Good morning. My name is Samia, and I will be your conference operator today. At this time, I'd like to welcome everyone to the United Therapeutics Corporation Fourth Quarter and Annual 2012 Financial Results Conference Call. [Operator Instructions] Remarks today concerning United Therapeutics will include forward-looking statements, which represent United Therapeutics' expectations or beliefs regarding future events based on the current assumptions. United Therapeutics cautions that such statements involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in the United Therapeutics' periodic and other reports filed with the SEC. There can be no assurance that the actual results, events or developments referenced in such forward-looking statements will occur or be realized. United Therapeutics assumes no obligation to update these forward-looking statements to reflect actual results, changes in the assumptions or changes in factors affecting such forward-looking statements. Thank you. Dr. Rothblatt, you may begin.

Thank you, operator. Good morning, everybody, on the conference call. I'm joined this morning by John Ferrari, our Chief Financial Officer; Roger Jeffs, our President and Chief Operating Officer; and Andy Fisher, our Chief Strategy Officer; and individuals in charge of Legal and Investor Relations. I'd like to start by making a few introductory remarks, and then welcome any questions that could be directed to Andy, Roger, John or myself. The press release that we issued this morning certainly makes this about as joyful a quarterly and annual conference call as any CEO could ask for. We're reporting record revenues, record profits, record profits per share. So across the board, it's just been a fantastic quarter and a fantastic year for United Therapeutics. Our excellent annual results reflect both our leadership in pulmonary hypertension medicines and our discipline in focusing company resources on transformative growth opportunities. One of the things which is especially noteworthy is that as of the end of 2012, our medicines are now being prescribed to more pulmonary hypertension patients in the United States than any other company's medicine. That's a high watermark that we've achieved after our several years of slugging it out against other companies which are much larger and better capitalized than we. I think the reason for this is completely due to the fact that physicians over time have found that the United Therapeutics medicines are the ones that they can rely on to provide superior results for their patients. Let me briefly mention what those medicines are, briefly mention some of their key highlights, and then say a word or 2 about our pipeline and then move into question-and-answers. Remodulin is a medicine which continues to grow now even though we're actually in the 10th year after its approval. But it's in…

[Operator Instructions] Our first question comes from Mark Schoenebaum of ISI Group.

Martine, could you just maybe explain to us why you made a decision to refile the oral treprostinil's NDA if that's possible, to comment on that?

Oh, sure. Definitely. That, to me, is a favorite topic. I think really that to not refile it would be the absolute worst decision I might have ever made as CEO of the company. We're talking, Mark, about a molecule that has been a lifesaver for thousands of patients. It's the key pharmaceutical ingredient in Remodulin, it's the API in Tyvaso. In all of its clinical trials, it resulted in p-values which were either statistically significant, in the case of the FREEDOM-M trial, or very close to statistical significance, in the case of the FREEDOM-C1 and C2 trials. As I know you know very well, Mark, when you're very -- statistical significance 0.05 is not some kind of like magic marker in the sense that a drug definitely positively works if it's less than 0.05. It definitely positively does not work if it's above 0.05. It's, instead of regulatory review, just sort of line on the sand and can be somewhat of a shaded line on the sand depending on compelling factors to take into account, especially for patient welfare. So the p-values for the C-1 and C-2 studies were so close to statistical significance, nobody doubted that the drug worked. Nobody thinks that the drug is a placebo. And in fact, when you begin to look at subsets of the patients, it has a dramatic benefit for many of the patients. With regard to the FREEDOM-M data, this drug had a, oral treprostinil, had a better demonstration of efficacy with high statistical significance than Remodulin or Tyvaso did. Again, just what I'm talking about here is the 6-Minute Walk outcomes which were greater for oral treprostinil than for Tyvaso or Remodulin. As you see from our financial results today, Mark, Remodulin is far and away the first choice of physicians for prostacyclin therapy delivered parenterally. Tyvaso is far and away the choice of physicians for prostacyclin therapy delivered via inhalation. Both of them continue to be prescribed by physicians to ever greater numbers of patients. So, of course, we are going to refile oral treprostinil, and of course, we're going to be relentless in getting this drug approved because sooner or later, it will get approved and it will be a great blessing to the patients who have it.

And what's your level of confidence that it will be approved? Then I'll drop off.

I think that -- I personally am a believer in the right things and the right outcomes resulting so long as one doesn't quit and give up first. So my personal belief is as long as we persistently do everything which is right and necessary, oral treprostinil definitely will get approved. And I know it sounds kind of silly to say quitters never win and winners never quit, but we are winners here and we're not going to quit on oral treprostinil.

Our next question comes from Michael Yee of RBC Capital Markets.

This is John [ph] on behalf of Michael Yee. Understanding the need to keep comments in general, can you describe to us the contingencies or outcome of the patent infringement case with Sandoz? And with the court case beginning, could you just clarify for us what -- when the department's some re-judgments to come, is it before year end?

Sure. Thank you for the question from RBC Capital. I'm going to like bounce that question over to our patent guru, Andy Fisher.

Thanks, Martine, and thanks for the question, John [ph]. The -- just to review a little bit, we filed a lawsuit against Sandoz about a year ago, after receiving Paragraph IV notification related to their ANDA filing. That case is currently underway and proceeding pursuant to a scheduling order entered by the court early last summer. The scheduling order is available through the court docket system, if anyone cares to review it. It sets a pretty specific calendar, with sort of specific time frames for different activities to occur. Right now, we're in the sort of pre-Markman briefing phase, and the court, I believe, will hold a scheduling conference in the spring to set the format and timing of the actual Markman hearing, which should take place, I think, sometime in Q2. Following that, the calendar specifies things such as briefing on some re-judgment motions and for those to conclude sometime in early 2014, and then we'll set a trial date sometime later in probably the mid-2014 time frame. So that's the general calendar. And like I said, everything so far, I guess, is proceeded pursuant to the calendar set by the court. As far as speculating on different outcomes, that's something we're really not going to comment on. I think all of you who are experienced pharma and biotech investors know what the potential outcomes of cases like these are and same rules apply to pretty much every case. We have said from the outset that we're very confident in intellectual property we have protecting this product and intend to enforce that IP vigorously as we proceed through the case.

Thanks, Andy. Great answer.

Our next question comes from Liana Moussatos of Wedbush Securities.

When you received the complete response letter for oral treprostinil, it sounded like the expectation was having to redo another trial before resubmitting. When you went back and looked at the data, did you see something new that you had not seen before that caused you to resubmit so soon or recently?

Liana, thanks for your question, and thanks for your excellent analyst coverage of our company as well over so many years past. As noted, we really don't want to get into discussing internal discussions with the FDA out of respect for the regulatory process and the PH community in general. But as Roger is in charge of this entire effort, Roger, would you like to provide any overall color that could be responsive to Liana?

Sure, Martine. And thanks for the question, Liana. Maybe I'll just start with sort of a topical response in that. In science, there are no absolutes, and different people can address the same scientific data set and reach different conclusions. And certainly, that played into -- came into play here. So when we got the complete response letter, that was our first view of some of their science at the cardio renal division scientific conclusions on our NDA submission. Subsequent to that, we had a face-to-face end of review meeting in December. Where we were able to respond to the questions and inform them about the rationality of our responses and why the data set made sense, particularly as an alternative dosage form. I think based on that favorable meeting, which we think was informative and even didactic at certain periods of time, our resubmission was thought to be warranted both by us and the division. And therefore, we did the resubmission, which was viewed as a complete response to all of the issues that we're gating in the complete response letter. As Martine has said, we won't comment on further discussions to that point. But I think you are correct that most of what we have shown them is perhaps reanalysis or reemphasis on analyses that we did previously and not new data. So the resubmission was accepted without the need for new data. So I think that's all I'll comment, otherwise, I'll start getting into details.

Our next question comes from Eun Yang of Jefferies. Eun K. Yang - Jefferies & Company, Inc., Research Division: Question on Remodulin. So since the Tyvaso launch, Remodulin annual growth has been mid to high single-digit versus in 20s previously. Can you tease out how much impact is due to -- the decline in annual growth, is it due to Tyvaso versus Remodulin being the choice of product?

It's an interesting question, and thanks for asking it. I think a certain part of the -- it's sort of like what Roger said previously, there's many different ways to view those numbers. And so I'm going to give you sort of a 360-degree answer if you'd like, taking a look at the same numbers from different perspectives. First of all, there is a factor of just the law of large numbers at play here. And as the base gets larger and larger, incremental revenues are going to grow at a -- represent a smaller percentage growth period-to-period. So there's a certain factor of law of large numbers at work here. That factor is not so important when one has a very wide, essentially unlimited or barely capped addressable and capture-able market, but with the case of subcutaneous and intravenous Remodulin, we may be coming very close to the size of the adjustable market. Physicians report a certain amount of resistance on the part of patients to putting up with a rigmarole associated with having a catheter either sewn or often painfully inserted into their body, hooked up to a pump that they have to carry around, sleep with, live with 24 hours a day. And in the case of the intravenous Remodulin, comply with extremely stringent infection control and sterility procedures. It's a big burden, and there's no doubt about it. We're dealing with an orphan disease population in the first place, probably just about 25,000 diagnosed and treated patients in the U.S. And of those, the patients who would be willing to put up with this kind of a rigmarole are going to be the most sick of the patients, given that there are other therapies available that can be taken orally. Generally speaking, the most quoted statistic…

Our next question comes from Phil Nadeau of Cowen and Company.

Martine, in your pipeline update, you didn't mention your neuroblastoma antibody? Could you give us an update on the status of the antibody, and how big of a market opportunity you think it could address?

Okay, great. Thanks much for the question from Cowen, and we certainly look forward to presenting at your company's event next week. And I'd like to ask Roger, who is managing the neuroblastoma program to kindly respond to your question.

Thanks for the question, Phil, happy to answer it. So just, again, for some background, our antibody C-1418, is a monoclonal antibody that binds to a lipid called GD2 on the surface of neuroblastoma cells. And for those who may know, neuroblastoma is the cancer of the peripheral nervous system and responsible for about 12% of all deaths due to cancer in children under 15, with about half of the patients with neuroblastoma having what's called a high risk form of the disease with very poor long-term prognosis and survival rate. There was a trial by NCI that showed improved survival. Subsequent to that trial, NCI has also recently completed a 105-patient safety and toxicity study with the antibody. And what we have done is acquired the rights to manufacture and commercialize C-1418 for the market. We are in late-stage process validation work. So we have done, I would say, 95% of the work that we need to do. There's certainly more work to do, but we are in the submission build phase now, both for the U.S. and Europe. And it is our intention to file, based on discussions with both the U.S. and EU regulatory authorities later this year. So that would suggest that this therapy would be approval -- be approved sometime in 2014. So we're very pleased with our -- the capability that our manufacturing team in Silver Spring and their ability to progress the process and the scale up of the antibody production. And we look forward to supporting this new market.

Great. Do you owe NCI a royalty?

I'm sorry, Phil?

Do you owe NCI a royalty on sales?

No, it was a license fee straight out, basically.

Our next question comes from Terence Flynn of Goldman Sachs.

This is Uya Chuluunbaatar, in for Terence Flynn. Just a question on the ongoing FREEDOM EV trial. Have you made any changes to the protocol?

Roger, would you like to answer that question?

Sure. So, again, for background, as Martine alluded to earlier, FREEDOM EV is our long-term time to clinical worsening study of oral treprostinil added to background therapy, to single-background therapy, in patients with pulmonary hypertension. They must be newly diagnosed with a duration of background therapy of no shorter than 30 days and no longer than 1 year. So we're going to follow those patients for several years and observe the time to clinical worsening and see the impact of oral treprostinil on top of single-background therapy. That study is enrolling. We plan to complete the study enrollment in 2014, and that would suggest a completion and unblinding of that study in first half of 2016. It's a global study. We have over 125 sites that we are initiating. And we're very pleased with the progress that we're making in that front. We have made and, with all protocols over their lifetime, there are amendments that go on. In fact, I think, when we look back to our original FREEDOM-M and FREEDOM-C and C2 studies, we had over 5 amendments. So we have, similarly here, we have an amendment to the protocol that has tweaking different aspects of the protocol, including some endpoint definition, as well as introducing a different dosing strategy. But again, that's normal for the course of development, and there'll be further amendments, I will predict now, I actually guarantee, over the next 3 to 4 years as we complete this protocol.

Our last question comes from Geoff Meacham of JPMorgan. Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division: So I guess a follow-up on FREEDOM EV. Is there a plan to design a formal interim analysis on this study? Do you feel like this could help the ongoing FDA review of oral? And then just a real quick one on Tyvaso. Could you talk about the new TD-100 device, how you think it's different relative to the current one?

Okay, Geoff, let me ask Roger, if you don't mind, Roger, to answer both those questions, and then I'll wrap up.

Yes, on the TD-100, so that's just -- that's the device that has some improvements that were somewhat FDA-mandated at the time of approval, so we had a post-marketing commitment to do certain things, like put an alignment key on the dome and the base and other aspects. And we've completed that. So those improvements were done, approved in late 2012, and we're launching that into the market basically the next quarter. So we'll be transitioning our patients to this newer device. I would also say that we're in development of a third-generation device, which we're actually calling the Gen 3 device, which is a further improvement in same mechanical aspects, so it won't require any new studies. But it's a miniaturization of the device, an improvement of the device and an improvement, in particular, in its intelligence, if you will, so that we can look at patient compliance and adherence. The question on FREEDOM EV, if you could remind me what that was again? Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division: Yes. Is there a plan -- I know one of your competitors has an interim analysis on their study. I'm wondering if it's possible with the current powering assumptions to design that into FREEDOM EV, and do you think that may -- could help out the ongoing FDA review if there is a more near-term data disclosure?

Yes. So in terms of an interim, we don't plan to do a study interim analysis. We're enrolling over 850 patients to accrue approximately 400 events. The difficulty with an interim, by the time that you collect the data to do the interim analysis, you've almost enrolled the complete study population. So it becomes a bit of a statistical waste of power. So it's not something we are keen to do. But I appreciate that other people are doing it, because, I think, they altered their sample size further. So they must be worried about events, right? But we can -- we'll evolve that thinking as we go. But currently, there's no plan to do that. As it relates to the current application, as we said, we've resubmitted the NDA based on the merits of the original filing, and we continue to believe that the merits of that original filing warrant approval. And we'll know, like we would in about 5 weeks time, what the outcome of that discussion is. And then we can -- based on the outcome, we can then figure out how to move forward with FREEDOM EV, either as part of the solution or part of the market expansion.

Thanks, Roger. Thank you, everybody, for your questions this morning. We're moving around to the halfway mark after the start of the question period, so let me wrap up, that we appreciate the opportunity to share our annual and quarterly results with you. Very pleased to be able to share such great results with you. All 3 of our products continue to do very well as we round 2012 and start off in 2013. Remodulin, we expect continued growth from Remodulin in the very near-term from international opportunities, Japan, China and Europe, and in the medium-term from the new implantable pump once that receives label expansion from the FDA, that we think has the prospects to as much as double the size of the Remodulin market. We expect continued growth in Tyvaso in part because we are seeing the signs of greater-than-ever confidence and interest in physicians, and we are expecting an inflection point with a faster uptake in growth starting this year. And also because of the factors that Roger just walked us through in terms of the second-generation and even third-generation inhalation devices, making that therapy easier and easier to use. And then finally, with regard to Adcirca, we have surpassed all competitive therapies in terms of that being the most prescribed drug for pulmonary hypertension. And instead of this being any kind of a plateau, we actually just see it as a launching pad for yet greater growth and the high likelihood that Adcirca will continue to be the foundational therapy for pulmonary hypertension. We have a really exciting pipeline. Roger talked about the FREEDOM EV study, and I touched on the TransCon treprostinil. There are other exciting things in our pipeline. We talked about the 1418. We've got some exciting antiviral opportunities in our pipeline and another entire prostacyclin platform based on the beraprost molecule, both in its sustained release and also in its TransCon formulation. So great pipeline, great currently marketed markets. We're really excited to be doing so much for the pulmonary hypertension patients in the community. And thank all of you for your support and interest in United Therapeutics. Have a great day.

Thank you for participating in today's United Therapeutics Corporation Fourth Quarter and Annual 2012 Financial Results Earnings Conference Call. This call will be available for replay beginning at 11:30 a.m. Eastern standard time through 11:59 p.m. Eastern standard time through March 5. The conference ID number for the replay is 89593584. The number to dial in for the replay is (855) 859-2056 or (404) 537-3406. Everyone, have a great day.