Chris Cline, CFA
Vice President, Investor Relations & Corporate Communications
Retrophin Reports First Quarter 2019 Financial Results
Top-line results from pivotal Phase 3 FORT Study in PKAN on-track for 3Q 2019
Enrollment ongoing in Phase 3 clinical trials of sparsentan for patients with rare nephropathies FSGS and IgAN
Continued quarter over quarter growth in net product sales
SAN DIEGO, May 7, 2019 - Retrophin, Inc. (NASDAQ: RTRX) today reported its first quarter 2019 financial results and provided a corporate update.
Top-line data from the pivotal Phase 3 FORT Study of fosmetpantotenate in pantothenate kinase-associated neurodegeneration (PKAN) are anticipated in the third quarter of 2019, followed by anticipated submissions for a New Drug Application (NDA) in the U.S. and Marketing Authorization Application (MAA) in the EU in 2020
The Company expects to make a decision on its option to acquire Censa Pharmaceuticals during the third quarter of 2019, following an evaluation of the complete Phase 2 proof-of-concept study results evaluating CNSA-001 in patients with phenylketonuria (PKU)
The two pivotal Phase 3 studies underway to support potential registration of sparsentan continue to enroll patients with focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN)
Net product sales for the first quarter of 2019 were $39.6 million, compared to $38.4 million for the same period in 2018
Cash, cash equivalents and marketable securities, as of March 31, 2019, totaled $447.6 million
“We continue to advance our pipeline to address significant unmet needs for people living with rare disease, and our execution in the first quarter has positioned us to reach the next key milestones this year for each of our late-stage programs,” said Eric Dube, Ph.D., chief executive officer of Retrophin. “Fosmetpantotenate and sparsentan remain central to our growth over the next several years and I am pleased with our progress in these pivotal programs. We remain on-track to report top-line results from our pivotal FORT Study in the third quarter, positioning us to potentially deliver the first approved treatment option for patients with PKAN. The ongoing studies to support sparsentan’s potential approval as a first-in-class treatment for FSGS and IgAN continue to enroll patients and advance toward the first readout next year. We look forward to building upon our momentum as we work toward our goal of generating multiple NDA and MAA submissions in the coming years and making a difference in the lives of the rare disease patients we serve.”
Quarter Ended March 31, 2019
Net product sales for the first quarter of 2019 were $39.6 million, compared to $38.4 million for the same period in 2018. The increase in net product sales is primarily attributable to growth of the Company’s commercial product Thiola®. The Company expects full year 2019 net product sales to continue on a similar growth rate compared to 2018.
Research and development (R&D) expenses for the first quarter of 2019 were $33.4 million, compared to $24.6 million for the same period in 2018. The difference is largely attributable to support of clinical and product development efforts related to fosmetpantotenate and sparsentan. On a non-GAAP adjusted basis, R&D expenses were $31.5 million for the first quarter of 2019, compared to $23.1 million for the same period in 2018.
Selling, general and administrative (SG&A) expenses for the first quarter of 2019 were $32.7 million, compared to $26.5 million for the same period in 2018. The difference is largely attributable to increased headcount as a result of the Company’s operational growth, and legal expenses. On a non-GAAP adjusted basis, SG&A expenses were $23.2 million for the first quarter of 2019, compared to $19.0 million for the same period in 2018.
The following information was filed by Retrophin, Inc. (RTRX) on Tuesday, May 7, 2019 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.