Phase 3 FORT study of RE-024 in PKAN to begin dosing mid-2017
Protocol development underway for pivotal Phase 3 trial of sparsentan in FSGS
First quarter revenues rose 16 percent to $34 million
SAN DIEGO, May 04, 2017 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today reported its first quarter 2017 financial results and provided a corporate update.
- End of Phase 2 meeting during the first quarter established regulatory path forward for sparsentan in focal segmental glomerulosclerosis (FSGS); protocol development for single pivotal Phase 3 trial ongoing
- Pivotal FORT study evaluating RE-024 in pantothenate kinase-associated neurodegeneration (PKAN) remains on track to initiate patient dosing mid-year 2017
- Net product sales for the first quarter of 2017 were $33.6 million, compared to net product sales of $29.0 million for the same period in 2016
- Cash, cash equivalents, marketable securities, and note receivable as of March 31, 2017 totaled $295.3 million
“I’m very pleased with our progress to start the year,” said Stephen Aselage, chief executive officer of Retrophin. “Our meeting with the FDA in the first quarter helped define the path forward for sparsentan, and progress continues on the development of a protocol that will enable us to begin the pivotal trial in FSGS. In addition, our recent advancements with RE-024 have positioned us to begin dosing the first PKAN patients in our Phase 3 study mid-year. These clinical achievements, along with strong operational performance during the quarter, have built solid momentum for the remainder of 2017.”
Quarter Ended March 31, 2017
Net product sales for the first quarter of 2017 were $33.6 million, compared to $29.0 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 first quarter of 2017 were $20.9 million, compared to $14.7 million for the same period in 2016. The increase is largely attributable to enhanced clinical efforts related to sparsentan and RE-024. On a non-GAAP adjusted basis, R&D expenses were $18.1 million for the first quarter of 2017, compared to $12.1 million for the same period in 2016.
