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Retrophin reports revenue up 16%, progress on 2 Phase 3 trials

August 13, 2017

Fosmetpantotenate (RE-024) Phase 3 trial underway in PKAN

Protocol design for pivotal Phase 3 trial of sparsentan in FSGS complete; sparsentan IP estate expanded to 2030 for FSGS

Second quarter revenues increased 16 percent to $39 million

Retrophin, Inc. (RTRX)  reported its second quarter 2017 financial results and provided a corporate update.

  • Dosed the first patient in the Phase 3 FORT (FOsmetpantotenate Replacement Therapy) Study of fosmetpantotenate (RE-024) in pantothenate kinase-associated neurodegeneration (PKAN)
  • Protocol design for Phase 3 trial of sparsentan in focal segmental glomerulosclerosis (FSGS) is complete and preparation for submission of the protocol to the U.S. Food and Drug Administration (FDA) is underway
  • Recent expansion of sparsentan intellectual property estate expected to extend U.S. and European exclusivity for treating glomerulosclerosis, including FSGS, until at least 2030
  • Net product sales for the second quarter of 2017 were $38.8 million, compared to $33.3 million for the same period in 2016
  • Cash, cash equivalents and marketable securities, as of June 30, 2017, totaled $296.0 million

“In recent months, we made great advancements on our strategic priorities to significantly enhance the value of our organization,” said Stephen Aselage, chief executive officer of Retrophin. “Underpinned by strong second quarter performance from our base business, we made important progress with both of our late-stage development programs, highlighted by the recent initiation of patient dosing in our Phase 3 FORT study in PKAN and completing the design of our Phase 3 protocol for sparsentan in FSGS. Given that there are no FDA-approved therapies for either of these conditions, we remain focused on the execution of our pivotal trials with the goal of bringing these novel medicines to patients in need.”

Quarter Ended June 30, 2017

Net product sales for the second quarter of 2017 were $38.8 million, compared to $33.3 million for the same period in 2016. For the six months ended June 30, 2017, net product sales were $72.4 million, compared to $62.3 million for the same period in 2016. The increase in net product sales is attributable to growth across the Company’s commercial products: Thiola®, Cholbam® and Chenodal®. The Company reiterates its full-year 2017 guidance of $150.0 to $160.0 million in net product sales.

Research and development (R&D) expenses for the second quarter of 2017 were $19.5 million, compared to $17.7 million for the same period in 2016. For the six months ended June 30, 2017, R&D expenses were $40.3 million, compared to $32.3 million for the same period in 2016. The increase is largely attributable to non-clinical and clinical efforts related to sparsentan and RE-024. On a non-GAAP adjusted basis, R&D expenses were $17.0 million for the second quarter of 2017, compared to $15.0 million for the same period in 2016.

Selling, general and administrative (SG&A) expenses for the second quarter of 2017 were $28.8 million, compared to $23.2 million for the same period in 2016. For the six months ended June 30, 2017, SG&A expenses were $52.0 million, compared to $42.3 million for the same period in 2016. The difference is largely attributable to an increase in headcount in support of the Company’s operational growth, an increase in marketing expenses related to the Company’s commercial portfolio, and a non-recurring advancement of approximately $2.0 million in legal fees. On a non-GAAP adjusted basis, SG&A expenses were $19.7 million for the second quarter of 2017, compared to $14.5 million for the same period in 2016.

Total other expense for the second quarter of 2017 was $1.6 million, compared to $9.4 million for the same period in 2016. The decrease is largely due to adjustment of the fair value of derivative instruments as a result of changes in the Company’s stock price.

Net loss for the second quarter of 2017 was $13.2 million, or $0.34 per basic share, compared to $13.4 million, or $0.37 per basic share for the same period in 2016. For the six months ended June 30, 2017, net loss was $24.3 million, compared to $2.2 million for the same period in 2016. On a non-GAAP adjusted basis, net income for the second quarter of 2017 was $1.1 million, or $0.03 per basic share, compared to $2.5 million, or $0.07 per basic share for the same period in 2016.

As of June 30, 2017, the Company had cash, cash equivalents and marketable securities of $296.0 million.

Program Updates

Fosmetpantotenate (RE-024)

  • In July 2017, the Company announced that the first patient had been dosed in the FORT Study, an international, registrational Phase 3 clinical trial assessing the safety and efficacy of fosmetpantotenate in approximately 82 patients with PKAN aged 6 to 65 years. The primary endpoint will be the change in score on the Pantothenate Kinase-Associated Neurodegeneration Activities of Daily Living (PKAN-ADL) scale, from baseline through 24 weeks of treatment. After completing the 24-week treatment period, all patients will be eligible to receive fosmetpantotenate as part of an open-label extension. The FORT Study is expected to be registration-enabling in the U.S. and Europe, and is being conducted under a Special Protocol Assessment (SPA) agreement, which indicates concurrence by the FDA that the design of the trial can adequately support a New Drug Application (NDA).
  • Additional study sites participating in the FORT Study are expected to begin patient enrollment over the remainder of 2017.
  • The four PKAN patients receiving RE-024 under physician-initiated treatment outside of the U.S. continue to receive therapy and remain stable.

Sparsentan

  • Following an End of Phase 2 meeting with the FDA in the first quarter of 2017, the Company announced plans to initiate a pivotal Phase 3 clinical trial of sparsentan in FSGS. The study will include an interim analysis of proteinuria to serve as the basis for an NDA filing for Subpart H accelerated approval of sparsentan. The confirmatory endpoint of the study is expected to compare changes from baseline in estimated glomerular filtration rate (eGFR), which is widely regarded as the best overall measure of kidney function.
  • The Company has completed protocol design for its Phase 3 trial of sparsentan in FSGS and is preparing its regulatory submission to gain alignment with the FDA in the second half of 2017, with the pivotal trial expected to initiate thereafter.
  • In the second quarter of 2017, the Company announced the expansion of its intellectual property estate for sparsentan, with newly issued patents in the U.S. and Europe. Notably, these patents covering the use of sparsentan for treating glomerulosclerosis, including FSGS, are expected to extend the Company’s exclusivity period for sparsentan until at least 2030.

Conference Call Information

Retrophin will host a conference call and webcast today, Wednesday, August 9, 2017 at 4:30 p.m. ET to discuss development updates and second quarter 2017 financial results. To participate in the conference call, dial +1-855-219-9219 (U.S.) or +1-315-625-6891 (International), confirmation code 60017665 shortly before 4:30 p.m. ET. The webcast can be accessed at retrophin.com, in the Events and Presentations section, and will be archived for at least 30 days. A replay of the call will be available from 7:30 p.m. ET, August 9, 2017 to 7:30 p.m. ET, August 16, 2017. The replay number is +1-855-859-2056 (U.S.) or +1-404-537-3406 (International), confirmation code 60017665.

https://yhoo.it/2vzxiv9

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