Good day, ladies and gentlemen. And welcome to the Retrophin Third Quarter 2015 Final Results Corporate Update Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I’d now like to turn the conference over to Chris Cline. Please go ahead.

Thank you, Jessica. Good afternoon everyone and thank you for joining Retrophin's third quarter 2015 financial results and corporate update call. With me today are Steve Aselage, Chief Executive Officer; Laura Clague, Chief Financial Officer; and Dr. Alvin Shih, Executive Vice President and Global Head of R&D. Before we begin, I have to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Retrophin. I encourage you to review the Company’s filings with the Securities and Exchange Commission, which identify specific risk factors that may cause actual results or events to materially differ from those described in the forward-looking statements. The content of this conference call contains time sensitive information that is accurate only as of today’s date, November 3, 2015. And the Company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I'll now turn the call over to Steve. Steve?

Thanks you, Chris. Good afternoon, everyone. Thank you for joining us on the call today. The third quarter marked the Company's best operating performance in our short history. Our commercial progress and focused investment in the business enabled us to reach operating cash flow positive and better ahead of schedule, while still allocating significant investments to the pipeline which is critical to long-term value creation for Retrophin. Starting with our commercial performance, we were able to continue top line growth with $28 million of sales for the quarter, a 16% increase from Q2. Thiola continues to add patients, Chenodal remains stable and Cholbam contributed its first full quarter of revenue. Moving specifically to Thiola, which continues to grow and add patients on a weekly basis, the number of patients initiating therapy in the third quarter slowed moderately, compared to last quarter due to reduction in new starts in July and August. Importantly, we saw the trajectory pick back up in September and we expect to be able to add a significant number of patients in the fourth quarter. Compliance levels remained stable in the 80% to 85% range compared to the approximately 50% levels when we acquired the product, which is a testament to the work being done for patients in our THIOLA Total Care Hub. The Total Care Hub provides support to patients related to adherence, which is critical to optimizing therapeutic outcomes and also ensures continuous supply, helps patients navigate reimbursement channels, delivers Thiola to the patient’s doorstep and provides a counselor available 24/7 to assist with any treatment related issues, including co-pay assessment. These specialty services provided by the hub are integral to optimizing therapeutic outcomes. To remind everyone, we believe there are approximately 4,000 to 5,000 candidates for Thiola. So, there is still many patients out…

Thanks, Steve. Our R&D efforts continued to move forward during the third quarter with advancement in the development of our key pipeline programs, sparsentan and RE-024 as well as efforts to improve the quality and lifecycle of our current marketed therapies. Regarding sparsentan which is our lead pipeline program, our clinical team remains focused on getting the DUET trial fully enrolled. Sparsentan is a dual endothelin receptor antagonist, an angiotensin receptor blocker that’s in development for the treatment of focal segmental glomerulosclerosis or FSGS. FSGS affects approximately 40,000 patients in the U.S. and is a significant cause of end-stage renal disease. The DUET trial is the largest industry sponsored trial to be attempted in FSGS. During the third quarter, we saw some seasonality in enrollment during the peak summer months, but we've been encouraged by substantial reacceleration in patient screening over the last couple of months. We've put some additional resources in place to continue the reacceleration trend. And at this point, we expect that our 100 subjects will be randomized in early 2016. If we can get that last patient randomized by early 2016, we expect top line data would likely be available in the third quarter of next year. In addition to our clinical efforts, we've also been working hand-in-hand with key opinion leaders and patient advocacy groups to put ourselves in position to act quickly, once the DUET data are available. Our goal is to make most impact and deliver a therapy for patients suffering from this potentially deadly condition, as soon as possible, if we see data next year that supports our belief that sparsentan has a meaningful impact on proteinuria caused by FSGS. We are also encouraged that last month, the committee for Orphan Medicinal Products of the European Medicines Agency gave a positive opinion…

Thank you, Alvin. Net sales from our three products, Thiola, Cholbam, and Chenodal were $28 million in the third quarter. The significant increase over the same period in 2014 is due to the addition of Thiola and Cholbam to our commercial portfolio. The 16% increase over the second quarter is mainly attributable to the continued uptake of Thiola and also our first full quarter of Cholbam revenue. We reported a GAAP net income of $105.6 million for the third quarter of 2015. Adjusting for extraordinary and one-time expenses, we ended the quarter with a net loss of $1.5 million. Significant adjustments and one-time items for the quarter included a $140 million gain on the disposal of assets related to the sale of our Pediatric PRV and a net benefit of $30 million for the change in fair value of the Company’s derivative instruments. These were offset by an income tax provision $38.8 million and $24.2 million of non-GAAP operating loss adjustments. Research and development expenses on a GAAP basis were $14.1 million for the third quarter compared to $12.6 million in the same period last year. The increase is a result of increased compensation and clinical trial expense related to the advancement of our lead development candidate sparsentan, as we continue to enroll more patients in the DUET study. On an adjusted basis, R&D expense for the third quarter was $11.2 million. Relevant non-cash expenses for the third quarter included $2.7 million of stock-based compensation. Selling, general and administrative expenses were $22.3 million on a GAAP basis in the third quarter compared to $17.4 million in the same quarter last year. The increase is largely due to increased stock-based compensation and amortization. On an adjusted basis, SG&A expense for the third quarter was $12.6 million with the significant one-time and…

Thanks Laura. This was another strong quarter which has the progress we have been able to make in a short period. We strengthened our balance sheet further which gives us flexibility and operations and business development opportunities. And we improved operating performance through commercial growth and measured expenditures to a point where we can support our investments in the future. We will move through the balance for the year and into 2016 focused on the significant catalysts ahead for sparsentan and RE-024 which we expect will create significant long-term value for our shareholders. I'll now turn the call back over to Chris to open up the lines for questions.

Thanks, Steve. Jessica, can we open the line for Q&A please?

[Operator Instructions] And our first question comes from Joseph Schwartz from Leerink Partners.

First of all, congrats on the progress continuing to grow Retrophin. I was wondering if I could start with Thiola, how do you feel about some of the previous calls you've shared with us such as growing that franchise by at least 30 patients per month; how should we take that in terms of the context that you are providing this quarter in terms of the a pretty slowdown and where -- how these sales -- the expanded sales force doing and how're they being allocated going forward? And then other than the sales force, are there any other initiatives that you're considering to drive more uptake into it?

This sales force has done great. We hired a very talented group of people that hit the ground running. One of those things we are seeing is some seasonality in the marketplace. That's not particularly unusual. I think I've both seen that before with other products and other companies. And we saw some slowdown during the summer. I think it's important to recognize even during the dark days of summer, July and August, we saw a growth week-over-week; we saw back closer to 30 new patients per month, once we got past Labor Day and into the fall. So, we're still very positive about the growth of Thiola. We're very happy with the performance of the new sales folks that came into the field. And we have our marketing group as I think a very creative group who've come up with very interesting new ideas about expanding reach through some non-traditional sales efforts including some telemarketing efforts to give our sales folks better leads and some other creative ways of getting more patients tested to see if they’re so -- as you know there are significant number of patients or patients not been diagnosed yet. And as we work our way through the known patients, it’s important for us to improve diagnostic efforts in urology and nephrology to find those additional patients and we're doing that.

And then may be one on Cholbam before I get back in the queue. Can you give us some more color on your ability to grow that franchise and your strategy to do so? How does the patient pipeline look there and what does it take to get more patients on therapy for Cholbam?

Cholbam, we're kind of on the front edge of the learning curve. I think our guys did a great job in moving clinical trial patients over to commercial therapy. That happened very quickly, very efficiently. We really, to be candid, expected to find more patients faster, once we got out into additional centers and started looking for non-study patients. That's been a slower process that we've anticipated. And we are stepping back at this point and trying to come up with some better approaches to have more targeted efforts and to -- which should be a relatively small number of centers, roughly 70 or so centers to treat these patients. But we have found pure patients in first couple of months after launch, than we expected. And it is causing us to step back and take a look at how we can maybe dig a little bit deeper to find those patients.

And our next question comes from Lisa from JMP Securities. [Ph]

I just want to dig in a little further on your efforts to increase diagnostics -- diagnosis rate, sorry, for sale. I know that was a big part of the driver for next year in terms of adding new patients. Can you maybe speak to little more specifics on your efforts there?

Sure. There are specific American Urologic Association guidelines on both testing, diagnosing, treatment, monitoring. Unfortunately those guidelines haven't been routinely followed. I think part of that is simply because the product hasn't been available, hasn't been supported up until relatively recently. So, we don't need to create new materials or come up with some kind of nifty new device to get people to do better testing or more routine testing. We simply need to utilize guidelines already in place, do educational work within urology and nephrology to encourage physicians, to do that testing, so that they can give patients optimal therapy. Our initial approach with Thiola as I think you know, was raised basically to focus on the known patients who’ve been on therapy, came off therapy for whatever reason. We feel like we've worked through most of that group now. And we're kind of moving into Phase 2 of a product launch which is to improve diagnosis. And as you said, that's critical for our growth over the next 12 months or so.

We’re sort of one month into the next quarter, can you say if return to the 30 patients per month in September has sort of continued through October?

We’ve seen the uptake we saw in September continuing to this month, yes.

Okay.

Excuse me, into last month, yes.

For Chenodal, can you maybe talk a little bit more specifically about what the agency is requesting?

Sure, I'm going to ask Alvin to grab that one, if you will.

Our discussions with the agency that have centered around what type of data would support the safety and efficacy claims of CTX. And I think the agency’s defaults mode is to always look for one or more controlled randomize prospective studies. And indeed that's what the starting position has been. We've had a very constructive dialogue with them to help them understand what the CTX patient population is like and what the dynamics are in that population and also for us to understand what level of data they think will be acceptable, if any short of a prospective study. And so that discussion is still ongoing and we hope to be able to get to an agreement on that.

Okay. When will you be kind of maybe meet them again, when will be the next update?

So, it depends on when our team can generate the data required to go to back to them with an improved proposal. And so we're working on that. We anticipate that the next interaction occur in the next couple of months.

Okay.

Maybe worth noting as well, if I can just add a quick footnote. Alvin and his team have really worked hard with both thought leaders within physician community and with patient advocacy groups in this area. And there has just been really clear feedback to us that our prospective study is not something that would be acceptable to the community.

Okay. I mean, does FDA kind of -- do they get that or not so much?

I think that they understand that difficulties and they're trying to work with us to figure out a way to address them. It's just a matter of being able to meet in the middle and where that middle ground is going to be.

Okay.

They certainly do understand and they've done the process through multiple rare diseases. So I think it’s just a matter of helping them understand the dynamics in this particular patient disease.

For Cholbam, you mentioned 200 to 300 patients that you think are out there. How does this break down to the single enzyme defect and peroxisomal?

Yes, we actually believe that that's the single enzyme defect group that's result of market research and trying to triangulate literature and primary market research that we've had through physician interviews and get individual physician estimates. But it is market research, it is epidemiologic. Until you actually have feet on the ground and all the centers are finding those patients, it’s unfortunately kind of a theoretical number. And we really need to do a better job of finding the individual patients. And as I said, we're working on our couple of ways to do that right now.

And what are your plans now for Europe that you have back on track for approval there? What's your commercial plan?

Right now, our only indication, meaningful indication in Europe is CTX for cholic acid. The next step before we do anything is to get the full marketing authorization. We hope to have that by the end of the year, not a guarantee but we believe we are on track to do that. We have European structure set up now, have European General Manager. And he has a plan in place to point some additional resources as soon as we have that marketing authorization to do a very controlled launch and to four target countries in the EU and to generate revenues in that way. We have had a -- we inherited a distribution partner in the EU and we have negotiated a transition period with that partner. They're helping us to transition to handling a product ourselves. And that's going to be a process that takes place really over the next probably five months or so.

And what countries that those include?

Initially, we would look at France, Germany, probably Italy and the Benelux area.

And our next question comes from Evan Seigerman from Deutsche Bank.

Just few on Thiola first. Was the slowdown during the summer just basically a seasonality thing or was there something else going on there that we should be aware about?

Good question, I'm not sure that I know the answer to that.

Okay.

Our assumption is, that it’s seasonal, seen that with other oral medications in the rare disease space in the past. So, it’s not particularly shocking. But sometimes it's important to step back and remember this is our first real year with this product. We just got Thiola, Chenodal last year and Cholbam we just launched a couple of months ago. So, whether you look at the summer or as we go into Q4 or we’ll go through the Thanksgiving and Christmas, New Year seasons, so be our first time through in those kind of an area. Products, we have seen big uptakes right before the end of the year, products we have seen slowdown, right before the end of the year; same thing in the summer. And I think our second year going around, we have a little better handle on what to expect, but this year we’re learning as we go.

That’s fair. And then was there any specific commercial push that happened in September or would set up September to accelerate the increase in the number of patients added on therapy?

There was no change in promotional strategy or efforts between August and September, no.

And then kind of looking at the broader Thiola franchise, what are you doing to kind of ensure like the longer term viability aside from the potential reformulation; is there anything else in place to kind of make sure that this can be sustained at least a few years out?

We have system set up that we think is designed to optimize patient experience. We feel like we have significant loyalty within our patient group and within our prescriber group and we have a system in place that gives them help with insurance, help with co-pays, help with medical information. So, I think the thing that we are doing is -- everything we can do from a support system standpoint and now after a fair amount of assessment on exactly what to do, we’ve made a decision and we won’t move forward, we’re trying to come up with a formulation for the product that enables a patient to go on a regimen that’s a little bit easier for them to maintain.

And then just a quick one on Cholbam, from the clinical trial, have all those patients converted to commercial drug at this point?

On the two patients who are on commercial drug, we have two patients on patient assistance which is essentially free drug and my understanding is that both of those patients were patients who were not U.S. citizens and that had a connection in United States and who were in the U.S. and were receiving drug as part of the trial protocol. And as you might guess, when you’ve got a non-U.S. citizen in States, it's a little trickier process getting them insured. We’re working that.

And then one for Alvin with sparsentan, so you had mentioned that you hope to get the 100 patients randomized by early 2016. If that’s the case, why are we looking at top line results into the quarter if it's only an eight-week end point?

Yes, because it does take a while even after the randomization to get the patients fully treated and then to -- again it will be a process of locking the database and going through all of the back end theses that need to happen in closing out the trial. It’s going to be a very complex process. And so, we’re going to put all the pieces in place to line it up as closely as we can to do it. But that really is a key, it’s just getting the patients treated and then being able to lock the database.

And then I know kind of again with the summer, it seems that enrolment slowed down a little bit, have you seen that pick up again? I guess similar to what we saw with Thiola, different stories there, but similar kind of slowdown and speed up?

Yes, absolutely. And there, this was completely expected and we’ve seen a kind of lot of trials because in the summer time patients don’t go to their physicians as frequently; people travel a lot and it just becomes harder to enroll patients during the summer time. And we’ve baked some of that in, but I’ll say that we experienced a lot of seasonality and similarly we saw a very sharp uptake after Labor Day because people started getting back into their routines. We were once -- we have always kept on top of these investigators keep this front of mind and we just saw the bounce back. And it's fair to say, I like the current trajectory that we’re on.

And then one final question kind of on the BD front. Is that still on the horizon for year-end or are we going to be looking at this maybe early 2016?

It's impossible to predict any specific time that a deal will get done. We’ve had -- we always have multiple different opportunities moving at any given moment. Frankly, we just walked away from one within the last couple of weeks, we’re moving on to other opportunities at this point. So, until you actually have the deal signed and can announce it, you just can’t accurately predict when a deal is going to happen.

And our next question comes from Joseph Schwartz from Leerink Partners.

I was wondering just following on the last question, if you could just characterize the number of type of business development opportunities that you're considering now, as the overall landscape continues to evolve. Are you evolving the types of things that you're targeting at all?

Well, to some extent that’s evolved a bit, largely due to the fact that we have a little bit of cash in the bank now that we didn’t have even a few quarters ago. But really, general focus has stayed the same ever since the management changed last fall. I mean for look for products that have exclusivity through either intellectual property or through orphan exclusivity that are either commercial products that maybe are brought some way that we feel like we can fix or late stage clinical products that we feel like we can jump in and help support to bring to market, things similar to the Cholbam deal that we did there last January. So, in very general terms, not much has changed in the last 12 months. We’re looking for assets that can create value by having our support move them forward. And we want to see that value creation take place in a near term timeframe, not further than two to three years out. One of the things that many of the folks on this call know is so many times we get spending so much of our time talking about how long a runway do we have with Thiola. We really want to diversify our portfolio in a way that takes some of that risk away, so that both the company and our investors know that we have long term prospects with the products we're adding in.

And then on Thiola, you mentioned that you'd like to increase the size of your safety stock, so where do you stand now and where would you like that to be?

I don't think we've given out specifics on where we stand but we've got reasonably comfortable right now. Short of some type of real surprise setting us, we would never have a problem. But we'd like to get -- I'd like to get safety stock up to at least a two-year stock of finished product and API. And that gives us safety net, so that if there should be a temporary interruption and either API or a finish line going down, that we're not cutting things too close. The history of Thiola is in an out of stock, was very tough on patients, I think most of you know, product had been available for about two months from we first took it over. One of the commitments we made was that we would spend the money, invest in pulling supplies, so that they would never have to go through that. Again we're continuing to do that right now on a little more aggressive pace than we have in the past as we have seen the market grow substantially.

And Joe, the other benefit of having that added supply is that it helps as we initiate the reformulation efforts. And so all of that ties together really nicely.

And then during the summer slowdown, did you see that there were patients that you were aware of but you were unable to start them on therapy because they didn't want to switch from something previously or start medical therapy at all or were you just finding fewer patients in that timeframe? Can you give us a little bit more color on what was going on in the trenches around then?

I'm not sure I can give you a specific reason. It's probably some combination of things which you get. Patients on vacation, you've got positions on vacations, you’ve got sales reps on vacation and you put the whole package together and things just go a little bit slower.

And our next question comes from Lisa from JMP Securities. [Ph]

I was just wondering if there's any updates on the new formulation of Thiola.

Yes, we've given that some thought in terms of how much we want to say about that. And as you know we don't have idea on Thiola. We want to develop and improve formulation, but we're not particularly eager to share specifics of that new formulation. And I think until we come relatively close to being able to put it out into the marketplace, we're probably going to stay pretty quiet about exactly what goes into that formulation work.

I'm showing no further questions at this time. I would now like to turn the call back over to Chris Cline for any closing remarks.

Thanks, Jessica. Thank you all for joining today. That concludes the call. We look forward to updating you on our progress next quarter.