Supernus Pharmaceuticals, Inc.

Supernus disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information for future development. As a reminder, Supernus' policy is to provide, update or reconfirm its financial guidance and guidance on corporate goals only by issuing a press release or filings updated guidance with the SEC in a publicly accessible document.

References to current cash, cash equivalent and investments are based upon balances as of June 30, 2013. All other guidance, including guidance relating to the company's expected expenses, year-end cash and corporate goals is as of today, August 13, 2013.

With that, I'll hand the call over to Jack Khattar, President and CEO of Supernus.

Good afternoon, and welcome to our second quarter 2013 financial results conference call. With me today on the call is Greg Patrick, Vice President and Chief Financial Officer of Supernus.

Starting with the launch of Oxtellar XR, the product continued to progress well during the second quarter with prescriptions as reported by IMS, increasing from 529 in the first quarter to 3,648 prescriptions in the second quarter. Over 1,100 target physicians have prescribed Oxtellar XR since launch, a substantial increase over the 450 target physicians prescribing Oxtellar XR that we last reported to you.

Based on IMS data for the week ending the 2nd of August, Oxtellar XR achieved a conversion share of the addressable oxcarbazepine prescriptions of approximately 1.34%, a significant increase over the 0.58% conversion share we reported during our first quarter Oxtellar XR launch update.

For the week ending July 19, among the target prescribers where our sales force has been concentrating its efforts, the conversion market share is 1.9%. In addition, for the same week, the conversion market share of Oxtellar XR is approximately 3.5% and 5.4% among the top target physicians per territory that have been called on 7x to 12x since launch and 13x to 18x, respectively.

We believe this is a significant share at this stage in the launch, showing a strong correlation between call frequency and market share levels and confirming that Oxtellar XR is promotion responsive.

Our sales force continues to be successful in increasing the number of calls on target physicians to an average of 1,500 calls per week compared to a previous high of 1,200 calls per week on average as reported in the first quarter of Oxtellar XR launch update.

Feedback from the field supported by results from a qualitative market research study confirm that prescribers of Oxtellar XR continue to be extremely pleased with what their patients are reporting regarding the efficacy and tolerability profile of Oxtellar XR. The top reasons physicians report for choosing Oxtellar XR are reduction in adverse events, once-a-day dosing and the ability to get patients on a higher dose of oxcarbazepine when needed.

Oxtellar XR has continued to achieve strong coverage in managed care with 142 million lives covered, 127 million on the commercial side and 15 million on Medicaid.

Comparing the early stage performance of Oxtellar XR to other extended release anti-epileptic products that have been launched, Oxtellar XR seems to be continuing to track in line with the weekly market share trends of Carbatrol. As a reference, Carbatrol achieved a 1.8% market share of the carbamazepine market in its first 12 months on the market, increasing to 4.7% in the second full year after launch.

In summary, our sales force is executing well in the field, and Oxtellar XR continues to be received well by physicians and patients, all leading to significant growth in the number of prescribing physicians and prescriptions.

Regarding Trokendi XR, we continue to expect final approval and commercial launch of Trokendi XR in the third quarter of 2013.

Finally, regarding the rest of the pipeline, we continue to progress SPN 810 with the goal of having a meeting with the FDA by the year end to discuss our plans for later-stage clinical studies and to progress SPN 812 with the development of a novel once daily formulation to be used later in Phase IIb study.

I'll now turn it over to Greg Patrick, our CFO, to walk you through the financial highlights.

Thanks, Jack, and good afternoon, everyone. I'd now like to summarize the financial results for the quarter and 6-months ended June 30, 2013.

Net product revenues were $0.2 million for the first -- for the 3-months ended June 30, 2013, based on 529 Oxtellar XR prescriptions filled at the pharmacy level during the first quarter. Consistent with industry norms, the net price of Oxtellar XR reflects deductions for one-time discounts paid to wholesalers to initially stock Oxtellar XR, as well as customary payer rebates, allowances and the cost of a co-pay rebate program.

Our product gross margin on net revenue was 97%. Research and development expense for the second quarter declined from $4.7 million in 2012 to $3.5 million in 2013, primarily because our Phase IIb study for SPN-810 was completed in 2012.

Selling, general and administrative expense for the second quarter increased from $4.6 million in 2012 to $12.2 million in 2013, reflecting increased sales and marketing costs associated with the commercial launch of Oxtellar XR and the expected launch of Trokendi XR in the third quarter of 2013.

Related to our $90 million convertible note offering, the company recorded a noncash charge of $8.6 million due to changes in fair value of derivative liabilities in the second quarter.

Net loss applicable to common shareholders for second quarter 2013 was $27.4 million or $0.89 per common share, based on the 30.9 million weighted average shares outstanding. This compares to a net loss of $10.3 million in the second quarter of 2012 or $0.61 per common share based on 16.8 million weighted average shares outstanding.

Excluding the charges for changes in fair value of derivative liabilities to $8.6 million and loss on extinguishment of debt of $1.2 million, non-GAAP net loss for the second quarter 2013 was $17.6 million.

For 6 months ended June 30, 2013, our net product revenue of $0.2 million is based on 529 Oxtellar XR prescriptions filled at the pharmacy level during the first quarter of 2013.

Consistent with industry norm, the net price of Oxtellar XR reflects deductions for one-time discounts paid to wholesalers to initially stock Oxtellar XR, as well as customary payer rebates, allowances and the cost of a co-payment rebate program.

R&D expense for the first half of 2013 was $8.1 million compared with $10.1 million in 2012. The decrease was primarily attributable to the completion of our Phase IIb study for SPN-810 in 2012.

SG&A expense for the first half of 2013 was $25.7 million compared with $7.4 million in 2012, increasing year-over-year due to hiring of our sales force, as well as cost associated with the commercial launch of Oxtellar XR and the expected launch of Trokendi XR in the third quarter of 2013.

Net loss applicable to common shareholders for the first half of 2013 was $45.8 million or $1.48 per common share, based on 30.9 million weighted average shares outstanding compared to $20.4 million or $2.21 per common share based on 9.2 million weighted average shares outstanding in 2012.

Excluding the charges for changes and fair value of derivative liabilities of $8.5 million and loss on extinguishment of debt of $1.2 million, non-GAAP net loss for the 6 months ended June 30, 2013, was $36.1 million.

Turning to our financial update. Cash, cash equivalents and marketable securities increased from $88.5 million at December 31, 2012, to $118.7 million at June 30, 2013.

On May 3, 2013, the company closed on an offering of $90 million convertible senior secured notes due 2019. Coincident with the closing, the company retired its ventured debt in its entirety.

Net proceeds post retirement were approximately $67 million.

Our cash burn forecast for 2013 continues to be in the range of $85 million to $95 million. Based on our current plans, Supernus continues to anticipate the cash, cash equivalents, unrestricted marketable securities and long-term investments as of June 30, 2013, should be sufficient to fund operations through the end of 2014, by which time we project to be cash flow breakeven.

For the 6 months ended June 30, 2013, the net value of Oxtellar XR sold to wholesalers was $4.2 million. Consequently, in addition to the $0.2 million in recognized revenue, as I mentioned earlier, we recorded $4.0 million of deferred revenue as of June 30.

That is $4.8 million in gross deferred revenue, net of $0.8 million in deferred cost and allowances.

I would like to add some context to these values. Gross deferred revenue or $4.8 million, represents approximately 12,600 scripts shipped to wholesalers as of June 30.

However, as Jack mentioned previously, approximately 3,600 of those scripts were filled at the pharmacy level on the second quarter. This implies that as of June 30, the net amount or approximately 9,000 scripts are in the pipeline.

Cash collections from the sale of Oxtellar XR in the quarter ended June 30, 2013, were approximately $1.8 million with a total of $4.4 million collected from wholesalers through the first 6 months. Accounts receivable as of June 30 were approximately $0.5 million.

We will now open up the lines for questions.

I just had a few. So first, on the 1,100 doctors that have prescribed the drug, I may have missed this, but did you say or can you say the number of those or the portion of those who were repeat prescribers?

Yes, we haven't mentioned the repeat prescribers. We've been seeing rates somewhere in the 50% to 70% depending on the week and so forth as repeat prescribers.

So I think we mentioned that at the previous earnings call last time that, that is very much in line with the satisfaction, the very high satisfaction level they've been reporting to us in the market research prescribers. So it's very much in line with that, obviously, and very reassuring when you see that kind of repeat levels.

Okay. And then just on the shipments to wholesalers, can you give us a sense of how many weeks of inventory wholesalers are keeping on hand?

Well, David, that number is going to be a number which will fluctuate greatly going forward. If we use the 9,000 scripts that I talked about just toward the end of my remarks, and we match up against that, let's say, roughly 1,600 scripts from the month of June, that would be somewhere around 5 months.

However, keep in mind that as demand builds, that those number of months of coverage are going to decline quite precipitously. Moreover, when we're looking at the 9,000 scripts that I referenced earlier, that represents both what's at the wholesalers as well as the pharmacy, so it's the entire pipeline, if you will.

We haven't disaggregated that 9,000 between what's actually sitting, if you will, at the big 3 wholesalers versus what is actually sitting at the pharmacy level. I might be able to give you a little bit color on that off-line.

H

Okay, just to be clear, you don't think that there was any sort of initial bolus of inventory or excess inventory that got built that would necessarily pressure the sales numbers as we go forward? You don't see that as something we need to think about?

No, in fact, I believe that the load-in at time of launch is very much what we expected. There had been repeat reorders.

We're seeing the months of coverage come down steadily as demand and throughput for the product build, and there's no reason for us to believe that there is any sort of excess inventory sitting any place.

Okay, and then one last one, if I may. This is switching gears to Trokendi.

I guess the question is, it looks like, you mean, you'll have a head start over the Upscher-Smith, topiramate product, but presumably, you'll be competing with them at some point. But I guess the question here is, do you believe that there's room for 2 extended-release topiramate products on the market.

And given that they have a clinical trial and you just -- and you have bioequivalents, how should we think about your counter detail strategy there?

I'm going to have to reserve any comment, David, as far as -- for competitive reasons and the obvious reasons here. It will be difficult for us to say anything specific, and obviously, when we see their data and what kind of data they have, then we will have a much better clarity as to the difference -- if there is any difference between the 2 products.

Of course, both of them seem to be once-a-day, extended-release topiramate products. Ever as far as the differentiation between the 2 products, they will have to be -- remain to be seen, once they come out with their data.

To answer the second part of the question, we believe there is room for 2 products. It is a fairly big market, and that's why we want to get out as soon as we can, obviously, to get a head start.

This is Josh, in for Annabel. In terms of the Oxtellar deferred product revenue, in 1Q, you guys were around 3.6 million, and now we're at 4.2 million, but your script numbers have obviously gone up substantially.

I was hoping you could kind of give us a little color between that discrepancy and then kind of lead us through what would be involved in getting those revenues on to the books.

Well, clearly, in the most recent quarter, there have been additional shipments into the wholesale and retail trade so that the amount of deferred revenue actually now has gone up by several hundred thousand dollars. In terms of months of supply, we can push some numbers off-line but I think you'll see that the months of coverage have dropped precipitously.

In terms of -- the next part of your question regarding what will it take to move that deferred revenue through the P&L, as Jack mentioned earlier, there were roughly 3,600 scriptts written in the second quarter. And assuming that we have all the data we need from Medicare, Medicaid rebate standpoint to be able to recognize revenue in the next coming 10-Q filing, those 3,600 scripts would flow through our P&L as revenue.

That's how it's going to come off the books. As we move forward into the year and as we get to a point where we anticipate being able to recognize revenue upon shipment to wholesalers, that bolus of deferred revenues is going to come entirely off the balance sheet.

So we would be recognizing, not only the scripts that have been written in the prior quarter, but anything which is sitting in deferred revenue will get expunged at that point in time.

Okay, great. And in terms of Oxtellar and the Paragraph IV filing that was submitted earlier by Octavius, are you guys planning a response?

Obviously, you have the 45-day window. And can you give a little color on that, please?

Well, we have already announced that we did file a complaint, and we did sue Watson. But moving forward, just so that everybody knows, we will not make any comment whatsoever on this case, obviously, for obvious reasons.

But basically, we did initiate litigation against Watson.

Well, thank you, everyone, for joining us today. We continue to be very excited about Oxtellar XR and the upcoming launch of Trokendi XR.

Thank you so much.