Rich Cockrell - Jack A. Khattar - Founder, Chief Executive Officer, President, Secretary and Director Gregory S. Patrick - Chief Financial Officer, Principal Accounting Officer and Vice President.

David A. Amsellem - Piper Jaffray Companies, Research Division Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division Ken Cacciatore - Cowen and Company, LLC, Research Division Joel Beatty.

Good morning, and thank you for joining us today for Supernus' Third Quarter 2014 Results Call. Results today are for the quarter ending September 30, 2014. Yesterday, the company issued a press release announcing third quarter financial 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 www.ir.supernus.com. Following remarks by the management, we will open the call to your questions.

We expect the duration of the call to be approximately 30 minutes. Now 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 the company's annual report on Form 10-K filed March 21, 2014. Actual results may differ materially from those projected in these forward-looking statements.

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on November 12, 2014, 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 maybe required by applicable securities laws. With that, I'd like to turn the call over to Jack..

first, SPN-810, which is for the treatment of impulsive aggression in ADHD, has received a fast track designation from the FDA. This is a major accomplishment as we believe the product represents true innovation in the treatment of a condition for which there are no approved treatments.

We have completed the scale-up at a commercial manufacturing site, had our end of Phase II CMC meeting with the FDA in September and are scheduled to have our end of Phase II clinical meeting next month. We expect to start our Phase III clinical program during the second half of 2015.

For SPN-812, which is a novel treatment for ADHD, as we announced previously, we have selected an extended-release formulation that will be the basis for the product that will be used in the pivotal trials. We expect to start the first pivotal trial during the second half of 2015.

We continue to progress development activities on the active drug substance, conducting further pharmacokinetic studies and preclinical activities that are eventually required for the completion of the new drug application.

Regarding corporate and business development activities, we are actively pursuing opportunities that sit well with our strong presence in neurology and CNS.

We continue to look for products, partnerships and strategic transactions that build on the success we have achieved so far and allow us to realize our vision of becoming a leading CNS pharma company.

Before I hand it over to Greg to go over the financial overview, I would like to summarize by saying that our company, including our commercial team and sales organization, have done on outstanding job in launching Trokendi XR and Oxtellar XR. These products continue to post solid prescription growth despite increased competition.

In the first 9 months of this year, both products combined have generated close to $60 million in net product revenues.

We continue to believe that the peak potential of both products combined is $400 million to $500 million, and that our proven track record and experience in navigating through Paragraph IV notifications will allow us to build long-term brands. We have built and will continue to strengthen our patent portfolio to protect Trokendi XR and Oxtellar XR.

With that, I will now turn it over to Greg to walk you through the financial results..

Thanks, Jack, and good morning. As I review our financial results, I will remind our listeners to refer to the third quarter 2014 earnings press release issued yesterday. We expect to file our Form 10-Q for the third quarter later this week. Net product revenue for the third quarter of 2014 was $22.5 million.

This is comprised of $15.3 million for shipments of Trokendi XR to wholesalers and $7.2 million for shipments of Oxtellar XR to wholesalers. Both of these products are still in a growth phase, having been launched in 2013.

As such, we believe the best basis for analyzing revenue growth is to compare revenue versus the prior quarter, as reviewing sequential quarters helps us to understand the momentum in revenue growth. As discussed during our last call, revenue for second quarter prescriptions filled at the pharmacy level for Trokendi XR was reported as $10.5 million.

Third quarter revenue for Trokendi XR based on shipments to wholesalers was $15.3 million and reflects a growth rate of approximately 50% as compared to prior quarter.

Net revenue from shipments of Oxtellar XR to wholesalers for the third quarter of 2014 was $7.2 million, an increase of $2.2 million or 44% over revenue from the prior quarter shipments to wholesalers, which was $5 million. Gross margin for the quarter was 94.1%. Going forward, we expect product gross margins to continue to exceed 90%.

Selling, general and administrative expenses for the third quarter 2014 were $17.3 million. Year-over-year, SG&A increased 18.6% from $14.6 million in the third quarter 2013. This reflects the expansion of the sales force to more than 150 reps in 2014 as compared to 90 reps in 2013, coupled with increased promotional and marketing-related programs.

Research and development expenses during the third quarter of 2014 were $4.7 million as compared to $3.8 million in the third quarter of 2013.

We expect our research and development costs to continue to increase for SPN-810 as we prepare for the December end of Phase II meeting with the FDA and for pivotal clinical trials that start in the second half of 2015. For the quarter, operating income totaled $29.1 million as compared to a $17.2 million loss in the third quarter of 2013.

Reported net income for the quarter -- for the third quarter 2014 was $27.9 million or $0.39 per diluted share as compared to a net loss of $24.1 million or a loss of $0.78 per diluted share reported for the third quarter of 2013.

This year-over-year increase of $52 million in net income primarily reflects the revenue generated from our commercial products, coupled with the $30 million payment from Healthcare Royalty Partners to acquire a portion of the royalty rights for Orenitram.

Approximately 50.8 million weighted average common shares were outstanding in the third quarter 2014 as compared to 30.9 million shares in the third quarter of 2013.

Adjusting our net income to remove the impact of the $30 million royalty monetization payment, loss on extinguishment of debt and changes in fair value of derivative liabilities, we have shown significant improvement since the beginning of the year. We removed these items as they are significant in amount, but ancillary to our primary operations.

Our non-GAAP net income was a loss of $14.5 million for the first quarter, net income of $2.6 million for the second quarter and a loss of $2 million for the third quarter.

As a reminder, the second quarter included an adjustment for Trokendi XR revenue as we switched our revenue recognition methodology from prescriptions filled at the pharmacy level to shipments to wholesalers. You can see that on a sequential basis, net income has improved substantially during the year.

We expect to see continued growth at income during the fourth quarter of 2014 and all of 2015. As of September 30, 2014, we had $88.3 million in cash, cash equivalents, marketable securities and long-term marketable securities, an increase of $25.6 million versus the balance of $62.7 million as of June 30, 2014.

Given the third quarter results, the company is raising its revenue guidance from approximately $105 million to a range of $115 million to $118 million.

The company is also reducing its cash burn guidance for the year, from a range of $5 million to $10 million to approximately $5 million and raising its guidance for year-end cash and marketable securities from a range of $75 million to $85 million to approximately $85 million, that is the upper end of the previous range.

The company anticipates achieving cash flow breakeven by year-end and being profitable in 2015. And I'll now turn the call back to Jack for some closing remarks..

We're closing in on a historic moment for Supernus, that of achieving our first $100 million in revenues. We're also excited to be in a position to achieve our objectives of being cash flow breakeven by year-end and becoming profitable.

We will start 2015 with a strong cash position that should allow us to continue our legacy of strong execution against our goals.

We are proud of all the remarkable milestones this company has been able to achieve in 2014, which is a relatively short period of time after having gone public in 2012 and after launching 2 products in 2013 in the neurology space.

We appreciate the support of our current shareholders and invite others to join us on this exciting journey in building a premier CNS specialty pharma company. And with that, we'll open it for questions..

[Operator Instructions] And our first question comes from the line of David Amsellem with Piper Jaffray..

Just a couple of questions.

First, can you comment on inventory levels for Trokendi and Oxtellar, how that changed, if at all, and whether you have inventory management agreements in place? Secondly, can you just give us a little color on the extent of step editing for both products and also the extent of access on the Medicare Part D plans? And then lastly, just on the business development front, what's the extent to which you would access capital, additional capital, in order to get a deal done?.

Okay. Let me take the first question first, David, in terms of inventory. With respect to inventory for both products, we're very cognizant that our supply chain is a, if you will, an outsourced third-party-driven supply chain. And so we must maintain reasonable and prudent inventory levels at all stages of the supply chain going forward.

That being said, the portion of the supply chain that we make sure that we protect is the bulk API supply -- portion of the supply chain because that's the one which takes the longest time and is also one which is sole-sourced.

Our inventory programs for both products generally cover on a forward-looking basis and it's impossible to calculate a forward-looking number based on historical results. But look at a forward-looking coverage somewhere in the range of 9 to 15 months and that's an all-in number.

So it includes all stages of production and assumes that instantaneously, we can convert what is intermediate-stage product to finished product. So if I say 15 months of coverage, it sounds like a lot, but you have to remember that, that includes product at very early stages of production.

And we -- I think going forward, that number will get managed down progressively over time, but recognize that we're still in very much of a growth mode for both products. It's necessary and prudent to we make sure that we're not caught short with respect to either of the 2 products..

So can you say, Greg, if -- how many weeks of inventory wholesalers are holding right now?.

Yes, that's a little bit of a different question. So the weeks of inventory, the wholesaler....

That was essentially my question.

I mean, how many weeks of inventory are on hand?.

Yes, somewhere around a month. And again, that's based on a -- that's a forward-looking number. So that's based on what we're looking at for demand for the next quarter -- next several quarters..

Okay.

And how is that managed? Is that managed in a tight range, relatively speaking?.

Well, we don't -- we fulfill orders when a wholesaler step up and order product. So we're very cognizant of what they're holding at their level. We can actually monitor it quite closely. Remember, they don't make money by holding more inventory than they need. So in that regard, their needs and our needs are alike.

We don't want them ordering excess product, which would then produce perturbations on our revenue stream going forward, and they have no interest in doing that. So we monitor it, they monitor it. I think Trokendi XR is probably fewer weeks than Oxtellar XR simply because it's a bigger product.

And you get to -- with products, you get to a certain kind of unit size where, at both the wholesaler level and pharmacy level, you can't have less than one unit of sitting on the shelf. So yes, it's monitored carefully by ourselves and by the wholesalers.

And we've kind of consistently seen it kind of run in the 4- to 5-week range at the wholesaler level, really, since the products got established..

Okay.

And then on reimbursements?.

Could you just recap what your question was on reimbursements?.

Yes. The question was on step editing and also on Part D access..

Well, I mean, the typical step edits we have on reimbursement is the generics step edit. And given that both markets are basically 90%-plus generic products, oxcarbazepine and topiramate, that means most likely the patient has already gone through a generic prescription on either one of these products.

So that's typically the kind of step edit that we get. As far as Medicare, that has been an evolving process for us over time. We first emphasized the commercial area as we launched the products and get coverage there, then we started with Medicaid, and Medicare is really the second part -- in the second phase for us from a growth point of view..

Yes. I'd also point out, David, that with respect to step editing for most plans, it's automatic step edit or it's automated step edit, meaning that when the pharmacist types in the prescription for the patient, you can pull up that patient's prescription history.

In most plans, if there's a record that they've received a generic product before, then automatically that edit has been satisfied, that step edit has been satisfied. So they step through the generic and they can verify they've taken a steric [ph] product before. And so they're free to dispense Trokendi XR, Oxtellar XR.

So it doesn't require manual intervention from the physician..

And the other thing I would add is when it comes to PAs or prior authorizations, which we see some of those, we have a very, very strong program supporting the physicians to go through these processes.

We handle a lot of the paperwork and issues for to make it as simple as possible as well, and we have a very specific program that supports both products. So we've had some success there also and really reducing the burden on physicians and having to go through PAs, if required..

And then I think, David, you asked a question about external development?.

Yes.

Capital access for -- to execute on M&A?.

Well, that's a question which -- it gets preceded by the famous "it all depends" phrase. So we look at it a lot. Many of the deal -- transactions we look at, I guess, would fall in 1 of 2 buckets. One would be a product which will be some sort of a co-promotion or in-licensing agreement with modest upfront and mostly royalty driven.

Those wouldn't require additional capital. Were we to do a transformative transaction in terms of acquiring a company or a company with multiple products, that would probably be an equity transaction, and we remain open to do that. So I think the only barrier to capital, external to the company, would be the covenants around our convert transaction.

We believe that the level of holdings at a convert are fairly modest right now at $36 million.

And that if we were to approach those investors with a transformative transaction, which would be in the best interest of the company and therefore their best interest as well, that we would either roll them into the next transaction or find a way to take them out..

Our next question comes the line of Annabel Samimy with Stifel..

Just to continue on the lines of the business development, could you just help us understand what your priorities are in terms of business development? You clearly have -- your products right now are humming along, but your pipeline is still, let's just call it, in mid-stages. It's going to be there for a little while until you start the Phase III.

So is your priority to bring in on-market products, late-stage products? How do you prioritize your business development?.

Yes. The key priorities, the first top priority is obviously a commercial product that will fit very nicely with our strategic focus in the neurology space.

Clearly, given now that we have a very big footprint in the neurology space with our 150-plus sales representatives, we look for products that could really fit well with our sales call and is very synergistic, where there is a great overlap from a physician point of view. So that is our top, top priority.

Right behind it would be a product, for example, that is either in registration or a product in late Phase III that is also within that same space. In addition to that, we look for opportunities that could also be a prelude for us in the psychiatry space.

So that allows us to get into the psychiatry space and prepare with experience in the field with sales representatives or sales force in the field about a couple of years before we bring in SPN-810 or SPN-812.

So that is another area we look at in case there is something from a commercial point of view that we can bring to the table here with a timing that will fit well with SPN-810 and SPN-812.

And then finally, and I wouldn't say that finally is really the least of the priorities, we pretty much run in parallel on all of them, on all fronts, we also look for transformative transactions from a strategic point of view that really makes us break through to the next level, meaning bringing products that could be new chemical entities, things with much longer patent protection and longevity into the marketplace.

Again, our focus is CNS and we continue to be disciplined in looking at CNS areas. But having said that, that doesn't mean if something comes up that could be opportunistic and that we can be very successful as we have proven so many times in this specialty area that we could commercialize and really grow, we're open to that as well..

Okay, great. That was helpful. And then if I could follow up with another question. Obviously, Trokendi is seeing some competitive entrants in the market. I mean, we're not going to hide it's Upsher-Smith. And we haven't really seen any kind of impact. Now your prescriptions are growing very nicely.

Do you see them in the marketplace? Have they helped your efforts? They clearly haven't hindered it.

So can you just help us understand the dynamic a little bit, given that they have a brand as well as an AG in the marketplace?.

Yes. I mean, the prescriptions, from what we see from prescriptions, obviously, most of the prescriptions they're getting are not on their brand.

As you would expect, given that they launched the product -- their brand and authorized generic at the same time, so naturally the bulk of their prescriptions, we see it on a weekly or monthly basis, is coming obviously on their authorized generic.

As far as promotional activity and activity in the marketplace, we knew that they had launched with about 80, 90 reps, give or take, initially. We don't know where they are right now. We bump into some of their folks every once in a while, as far as effort and activity.

But their main message has been, mainly at this point, not necessarily promoting the Qudexy XR as a brand. It's been more of a cost price kind of strategy at this point.

So far, have they helped in increasing the awareness and the importance of topiramate extended release in general? I have to believe so because we have more people talking about topiramate extended release, obviously.

And then at the end of the day, it's an issue of how you differentiate yourself and how do you really sell the real benefits to the patients and convincing the physicians that these products are important for the patients. And actually, we have some of the strongest data as far as preference.

I mean, 93% of patients who tried Trokendi XR prefer them over Topamax. I really don't know when was the last time 9 out of 10 people even agreed on one thing. So 93% of patients, that really is an overwhelming preference and these patients tried both products sequentially as would be in a real clinical setting.

And at the end of the 4-week treatment, we asked them which -- a very simple question, which one do you prefer? Which really is a measure of their collective overall experience on both products, whether it's side effects, whether it's efficacy, the whole collective experience..

[Operator Instructions] And the next question comes from the line of Ken Cacciatore from Cowen and Company..

Jack, you were very consistent when you were launching these products. You had to stay focused on Trokendi and Oxtellar. You really couldn't pick your head up and talk about business development because there would be no company to even leverage if you didn't execute.

It sounds in your voice like we're getting to the point where you're feeling a bit more comfortable now talking about business development.

So just wondering, how close are we as you work through some of the opportunities that you're looking at? And maybe state it even differently, once the ideal timing, although nothing in life is ideal, or you can't dictate terms all the time, but what would be an ideal time to layer something into the portfolio? And then I have a follow-up..

Yes, thanks. I think you're absolutely right. I mean, we had to execute on Trokendi XR and Oxtellar XR. That is the primary and has been the primary objective for us, and without them, we don't have a company. So you're absolutely right on that.

And you're also absolutely right in looking at it by what is really the ideal time for us because we can never predict when these deals happen or not. Obviously, as we all know, we could work on 100 things and maybe one will end up happening at the end of the day. The ideal time for us is really in 2015, always has been in 2015 and not 2014.

And the reason for that is for the main factor you mentioned, is we wanted to get Trokendi XR and Oxtellar XR very well entrenched in the market, very well established on a very high-growth trajectory.

And also, you know we didn't know what to expect because we did have increased competition in both markets, with Aptiom launching, the other topiramate XR launching. So we had to be very careful in what we do from a sales force point of view, paying attention to these products and continue to have and execute a very strong launch.

And therefore, ideally, it is 2015. Is it more the second half of 2015, the second quarter of 2015? Probably sometime around that time it will be reasonable for us to believe that, that there will be something we can certainly execute.

Because, again, we don't want to bring in a third product and make everybody feel happy and great, but then we don't have the capacity to execute well on that third product as well, like we've done with Trokendi XR and Oxtellar XR, and without, without taking our eye off the ball on both products that we already have.

So it's a delicate balance, and the timing is very important for us to get right, not just to rush into a deal just to do a deal. We have to do it right, and we have to be able to execute once we do the deal, like we've always executed in the past..

Great.

And then on 810, just wondering, as you approach the Phase II meeting, in terms of the potential size and length of the upcoming study you're going to be discussing and maybe the primary and secondary endpoints, just give a little of perspective of what you're hoping to accomplish as you enter that meeting?.

Yes. I mean, we had, as we said, in September, the CMC end of Phase II meeting, and that was actually went reasonably well. No showstoppers there, so I'm pleased to report on that.

As far as the clinical end of Phase II meeting, which will be before year-end, we're looking at protocols, clinical trials that are not necessarily that lengthy or not necessarily unreasonably large. This is a well-defined area.

We're also very pleased with some of the progress we've made on the outcome measurement instrument and the development of that measurement instrument that we can include in the protocol and so forth. So what we are hoping to accomplish, obviously, is an agreement with the FDA on the protocols and the designs.

We do expect that we will be required, as we said in the past, to have 2 Phase III studies that we need to do for the ADHD area.

And then what remains open for discussion is clearly what else will the FDA require us to do if we choose to go with impulsive aggression and also autism or bipolar or schizophrenia or -- I mean, this is a huge market opportunity, and clearly, we want to -- first, our goal is to get the product to the market as soon as possible with the shortest period of time, with the least amount of investment, initially get it to the market and then continue to augment and expand the label as time goes on.

So whether that would require another one Phase III in autism, in autistic patients, and another Phase III in bipolar, and then they can give us a broad label that really remains open to discussion at that meeting.

And we certainly will update you guys on how those discussions go once we go through the meeting, digested and have a clear direction as to how the development program is going..

And we have time for one more question, coming from the line of Joel Beatty with Citi..

My first question is related to Trokendi and the competition from Upsher-Smith.

Have you seen any changes in reimbursement discussions with payers related to that prior to being on the market now? And then also, have you been seeing a difference in tier levels for the 2 products?.

The answer to both questions is really no. Nothing significant or -- and nothing major on both ends. Actually, their product is also being -- is -- has very high reversal rates, interestingly, which you wouldn't have expected given the strategy they went through. So the answer is no on both of them..

Okay, great. And then one last question on the revenue per script. I noticed that it seems a little bit higher this quarter compared to last quarter for both products.

What were the factors behind that?.

Well, we have taken a price increase on Trokendi XR, I believe, in September, if I remember -- I don't remember the exact week. We had taken, I think, about a 7% price increase. So you may have started to see some of that impact. And we have taken a price increase in July or August on Oxtellar XR, which is about 13.9%.

So that's probably -- some of that is obviously starting to show impact on the dollars..

That concludes the time we have for questions. I'd like to turn the call over to Jack Khattar for any closing remarks..

Well, thank you very much for joining us today. We appreciate it. We look forward to finishing the year of 2014 in a very strong position and setting the stage for what we believe will be another exciting year in 2015. And as we mentioned, we really appreciate your support and invite others to join us on this exciting journey. Thank you..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Have a good day, everyone..