Management to Host Conference Call and Webcast today at
"We are pleased with our operational and strategic advancements in the second quarter," said
Pipeline Update
RE-024
- New data from two PKAN patients enrolled in investigator-sponsored studies demonstrated signs of clinical improvement. Additional details and important disclosures were made available on a recent Current Report on Form 8-K.
Sparsentan
- The DUET study, a Phase II clinical trial of sparsentan in patients with Focal Segmental Glomerulosclerosis (FSGS), continues to enroll toward the target of 100 total subjects.
RE-034
Retrophin has obtained regulatory guidance on the design of clinical trials of RE-034 in Infantile Spasms (West Syndrome) and Nephrotic Syndrome.- Further analysis is ongoing to determine the optimal formulation to advance into clinical trials, which may be initiated as soon as the first quarter of 2015.
Syntocinon Nasal Spray
Retrophin is evaluating options to maximize the value of the oxytocin program.- The Company continues to support the ongoing efforts of academic investigators exploring the potential therapeutic use of oxytocin in multiple indications.
New Pipeline Drugs
Retrophin has a broad pipeline of early stage programs focused on rare diseases, and will provide further details as those programs reach the clinic.
Second Quarter 2014 Financial Results
Net Income (Loss)
Non-GAAP net loss for the second quarter of 2014 was
GAAP net income for the second quarter of 2014 was
Net Sales
Net sales for the second quarter of 2014 were
Operating Expenses and Other
Operating expenses for the second quarter of 2014 increased to
- Cost of product sales for the second quarter of 2014 was
$1.2 million , compared to$0 for the same period in 2013. - Selling, general and administrative ("SG&A") expenses for the second quarter of 2014 totaled
$11.3 million on a GAAP basis, compared to$4.5 million for the same period of 2013. Non-GAAP SG&A expenses totaled$5.7 million for the second quarter of 2014, compared to$2.0 million for the same period in 2013. Non-GAAP SG&A expenses exclude stock-based compensation expense, depreciation and amortization expense, transaction and license fees and legal settlement expenses. - Research and development ("R&D") expenses were
$13.7 million for the quarter endedJune 30, 2014 on a GAAP basis, compared to$0.6 million for the quarter endedJune 30, 2013 . Non-GAAP R&D expenses totaled$12.6 million for the second quarter of 2014, compared to$0.6 million for the same period in 2013. Non-GAAP R&D expenses exclude stock-based compensation expense and depreciation and amortization expenses.
Net interest and finance expenses totaled
At
In
During the second quarter of 2014, the Company raised total gross proceeds of
Financial Guidance
| Revenue forecast | |||
| 2014 | |||
| 2015 | |||
|
EPS (non-GAAP) Forecast* |
|||
| 2015 | |||
* See "Use of Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included in this press release.
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, transaction and license fees, change in fair value of derivative liabilities, depreciation expense, 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, transaction and license fees, legal 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; (iv) the non-GAAP net income (loss) (and the related per share) guidance measures exclude from estimated GAAP net income intangible asset amortization and depreciation expense, stock-based compensation expense, transaction and license fees, interest and finance expenses; and adjust the income tax provision to the estimated amount of taxes that are payable in cash.
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 II clinical trials will fail to demonstrate that Sparsentan is safe or effective; risk that the Sparsentan Phase II program will be delayed for regulatory or other reasons; risk that the Company will be unable to file an IND for RE-024 or RE-034 or initiate Phase I clinical trials for regulatory or other reasons; and risk that the Syntocinon program will not advance to Company sponsored clinical trials. 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
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 39,880,286 | $ | 5,997,307 | ||||
| Marketable securities | 3,563,914 | 132,994 | ||||||
| Accounts receivable | 1,600,769 | - | ||||||
| Other Receivable | 5,963,889 | - | ||||||
| Inventory | 496,685 | - | ||||||
| Prepaid expenses and other current assets | 1,891,433 | 1,370,943 | ||||||
| Total current assets | 53,396,976 | 7,501,244 | ||||||
| Property and equipment, net | 511,275 | 127,427 | ||||||
| Security deposits | 288,997 | 244,058 | ||||||
| Restricted cash | 40,000 | 40,000 | ||||||
| Other asset | 1,927,757 | - | ||||||
| Investment | 400,000 | - | ||||||
| Intangible assets, net | 98,034,363 | 12,586,150 | ||||||
| Goodwill | 935,935 | - | ||||||
| Total assets | $ | 155,535,303 | $ | 20,498,879 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Deferred technology purchase liability, current portion | $ | 1,500,000 | $ | 1,634,630 | ||||
| Accounts payable | 10,625,117 | 3,553,567 | ||||||
| Accrued expenses | 7,233,493 | 3,526,434 | ||||||
| Securities sold, not yet purchased | 144,850 | 1,457,901 | ||||||
| Other Liability | 588,601 | - | ||||||
| Contingent consideration, current portion | 3,053,486 | - | ||||||
| Derivative financial instruments, warrants | 24,839,144 | 25,037,346 | ||||||
| Total current liabilities | 47,984,691 | 35,209,878 | ||||||
| Note payable | 39,834,960 | - | ||||||
| Convertible debt | 42,978,042 | - | ||||||
| Other liability | 12,783,110 | - | ||||||
| Contingent consideration | 9,746,515 | - | ||||||
| Deferred technology purchase liability | 1,000,000 | 1,000,000 | ||||||
| Deferred income tax liability, net | 141,151 | 2,600,899 | ||||||
| Total liabilities | 154,468,469 | 38,810,777 | ||||||
| Stockholders' Equity (Deficit): | ||||||||
|
Preferred stock Series A |
- | - | ||||||
|
Common stock |
2,668 | 1,855 | ||||||
| Additional paid-in capital | 133,448,275 | 50,189,127 | ||||||
| Treasury stock, at cost, 379,591 and 130,790, respectively | (3,214,608 | ) | (957,272 | ) | ||||
| Accumulated deficit | (129,578,400 | ) | (67,435,621 | ) | ||||
| Accumulated other comprehensive income (loss) | 408,899 | (109,987 | ) | |||||
| Total stockholders' equity (deficit) | 1,066,834 | (18,311,898 | ) | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 155,535,303 | $ | 20,498,879 | ||||
| UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| Net product sales | $ | 5,741,734 | $ | - | $ | 5,769,634 | $ | - | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 1,207,395 | - | 1,208,295 | - | ||||||||||||
| Research and development | 13,697,991 | 605,203 | 20,584,717 | 713,937 | ||||||||||||
| Selling, general and administrative | 11,340,071 | 4,494,699 | 21,432,093 | 6,636,449 | ||||||||||||
| Total operating expenses | 26,245,457 | 5,099,902 | 43,225,105 | 7,350,386 | ||||||||||||
| Operating loss | (20,503,723 | ) | (5,099,902 | ) | (37,455,471 | ) | (7,350,386 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Interest income (expense), net | (2,178,937 | ) | 5 | (2,178,401 | ) | (41,558 | ) | |||||||||
| Finance expense | (4,708,280 | ) | - | (4,708,280 | ) | - | ||||||||||
| Realized gain on sale of marketable securities, net | 370,177 | - | 374,841 | - | ||||||||||||
| Change in fair value of derivative instruments | 32,978,586 | 56,041 | (20,635,216 | ) | (2,395,618 | ) | ||||||||||
|
Loss on transaction denominated in foreign |
- | (4,657 | ) | - | (3,873 | ) | ||||||||||
| Total other income (expense), net | 26,461,546 | 51,389 | (27,147,056 | ) | (2,441,049 | ) | ||||||||||
| Income (loss) before provision for income taxes | 5,957,823 | (5,048,513 | ) | (64,602,527 | ) | (9,791,435 | ) | |||||||||
| Income tax benefit | 2,525,124 | - | 2,459,748 | - | ||||||||||||
| Net income (loss) | $ | 8,482,947 | $ | (5,048,513 | ) | $ | (62,142,779 | ) | $ | (9,791,435 | ) | |||||
| Net income (loss) per common share, basic | $ | 0.33 | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | |||||
| Net loss per common share, diluted | $ | (0.90 | ) | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | ||||
|
Weighted average common shares outstanding, |
25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
|
Weighted average common shares outstanding, |
27,326,442 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
| RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| GAAP reported net income (loss) | $ | 8,482,947 | $ | (5,048,513 | ) | $ | (62,142,779 | ) | $ | (9,791,435 | ) | |||||
| Share-based compensation | 5,008,272 | 128,388 | 10,014,627 | 287,593 | ||||||||||||
| Intangible asset amortization and depreciation | 392,985 | 53,139 | 520,171 | 105,307 | ||||||||||||
| Change in fair value of derivative liabilities | (32,978,586 | ) | (56,041 | ) | 20,635,216 | 2,395,618 | ||||||||||
| Transaction and license fees | 1,068,356 | 125,000 | 1,977,996 | 225,000 | ||||||||||||
| Legal settlements | 327,208 | 2,219,424 | 327,208 | 2,234,424 | ||||||||||||
| Net interest expense and finance fees | 6,887,217 | - | 6,886,681 | 41,558 | ||||||||||||
| Income tax adjustments | (2,525,124 | ) | - | (2,459,748 | ) | - | ||||||||||
| Non-GAAP adjusted net loss | $ | (13,336,725 | ) | $ | (2,578,603 | ) | $ | (24,240,628 | ) | $ | (4,501,935 | ) | ||||
| GAAP reported net income (loss) per common share, basic | $ | 0.33 | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | |||||
| GAAP reported net loss per common share, diluted | $ | (0.90 | ) | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | ||||
|
Non-GAAP adjusted net loss per common share, basic and |
$ | (0.52 | ) | $ | (0.21 | ) | $ | (0.99 | ) | $ | (0.39 | ) | ||||
| GAAP Weighted average common shares outstanding, basic | 25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
| GAAP Weighted average common shares outstanding, diluted | 27,326,442 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
|
Non-GAAP Weighted average common shares outstanding, |
25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | ||||||||||||||||||||||||||
| CERTAIN LINE ITEMS AND OTHER INFORMATION | ||||||||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||||||||
| Three Months | ||||||||||||||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | |||||||||||||||||||||||
| Reported | Adjustments | Adjusted* | Reported | Adjustments | Adjusted* | |||||||||||||||||||||
| Net product sales | $ | 5,741,734 | $ | - | $ | 5,741,734 | $ | - | $ | - | $ | - | ||||||||||||||
| Cost of goods sold | 1,207,395 | - | 1,207,395 | - | - | - | ||||||||||||||||||||
|
Research and |
13,697,991 | (1,115,330 | ) | (a) | 12,582,661 | 605,203 | (36,683 | ) | (a) | 568,520 | ||||||||||||||||
|
Selling, general and |
11,340,071 | (5,681,491 | ) | (b) | 5,658,580 | 4,494,699 | (2,489,268 | ) | (b) | 2,005,431 | ||||||||||||||||
| Operating loss | (20,503,723 | ) | 6,796,821 | (13,706,902 | ) | (5,099,902 | ) | 2,525,951 | (2,573,951 | ) | ||||||||||||||||
|
Interest income |
(2,178,937 | ) | 2,178,937 | - | 5 | - | 5 | |||||||||||||||||||
| Finance expense | (4,708,280 | ) | 4,708,280 | - | - | - | - | |||||||||||||||||||
|
Realized gain on sale of |
370,177 | - | 370,177 | - | - | - | ||||||||||||||||||||
|
Change in fair value of |
32,978,586 | (32,978,586 | ) | - | 56,041 | (56,041 | ) | - | ||||||||||||||||||
|
Loss on transaction |
- | - | - | (4,657 | ) | - | (4,657 | ) | ||||||||||||||||||
|
Income (loss) before |
5,957,823 | (19,294,548 | ) | (13,336,725 | ) | (5,048,513 | ) | 2,469,910 | (2,578,603 | ) | ||||||||||||||||
| Income tax benefit | $ | 2,525,124 | (2,525,124 | ) | - | $ | - | - | - | |||||||||||||||||
| Net income (loss) | $ | 8,482,947 | $ | (21,819,672 | ) | $ | (13,336,725 | ) | $ | (5,048,513 | ) | $ | 2,469,910 | $ | (2,578,603 | ) | ||||||||||
|
Net income (loss) per |
$ | 0.33 | $ | (0.52 | ) | $ | (0.41 | ) | $ | (0.21 | ) | |||||||||||||||
|
Net loss per common |
$ | (0.90 | ) | $ | (0.52 | ) | $ | (0.41 | ) | $ | (0.21 | ) | ||||||||||||||
|
Weighted average |
25,635,277 | 25,635,277 | 12,253,599 | 12,253,599 | ||||||||||||||||||||||
|
Weighted average |
27,326,442 | 25,635,277 | 12,253,599 | 12,253,599 | ||||||||||||||||||||||
| RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | ||||||||||||||||||||||||||
| CERTAIN LINE ITEMS AND OTHER INFORMATION | ||||||||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||||||||
| Six Months | ||||||||||||||||||||||||||
| GAAP | Non-GAAP | GAAP | Non-GAAP | |||||||||||||||||||||||
| Reported | Adjustments | Adjusted* | Reported | Adjustments | Adjusted* | |||||||||||||||||||||
| Net product sales | $ | 5,769,634 | $ | - | $ | 5,769,634 | $ | - | $ | - | $ | - | ||||||||||||||
| Cost of goods sold | 1,208,295 | - | 1,208,295 | - | - | - | ||||||||||||||||||||
| Research and development | 20,584,717 | (1,561,978 | ) | (a) | 19,022,739 | 713,937 | (36,683 | ) | (a) | 677,254 | ||||||||||||||||
|
Selling, general and |
21,432,093 | (11,278,024 | ) | (c) | 10,154,069 | 6,636,449 | (2,815,641 | ) | (c) | 3,820,808 | ||||||||||||||||
| Operating loss | (37,455,471 | ) | 12,840,002 | (24,615,469 | ) | (7,350,386 | ) | 2,852,324 | (4,498,062 | ) | ||||||||||||||||
| Interest income (expense), net | (2,178,401 | ) | 2,178,401 | - | (41,558 | ) | 41,558 | - | ||||||||||||||||||
| Finance expense | (4,708,280 | ) | 4,708,280 | - | - | - | - | |||||||||||||||||||
|
Realized gain on sale of |
374,841 | - | 374,841 | - | - | - | ||||||||||||||||||||
|
Change in fair value of |
(20,635,216 | ) | 20,635,216 | - | (2,395,618 | ) | 2,395,618 | - | ||||||||||||||||||
|
Loss on transaction |
- | - | - | (3,873 | ) | - | (3,873 | ) | ||||||||||||||||||
|
Net loss before provision for |
(64,602,527 | ) | 40,361,899 | (24,240,628 | ) | (9,791,435 | ) | 5,289,500 | (4,501,935 | ) | ||||||||||||||||
| Income tax benefit | $ | 2,459,748 | (2,459,748 | ) | - | $ | - | - | - | |||||||||||||||||
| Net loss | $ | (62,142,779 | ) | $ | 37,902,151 | $ | (24,240,628 | ) | $ | (9,791,435 | ) | $ | 5,289,500 | $ | (4,501,935 | ) | ||||||||||
|
Net loss per common share, |
$ | (2.54 | ) | $ | (0.99 | ) | $ | (0.85 | ) | $ | (0.39 | ) | ||||||||||||||
|
Weighted average common |
$ | 24,491,477 | $ | 24,491,477 | $ | 11,492,475 | $ | 11,492,475 | ||||||||||||||||||
| * Explanation of Adjustments and Certain Line Items: | ||
| (a) | Share-based compensation expense | |
| (b) | Share-based compensation expense of |
|
| (c) | Share-based compensation expense of |
|
| RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2015 FINANCIAL GUIDANCE | ||
| (In thousands, except per share amounts) | ||
| (Unaudited) | ||
| GAAP net loss | ||
| Intangible asset amortization and depreciation | 6,000 - 7,000 | |
| Stock-based compensation expense | 15,000 - 18,000 | |
| Transaction costs and license fees | 4,500 | |
| Interest expense | 10,000 - 12,000 | |
| Non-GAAP adjusted net income | ||
| GAAP net loss per common share, basic and diluted | ||
| Non-GAAP adjusted net income per common share, basic and diluted | ||
| Weighted-average common shares used in per share computations | 27,500 - 28,500 | |
CFO
marc@retrophin.com
or
Manager, Investor Relations
IR@retrophin.com
Source:
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