Good afternoon and welcome to the Supernus’ Fourth Quarter and Fiscal Year 2012 Financial Results Conference Call. Please note this event is being recorded.
Before we get started, I would like to remind you that matters discussed on this call contain forward-looking statements that involve risks and uncertainties, including, but not limited to those relating to the commercial efforts related to Oxtellar XR and Trokendi XR. Actual results may differ materially from the results predicted and recorded results should not be considered an indication of future performance.
These and other risk factors are more fully discussed in our annual report on Form 10-K that we expect to file with the SEC by the end of this week and it will be most particularly dealt with under the caption Risk Factors. Supernus disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information or future developments.
As a reminder, Supernus’ policy is to only provide financial guidance and guidance on corporate goals for the current fiscal year and to provide update or reconfirm its guidance only by issuing press release or filing updated guidance with the SEC in a publicly accessible document. Reference to current cash, cash equivalents and investments are based upon balances as of December 31, 2012. All other guidance including guidance relating to the company's expenses, year-end cash and corporate goals is as of today, March, 14, 2013.
With that, I will hand it over Jack Khattar, President and CEO of Supernus.
Thank you. Good afternoon and welcome to our fourth quarter and year-end 2012 financial results and business update conference call. With me today on the call is Greg Patrick, Vice President and Chief Financial Officer of Supernus.
2012 was a very a successful year for Supernus and we are off to a great start in 2013. I would like to summarize the operational and financial accomplishments of 2012 and provide an update on our Oxtellar XR product launch, Trokendi XR in our pipeline. We are very proud of our accomplishments in 2012 and I'll give you some of the highlights.
We transitioned from a development stage private company to a publicly traded commercial pharmaceutical company. Our initial public offering raised gross proceeds totaling $52 million and the follow-on public offering raised an additional $48 million. We built our commercial organization including an experienced sales and marketing team in preparation for the launch of our lead epilepsy product Oxtellar XR, extended-release oxcarbazepine, which was approved by the FDA in October and for which we received confirmation from the FDA that it has been granted three years marketing exclusivity.
In addition, we received tentative approval in June for Trokendi XR, extended-release topiramate and later in October announced that the USPTO issued two patents covering the product. Finally, in 2012 we continued to develop our pipeline through the successful completion of a Phase IIb trial with positive topline results of SPN-810, our novel treatment for impulsive aggression in ADHD patients.
While 2012 was a remarkable and exciting year for us with so many critical accomplishments, we are even more excited about 2013 which started with the launch of our first product Oxtellar XR. While this launch is still in its very early stages, I'll try to shed some light on some early indicators. As you know, Oxtellar XR is a novel once daily extended-release oxcarbazepine. It is an anti-epileptic drug approved as adjunctive therapy in partial seizures in adults and children six to 17 years old. In early 2013, we hired approximately 75 sales representatives and started promoting Oxtellar XR in February.
Starting with distribution, we are very pleased to tell you that all major wholesalers and several regional wholesalers have stocked the product. We also have a pharmacy assistant service that assist our patients in finding a local pharmacy that can quickly order the product and fill their prescription.
Regarding managed care, we have exceeded our expectations with more than 120 million commercial lives already covered. As we expected, coverages with a Tier-3 unrestricted status. In addition to that, we now have 7 million Medicaid lives also covered with no prior authorization or with other authorization. We expect more lives to be added on a state-by-state basis as the various states go through their approval process.
For your reference, anti-epileptic drugs are a protected class where coverage by Medicaid is mandatory and Medicaid represents about 27% of the oxcarbazepine prescriptions in the U.S. So overall, we're very pleased with the managed care situation and we have not encountered any unexpected issues.
Regarding our sales efforts in the field, our sales force is targeting the top six deciles of high prescribing physicians. Initial feedback from the field and I emphasize, initial, given how early in the launch cycle we are has been very encouraging. Our representatives are able to access our target physician audience and are getting sufficient time with them. The message we are delivering in the physician’s office about the benefits of Oxtellar XR seems to resonate well with physicians who are familiar with and are current prescribers of immediate release of oxcarbazepine. In addition, we have started to hear from the field of our positive experiences by patients with Oxtellar XR that are being reported by physicians.
While we are very early in the launch and we don’t have ample prescription data to report on, we are seeing a good movement of samples and starter kits in physician offices. We also have started to receive reorders from wholesalers signalling potential movement of product from pharmacies. Again please note that it is way too early in the launch for us to use such early indicators as a surrogate for actual prescription data.
To sum it up, we are very encouraged with some of the early signs we are seeing across key areas of the launch. We expect all such early indicators will hopefully translate into a positive uptake in prescriptions. We should be in a much better position to look at prescription data in the upcoming weeks.
Finally, regarding revenues, we plan to follow common standards of practice and GAAP by recording Oxtellar XR revenues on a pull-through basis once gross to net assumptions are reliable. Greg will give you more details in a few minutes.
Moving on to Trokendi XR, we are on-track in our planning and preparation to launch the product in the third quarter of this year. I would like to take a few minutes to update you on recent communications with the FDA that should help you understand where do we stand with our NDA and obtaining the final approval.
As you remember in June, 2012, we received from the FDA the tentative approval on Trokendi XR because of a paediatric exclusivity that Topamax has and that expires on June 22, 2013. So the FDA specified in its tentative approval letter to us, which is publicly available, the company needed to submit a request for final approval to get the final marketing approval for Trokendi XR. The company submitted such a request in early December, 2012, as an amendment to the NDA including a safety update in new package insert and new packaging configurations that we believe can enhance our launch and product offerings.
Recently, the FDA informed the company that should the FDA approve our amendment it will most likely be in the form of a tentative approval because the review period of such amendment would be expected to conclude in the second quarter prior to the June 22, 2013 expiration date of the pediatric exclusivity. We continue to expect getting the final approval and commercially launching Trokendi XR in the third quarter of 2013.
Regarding the rest of our pipeline, in November, 2012, we announced positive topline results from our Phase IIb study on SPN-810 for the treatment of impulsive aggression in ADHD patients. Since we issued the topline results we have been analyzing the full dataset and working on putting together a package that outlines our development plan including a proposed Phase III design to discuss in detail with the FDA later this year.
I will now turn it over to Greg Patrick, our CFO, to walk you through the financial highlights.
Thanks Jack and good afternoon everyone. I would now like to summarize the financial information for the quarter and the year-ending December 31, 2012.
Cash, cash equivalents and marketable securities were $88.5 million at December 31, 2012. Research and development expense for the fourth quarter declined from $7.5 million in 2011 to $5.2 million in 2012 due to lower clinical trial costs for Oxtellar XR.
Selling, general and administrative expense for the fourth quarter increased from $2.8 million in 2011 to $8.7 million in 2012 reflecting higher sales and marketing expenses in anticipation of the 2013 launch of Oxtellar XR and Trokendi XR.
Net loss for the fourth quarter 2012 was $13.5 million or $0.51 per common share compared to a gain of $82 million or $40.14 per common share in the fourth quarter of 2011. The gain in the fourth quarter of 2011 was due to the sale of the TCD royalty subsidiary which is reported as a discontinued operation.
Excluding the impact of the sale of the TCD subsidiary, net loss for the fourth quarter of 2011 was $10.7 million. Looking forward in 2013, we are of course in the process of launching our first two products. In order to support these commercialization efforts and to continue to develop our psychiatry pipeline, we project that cash burn for the year will range from $95 million to $105 million.
We believe our cash, cash equivalents, and marketable securities as of year end 2012 should be sufficient to fund operations into the fourth quarter of 2013. I would like to close with a few words regarding how we envision recognition of revenue to proceed.
As most investors appreciate before revenue associated with the sale of the product to a patient can be recorded on the books of the company, we must first be able to determine the dollar amount of the rebates and allowances which were incurred in conjunction with filling that prescription.
Most of this information is received on a quarter lag basis. For example, the rebates and allowances which were incurred in filling prescriptions during the first quarter will not be reported to the company until late in the second quarter that is in the May-June timeframe. Assuming availability of the requisite data, the company believes that it maybe able to report revenue for Oxtellar XR prescriptions that were sold in the first quarter in our second quarter financial results.
This information will be reported to investors by the company in early August when it files its quarterly report on Form 10Q for the second quarter. In the following quarter assuming data on rebates and allowances for prescriptions that were filled in the second quarter are received in August and September, the company would be able to report revenue for Oxtellar XR prescriptions that was sold in the second quarter in our third quarter financial results.
This means that second quarter revenue will be reported to investors by the company in the early November timeframe in its third quarter Form 10Q. Once the company can establish a repeatable pattern of payer, distributor, Medicaid and Medicare rebates and allowances, the company can transition to contemporaneous revenue recognition that is recognizing revenue upon shipment to distributors and wholesalers. It is premature to speculate on when this might happen but it is probably no earlier than early 2014.
I'll now turn it over to Jack for the closing remarks.
All of us at Supernus are excited about 2013 and look forward to updating you on our progress throughout the year. We are pleased with the very early signs we have shared with you today about the Oxtellar XR launch and look forward to sharing with you prescription data and more insights as we get further into the launch. We are also excited about our plans for Trokendi XR and continue to be the on track for the launch in the third quarter.
We want to thank you for your continued support and now we would like to open the call for questions.
(Operator Instructions) Our first question comes from Corey Davis from Jefferies.
Corey Davis - Jefferies
Thank you for your guidance. I think your cash burn but can you give us a little more help on the split roughly between R&D and SG&A. I am assuming R&D will be roughly flat and most of the increase is going to be in SG&A but are you building in a lot more R&D spend for the new Phase 3?
Hi, Corey this is Greg Patrick speaking. Your sub position is exactly spot on. R&D spending on a year-over-year basis will be essentially flat and the bulk of the increase in expenditures is going to be through the SG&A line of course but the [partner] into that is going to be around our sales force and our marketing programs to launch our two new products. So I would say, essentially the entire increase tied up in sales and marketing arena.
Corey Davis - Jefferies
And second question, I was a little bit confused about your explanation of revenue recognition. I understand why you can’t report wholesaler stocking and I think most companies that are just starting out, report revenue on a pull through demand basis but still real time in a quarter. So maybe a little bit more explanation as to why I think you said you are going to report it on a one quarter lagging basis?
Right. We've actually done a lot homework in this arena and we very much an expertise on the some of the partners with which the company is working and clearly it would be preferable if we had information on rebates and allowances and time so that we can close the quarter and recognize revenue on a pull through basis for that same quarter.
However, according to the schedules that we are seeing, we don't start seeing rebate and allowance data until in the context of this Corey until the middle of May, of course the middle of May is when we are actually filing our first quarter (inaudible) so that information comes in just at the time that we are filing our financial results.
And it spreads out over really the next three to four weeks. And so because of that the dislocation in time there is no other choice for us for the first and probably the second quarter to be reporting revenue except on a quarter like basis but what we are looking forward to though is once we establish those relationships meaning, we understand how much is following through Medicaid, we understand what the deposition of rebate and allowances are for managed care.
We can then it's unjuntured move forward to contemporary this revenue recognition, but that’s going to take us at least a couple of four quarters before we can see, what we believe to be a repeatable pattern. We review this extensively in both internally and externally including obviously our external auditors and we are all on the same page in terms of what needs to be done here.
Corey Davis - Jefferies
Okay. Thank you for that. And Medicaid at 27% of all oxcarbazepine scripts would you expect that the Medicaid percent of Oxtellar is roughly going to mirror that or more or less?
Yeah. I will take that Corey. Probably in general, we would expect it to mirror that may be we could be a little bit lower, we don't have really very hard data to speculate or say a lot of the Medicaid to be in the psycho arena versus epilepsy, which really don't have a solid data to decipher that.
So given that Oxtellar XR is mainly and obviously is only being promoted in epilepsy and that is only thing we have on the label and we are going to neurologist for our product. Is it possible that we will have a less or a lower percentage in Medicaid that could be, but it is very hard for us today to stand here and really predict anything like that.
Corey Davis - Jefferies
And last question is you referenced some the amendments you made to that Trokendi NDA, can you elaborate a little bit more on that, why you think it might be now a slightly better label then you did previously?
Basically some of things are being included in the amendment and I am trying up to be too specific here obviously given the competitive situation when around that product. You have routine safety updates that you typically have to include with any filing with agency which was part of that amendment.
And we also took opportunity given that we are launching in the third quarter, we took the opportunity of developing some very nice packaging configurations that we wanted to add to enhance and launch and so forth.
And then the same thing as far as the package insert, if there are changes on the reference product like (inaudible) there are certain changes on their label. We will have to account for some of those changes. So the amendment incorporated all these different elements and because typically review of an amendment is about six months that's why we said earlier in the call, basically that the PDUFA so to speak of that amendment is prior to the June 22, 2013 exploration of the pediatric specific and therefore we wanted to alert the street and investors that we could potentially get a second tentative approval but that is just a matter of logistics more than anything else and our launch continues to be on time for the third quarter of this year.
Our next question comes from Ken Cacciatore from Cowen & Company.
Ken Cacciatore - Cowen & Company
Just a question on the launch and maybe can you talk about you are clearly sampling fairly aggressively early on, can you talk about co-pay assistance, are we going to start to see that early and then maybe also on costs per therapy where the dosing is shaking out. I know its real early days here but can you talk about how the doses, where we are in terms of average dose as the patients get started and then I have a follow-up.
Yeah, as far as the launch let me also start by saying I mean typically the way we look at these launches and how we can give you a feel whether the launch is going well or not as we said earlier, given we just launched about really a couple of weeks ago if you look at the and account for the fact that the sales force industries around February 4 by the time the sales force obviously gets to the physician, set up the appointment and all that in reality we probably are only about two weeks into this launch. And all the early indicators as far as obviously the distribution of the wholesaler, the managed care situation has been very, very, we've been very, very pleased with that.
The time we've been getting with physicians has been really on the positive favorable side. Physicians are giving us the access; they are giving us the time. We are able to go through our call with them through the presentation and the message has been received very well about Oxtellar and the true benefits that this product can bring to the patients. So we are obviously very, very encouraged with all these early signs and again are very early signs and to your question on the co-pay we are starting to see some movement on the copay, movement meaning some redemption of these co-pay cards but typically what we have just to walk you through as an example as to what would happen, a patient walks into the physician’s office, they walk out to typically with a starter kit. Our starter kit includes basically the co-pay card instructions pharmacy locator service, information about the product, medication guide and basically the patient will go to the pharmacy, present the co-pay card, the out of pocket is $15 so it’s a very reasonable out of pocket on the product. And the co-pay card can be up to 12 prescriptions.
So it’s a fairly good time period where the patient can try the product for a reasonable amount of time and get used to it and get the benefit out of the products. So as far as redemptions it’s really early for us to predict and come up with any patterns. As far as usage between the different strengths again really early data for us to really come up with any specific trend and say you know the 600 milligrams is being used more than the 300 or vice versa. But typically I'll just give you an idea a prescription on a 30 day prescription; it’s about 60 tablets per prescription, that's what we expect to be happening on an average.
Ken Cacciatore - Cowen & Company
And then I don't know if it’s too early, but are you starting a little bit of the pre managed care discussion which can be and maybe some early feedback on how those discussions are going.
I mean as you probably have garnered from the discussion and the results we’ve had on managed care already you know with so many lives covered, clearly we've done a lot of work on Oxtellar XR ahead of the launch and we will certainly be doing the same thing with Trokendi and I'll just leave it that way but we certainly hope and look forward to get very similar coverage if not better on Trokendi
Thank you and our next question comes from David Amsellem from Piper Jaffray.
David Amsellem - Piper Jaffray
Thanks and just a couple on my end. First, what's your view on the earliest potential timeframe for when we could see paragraph or filings on Oxtellar XR and eventually Trokendi?
It's really a tough question to answer, David and speculate on it obviously. We’ve always held the view that it had been historically very difficult for people to develop a once-a-day oxcarbazepine. And we say that from facts we've known from other folks in the industry and we've given some examples I think before people who try to do it but it was more challenging scientifically.
So we certainly hope from our end as you know, that should not really allow generic companies to be too quick and filing a Paragraph 4 and that’s really the only thing I can tell you at this point. So Trokendi XR or a similar thing, we believe we have a very, very unique profile with our product and a very novel formulation and therefore hopefully the Paragraph 4 won't come in too early but difficult to predict.
David Amsellem - Piper Jaffray
Okay, that’s helpful and then in terms of once you get the sort of steady state revenues on Oxtellar and eventually Trokendi and given then it's mostly a tier-3 product and again thinking further a field, once you are recognizing revenue, can you give us some color on how we should think about this spread between gross to net, given the extent of discounting and rebating allowances and given that (inaudible)
Yeah. I mean the gross to net on an average we expected to be in the 28% or 30% range, it might shift a little bit from one product to the next, but you will be in a good range around that.
David Amsellem - Piper Jaffray
Okay. Then just remind us the extent that which you are expanding the sales force to support Trokendi?
Yeah. We are shooting for as we mentioned the several times before is we are really looking for on a total basis once we have both products in the market without getting a again into the specific just to when we are adding what number of sales people in what quarter. But by the end of the year, we are looking at around somewhere in 130 to 140 reps that are promoting both products.
David Amsellem - Piper Jaffray
Okay. Last question if I made is on molindone SPN-810, you mentioned in phase III, I mean what gives you confidence that the next trial would be a phase III and just give us a may be some color on whether it's going to be a multi-dose study and how you are thinking about overall design?
The confidence we have or the information we have so far is clearly from the phase IIa study that we have done historically before and then the recent phase IIb, which we finished in November, which when you look at both studies and the indicator they have given us as far as does this molecule really work in that field or that discipline of behavioural therapy and we believe the answer is a strong yes.
So the key for us is with all the data we have generated to-date on this product and not just the phase IIb trial, but some of the other PK trials that we have done historically can we come up with a very strong simulation where we can relate the PK/PD relationship and be able to go to the FDA and discuss with them, what kind of doses we can go with for the molindone molecule to treat that specific condition and we are as we mentioned before, we are in the middle of doing all this analysis that is another very quick simple analysis to do, compiling data from several studies including the Phase IIb and truly come up with very solid scientific modeling stimulations.
Once we do all that our plan is to put the package together and as we mentioned again, I mean our goal is to move forward towards later stage Phase III studies. Now whether we are successful or not obviously that will depend on our discussions with the FDA and the position or approach they take after seeing our results, the stimulation and all that data.
So we really don't have the very, very clear answer right now as to what that Phase III could look like, we are in the middle of putting all this plans together, but hopefully before the year end we should have a much, much better and clear picture regarding the whole program and what should we expect from the Phase III program point of view and what kind of studies to expect and how big and how small this studies will be.
Thank you. (Operator Instructions) our next question comes from Annabel Samimy from Stifel.
Annabel Samimy - Stifel Nicolaus
Just following on the top of the 810 you mentioned we are not going to really get clarity on that until year end, so does that mean that you don't have any FDA meeting schedule today and are we going to see any addition analysis that you have done on the clinical Phase IIb?
Yeah, no we will have a meeting with the FDA this year what I meant with my comment is that that will be post the meeting given the results of the meeting. So our plan for this year is to put the package together, do the analysis, complete all that, meet with the FDA and then based on that meeting come up with a final plan and a clear path on the development of the product.
Annabel Samimy - Stifel Nicolaus
Okay. I guess a lot of my other questions have been answered but on the guidance of the cash burn between 95 and 120, I believe is what it was I mean I guess it goes without saying your cash level is $88 million. So in terms of some of the options you have in front of you are there any kind of non-diluted financing options you have that could get to where you need to be until you reach that critical sales level and I assume that there's going to be no further development of 810 until you settle that and are there any other outlets or options that you are considering?
Yeah, sure, just a very small correction, the cash burn we are expecting is 95 to 105 for the year at the upper end and the really short answer to your question is absolutely I mean our preference and our goal will be to explore all options, potential options for us that are non-dilutive. You may recall and we mentioned that several times also given we have eventual depth situation that we are looking to potentially structure that. So we have several options that are not necessarily equity based options where we can potentially raise the funds that we are looking for to get us to where we need to be as far as cash flow positive. And definitely it will be our primary goal for the year.
Annabel Samimy - Stifel Nicolaus
Okay, and in terms of the out licensing I imagine that was just before current pipeline products as opposed to approved tentatively approved products that you are building up the sales force and have you been considering any US licensing?
Yeah, I mean as far as all our assets again we always maintained the same strategy and we said we do seek and have been seeking partnerships for all our products the Oxtellar XR to Trokendi or even the psychiatry products for markets outside the US. So that will apply to all of them.
In the US, we also have said that as far as our psychiatry portfolio if there is an option for us that makes sense where we can continue to speed up and progress these products in the pipeline with a partner, we are open to discussions and we continue to talk to folks about those other options as well and as these partnerships do bring in cash for the company then at that time we will know obviously. But clearly in general, we would like to maintain as many rights as possible for us in the US market as our priority for all the products.
Our next question comes from Jonathan Eckard from Citi.
Jonathan Eckard - Citi
I just had a question on the guidance. So the 95 to 105 cash burn, does that incorporate any internal asset revenue estimates from the company and if that does during the course of the year, if those estimates are changed how would you notify the street?
Jonathan thanks for the question, there are broadly speaking five components to the cash burn guidance just to notice that in a structured manner. Clearly, revenue is part of that but also part of the cash burn guidance that's tied to revenue involves inventory and receivables assumptions going forward because as we're building sales and we're also investing in working capital.
And in parallel with that, as (inaudible) touched on at the onset of call, he made some assumptions about operating expense. So the SG&A and R&D expenses flow through that equation as well. Nonetheless, component to cash flow has to do with our venture debt which Jack touched on briefly a moment ago and those expenditures looking forward layout to the penny in our SEC filings.
So to circle back to the second part of your question, as our revenue expectations may change going forward, we communicate that to the street and modify upwards and downwards our cash burn guidance for the year. So if there is a material movement in that regard, and if it's material with respect to our cash burn, we go back with our revised guidance in terms of cash burn for the 12 months.
Jonathan Eckard - Citi
Thanks. And then with regard to how the street can get some clarity with regard to how the launch maybe doing, in the past, IMS has done a reasonable job of tracking other anti-epileptics sales. Would you feel, maybe not in the precise manner but would IMS; do you feel is there any reason why IMS would not at least directionally track Oxtellar XR fairly well?
We're looking at Jonathan this is Jack. We are looking at obviously (inaudible) IMS data and the key difference between the two is that IMS does not include Wal-Mart for example in which cases, in some cases it might be a big portion. We don’t know for sure at this point obviously with Oxtellar XR whatever the IMS data ends up being a real predictive of the product sales or not versus (inaudible) but certainly in the next few weeks or month or so, I mean we will try to fine tune here the parameters, and the metrics that we will be able and should be able to communicate to the street and the kind of data, we are looking at internally to help people understand how the launch is going. That certainly would be one of our goals to be as open as possible with everyone and make them understand how the uptake of the product is going from a prescription point of view.
Jonathan Eckard - Citi
Okay. Thanks and if I could just one more question. When you report first quarter’s sales in the second quarter that you made a comment in your prepared remarks that wholesalers have stopped the drug. I am guessing that you probably would have enough clarity based on the amount of rebates to be able to break out, how much of the sales could be stocking versus demand is that an accurate assumption?
The answer Jonathan is a little bit yes and little bit no. The revenue we are going to be showing is going to be as Corey mentioned at the start of the Q&A is going to be out pull through basis, so we are actually be looking for prescription, which have been filled at the pharmacy level.
Jonathan Eckard - Citi
And for those prescriptions, for us to be able to recognize revenue for the first quarter, remember that first quarter is going to be a stubbed period because we have only launched in early February. We’ll have to match those prescriptions up to against rebates and allowance are applicable to those. So to the extent that there is Medicaid in there, we are going to have to make sure that we know for those patients, where are they from and what the Medicaid rebates look like.
Similarly at manage care we are going to have to identify which plans are flowing through and make sure that we are matching up those rebates and allowances for those prescriptions. To the extent that which we have stocking and we received cash from wholesalers and distributors from where the shipments that’s going to be recorded as deferred revenue, and so obviously we are getting the cash and cash is going to appear the balance sheet and that’s on the left side of balance sheet, right side of balance sheet is going to be the deferred revenue which is going to be, where we have recorded those proceeds from wholesalers and distributors, they don’t become revenue though then until we can actually clarify on a pull-through basis that those shipments have turned to descript.
Jonathan Eckard - Citi
Thank you very much.
Operator I think we have time for one more question.
(Operator Instructions) I am sorry, no one in queue at this time, sir.
Okay, well, thank you all for attending our conference call. We look forward to talking to you, thank you.
Ladies and gentlemen, thank you for participating in today's conference. This concludes our program. You may all disconnect and have a wonderful day.
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