Good morning, ladies and gentlemen, and welcome to Supernus Pharmaceuticals Second Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later we'll conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the conference over to Peter Vozzo of Westwicke Partners, Investor Relations for Supernus Pharmaceuticals. You may begin.

Thank you, Juan. Good morning, everyone, and thank you for joining us today for Supernus Pharmaceuticals Second Quarter 2017 financial results conference call. The update discussed today is for the three months ended June 30, 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 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 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 our 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 August 3, 2017, at approximately 9:00 a.m. Eastern Time. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws. I will now turn the call over to Jack.

Thank you, Peter. Good morning, everyone, and thanks for taking the time to join us as we discuss our 2017 second quarter results. We're pleased with our results in the second quarter and specifically with the launch of Trokendi XR in migraine that is the key driver behind our excellent financial performance. During the quarter, net product sales increased by 46%, and operating income grew by 124% over the second quarter of last year. Our year-over-year performance continues to be driven by solid demand for our products. Total prescriptions for Trokendi XR and Oxtellar XR, as reported by IMS, showed growth of 28% in the second quarter of 2017 over the same period in 2016. For Trokendi XR, prescriptions for the second quarter of this year totaled 124,229 prescriptions, representing a 33% increase over the same quarter last year. And for Oxtellar XR, prescriptions were 34,523, representing an increase of 12% over the same quarter last year. The company launched Trokendi XR in April 2017 as a new treatment for prophylaxis of migraine headache in adults and adolescents 12 years and older. We are especially pleased with the robust acceleration in prescription growth that we have seen behind the launch. To put this acceleration and prescription growth in perspective, for the second quarter of 2017, total prescriptions for Trokendi XR increased by 22,534 prescriptions or 22% from the first quarter of 2017. This compares to an increase of 6,996 prescriptions or 8% in the second quarter of 2016 over the first quarter of 2016. Similarly, for the same sequential quarter-to-quarter time periods, new prescriptions for Trokendi XR increased by 14,594 prescriptions or 31% in 2017 compared to 2,352 prescriptions or 6% in 2016. The trend of accelerated growth in prescriptions continued through also the recent weeks in July. We believe…

Thanks, Jack, and good morning, everyone. As I'll review our second quarter financial results, I am reminding our listeners to refer to the second quarter 2017 earnings press release issued yesterday after the market closed. Net product sales for Trokendi XR for the second quarter of 2017 were $56 million, a 49% increase compared to the prior year period. Net product sales for Oxtellar XR in the second quarter of 2017 were $17.3 million, a 36% increase as compared to the prior year period. Total net product sales for the second quarter of 2017 were $73.3 million compared to $50.3 million in the second quarter of 2016 or 46% higher than prior year. Total revenue for the quarter of $75.8 million included net product sales of $73.3 million, noncash royalty revenue of $1.2 million and license revenue of $1.3 million as compared to $50.3 million, $1.2 million and $86,000, respectively, in the second quarter of last year. Gross-to-net deductions for the second quarter for Trokendi XR and Oxtellar XR were essentially unchanged compared to the first quarter of 2017. We expect gross-to-net deductions for both products to remain relatively flat for the remainder of the year. Research and development expenses in the second quarter of 2017 were $10.8 million as compared to $11.1 million in the second quarter last year. This decrease is primarily due to the completion of enrollment in 2016 of the Phase IIb trial for SPN-812. Selling, general and administrative expenses in the second quarter of 2017 were $35.1 million as compared to $26.1 million in the same quarter last year. This increase is primarily due to promotional activities and programs related to the 2017 -- excuse me, April 2017 launch of the migraine headache indication for Trokendi XR. For the second quarter, operating income totaled $26.1…

Thank you. [Operator instructions] Our first question comes from David Amsellem of Piper Jaffray.

Okay. Thanks. So I had just a couple of questions. First, and I may have missed this, so I apologize. But can you talk about the amount of sales for both for either product that were impacted by inventory builds, if that was a tailwind for the quarter? And just talk us through how much inventory is on hand and what should be steady-state. And then secondly, this is sort of a longer-term question on Trokendi. But as prescription volumes continue to grow, the footprint of the product continues to grow, how should we think about the payer landscape in 2018? Do you think it could be more restrictive as this becomes a more higher volume product? And could we see perhaps wider gross-to-net next year? So maybe you can talk to that as well.

Okay. David, with respect to inventory build for the second quarter, let's go back to the first quarter where we noted that there was actually a contraction in the pipeline, which had an impact on our net product sales of approximately $5 million for the first quarter. Now when we talk about inventory coverage, our perspective is measuring it in terms of weeks of coverage. So of course, as product franchises, both for Oxtellar XR and Trokendi XR grow, the number of units in the pipeline is naturally going to grow along with that, just because the franchise is larger. When we refer to contraction, we're actually referring to the numbers in weeks of coverage. So, in the first quarter, we noted that there was an impact of roughly $5 million. We have carefully monitored that in the second quarter. And we have ascertained the best of our ability to measure this that the recent coverage between the first and the second quarter haven't changed. Now that does not mean that the number of units in the pipeline haven't changed. It's clear there's been a significant secular increase. And that product [Oxtellar XR], particularly for Trokendi XR, first quarter to second quarter. So, units in the pipeline have increased. Weeks of coverage in pipeline, as measured between first and second quarter, have not increased. What this means that there's a permanent deduction to the pipeline in terms of weeks of coverage. It would appear so. It reduced in the first quarter. It's stable in the second quarter. Third quarter, we'll probably report back on that when we've got the third quarter closed. Regarding your question about coverage and whether -- going forward, whether we would expect managed care to be more restrictive with respect to access to Trokendi XR for migraine indication, we haven't seen any indication of that, whatsoever. In fact, even before the launch of the migraine indication, there was relatively little in the way of restrictions in terms of managed care prescription for off-label uses of Trokendi XR. I'm not aware of any managed care initiative to make that more restrictive now that it's actually on-label rather than off-label.

No, that's helpful. Just to be clear, just as follow-up on the managed care question, do you have -- you've seen -- I know this is early. Have you seen patients -- migraine patients having to step through the immediate-release topiramate in order to get access to Trokendi, or has that been pretty rare?

No. That's actually very commonplace. That's been in place for years. They -- so what typically happens is -- for many managed care plans is that when you walk into the pharmacy that you need to demonstrate that you've been on the IR topiramate. And in fact, that's done in automated fashion, given though that the market is -- when we launched, it was essentially entirely generic. That was something that every patient satisfied unless they were new to the world topiramate user. So that has been in place for a long time. It's handled in automated fashion. It never really was much of a barrier just because of the expensive generic prescriptions -- prescribing behavior in the marketplace already.

Okay. Thanks.

Thank you. Our next question comes from Annabel Samimy of Stifel.

Hi guys. This is Andrew in for Annabel. Just a couple of questions. So, based on the run rate this quarter, it looks like guidance implies relatively low incremental growth in Trokendi and perhaps even declines in its sellers. So, was there something in the quarter that was unusual that would lead to a conservative second half expectation? And I have a second question on SPN-810.

We've got to review your math with you offline. I do not -- not in accord with your projection. Our guidance clearly shows a secular increase from quarter-to-quarter. We don't provide quarterly guidance. But given what we've done year-to-date and given our guidance, I think the difference would imply that both products will grow substantially over the year. Clearly, Trokendi XR is growing faster in percentage as well as dollar amounts. But if you want to talk about that one offline, I'd be glad to do that.

Great. And so, then on 810, so expansion into adolescence, will that solve the problem, which you've been seeing, because it doesn't seem to be a matter of finding patients as opposed to getting them onboard?

Yes, as far as 810, I mean, we are actually very encouraged by this new development, because you might recall, we have developed a diary and the scale initially for the pediatric population. And we have done -- in the meantime, we have done some extra work on the diary and the scale, and we have shown to the FDA that the diary and the scale need to change with the -- to measuring impulsive aggression in adolescent population. So, this is actually a new recent development, very positive one. And therefore, we have approached the FDA with these results, of that work that we have done. And we are awaiting the response as far as potentially including the adolescent population. So, we don't know at this point when we will be able to include the adolescent population. If we get the response in a good timing where it doesn't mess up the Phase III program that we have ongoing right now, then we will do it. But if it's a little bit too late, because enrollment has gone a little bit faster or has moved on and the agreement from the -- regarding the protocol assessment and changing the protocol assessment to include adolescent population that comes a little bit later, then that's okay too. But our plan is to really develop this product obviously for both populations.

Great. Thank you, guys.

Thank you. Our next question comes from John Boris of SunTrust.

Thanks for taking the questions and congratulations on the results. First question for you, Jack, just has to do with Trokendi XR. Of the prescriptions you generated in the quarter, what percent were switches and from established patients that are taking the immediate-release Trokendi versus new patient starts in the treatment of migraine? And then a question for you, Greg, just has to do with the number of selling days in 2Q. And what number of selling days do you anticipate in 3Q? And does that match what you had previously year-over-year in the quarters? And then I have a couple of pipeline questions.

Yes, sure. Regarding your question on the prescriptions, I would say, John, that the majority is switching. That is also our thrust behind the launch is switching, converting patients, existing patients from immediate-release to extended-release Trokendi XR. So that -- and our commercial organization has been executing extremely well on that plan and on that positioning in the marketplace. So, I will have the say that most of the growth is coming from the switching. I will give you another important metric, which is really interesting is that so far, during the launch -- so far into the launch, we've seen a change -- a significant change in behavior in physicians, which is obviously reflected in the growth in the prescriptions. But we believe we have still a long runway as far as our whole position in the universe and seeing that same change in behavior in a much broader sense. So, we think we're still in the early phase of the launch of migraine.

But Jack, are you seeing a step-up from 50-milligram users that's a noneffective dose to 100 milligram?

Yes. I mean, our positioning has been to push on the 100 milligram, which is the clinically proven effective dose of topiramate in migraine. That's clearly what the data shows from a clinical point of view. And physicians are really seeing the differences between the two. And not only that, a lot of physicians were unaware and were not conscious about the clinical data that Topamax actually has shown that the 50 milligram was not statistically different than placebo in the Phase III trials that Topamax had. So, it's been an eye-opener for a lot of physicians out there, especially that now we can talk about this clinical data, provide them with that education in how and what is the best usage of topiramate for prevention of migraine. And Trokendi XR, as we mentioned many times, is extremely suited, perfect optimal delivery to allow physicians to get to the 100 or even to 200 milligram with a much better pharmacokinetic profile and potential benefits from a tolerability perspective.

John, this is Greg. With respect to the number of selling days, frankly, I have not counted those. I can do that and get back to you. We've got to have that discussion with you. My expectation in the second quarter, third quarter are pretty much the same, given that we've got a multi-day holiday in the third quarter. You also have Memorial Day in the second quarter. So, I don't think that there's going to be a big impact there, but I can get back to with respect to that. I can't recall the other question you asked.

Just has to do with the pipeline. Just -- there's obviously a lot of interaction in the FDA in the quarter, most notably, just focus on bipolar. You had a meeting with the FDA about the investigator-initiated trial. It certainly seems as though there is a concerted effort by the FDA to try and streamline the process. Is there any chance that this investigator trial counts as 1 of 2 trials that would potentially be pivotal? And then any outcome from your SPN-812 meeting with the FDA on the initiation of your Phase III trial.

Yes. Starting with bipolar trial for Oxtellar XR, just to clarify, this is an investigator trial, so we didn't have any specific interaction with the FDA on that trial, per se. It's not under specific IND or anything like that. So, from that perspective -- now at the right time, yes, we will approach the FDA as far as to the requirement in the end that will be needed, what will the filing have to be and what will it have to include: 1 Phase III, 2 Phase IIIs, and whether the FDA's perspective on that will change over the next year or so, we don't know. That's yet to be defined at this point. But the basis -- the base assumption is we have to do two Phase III programs. And we will start these programs, I mean, as soon as possible, as we start seeing what's happening in the investigator trial, which is more like a proof-of-concept kind of trial at this point. As far as our interaction with the 812, as we said, based on the meeting we had with them and actually similar to the situation on 810, we have decided to move with an expanded program, so to speak, with both pediatric and adolescent patient population. So, what we have proposed and the things we're looking at now is initiating potentially trials in both patient populations at the same time. So, we still continue to be excited about this program and look forward to really start dosing patients around the school year.

That's great. Thanks, and again congrats on the results.

Thanks.

Thank you. [Operator instructions] Our next question comes from Bill Tanner of Cantor Fitzgerald.

Thanks for taking the questions. Jack, I had one on -- just some color on the Trokendi update -- uptake, rather, in migraine? Is this kind of a dynamic, where the physicians are at least initially prescribing it to a few patients and seeing what the response is? And if that is the case, I mean, is this something that the guys in the field see their momentum beginning to build, if there's any kind of semiquantitative or qualitative comments you can make on that would be helpful. And then I have a follow-up.

Yes, it's really a combination of several dynamics, one of which I touched on, which is, the first, more education. The physicians are saying, okay, now I understand why I've been seeing in my clinical practice what I've been seeing with patients and why I haven't been able to titrate patients to higher doses that actually work. Now I understand, I now -- I remember the data, or this is the first time I see the clinical data on topiramate and migraine. Because remember, Topamax hasn't been promoted in the physicians' office since probably 2009 and the product went generic. So, this is a new educational era or stage for a lot of these physicians, reminding them of what the data actually looks like. So, it's a combination of a lot of physicians saying, okay, now I understand, and therefore, my current patients who have been struggling with the 50, and trying to push them up to 100. And then they get to the side effects with the immediate-release and I have to titrate them back down to 50 or 75 or whatever. Now I feel more confident as a physician, try to push them to the 100 milligram, 200 milligram. In addition to that, as time goes on through the launch and as physicians obviously see for themselves in their own clinical practice what is going on within their own patient population, then you would expect -- and given that the product -- I mean it has been delivering amazing. I mean, these products -- I know we talk a lot of their growth over the years. But in the end, they are extremely good products, both of them, Oxtellar XR and Trokendi XR. And in the end, they actually deliver on these benefits. So, when the physicians starts seeing that delivery on these benefits, then they feel more confident in broadening or penetrating more into their patient population and adding more patients to Trokendi XR. So, it's really a combination of trying it with few patients, getting that confirmation that yes, the 50 milligram doesn't work because of all these issues. Yes, if I put it to 100 milligram, I get all these side effects and tolerability balance, yes, I've been compromising by putting patients on once-a-day immediate-release, which I know I shouldn't, because it's not designed to be a once-a-day, but I do it as a physician at might to let patients sleep through the side effects. And I know that potentially in the morning, they may not have enough drug in their system. So now that they're really understanding all these issues and how they have been compromising and to compensate and design their own therapy around the issue of tolerability and so forth with the immediate-release product that is not designed to be once-a-day. So finally, they're saying, I've got now potentially the perfect solution for all these issues I've been looking for.

Got it. And just want to revisit the 810 comments you made about, including adolescent subjects. I mean, is this something where there's going to be an amendment to the ongoing trials? Is this something that's going to be separate? Just trying to understand a little better how you might expand that without, I guess, increasing the complexity of the trials to do the analysis.

Yes. Well, the first thing I should say and make sure everybody understands, we will not do anything that compromises the statistical analysis in these studies. So therefore, if the decision or the agreement from the FDA comes in on the adolescent population too late in the process, then we won't touch the Phase IIIs that are going on today. If it comes a little bit earlier, that we can still have enough from a sample size, from statistics perspective, enough on both patient populations in the current Phase III programs, then clearly, we will do it. So, it's all going to depend on when we get that agreement from the FDA. Again, because it's a Special Protocol Assessment, we don't want to do anything. We had a very good verbal discussion with them, going through all that data, and they seem to agree with us. And we send them the protocol amendment to include that and justification for all that. We're just waiting for them to say yes. Again, depending on when that answer comes in, we will assess it at that time, whether we will do anything different with the current Phase III programs. Or if it comes a little bit later, then it just could be -- it just -- extending their current Phase III programs to later include the adolescence population. But all this, again, is a very positive development, at least the way we view it.

Sure. And do you have any sense as to the timing? And I'm assuming that when you hear something, then the company would disclose that?

We've talked to them. It's been now probably a couple of months. Typically, with the fast-track development, you would expect an answer earlier than that, but we haven't encountered that speed lately. Maybe they are swarmed in their division. So, it should be anytime hopefully. I mean, that's what we are hoping.

Okay. Great. Thanks very much.

Thank you. We have time for one last question from Ken Trbovich of Janney.

Thanks for taking the question. Gentlemen, I just want to get a sense with the two Phase III programs likely to overlap in 2018. It suggests that we should be anticipating higher R&D in 2018 than 2017. But it just wasn't clear to me whether you're going to try to control enrollment in the 812 study to sort of target a fixed number or if you're going to let that enrollment dictate the expenses for '18?

All right. With respect to the spending for the rest of the year, clearly, what we've achieved for the first 6 months versus our guidance for the last 6 months, we're anticipating a very sharp increase in spending for R&D. And that's because the anticipated commencement of the Phase III trials, as many as 4 Phase III trials, for SPN-812 in the fourth quarter and the ongoing SPN-810 Phase III trials. So, we could have as many as 6 trials going on as of the end of the year. Now that will clearly annualize to a substantial increase year-over-year between 2017 and 2018. We haven't spoken about what the magnitude of that increase might be. Now we've got a little bit more thought, but I think if you assume that the back-end run rate for this year -- for the last 6 months is going to probably be reflective for the full year 2018, that would get you to a pretty good number in terms of what the expected spending for 2018 may look like.

But we -- I mean, we have said previously that yes -- I mean, we do expect '18 to be a strong year for us and investment in R&D, as you rightfully picked up, as we prep by then, as Greg said, potentially, several, several Phase III programs between 810, 812. And also, we will remind everyone that even the Phase III programs, when they end, we continue them through the open-label extension as well, which on both products, we plan to keep these programs going for approval. So yes, the spending will be heavier in 2018, absolutely.

And then just a quick follow-up, if I may. Is it possible we could see 812 data before 810?

I've been in this business for 30 years. Everything is possible in drug development. So, the answer is yes.

But you won't have the challenges on the enrollment -- with this patient profile, you won't have the same challenges on enrollment that you have with 810.

Yes. I mean, the 812 is a straight ADHD program. 810, the challenges are built-in by design, for our design of the trial on purpose because of the diary, because of the nature of that patient population. So, it's a little bit different -- not a little, but fairly different as far as that. So, given that, on the surface, is it possible? Yes, it is a possibility. And we are running hard and fast on all programs. And to your earlier question, we're not going to slow it down or speed it up to monitor spending. We want these programs to go as fast as possible on both products.

Terrific and congratulations on a great quarter.

Thank you.

Thank you. I'd now like to turn the call over back to Mr. Khattar for closing remarks.

Supernus continues its track record of executing well on its plans and has just delivered another strong quarter. We are very excited about our progress in first half of 2017 with a record revenues and operating income of $133 million and $43 million, respectively. The launch of the migraine indication is setting the stage for Trokendi XR to become a leading treatment for the prophylaxis of migraine. Our growth plans for Trokendi XR and Oxtellar XR, including the expansion of our sales force in the fourth quarter, will put us in a strong position to continue to deliver robust future growth behind both brands. We also look forward to continuing our progress on SPN-810 and initiating the Phase III trials on SPN-812. Thank you, everyone, for joining us this morning, and we look forward to updating you through the rest of the year.

Thank you, ladies and gentlemen, for attending today's conference. This concludes the program. You may all disconnect. Good day.