Chris Cline, CFA
Vice President, Investor Relations & Corporate Communications
Retrophin Reports First Quarter 2018 Financial Results
Company obtains FDA and EMA feedback on pathway to NDA and MAA filing for sparsentan in IgA nephropathy; single Phase 3 trial expected to initiate in the fourth quarter of 2018
Pivotal Phase 3 DUPLEX Study of sparsentan in FSGS underway to support Subpart H NDA filing
Revenue rose 14 percent to $38 million during the first quarter of 2018
SAN DIEGO (May 1, 2018) - Retrophin, Inc. (NASDAQ: RTRX) today reported its first quarter 2018 financial results and provided a corporate update.
The Company recently obtained regulatory feedback from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the development pathway for sparsentan in IgA nephropathy (IgAN); a single registration-enabling Phase 3 clinical trial is expected to initiate in the fourth quarter of 2018
In April 2018, the Company announced that the first patient had been enrolled in the DUPLEX Study, a pivotal Phase 3 clinical trial evaluating sparsentan in focal segmental glomerulosclerosis (FSGS); top-line data from the interim endpoint efficacy analysis are expected in the second half of 2020
Net product sales for the first quarter of 2018 were $38.4 million, compared to $33.6 million for the same period in 2017
Cash, cash equivalents and marketable securities, as of March 31, 2018, totaled $264.1 million
“We made significant development advancements to start the year with our recent regulatory feedback on sparsentan’s development path in IgA nephropathy and the initiation of our pivotal Phase 3 DUPLEX Study in FSGS,” said Stephen Aselage, chief executive officer of Retrophin. “The prospect of running parallel registrational trials is exciting not just for us, but also for patients with FSGS and IgA nephropathy worldwide. We look forward to building upon our momentum in the clinic, as well as the continued growth of our commercial products to further our efforts in delivering life-changing therapies to patients living with rare diseases.”
Quarter Ended March 31, 2018
Net product sales for the first quarter of 2018 were $38.4 million, compared to $33.6 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 first quarter of 2018 were $24.6 million, compared to $20.9 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 $23.1 million for the first quarter of 2018, compared to $18.1 million for the same period in 2017.
Selling, general and administrative (SG&A) expenses for the first quarter of 2018 were $26.5 million, compared to $23.1 million for the same period in 2017. The difference is largely attributable to an increase in headcount as a result of the Company’s operational growth, as well as marketing initiatives to support its commercial portfolio. On a non-GAAP adjusted basis, SG&A expenses were $19.0 million for the first quarter of 2018, compared to $14.5 million for the same period in 2017.
Total other expense for the first quarter of 2018 was $0.2 million, compared to total other income of $1.3 million for the same period in 2017. The difference is largely attributable to a change in accounting guidelines in which adjustments to the fair value of derivative instruments no longer impacts the net income or loss of the Company.
Net loss for the first quarter of 2018 was $18.4 million, or $0.46 per basic share, compared to $11.1 million, or $0.29 per basic share for the same period in 2017. On a non-GAAP adjusted basis, net loss for the first quarter of 2018 was $5.6 million, or $0.14 per basic share, compared to net income of $0.3 million, or $0.01 per basic share for the same period in 2017.
As of March 31, 2018, the Company had cash, cash equivalents and marketable securities of $264.1 million.
The following information was filed by Retrophin, Inc. (RTRX) on Tuesday, May 1, 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.