Exhibit 99.1
![LOGO](https://capedge.com/proxy/8-K/0001193125-20-005878/g844787g0112235656322.jpg)
Contact:
Chris Cline, CFA
Senior Vice President, Investor Relations & Corporate Communications
888-969-7879
IR@retrophin.com
Retrophin Provides Corporate Update and 2020 Outlook
SAN DIEGO (January 13, 2020) -Retrophin, Inc. (NASDAQ: RTRX) today announced that, based on preliminary and unaudited financial data, the Company expects net product sales for the fourth quarter of 2019 to be approximately $47 million. For the fiscal year 2019, the Company expects total net product sales of approximately $175 million. The Company also provided a general update on its development programs, including anticipated milestones for 2020.
“Our outlook for 2020 is clear. We are focused on maximizing the potential for sparsentan, if approved, to change the treatment paradigm in the years to come for patients living with FSGS and IgA nephropathy,” said Eric Dube, Ph.D., chief executive officer of Retrophin. “With this objective, our R&D team is centering its efforts on patient enrollment and trial conduct to advance our pivotal DUPLEX and PROTECT studies and position us for the first NDA and CMA submissions for sparsentan next year. Our commercial organization will continue to focus on identifying and treating new patients with our approved products, and further strengthen our capabilities to support future product launches.”
Program Updates and Anticipated Upcoming Milestones
| • | | The Company remains focused on advancing the development of sparsentan to become a potential new treatment standard in rare kidney conditions and anticipates the following upcoming milestones: |
| • | | The Phase 3 DUPLEX Study is expected to reach enrollment of the first 190 patients with focal segmental glomerulosclerosis (FSGS) in the first half of 2020.Top-line efficacy data from the36-week proteinuria endpoint analysis from the first 190 patients in the study remainson-track for the first half of 2021. Successful achievement of the proteinuria endpoint is expected to serve as the basis for submission of a New Drug Application (NDA) under the Subpart H accelerated approval pathway in the U.S. and Conditional Marketing Authorization (CMA) consideration in Europe. |
| • | | The Phase 3 PROTECT Study is expected to reach enrollment of 280 patients with IgA nephropathy (IgAN) by early 2021.Top-line efficacy data from the36-week proteinuria endpoint analysis from 280 patients in the study remainson-track for the first half of 2022. Successful achievement of the proteinuria endpoint is expected to serve as the basis for submission of an NDA under the Subpart H accelerated approval pathway in the U.S. and CMA consideration in Europe. |
| • | | In 2020, the Company expects continued organic growth of its rare nephrology and hepatology products. |
In late February, the Company expects to announce complete full year 2019 financial results and provide a corporate update.
About Retrophin
Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company’s approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading toend-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin’s R&D efforts are supported by revenues from the Company’s commercial products Chenodal®, Cholbam®, Thiola® and Thiola ECTM.