Operator
Operator
Good morning. My name is Brian and I will be your conference operator today. At this time, I would like to welcome everyone to United Therapeutics Corporation 2015 Fourth Quarter and Annual Financial Results. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-answer session. Remarks today concerning United Therapeutics will include forward-looking statements representing the company's expectations or beliefs regarding future events. The company cautions that these statements involve risks and uncertainties that may cause actual results to differ materially. Please see the company's latest SEC filings, including Form 10-K and 10-Q for additional information on these risks and uncertainties. The company assumes no obligation to update forward-looking statements. Today's remarks may also include financial measures that were not prepared in accordance with the U.S. generally accepted accounting principles. Reconciliations of non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures can be found in our earnings release available in our website at www.unither.com. Finally, please note that today's remarks may include reporting on the progress and results of clinical trials or other developments with respect to the company's products. These remarks are intended solely to educate investors about the company and 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 labeling or to provide all available information regarding the product, 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 your conference. Martine A. Rothblatt - Chairman & Co-Chief Executive Officer: Thank you, Brian. Good morning, everybody and welcome to United Therapeutic's full year 2015 and fourth quarter 2015 earnings call. Joining me on the phone this morning is our President and Co-CEO, Dr. Roger Jeffs, who will lead the call, as well questions can also be directed to our Chief Strategy Officer, Andy Fisher and our Chief Financial Officer, James Edgemond. Roger would like to begin with an introductory set of remarks to provide the scope for the call. Dr. Jeffs, could you please begin. Roger A. Jeffs - President, Co-Chief Executive Officer & Director: Yes, certainly, and thanks for the introduction, Martine, and I'd also like to welcome Dr. David Zaccardelli, our Chief Operating Officer, who's also on the call today. Welcome to all of those listening in this morning. 2015 was another banner year of growth for United Therapeutics, both in terms of therapeutic reach of our products to the patients that we endeavor to serve and with respect to operational performance. I'll take the opening time period to provide a summary across two main areas. First, I'll review our annual and quarterly financial results. And secondly, I'll provide some brand-specific updates with principal focus on Orenitram. With regard to the financial performance, we're very pleased with our top line 2015 financial results, as total revenues approached $1.5 billion, a 14% increase compared to 2014. These strong financial results generated annual net income of $652 million, a 92% increase from 2014 and non-GAAP earnings of $632 million, a 26% increase from 2014. With respect to Q4, quarterly revenues were $405 million, an increase of 17% or $59 million as compared to Q4 2014. This represents our highest ever quarterly revenues. These gains were driven primarily from an $18 million increase in Adcirca net product sales to $92 million, a $17 million increase, and Orenitram net product sales to $37 million, and a $15.7 million in net product sales of Unituxin which we launched in the third quarter of 2015. Remodulin and Tyvaso also experienced low-single digit revenue growth quarter over quarter as well as year-over-year, reflecting the continued durability of these products. Our reported GAAP net income was $105 million or $2.10 per diluted share for the quarter ended December 31, as compared to the net income of $116 million or $2.17 per diluted share in the fourth quarter of 2014. Our non-GAAP earnings for the quarter grew 21% to $183 million or $3.68 per diluted share as compared to $152 million or $2.83 per diluted share in the fourth quarter of 2014. The significant non-GAAP earnings adjustment for the quarter excludes the impact of our share-based compensation expense. A reconciliation of reported GAAP net income to non-GAAP earnings is provided in our financial results press release. We continue to report non-GAAP earnings for investors to evaluate and compare the performance of our core operations. Turning to the balance sheet and the statement of cash flows, as of December 31, cash, cash equivalents and marketable securities approached $1 billion and the net increase of $174 million since December 31, 2014 is primarily due to both the positive cash flow generated from operations totaling $383 million and the $350 million sale in Q3 of our Rare Pediatric Priority Review Voucher received in connection with Unituxin's approval. These increases in cash were partially offset by the repurchase of our common stock for $394 million under a share repurchase plan authorized in 2014 and completed in 2015 and the settlement of early convergence of our convertible notes in the amount of $133 million. Overall, the very strong financial results of the fourth quarter and full year of 2015 will enable us to continue returning value to our shareholders by advancing our innovative product pipeline, as well as by repurchasing shares through our current $500 million share repurchase program. Now I'll switch gears and, as promised, I'll spend a little time on brand-specific performance, specifically, Orenitram. As already mentioned, Orenitram continues to grow with Q4 being our strongest revenue quarter, having achieved 8.4% greater revenue than in Q3 and 85% higher than Q4 2014. Orenitram revenues were driven principally by new patient starts, which were 14% higher in Q4 than in Q3 2015 and 105% higher than in Q4 2014. The growth in new patient starts continues to be driven by an increasing number of prescribers. We now have over 600 prescribers who have started a patient on Orenitram. Similar to previous quarters, approximately 70% of starts in Q4 were from patients new to prostacyclin, with 30% being transitions from either Tyvaso or Remodulin. And while this has kept the growth of Remodulin and Tyvaso relatively stable, it is important to note that the total number of patients on any form of treprostinil continues to grow, which, again, achieves our stated objective of treating more and more patients with one of our available forms of treprostinil. Across all patients on Orenitram, the average total daily dose is 10.2 milligrams, similar to Q3. We anticipate this average will increase as increasing number of patients begin their second commercial Orenitram therapy. To this end, we continue to assess longitudinal dosing patterns. We reported in Q2 that the average total daily dose across all patients was approximately 8 milligrams at three months, 10 milligrams at five months and 12 milligrams at 10 months. Those numbers remain consistent with more and more patients achieving those exposure levels. We can now add that the average total daily dose is approximately 13 milligrams at month 12 and 14 milligrams at month 14. This continues to support that dose titration is most aggressive in the early titration phase and then continues at a slower pace as the balance of benefit to risk is achieved, but, nonetheless, titration continues as is expected and, as has been shown historically, is required for this class of therapy. There will, obviously, be greater and greater impact of dose on revenues as patients increase their duration on therapy. Internally, we know that future revenues can be closely predicted by the number of patient referrals in the preceding quarter. Q4 referrals were approximately 10% higher than Q3, which, obviously, bodes well for Orenitram performance in Q1 of this year. In fact, January was our highest revenue month ever for Orenitram. Having said that, we appreciate that, with the January launch of Uptravi, Actelion's non-prostanoid IP1 selective agent, that there is a great deal of investor interest in the potential impact to our prostacyclin franchise. It is obviously very early in the Uptravi launch cycle, but as noted, January was our highest month of revenue for Orenitram. Of course, it is not unrealistic that there could be a near-term competitive impact. We continue to believe that there is room in the oral prostacyclin space for both companies to succeed and that promotion of the prostacyclin pathway by both companies will only enhance awareness and increase the overall number of patients treated by prostacyclin. And let me explain why we view this competition as a good thing. Our view is this is a marathon and not a sprint, as PAH is a chronic and typically slowly progressive disease. Life expectancy is years and not months. Orenitram possesses multiple factors that make it well-suited for success of the duration of this disease course. For example, preceptor binding diversity of treprostinil provides not only IP1 vasodilator activity, but broader binding to DP1 and EP2 receptors that conveys inhibition of platelet aggregation and anti-proliferative effects, thus addressing the hallmark pathologies of vasoconstriction, platelet aggression, and intimal and smooth muscle cell proliferation. Thus, treprostinil pharmacology directly addresses the multiple pathobiologies that exist. But perhaps most importantly, like Remodulin, and it's clearly noted with our longitudinal dosing data, Orenitram is aggressively titratable without a label dose ceiling, as is the case with Uptravi. Thus, Orenitram provides a viable management option for today – not only for today, given its pharmacologic diversity, but also for tomorrow, as an absence of label dose ceiling means that this unrelenting disease can be continually managed with escalating dose. These critical attributes speak strongly to the long-term value proposition of treprostinil portfolio. And with those comments, Martine, I'll turn the call back over to you. Martine A. Rothblatt - Chairman & Co-Chief Executive Officer: Roger, just an absolute brilliant overview of the entire pulmonary hypertension field. Thank you. Thank you so, so much. Brian, we can open up the lines to fresh questions.