Chris Cline, CFA
Vice President, Investor Relations & Corporate Communications
Retrophin Reports Second Quarter 2018 Financial Results and Announces CEO Transition Plan
Patients continue to enroll in Phase 3 FORT Study of fosmetpantotenate in PKAN and Phase 3 DUPLEX Study of sparsentan in FSGS
Phase 2 proof-of-concept study of CNSA-001 in patients with PKU set to initiate; top-line results expected in early 2019
Retrophin Chief Executive Officer Stephen Aselage announces his decision to retire; Board of Directors initiates search for successor
SAN DIEGO, July 26, 2018 - Retrophin, Inc. (NASDAQ: RTRX) today reported its second quarter 2018 financial results and provided a corporate update.
In June 2018, the Company announced the initiation of enrollment for pediatric patients with pantothenate kinase-associated neurodegeneration (PKAN) in the Phase 3 FORT study of fosmetpantotenate following a scheduled clinical safety review by the independent Data Monitoring Committee (DMC); top-line data remains on-track for second half of 2019
Patient enrollment in the Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) continues; top-line data from the interim efficacy analysis are expected in the second half of 2020
Start-up activities continue in anticipation of initiating a pivotal study of sparsentan in IgA nephropathy (IgAN) during the fourth quarter of 2018
Phase 2 proof-of-concept study evaluating CNSA-001 in phenylketonuria (PKU) is expected to commence patient dosing in the coming weeks; top-line data are expected in early 2019
Net product sales for the second quarter of 2018 were $41.3 million, compared to $38.8 million for the same period in 2017
Cash, cash equivalents and marketable securities, as of June 30, 2018, totaled $255.7 million
“Our sustained clinical and operational execution has further propelled us toward our goal of having three pivotal Phase 3 studies underway by the end of 2018,” said Stephen Aselage, chief executive officer of Retrophin. “In addition, with a Phase 2 proof-of-concept study of CNSA-001 in PKU nearing initiation, we believe we are entering a significant period of growth for Retrophin as our pipeline advances toward major inflection points. This progress underscores our commitment to delivering life-changing therapies to people living with rare diseases who have few or no approved treatment options.”
Quarter Ended June 30, 2018
Net product sales for the second quarter of 2018 were $41.3 million, compared to $38.8 million for the same period in 2017. For the six months ended June 30, 2018, net product sales were $79.8 million, compared to $72.4 million for the same period in 2017. The increase in net product sales is attributable to growth across the Company’s commercial products: Chenodal®, Cholbam® and Thiola®. The Company continues to expect full year 2018 net product sales to be in the range of $170.0 to $180.0 million.
Research and development (R&D) expenses for the second quarter of 2018 were $34.5 million, compared to $19.5 million for the same period in 2017. For the six months ended June 30, 2018, R&D expenses were $59.1 million, compared to $40.3 million for the same period in 2017. The difference is largely attributable to support of non-clinical and clinical efforts related to fosmetpantotenate and sparsentan, as well as development funding to support the advancement of CNSA-001. On a non-GAAP adjusted basis, R&D expenses were $32.6 million for the second quarter of 2018, compared to $17.0 million for the same period in 2017.
The following information was filed by Retrophin, Inc. (RTRX) on Thursday, July 26, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.