Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN)
Q1 2014 Results Earnings Conference Call
May 13, 2014, 9:00 AM ET
Rich Cockrell - IR
Jack Khattar - President & CEO
Greg Patrick - CFO
Ken Cacciatore - Cowen & Co.
David Amsellem - Piper Jaffray
Bill Tanner - FBR Capital Markets
Oliver Eckhard - Orchard Hill
Good day, ladies and gentlemen, and welcome to the Supernus Pharmaceuticals First Quarter 2014 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this call is being recorded.
I would now like to introduce your host for today‘s conference, Rich Cockrell. Please go ahead, sir.
Thank you, Daniele, and thank you all and welcome to Supernus’ first quarter 2014 financial results conference call. This is where we’ll discuss the first quarter ended March 31, 2014. Yesterday afternoon Supernus issued a press release announcing first quarter 2014 financial results.
And on the call today are Supernus’ President and Chief Executive Officer, Jack Khattar; and Vice President 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 your call -- the call up to your questions. And we expect the duration of the call to be approximately one hour.
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 can be identified by such words as expect, plan, will, may, anticipate, believe, should, intends, and other words of similar meaning.
Any such forward-looking statements are not guarantees of future performance and involve risk and uncertainties, including those noted in the Risk Factors section of the company’s annual report on Form 10-K filed on 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 May 13, 2014 at approximately 9:00 am Eastern Time. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company’s most recent press release and current filings with the SEC. Supernus declines any attempt or obligation to update these forward-looking statements except as may be required by applicable securities laws.
With that, I’d like to turn the call over to the company’s President and CEO, Jack Khattar.
Thank you, Rich, and good morning, everyone. We appreciate you joining us today as we discuss our first quarter results. Since the beginning of the year, we have been focused on the expansion of our sales force to more than 150 representatives and the commercial success of Trokendi XR and Oxtellar XR.
We’re very pleased to report that as of May the expansion has been substantially completed. As a result, the number of sales calls delivered to target physicians grew by more than 20% in the first quarter of 2014 compared to the fourth quarter of 2013. We expect continued increase in our sales calls as the full impact of the sales force expansion takes effect over the next few months. Our sales force is now fully focused on detailing physicians instead of recruiting and training activities, and we’ll be able to expand our reach and call frequency for the physician audience for both products.
The latest trend in prescription growth is very encouraging. The four-week moving average ending the week of May 2 as reported by IMS for Trokendi XR and Oxtellar XR combined prescriptions was 12,069, representing a solid growth of 50% compared to the first four week average in the year of 8,049 prescriptions.
Again, we managed to post such growth while at the same time execute on the expansion of our sales force. The recent expansion provides us with great momentum toward reaching the monthly prescription rate of approximately 30,000 that will allow us to become cash flow breakeven by year end.
Regarding the first quarter of 2014, total prescriptions for Trokendi XR and Oxtellar XR totaled 30,208, increasing by 9,098, or 43%, compared to the fourth quarter of 2013. Trokendi XR prescriptions for the first quarter were 18,727, representing a 66.6% increase over the 11,244 prescriptions in the fourth quarter of 2013 while Oxtellar XR prescriptions increased by 16.4% to 11,481 prescriptions.
Both products have seen increased managed care coverage. For Oxtellar XR, we now have 150.3 million lives covered with 129.7 million lives in commercial and 20.6 million lives in Medicaid. Similarly, Trokendi XR coverage increased to 143.8 million lives with 116 million in commercial and 27.7 million lives in Medicaid.
Regarding the intellectual property, we have expanded our patent protection on Oxtellar XR and Trokendi XR. We now have three patents protecting Oxtellar XR and three more protecting Trokendi XR. These patents provide protection through 2027 and we are focused on further expanding our patent protection on both products.
While the majority of our focus is on the commercial success of Trokendi XR and Oxtellar XR, we are continuing to develop our pipeline candidates, SPN-812 for ADHD and SPN-810 as a first-in-class product for impulsive aggression in patients with ADHD.
For SPN-810, we are now designing a Phase III trial for which we expect to commence patient building during 2015. We have initiated manufacture of full-scale dosage form batches in conjunction with technology transfer to a commercial scale manufacturer.
For SPN-812, we will be initiating a pharmacokinetic study in May with several extended-release formulations and select a final formulation that will later be the subject of a Phase 11b trial. During the first quarter, we also announced the issuance of our European and Canadian patents for SPN-812. These patents which are the first to issue on SPN-812 will provide protection for the product through 2029. With both product candidates, we also continue to make progress on animal carcinogenicity and toxicity studies that will be required for potential NDA filings.
Finally, on Orenitram, we’re excited about the product’s expected U.S. launch in 2014 as a novel oral treatment for pulmonary arterial hypertension by our partner, United Therapeutics. The launch, when it happens, will trigger a milestone payment of $2 million to Supernus.
I will now turn the call over to Greg Patrick, our CFO to discuss our financial results.
Thanks Jack. As I review our financial results, I’d like to remind our listeners to refer to the first quarter 2014 earnings press release issued yesterday as well as our Form 10-Q for the first quarter, which will be filed later this week.
Net product revenue for the first quarter of 2014 was $9 million. This is comprised of $4.1 million for Trokendi XR and $4.9 million for Oxtellar XR. As we discussed during our most recent investor call, revenue from Trokendi XR will continue to be reported on a quarter lag basis until we have sufficient data to estimate rebates, returns and allowances upon shipment to wholesalers. As a result, revenue for Trokendi XR for the first quarter, $4.1 million was based on 11,244 prescriptions which were filled in the fourth quarter of 2013.
On a quarter-over-quarter basis, this compares to $300,000 recorded for Trokendi XR in the fourth quarter of 2013, which was based on approximately 1,300 prescriptions filled at the pharmacy level during the third quarter of 2013.
You may have noticed that the company has recorded net deferred product revenue on its balance sheet as of March 31 in the amount of $12.3 million. This represents Trokendi XR, which has been sold to wholesalers but not filled as prescriptions as of December 31, 2013.
The total, representing approximately 30,000 prescriptions, can be separated into two constituent parts. First, approximately 60% or 18,000 prescriptions represents scripts filled at the pharmacy level in the first quarter of 2014. We expect this amount to be recorded as product revenue in the second quarter.
The second component, approximately 40% or 12,000 prescriptions represents products sold to wholesalers and which was in their distribution channel as of March 31, 2014. The two pieces comprising $12.3 million in total are recorded on the balance sheet as of March 31 as net deferred product revenue.
Net revenue from shipments of Oxtellar XR to wholesalers for the first quarter of 2014 was $4.9 million, representing an increase of $1.1 million or 26% over shipments to wholesalers during the fourth quarter of 2013. As discussed during our most recent investor call, Oxtellar XR revenue is now reported based on shipments to wholesalers rather than on prescriptions filled at the pharmacy level.
Gross margin for the quarter was 94.8% compared to 89.6% in the fourth quarter 2013. Going forward, we continue to expect product gross margins to exceed 90%.
Selling, general and administrative expenses for the first quarter 2014 were $17.5 million as compared to $13.5 million for the same period in 2013. Higher expense is attributable to our sales force expansion coupled with marketing programs supporting the commercialization of Trokendi XR and Oxtellar XR. Research and development expenses during the first quarter 2014 were $4.5 million, essentially flat as compared to prior year.
For the quarter, operating loss totaled $13.4 million as compared to $11.4 million in the fourth quarter of 2013. Operating loss increased primarily because of higher expenses associated with the sales force expansion.
The reported net loss for the first quarter 2014 was $15.5 million or $0.38 per share as compared to $18.4 million or $0.60 per share reported for the first quarter of 2013. The lower net loss during the period reflects revenue generated from our commercial products, Oxtellar XR and Trokendi XR, which were launched in February 2013 and August 2013, respectively.
Net product revenue generated during the period were offset by expenses related to the sales force expansion, increased marketing and commercialization activities and the non-cash loss on extinguishment of debt. The weighted average common shares outstanding in the first quarter 2014 were approximately 41.1 million as compared to approximately 30.9 million in 2013.
As of March 31, 2014, $50 million worth of six-year notes bearing interest at 7.5% per annum have been converted to common stock. Excluding a non-cash gain of $0.7 million related to changes in the fair value of derivative liabilities, and a $1.7 million loss on extinguishment of debt consequent to conversion of the company’s notes, the non-GAAP net loss for the first quarter of 2014 was $14.5 million.
As of March 31, 2014, we had $70.5 million in cash, cash equivalents, marketable securities and long-term marketable securities compared to approximately $90.9 million as of December 31, 2013. Cash burn for full-year 2014 is forecast to range from $35 million to $45 million with the year-end cash balance projected to range from $45 million to $55 million.
Finally, we anticipate revenue recognition for Trokendi XR will transition to contemporaneous revenue recognition based on shipments to wholesalers during calendar year 2014. When this transition occurs, the quarterly revenue numbers will include prescriptions filled at the pharmacy level during the current quarter, prescriptions filled at the pharmacy level in the prior quarter and prescriptions held in the wholesaler distribution channels as of the reported quarter. Deferred product revenue will be eliminated at that point.
Based on this assumption, we expect reported total revenue for calendar year 2014 to be in the range from $75 million to $85 million.
We will now open the call for questions.
(Operator Instructions) And our first question comes from Ken Cacciatore from Cowen & Co. Please go ahead.
Ken Cacciatore - Cowen & Co.
Just wanted to ask, with the sales force now substantially completed and in place, it’s an impressive number and you’re doing a good job of reaching your -- I don’t call in detailing levels, but I was wondering as you think about business development, when do you think this sales force would be prepared to take on more product? Can you talk about maybe assets that are available or how much time you spend thinking about business development? I know we’re still in the early stages, but are you looking down the road or are there some assets that maybe identified to help leverage the sales force? Thank you.
I’ll take this one. Ken, actually we have been, even in the past couple of years, we have been very active in looking at assets that will fit strategically in our portfolio of neurology and/or psychiatry products. And we’ve looked actually very seriously at several opportunities in the past 12 to 18 months and we continue to do that. So that’s always a very ongoing process, and of course, more so now than that we have significant sales force in the neurology space and psychiatry space.
However, I will repeat a little bit something I said, I think, in the previous call is the fact that we can also forget that we are still in the launch mode of Oxtellar XR and Trokendi XR. So the timing for bringing a third asset will obviously depend highly on the uptake of Trokendi XR and Oxtellar XR. We don’t want to do anything just to bring in a third product on the sales force because that will come in at a cost as well. As far as the frequency, we will be able to dedicate to Oxtellar XR and Trokendi XR. But the short answer is we’re very active in this space. We are aggressive also in our discussions and we seriously look at a lot of opportunities.
And now our next question comes from David Amsellem from Piper Jaffray. Please go ahead.
David Amsellem - Piper Jaffray
Just a couple. So I may have missed this earlier, but can you talk about inventory levels, how much inventory is in the channel, if it’s fluctuated meaningfully and if you have inventory management agreements around both products, just wanted to get some color there. And then, the second question is on Trokendi, we know that Upsher-Smith will be in the marketplace. So I guess the question is this, how do you feel about your ability to compete with another once-a-day Topiramate, yes you did have a head start, but there is going to be a lot more noise out there, so I just wanted to get your take on how the Upsher product would impact Trokendi XR, if at all. Thanks.
I’ll take the Upsher-Smith question and then I will let Greg to make the comment on the inventory. Regarding Upsher-Smith, clearly we can’t be too specific of regarding what we know or what we think they are going to be doing and so forth. We expect them to launch at any time at this junction. We continue to believe that the market is significant as far as the size of the opportunity to accommodate two products.
The differentiation between the two products is probably not too much, but we really don’t know what their positioning is going to be, what their pricing strategy is going to be and so forth. So it’s a little bit hard for us to really project as to what exactly the impact. As you rightfully pointed out, we clearly have the first-mover’s advantage here. Also in the marketplace, we‘ve established the brand name, we have a very strong brand awareness among the physician audience and so forth. So that should help us.
However, again, there should be plenty of room for two products in the space. As evident with a previous example in the same market, for example, with Tegretol XR and Carbatrol, two products that are pretty similar in nature, twice a day extended-release carbamazepine and we’re able to coexist and have a nice business on both of them. So, we don’t expect this to be a little bit different but all this is yet to be seen obviously depending on when they launch and their strategy when they launch the product.
Dave, this is Greg. With respect to the question you asked with -- vis-a-vis inventory, so let’s take Trokendi XR first. In our prepared comments, I mentioned that our deferred revenue balance at the end of March was about $12 million and I bifurcated that between what was sold as prescriptions as of that date versus what was sitting in the distributor and wholesaler pipeline as of that date.
So the 12.3 million in dollars can be translated into roughly 30,000 prescriptions. And of those 30,000 prescriptions, roughly 12,000 of those are in the pipeline. We can juxtapose that against the prescriptions for Trokendi XR in the first quarter, it’s a measure of what was sitting in the pipeline as of the end of the March with what was sold during the prior quarter and the numbers were almost the same, it’s about 12,000 prescriptions sold in the quarter, and 12,000 prescriptions sitting in the pipeline.
Of course, I think everybody in the call appreciates that. It’s a little bit like driving your car by looking at the rear-view mirror. The prescriptions that were sold in the first quarter compared to what was sitting in the pipeline is a comparison that one can make but arguably looking at forward-looking Trokendi sales during the second quarter and comparing it to what’s sitting in the pipeline is a more appropriate measure and I’m sure your model will allow you to do that. So based on ex-post basis, it’s about a quarter’s worth of coverage.
And the same dynamic would be true for Oxtellar XR as well. For Oxtellar XR, the roughly 16,000 prescriptions we believe sitting someplace of the distribution channel either it the wholesalers or pharmacies and again you compare that to the prescriptions sold in the first quarter, those numbers are very similar, but again you need to look at them on a go-forward basis not ex-ante basis.
And our next question comes from Bill Tanner from FBR Capital Markets. Please go ahead.
Bill Tanner - FBR Capital Markets
Jack, I had a couple of pipeline questions for you. As it relates to 810, you said that you’re working on a design of the trial, curious if you can provide any details as to the target population and maybe what the endpoints would be? And then, also I know that you talked about the potential for the compound in the impulsive aggression beyond ADHD, so it would be interested in how you might be able to expand that? And then I have another one after that.
Sure. I mean my guess today and it’s an educated guess given the discussions we’ve had as to where we probably will end up, but it’s not certain because a lot of things to change between now and the time we started the study is, the first Phase III trial most probably will be in the ADHD population. So, in other words, we will start the study for impulsive aggression in ADHD patients, these are patients who are ADHD, they are welcomed for, for their ADHD treatment and SG&A spend will be an add-on to their current ADHD treatment.
And as far as the current activities with the design and so forth, we are working on several fronts as far as the size of the trial, the different arms, the different dose strengths, we’re also applying to finalize as well as the outcome measurement tool agreement with the FDA on that as well, because again just to remind everyone this is a truly new scientific exploration here.
I wouldn’t use the word exploration in the full sense, but exploration in the sense that this is really a new condition, really very exciting development program and we are really pioneering a lot of new things here. So we want to make sure everything is keyed up before we start the Phase III.
And your next question was?
Bill Tanner - FBR Capital Markets
Well, and Jack and then would that then be in your Phase IIa. We had patients or subjects who were six to 12, so whether it be a pediatric indication or a child indication initially or not necessarily?
The Phase IIb study, as you said, was in the six to 12 as well as the Phase IIa, both of them were at six to 12, but that doesn’t mean we may not include in the Phase III adolescent arm to expand the use maybe into the 17 -- up to the 17 years of age. So that is still into consideration at this point. I can’t tell you for sure we’re going to go first with six to 12 and then expand or should we able to do that in the same Phase III.
Bill Tanner - FBR Capital Markets
And then the second question I have was on 812, you mentioned that you do some PK studies with various formulations and if you can get IP on those, you could have protection through essentially through the end of the next decade. And I’m just curious since the compound I think has been used in Europe but not here, how important it is to get the extended-release IP and then just I’m not that familiar with that, given the extended-release would actually provide a clinical benefit as your epilepsy drugs over the immediate release?
The molecule, as you said, was in Europe for many years as an anti-depressant. So the first set of patents that we have issued for example is the use patents for us, for example, in Canada and Europe as we mentioned already issued, so this is for the novel use of that molecule in ADHD.
In addition to that IP protection, we will definitely have IP protection working on the formulation and the drug delivery side with the extended-release formulation. So that will be another layer of protection for that molecule and then the third layer of protection obviously this molecule will be a new chemical entity for the United States because it was never developed in the U.S. so you will have your typical five-year exclusivity, regulatory marketing exclusivity.
So we have different avenues. We are providing longevity for that asset as well as on the API, we’re working on different ways to synthesize the API because this molecule is very old and there aren’t any suppliers that make that API, so we’re creating IP around that product as well.
So the trial that we started this May, which is a PK study, we basically have several prototypes, different extended-release formulations and we’re trying to choose the final formulation which we will be basically -- the final product that will go into a Phase IIb trial.
Just a quick reminder here, we’re not trying to, with our PK profile in an extended-release formulation, to match any specific currently existing immediate-release product. So what we’re trying to do in this PK trial is just trying to optimize as much as possible the PK profile to make sure we get the best clinical outcome.
And the answer is yes, regarding side effects, tolerability and so forth, we certainly expect the extended-release formulation to even further enhance the tolerability of Viloxazine, which is known to be a very well tolerated molecule anyway, but if we can improve it further with the extended-release formulation that will be additional plus.
And our next question comes from Jonathan Eckard from Citi. Please go ahead.
This is (indiscernible) calling in for Jon. Thanks for taking the question. What contributed to the improvement in gross margin this quarter over the previous year and this is the rate we should expect to continue?
The primary contribution to gross margin was, let’s say, it’s more of a -- represents what we expect to be happening on a go-forward basis, and I won’t say that the margins will stay at the 94% level that we have for this most recent quarter. But we have said over past several calls about maintaining that. We expect product margins north of 90%.
The improvement really had to do with some one-time expenses that we incurred in the fourth quarter of 2013 which we didn’t believe would repeat again in the first quarter and they, in fact, have not. There is always bit of a shakeup period with any manufacturing costs such as just scaling it up and making commercial scale product and for the products that hit those strides. So we had some of those one-time expenses hit in the fourth quarter that did not reappear in the first and the margins reacted accordingly.
(Operator Instructions) And our next question comes from Oliver Eckhard from Orchard Hill. Please go ahead.
Oliver Eckhard - Orchard Hill
Two quick ones. One, Greg, for you on the deferred revenue, just trying to go through the math, but if I look at the $12.3 million down and about a $5 million run-rate on Oxtellar, is it fair to assume if you were to release this in the second quarter that you’re going to get some more closer, to over $20 million in revenues? And then, secondly, Jack, it’s more of a strategic thought from you. I know in the past you guys have monetized these royalty streams, and clearly it looks like you have a pretty comfortable cash balance, but I was wondering if you have any thoughts on that and if there are plans regarding that? Thank you.
Sure. Well, Oliver, in terms of deferred revenue, you mentioned Oxtellar XR as part of deferred revenue. Oxtellar XR is not part of deferred revenue whatsoever. There is no deferred revenue with respect to Oxtellar XR whatsoever.
So the deferred revenue is solely with respect to Trokendi XR. And as I mentioned, with respect to the $12.3 million, roughly 60% of that represents scripts which are sold in the first quarter of 2014. Now, I do want to remind everybody on the call this is largely on a gross basis, so that $7 million of revenue would not turn into $7 million of net revenue because you’ve got to put rebates, allowances, returns against that.
So that would come back if we were to transition to contemporaneous revenue recognition, clearly that could -- one way or the other, we’ll recognize that in the second quarter because that even if we don’t transition to contemporaneous revenue recognition, we’re going to recognize that.
In addition, we would recognize all the scripts for the second quarter and that would be substantially -- one would expect that would be substantially higher than 12,000 prescriptions and so depending on whatever your projection and your model is for the second quarter, we would realize that in the second quarter if we transition to contemporaneous revenue.
And the third element in the trifecta is what’s sitting in the distribution channel. Now, if Trokendi XR behaves in a similar manner to Oxtellar XR did at the fourth quarter, that number would be kind of in -- could be in the $3 million to $5 million range, probably to the higher end of the range, not the lower end of the range. So those are the three pieces. So you’ve got $6 million in change or $7 million of gross revenue, which we already know about. You’ve got the second quarter’s prescriptions which you have to estimate and you’ve got another let’s say $5 million of estimated and that’s just purely a guesstimate what’s sitting in the distribution channel as of June 30th.
Those three rolled together would become the Trokendi XR number -- revenue number in the second quarter. Could it be $20 million? I suppose so, but that’s at this juncture that’s just pure speculation and I can’t go any further on that discussion.
Regarding the royalty monetization, Oliver, I mean you’re right in the sense obviously historically we’ve done actually three different transactions on the royalties and raised more than $190 million, which allowed us to fund the company and so forth. Clearly, we are looking at all these options strategically.
Yes, we had been in discussions with folks regarding potential royalty monetization on United Therapeutics. And at the right moment obviously if there is anything that -- we will disclose and we’ll announce if there is a transaction that we do but we certainly are exploring every potential avenue here as to how we can maximize from a value point of view to the company.
If we raise any cash from royalties strategically, how can we use that cash is a -- are we better off to use it in one way versus another or are we better to collect it later on from a pure earnings point of view. So, obviously we’re looking at all these options and evaluating the different value for the different strategies. But the answer is yes, we are looking at that as a potential strategy.
And I’m not showing any further questions. I would now like to turn the call back to Jack Khattar for any further remarks.
Thanks everyone for joining us today on the call. We are very excited about the ongoing commercial success of both products, Oxtellar XR and Trokendi XR, as well as the continued development of our pipeline products. We believe 2014 will be a very exciting year for us and we certainly look forward to speaking with you again in a few months when we update everyone on the results from the second quarter of 2014. Thank you.
Ladies and gentlemen, thank you for participating in today’s conference. This does conclude today’s program. You may all disconnect. Everyone have a great day.
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