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Healthcare - Biotechnology - NASDAQ - US
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$ 1.52 B
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2014 - Q3
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Executives

Chris Cline - Manager, IR Steve Aselage - CEO Alvin Shih - EVP, R&D and CMO Marc Panoff - CFO.

Analysts

Zachary Prensky - Little Bear Investments Jacob Ma-Weaver - Cable Car Capital.

Operator

Good day ladies and gentlemen and welcome to the Retrophin Third Quarter 2014 Operational and Financial Update. 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, Chris Cline Manager of Investor Relations for Retrophin. You may begin..

Chris:.

Steve Aselage

Thank you, Chris. Good afternoon everyone, welcome to the Retrophin third quarter 2014 earnings call. I'm extremely pleased with the progress that has been made in the third quarter by both commercial and research organizations. I'm particularly encouraged by the net revenue increase of 46% from last quarter to $8.3 million.

The increase was led by Thiola which continues to add patients each week. As I'm sure you're aware at the end of the quarter market rate have transitioned for the Company.

I am pleased to report that after a very short period of time, I've been impressed by the talent level of our employees, by their efforts in moving the Company forward through a challenging period. I've spent considerable time speaking with our partners and investors and I'm grateful for their support all that they've shown.

It is important to have a clear understanding of current realities and future opportunities and we want to share that picture with you today. We have worked with our primary lenders. We continue to be unequivocally supportive to renegotiate the terms of our loans as we will remain in compliance with covenants.

And I have the operating parts of [indiscernible] to execute our strategic priorities and act opportunistically when evaluating business development prospects over the longer term.

Our priorities as we move out of the transition period will be to leverage the current commercial business, concentrate on the advancement of pipeline assets that will maximize return and continue to vigorously pursue business development opportunities that fit within Retrophin's core capabilities.

Additionally, it is critical that we have spending under better control and I feel that we've made substantial progress in ways that will become clear in subsequent quarters. We will continue to move towards our goal of being cash flow positive at some point in 2015.

Due to a slower than expected process of getting patients back on Thiola after the supply shortage, we are adjusting guidance on revenues for 2014 to a range of $26 million to $29 million from the previous range of $30 million to $35 million. We have also removed the previously stated 2015 guidance.

Going forward we plan to give the coming year's outlook during year-end earnings call. It is important to note that while we had a slower than anticipated start to getting patients back on the Thiola therapy. We have seen a better than expected acceleration in identifying and starting new patients since the launch.

So we are optimistic for significant growth in 2015. Commercially we will continue to capitalize on the tremendous job our sales force has done thus far with the Thiola re-launch. Thiola continues to be a leading treatment for patients with persistent system area and I am excited about the first full quarter performance.

We have seen continued growth and as of last week believe we have surpassed the number of patients that were previously on therapy before the supply outage. We are also encouraged that we have been able to growth the subscriber base significantly since the beginning of September.

As a result we expect to slightly increase the size of all our Thiola sales force to give us broader reach and to further increase patient growth. Besides growing the number of patients on therapy, we delivered considerable upside potential for Thiola as we improved both compliance and persistence.

To date we have been very pleased with payer support and patients indicate that they are extremely pleased by the increased levels of service, support and use of access to therapy. Chenodal generated second full quarter sales and we are pleased that the patient base remains stable in payers supported study.

With the current label we believe we will continue to add low single-digit patients each year. Importantly for patients suffering from cerebrotendinous xanthomatosis or CTX, we have decided to pursue adding this indication to the Chenodal label after receiving feedback from multiple sources.

Remember that CTX is extremely difficult to diagnose and is often not found before neurologic damage has occurred. By including CTX on the Chenodal label, not only would we expect to achieve seven years orphan exclusivity in the U.S.

but we would also be able to honor our commitment to patients by increasing awareness through education, promotion, improved diagnostic efforts and ensuring that any CTX patient in need of Chenodal has access to therapy.

Moving to the pipeline which Alvin will speak to in greater detail shortly, I'm pleased that our recently announced divestment will allow us to focus on aggressively moving forward the assets that we believe can provide the greatest opportunity, specifically Sparsentan for FSGS and RE-024 will kick in.

After our internal assessment it was very evident that Vecamyl, Syntocinon and ketamine do not possess clear development value for Retrophin and would distract from our focus, from our core capabilities and goals. With a streamlined effort on compound we will be able to produce marked progress for our pipeline and meet our developmental goals.

Lastly I want to briefly focus on our business development efforts. As a company we believe our business model of combining novel rare disease research with the aggressive pursuit of complementary assets is the best way to drive persistent returns for our shareholders.

Our concentration will be directed towards late stage clinical or commercial orphan disease assets with strong IP where we believe we can unlock considerable value without having to add significant infrastructure. With that I would like to now ask Alvin to go through our progress on the pipeline. Alvin..

Alvin Shih

Thanks Steve. The third quarter and the subsequent weeks marked a period of continued progress for the R&D organization and has allowed us to increase our focus on the most promising assets in our pipeline. Our strategy remains centered on rare diseases, which are characterized by severe unmet medical needs.

We believe the scientific, clinical and regulatory environment remained very positive for the development of novel and transformative therapies in the rare disease space. And consistent with the strategy we’re fully committed to sparsentan and RE-024 as the primary drivers of value creation for the company over the next several years.

Similarly RE-034 provides us with several attractive options to generate value with a program that will be ready for the clinic in the near-term. With a sharpened focus on these quality assets we’re well positioned to be a leader in rare disease research and development.

Sparsentan is being developed for the treatment of focal segmental focal segmental glomerulosclerosis or FSGS. Progress in the Phase II DUET clinical trial has been steady. There are 20 sites enrolling with several additional sites scheduled to activate in the coming months.

We’re also working with regulators to lay the ground work for European sites to open in 2015. [Indiscernible] which is the leading patient efficacy group for rare kidney disorder patients is working closely with our clinical team to help accelerate enrollment.

We continue to target 100 total subjects and are pleased to report that a recent data safety monitoring board review of unblinded data has now allowed of pediatric enrollment to proceed. Based on discussions with our investigator network and analysis of enrollment trends up till now.

We now anticipate enrolling the last patient into DUET by the end of 2015, which should more closely align with enrollment metrics in rare disease trials across the industry.

We’ve learned from our initial experiences in attempting to run the largest ever FSGS trial and believe we now have a better road map for achieving full enrollment in a shorter time as possible. This will speed up enrollment and help us achieve our goal of having that last patient consented by the end of 2015.

Our second pipeline asset RE-024 for the treatment of pantothenate kinase-associated neuro degeneration, or PKAN continues to generate significant interest in the PKAN patient community.

Two PKAN patients outside the United States have been receiving RE-024 through physician initiated studies and they continue to demonstrate sustained clinical benefits with an acceptable safety profile.

Additional physician initiated requests will be evaluated on case-by-case basis but our development strategy is now focused on filing an IND with the U.S. FDA and initiating a clinical program. We believe we’ll be ready to file an IND at some point in the first half of 2015 and we’ll provide additional guidance as we make progress towards that goal.

We also continue to develop RE-34, a synthetic form of the ACTH peptide. We’ve made meaningful progress in the third quarter that will enable us to pursue multiple strategic options including the potential for a U.S. IND submission in clinical trial in 2015.

We have discussed multiple potential rare disease indications with regulators and we’ll be further evaluating these development options as we complete the work to enable this asset to enter the clinic. Finally I’d like to touch briefly on our early stage research efforts.

We have a very talented group of discovery scientists who are working on internal projects to ensure sustainability of our pipeline in rare diseases and we’re also exploring potential collaborations with patient advocacy groups, accelerating share risk in the drug development process.

As projects mature and move closer to the clinic we’ll provide appropriate updates. So with that I’ll turn the call over to Marc Panoff, our CFO..

Marc Panoff

Thank you, Alvin. I will provide a brief overview of our third quarter 2014 financial results. Our net product sales for the third quarter 2014 was $8.3 million from the sale of our three marketed products, Chenodal, Thiola, and Vecamyl. We reported a net loss of $19.6 million for the quarter ended September 30, 2014.

The third quarter 2014 net income included stock based compensation expense of $4.7 million, severance expense of $4.6 million and income of $6.4 million for the change in fair value of derivative instruments related to warrants issued in connection with our 2013 private placements.

Excluding these accounting treatments and one-time items actual cash flow used from operations and cash interest for this quarter was $14.2 million. Research and development expenses increased to $13 million for the three months ended September 30, 2014, compared to $1.4 million for the three months ended September 30, 2013.

The increase is due to higher headcount and external costs associated with the progress of our pipeline programs including Sparsentan, RE-024 and RE-034. Non-cash expenses including stock based compensation and amortization expense accounted for $2 million of R&D expenses for the quarter ended September 30, 2014.

Selling, general and administrative expenses for third quarter of 2014 totaled $18.6 million compared to $3.8 million for the same period of 2013. The increase reflects higher headcount in professional fees and related expenses due to the expansion of our business through the acquisition and license of our commercial products.

Third quarter 2014 SG&A included a one-time severance charge or $4.5 million related to the separation agreement with Martin Shkreli and letter of intent for the sale of the non-core assets to Turing pharmaceuticals.

Non-cash expenses including stock based compensation in depreciation and amortization accounted for $3.5 million of SG&A expenses for the quarter ended September 30, 2014 compared to $1.7 million for the quarter ended June 30, 2014. Retrophin had approximately $38 million in cash and marketable securities as of September 30, 2014.

I will now turn the call back over to Steve for his closing comments..

Steve Aselage

Thanks Marc. Overall the third quarter puts Retrophin in position of strength to execute on our strategic priorities after this period of transition. I would also like to highlight that we recently added two directors with remarkable industry pedigrees, who have already provided considerable guidance as we enter a new year for Retrophin.

The commercial strength and exciting pipeline value proposition and creative business development efforts make me more confident than ever that Retrophin will deliver significant value to shareholders and continue to make a difference in the larger patients with rare diseases. With that we’d be happy to open up the call for questions.

Chris?.

Chris:.

Operator

Thank you. (Operator Instructions) Our first question comes from Zachary Prensky with Little Bear Investments. Your line is now open..

Zachary Prensky - Little Bear Investments

I appreciate the opportunity. I’ve got two questions here. Number one relates to the current liability section of the release. There is a $9.9 million acquisition related contingent consideration.

Could you elaborate as to which asset that refers to and approximately where will those payments be made? Is that 2015 or is that 2016 liability which has to be paid or is it immediate? That’s the first question.

And my second question with regards to Sparsentan ongoing trial, as it relates to the R&D expense for the quarter, assuming that you’re correct and the trial finishes enrollment by the end of the year, can you give us some sort of idea as to what percentage of our R&D spend is related to that trial and how much the quarterly [indiscernible] so far as R&D expense is concerned is related to the cost of Sparsentan trial which should be right down over the next quarter or two..

Marc Panoff

Hi, Zack. This is Marc Panoff. Good to hear your voice. I can answer the first question. The contingent consideration liability relates to future royalties that will be paid to the Manchester principles.

Because we acquired the entire company we were required to present value our expected royalties to the principles and we recorded all upfront in my ability. So it’s a current and a non-current portion. So those will be paid out over years to come..

Zachary Prensky - Little Bear Investments

Years, plural?.

Marc Panoff

Correct..

Zachary Prensky - Little Bear Investments

Okay, and so that’s 9.9 less the current portion, which I guess would be in account payable, right?.

Marc Panoff

Correct. So let me just, well -- I believe there is a separate law -- if that's in current liabilities that would probably relate to the more current..

Zachary Prensky - Little Bear Investments

I see. I wasn’t correct. I didn’t realize that yet. Under the current liability that is also acquisition related contingent consideration of $2.2 million. You’re right. I apologize I must see that there. Okay, thank you that answers the first question..

Alvin Shih

Sure. And Zack, maybe I can take a stab at the question around Sparsentan. I don’t think in our financials we broken out the exact amount of expense for this Sparsentan trial. It is less than half of the overall R&D expenditures or it continues to be a significant piece of it.

As you know it’s a strategic priority for our Company and so we’re continuing to invest in it and we’ll fully fund the trial to make sure that it gets to full enrollment by the end of 2015. So it will continue to be an ongoing expense throughout the year..

Zachary Prensky - Little Bear Investments

Throughout the year of 2015?.

Alvin Shih

Throughout the year of 2015, correct..

Zachary Prensky - Little Bear Investments

Got it and as the current number stands, you say as far as this quarter it was less than 50% of the R&D spend?.

Alvin Shih

Correct..

Steve Aselage

It might be worth mentioning that Sparsentan percentage of overall spend is a little bit lumpy from quarter-to-quarter where any type of manufacturing around this done for the product goes into the R&D bucket as far as capturing those costs.

So when a supply run is done, you see a bump up and in quarters when there is no supply or manufacturing done then you see that percentage bump down..

Operator

(Operator Instructions) Our next question comes from Jacob Ma-Weaver with Cable Car Capital. Your line is now open, please go ahead..

Jacob Ma-Weaver - Cable Car Capital

Thanks for giving me the opportunity to ask a question. [Indiscernible].

Steve Aselage

I apologize but I got [indiscernible] question. I was not able to understand what you’re asking on them.

Can somebody repeat that?.

Jacob Ma-Weaver - Cable Car Capital

I’ll try it again. Apologizes for the connection.

I was just hoping to hear some personal standpoint why you decided to stay on as CEO of the Company ahead?.

Steve Aselage

I got it, it was actually a variety of reasons. [Indiscernible] something on I’m doing an interim role in transitioning to more full time CEO and as I got into the role a couple of things changed.

First of all it became fairly clear to me that the situation we were in made it very advantageous for whoever had some history to understand some of the issues and the nuances of the situation that we were dealing with. Secondly I became really tremendously impressed with the people that I find myself working with.

There was firmly lot of questions after transition as to who would stay, who would go and what the attitude was going to be, what people were going to pull the way, what people we’re going to stay, and as a group just been incredibly [indiscernible] employees continue to manage probably through the rest of the organization.

The amount of progress has been made the amount of team work that has been shown in pulling this company forward has been incredible, and I’ve taken a lot of personal satisfaction out of working with this group, people here that are [indiscernible] I feel some responsibility to them as well.

But probably most importantly the longer time I spent working with the group, the more so we could really achieve some significant progress and personal value here and I fairly enjoyed that couple of months, six weeks I guess and when the board asked me if I would stay I said yes, [indiscernible]..

Jacob Ma-Weaver - Cable Car Capital

Thank you.

And then to plenty of question now you can enroll assuming at this point you’re able to disclose what proportion of the patient on that medication that was feeling some [indiscernible] for the company?.

Steve Aselage

I don’t have the exact number. I would say that it’s a relative small proportion that is on any kind of pre-drug program if that’s what you mean by patient assistance.

That number has steadily gone down as we got in patient’s transition in to our Thiola care center hub but there are significant numbers of patients who go through a charitable organization to get help with co-pays or co-insurance costs and I would have to go back and get the exact percentage on that. I don’t have that off the top of my head.

What I can say is a vast majority of patients have got excellent insurance coverage. We are not getting pushed back from payers in any significant way and we're very comfortable with the reimbursement status and the patients seem very happy to have the level of care and support that we've been able to provide, that wasn't available previously..

Operator

This concludes our Q&A session. I would now like to turn the call back to Chris Cline for any closing remarks..

Chris Cline Chief Financial Officer

Thanks Amanda and thank you all for joining us for Retrophin's third quarter update. We look forward to speaking with you next quarter. Have a good day..

Operator

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

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