Full Press Release Details
Vice President, Investor Relations & Corporate Communications
Retrophin Provides Corporate
Update and 2019 Outlook
Top-line readout of pivotal FORT Study in PKAN expected 3Q19
SAN DIEGO (January 7, 2019) - 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 2018 to be approximately $44 million. For the fiscal year 2018, the Company expects total net product sales of approximately $164 million. The Company also provided a general
update on its development programs, including anticipated milestones for 2019.
With key data readouts from the FORT Study of fosmetpantotenate in
PKAN and the CNSA-001 Phase 2 proof-of-concept study expected in 2019, Retrophin is positioned to create significant value for
patients and shareholders this year, said Stephen Aselage, former chief executive officer of Retrophin. The Company closed 2018 with the initiation of the PROTECT Study of sparsentan in IgA nephropathy, our third pivotal development
program, continued growth of the base commercial business and most recently hired its new president and chief executive officer, Eric Dube, Ph.D. These clinical and commercial achievements provide strong momentum entering the new year, and I look
forward to working with Eric to ensure a seamless transition to drive our continued success.
Program Updates and Anticipated 2019 Milestones
In late February, the Company expects to announce final financial results from the fourth quarter and
full-year 2018, as well as provide a corporate update.
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 late-stage assets targeting rare diseases with significant unmet medical needs, including fosmetpantotenate for pantothenate kinase-associated neurodegeneration (PKAN), a life-threatening
neurological disorder that typically begins in early childhood, and sparsentan for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including a joint development arrangement evaluating the potential of CNSA-001 in
phenylketonuria (PKU), a rare genetic metabolic condition that can lead to neurological and behavioral impairment. Retrophin s R&D efforts are supported by revenues from the Company s commercial products Chenodal , Cholbam and Thiola .
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Without
limiting the foregoing, these statements are often identified by the words may , might , believes , thinks , anticipates , plans , expects , intends or similar
expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that
could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ
materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company s business and finances in general, success of its commercial products as well as risks and uncertainties associated with
the Company s preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with market acceptance of its marketed products including efficacy, safety, price, reimbursement and benefit over competing therapies. The
risks and uncertainties the Company faces with respect to its preclinical and clinical stage pipeline include risk that the Company s clinical candidates will not be found to be safe or effective and that current or future clinical trials will
not proceed as planned. Specifically, the Company faces the risk that the Phase 3 clinical trial of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned;
risk that the Phase 3 clinical trial of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan as planned; risk that the Phase 3 clinical trial of fosmetpantotenate
will not demonstrate that fosmetpantotenate is safe or effective or serve as the basis for an NDA filing as planned; and for each of its development programs and for its partner s CNSA-001 program, risk
associated with enrollment of clinical trials for rare diseases and risk that ongoing or planned clinical trials may not succeed or may be delayed for safety, regulatory or other reasons and risk that the product candidates will not be approved for
efficacy, safety, regulatory or other reasons. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company s
dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with its option to acquire Censa
Pharmaceuticals and the CNSA-001 program; risk that the NDA for the new formulation of Thiola will not be approved by the FDA; and risks and uncertainties relating to competitive products and technological
changes that may limit demand for the Company s products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in
forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to
the full discussion of risks and uncertainties as included in the Company s most recent Form 10-K, Form 10-Q and other filings with the Securities and Exchange