Supernus Pharmaceuticals, Inc.
Q1 2017 Earnings Call Transcript

Published: 10 May 2017

[Peter Vozzo:]

Thank you, Carmen. Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals' first quarter 2017 financial results conference call. The update discussed today is for the three months ended March 31, 2017. 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 by management, we will open the call to questions. We expect the duration of the call to be approximately 45 minutes. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflects Supernus' current perspective on existing trends and information that can be identified by such words as expect, plan, will, may, anticipate, believe, 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 2016 annual report on Form 10-K which was filed on March 16, 2017. 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 May 10, 2017, at approximately 9

[Jack Khattar:]

Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us as we discuss our 2017 first quarter results. We're pleased with our financial and operational performance in the first quarter and with the continued progress in our business. We continue to drive strong growth for Oxtellar XR and Trokendi XR, and are excited about the recent launch of Trokendi XR in migraine. During the quarter, net product sales increased by 31%, and operating income grew by 161% over the first quarter of last year. Driving year-over-year performance is the continued solid prescription demand for our products. Total prescriptions for Trokendi XR and Oxtellar XR as reported by IMS grew by 17% in the first quarter of 2017 over the same period in 2016. Trokendi XR, prescriptions for the first quarter totaled 101,695, which is an 18% increase over the same quarter last year. And for Oxtellar XR, prescriptions were at 33,160, representing an increase of 15% over the same quarter last year. After receiving final approval from the FDA in April 2017, the company launched Trokendi XR as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. While it is still early in the launch, for the first three weeks post launch, IMS prescription data for Trokendi XR show a strong upward trend in total and in new prescriptions. During the three week post launch, total prescriptions were 26,472 compared to 24,109 in the three weeks prior to the launch, representing a 10% increase. Similarly for the same three week post launch, new prescriptions were 12,978 compared to 10,898 in the three weeks prior to launch, representing an impressive 19% increase. We are very encouraged by this early IMS prescription data and continue to believe that the migraine indication will play a major role in maximizing the potential of Trokendi XR. Consistent with these early data, feedback from the field indicates that physicians are very receptive to the new indication, and appreciate the unique benefits that Trokendi XR brings to migraine patients. With its novel formulation, Trokendi XR provides full 24 hour coverage for patients with smooth pharmacokinetics compared to immediate release topiramate products, making it an important new prophylactic treatment option for adult and adolescent patients suffering from migraine headache. At the recent American Academy of Neurology, AAN Annual Meeting in Boston, we presented positive data the further highlight the important role Trokendi XR plays in improving the lives of patients in migraine and epilepsy. The presentation was based on a retrospective study and analysis of a large national claims database, including more than 10,000 patients comparing Trokendi XR extended-release topiramate to immediate-release topiramate. The analysis shows that patients on Trokendi XR have significantly higher adherence rates, longer treatment persistent periods and much lower discontinuation rates. In addition, we were excited to see data that were independently generated and presented on the AAN meeting by Dr. John [indiscernible] from George Washington University on Trokendi XR in chronic migraine patients. Data from an open label study of 51 chronic migraine patients show that patients who converted from immediate-release topiramate to Trokendi XR experienced fewer cognitive effect such as confusion and difficulty with verbal fluency or word finding. And that 82% of these patients reported increased satisfaction with that treatment. These data are consistent with data that Supernus had generated in earlier studies on Trokendi XR. Turning now to our pipeline and starting with SPN-810, which is currently in development for impulsive aggression in patients 6 to 12 years of age who have ADHD. Enrollment continues in both Phase III trials. Protocol revisions that we implemented to improve patient retention during the screening period and programs to drive patient involvement for the Phase III trials are showing positive results. To date, enrollment in the open-label extension by those who completed the trials remains high, currently exceeding 80%. We continue to expect enrollment through 2017. Regarding SPN-812, currently in development for patients 6 to 12 years of age with ADHD, plans are in place to initiate Phase III clinical testing during the second half of 2017. We are on track to meet with the FDA in the second quarter of this year for an end of Phase II meeting. Finally, we continue to be active on the corporate development side looking for neurology and psychiatry assets that represents a strategic fit with our portfolio. I'll now turn the call over to Greg, who will provide more details on our first quarter operating performance.

[Greg Patrick:]

Thanks, Jack, and good morning, everyone. As I review our financial results, I'll remind our listeners to refer to the first quarter 2017 earnings press release issued yesterday after the market closed. Net product sales for Trokendi XR for the first quarter of 2017 were $42 million, a 30% increase compared to the prior year period. Net product sales for Oxtellar XR in the first quarter of 2017 were $14.4 million, a 34.6% increase as compared to the prior year period. Total net product sales for the first quarter of 2017 were $56.4 million compared to $43 million in the first quarter of 2016. Total revenue for the quarter, $57.6 million, included net product sales of $56.4 million, noncash royalty revenue of $1.1 million and license revenue of $58,000 as compared to $43 million, $1.1 million and $50,000, respectively in the first quarter of last year. Consistent with patterns we observed in the first quarter of past years, product prescriptions and net product sales for the first quarter of 2017 were impacted by the continued shift of patients to high deductible and high co-pay plans. In addition, lower wholesaler and retail inventory levels during the first quarter of 2017 as compared to the fourth quarter of 2016 had the effect of reducing net product sales by approximately $5 million in the first quarter of 2017. Gross-to-net deductions for the first quarter for Trokendi XR were approximately 37%, while gross-to-net deductions for Oxtellar XR in the first quarter were approximately 44%. Gross-to-net deductions are higher as compared to the fourth quarter of 2016, primarily because of the higher co-pay support to patients. Research and development expenses in the first quarter of 2017 were $9.6 million as compared to $10.6 million in the same quarter last year. This decrease is primarily due to the completion of enrollment in the Phase IIb trial for SPN-812 which occurred in the third quarter of 2016. Selling, general and administrative expenses in the first quarter of 2017 were $28.2 million as compared to $25.2 million in the same quarter last year. This increase is due to marketing program development, sample production and other activities related to preparing for the migraine headaches indication for Trokendi XR, which occurred in April 2017. For the first quarter, operating income totaled $16.8 million, a 160% increase over $6.4 million in the same period last year. This improvement in operating income is primarily driven by increased net product sales, coupled with relatively flat operating expenses. Net income for the first quarter of 2017 was $10.3 million or $0.19 per diluted share as compared to net income of $4.8 million or $0.08 per diluted share in the first quarter of 2016. Diluted earnings per share for the first quarter of 2017 includes an effective tax rate of 36.5% as compared to an effective tax rate of 4% during the first quarter of 2016. We expect that the tax rate for the remainder of 2017 will approximate the tax rate throughout the first quarter. Approximately 52.8 million weighted average diluted common shares were outstanding in the first quarter of 2017. Compared to 51.2 million diluted shares in the first quarter of 2016. As of March 31, 2017, we had $176.3 million in cash, cash equivalents, marketable securities and long-term marketable securities as compared to $165.5 million as of December 31, 2016. As of May 8, 2017, approximately $1.6 million of the company's six year $90 million notes remain outstanding. During the second quarter of 2017, the company initiated the process of calling the remaining outstanding principal balance of its six year notes. We anticipate that this process will be completed during this quarter. Now turning to full year 2017 guidance. We continue to expect full year of 2017 net product sales to be in the range of $265 million to $275 million; R&D expenses to be approximately $55 million; and operating income to range from $75 million to $80 million. Full year 2017 operating income includes approximately $5 million of non-cash royalty revenue. I will now turn the call back to the operator for questions.

[Operator:]

Thank you. [Operator Instructions] And our first question is from the line of Ken Cacciatore with Cowen and Company.

[Ken Cacciatore:]

Just a question as you talked about business development. I wanted to understand the sales force. You're rolling out migraine right now, could you just talk about the capacity that sales force has in terms of taking more? And then also, when it comes to 810 and 812, maybe just a reminder of the potential market opportunity for both as kind of briefly as you can, maybe frame it for us and give us some perspective? Thank you.

[Jack Khattar:]

Regarding the capacity of the sales force, no question that currently we are very busy with the migraine launch and very excited about how the launch has been executed, although it's early in the launch at this point. So certainly, we're not looking at adding an asset right away. But if we find something, we're not going to stop pursuing it because of the capacity of the sales force. If it does require an incremental expansion of the sales force, we'll be willing to do that to accommodate the new selling effort and the new promotional effort that whatever new asset we bring on board could require. Regarding the SPN-810 opportunity, as a reminder, this is an extremely prevalent disease, impulsive aggression, across so many disease areas. It is comorbid in ADHD, which is the first area we're pursuing in our development program. It is also comorbid with many other CNS disorders such as PTSD, schizophrenia, autism and so forth. We believe this market opportunity exceeds $5 billion, and all the research that we have done to date, some of which is very extensive, some of which is very quantitative research points to the fact, and we believe this that the product is $1 billion or more for Supernus. So this is a tremendous opportunity. We are the first company to develop a product for this indication. Again, of all the diseases very well known, psychiatrist understand this disease and know how to diagnose the disease. There's no product that is approved for the treatment of impulsive aggression, and Supernus is pioneering this whole clinical development. As you recall, we have developed a novel diagnostic tool which we are using in our clinical studies, and truly pioneering the whole field in this area. So we're very excited about 810. And likewise, although you didn't asked about it, SPN-812, given the data that have we gotten on Phase 2b, we are very excited about SPN-812 and its potential as well. And even a very small penetration of the ADHD market by SPN-812 also gets it to $1 billion product. So we're really excited about both products in psychiatry.

[Operator:]

And our next question comes from the line of David Steinberg with Jefferies. Your line is open.

[David Steinberg:]

You mentioned uptick in scripts recently as to the results of the early stage of the migraine launch. Just curious what you're thinking about sales force. Will you right size if you see a significant uptick? What are you thinking about adding new reps? And how many reps might you add? And then secondly, capital allocation, are you still actively looking? And what are you seeing in terms of prices in particular, private companies as well as individual products to add to your portfolio?

[Jack Khattar:]

Yes. Regarding the sales force sizing and potentially adding new representatives to our sales force. We continue to hold the same premise that we have mentioned earlier. We will be watching the migraine launch very closely as we are with data that we've seen in the first three weeks is truly impressive. I mean, specifically, when you look at the increase in new prescriptions in the last three weeks on a weekly sequential basis, it's increased in a very significant manner, so we're very encouraging that. However, we will watch the migraine launch for the next quarter. So we would like to get at least a full data set for a full quarter before we make a decision on an expansion in the sales force. So probably that decision will have to come in sometime in summer or mid to late third quarter of this year after we get the full second quarter IMS prescription data. As far as capital allocation and priorities and business development, corporate development. Again, we're heavily prioritizing a lot of the opportunities in the neurology and psychiatry space. Neurology, things that are very synergistic would overlap full point with our current products. And in the psychiatry, any products that we could potentially commercialize about a year ahead of SPN-810 or 812, we will certainly look at those as well. As far as prices of assets, it's always a competitive process. It's, the prices haven't really settled that much. There is still a lot big premiums being paid for certain assets. And in our situations, as we've always been, we continue to be disciplined in looking at these things. We have a very solid process in how we screen for opportunities and how we determine what I really the value of some of these assets, so we don't end up overpaying and over diluting the company.

[David Steinberg:]

Just one quick follow-up. So your tax rate is creeping up and [tax rate] shortly this year, as you look downstream, any opportunities to lower your tax rate in any way? Or should we assume a full tax rate for the foreseeable future?

[Greg Patrick:]

Yes. David, this is Greg. I think it's probably best to assume that it can be [count] it will continue to go forward pretty much in the same range that we indicated that I just referenced earlier today. There are some things that we're looking at actively to try to manage that down. But I would say those would be more incremental. For us to do something dramatic, we would have to be looking at some sort of transformative transaction to really effectuate step change in the tax rate. And while we've entertained that in the past, we're cognizant that our primary method is to run the business and efficiently. We'd love to drive the tax rate down but the tax rate issue is not going to drive our overall business strategy.

[Operator:]

And our next question comes from the line of John Boris with SunTrust. Your line is open.

[John Boris:]

Jack, first question has to do with the existing assets with the litigation overhang removed off of both assets. I think you've stated that each asset, in total, could be in around the range of about $500 million. In light of the longer life that each asset has and now nearing the migraine indication possibly, a bipolar indication, just your thoughts around the sizing of the aggregate of those 2 assets going forward. Second question on Oxtellar XR and bipolar, your exploratory study, timing for that and then can you give us maybe some history, this works on sodium channels, I think, it also work on sodium channels, how successful were they when they got that indication? And then lastly, Greg, can you just walk us through some of the mechanics on the tax side of the equation from an accounting standpoint that resulted in a higher tax rate in the quarter?

[Jack Khattar:]

Yes, John. Regarding the peak for tangible for Trokendi XR and Oxtellar XR. We've always said there are around the $500 million or more. That number always included the migraine potential for Trokendi XR clearly. But it did not include the potential of Oxtellar XR in the bipolar indication. So when you factor into the equation the breadth of Oxtellar XR in the bipolar market, we think the peak potential of both of these products combined will approach to $750 million instead of the $500 million. And the reason we say that is because the bipolar market is a very significantly large market compared to epilepsy. It consists of about 53 million prescriptions a year. And to your question about sodium channel blocker such as oxcarbazepine and or lamotrigine, which is the franchise that you referenced, as the make whole actually accounts for about 16% of that 53 million prescription market. So sodium channel blockers are very well-established in the community, as far as their effectiveness in the use of bipolar. Oxcarbazepine itself is currently also being utilized heavily in bipolar, although the indication was never on [indiscernible] capital back in the days. And actually about 2 million prescriptions we estimate according to IMS of oxcarbazepine are currently for psychiatric disorders. And we are completely excluded from that market because obviously, we don't promote Oxtellar XR in psychiatrist's offices. So our use in Oxtellar XR is very, very minimal in bipolar currently. And that's why we believe if we -- and successfully develop the bipolar indication for Oxtellar XR, it will open up a whole new market for us. And therefore, increasing the potential for that franchise significantly. So we are very excited about that. As far as the timing of the bipolar study for this year, we expect it to start in the third quarter of this year, the investigator-initiated trial. And hopefully, with some initial positive data from that trial, if it comes in, in 2018, then we will make a decision on initiation of Phase 3 program.

[Greg Patrick:]

Regarding, John, the tax rate question, this is a little bit of a complex issue and I'll try to be brief. And if we need to follow-up discussion we will be glad to do that. If we go back in time to when the company was a development stage company, in its early period as a commercial company, the company built up significant net operating losses, in fact, in excess of $150 million. And those net operating losses never -- were manifested on our balance sheet or our financial statements because during this period, we cannot make an affirmative statement that we would more likely than not use those net operating losses going forward. And so if you went back and historically, you would see nothing on our financial statements that reflect any of that. The [indiscernible] for us in terms of the tax situation occurred in the third quarter of last year, third quarter of 2016, when the company made the judgment that it was more likely do not that these NOLs would be in fact used going forward. The basis for that judgment is a little bit complex and we should discuss it offline, but let's just take that as a given, that we made an affirmative statement that we would be able to use these NOLs going forward. And so if you looked at our third quarter results, as I'm sure you've had, you'll notice a couple of very interesting things going on. Number one, I will deferred tax as it appears in our balance sheet, that in effect, represents the value of those NOLs and we recorded that in the third quarter of last year. And at the same time, we ran through the P&L when in the fact that look like it was a negative tax impact. So actually, our net income our operating income by the amount of that charge. And so that very much landscapes completely made our third quarter results completely different and much more favorable than anybody could have ever expected. From that point on forward, what we record as a company, fourth quarter last year was a little bit of a different quarter, I think the first quarter this year more represented it. What we're recording in fact is a book tax rate, which reflects really the ongoing underlying statutory rate that the company expects to be paying long-term. You might say though why is that? And what happened to our NOLs? Well the NOLs still the value of NOL is still on the balance sheet and the way that manifests itself is rather than pay cash taxes, so we're recording a book tax and you can see those impact our net income for the quarter. But rather than writing large checks in an amount equivalent to that, we're in effect reducing the deferred tax asset, so we're reducing that liability by offsetting it, but as a reduction against the deferred tax asset. So in effect, we look at different paying tax, we're paying tax on a book basis. But on a cash basis, we are not. Our cash tax will be more in line with where it has been over the past several years. Beyond 2017, the speculative that I expect that we would be in fact a cash paying, full cash taxpaying entity as well as a book taxpaying entity sometime in 2018 and beyond. But for this year, we would expect to see that disparate between the book tax rate and the cash tax rate. I hope that answers that.

[Operator:]

And our next question comes from the line of Annabel Samimy with Stifel. Your line is open.

[Annabel Samimy:]

First on the gross-to-net this year for both Trokendi and Oxtellar. Is this is a proper go forward rate? Or is there some quarter dynamics that would've caused it to be higher now? The second thing specifically on Trokendi, the average net realized price. Can you just tell us with the launch in migraine, are these patients going to be using a lower dose than it's a blend kind of put pressure on the average price of the prescription going forward? And then finally, you mentioned the bipolar indication for Oxtellar and trying to maximize that opportunity. I guess your life is at 2027 is that correct?

[Greg Patrick:]

Yes, that's correct.

[Annabel Samimy:]

So you do have sufficient time to maximize that opportunity then. Do you have any sense of how long the program, the development program would take? Is it just a similar Phase 3? Or would it be a much larger broader program that would cut into that life?

[Jack Khattar:]

Sure. Annabel, let me start with the last question on the bipolar for Oxtellar XR. I mean, the program will take probably a good 3 years from start to finish. So if we were to launch Oxtellar XR in bipolar, we're probably looking at the 2020, 2021 timeframe, my guess. It's a really wild guess at this point, but it should be close to what reality will end up being. So yes, we will have enough time assuming we will have complete coverage on Oxtellar to all through 2027, which we expect to get a good return on our investment on that program. Sorry, your second question Trokendi XR usage in migraine. Again, it's a little early for us but typically, migraine doses are lower, the daily dose for migraine is lower typically than in epilepsy. So if we are very successful in migraine, naturally, we would expect the daily dose to, on an average, to be a little bit lower versus what it used to be in the past. It's more likely to be in the 100 milligram, although if you actually look at the [trokomax] clinical data the 100-milligram and 200-milligram are the effective doses. And when we go to 50-milligram or less, actually the data did not show any statistical significance or separation versus placebo. So given the power ability of Trokendi XR, which we hear, continue to hear from the field that it is much better than immediate-release topiramate, we might see physicians actually using 100-milligram or higher if they really want to get the higher efficacy. So I would wait for another quarter as we said earlier to see whether that will shift completely. But I could say in a fairly certain manner that the daily dose will probably be closer to the 100 milligrams.

[Greg Patrick:]

And there was a question that I was going to respond to that. As I mentioned in my remarks, in the first quarter, because like the onset of the high deductible patient programs and the effect that it has in terms of patients fulfilling their prescriptions, we have substantially enhanced our co-pay program for both products in the first quarter, and we see that manifested in higher gross-to-net deductions. For example, for Trokendi XR compared to fourth quarter of 2016 versus first quarter of 2017 is an impact of 3 to 4 percentage points. And most of that, let's say, virtually all of that, is attributable to the co-pay program. Do we expect it to go back down to the 33% in the fourth quarter? Probably not because there's some other things going on there, but I certainly expect that to improve vis-à-vis the 37% that I referenced in my remarks earlier today. So yes, there is something unusual going on in the first quarter.

[Annabel Samimy:]

And just if I could go back to the question on Trokendi in migraine. Do you know at this point whether physicians are using 100-milligram? Or are they still using lower than that?

[Jack Khattar:]

Yes. Currently, in the migraine market, specifically, on topiramate with immediate-release products, most of the usage is 50-milligrams or lower.

[Annabel Samimy:]

And then with your product?

[Jack Khattar:]

Well, we just launched 3 weeks, so we don't have really a very solid pattern at this point to point to. And I don't want to really discuss too much of our positioning of the product and so forth on the call but currently, people are using immediate-release products in the 50-milligram and lower, which is a very soft therapeutic dose.

[Operator:]

Thank you. And our next question is from the line of David Amsellem with Piper Jaffray. Your line is open.

[David Amsellem:]

Just a question on Oxtellar in bipolar. So can you just elaborate on what you think you'd need to do in a Phase 3 program? How long that program would take? When do you think would be the earliest you'd get a label expansion in bipolar? And then since it's an adult psychiatry setting, I'd surmise that it wouldn't necessarily synergize all that well with an adolescent and child psychiatry setting for the ADHD business. So maybe you can talk about the kind of sales force you would need to deploy if you were to get a label expansion for Oxtellar in bipolar.

[Jack Khattar:]

Yes, sure. Regarding the program itself, we will need to do two Phase 3 trials in bipolar. As I mentioned earlier, most likely, if the initial study we're doing this year is positive, we'll initiate Phase 3 potentially next year on bipolar for Oxtellar XR. This study will take probably about a year, a little bit longer than that. And then hopefully, and then launching the product in the 2020, 2021 timeframe. As far as the sales force itself, it isn't psychiatry, and the asset will be in adult psychiatry. But that is an area which eventually we will be in with our ADHD products. Our ADHD products are not going to develop just for pediatrics. So there will be synergy eventually in the psychiatry space overall. So all going to end up depending on the timing, David, as far as Oxtellar XR launch and bipolar and then the launch of SPN-812 and 810 as well when we add those indications for these two products.

[David Amsellem:]

Okay, and as a follow-up, you've talked about in the past potentially adding a psychiatry-focused asset in the near-term that you can build a sales organization around. And I know you alluded to business development and in your scripted remarks earlier in the Q&A, but how big of a priority is it for you to find a psychiatry asset in the near-term, so you can jump start your commercial organization efforts there?

[Jack Khattar:]

Yes. I mean, the ideal timing is about a year before 812 and 810. 812 and 810, both of them, again, are going to be in the 2020, 2021. We're going to have a very high quality problem where we have actually so many opportunities in psychiatry between Oxtellar XR and bipolar, SPN-812 and SPN-810. And the timing of these three assets, as you would imagine, we will shift around for a while until these programs are set in place and we have more predictability and sight into the future as to when actually we'll end up launching these three assets. So for us to pay money to bring in another asset in psychiatry, it really has to be launched in the 2019 time frame. If it's later than that, it really doesn't make any sense for us to bring it in. So as far as priority, we continue to look for these assets because anything that could accelerate our growth and accelerate our penetration into the psychiatry office is going to be tremendously valuable for us. So it is still a priority and we continue to look and we are looking at assets in that time frame. Although having said that, as you probably imagine, I mean, there are and always too many assets available out there that fits exactly are timing but that's what we get paid to manage all these issues. These are high quality problems to look at.

[Operator:]

And our last question comes from the line of Bill Tanner with Cantor Fitzgerald.

[Bill Tanner:]

Jack, I don't want to put words in your mouth but it sounds like the migraine launch is going better as expected. So I'm just curious if you have a thought on whether the ceiling is higher potentially for that indication? Or if the, I guess, or maybe the ramp is just faster. And then is there, what will be the ways to strike while the iron is hot to take advantage of this, thinking about promotional efforts or maybe not this just relates to more sales people. Maybe just your thoughts on that and then I have one follow-up, please.

[Jack Khattar:]

Yes, sure. Look, we are extremely excited, very excited about the first three week data. Now having said that, it is early in the launch. We try to be conservative as far as how we will look at things but we're extremely excited about the uptake and the initial uptake. It is a little bit better than we expected, I would say that. Our sales force has been tremendous. I mean, they've executed amazingly on the launch and we had a very, very strong marketing program behind the product launch. So the whole commercial team did an outstanding job in launching the products. So we're extremely excited about the initial uptake. Will that mean that there is really a much higher ceiling for migraine? Will that mean that the potential of Trokendi XR in migraine is way, way much higher than we expected? Yes, that is a possibility. No question about it. If we continue the effort as we have in the last three weeks, if we continue that intensity as far as our promotional effort, and at the end of the day, I mean, the product actually performs very well and it really delivers significant benefits to the patients because you could have the best sales force effort the best marketing efforts, if the product does not deliver, it really doesn't matter much. And that's really another exciting portion here that actually Trokendi XR delivers extremely high new benefits, unique benefits for these patients and our promotional efforts therefore, and up bearing the fruits of this extremely great program. So we're extremely excited about migraine. No question about it. It is a possibility that it could mean a much higher ceiling or potential Trokendi XR than expected. And hopefully, in the next earnings call, we will be delivering even better news than this stuff we're excited about right now. I hope that helps but again, I want to caution people, it is three weeks into the launch. It's still early but I would rather have this kind of data in the first three weeks than something else.

[Bill Tanner:]

And then as it relates to 810, you did take off some other indications beyond impulse aggressive, PTSD, schizophrenia and autism. I guess one question I would have is, is there anyway to leverage the ADHD clinical workforce, some of the other indications, so that you could say, economically and efficiently arrive at an approval for broader indication? Is this something where obviously with the reimbursement environment like it is off-label, maybe look at but just wondering, if you think for these other indications, you really would be to go after them formally? And then as they're learning from ADHD, that can maybe cut the time and obviously reduce the cost?

[Jack Khattar:]

Well, absolutely. I mean, we are going after the same indication, just to clarify. The indication is impulsive aggression. It's just that it would be studied in different patient population that have other diseases. So because of that, and we believe, impulsive aggression as a condition is not really different in an ADHD patient versus an autistic patient versus a schizophrenic patient or PTSD and so forth. Scientifically, the disease, the condition is the same across all these areas. And therefore, absolutely, we expect synergies in the program moving forward, so the initial push is in the ADHD population. And then the remaining matter really is an issue of negotiating with the FDA and see what will they ask us to do. Will they ask us to do 1 more Phase III in 1 more area and would they ask us to do 2 Phase IIIs, 1 in autism, 1 in PTSD, and then we get the full indication of much broader indication, so that remains to be seen. But the good news here, at least in our perspective, everything that we have done so far scientifically, all the we talked to, they believe that the disease is exactly the same regardless of the patient population and therefore, that should help us with our discussions with the FDA to hopefully make the program very synergistic.

[Greg Patrick:]

And Bill, in terms of learnings of existing 810 program, I think a lot of that is directly transferable into these additional Phase III trials that Jack alluded to. We heard a lot about some of the challenges that was having in terms of recording events, dealing with the handheld device to record those events, communicating the scale to physicians and to office coordinators and the like. I think we have learned a ton in terms of how to execute this trial that would be to subsequent trials.

[Operator:]

And ladies and gentlemen, this concludes our Q&A session for today. I would like to turn the call back to Jack Khattar for final remarks.

[Jack Khattar:]

Thanks. We are off to a great start for the year and are tracking well towards our full 2017 financial guidance and towards achieving our goals on our pipeline programs. We look forward to several key milestones this year, including continued strong execution on the launch of the migraine indication for Trokendi XR, starting new growth initiatives on Oxtellar XR… [Technical Difficulty]

[Operator:]

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program, and you may all disconnect. Have a wonderful day.