Earnings Labs

Travere Therapeutics, Inc. (TVTX)

Q4 2015 Earnings Call· Thu, Feb 25, 2016

$41.12

+0.76%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-0.27%

1 Week

-0.55%

1 Month

-12.40%

vs S&P

-17.30%

Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Retrophin Incorporated Fourth Quarter and Full Year 2015 Financial and Operational Update 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 conference is being recorded. I would now like to introduce your host for today’s conference, Mr. Chris Cline. Sir, you may begin.

Chris Cline

Analyst

Thank you, Lauren. Good afternoon everyone and thank you for joining Retrophin’s fourth quarter and full-year 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, February 25, 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 the call over to Steve. Steve?

Steve Aselage

Analyst

Thanks you, Chris. Good afternoon, everyone and thank you for joining us to talk about the progress we made in 2015 and our outlook for 2016. We closed ‘15 with fourth quarter performance that continued the momentum we built earlier in the year and leaves us well-positioned for to be a transformational 2016 for Retrophin. From an operating perspective, we grew top-line revenues for the seventh consecutive quarter and leveraged our cost controls to remain disciplined in our deployment of capital, which resulted in another quarter of positive operating cash flow generation. The growth in total net product sales to $30.4 million for the quarter was driven by new patient admissions to all three products. Thiola was the largest contributor to this growth in the fourth quarter and continues to add patients on a weekly basis. 2015 was about expanding our knowledge of the cystinuria marketplace and understanding the true potential for the product. Specifically we were focused on reaching the remaining portion of cystinuria patients. We’ve been treated with Thiola prior to the supply disruption in 2014 and those who were aware of the therapy but had not yet received it. 2016 will be about applying this knowledge to ensure we reach the maximum number of patients possible within what we believe is a population of 4,000 to 5,000 cystine stone forming patients, who could benefit from Thiola. We’ll do that, we’re primarily targeting diagnosed patients who maybe on earlier lines of treatment or even other therapies, specifically we have already initiated several programs to improve our commercial efficiency and gain greater traction in the field. One way we hope to spur further growth is through a new program we launched in late January. This effort gives us access to laboratory data which will direct us more quickly to…

Alvin Shih

Analyst

Thanks Steve. The R&D organization closed 2015 with a number of achievements that helped further lay the groundwork for very important year ahead. And we anticipate in 2016 the pipeline will continue to come into focus with the potential successful achievement of several important milestones. Specifically related to sparsentan, which is our lead development program, the clinical team made a big push in the fourth quarter of 2015 and was able to make up for some of the weakness we saw in enrollment due to the seasonality in the summer months of 2015. I’m happy to report that we’re on-track to have the 100-subject randomized in the DUET study by the end of the first quarter. And this would put us on track for a, top-line readout in the third quarter of 2016. The DUET trial was designed to detect the clinically meaningful reduction in proteinuria after eight weeks of treatment compared to an active control. Based on the fact that angiotensin blockade is commonly used as a backbone of therapy in FSGS. We chose to use irbesartan as the active controlling DUET. And we believe this reflects the real-life therapeutic decision-making the patients and doctors will be faced with. What gives us confidence in sparsentan is the emerging body of mechanistic evidence supported by clinical data and other chronic kidney diseases that show endothelin antagonists have an additive effect on proteinuria over and above that [indiscernible]. In multiple studies using several agents, it’s clear that the proteinuria reducing effect of endothelin receptor antagonists quite significantly. From a safety perspective, the limitation of endothelin receptor antagonist use in chronic kidney diseases has traditionally been fluid retention which can lead to significant complications for this patient population. We hypothesize that the relative selectivity of sparsentan for endothelin Type A receptors over…

Laura Clague

Analyst

Thank you, Alvin. Net product sales from our commercial portfolio consisting of, Thiola, Cholbam, and Chenodal were $30.4 million in the fourth quarter and $99.9 million for the full year 2015. The increase for the fourth quarter over the same period in 2014 is due to growth in the number of patients receiving Thiola and Chenodal treatments and the addition of Cholbam to the commercial portfolio. We reported a GAAP net loss of $2.5 million for the fourth quarter and a net income of $117.2 million for the full year 2015. Adjusting for extraordinary and one-time expenses, net income was $2.6 million for the quarter and $11.8 million for the full-year 2015. Significant adjustments for the quarter included $18.5 million of non-GAAP operating loss adjustments offset by a $10.5 million income tax benefit and a net benefit of $2.9 million related to the company’s derivative instruments. Research and development expenses on a GAAP basis were $15.5 million for the fourth quarter and $50.4 million for the full-year 2015. The increase in the fourth quarter is a result of increased compensation and clinical trial expense related to the advancement of our lead development candidate sparsentan, as it nears completion of enrollment of the DUET study. On an adjusted basis, R&D expense for the fourth quarter was $12.6 million and $40.3 million for the full-year 2015. Relevant non-cash expenses for the fourth quarter included $2.8 million of stock-based compensation and amortization. Selling, general and administrative expenses were $22.7 million on a GAAP basis in the fourth quarter and $79.5 million for the full-year 2015. The increase in the fourth quarter is largely due to increased compensation and amortization related to the expansion of commercial effort and the addition of Cholbam to the commercial portfolio. On an adjusted basis, SG&A expense for the…

Steve Aselage

Analyst

Thanks Laura. I do want to take a step back and recognize the progress that was made in 2015 as a result of our employees’ dedication and hard-work while executing on the strategic plans. There were many significant achievements in the year including but not limited to, top-line growth each quarter with broad expansion of access for patients through all of our commercial products, numerous regulatory milestones that will ensure additional value for our pipeline assets including infant drug and fast-track designations, the acquisition and approval of Cholbam and the subsequent PRV sale and the ramping up of enrollment in the DUET trial for sparsentan and RE-024 moving into the clinic in the U.S and completing its Phase 1 trial in healthy volunteers. From a financial perspective, we entered 2015 with a $56 million top-line run rate and operating expenses we’re only just started to benefit from the controls put in place at the end of 2014. Our balance sheet was limited to only $28 million in ash alongside expensive restrictive debt and convertible notes. We now move into 2016 with top-line growth expected to reach $130 million to $140 million and our fortified balance sheet consisting of more than $320 million in cash receivables with no restricted debt. This progress enables us to set our sights higher. We plan to leverage our advancements from last year to move through 2016 with a focus of moving our pipeline forward and continuing commercial execution so that we can showcase the true value potential of the company for our shareholders. I will now turn the call back over to Chris to open up the lines for questions. Chris?

Chris Cline

Analyst

Thanks Steve. Lauren, can we open up the line for questions please?

Operator

Operator

Yes, sir. [Operator Instructions]. Our first question comes from Joseph Schwartz from Leerink Partners. Your line is open.

Unidentified Analyst

Analyst

Hi everyone Mrs. Brad in for Joe. Thanks for taking my question. I’m curious Thiola, how much revenue growth do you feel is less then specifically what are the drivers in this direction you specifically mentioned the patient-friendly formulation and development. I’m curious to hear any more thoughts or color around that and timing for that? And then conversely, how much of the barrier to growth if at all if the action announcement improvements earlier this month? Thank you.

Steve Aselage

Analyst

Sure, we see, thanks. We see significant upside with Thiola really through all of this year and into 2017, we feel like we’ve got a good start. We’ve seen good growth but this is a product that takes time, takes education. And one of the things that I mentioned during the script was, there are, we feel patients in many centers scattered around the country. We just haven’t been able to find yet. We feel that use of this laboratory data is going to allow us to direct our sales force really to become much more efficient, much more effective in finding those patients and getting those patients on to therapy. So, significant upside to continue, we’re going to grow that product for the foreseeable future. Now with regards to the second part of your question related to the compounding pharmacy we don’t see any impact at all on our current or future business. It’s a formulation that we don’t think makes sense, we don’t think it should come to market. It’s a product that if it comes out as described would be considered a new drug, not just a compounded version of Thiola. And you can’t launch the new drug in the United States without FDA approval. So, we’re not losing any sleep about that one.

Unidentified Analyst

Analyst

Okay, great. Thanks for the color. And on the patient-friendly formulation that was mentioned, when can we expect more details around what that would look like and when that could be launching?

Steve Aselage

Analyst

Yes, I don’t anticipate of really providing any details on that until we get pretty close to being able to roll it out for utilization. And that would be probably 2017 some time. And as we get closer we’ll give you a little tighter timeline. But we’re still early on with that. And the only thing I’d be willing to say certainly right now is we won’t get it out in ‘16, it will be at least ‘17 before it comes out.

Unidentified Analyst

Analyst

Okay, great. Thanks for the answers. Appreciate it.

Steve Aselage

Analyst

Sure.

Operator

Operator

[Operator Instructions]. And I’m showing no questions at this time.

Chris Cline

Analyst

Great. Thank you, Lauren. With that we’ll wrap up the call. And we look forward to hearing or giving you all our progress next quarter. Thank you for joining.

Operator

Operator

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