Retrophin, Inc. (NASDAQ:RTRX)

NEW YORK--(BUSINESS WIRE)--Retrophin, Inc. (NASDAQ:RTRX) today announced it is updating its revenue outlook for 2014 and 2015.

“We are very pleased with the site-initiation process, enrollment-to-date and investigator enthusiasm for sparsentan in FSGS.”

“Reimbursement of Chenodal has remained robust, and initial efforts to find undiagnosed cerebrotendinous xanthomatosis (CTX) patients are promising,” said Martin Shkreli, Founder and CEO of Retrophin. “We have raised our guidance for 2014 and 2015 revenue accordingly.”

Shkreli concluded, “We are very comfortable with our current cash balance and future obligations. The success of Chenodal significantly reduces our cash needs and may propel the company to profitability in the near-term. As such, we have no need or desire to explore a dilutive equity offering unless it is accompanied by an accretive and strategic acquisition. Retrophin remains opportunistic with respect to M&A and has strong access to both debt and equity capital.”

RE-024

• On Friday, April 11, Retrophin received an update from RE-024 clinical investigators that, despite several investigator-sponsored IND filings for RE-024 in the United States, the U.S. Food and Drug Administration (FDA) has been unwilling to grant a clinical trial through this mechanism.
• The Company intends to file a company-sponsored IND in May or June 2014, with a Phase I clinical trial in PKAN patients beginning in June or July 2014.
• The Company continues to support efforts to launch an investigator-sponsored trial outside of the United States.
• IND-enabling studies for RE-024 are underway, and several of these studies have been completed. To date, RE-024 has no discernible toxicity in mice and rats.

Shkreli added, “While we are disappointed the FDA has been unwilling to grant expedited access to RE-024 for children with a lethal disease, we respect its decision and are motivated by the enthusiastic and brave physicians and patients who desperately want access to this promising molecule. The small delay is frustrating to all of our stakeholders, but we expect the issue will be resolved in the near term and we are taking steps to grow our R&D infrastructure to avoid similar experiences in the future.”

Sparsentan

• DUET, the Phase II/III clinical trial for sparsentan in patients with Focal Segmental Glomerulosclerosis (FSGS) is enrolling well.
• The Company projects enrollment to complete by year-end or in early 2015.

Shkreli commented, “We are very pleased with the site-initiation process, enrollment-to-date and investigator enthusiasm for sparsentan in FSGS.”

RE-034

• Retrophin has begun trial initiation activities for Phase III trials of RE-034 in Infantile Spasms and Membranous Nephropathy.
• The Company anticipates launching Phase III trials for RE-034 in the third quarter of 2014.

Shkreli said, “We are pleased with the speed and technical success we’ve been able to achieve in manufacturing RE-034 and the promising dialogue we’ve had with FDA.”