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Retrophin Inc. (NASDAQ:RTRX)

Q4 2013 Earnings Conference Call

March 27, 2014 04:30 PM ET

Executives

Marc Panoff - CFO

Martin Shkreli - CEO

Analyst

Operator

Good day, ladies and gentleman, and welcome to the Retrophin Incorporated 2013 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instruction will follow at that time. (Operator Instructions) As a reminder, this conference call is being recorded.

I will now like to introduce your host for today’s conference Marc Panoff, Chief Financial Officer of Retrophin, you may begin.

Marc Panoff

Thank you. Good afternoon everyone. Thank you participating in today’s call. Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involved risks and uncertainties regarding the operations and future results of Retrophin.

I encourage you to review the Company’s filing with the Securities and Exchange Commission which identifies 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 times sensitive information that is accurate only as of today’s date March 27, 2014. 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 will turn the call over to Martin Shkreli, Chief Executive Officer of Retrophin. Martin?

Martin Shkreli

Thank you Marc and thanks everyone for joining us this afternoon. 2013 was a busy year for Retrophin where we substantively advanced our mission of becoming a diversified but fast growing pharmaceutical company focused on the treatment of severe diseases. I will now provide updates on our drug portfolio, Syntocinon. In December 2013, we entered into a license agreement with Novartis for Syntocinon Nasal Spray, the intranasal formulation of a synthetic version of the naturally-occurring peptide hormone Oxytocin. The drug was approved in 1960 to assist initial postpartum milk ejection that was discontinued by Novartis in 1997 for commercial reasons. We plan to reintroduce Syntocinon Nasal Spray for the approved indication and also to develop it for potential use of the treatment for schizophrenia and autism.

Our conversations with the FDA have been productive and we do not believe any clinical trial work will be required for the reintroduction of Syntocinon. We are making progress on our CMC filing and expect to re-launch Syntocinon in Q3 2014. Since we’ve last spoke, we have continued our discussions with doctors, nurses and with lactation consultants and we’re convinced that there is a need for an approved treatment for milk let down. Research on intranasal Oxytocin for psychiatry indication shows great promise as well, over the past four year, there have been three randomized double blind placebo controlled schizophrenia trials conducted in patients whose symptoms were not adequately controlled with a typical antipsychotics.

All three studies suggest an intranasal Oxytocin administered as an adjuvant to subject antipsychotic drug improves positive and negative symptoms as assessed by pan-scale significantly more than placebo. Two significantly larger studies of intranasal Oxytocin are being conducted in schizophrenia and we expect results from both academics with studies later in 2013.

RE-024; RE-024 is our pipeline candidate for Pantothenate Kinase-Associated Neurodegeneration also known as PKAN. It is a replacement therapy for phosphopantothenate the substrate missing in patients with PKAN. PKAN is a life-threatening neurological disorder that causes dystonia and neurodegeneration. Onset typically occurs prior to age 10 and many patients die before age 20. Given the severity of the disease, we approached our work on PKAN with urgency. Our conversations with global regulatory authorities are promising and we believe dosing and a physician sponsored or name patient Phase 1 trial will begin eminently.

We are committed to the rapid disclosure of the first patient experience of RE-024 approximately one quarter after dosing of the Phase 1 trial begins. RE-034, last December we announced our plan to develop RE-034 a long-acting analog of the naturally-occurring adrenocorticotropic hormone or ACTH formulated with zinc. Synthetic ACTH is also known as Cosyntropin Tetracosactrin. We intend to initiate clinical trials of RE-034 as a treatment for infantile spasms for West syndrome and nephritic syndrome.

We have indicated that we will complete an IND filing and Phase 1 PK study in the first half of this year and Phase 3 pivotal trials shortly thereafter to remain on-track to initiate these activities. The FDA has recently confirmed we will be able to support the effectiveness of RE-034 in infantile spasms without a placebo controlled trial which is significantly positive development for this program. We stay tuned as more trial design of this program becomes available. Sparsentan, we have initiated enrollment into U.S. the Phase 2-3 study which we believe will form the basis for filing for FDA approval for sparsentan our investigational candidate for the focal segmental glomerulosclerosis or FSGS.

At a recent investigator meeting, we saw enthusiasm for the trial reflecting the need for treatment for this disease for which there is no approved drug. We expect to complete patient enrollment for sparsentan in the duet study at year end 2014 and report results from the trial in Q1 2015. Chenodal, we close the acquisition of Manchester Pharmaceuticals and our booking revenue was the new owner of Chenodal and Vecamyl. Chenodal is the standard of care for the severe genetic disease, cerebrotendinous xanthomatosis or CTX. And all of our prescriptions are for CTX patients. We believe as many as 500 to 1000 patients suffer from CTX in the United States. We have initiated efforts to assist physicians in the earlier diagnosis of CTX. Indeed CTX is one of the few rare genetic diseases with a proven treatment and earlier diagnosis permits treatments to prevent permanent damage.

There are several other bio and/or genetic abnormalities other than CTX which we believe Chenodal will be an effective treatment for. These diseases are an opportunity for Retrophin to expand the revenue potential of Chenodal beyond CTX, which we have previously noted is a $100 million to $250 million opportunity. Chenodal is a potent FXR agonist. Accordingly, we’re planning initiating a trial of Chenodal on primary biliary cirrhosis later this year.

Finally, Retrophin believes Chenodal was and is fundamentally underpriced as a rare genetic disease drug. We will be announcing a new price for Chenodal as early as next week which will be substantially higher than its current approximate $110,000 price for patient per year.

With that I’m going to turn it over to Retrophin’s Chief Financial Officer, Marc Panoff, who will share with you last year’s financial highlights. Marc?

Marc Panoff

I will provide a brief overview of 2013 financial results. Our net loss for the year ended December 31, 2013 was $33.8 million. Research and development expenses increased to $7.1 million for the year ended December 31, 2013. General and administrative expenses for the year were $16.9 million. Our cash balance at the end of 2013 was approximately $6 million, and we subsequently raised gross proceeds of $40 million from a public offering of our common stock in January 2014. We are reiterating our guidance for 2014 revenues of between $10 million and $12 million, and guidance for 2015 revenues of between $19 million and $21 million. Martin?

Martin Shkreli

Thank you Marc. Our business is diversified and poised for growth with respect to both or marketed products as well as our pipeline. Our very early stage pipeline is progressing as well. We plan to have at least one new internally developed product candidate this year which will be a straightforward solution for rare genetic disease. The opportunities to acquire existing business that will grow up portfolio we’re also intriguing; we expect to be able to announce commercial acquisition in the near future, although there can be no assurances that any such deal will be completed.

Our access to capital, both equity and debt is very robust and we thank or investors and prospective lenders for their faith in the company and our approach.

I’ll now turn the call over to the operator for questions.

Question-and-Answer Session

Operator

(Operator Instructions) I’m sorry; there are no questions at this time.

Martin Shkreli

Okay, thank you very much for dialing into the Retrophin call, and we will talk to you next quarter.

Operator

Ladies and gentleman, thank you for participating in today’s conference. This does conclude today’s conference. You may now disconnect. Have a great day everyone.

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