United Therapeutics Corp (UTHR) 2015 Q4 法說會逐字稿

Good morning. My name is Brian, and I will be your conference operator today. At this time, I would like to welcome everyone to the United Therapeutics Corporation 2015 fourth quarter and annual financial results.

(Operator Instructions)

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 US generally accepted accounting principles. Reconciliations of non-GAAP financial measures to the most directly comparable US GAAP financial measures can be found in our earnings release available on 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 to 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 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 your conference.

Thank you, Brian. Good morning everybody and welcome to United Therapeutic 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 be also 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 and provide the scope for the call. Dr. Jeffs, could you please begin?

Certainly. Thanks for the introduction, Martine, and I would also like to welcome Dr. David Zaccardelli, our Chief Operating Officer, who is 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 will review our annual and quarterly financial results. Secondly, I will provide some brand specific updates, with principal focus on Orenitram. With regard to the financial performance, we were very pleased with our topline 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 in 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; this 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 reported 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 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 and new patient starts continues to be driven by an increasing number of prescribers. We now have over 600 prescribers who have started the patients on Orenitram. Similar to previous quarters, approximately 70% of starts in Q4 were from patients new to Prostacyclin, with $0.30 -- 30% being transitions from either Tyvaso or Remodulin.

While this 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 year of 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 a balance of benefit to risk is achieved.

But nonetheless, titration continues, as is expected, and 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's 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 for the -- in the oral prostacyclin space for both companies to succeed and that promotion of prostacyclin pathway by both companies will only enhance awareness and increase the overall number of patients treated by prostacyclin.

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 over the duration of this disease course.

For example, receptor-binding diversity of treprostinil provides not only IP1 dilator activity but broader binding to DP1 and EP2 receptors that conveys inhibition of platelet aggregation and anti-proliferative effects. That's addressing the hallmark pathologies of vasoconstriction, platelet aggregation and [intimal in] smooth muscle cell proliferation. Thus, treprostinil pharmacology directly addresses the multiple path of biologies that exist.

But perhaps most importantly, like Remodulin and it's clearly noted with our longitudinal dosing data, Orenitram is progressively titratable without a label dose ceiling, as is the case with Uptravi. Thus, Orenitram provides a viable managed 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 our treprostinil portfolio. And with those comments, Martine, I will turn the call back to you.

Roger, just an absolute brilliant overview of the entire pulmonary hypertension field. Thank you. Thank you so, so much. Brian, we can now open up the lines to fresh questions.

(Operator Instructions)

Liana Moussatos, Wedbush Securities.

Thank you for taking my questions. Can you talk about the growth drivers to maintain the growth that you enjoyed for the past years for the next five years. It looks like Unituxin is taking off. You have Orenitram, implantable pump, anything going on with Remodulin in China and Japan and any new products you think you guys could announce this year?

Yes, that's nice to hear from you. Thanks for your question. The greatest growth driver, which is perhaps very much underappreciated, was the one that Roger described in his introductory remarks, which is that with the advent of the new therapy pulmonary hypertension, has gone from a disease which is generally, I'll call it, average fatal within less than three years to one which is -- can be chronically managed for quite a number of years.

Because the number of people who are diagnosed each year with pulmonary hypertension, in other words, what we would call the incidence of pulmonary hypertension is either steady or actually increasing, both with population growth and with more greater awareness from all of the competitive activity.

The main fact, though, is that the number of people dying each year from pulmonary hypertension is shrinking because the longevity of each patient is longer. And of course, when you have a steady, or even growing incident and an extended lifespan as a result of the new therapies, the simple arithmetic is that the prevalence of the disease will continue to increase and the number of patients being treated with pulmonary hypertension will begin -- will continue to increase.

When we were having these calls just a few years ago, the number of patients treated was 10,000 and then when we had the calls about half that time back, it was up to 20,000. Now the number of patients being treated is over 30,000. The extrapolation is that it's just going to continue to increase.

As you are aware, the endpoint for the Orenitram FREEDOM-EV study which we plan to complete enrollment in 2016 so that addresses one of your questions, and readout in 2017 that addresses another one of your questions. The endpoint for that study is to reduce the morbidity and mortality from pulmonary hypertension, which is a fancy way of saying that the patient should hopefully be living longer and the mean survival should be longer so that, in and of itself, leads to there being a larger number of patients than we think.

Endpoints like this is going to result in a number of pulmonary hypertension patients cresting 40,000 and then cresting 50,000. So it's this organic growth of the pulmonary hypertension market, combined with the new therapies that we have such as the implantable pump, the combination therapy with Tyvaso, the Orenitram new label.

That all of these things are going to create drivers for future growth in the pulmonary hypertension market plus the rapid uptake that we have experienced with Unituxin and the growing list of indications that, that type of therapy may be useful for how there's really positively for the future growth of Unituxin as well. Thanks, Liana.

Thank you.

Jessica Fye, JPMorgan.

Hi there. Good morning. Thanks for taking my question. I appreciate the color on the average dose of Orenitram at various time points. I guess my question is, can you talk about whether you expect that, over time, physicians might titrate patients faster than they have been thus far? For example, is it possible looking out to the future, patients might titrate up to an average dose higher than what you're seeing right now at the one-year mark?

Thanks. Dr. Jeffs, could you please provide additional color on Orenitram?

Sure. Good morning. Jessica. Thanks for joining the call. So I think we have enough commercial experience now with patients that I probably don't anticipate that the titration slope will change in -- over time.

And the reason that -- the other thing, too, remember there is a bit of an art to the dosing of any prostacyclin that you're trying to balance the benefit versus the tolerability profile. These are powerful agents that have side effects. It's an artful in slow titration and again, as we said, it's a marathon and not a sprint.

You're not trying to just dump a lot of drug on board because there's really no need to do that. You want to walk them up to a tolerable post that is effective and then as the disease progresses and symptoms revert, then you increase the dose to provide them further benefit.

So I think the numbers that we're seeing, particularly through month 12, I think are fairly consistent but it's roughly if you just did the math, it's about 1 milligram a month on average across the 12 to 14 months now. I think what you'll see though, Jessica, is that as patients in the commercial space for us with Orenitram getting to years two, three, and four, they will obviously need more and more dose of Orenitram.

The disease is unrelenting. None of these therapies, ours included, cure the disease. They really are treating the symptoms and trying to improve the clinical outcome of patients. But the disease will progress. The only response to that with prostacyclin is to titrate the drug and I think that's one of the attributes that we're most excited about with treprostinil, from a competitive standpoint, is that it doesn't have a dose ceiling.

We can continue to manage the patients not only in the short term, given its pharmacologic profile but also in the long term, given its dosing profile. So we think it will be the treatment of choice for the foreseeable future for these patients.

Got it. Thank you.

Thanks, Dr. Jeff. Thank you. Brian, next question

Michael Yee, RBC Capital Markets.

Hi. Good morning. This is Judy on for Mike Yee at RBC. Thanks for taking my question. Congrats on the quarter. One question, if you don't mind. Could you remind us -- I know you talked about the FREEDOM-EV completing enrollment this year but could you remind us what other near-term catalysts we could be looking at in the near future?

I know there is a March upcoming PDUFA for Medtronics pump system but then you said you were -- you filed your own NDA and you are trying to get that accelerated. What kind of timetable are we talking about here and perhaps with the bear market right now, are there any interesting assets you're looking at since in the past, that you have commented about M&A a little bit.

Yes. Thanks for the question. Dr. Zaccardelli is on the call and he is responsible for the Medtronic joint venture. So, Dr. Zaccardelli, could you address the question?

Thank you, Martine. Happy to -- and thank you for the question. Just as a brief recap on our implantable pump program, as you know, it's a collaboration with Medtronic. That continues to progress. As you mentioned, the PMA is still under review. And we do expect an action date in March.

In addition, we have an NDA filed and that has passed the day 60 and is currently under review, expecting a day 74 letter later on in February. In addition, we expect an action date on the NDA in October of 2016. Medtronic continues to answer queries from the FDA regarding the PMA.

And depending on the action in March, Medtronic will continue to answer queries from the FDA through 2016 as needed, keeping in mind that we have an active NDA under review at the same time. So we still continue to believe that both the PMA and the NDA could be approved in 2016. And I think that summarizes the status of our current Medtronic collaboration.

Thanks, Dave. Perfect. Next question, Brian.

Mark Schoenebaum with Evercore ISI.

Hi Brian. Thanks for all the energy. You've got a great operator, Martine. I hope you well know --

I felt the same way. (laughter)

Definitely had a coffee this morning. Hi, I was just wondering if I could turn to the numbers a little bit. Sometimes --

We've got James Edgemond on the phone and he knows those numbers in and out.

Okay, great. I know sometimes you're a little bit more forthcoming in the Q&A and your predictions have proven to be correct more often than not. So it's a question around Orenitram. So Orenitram, you said the dose was stable quarter on quarter. Starts -- new patient starts, however, were up 14% but sales were only up about 8%. 8% is healthy but I'm trying to sort this map out. So what's the difference here?

Is it persistence or patients dropping out? Why weren't sales up closer to 14%? Maybe it's the pace of starts. And then the follow-on to that is the Street consensus right now is at about $200 million, I believe, for Orenitram which means you're going to have to continue to grow pretty robustly sequentially.

And I felt like Roger's comments were, you know, he was being honest and saying, look, with selexipag launching, it's just hard to predict and that could -- makes predicting the revenue run rate for Orenitram more difficult. So I'm just wondering if you could help us at all, with whether or not you're comfortable with where roughly where the Street is on Orenitram on the year and help me reconcile the quarter-on-quarter growth in sales. Thank you very much.

Sure. Thanks. But for those type of numbers, Rogers is the person to know the in and out with them. Roger?

Yes. Good morning, Mark. Always good to hear from you. So I think that the ordering patterns -- remember, our customers are the specialty pharmacies. It's a calculus that they have to do that's based on starts, pending referrals, the changing dose for the patients on drug, and then attrition as well. It's kind of the points that you've mentioned.

It's also -- there's also -- there's a little bit of art to that in terms of how they predict what their inventory requirements will be. And then they have some contractual requirements to -- in terms of keeping a certain number of days on hand. So as we said, many, many, many times, there is a lot of quarter-over-quarter fluctuation in ordering patterns.

The better way to view our business, we think, is annually. And even if you look at Remodulin and Tyvaso and we have done this. If you look at quarterly revenues from 2006 to now, even with these mature products, you are seeing some bounce from quarter to quarter. But then when you look at it from -- with an annual lens, you get a much more clearer and cleaner pattern to the growth. I think for the last five years, for example, our CAGR has been 20%, if you include this year's revenues.

So in terms of Orenitram and Street expectation, we really -- I think if we achieve our goals, which is to add 1,000 patients per year, that we will approach the Street expectation. We don't -- we have our own expectation for what we want to do. Our annualized -- our goal for 2015 was to achieve $100 million for Orenitram. We did $118 million. So that's why we say it was a banner year because we massively exceeded the goal.

Part of that is driven by starts, part of that is driven by dose increment over time; that's why we are giving you the longitudinal dose data. And I think where the model potentially inflects a little bit as we go out in time is that as patients mature and get into year two, in particular and then year three and year four, as you've seen, the dose will increase and then our prevalent patient base will create more revenues because the dose is improving.

So we hope to add the patients that we expect this year. We expect that the patients that we have will increase the dose. And as long as we don't lose a significant number of patients, for whatever reason, intolerance, competitive disadvantage, whatever you want to call it, then we should be fine.

So we don't provide forecast, that we are comfortable with what we've said in the past, that if we had 1,000 patients per year over five years, that is 5,000 patients. That's patients over time reach a, let's say, an average therapeutic dose of that will port $200,000 in revenues; that's a $1 billion product opportunity. So simplistically, Mark, that's how we look at it and we don't see any reason to shy away from those expectations.

Thank you very much.

Geoff Meacham, Barclays.

Hi. This is Evan Seigerman on for Jeff. Thanks for taking our questions. So after you monetize the PRV and a very healthy cash balance, how should we think about potential business development? Would you be looking at assets within your core competencies of the pulmonary -- PH or do you want to explore other therapeutic areas and kind of what stage would you prefer to get in at? Thank you.

We have been very opportunistic in the way that we look at expanding the Company. Our core mantra is to identify corridors of indifference and run like (expletive) on them. That's what we did in the first case with pulmonary hypertension, nobody was interested in the field, all the patients dying. We ran like (expletive) down that corridor and are now generating $1.5 billion a year in revenue from that field, up from $750 million in revenues just five years ago.

And as we've mentioned that previous call, we expect these revenues to be able to double again in five years through the growth from Remodulin, Tyvaso and both in the implantable, disposable and combination versions as well as Orenitram reaching its blockbuster potential of $1 billion. So that's the heart and soul of the Company's business development and core expansion. Beyond that, when we saw another corridor of indifference, pediatric oncology, and specifically, neuroblastoma with no approved therapy for it, we ran like (expletive) down that corridor.

As a result, I think that we have brought a great gift to the patients, families and physicians caring for neuroblastoma patients with the first-ever FDA approval for drug to treat that indication. And it looks like it will be a gift that keeps giving, as people begin to explore the potential of that platform for other oncology indications. And that's pretty much our mantra, is just to keep to the -- find the corridor of indifference, where there are no or no effective therapy and then charge down that corridor to become first and dominant in that field. Thanks.

Thank you.

Brian, next question.

Phil Nadeau, Cowen & Company.

Good morning. Thank you for taking my questions. A question that's really kind of a follow-on to Mark's and that is on persistence. You gave us part of the equation of predicting revenue and when we look at how dose is going to change over time, but I think it's also important to know what proportion of patients are able to stand therapy over the long haul?

So I was just curious if you could share with us some estimate of what the withdrawal rate is from Orenitram and maybe the reasons for withdrawal when they happen? Is it competition or is adverse events? And if so, which ones? Thank you.

Dr. Jeffs?

Yes, sure. Thanks Phil. So I think we've stated previously that the rate of loss for every 100 patients we start, we lose approximately 15. The reasons that we lose them are basically from intolerance. Again, these are -- treprostinil is a very powerful agent.

It does a lot of good things; it also causes a lot of vasodilator-type side effects: headache, nausea, GI distress, and some other things, as does Uptravi. If you look at their package insert, the profile and type of adverse events is similar and it's similar to epoprostenol as well. So that's the main reason. We haven't seen any competitive loss and again, it's very early in Uptravi's launch.

I don't think switching patients from Orenitram to selexipag would necessarily be a wise thing to do. There's no idea about those comparability. As I stated, the receptor diversity is quite different. There's a unidimensional IP1 selective agent. We find multiple receptors. Our drug is titratable so patients that achieve higher dose may not actually be able to switch to selexipag.

So we don't see that happening and we don't expect that to happen. The attrition, we've look carefully at the rate of loss and trying to minimize the attrition. Again, it gets into that artful practice of making sure new physicians, in particular, change the dose appropriately; that they don't become too aggressive or go too easy because you want to make sure you get some therapeutic effect so that the side effects are not bothersome.

And then on the other hand, you don't want to go too hard so that you generate too many side effects and the patient wants to come off therapy. So that's a lot of what we do, both with our sales team in terms of educating about how the drug was dosed in the clinical trials and then also with our support specialist, both from the specialty pharmacies and through our medical affairs department, educating new physicians, in particular, about the historical and artful practice of prostacyclin dosing.

Great. Excellent answer. Thanks, Dr. Jeffs. Brian, you've been wonderful. We have time for just one more question.

Joseph Schwartz, Leerink Partners.

Good morning, everyone. This is Brad in for Joe. Thanks for taking my question. I'm curious about what possible changes are on the horizon in PAH from a payer's perspective? I'm curious to know if payers are showing any increased willingness to manage access for any your patients for restrict pricing power on any products? And along that lines, have you been engaged at this point, up to this point, in any conversations about outcomes-based reimbursement from PAH. Thank you

Yes, very -- a little bit different question there. So the way we are organized within the United Therapeutics, the function called strategic operations, which includes all of the direct relationships with the major payers, both in the US and abroad as well as Medicare, is managed by James Edgemond, the Chief Financial Officer. And James is on the call. James, can you provide some color on that?

Yes. Thanks Martine. Thank you for the question. So in terms of going forward, in terms of reimbursement, we have not seen any significant changes in terms of reimbursement patterns with any of our therapies going forward. And in terms of outcomes-based reimbursement discussions, there's again, we haven't been able to -- or haven't had those discussions on a going-forward basis as well.

And this operation has a very broad team underneath it in terms of Jay Watson, who are in constant contact in terms of the market and the reimbursement aspects of our therapies. And we've been very successful at this point in getting the therapies reimbursed for our patients. And if we're not able to, we actually provide those therapies free to the patients to make sure they're getting the proper treatment.

Excellent. Excellent. Excellent. Well, everybody, thank you very much for joining the conference call and Brian, thank you for organizing it. Please feel free to check back in with our Investor Relations. We present at most of the more important healthcare conferences during the course of the year. Operator, you can now conclude the call.

Thank you and thank you for participating in today's United Therapeutics Corporation conference call. A rebroadcast will be available for replay for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code 497-17-416. Thank you, everyone. You may now disconnect.