Earnings Labs

Travere Therapeutics, Inc. (TVTX)

Q3 2016 Earnings Call· Thu, Nov 3, 2016

$41.12

+0.76%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to Retrophin Inc. Third Quarter 2016 Financial Results and Corporate Update Conference. 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 would now like to introduce your first speaker for today, Senior Director, Investor Relations, Mr. Chris Cline. Please go ahead, sir.

Chris Cline

Analyst

Thank you, Andrew. Good afternoon everyone, and thank you for joining Retrophin's third quarter 2016 financial results and corporate update call. With me today are Steve Aselage, Chief Executive Officer; and Laura Clague, Chief Financial Officer. 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, 2016, 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 it over to Steve. Steve?

Steve Aselage

Analyst

Thanks, Chris. Good afternoon, everyone and thank you for joining us. The third quarter was a pivotal one for Retrophin. In September we announced positive top line results from our Phase 2 DUET of sparsentan and focal segmental glomerulosclerosis or FSGS. In the study of the overall sparsentan treatment group due to primary efficacy endpoint measuring proteinuria reduction versus an active competitor, irbesartan. The results showed that after an 8 week double-blind period, treatment with sparsentan resulted in a greater than two fold reduction of proteinuria compared to irbesartan. Additionally, the data showed a statistically significant reduction of proteinuria in the combined 400 and 800 milligram dose cohorts. The data also suggests that sparsentan was safe and generally well tolerated. These preliminary finding service proof-of-concept for sparsentan's novel approach to FSGS treatment. More recently, we were very pleased to learn that additional data from DUET has been accepted for presentation in a late breaking oral solution at the ASM Kidney Week later this month. We look forward to making more data from the study available to the nephrology community and giving a broader sense for sparsentan's potential. Additional supportive data from the sparsentan program and research from our academic collaborators will also be presented at the meeting. For example, in an oral session, our collaborators from the Neptune Consortium will present a clinical outcome assessment with proteinuria in FSGS patients. As outlined in the abstract, these data support the use of proteinuria as a surrogate endpoint in FSGS and we look forward to the reception of those findings within the community. We believe their data along with the presentation of other relevant data from the program. We'll help raise awareness of sparsentan's potential in FSGS among the world's foremost nephrology experts in attendance. Following Kidney Week, the next step for…

Laura Clague

Analyst

Thank you, Steve. Net product sales from our commercial portfolio were $33.9 million in the third quarter of 2016, and as Steve mentioned, a 21% increase over the same period last year. We reported a GAAP net loss of $37.1 million for the third quarter of 2016 compared to net income of $105.6 million for the same period in 2015. Adjusting for extraordinary in one-time expenses resulted in a net loss of $3.4 million for the quarter compared to a net loss of $1.9 million in the same period last year. Significant non-cash adjustments for the quarter included $17.1 million of non-GAAP operating loss adjustments, $10.1 million related to the company's derivative liability resulting from share price fluctuation, and an income tax expense of $6.5 million due to an increase in valuation allowance against deferred tax assets. Cost of goods sold during the third quarter of 2016 was $1.6 million compared to $0.5 million in the same period last year. This increase was due to a one-time charge related to supplier startup and yield variances for one of our commercial products and we expect COGS to return to normal levels next quarter. We recorded a non-recurring legal fee settlement charge of $5.2 million in the third quarter of 2016 which was related to the advancement of legal fees associated with our former CEO. We expect that at least some portion of the $5.2 million will be recovered to the Company's D&O insurance policy but the specific value of that is not estimable at this time. R&D expenses on a GAAP basis were $18.4 million for the third quarter of 2016 compared to $14.1 million for the same period in 2015. The increase over the same period last year is due to higher clinical expense related to sparsentan and RE-024. On…

Steve Aselage

Analyst

Thanks, Laura. As I mentioned at the beginning of the call, the third quarter was pivotal for Retrophin. I'm pleased with all of the progress made thus far and with the Company's continued focus on key programs. That focus is enabling us to execute on our mission of delivering life-changing therapies to people living with rare disease. During the quarter we started to highlight the transformative potential or developmental assets with the positive topline read out from DUET. He is finding friendly support or believe that sparsentan can be safe, effective, and novel approach to treating FSGS. And we will continue that momentum as we close out the year with additional data from DUET in the initiation of the RE-024 efficacy study in PKAN patients. The future is clearly bright for Retrophin and we expect to deliver on these key milestones or growing topline revenues to create a greatest amount of value for our many stakeholders. I'll now turn the call back to Chris and open up the line for Q&A. Chris?

Chris Cline

Analyst

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

Operator

Operator

Certainly. [Operator Instructions] And our first question comes from the line of Joseph Schwartz with Leerink Partners. Your line is now open.

Joseph Schwartz

Analyst

Great, thanks very much, thanks for taking my question. We are looking forward to seeing your full DUET data for sparsentan and ASN and meanwhile an abstract is available for the observational cohort study that will be presented there. And that highlights the value of achieving a complete remission in FSGS. So I was wondering if you will be presenting sparsentan data in this way for DUET or in future studies and if you think the FDA wants to see statistically significant improvements in complete remissions before approving a drug in FSGS?

Steve Aselage

Analyst

I think there has been data published including - with FDA authorship that both complete remissions and partial remissions convey some patient benefit in nephritic syndromes and I believe membranous nephropathy was a publication that's been reviewed most routinely. We feel that both of those are important measurements. I think you're aware that the data being presented at ASN is completely embarked, we can't even talk about what that is going to be presented much less of what it says but we're looking forward to be unable to get all of that information out. We think it's going to answer a lot of the questions that we've gotten since the top line data was released a few weeks ago.

Joseph Schwartz

Analyst

Okay, great, we'll stay tuned then. And then also I was wondering if you can give us an update on the search for Alvin's replacement and what activities are you most focused on - are most critical that his replacement address.

Steve Aselage

Analyst

Sure. We're making good progress on search for replacement. We've got an active search ongoing. We are interviewing candidates. Currently it have - pleasantly surprised I guess by how many quality candidates have come into the coin [ph]. So we're moving forward, we're going to take our time and make sure we get the absolute best person, the best fit; both culturally and with technical skills and feel comfortable that we're on-track to do that in the fairly near-term. But again, it's not a situation where we want to rush into or hire or just to fill the position; we want to get the right person for the job.

Joseph Schwartz

Analyst

Great. Thanks very much for the added information.

Operator

Operator

And our next question comes from the line of Do Kim with BMO Capital Markets. Your line is now open.

Do Kim

Analyst · BMO Capital Markets. Your line is now open.

Good afternoon, thanks for taking my question. I'm also looking forward to seeing your data ANS, could you tell us if the open labeled data will also be available, is that something you could disclose to us without breaking the embargo rules [ph].

Steve Aselage

Analyst · BMO Capital Markets. Your line is now open.

Yes, actually I can't get into the contents of what their presentation will entail, the only thing I can tell you is that we're going to include as much information as humanly possible to answer as many of the questions that we've gotten as we can.

Do Kim

Analyst · BMO Capital Markets. Your line is now open.

Ok, thanks, and looking ahead, do you anticipate needing additional support for the commercial and launch for sparsentan or will you be able to use the existing sales infrastructure you already have.

Steve Aselage

Analyst · BMO Capital Markets. Your line is now open.

We would build on the existing sales infrastructure, it would require some with larger sales force to launch sparsentan.

Do Kim

Analyst · BMO Capital Markets. Your line is now open.

Do you have a number of additional reps that you would need?

Steve Aselage

Analyst · BMO Capital Markets. Your line is now open.

We have a ballpark number, but we haven't done a formal sales force sizing assessments yet, and without really doing a solid assessment I would be hesitant to throw out a guess.

Do Kim

Analyst · BMO Capital Markets. Your line is now open.

Okay, and - this question maybe a little premature, but now that the DUET file was successful, and as you look at future development for sparsentan, have you thought about other rare kidney diseases? Where participate maybe appropriate to those indication.

Steve Aselage

Analyst · BMO Capital Markets. Your line is now open.

Yes, I think that's a great question and it's one we're taking a hard look at right now, surely some of the other nephritic syndromes, like IGA nephropathy or membranous nephropathy or things that we want to take a hard look, make a decisions as to whether or not it would be worthwhile investing in some sparsentan we can work in those areas.

Do Kim

Analyst · BMO Capital Markets. Your line is now open.

Ok, thank you very much.

Steve Aselage

Analyst · BMO Capital Markets. Your line is now open.

Sure, thank you.

Operator

Operator

[Operator Instructions] And we have a question coming from the line of Liisa Bayko with JMP Securities your line is now open.

Liisa Bayko

Analyst

Hi, thank you for taking my question. As you put time now review and contemplate the date a little bit more of you. Has it - to you is that clear that there's kind of one dose that emerges and when the makes the most sense based on a balancing of obviously safety and efficacy.

Steve Aselage

Analyst

Yes, I don't think we're going to really be able to answer the question until we get all the details from the study. There's initial analysis being done, we're getting information, I guess I would characterize it as coming in waves. Until we get all of the information consort out details on of those space of both efficacy and safety. We also need to see how many patients that a dose change. In the arm both for 800 milligram armed, so we still have some work to do before we can settle on a specific dose. And I would say also that it may well come out that we have a dose range that - many products ever range from any sort of a low dose and titrated up to a taller ability or you start a dose and titrate down until you get a patients comfort level, and we still got some work to do. I give you a long winded answer to a pretty simple question, that’s long answer for simple question. Short answer is we're not sure yet.

Liisa Bayko

Analyst

Okay, thanks. If you were let out that the policy you have in the market today, you know which - I know you don't break down sales, where did you see the most growth this quarter, thank you.

Steve Aselage

Analyst

Yes, we actually saw all of our growth were virtually all of our growth on the Thiola side; as I mentioned there we did see new patient starts routine at all and would call mom - but we also lost some patients in both of those groups and it ended up with those products being relatively flat. I think one of the things that we are saying is maybe worth commenting on is for these ultra-rare diseases, we're just not going to see steady quarter-over-quarter growth, is not going to be predictable. And it's really going to be the year-over-year, type of growth numbers, you can count on it I think they're going to be more predictive of the long term future of the products. And that's not unusual and rare diseases. If you go back up in Q1 we're really excited we saw kind of a spike and starts in both, Chenodal and Cholbam. And we thought that might be a of future quarters in it turns out we've just seen some lumpiness where we've had some quarters later substantially larger, and then this quarter was probably the smallest net growth quarter since we launched the two products and we're going to continue to see some ups and downs would be my guess.

Liisa Bayko

Analyst

Thank you very much.

Operator

Operator

And at this time I'm show no further questions. So with that said I'd like to turn the conference back to Senior Director, Investor Relations, Chris Cline for any further remarks.

Chris Cline

Analyst

Thanks, Andrew. This concludes our update call. Thanks everyone for joining today. We look for up to updating you on our progress next quarter.

Operator

Operator

Ladies and gentlemen thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day.