Good morning, ladies and gentlemen. My name is Tyrone. I will be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation Third Quarter Earnings 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 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 United Therapeutics periodic and other reports filed with the SEC. There can be no assurance that 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 assumptions or changes in factors affecting such forward-looking statements. Thank you. Dr. Rothblatt, you may begin your conference.

Thank you, operator. Thank you, everybody, for dialing in to United Therapeutics Third Quarter 2013 Financial Results. My name is Martine Rothblatt; and I'm joined today by our President, Dr. Roger Jeffs; our Chief Financial Officer, John Ferrari; and our Chief Strategy Officer, Andrew Fisher. Andy is particularly available to answer any questions with regard to intellectual property. I'm extremely pleased with the results of the third quarter. Our medicines are now prescribed for more PAH patients in the U.S.A. than any other company. Total net revenues for the quarter ended September 30 were $302.2 million, up from $242 million for the quarter ended September 30, 2012. Gross margin from sales was $269 million for the quarter ended September 30, compared to $212 million for the same quarter last year. I'd also like to draw attention to the fact that we now report non-GAAP earnings in lieu of earnings before noncash -- noncash charges. And this report of non-GAAP earnings is the result of helpful suggestions from our shareholders that this would bring our non-GAAP earnings reporting more in line with that of many of our other peers. The non-GAAP earnings were $2.98 per basic share or $2.78 per diluted share. As you can see from these numbers, United Therapeutics' revenues are clearly on an upward trajectory. And when I take a look at our, at our leading revenue generator, Remodulin, I'm kind of reminded of this quotation back from the 20th century. I believe it was Winston Churchill, World War II, but don't hold me to this and don't hold it against me if I didn't know for sure that it was Winston Churchill, for our English holders. But I believe he said something along the lines of, "This is not the beginning of the end, but the end…

[Operator Instructions] First question is from Geoff Meacham of JPMorgan. Anupam Rama - JP Morgan Chase & Co, Research Division: This is Anupam Rama in for Geoff Meacham. Just a quick question, you talked about the implantable pump as the Remodulin driver. But I was also wondering if you could expand on your thoughts about geographic expansion for Remodulin? And particularly, you've updated us on previous calls about China and Japan.

Sure. Dr. Jeffs, in addition to being in charge of the clinical development, is also in charge of the company's sales and marketing both U.S. and x U.S. He's had some great accomplishments in that area. And Roger, if you could talk about them?

Yes, happy to. And good morning, everybody. So as people are aware, we had approval of Remodulin in China in the second quarter of this year. And then, we need to do some drug importation, some pricing metrics and other things. So we expect to launch in China in, probably, the second quarter of 2014, plus or minus several weeks or months around that window. In Japan, the filing for Remodulin has been made by our partner, Mochida. And we expect that approval to come also in 2014. So the Asian markets, in particular, will start providing revenue opportunity to -- revenue opportunity to us in 2014, but not prior to that. We're excited about the opportunity. The number of patients treated in China will be large. The cost of revenue to us for each patient will be lower, obviously, than what we achieve currently. But I think in aggregate, there's an opportunity to have material growth in our revenues as we move through the years in the launch in China. In Japan, we think the opportunity, currently for prostacyclins alone, is in the hundreds of million dollar range based on the opportunity that Flolan has enjoyed, as well as Ventavis. We think subcu Remodulin, given its share base here in the States, which is prostacyclin, has the majority share of parenteral product that Remodulin will quickly displace Flolan and also port 100 or more million dollars of revenue opportunity in the years as it reaches its growth opportunity. So there's a lot of sort of near-term current upside in Remodulin, particularly in China and Japan. Other countries are opening up as well, South Korea, Taiwan, et cetera, which we do through our partner, Ferrer. So we've certainly gone in that direction in terms of Asian growth, and excited about what the future holds for rest of world growth. In Europe, we've also -- I should remind that the audience that we have, most of our approved territories have approved intravenous Remodulin, and we're starting to get scripts and reimbursements for intravenous Remodulin. We've been somewhat strategic, however, where we've launched IV Remodulin in Europe because of pricing considerations and other austerity measures that are ongoing in Europe. But we're starting to see revenues from Europe for intravenous Remodulin. I'm very happy with the launch effort that our UTel [ph] office has made in that regard.

Thanks, Roger. That was a great summary. And for those of you who follow politics -- geopolitics, and you've heard the phrase "pivot to Asia," you know who invented that. Folks right here at UT.

Our next question is from Terence Flynn of Goldman Sachs.

This is Uya in for Terence. I just wanted to follow-up on Tyvaso. Can you just give us a little bit of color on why it's particularly strong this quarter? And can you also comment on the average treatment duration? And also, and separately, can you give us some timeline on the implantable pump? When do you expect Medtronic to have the secondary endpoints, announce this and be able to file?

Sure. Thanks for the questions from the lady from Goldman Sachs. Let me address the second question first, and Roger will sketch out a couple of his notes in the meantime and talk about this really great revenue driver for us and equal to our [indiscernible] top product. Tyvaso is really tied with Remodulin, in our view, as the major revenue producer for the company. So he'll talk about that in just a moment. We are not giving any forward-looking guidance on the date when we would launch the implantable pump. And it's sometimes very tough to do so because, as I mentioned, PAH doctors throughout the country are literally waiting with bated breath, and I'm not exaggerating there, for an implantable pump, it seems somehow shocking that given the lethality of pulmonary hypertension, especially once one is at the Functional Class IV level, that more than half of the patients who die from PAH never go on any form of prostacyclin, whether from our competitors, like Flolan or ourselves, Veletri or Remodulin. And again, it's because there is a fear factor associated with the pump that probably none of us sitting in the conference room can fully appreciate. So we would love to give people a concrete date of hope when that would be available. But I think worse than giving people hope is giving them hope and then, it's like dashed in terms of the timeframe in some way. And in this case, we are dependent upon 2 things outside of United Therapeutics' direct control: a, we're dependent upon Medtronic, which is a company far larger and bigger than us and it's really through their, frankly, it's through I think their grace and kindness that they have partnered with us on this program. It's a gigantic company and these revenues will not be big, big revenues to Medtronic. So we really have no influence or leverage over them, and we just really have gratitude for Medtronic. So I can't predict their timeframes internally, nor even probably can anyone there because multiple -- multiple departments within Medtronic must pass on something like a product marketing application that's going to engage their manufacturing group, their regulatory group, their compliance group, sales and marketing group, et cetera. Secondly, there's the FDA itself. And of course, for those of you who have followed Farid Naki [ph], followed United Therapeutics for a number of years, knows we have never gone out and predicted when the FDA is going to make any particular decision. So with those 2 things totally outside our control, hopefully, you'll understand why we can't make a forward-looking projection as to a launch date for the implantable pump. But what we can do is we can give you some really clear insight on why Tyvaso has become such a growth juggernaut and is such a desirable drug and the mean duration of patients on that drug. And to all of those questions, I'd turn the microphone over to Roger.

Yes, thank you, Martine. So we're very pleased with the performance of Tyvaso in the marketplace. And I think there's really 3 drivers of that success. One is the increased number of prescribers. We currently have over 800 doctors prescribing Tyvaso. The increased number of scripts per prescriber has been an initiative that our commercial team has been keen to manage, and we're seeing increased scripts per prescriber. And finally, the increased duration of the prescription once it's started, which now has moved from a median of 18 months to a median of 19 months. And certainly, that's a continuing revenue driver as you improve the time on therapy. The other things that we've done to support these 3 levers is we've recently had a sales force expansion, and the focus of that is to appropriately reach and teach to new prescribers on either how to treat with Tyvaso or when to refer to physicians that can treat appropriately. And then, finally, I would say, innovation has helped Tyvaso. We've relaunched an improved device, the TD-100, that gave us a chance to visit with docs and teach about the device. We've recently had a label amendment, which talks about the long-term clinicity of the therapy and its benefits, including the use of 12 breaths 4 times a day if needed. And I think all of the these things, in aggregate, have led to the growth that we've seen and the success. But I would have to commend our commercial sales and marketing team on the fantastic job that they've been able to do in the marketplace.

Thanks, Roger. Perfect.

Our next question is from Robyn Karnauskas of Deutsche Bank.

This is Mujib on behalf of Robyn. So my question is on the uses of cash. So can you please help us understand how you plan to use your cash going forward in terms of buybacks or business development program since you have a strong balance sheet?

Yes. Thank you very much, and we thank your sponsor, Deutsche Bank, for participating in the call. Our principal use of cash above that, that we need for operations, which, of course, continues to -- we spend more cash on operations each year as our revenues grow each year. In terms of cash accumulated above and beyond that, there are principally 3 buckets into which that cash would go. One bucket would be into reducing the number of outside -- of outstanding shares through cash buybacks. United Therapeutics has been one of the most aggressive share buyback firms in the biotech space. And in a moment, I'm going to turn the mic over to our CFO, John Ferrari, who would probably have these numbers a little bit more at hand. But maybe John, while I'm wrapping up here, you might be able to give an indication of approximately -- it doesn't have to be exact, what percentage of outstanding shares the company has bought back since its inception of buyback several years ago. But I think when you see the number, you'll see we are in the top tiers of biotech companies in terms of percentage of outstanding shares that we've bought back. We plan to continue buying back shares. And so that is, certainly, a #1 use of cash. Obviously, that is nothing more or less than, really, the financial equivalent of dividend-ing accumulated profits back to the shareholders. And so we're really happy and pleased to do that. The second thing is that from time to time, we have various capital expansion projects. One of the things we've done to reduce risk at the company is to bring more and more elements of manufacturing in-house because whenever we have manufacturing being done by a third-party vendor, there's a…

We've purchased almost 20%.

Wow. I mean even me, I should be jaded as a CEO but I'm not. I'm just so proud and so impressed. And I think you'd have to look a little bit harder to find biotech companies that have retired 20% of their outstanding shares. Thanks, John. Thank you, Deutsche Bank.

The next question is from Mark Schoenebaum of ISI Group.

Martine, it's Salim stepping in for Mark. I just had a couple of questions. On the safety pump, I know you mentioned you can't provide any guidance. Earlier this year, you mentioned that you could launch it in 2015. Are you officially retracting that statement now? And then, also, was there -- I know there's some disclosures in the Q around hardware and software modifications. Are those things new to you? Or were you aware of those before or was there any other disclosure made in the Q that's new to you? And then, just on the Remodulin implantable pump, just some clarification on your statement about doubling Remodulin revenues? Are you anticipating any cannibalization from IV to implantable pump or is this going to be completely a new set of patients that are going to adopt the implantable pump?

Sure. So going through all those questions, I don't really think there's anything new at all being disclosed in this conference call. So everything is totally within what's been disclosed before and certainly, nothing is being retracted from before. All that -- let me go to your questions from sort of, I guess, the back end forward. So first of all, we have said for quite a while -- and it's because doctors have said for quite a while, that they cannot get more than half of their end-stage patients on the pump because the patients refuse to go on it. In fact, it's sobering to think there's a growing number of patients who actually demand to be removed from a pump and taken back upstream to an inhaled therapy. There's a recent publication by Dr. [indiscernible] reporting about 40 patients have gone from a parenteral delivery back to inhaled delivery. I would say, most centers with a significant number of pulmonary hypertension patients have had the experience of a patient who insisted on going off the pump. Now again, to keep things in perspective, this is a minority, people who want to go off it. The growth of Remodulin demonstrates more and more people want to go on it, and they're on it for longer and longer periods of time. Average time on Remodulin is now about 2 years. That's been a tremendous growth vector, and a huge credit to our strategic operations and commercialization groups who have -- who have been able to share information and techniques with prescribers, that have been helpful to patients' [indiscernible] and stay on a couple of years. But the basic Gestalt impression from PAH physicians is that about half of their patients who should go on a parenteral prostanoid refuse to. And…

The next question is from Liana Moussatos of Wedbush Securities.

Liana, I'm so glad we got to your question in. This will be our last question, but you've been such a long-term and astute observer of the company, I'm glad we got your question in.

Can you talk about the status of the neuroblastoma program in the earlier-stage pipeline?

Excellent. That's why I'm so glad that your question got in. Great question. Very helpful for everybody. Roger?

Yes. Thank you, Martine. I'm very excited about the neuroblastoma program. It's basically the birth of what we are calling the Unither Oncology Group. It's led by Dr. Mary Smith, who's done a fantastic job working with NCI, in particular, to get the chimeric 14.18 antibody that's been shown to improve survival in patients with severe refractory neuroblastoma. We are in a very, very labor-intensive submission-build period. And the first submission that we're going to do is to the European authorities. We'll file an MAA in December. There's actually a filing date that's given to us, and it's in early December. So we're in the latter stages of building that submission. The components of that submission are the Phase III study that the cooperative groups did, the Children's Oncology Group. The follow-on 105-patient safety study, and then we did a PK study in -- a large number of patients to show equivalents between the products, if you will, from the NCI-produced lot of 14.18 and what we now manufacture at scale by a slightly different and, what I'd call, an improved process. So all of that has come together. That submission build will be done by December because it's a mandated date. In addition, we are building the submission for the U.S. regulatory authorities, and that will go in, in the latter part of the first quarter of 2014. That's on an accelerated review period, which is nice. So in actuality, even though Europe is filed first, it may be the U.S. application that's approved first, just given the 6 months versus the 10- to 12-month review that we'll get in Europe. But very excited. It's at the core vision and mission of this company to benefit patients with unmet medical need, and these patients are at the extreme end…

Beautiful, Roger, thanks. A very robust pipeline, and thank you for managing it so expertly. That concludes our third quarter conference call. And I want to thank everybody for being on the lines. As you can see, it's a record quarter for us in terms of revenues. It's a record quarter for us in terms of non-GAAP earnings. The pipeline, as Roger just delineated, is robust. Everybody at the company is very busy. We've just pushed through 700 people in terms of company-wide headcount. So it's really very exciting to be at a company which is 17 years old, and you can say that all we are is at the end of the beginning. And we have the very exciting middle phase of our growth, and then even beyond that to go as we move into the rest of the 20 teens and 2020s. Thanks so much for your attention this morning. And we look forward to seeing you at an upcoming healthcare conference. Thank you, operator.