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Travere Therapeutics, Inc. (TVTX)

Q1 2015 Earnings Call· Tue, May 12, 2015

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to the Retrophin Inc's, First Quarter 2015 Financial Results Incorporate 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 follow at that time. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference, Chris Cline, Manager of Investor Relations. Sir, you may begin.

Chris Cline

Analyst

Thank you, Kate. Good afternoon everyone and welcome to Retrophin's first quarter 2015 financial results and corporate update call. Here 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 would like 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, Mary 11, 2015. 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?

Steve Aselage

Analyst

Thank you, Chris. Good afternoon everyone and thank you for joining us today. We are very happy about the progress we made in the first quarter which was full of achievements that will drive fundamental long term growth to Retrophin and our stakeholders. Operationally, we grew Thiola at a very solid pace. We executed a highly accretive acquisition of Cholbam which diversifies our commercial portfolio and makes us a leading provider of treatment for bile acid disorders. We significantly de-risk the balance sheet with a successful follow-on equity offering. From a commercial perspective, I am very pleased with the 23% top line growth over the last quarter in order to capitalize on the momentum we’ve build with Thiola and to effectively launch Cholbam or increasing our sales force to 24 sales representative. This will expand our commercial reach to cover approximately 2,200 physicians treating cystinuria bile acid synthesis disorder and peroxisomal disorders. Thiola continues to grow meaningfully. As of May 8th, we had more than 725 patients on Thiola. We expect that number to grow significantly throughout 2015 and 2016. Thiola continues to be considered the standard of care for persistent cystinuria patients and we are working to establish routine monitoring of cystine levels and target urinary cystine concentration levels to up guide treatment of dosing. We continued to pride ourselves on providing a first class patient experience which appears to be positively impacting compliance. Prior to our re-launch, compliance have been approximately 50% and while it is still very early on, we are now seeing compliance in the 80% to 85% range. This is a testament to the work being done by our total care hub which provides access and delivery of therapy to patients 24/7 medical support and educational resources. Moving on to Cholbam, which we recently acquired…

Alvin Shih

Analyst

Thank you, Steve. The first months of 2015 were very productive for our research and development. Our focus remains on advancing innovative therapies for rare genetic diseases, as well as optimizing the existing product portfolio through lifecycle management. On the development portfolio, one of our highest priories is enrolling patients into our Phase 2 DUET study, which is testing our lead assets Sparsentan and focal segmental glomerulosclerosis or FSGS. Our clinical operations team is working diligently to achieve our target of completing enrollment of 100 FSGS patients in this study by the end of this year. We have more than 30 active sites worldwide will provide further updates as we make progress. I am happy to share that the Data Monitoring Committee met for the second time recently and has approved the continuation of the study and the opening of the highest dose cohort. We continue to work hand on hand with NephCure, the leading patient efficacy group in the space as well as NEPTUNE contortion of physicians and academic medical centers who are actively managing FSGS patients. Shifting attention to the earlier stage pipeline, there has been positive news flow in recent weeks with the progress RE-024 which is out novel therapeutic in development for the treatment of pantothenate kinase-associated neuro degeneration, or PKAN. In the first quarter, we filed an investigational new drug application with the FDA and last month, the agency gave us clearance to proceed with the Phase 1 study. This study will to aim to assess the safety tolerability and pharmacokinetics of single doses of RE-024 in healthy volunteer subjects. Our clinical teams preparation allowed us to initiate screening of healthy volunteers for the Phase 1 trial almost immediately after received FDA clearance and we expect to begin dosing in the very near future. Also…

Laura Clague

Analyst

Thank you, Alvin. From the financial perspective, the first quarter marked significant advancement for Retrophin. Our net products sales continued to grow and our new finance team is focused on efficiencies and cost controls at the end positively impact our ability to reduce expenses. We’re also able to bolster our balance sheet with net proceeds of 140 million from our follow-on equity offering of approximately 7.9 million shares. This offering was significantly oversubscribed and closed at the end of March. Net product sales consisting of Thiola and Chenodal were 17.4 million in the first quarter. The 23% increase over the last quarter is largely attributable to the re-launch of Thiola. As Steve pointed out earlier, we continued to expect meaningful growth of Thiola as we make additions to our sales force and target new physicians. We’re also excited about our recent acquisition of Cholbam which added as third commercial asset and will contribute to net product sales net quarter. We’ve reported GAAP net income of 39.7 million for the first quarter of 2015. Adjusting for extraordinary and onetime expenses, we ended the quarter with a net loss of 1.1 million. The key elements of the change this quarter are due to the accounting for our Cholbam acquisition including the gain that resulted from valuation of the related where pediatric disease priority review voucher that came with approval. This gain of 48.6 million was reported net of tax. You will also note on our balance sheet that our intangible assets increased due to the addition of the fair value of the acquired product rights for Cholbam and the acquisition related contingent consideration increased reflecting the future royalties and milestone we will pay for Cholbam. It’s important to note that we placed a value on a voucher in our Q1 financial statements…

Steve Aselage

Analyst

Thanks Laura. While we are proud of progress we’ve made this start 2015, we have our site set much higher. Retrophin has now been in a better position and create significant value for the stakeholders. We’re moving into the balance of ‘15 with growing revenue base, we will benefit it from a third growing assets starting in the second quarter, while leveraging stronger cost controls will allow us to continue operating more efficiently. We now have a stronger balance sheet that will enable flexibility and pursue our business development strategy and pipeline advancement. We look forward to continuing the executing of our strategic plan. With that I will now turn over the call to Chris for questions. Chris?

Chris Cline

Analyst

Thanks Steve. Kate, can you please open the line for Q&A.

Operator

Operator

[Operator Instructions] And our first question comes from the line of Robyn Karnauskas of Deutsche bank. Your line is open. Please go ahead.

Robyn Karnauskas

Analyst

Hi guys, thanks for taking my questions. So two questions actually. Fist regarding Thiola, so you feel like you have reached all the low handing fruits to patients that were out there that they have previously been on therapy and how do we think about those patients you know like this kind of patients that would coming on over the course, how do we think about the year? And then the second question is regarding RE-024, when could we get there and is a stock that these patients staying on drug, do we know that that means efficacy or does that mean that drug is just phase. And so can we read and see anything as efficacy given, how long these patients have been on drug? Thanks.

Steve Aselage

Analyst

Sure. Let me start with the Thiola. I would now say we’ve got all the low hanging fruit, but I think the majority of the patients who are on therapy previously we’re happy with the results we’re getting and really wanted to go back on. Those patients were back on therapy. What we have focused initial efforts on is getting back to the physicians who were previous prescribers of Thiola and I think we’ve done a pretty good job of covering that prescriber universe. While we haven’t been able to do here is good to add into some of the clinics that don’t have a history of prescribing Thiola. We feel that there is a significant opportunity there and there is going to be ability to further grow the patient base as we increase our reach. And as we mentioned previously, we are expanding the sales force with 16 people who did an incredible job and covering most of the major centers, but we feel like by expanding up to 24, we’re going to increase our coverage universe by 500 to 600 additional potential prescribers. We think that’s going to help drive business over the rest of the year.

Alvin Shih

Analyst

And Bobyn, let me address your questions on RE-024 or you have some follow-up for Steve.

Robyn Karnauskas

Analyst

Just on the follow-up there. So when we think about like the trends when you are going from getting logging for patients, they are going up there and getting new patients. Should we think about how like the average patients for monthly come in a little bit before those sales people kind of ramp up, so should we expect to see fewer patients for month in the near term that steady stream going into the back half of the year as those patients are brought on therapy or how do we think about that?

Steve Aselage

Analyst

Well I think you may want to think about in terms of we got a big ball of certifications initially and I think the - prior to this call the two data points we gave you showed roughly 50 new patients per month coming in. The actually accumulation or increase in patients over the last couple of months has been a little bit slower than that, it was between 35 and 40 new patients per month, whether we can keep study or whether we can even ramp it up a little bit with some better coverage remains to be seen. I can’t give you kind of a crystal ball diagnosis of exactly where the line is going to become stable and see it week-over-week, month-over-month consistency of patient growth. What I can see is we feel comfortable that we are going to see meaningful increases in patients numbers the rest of this year. But it looks at those point like we’re not going to be able to continue that 50 patients a month trend that you saw late Q4 and early Q1.

Robyn Karnauskas

Analyst

Great, thanks.

Alvin Shih

Analyst

And let me tackle your questions on RE-024. The Phase 1 trial is not designed to be a factored study, so we - envision that we’ll get the results on that relatively soon, certainly before the end of the year and the goal would be to have that safety, tolerability and PKAN data and have that date be submitted for publication before the end of the year. So with regard to the - go ahead Robyn.

Robyn Karnauskas

Analyst

Sorry, go ahead. Sorry, I was asking the question again.

Alvin Shih

Analyst

Yeah, so I would say in terms of the four patients outside the U.S. who are still on therapy, I think it’s an optimistic signal that they in combination what the investigators have chosen to remain on therapy. I don’t want to read more into that date that is wanted before of course these are outside U.S. trials that are really uncontrolled by nature. I think what it does help us is understand the safety profile which is important and then helps us think about how efficacy will ultimately be measured in trials when we are able to conduct those in the patient setting in the U.S.

Robyn Karnauskas

Analyst

Great, thank you.

Operator

Operator

Thank you. And our next question comes from the line of Joe Schwartz of Leerink Partners. Your line is open. Please go ahead.

Joseph Schwartz

Analyst

Thanks very much and congratulations on all the progress. First of all if you could give us an update on the process to update the Chenodal label for the CTX indication, what is involved there?

Steve Aselage

Analyst

Yeah. So Joe, the process is that we have to remain in discussion with the FDA and map out a mutually agreeable process by which we get that on label. It’s a very unusual situation, so this is one where it really does require close communication, negotiation with the agency. So we have met with the agency and have submitted a plan that we believe will be achievable and acceptable. And at this point, we are waiting for feedback from the agency. So when we have something further to report, we will provide an update.

Joseph Schwartz

Analyst

Okay, great. And then what we can define if anything from the recent DSMB decision to enroll patients in the highest dose cohort of DUET, where there certain rates of DEMA for example that were pre-specified that would have prevented that from happening?

Steve Aselage

Analyst

No, I think all we say at this point is that based on their review of the blinded data they saw fit to open enrolment for the highest dose cohort. So that’s really all I would read into it at this point because the date are blinded.

Joseph Schwartz

Analyst

Okay. And then maybe I can squeeze in a one last one. How do you expect to develop RE-034, what are the next steps for this and do you think you will wait for Sparsentan do that data before advancing this asset into clinical trial or do you have plans to move ahead regardless?

Steve Aselage

Analyst

Yeah, right now we are trying to maximize our strategic options with this early stage asset. We’re considering multiple development pads and mapping out how we might push this forward into the clinic. As you know we filed a provisional pantothenate application to cover the novel formulation. And right now that’s forming a basis trying to figure out the appropriate path because this sent to IND enabling studies this year.

Joseph Schwartz

Analyst

Maybe one last, last question, given that Acthar was approved with a pretty non-traditional lease nowadays root at the FDA, how - what was the regulatory pathway be that you envision, would it be something life 505(b)(2) anything more abbreviated in a full-fledged clinical trial program?

Steve Aselage

Analyst

Yeah, right now that’s part of the discussion that we would have to have with the regulators. So I don’t have a definitive answer for you right there.

Joseph Schwartz

Analyst

Okay, well thanks for taking all my questions.

Steve Aselage

Analyst

Sure.

Operator

Operator

Thank you. And our next question comes from the line of Do Kim with Nomura Securities. Your line is open. Please go ahead.

Do Kim

Analyst · Nomura Securities. Your line is open. Please go ahead.

Hi. Thank you for taking my question. A question for Alvin on RE-024, I was hoping that you could provide more details on the Phase 1 study design like how many doses will be evaluated, what is the dose that being used in the investigator initiated studies fall, maybe the time points for PKAN measurement? And also maybe if you could go over how PKAN is diagnosed and whether there is a system in place to identify the patients or is the population is under diagnosed like some other rare diseases?

Alvin Shih

Analyst · Nomura Securities. Your line is open. Please go ahead.

Yeah, so let me try to address those questions and if I forget anything just jump in. So the Phase 1 is intended to dose, as I mentioned it’s a single ascending dose trial and it will cover multiple doses that will bracket the clinical doses that we have already been seeing. So we intend on starting below and then going higher than the doses that we’ve seeing in the ex-U.S. experience so far. We’ve designed it to be as flexible as possible. Right now the plan is to have five dosing cohorts. And you asked about PKAN measurements, we will be looking at PKAN over the course of several days and of course most of those measurements would occur early on, so that we make sure we get a good assessment early on in therapy and we’ll got out to a time period of a couple of days.

Do Kim

Analyst · Nomura Securities. Your line is open. Please go ahead.

Great. Just could you tell us how the population of our patient of PKAN is diagnosed and whether or not that is - the population is under diagnosed like some other rare diseases?

Alvin Shih

Analyst · Nomura Securities. Your line is open. Please go ahead.

Sure. Our sense is that just with any rare disease where no current therapy exists, the diagnosis is probably lower than it should be. With PKAN there are a couple of different avenues of diagnosis, the first is radiologic. So as patients present with this certain consolation symptoms that presumable a movement disorder as well as neurodegeneration, they often get a MRI and then MRI will have a very typical pattern which is called the eye of the tiger sign and so that one way of moving towards the diagnosis. The other means of diagnosis is by running generic tests to have the PKAN gene sequence to understand if there is a definitive generic defect going on. So those are really the two avenues of diagnosis. We do think it’s somewhat under diagnosed and part of the development work that we’ll be doing is really trying to map out where these patients are and how many of them there are. Our estimate right now is that they are between one and three per million population, but that’s a number they would have to be verified overtime.

Do Kim

Analyst · Nomura Securities. Your line is open. Please go ahead.

Great, thank you for taking my questions.

Operator

Operator

Thank you. And I am showing no further question at this time, I’d like to turn the call back over to Chris Cline for any closing remarks.

Chris Cline

Analyst

Thanks Kate. With that I’ll bring the call to an end. Thank you all for joining us today and we look forward to updating on our progress next quarter.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone have a great day.