Retrophin, Inc. (NASDAQ:RTRX) today reported its financial results for the quarter ended March 31, 2014.
"The first quarter of 2014 was a transformative period for Retrophin," said Martin Shkreli, Founder and Chief Executive Officer of Retrophin. "We listed our stock on the NASDAQ and completed a successful public offering in January. In March, we acquired Manchester Pharmaceuticals and became a commercial company with two FDA-approved products. The robust reimbursement of Chenodal and our initial efforts to identify undiagnosed cerebrotendinous xanthomatosis, or CTX, patients have been especially encouraging. We are raising our revenue guidance to reflect this positive operating momentum."
He added, "We continue to aggressively pursue product acquisition candidates, and our list of attractive targets and access to capital remain robust. We also look forward to continuing to advance our pipeline as we work toward bringing these promising therapies to patients with catastrophic diseases who desperately need treatment options."
- IND-enabling studies for RE-024 have completed. To date, RE-024 has no discernible toxicity in mice, rats or primates.
- Named-patient dosing for RE-024 has begun outside of the United States in investigator-sponsored trials.
- Retrophin continued its enrollment for DUET, the Phase II/III clinical trial for sparsentan in patients with Focal Segmental Glomerulosclerosis (FSGS).
- The Company projects enrollment to complete by year-end 2014 or in early 2015.
- Retrophin began 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.
Syntocinon Nasal Spray
- Retrophin plans to re-launch Syntocinon Nasal Spray later this year.
- The Company will have more clarity after a meeting with the U.S. Food and Drug Administration scheduled for later this month.
New Pipeline Drug
Retrophin expects to announce an addition to its pipeline in 2014, a treatment for an ultra-orphan indication from its internally derived portfolio.
First Quarter 2014 Financial Results
Retrophin reported a net loss of $70.6 million for the quarter ended March 31, 2014, which included a charge of $53.6 million related to the change in fair value of its derivative financial instruments. During the same period in 2013, Retrophin recorded a net loss of $4.9 million.
Research and development expenses were $6.9 million for the quarter ended March 31, 2014, compared to $0.2 million for the quarter ended March 31, 2013. Stock-based compensation accounted for $0.4 million of research and development expenses for the quarter ended March 31, 2014. There was no stock-based compensation related to research and development for the quarter ended March 31, 2013.
General and administrative expenses were $10.1 million for the quarter ended March 31, 2014, compared to $1.7 million for the same period in 2013. Stock-based compensation accounted for $4.6 million of general and administrative expenses for the quarter ended March 31, 2014, compared to $0.2 million for the quarter ended March 31, 2013.
Total operating expenses were $17.0 million for the quarter ended March 31, 2014, compared to $1.9 million for the quarter ended March 31, 2013. Total stock-based compensation accounted for $5.0 million for the quarter ended March 31, 2014, compared to $0.2 million for the quarter ended March 31, 2013.
Retrophin's balance sheet at March 31, 2014 included $5 million in cash, cash equivalents and marketable securities.
Conference Call Information
Retrophin will host a conference call and webcast today, Wednesday, May 14 at 8:30 a.m. ET to discuss first quarter 2014 financial results.