where your stock is, is that something you consider going forward? Thanks.

[Jack Khattar, President and Chief Executive Officer]

First, quick answer and quickly action, probably enough on the share buyback. I mean, we are a growth company and we actually – our intent is to use the cash, as you said, in growing the company and bringing other opportunities from the outside. Given the nature of the first – the question that Ken asked actually, as far as potential valuations getting to a little bit more reasonable zip code, so to speak, and our intensity as far as looking at these transactions, I mean, there is a good chance. We will use that that cash and that’s what it’s for is to end up using it for external growth activities, not to give it back in the share buyback or dividends or anything like that.

[David Steinberg, Jefferies]

Is it safe to say that there’s a good chance you would buy something before your sales force moves into action launching 812 next year?

[Jack Khattar, President and Chief Executive Officer]

It’s really hard to predict that finding very, very specifically. But if we do something, obviously, we’ll make sure that doesn’t distract us from the launch of SPN-812. It will have to either stand on its own or we will find the synergies and the infrastructure overlap and benefits in a different area in the business. So anything we do will make sure it does not distract our launch of SPN-812.

[David Steinberg, Jefferies]

Thanks.

[Operator]

Thank you. Our next question comes from the line of Patrick Trucchio with Berenberg Capital. Your line is now open.

[Patrick Trucchio, Berenberg Capital Markets LLC]

Hi. Good morning. First question regarding the existing products. I’m wondering, if the payer dynamics and the prescription trends you discussed this morning alter your view for peak revenue, potential for Trokendi and Oxtellar and migraine and epilepsy of at least $500 million. And can you remind us what the timeframe is for this peak potential? Then I have a few follow-ups on 810.

[Gregory Patrick, Chief Financial Officer]

Yes. On that – the $500 million of peak potential, as I mentioned couple of times before, Patrick, it’s not going to happen at the same year, right? Because the peak of Trokendi XR is in a certain year, but the peak of Oxtellar XR is much later. So it’s not like, it’s going to happen in the same fiscal year that both products will hit that peak.

So when you look at it that way, absolutely, we still believe combined peak, as far as revenue generated by these two products for this company is $500 million or more, because Oxtellar XR, of course, is going to go to 2027, even potentially more than that with the bipolar and so forth.

So that’s really where, obviously, that’s the remark that we’ve been making over the years. And, of course, our hope is that, as far as the market itself for Trokendi XR, it will continue to stabilize and the recovery in Trokendi XR will continue around the kind of levels that we’ve seen at this point, as well as prescription growth.

[Patrick Trucchio, Berenberg Capital Markets LLC]

So regarding Phase III data release for 810 that’s expected in the fourth quarter of this year, can you tell us how the impulsive aggressive behaviors are being defined? Secondly, what frequency of impulsive aggressive behaviors for seven days relative to placebo would be considered a clinically relevant improvement? Thirdly, are there any comparable studies to benchmark the frequency of impulsive aggressive behaviors, too? And finally, can you tell us how 810 is expected to fit in the treatment paradigm for IA with ADHD?

[Jack Khattar, President and Chief Executive Officer]

Yes. Let me see if I can cover all of them. As far as the number of frequency of episodes, which is the endpoint, the – it’s the change in the number of these episodes and the frequency of these episodes during that 28-day period versus the placebo. So as long as we separate from the placebo from statistical significance point of view, obviously, the fraud is considered successful.

In general, and this is really a very rule of thumb kind of thing. From a clinical perspective, if you look at the Phase IIb study, we had an improvement between 58% and 62%, if I’m not mistaken, if my memory serves me well. So somewhere, clinicians tell you an improvement of 50% or higher versus the baseline clinically, would be something that is a meaningful signal. And when we got back into Phase IIb study, it’s somewhere in the 58% to 62% on the low dose and the medium dose.

So we are still with a hope, obviously, in the Phase III study, we’ll have something consistent with what we saw in the Phase IIb study that we think would be meaningful. And again, as far as the success of the trial itself, it has to be, of course, compared to what the placebo arm shows.

And then as far as the – how 810 will fit in the treatment paradigm that exists today, as I mentioned earlier, today, physicians just scramble around and try to use a lot of different agents who are not designed to treat impulsive aggression. They are not proven to treat impulsive aggression and there was no data whatsoever to show any of these off-label drugs are being used that they actually have any meaningful benefit for the patients.

If they do a lot of them, it’s very short-term and it’s very temporary, a quick reaction to the drug and then it goes away, because they’re not really working on impulsive aggression, as would SPN-810. So clearly, we would look for SPN-810 to be the first-line treatment. It will be the only product ever clinically studied, developed the right way through the regulatory process with good Phase III data hopefully.

And we’ll find out in the next quarter that we can actually promote the physicians and explain to them how this product is actually designed to treat impulsive aggression with data. And, of course, if it gets approved, that means it’s a good product that works well for these patients and nothing else is ever approved for feeding this condition.

So we clearly would be the treatment of choice and should be the treatment of choice, because all these other agents, specially all other anti-psychotics have major issues that they cause for children, when they are given to these children from weight gain, metabolic changes, prolactin hormone increases and all kinds of issues for the children, where molindone actually, our product, which was the SPN-810 hadn’t shown any of these different – to the same levels that any of these agents have shown historically.

So we’re very, very obviously excited about how this product can be positioned in the marketplace, and the role it can really play. And for once and for all that product that actually is designed to treat this condition.

[Patrick Trucchio, Berenberg Capital Markets LLC]

That’s helpful. Thank you very much.

[Operator]

Thank you. [Operator Instructions] Our next question comes from the line of David Amsellem with Piper Jaffray. Your line is now open.

[David Amsellem, Piper Jaffray]

Thanks. So I had a question – couple of questions on Oxtellar. So wanted to get your thoughts on what has happened regarding the monotherapy label expansion? And do you think you’re going to be able to get any kind of inflection or significant inflection in terms of growth as a result of that label expansion? It doesn’t look like we’ve seen all that much there. So help us understand your thought process there?

And then regarding bipolar, looking further ahead, just given the overall payer landscape and the usage of sodium channel blockers in bipolar, help us understand your thought process regarding access to these sites you eventually do get a label expansion in bipolar for that product? Thanks.

[Jack Khattar, President and Chief Executive Officer]

Yes, sure. For the first question, as far as the monotherapy, as everybody would recall, we did say that we are launching the monotherapy, but it’s not going to have the same inflection point of people. So way back in 2017 under migraine with Trokendi XR. So the way we look at monotherapy, this is an area for us to continue to give us the growth in a very steady consistent growth.

And I would say, growing by 12% in real prescriptions for a product, again, that is into its seventh or eighth year, that is pretty remarkable in a very competitive area in the epilepsy space. So we’ve read it in college with what we’ve seen so far. It’s only six months into the launch of this product with a sales force and the support that we gave it and the extra attention that we gave it in the first six months.

So we continue to be optimistic. You’re not going to see an inflection point, if I understand what you’re referring to, that’s going to be like a hockey stick or anything like this. But you will see very slow migration towards higher and consistent growth rates, which has been the case in the past six months.

As well as in the first quarter of this year, if you remember, Oxtellar XR actually did not witness a decline that is typical with a lot of the brands in that space. And we believe that is actually part of the fact that we are launching the monotherapy indication at that time as well.

As far as the bipolar, yes, I mean, the payer landscape, of course, is difficult and continues to be a difficult. Of course, the – what really speaks for it at the end of the day is the Phase III data that we will have to generate with clear differentiation versus some of the other agents out there. It will be the first and all the oxcarbazepine controlled release to be approved for bipolar.

Some of the benefits that we have today in epilepsy will apply definitely for the bipolar patients as well, as far as a lot of the patients seeing the remarkable difference and the side effects and tolerability profile that they see with oxcarbazepine immediate release, for example. So whether you’re an epileptic patient or a bipolar patient, those benefits we expect them to translate as well into the bipolar population.

[David Amsellem, Piper Jaffray]

Thank you.

[Operator]

Thank you. We have time for one last question. Our last question comes from the line of as Esther Hong with Janney. Your line is now open.

[Esther Hong, Janney Montgomery Scott LLC]

Hi. Thanks for taking my question. So on SPN-812 regarding launch expectation, data is demonstrated from SPN-812, a quick onset of action about a week. So can we expect a longer – a stronger launch than would normally be expected, maybe driven by demand building through word-of-mouth between parents and physicians? And then on the flip side, given that stimulants are recommended as first-line therapy, do you believe educating physicians will be a higher hurdle than with other products? Thanks.

[Jack Khattar, President and Chief Executive Officer]

I’ll start with the second question as I lead into the next question. As far as ADHD in general, physicians are very well educated, obviously, about a lot of these products, stimulants, non-stimulants, what typically are the treatment paradigms and so forth.

However, we do expect 812 to actually shake that paradigm and to give physicians an option that they haven’t had before. And that’s where we believe the uniqueness of 812 is and the excitement around 812 that we continue to see from KOL, as we continue to share the data with them and educate them on what this product and the profile of this product, specifically, as you pointed out, as far as the fast onset of action.

From a non-stimulant that they haven’t really seen historically and they continue to struggle with products like Strattera out there. So we certainly look at this product 812 to be a real meaningful game changer for many, many of these patients, as we pointed out in our Investor Day as well, given the clear differentiation it has, specifically with the – how quick it works, but not only how quickly it works, it’s actually – it’s not trouble at all for the physician and all the patients, because you don’t even need to titrate for many of these patients.

So you give a child 100 milligram, you don’t even need to titrate the 100 milligram in the first week, they know whether it’s going to start working or not. The parents will really know. They don’t have to wait before five, six weeks. They normally are used to with the Strattera product that they’ve experienced historically. So how quickly this product work, how easy it does work, actually, without a very complex titration mechanism. These are very different than the current marketplace and the options out there.

And then secondly, the fact that it works in a hyperactive, as well as the – in attention of subscales of the product equally, of the condition equally is another major benefit that this product brings in. So we see all these different angles, obviously, helping the product to be positioned as the first-line treatment, and why even try a child on a stimulant-controlled substance if you have an option like SPN-812, there’s no reason for the parent or the physician to even consider a stimulant.

If you have an option that you will know from week one that is it going to work or not. And what it is very simple to actually titrate and most of the cases, you don’t need even titration. And second of all, this is now a product that you also could potentially sample as well and they can try versus controlled substances where they cannot sample. And as well in dealing with refills, you don’t have to deal with the complication of refills for controlled substances.

So it’s really – if you step away from it, if you’re a physician or a parent, you look at 812 and you say, there is no downside. I’ll try it. And why wouldn’t I try it first? It’s easy. It’s simple. And then I will wait only for a week and see if it works or not. So it’s certainly we believe all these key points and, of course, the safety and the tolerability and the flexibility and how high you can go without even risking any of the safety and tolerability by going all the way to 400 milligram to 600 milligram.

So it’s remarkable and flexible dosing scheme that physicians also have at the disposal to treat patients with different condition as far as the severity of the condition, and how easy it is to use. So clearly, all the aspects are there for us to position this product as a first-line treatment.

[Operator]

Thank you. This concludes today’s question-and-answer session. I would now like to turn the call back to Jack Khattar for closing remarks.

[Jack Khattar, President and Chief Executive Officer]

Thank you. We are focused on advancing our late-stage pipeline as we look forward to building our next phase of future growth at Supernus. The remainder of 2019 represents a cornerstone in our future with three important milestones First, the submission of the NDA for SPN-812; second, getting the first set of Phase III data on SPN-810; and third, initiating the Phase III bipolar program on SPN-604. In addition, we are excited and we are well on our way in the preparations for the potential launch of SPN-812 next year, if approved by the FDA.

Finally, we look forward to building on the momentum we have behind Oxtellar XR and to the continued recovery and growth behind Trokendi XR. Thanks, again, for joining us this morning. We look forward to sharing with you the upcoming updates for the rest of the year.

[Operator]

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone, have a great day.