Good morning. My name is Kevin and I'll be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation Fourth Quarter and Annual 2013 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Remarks today concerning United Therapeutics Corporation will include forward-looking statements, representing the Company's expectations or beliefs regarding future events. The Company cautions that such statements involve risks and uncertainties that may cause actual results to differ materially from those projected in the forward-looking statements. Please see the Company's latest forms 10-K and 10-Q and subsequent filings with the SEC for additional information on those risks and uncertainties. There can be no assurance that the actual results, events or developments referenced in these statements will occur or be realized. The Company assumes no obligation to update forward-looking statements to reflect the actual results, new information or changes in underlying assumptions. Today's remarks are intended to educate investors about the Company. This may include reporting on the progress and results of clinical trials and other developments with respect to the Company's products. Today's remarks are not intended to promote the Company's products, to suggest that they are safe and effective for any use other than what is consistent with their FDA approved labelling. Once we provide all available information regarding the products, their risks or related clinical trial results, anyone seeking information regarding the use of one of the Company's products should consult the full prescribing information for the products available on the Company's website at www.unither.com. Thank you. Dr. Rothblatt, you may begin the conference.

Thank you very much, operator, and good morning to everybody joining our 2013 annual financial results conference call which will also cover the fourth quarter 2013 results. I'm joined in the conference call today by our President and Chief Operating Officer, Dr. Roger Jeffs; by our Chief Financial Officer, Mr. John Ferrari; and by our Chief Strategy Officer, Mr. Andy Fisher, who is also especially good at answering questions relating to patents, IP and litigation. Just to give a brief introductory talk here and then open up the phones to questions and I'll be pleased to either answer them myself or to refer the questions to Roger, John or Andy as would be most appropriate. So reflecting back on 2013, I think it's pretty indisputable that 2013 was the best year in United Therapeutics Corporate history. It was a year in which our revenues for the first time not only crossed $1 billion, which was our original forecast for this year, but in fact soared 10% above that. It's a year in which our annual non-GAAP earnings crossed over $0.5 billion, and that is certainly a sign of a well-operating company that can deliver non-GAAP earnings of over $0.5 billion on revenues of just over $1 billion. If you're taking a look at the financial results, you'll notice that the GAAP earnings per share showed a loss for the year. However, this is simply an artefact of the accounting treatment for the share tracking awards which we issued to our employees in lieu of equity-based stock compensation or restricted shares. These types of share tracking awards are required by the accounting rules to be mark-to-market every quarter. And continuing on the theme of this being our best year ever, in 2013 and in the fourth quarter in particular, our stock…

(Operator Instructions) Our first question comes from Mark Schoenebaum with ISI Group.

This is Salim in for Mark. Just had two questions. One on tax, so with all the discussion on tax these days, I was wondering if there was any discussion in UTHR about lowering your tax rate, and if not, what's the downside if not having that discussion? And then on patents, so the 393 process patent that you got last year and the 137 method patent that you just got last week, can you confirm that Sandoz has not certified on those patents yet?

Thanks Salim for all those questions, and I'm going to ask John Ferrari, our Chief Financial Officer, to address the tax question and then ask Andy Fisher, our Chief Strategy Officer, to address the patent question. John?

Thanks Martine. We are always interested in reducing our tax rate. I think yesterday you saw a blip, was going up in part because of our share-based comp increase and some real correlation with [62] (ph) with the tax code, but historically for last several years, our tax rate has been at 30% or under 30% which for a pharmaceutical company is actually pretty good. So we're always taking steps to see if we can generate business credits and do things to keep in tax rate at a fair rate, around 30% or lower.

Thanks John. Andy, can you talk about the new patent?

Sure. So yes, you have noted that last I think late summer we added that 393 patent for the Orange Book for Remodulin. It's actually listed for all three of our treprostinil based products. And then just last week we added another patent to the Orange Book for Remodulin, the 137 patent. As you'll read in our K, we actually have a related patent that's issued today and will also be looked at in the Orange Book for Remodulin. As of yet, Sandoz has not certified on any of those patents and we're not able to comment on the impact of the litigation if any as of yet. So all I can say on that is I guess stay tuned.

Thanks so much, Andy, and compliments Andy to you and your entire patent team and to Roger and his entire chemistry and chemistry R&D team which has wrapped up so much of these patents and selling patent positions. One thing which both of you who were not on the Orenitram launch call, that new product of ours is covered by I believe eight Orange Book patents going out to the end of the 2020. So not only is the Company's pipeline very bright but the other thing that's really, really exciting for us is that our IP protection is strong and goes out until 2020. Operator, can you please let the next person ask the question?

The next question comes from Salveen Richter with Canaccord.

I'm just wondering with over $1 billion in cash, just what your plans might be there for uses of cash, and then just maybe the status of your launch prep for Orenitram, where you stand and what are you doing ahead of launch here?

Thanks so much. Great two questions. So I will touch on the question about cash and strategies with regards to the use of the cash, and following that I would like to ask Dr. Roger Jeffs to address your question about early launch preparations for Orenitram. So with regard to our cash, our position for using the cash is two-fold. First, we are constantly on the lookout for acquisition opportunities where we can strategically expand our footprint. These are in pulmonary life-threatening conditions where of course we are already very strong in pulmonary hypertension but we would like to expand into other pulmonary conditions given the large base of understanding that we have for that disease sector, or for other areas where we have a growing strength, and one of those is in orphan oncology. And as you may be aware, we filed I believe last month or a little bit before that for the regulatory approval for our 14.18 MAb as a treatment for neuroblastoma in the European Union and we will be making a similar trialling for that biologic in the United States within the next couple of months or so. So certainly before the end of this year, we are hopeful of our launching a product into the orphan oncology space and that is another area where we would be keen to use our cash to make a strategic acquisition that could build on our success in having successfully manufactured a biologic for the treatment of an orphan oncology condition, and hopefully crossing our fingers on successfully getting it approved in both Europe and the U.S. The other use of our cash other than strategic acquisitions is to return a greater amount of value to our shareholders by engaging in share buyback and we are currently in the middle of a $400 plus million share buyback. This is not any kind of forecast or a promise or guidance but we expect that that will be completed this calendar year, and as we continue to accumulate more cash, such cash which is above what we need for strategic acquisitions, we would use for further buyback. And just to give you a data point in terms of the probability of my statements on this, we have already with the numerous previous buybacks we've done, bought back just about 20% of our outstanding shares. So that's a pretty good scorecard in terms of our peers and I think strong evidence of our inclination to that direction. So with that answer to your question on the cash balance, I'd like to turn to Roger to give us all a briefing on the preparations for Orenitram launch.

Sure Martine and thanks for the question. So we are in and all-systems-go preparatory period with regards to logistics for Orenitram's launch which we still anticipate by midyear. So in that regard just this week in fact we are manufacturing commercial batches, doing product labelling and packaging in our facility here in Research Triangle Park, a lot of effort in that regard. We are also developing our promotional and brand campaign and then training materials around that brand campaign so that we stay consistent with the labelling for the product. And then finally another important logistical effort that the Company is doing under Jay Watson's leadership with strategic ops is building our patient portal or hub assist center that have had rave remarks for their assistance with patients, for patients with Tyvaso or Remodulin, and help build that infrastructure so that we are there to support patients as they come towards Orenitram therapy as a future therapeutic option for them. So really in a heavy logistical phase right now, lots of activity, lots of energy and excitement as we build into the midyear launch.

Thanks Roger, super answer. Great question. Operator, could you please open up the line for the next question?

The next question comes from Liana Moussatos of Wedbush Securities.

Congratulations on an outstanding year and can you give us a little bit more information on the pipeline product status like implantable pump and TransCon Tre self injectable?

Sure. Great questions, Liana. Thanks very much for the congratulations. So I will touch on a little bit of that and perhaps I'd like to ask Dr. Jeffs to comment about the TransCon product and I will talk a little bit about the implantable pump. So with regards to the implantable pump, this is Liana I think probably going to be looked back in maybe five or ten years' hindsight as one of the most revolutionary development in pharmaceutical delivery of any drug. And by the way, 99% of the credit of this goes to Medtronic. Their SynchroMed II pump allows the pharmaceutical to be delivered continuously inside the body thereby avoiding the need for a puncture of the skin with the associated infection risk that goes along with that and the great inconvenience and awkwardness to patients having to walk around with both a pump and a catheter outside their body, day and night sleeping with it, bathing with it, you could just imagine the logistical nightmares. So Medtronic's SynchroMed II pump has been used very successfully for example intrathecal delivery of drugs, and our partnership with Medtronic is the first opportunity to use this technology for continuous intravascular space delivery of the drug, in our case of course Remodulin or treprostinil. So we are very honored to work with Medtronic on this and the first big step was to find out what the FDA expected in terms of regulatory approval and what they expected was a safety study. They did not require an efficacy study because Remodulin delivered by a Medtronic bump is no more or less of an intravenous Remodulin therapy than delivered by an outside of the body pump as we do it today. So no efficacy study was required, just the safety study. That safety…

Thanks, Martine, and good morning, Liana. So the TransCon technology for those who aren't familiar with it, is a license we did with our development partner, Ascendis, where treprostinil is formulated with a 20,000 [indiscernible] PEG via proprietary linker in a 4-to-1 [indiscernible] treprostinil 2 PEG. When it's complexed as this PEG-linker-treprostinil [indiscernible], it is inert and at least in animal studies today when injected it doesn't have any pain because it's inert until it's hydrolyzed in the plasma. So what we're doing is working with Ascendis to do a lot of the IND enabling studies. This includes cardiovascular safety and pharmacology, toxicology and some PK and PD studies which are not trivial because we have to not only track the state of treprostinil from the linker but also the linker and the PEG-morbidity itself. Those studies are progressing nicely and we are also making Phase 1 CTM which is also not a trivial matter for all of those who've worked in the PEGylation field and tried to go around the nuances of PEG parity. But having said, we're again having some very good success with our chemistry and all of that is building to a 2014 IND filing so that we hope to inject our first patient with this agent this year, and with the real goal to see first and foremost their side pain associated with the injection, and if not, then what is the state of treprostinil in the plasma and can we achieve therapeutic levels of treprostinil over sustained interval. The hope would be that we only have to give this injection once or maybe twice per week or even fewer times depending on the PK but we will certainly sort that out once we are in-human. So again another reason why we are very excited at United Therapeutics about our development pipeline and all that is in front of us in 2014 and beyond with our pipeline. Thank you, Martine.

Fantastic, Roger, excellent review of TransCon. Thank you, Liana, for your questions. Operator, we have time for one more question.

The next question comes from Robyn Karnauskas with Deutsche Bank.

This is Mohit Bansal for Robyn. Congratulations on all your progress this year. So I have one question on your neuroblastoma drug, so could you please help us understand the market opportunity with this drug and then how should we think about the pricing and then what are the next steps to gain the approval?

Excellent question. So we're talking about our first entry into orphan oncology, a neuroblastoma drug. The questions, I'm going to have to Roger to respond to because his team has been responsible for the development and regulatory highlights and also he will be managing the marketing and launch of that drug both in Europe and the U.S. So Roger, could you address the three points of the question?

Yes, so in terms of – let me talk about where we are with filings first, I think Martine touched on this. We filed in December with the European authorities and we anticipate filing in the coming months in the U.S. In fact we just had our pre-BLA meeting with the FDA and that meeting went very well. So they are anxious and I would say very receptive to receiving this application given the high unmet need. With regard to the number of patients that are addressable, just remind the callers that the antibody will be indicated if approved for high-risk neuroblastoma patients. If you look at the population numbers, we think that the numbers are between 350 to 500 patients in U.S. per year with an equal amount in Europe. So the addressable market in U.S. and Europe is about 1,000 patients. And even now I think pre-approval if you look at the number of those patients per year that receive the therapy, it's in the 80% to 90% range of patients. I mean this is a high unmet need with very dire outcome and this antibody has been shown, in clinical studies at least, to improve survival. So it's certainly something that physicians feel is the necessary part of the treatment algorithm already. So I think that's kind of where we are. With regards to pricing, we are still working through the price of the therapy. It is a monoclonal antibody and will be priced accordingly but we also are considerate and we did license this from NCI and that the Children's Oncology Group was instrumental in doing the research and it really wasn't on our nickel, so we'll be sensitive to that when we price the therapy and we will try to price it responsibly and fairly.

Thanks Roger and perfect 360 degree answer. Operator, my Head of Investor Relations reminded me that on the annual call, the time period is 45 minutes, not 30 minutes, my bad on that. So can you please take the next caller?

The next question comes from Phil Nadeau with Cowen & Co. Phil Nadeau - Cowen & Co.: Just a couple of financial questions. So first [indiscernible] moving pieces going into 2014, much in as you highlighted, John, if you [indiscernible] maybe more detailed guidance on your expectations for trends in both revenue and expenses for 2014? And then second question on Q4 2013, you did comment some of what we were modeling, I'm curious whether there was inventory changes in the quarter.

John, if you would not mind first just commenting on the inventory and then I'll answer the rest of the question.

Sure Martine. So inventory during the quarter, Remodulin inventory dropped in both value and patient days and there was a slight increase in inventory for Tyvaso during the quarter.

So with regards to revenue, I think the best guide that I can really suggest you is to take a look at the trends that have been present for the past several years with regards to Remodulin, Tyvaso and Adcirca. These drugs seem to me to grow pretty linearly into their market space and all three of them are still a good ways away from total saturation of their market. So let's take a look at Remodulin for starters. You are talking about here as I just described in answer to Liana's question, you're talking about a pretty invasive therapy. The patient have to wear a pump which is operating 24 hours a day. It's connected to a catheter which is then wound into either their skin subcutaneously or intravenously. So obviously, this is a therapy which is generally reserved for patients that are late New York Heart Association functional class III or perhaps functional class IV. And there are by most public estimates that I've read somewhere between 25,000 and 30,000 patients treated for pulmonary hypertension in the U.S. and usually the numbers that I see, say about 40% of them, are functional class II, about 40% of them functional class III, and maybe 10% class IV and 10% class I. That's kind of how the bell curve wraps around that population. So if you're looking at the class IV, you're seeing that there is maybe something like 2,500 to 3,000 class IV patients, and then if you're looking at the late class IIIs, total class III there might be something like 10,000 to 12,000, so the late class IIIs might be something like 2,000 to 3,000 out of that. So I've told you looking as an addressable market for Remodulin of about 6,000 patients in the U.S. Now…

Our next question comes from Bret Holley with Guggenheim Securities.

I'm just wondering, and maybe you can't answer for competitive reasons, I'm just wondering how you are thinking about incentivizing your sales force relative to Orenitram and how you might carry the products [indiscernible] launch of Orenitram?

That is a bit of an unusual question but as Dr. Jeffs is in charge of the Orenitram sales force, I will transfer to him.

I think probably the best answer is to say, you're correct that we won't comment on that.

Okay, fair enough.

Next question, operator.

The next question comes from Geoff Meacham with JPMorgan.

This is Carter on for Geoff. The question is kind of a feedback on Bret's question, following conversations and launch plannings, do you have any incremental color on your pricing strategy, do you still intend to remain agnostic in terms of pricing? And then the other question is, I don't believe you mentioned any incremental details today on your antiviral program, previous status on that and your rationale going into antivirals?

Let's start at the beginning. So nothing has changed since our launch – since our approval conference call guidance on Orenitram. We do intend to price it so that it is agnostic in terms of revenue between Tyvaso and Remodulin. So there will be no revenue cannibalization as a consequence of the growth of Orenitram, since first of all the vast majority of the growth is going to be into patients who are not currently on Remodulin and Tyvaso, and for those patients who transition from Remodulin and Tyvaso, the net revenues that we generate from the patients would be roughly equivalent, whether they are on Remodulin or Orenitram or Tyvaso. So it is priced on a per milligram basis whereas Remodulin is delivered on a nanogram per kilogram per minute basis, Tyvaso is basically a fixed price per vial, so it's not possible to give kind of an exactitude of comparison for the prices among these three drugs, but as best as we can determine the net revenues per patient to us are going to be roughly equivalent across all three drugs. The antiviral program is doing very, very well. It has reached the necessary level of success in terms of testing our new antiviral candidate in animals who have allowed us to file an IND to begin our first in-human testing of this lead antiviral product we call UV-4, Unither Virology 4, against dengue disease. This development is as you may recall pursuant to a significant contract that we received through the NIH. The government feels that there is an important unmet medical need to develop a broadband antiviral generally and in particular one against agents for which there are no acceptable treatments to-date such as dengue. So the government took a look at our antiviral platform and…

Thank you.

Great. Operator, we have time for one last question. This would be the last question.

The next question comes from Matt Kaplan with Ladenburg Thalmann.

Couple of things. Could you comment a little further on the status of the Sandoz litigation, and then in terms of pipeline, give us an update on beraprost?

Let me turn the first question over to our IP guru, Andy Fisher, and then I will talk about beraprost.

Thanks Martine. The current status of the Sandoz litigation is that we've sort of come to the end of a lot of the formal part of the pre-trial preparation including that discovery, expert discovery is nearing an end. The summary judgment process is underway and those motions and responsive motions and hearings are at least calendared to be completed within the next several weeks or month or so, and trial is currently scheduled for this spring. So that's the basic rundown of the status of the case.

Thanks Andy. With regard to beraprost, this is an analogue of prostacyclin, as I described earlier in the call, prostacyclin being the key molecule that's diminished in pulmonary hypertension patients and giving rise to their symptoms. Beraprost is a different analogue than treprostinil which is the active agent in Remodulin and Tyvaso and Orenitram. We in-licensed beraprost exclusively from Toray Industries in Japan several years ago and have been exploring it for the past few years to find out what type of treatment regimen would be best attuned to its pharmacokinetics and pharmacodynamic properties. It does have different PK and PD properties from treprostinil which gave rise to the observation by Dr. Lewis Rubin, one of the leading gurus in the pulmonary hypertension field, that the PK/PD properties of beraprost were ideally suited to be matched with Tyvaso, the inhaled treprostinil analogue. So we discussed that with the FDA. They were very, very excited especially with the type of morbidity/mortality protocol that we described to them which has a key element of failure to improve something we have seen with [indiscernible] for very much. We described it, we discussed the protocol with the leading centers in the United States. All of these centers have been very excited about the protocol as well. And hence, this year we launched the BEAT trial which is an acronym for Beraprost Extended release in Addition to Tyvaso, and this is a clinical trial in which each time a patient takes Tyvaso inhalation, they take a beraprost pill, and the quick uptake and quick follow-off of Tyvaso is balanced with the slower uptake and slower follow-off of beraprost, allowing a patient to have both a continuous level of prostacyclin analogue in his system as well as a mix of different prostacyclin receptor characteristics between treprostinil…