Management to Host Conference Call and Webcast Today at
"The first quarter of 2014 was a transformative period for Retrophin," said
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."
Financial Guidance
| Current revenue forecast | Previous revenue forecast | |||||
| 2014 | ||||||
| 2015 | ||||||
Pipeline Update
RE-024
- 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.
Sparsentan
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.
RE-034
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
First Quarter 2014 Financial Results
Research and development expenses were
General and administrative expenses were
Total operating expenses were
Retrophin's balance sheet at
Conference Call Information
About
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. 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. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect the Company's business. 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 filings with the
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| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||||
| (Unaudited) | ||||||||||
| ASSETS | ||||||||||
| CURRENT ASSETS: | ||||||||||
| Cash | $ | 3,695,463 | $ | 5,997,307 | ||||||
| Accounts receivable | 28,800 | - | ||||||||
| Inventory | 349,130 | - | ||||||||
| Marketable securities | 1,345,339 | 132,994 | ||||||||
| Prepaid expenses and other current assets | 1,023,564 | 1,370,943 | ||||||||
| Total current assets | 6,442,296 | 7,501,244 | ||||||||
| Other assets | 2,086,641 | 411,485 | ||||||||
| Indefinite lived intangible assets | 10,567,736 | 10,560,355 | ||||||||
| Goodwill | 1,036,160 | - | ||||||||
| Other intangible assets, net | 73,915,788 | 2,025,795 | ||||||||
| TOTAL ASSETS | $ | 94,048,621 | $ | 20,498,879 | ||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||||
| CURRENT LIABILITIES: | ||||||||||
| Accounts payable | 9,013,324 | 7,080,001 | ||||||||
| Notes payable | 31,282,972 | - | ||||||||
| Fair value of derivative liability, warrants | 69,350,988 | 25,037,346 | ||||||||
| Other current liabilities | 3,799,913 | 3,092,531 | ||||||||
| Total current liabilities | 113,447,197 | 35,209,878 | ||||||||
| OTHER LIABILITIES | 15,993,635 | 3,600,899 | ||||||||
| TOTAL STOCKHOLDERS' DEFICIT | (35,392,211 | ) | (18,311,898 | ) | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $ | 94,048,621 | $ | 20,498,879 | ||||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| Three Months Ended |
||||||||||
| 2014 | 2013 | |||||||||
| (As Restated) | ||||||||||
| Net product sales | $ | 27,900 | $ | - | ||||||
| Operating expenses: | ||||||||||
| Cost of goods sold | 900 | - | ||||||||
| Research and development | 6,886,726 | 158,690 | ||||||||
|
Selling, general and administrative |
10,092,022 | 1,726,923 | ||||||||
| Total operating expenses | 16,979,648 | 1,885,613 | ||||||||
| Operating loss | (16,951,748 | ) | (1,885,613 | ) | ||||||
| Other income (expenses): | ||||||||||
| Interest income (expense), net | 536 | (40,779 | ) | |||||||
| Realized gain on sale of marketable securities, net | 4,664 | - | ||||||||
| Change in estimated fair value of derivative liability | (53,613,802 | ) | (2,942,343 | ) | ||||||
| Total other expense, net | (53,608,602 | ) | (2,983,122 | ) | ||||||
| Loss before provision for income taxes | (70,560,350 | ) | (4,868,735 | ) | ||||||
| Income tax expense | (65,376 | ) | - | |||||||
| Net loss | $ | (70,625,726 | ) | $ | (4,868,735 | ) | ||||
| Net loss per common share, basic and diluted | $ | (3.03 | ) | $ | (0.46 | ) | ||||
|
Weighted average common shares outstanding, basic and |
23,334,967 | 10,697,129 | ||||||||
CFO
marc@retrophin.com
Source:
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