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Supernus Pharmaceuticals, Inc. (SUPN)

Q4 2014 Earnings Call· Wed, Mar 11, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to Supernus Pharmaceutical Fourth Quarter and Full Year 2014 Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session. Instructions will follow at that time. [Operator Instructions]. As a reminder this conference call is being recorded. I now like to turn the conference over to Peter Vozzo. You may begin.

Peter Vozzo

Analyst

Thank you, Nicole. Good morning, everyone and thank you for joining us today for Supernus Pharmaceutical’s 2014 Fourth Quarter and Full Year Financial Results Call. Results discussed today are for the quarter and year-ended December 31, 2014. Yesterday, after the market close the company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Greg Patrick. Today's call is being made available via the Investor Relations section of the company's website at www.ir.supernus.com. Following remarks by the management we will open the call to questions. We expect the duration of the call to be approximately 45 minutes. During the course of this call management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information and can be identified by such words as expect, plan, will, may, anticipate, believe, should, intend and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factor section of our annual report on Form 10-K, which we expect to file later this week. 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 March 11, 2015 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. I will now turn the call over to Jack.

Jack A. Khattar

Analyst

Thank you, Peter, and good morning, everyone. I appreciate everyone taking the time to join us as we discuss our 2014 fourth quarter and full year results. I'm very excited about our results, the continued solid growth in our business and our prospects moving forward. Let me give you some of the key highlights. Total product revenue for the fourth quarter was $30 million, substantially exceeding the product revenue guidance of $24 million to $26 million we provided during our third quarter conference call in November. Also back in November we projected that we would become cash flow positive by the end of the fourth quarter. We exceeded that guidance too as we were significantly cash flow positive for the entire fourth quarter. Underlying our net product revenue is strong growth and prescriptions for Oxtellar XR and for Trokendi XR. Total prescriptions for the quarter; as reported by Symphony increased by approximately 12,963 prescriptions or 22% over the third quarter of 2014, a total of 70,739 prescriptions. Trokendi XR prescriptions for fourth quarter totaled 50,583, which is a 28% increase over the 39,524 prescriptions for the third quarter of 2014. Oxtellar XR prescriptions for the fourth quarter totaled 20,156, representing a 10% increase over the 18,252 prescriptions in the third quarter. 2015 first quarter to-date total prescriptions for Trokendi XR and Oxtellar XR are 15% higher than the comparable period in the fourth quarter of 2014. Throughout 2015 we will continue to promote our brands with our sales and marketing teams fully focused on maximizing the potential. We continue to believe that the two products combined have the potential for peak sales of $400 million to $500 million. Both products continue to offer patients significant clinical benefits and reasons to switch from immediate release products. For instance in a recent…

Gregory S. Patrick

Analyst

Thanks, Jack and good morning everyone. As I review our financial results I'd like to remind our listeners to refer to the fourth quarter and full year 2014 earnings press release issued yesterday after the market close. We expect to file our Form 10-K for 2014 later this week. Net product revenue for the fourth quarter of 2014 was $30.5 million comprised of $22.9 million for Trokendi XR and $7.6 million for Oxtellar XR. Having been launched in 2013, both of these products are clearly still in a growth phase. As such we believe the best framework for analyzing revenue growth is to compare revenue versus the prior quarter as reviewing sequential quarter’s helps us to understand the momentum in revenue growth. Fourth quarter product revenue for Trokendi XR $22.9 million is 50% higher as compared to third quarter 2014. On a sequential basis, Trokendi XR revenue grew by $7.6 million. Fourth quarter product revenue for Oxtellar XR was $7.6 million, compared to $7.2 million in the third quarter of 2014. Total revenue for full year 2014 was $122 million compared to $12 million in 2013. Please note that this year-over-year comparison is affected by the change in revenue recognition methodology, which transitioned in 2014 to contemporing [ph] its recognition based on shipments to wholesalers and distributors. Revenue in 2014 included $89.6 million in product revenue, $30 million in royalty monetization revenue and licensing revenue of $2.5 million. Gross margin for the quarter was 92.5% and for the year was 93.6%. Going forward we continue to expect product gross margins to exceed 90%. Selling, general and administrative expenses were $18 million for the fourth quarter and $72.5 million for the full year, as compared to $15.2 million and $55.6 million in the same periods in the prior year. The increase…

Operator

Operator

Thank you. [Operator Instructions]. Our first question comes from the line of Ken Cacciatore of Cowen & Company. Your line is now open.

Ken Cacciatore

Analyst

Good morning guys. Thank you very much. Just a question, with the really good performance here in getting these products established, I know Jack that you wanted the sales force focused, but can you talk about potential business development, now that you’ve kind of seem to have inflected and garnered critical mass? And second question is around 810, can you just describe that molecule in a little bit more detail and the indication that you’re going for, help us nuance maybe what the opportunity is as you describe it? Thank you.

Jack A. Khattar

Analyst

Yes, sure. Yes, starting with the business development activities, clearly that now we feel very good and very strong about Oxtellar XR, Trokendi XR. They’re well established. We continue to grow them. They are still and I would emphasis, they are still in the early stage of growth obviously and that gives us certainly in 2015 much more room for us to really emphasize business development and the activities there. We have been active, as I said for many times, that we have been active even over the last couple of years in business development activities. But certainly from a timing point of view we see 2015 as a much more appropriate time for us to execute something, that will be a strategic fit and that really fits very well with the large footprint that we have in the neurology space. As far as 810 this was truly an innovative program that we are pioneering in this field. As most of you may know impulsive aggression is a disease that is very prevalent across many, many areas. It is prevalent in ADHD and autism, bipolar, schizophrenia and dementia. And our estimate at this point even if we look only at ADHD autism and bipolar, we believe the market opportunity is north of $3 billion and this is an area where there are no approved products today for that condition, although it's a very well recognized condition and clearly as the FDA recognized last year in giving us the fast track designation because it's a critical unmet need for which there are no products that are well developed specifically for that condition and approved for that condition. So we believe this is a huge, huge opportunity for Supernus. We are very proud to be on the cutting edge here as far as clinical development. We are developing a whole new scale and we, as I mentioned in our remarks we have developed that scale and we have validated the scale and we are sharing that with the FDA in the next few months before we start the Phase 3 study. This is a truly an innovative clinical program. The molecule itself it is very, very old anti-psychotic, it’s dopamine serotonin antagonist and it really works very, very well in treating aggression. And the data that we have seen in the Phase 2a as well as the Phase 2b studies earlier in the last few years shows a very strong signal that this drug we believe should work very, very well in these stations. And that's why we will be doing the Investor Day actually in June 17 to get into more details about this unique and very innovative program 810, as well 812 and we will also try to give you an assessment of the market opportunity for both products also.

Ken Cacciatore

Analyst

Great. Thanks guys.

Operator

Operator

Thank you. [Operator Instructions]. Our next question comes from Annabel Samimy of Stifel. Your line is now open.

Annabel Samimy

Analyst

Hi. Thanks for taking my question, and congratulations on a good quarter. Just along the lines of business development, can you talk about your capacity? You have about $94 million but with the EBITDA, what kind of EBITDA that you have for 2015 and what kind of size are you thinking about in terms of business development and with the programs that are moving quite rapidly into Phase 3 and potentially as extensive as they are, are you ready for some transformative deals, or is it just going to be product selection or accretive assets? Thanks.

Jack A. Khattar

Analyst

Yes, I'll take the second part of the question, I'll let Greg answer the first part. As far as the kind of products or companies or transactions that we are looking for, let me try to clarify that from a priority point of view as far as our priorities typically the first we are looking at a product that would sit very nicely within the footprint that we have from a sales force perspective of the commercial team and the organization that we put in place. So our priority would be things in the neurology and/or adjacent areas, whether psychiatry to really fit within the sales force that we have. Second priority will be something that could be a pipeline product but is actually more advanced than 810 or 812. There is clearly no sense for us to go after opportunities that bring us Phase 2 program or a Phase 1 program. So if we are focused on bringing a pipeline product that will be something that could potentially be ahead of 810 from a timing perspective and ahead of 812. And then finally if there was a company type of transaction that can be more transformative, clearly we're very open to that as well that could really change Supernus and bring it to a much higher level in a much quicker timeframe than if we were doing it as we've been doing it boot strapping it from the beginning. Regarding the capacity of doing deals, clearly we do have more capacity in doing product deals, obviously and depending on the size of the deal and as the transactions get bigger in size and so forth, we have capacity from a leverage debt and so forth and I'll let Greg speak a little bit more specific about numbers.

Gregory S. Patrick

Analyst

Right. I am going to use the same framework that Jack articulated because I think it's a very useful one and underscore -- we look at any and everything. I think in terms of financing capacity that's probably the last barrier that we worry about. So kind of following along Jack’s structure if it is a product that we would drop into our sales force, those tend to have or can have very minimal upfront payments and they tend to be more of a pay as you go kind of opportunity. So most of the economics would be wound around royalties, ongoing cost sharing agreements and the like. And that clearly we can fold into our existing P&L and balance sheet structure. If it is a pipeline product, that too we believe that we have got with the growing income stream over the next several years ability to self-fund that. With a balance sheet of almost a $100 million we clearly have cash on balance sheet. So we believe that would not require any extra extraneous financing to be undertaken and finally if it is a transformative deal and a deal with another company, I think there is that’s clearly moving into the equity at the outsized, very large transaction. If it is small transaction more where Supernus would be the larger of the two merged companies, then as Jack suggested we could do something around restructuring our existing convert deal and probably expand -- then go back to the market with an expanded convert deal to raise additional capital that was necessary.

Annabel Samimy

Analyst

Okay. Is there any leverage ratio that you are thinking in terms of targeting or the max leverage ratio that you have?

Gregory S. Patrick

Analyst

Yeah, I think the leverage ratio probably something in 20% to 30% ultimately would make sense. We are sensitive in the next couple of years as we are continuing to ramp up our commercial products and grow our income streams, that we do find ourselves overly encumbered with leverage because just the servicing requirement to that can create a bit of headwind both from the cash flow and P&L standpoint. But I would say ultimately something in kind of 20% to 30%, 30% kind of be an outside number would make sense for us.

Annabel Samimy

Analyst

Okay. And if I could ask you on your guidance, if I look at the assumptions that you draw there, I end up with vastly differently operating income then the $6 million to $10 million that you pointed to. So that must mean that there is some change in the SG&A line that would be the only variable. So maybe you can help us understand what the trajectory of SG&A should be going forward. Do you have any unusual expenses for the year, any plans on expanding the sales force or increasing anything over there?

Gregory S. Patrick

Analyst

Actually the other line to pick on would be the R&D line. That’s the one where the expenses will significant grow. I am going to put a plug in for our Investor Day at June 17th that we, as Jack mentioned, plan on laying out not only the clinical programs but also the spending requirements for these programs and the market opportunity for our programs. But I would say that as Jack and I have said on numerous occasions that in bringing both of these products to market will probably require something in the range of, broad range of number $70 million to a $100 million for each of these product opportunities. And so if you keep in mind that probably will be a four year development cycle and aggregate that spending that, just simple math would suggest that R&D needs to move up substantially from where it has been over the past couple of years. 2014 was just a little bit below $20 million. 2015 is probably a 50% or more year-over-year increase. So that that’s clearly going to absorb and everything else being equal we will drop far more income to the bottom line but R&D spending is clearly going to absorb a lot of that income capacity.

Jack A. Khattar

Analyst

And to your question, Annabel on the sales force, we have no plans to expand or anything there. I would just remind everyone that there will be an annualization effect in 2015 versus 2014 for the expansion of the sales force. So whatever the numbers are in 2014 they will be higher in 2015 just because when we brought in the extra 50 or 60 reps half way through 2014 you got to annualize that extra cost and so you are going to see a bump clearly in 2015 of that cost but that’s not due to the expansion for -- that’s not due to any further expansion.

Gregory S. Patrick

Analyst

Right and that affects both sales and market expenses, so it’s probably in the range of $4 million to $5 million year-over-year increase versus where we were in 2014.

Annabel Samimy

Analyst

Okay. And if I can ask one more question on Trokendi XR, has the thought of expanding into the migraine area become any kind of priority for you? I know in the past you've sort of commented that neurologists appreciate your focus on epilepsy. But do you have any plans expanding into migraine, at any point? Thanks.

Jack A. Khattar

Analyst

It is always something we look at certainly and if you don't mind I will just reserve making any comments for competitive reasons.

Annabel Samimy

Analyst

Okay, great thank you.

Operator

Operator

Thank you. We have time for one more question from the line of David Amsellem of Piper Jaffray. Your line is now open.

David A. Amsellem

Analyst

Thanks a just a few so. First can you just give us a refresher on where things stands on the litigations with the generics on both the Oxtellar and Trokendi and maybe if you can talk about how confident you are, you can get those cases settled, so that's number one. Number two is on the molindone opportunity. Can you talk about how do you thinking about it commercially in terms of the extent to which you need to expand the sales force, how many reps you need to support it? How are you thinking about the physician call audience bearing in mind that this is somewhat of a market that you are going to be developing? So how should we think about that going forward and with the pipeline in general, this is my last question, are you contemplating any partnerships out licensings of either the asset in late stage development either for the U.S. or even ex-U.S.? Thanks.

Jack A. Khattar

Analyst

Yes, sure. Regarding the first question, David on the IP and the litigation, I mean that's moving forward on both products. Oxtellar XR is clearly ahead from a process point of view versus Trokendi XR. And on that one we are always and have been always confident about our IP and the strength and we continue to add more patents to our portfolio to protect both products. So we're very confident as far as the outcome or potential outcome of these courts [ph]. Clearly we can give people the certainty, 100% certainty of the outcome. But we continue to be very bullish about how the case is proceeding and so forth. As far as settlement itself we keep all options open. So we are open to all kind of options in these kinds of situations if they make sense obviously. So the answer is yes, all these options are on the table to do the right thing for us. The key thing I always like to remind people of is that our patents go all the way out to 2027, 2029 in certain cases. So these are not the cases where we are faced with expirations on patents in 2020 or 2019. And that certainly helps us and also the strength of the patents themselves are pretty good. And I've also mentioned and not that, that will have any implication on Oxtellar XR and Trokendi XR that we do have a very strong track record in navigating through these issues defending these kind of cases and actually in the fall of last year for the first time ever a pharmaceutical company actually won IPR challenges in our industry and the win was on three patents with three challenges. And that pharmaceutical company is Supernus. So we tend to be very…

David A. Amsellem

Analyst

Hey, that’s helpful. Thank you.

Operator

Operator

Thank you. And I would like to turn the call back over to Jack for any closing remarks.

Jack A. Khattar

Analyst

Thank you. We are proud of the remarkable achievements in 2014 and the progress we made since going public in 2012 and since launching two products in 2013. We substantially exceeded our revenue and cash flow guidance for 2014 and achieved for the first time as a public company, profitability. We view 2015 as a new chapter for Supernus, given that we have achieved profitability and have built a significant cash position. We now have entered our second phase in building the company to be a leading specialty CNS company. Our strategy in building Supernus has always been to first establish a strong position in CNS with Oxtellar XR and Trokendi XR and then generate significant future cash flows from their success in the market. Such cash flow will now allow us to develop our innovative high value pipeline products and facilitate the execution of potential strategic business development transactions. Thanks for joining us today. We look forward to another strong year in 2015 and to updating you during our next earnings call and Investor Day on June 17. Thank you.

Operator

Operator

Thank you. Ladies and gentlemen this does conclude today’s program. You may disconnect. Have a great day everyone.