Second quarter revenue of
Full year 2015 revenue projected to be
- Net product sales for the second quarter 2015 were
$24.1 million , compared to net product sales of$5.7 million in the second quarter of 2014 - Non-GAAP operating income for the second quarter 2015 was
$3.2 million , compared to a non-GAAP operating loss of$11.5 million for the same period in 2014 - Cash, cash equivalents and marketable securities as of
June 30, 2015 totaled$133.6 million
"We are very pleased with the ongoing progress made in the second quarter," said
Quarter Ended
Net product sales for the second quarter of 2015 were
Selling, general and administrative expenses for the second quarter of 2015 were
Research and development expenses for the second quarter of 2015 were
Total other expense for the second quarter of 2015 was
Income tax expense for the second quarter of 2015 was
Net loss for the second quarter of 2015 was
Commercial Product Updates
Thiola® (tiopronin)
Retrophin continued to add Thiola patients on a weekly basis and expanded the number of prescribing physicians in the second quarter.- The Company's recently expanded 24-member salesforce began marketing on
July 1, 2015 and is expected to significantly expand Thiola coverage.
Cholbam® (cholic acid)
Retrophin successfully completed the transfer of approximately 30 patients from the clinical trial extension to Cholbam commercial therapy. Additionally, new patients have been identified and have started therapy.- The Company is currently restructuring relationships with its distribution partners in both
Europe andAsia to optimize commercial market opportunities outside ofthe United States .
Chenodal® (chenodeoxycholic acid)
- Chenodal experienced moderate growth of new cerebrotendinous xanthomatosis (CTX) patients initiating therapy in the second quarter.
Retrophin continues progress towards creating an acceptable submission to theU.S. Food and Drug Administration (FDA) for the addition of CTX to the Chenodal label.
Pipeline Updates
Sparsentan
- The Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) continues to enroll toward the target of 100 patients by year-end 2015.
RE-024
- The Company's Investigational New Drug (IND) application for RE-024 was cleared by the
FDA during the second quarter, and a Phase 1 study to evaluate safety and tolerability in healthy volunteers is currently being conducted. Pending a positive outcome in the Phase 1 study, the Company will request a meeting with theFDA to discuss the next clinical study for RE-024. - RE-024 received orphan drug designation from the
FDA for the treatment of pantothenate kinase-associated neurodegeneration (PKAN), which will provide seven years of U.S. marketing exclusivity if approved. - The
FDA also granted RE-024 Fast Track designation which allows for more frequent interaction with the agency during the development process and may lead to an expedited drug approval and earlier patient access.
RE-034
Retrophin continues preclinical development of RE-034, which could include initiation of IND-enabling studies within the next 12 months.
Second-Half 2015 Outlook
The Company expects full year 2015 net product sales to be in the range of
Conference Call Information
Use of Non-GAAP Financial Measures
To supplement Retrophin's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Retrophin's management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition,
Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; Because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company's competitors and other companies.
As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, change in fair value of derivative liabilities, depreciation expense, non-cash interest and finance expenses; adjust the income tax provision to the estimated amount of taxes that are payable in cash; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, legal fee and settlements, and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, intangible asset amortization, stock-based compensation expense, transaction and license fees and depreciation expense.
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. 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, as well as risks and uncertainties associated with the Company's pre-clinical and clinical stage pipeline as well as its sales and marketing strategies. Specifically, the risks and uncertainties the Company faces with respect to its pre-clinical and clinical stage pipeline include risk that the Company's research programs will not identify pre-clinical candidates for further development and risk that the Company's clinical candidates will not be found to be safe or effective. Specifically, the Company faces risk that the sparsentan Phase 2 clinical trials will fail to demonstrate that sparsentan is safe or effective; risk that the sparsentan Phase 2 program will be delayed for regulatory or other reasons; risk that the Company will be unable to complete Phase 1 clinical trials of RE-024, risk that RE-024 will not progress to Phase 2 or later clinical trials for safety, regulatory or other reasons; risk that the Company will be unable to file an IND for RE-034 or initiate Phase 1 clinical trials for regulatory or other reasons, and for each of the programs risk associated with enrollment of clinical trials for rare diseases. The Company faces risks associated with market acceptance and competition for its marketed products. The Company faces risk that it will be unable to raise additional funding 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 intellectual property rights of third parties; 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 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
CONSOLIDATED BALANCE SHEETS | ||||||||||
(in thousands) | ||||||||||
|
||||||||||
(unaudited) |
2014 |
|||||||||
Assets | ||||||||||
Current assets: | ||||||||||
Cash | $ | 127,746 | $ | 18,204 | ||||||
Marketable securities | 5,862 | 9,556 | ||||||||
Accounts receivable, net | 11,467 | 7,960 | ||||||||
Inventory, net | 2,005 | 801 | ||||||||
Pediatric priority review voucher, held for sale | 96,250 | - | ||||||||
Prepaid expenses and other current assets | 1,407 | 813 | ||||||||
Total current assets | 244,737 | 37,334 | ||||||||
Property and equipment, net | 509 | 671 | ||||||||
Other asset | 2,016 | 2,265 | ||||||||
Intangible assets, net | 168,251 | 94,265 | ||||||||
Goodwill | 936 | 936 | ||||||||
Deferred tax asset | 8,691 | - | ||||||||
Total assets | $ | 425,140 | $ | 135,471 | ||||||
Liabilities and Stockholders' Equity (Deficit) | ||||||||||
Current liabilities: | ||||||||||
Deferred technology purchase liability | $ | 1,000 | $ | 1,000 | ||||||
Accounts payable | 4,778 | 7,124 | ||||||||
Accrued expenses | 20,328 | 27,883 | ||||||||
Other liability | 897 | 938 | ||||||||
Acquisition-related contingent consideration | 4,363 | 2,118 | ||||||||
Derivative financial instruments, warrants | 91,200 | 27,990 | ||||||||
Deferred income tax liability | 8,691 | - | ||||||||
Note payable | 41,125 | 40,486 | ||||||||
Total current liabilities | 172,382 | 107,539 | ||||||||
Convertible debt | 43,593 | 43,288 | ||||||||
Other liability | 12,149 | 12,234 | ||||||||
Acquisition-related contingent consideration, less current portion | 46,235 | 9,520 | ||||||||
Deferred income tax liability, net | - | 141 | ||||||||
Total liabilities | 274,359 | 172,722 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' Deficit: | ||||||||||
Preferred stock Series A |
- | - | ||||||||
Common stock |
3 | 3 | ||||||||
Additional paid-in capital | 318,280 | 140,851 | ||||||||
Treasury stock, at cost, none and 379,591, respectively | - | (3,215 | ) | |||||||
Accumulated deficit | (168,262 | ) | (179,175 | ) | ||||||
Accumulated other comprehensive income | 760 | 4,285 | ||||||||
Total stockholders' equity (deficit) | 150,781 | (37,251 | ) | |||||||
Total liabilities and stockholders' equity (deficit) | $ | 425,140 | $ | 135,471 | ||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
|
||||||||||||||||
(in thousands) | ||||||||||||||||
Three months ended |
Six months ended |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
(unaudited) | (restated) | (unaudited) | (restated) | |||||||||||||
Net product sales | $ | 24,068 | $ | 5,742 | $ | 41,440 | $ | 5,770 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of goods sold | 637 | 35 | 912 | 36 | ||||||||||||
Research and development | 10,563 | 13,310 | 20,910 | 20,253 | ||||||||||||
Selling, general and administrative | 19,692 | 9,579 | 34,547 | 24,725 | ||||||||||||
Total operating expenses | 30,892 | 22,924 | 56,369 | 45,014 | ||||||||||||
OPERATING LOSS | (6,824 | ) | (17,182 | ) | (14,929 | ) | (39,244 | ) | ||||||||
OTHER INCOME (EXPENSE): | ||||||||||||||||
Litigation settlement gain | 15,500 | - | 15,500 | - | ||||||||||||
Early prepayment penalty | (2,250 | ) | - | (2,250 | ) | - | ||||||||||
Other income (expense), net | 402 | 370 | 229 | 375 | ||||||||||||
Interest income (expense), net | (2,922 | ) | (2,179 | ) | (6,720 | ) | (2,179 | ) | ||||||||
Finance expense | - | (4,708 | ) | (600 | ) | (4,708 | ) | |||||||||
Change in fair value of derivative instruments-loss | (29,418 | ) | 32,979 | (66,171 | ) | (20,635 | ) | |||||||||
Bargain purchase gain | - | - | 49,063 | - | ||||||||||||
Total other income (expense), net | (18,688 | ) | 26,462 | (10,949 | ) | (27,147 | ) | |||||||||
LOSS BEFORE INCOME TAXES | (25,512 | ) | 9,280 | (25,878 | ) | (66,391 | ) | |||||||||
Income tax benefit (provision) | (15 | ) | 2,525 | 40,006 | 2,460 | |||||||||||
NET INCOME (LOSS) | $ | (25,527 | ) | $ | 11,805 | $ | 14,128 | $ | (63,931 | ) | ||||||
PER SHARE DATA: | ||||||||||||||||
Net income (loss) per common share, basic | $ | (0.73 | ) | $ | 0.46 | $ | 0.45 | $ | (2.61 | ) | ||||||
Net income (loss) per common share, diluted | $ | (0.73 | ) | $ | (0.77 | ) | $ | 0.44 | $ | (2.61 | ) | |||||
Weighted average common shares outstanding, basic | 34,957,134 | 25,635,277 | 31,079,053 | 24,491,477 | ||||||||||||
Weighted average common shares outstanding, diluted | 34,957,134 | 27,326,442 | 34,825,722 | 24,491,477 | ||||||||||||
Comprehensive Income (Loss): | ||||||||||||||||
Net income (loss) | $ | (25,527 | ) | $ | 11,805 | $ | 14,128 | $ | (63,931 | ) | ||||||
Unrealized gain (loss) | (30 | ) | (103 | ) | (7 | ) | 519 | |||||||||
Foreign currency translation | (298 | ) | - | (3,519 | ) | - | ||||||||||
Comprehensive Income (loss) | $ | (25,855 | ) | $ | 11,702 | $ | 10,602 | $ | (63,412 | ) | ||||||
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | ||||||||||||||||
(unaudited) | ||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
2015 | 2014 | 2015 | 2014 | |||||||||||||
GAAP OPERATING LOSS | $ | (6,824 | ) | $ | (17,182 | ) | $ | (14,929 | ) | $ | (39,244 | ) | ||||
R&D Operating Expense | (10,563 | ) | (13,310 | ) | (20,910 | ) | (20,253 | ) | ||||||||
Stock Compensation | 1,748 | 410 | 3,968 | 958 | ||||||||||||
Transaction & license fees | - | 696 | 150 | 1,565 | ||||||||||||
Amortization & Depreciation | 193 | 63 | 414 | 305 | ||||||||||||
Subtotal non-GAAP items | 1,941 | 1,169 | 4,532 | 2,828 | ||||||||||||
NON-GAAP R&D EXPENSE | (8,622 | ) | (12,141 | ) | (16,378 | ) | (17,425 | ) | ||||||||
SG&A Operating Expense | (19,692 | ) | (9,579 | ) | (34,547 | ) | (24,725 | ) | ||||||||
Legal Expense (A) | 1,388 | 2,095 | 3,351 | 2,095 | ||||||||||||
Stock Compensation | 3,244 | 2,218 | 6,598 | 5,075 | ||||||||||||
Amortization & Depreciation | 3,463 | 166 | 5,021 | 179 | ||||||||||||
Subtotal non-GAAP items | 8,095 | 4,479 | 14,970 | 7,349 | ||||||||||||
NON-GAAP SG&A EXPENSE | (11,597 | ) | (5,100 | ) | (19,577 | ) | (17,376 | ) | ||||||||
Subtotal non-GAAP items | 10,037 | 5,648 | 19,502 | 10,177 | ||||||||||||
NON-GAAP OPERATING INCOME (LOSS) | 3,213 | (11,534 | ) | 4,573 | (29,067 | ) | ||||||||||
GAAP NET INCOME /(LOSS) | (25,527 | ) | 11,805 | 14,128 | (63,931 | ) | ||||||||||
Non-GAAP Operating Loss Adjustments | 10,037 | 5,648 | 19,502 | 10,177 | ||||||||||||
Finance Expense | - | 4,708 | 1,650 | 4,708 | ||||||||||||
Change in fair value of derivative instruments-loss | 29,418 | (32,979 | ) | 66,171 | 20,635 | |||||||||||
Bargain purchase (gain), net (A) | - | - | (49,063 | ) | - | |||||||||||
Income Tax (benefit)/provision (A) | 15 | (2,525 | ) | (40,006 | ) | (2,460 | ) | |||||||||
NON-GAAP NET INCOME (LOSS) | $ | 13,943 | $ | (13,343 | ) | $ | 12,382 | $ | (30,871 | ) | ||||||
PER SHARE DATA: | ||||||||||||||||
Net gain (loss) per common share, basic | $ | 0.40 | $ | (0.52 | ) | $ | 0.40 | $ | (1.26 | ) | ||||||
Weighted average common shares outstanding, basic | 34,957,134 | 25,635,277 | 31,079,053 | 24,491,477 | ||||||||||||
(A) Non-recurring items | ||||||||||||||||
View source version on businesswire.com: http://www.businesswire.com/news/home/20150804006796/en/
Director, Investor Relations
646-564-3680
IR@retrophin.com
Source:
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