UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________
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FORM 8-K
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CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported) August 12, 2014 |
RETROPHIN, INC.
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(Exact name of registrant as specified in its charter)
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Delaware
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001-36257
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27-4842691
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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777 Third Avenue, 22nd Floor, New York, NY
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10017
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code (646) 837-5863
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(Former name or former address, if changed since last report.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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¨
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13a-4(c))
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RETROPHIN, INC.
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Date: August 12, 2014
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By:
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/s/ Marc Panoff | |
Name: Marc Panoff
Title: Chief Financial Officer
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Retrophin, Inc.
Marc Panoff, CFO
646-564-3671
marc@retrophin.com
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Retrophin, Inc.
Chris Cline
Manager, Investor Relations
IR@retrophin.com
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·
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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.
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·
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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.
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·
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Retrophin has obtained regulatory guidance on the design of clinical trials of RE-034 in Infantile Spasms (West Syndrome) and Nephrotic Syndrome.
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·
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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.
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·
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Retrophin is evaluating options to maximize the value of the oxytocin program.
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·
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The Company continues to support the ongoing efforts of academic investigators exploring the potential therapeutic use of oxytocin in multiple indications.
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Retrophin has a broad pipeline of early stage programs focused on rare diseases, and will provide further details as those programs reach the clinic.
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Cost of product sales for the second quarter of 2014 was $1.2 million, compared to $0 for the same period in 2013.
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·
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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.
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·
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Research and development (“R&D”) expenses were $13.7 million for the quarter ended June 30, 2014 on a GAAP basis, compared to $0.6 million for the quarter ended June 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.
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Revenue forecast
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2014
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$30 million - $35 million
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2015
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$60 million - $70 million
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EPS (non GAAP) Forecast*
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2015
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$0.75 - $1.25
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RETROPHIN, INC. AND SUBSIDIARIES
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CONDENSED CONSOLIDATED BALANCE SHEETS
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June 30, 2014
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December 31, 2013
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(Unaudited)
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Assets
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Current assets:
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Cash
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$ | 39,880,286 | $ | 5,997,307 | ||||
Marketable securities
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3,563,914 | 132,994 | ||||||
Accounts receivable
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1,600,769 | - | ||||||
Other Receivable
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5,963,889 | - | ||||||
Inventory
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496,685 | - | ||||||
Prepaid expenses and other current assets
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1,891,433 | 1,370,943 | ||||||
Total current assets
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53,396,976 | 7,501,244 | ||||||
Property and equipment, net
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511,275 | 127,427 | ||||||
Security deposits
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288,997 | 244,058 | ||||||
Restricted cash
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40,000 | 40,000 | ||||||
Other asset
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1,927,757 | - | ||||||
Investment
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400,000 | - | ||||||
Intangible assets, net
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98,034,363 | 12,586,150 | ||||||
Goodwill
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935,935 | - | ||||||
Total assets
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$ | 155,535,303 | $ | 20,498,879 | ||||
Liabilities and Stockholders' Equity (Deficit)
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Current liabilities:
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Deferred technology purchase liability, current portion
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$ | 1,500,000 | $ | 1,634,630 | ||||
Accounts payable
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10,625,117 | 3,553,567 | ||||||
Accrued expenses
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7,233,493 | 3,526,434 | ||||||
Securities sold, not yet purchased
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144,850 | 1,457,901 | ||||||
Other Liability
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588,601 | - | ||||||
Contingent consideration, current portion
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3,053,486 | - | ||||||
Derivative financial instruments, warrants
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24,839,144 | 25,037,346 | ||||||
Total current liabilities
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47,984,691 | 35,209,878 | ||||||
Note payable
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39,834,960 | - | ||||||
Convertible debt
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42,978,042 | - | ||||||
Other liability
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12,783,110 | - | ||||||
Contingent consideration
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9,746,515 | - | ||||||
Deferred technology purchase liability
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1,000,000 | 1,000,000 | ||||||
Deferred income tax liability, net
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141,151 | 2,600,899 | ||||||
Total liabilities
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154,468,469 | 38,810,777 | ||||||
Stockholders' Equity (Deficit):
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Preferred stock Series A $0.001 par value; 20,000,000 shares authorized; 0 issued and outstanding
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- | - | ||||||
Common stock $0.0001 par value; 100,000,000 shares authorized; 26,681,514 and 18,546,363 issued and 26,301,923 and 18,415,573 outstanding, respectively
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2,668 | 1,855 | ||||||
Additional paid-in capital
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133,448,275 | 50,189,127 | ||||||
Treasury stock, at cost, 379,591 and 130,790, respectively
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(3,214,608 | ) | (957,272 | ) | ||||
Accumulated deficit
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(129,578,400 | ) | (67,435,621 | ) | ||||
Accumulated other comprehensive income (loss)
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408,899 | (109,987 | ) | |||||
Total stockholders' equity (deficit)
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1,066,834 | (18,311,898 | ) | |||||
Total liabilities and stockholders' equity (deficit)
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$ | 155,535,303 | $ | 20,498,879 |
RETROPHIN, INC. AND SUBSIDIARIES
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UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
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(Unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2014
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2013
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2014
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2013
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Net product sales
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$ | 5,741,734 | $ | - | $ | 5,769,634 | $ | - | ||||||||
Operating expenses:
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Cost of goods sold
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1,207,395 | - | 1,208,295 | - | ||||||||||||
Research and development
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13,697,991 | 605,203 | 20,584,717 | 713,937 | ||||||||||||
Selling, general and administrative
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11,340,071 | 4,494,699 | 21,432,093 | 6,636,449 | ||||||||||||
Total operating expenses
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26,245,457 | 5,099,902 | 43,225,105 | 7,350,386 | ||||||||||||
Operating loss
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(20,503,723 | ) | (5,099,902 | ) | (37,455,471 | ) | (7,350,386 | ) | ||||||||
Other income (expenses):
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Interest income (expense), net
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(2,178,937 | ) | 5 | (2,178,401 | ) | (41,558 | ) | |||||||||
Finance expense
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(4,708,280 | ) | - | (4,708,280 | ) | - | ||||||||||
Realized gain on sale of marketable securities, net
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370,177 | - | 374,841 | - | ||||||||||||
Change in fair value of derivative instruments
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32,978,586 | 56,041 | (20,635,216 | ) | (2,395,618 | ) | ||||||||||
Loss on transaction denominated in foreign currencies
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- | (4,657 | ) | - | (3,873 | ) | ||||||||||
Total other income (expense), net
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26,461,546 | 51,389 | (27,147,056 | ) | (2,441,049 | ) | ||||||||||
Income (loss) before provision for income taxes
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5,957,823 | (5,048,513 | ) | (64,602,527 | ) | (9,791,435 | ) | |||||||||
Income tax benefit
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2,525,124 | - | 2,459,748 | - | ||||||||||||
Net income (loss)
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$ | 8,482,947 | $ | (5,048,513 | ) | $ | (62,142,779 | ) | $ | (9,791,435 | ) | |||||
Net income (loss) per common share, basic
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$ | 0.33 | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | |||||
Net loss per common share, diluted
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$ | (0.90 | ) | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | ||||
Weighted average common shares outstanding, basic
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25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
Weighted average common shares outstanding, diluted
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27,326,442 | 12,253,599 | 24,491,477 | 11,492,475 |
RETROPHIN, INC. AND SUBSIDIARIES
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RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
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(Unaudited)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2014
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2013
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2014
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2013
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GAAP reported net income (loss)
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$ | 8,482,947 | $ | (5,048,513 | ) | $ | (62,142,779 | ) | $ | (9,791,435 | ) | |||||
Share-based compensation
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5,008,272 | 128,388 | 10,014,627 | 287,593 | ||||||||||||
Intangible asset amortization and depreciation
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392,985 | 53,139 | 520,171 | 105,307 | ||||||||||||
Change in fair value of derivative liabilities
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(32,978,586 | ) | (56,041 | ) | 20,635,216 | 2,395,618 | ||||||||||
Transaction and license fees
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1,068,356 | 125,000 | 1,977,996 | 225,000 | ||||||||||||
Legal settlements
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327,208 | 2,219,424 | 327,208 | 2,234,424 | ||||||||||||
Net interest expense and finance fees
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6,887,217 | - | 6,886,681 | 41,558 | ||||||||||||
Income tax adjustments
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(2,525,124 | ) | - | (2,459,748 | ) | - | ||||||||||
Non-GAAP adjusted net loss
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$ | (13,336,725 | ) | $ | (2,578,603 | ) | $ | (24,240,628 | ) | $ | (4,501,935 | ) | ||||
GAAP reported net income (loss) per common share, basic
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$ | 0.33 | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | |||||
GAAP reported net loss per common share, diluted
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$ | (0.90 | ) | $ | (0.41 | ) | $ | (2.54 | ) | $ | (0.85 | ) | ||||
Non-GAAP adjusted net loss per common share, basic and diluted
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$ | (0.52 | ) | $ | (0.21 | ) | $ | (0.99 | ) | $ | (0.39 | ) | ||||
GAAP Weighted average common shares outstanding, basic
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25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
GAAP Weighted average common shares outstanding, diluted
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27,326,442 | 12,253,599 | 24,491,477 | 11,492,475 | ||||||||||||
Non-GAAP Weighted average common shares outstanding, basic and diluted
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25,635,277 | 12,253,599 | 24,491,477 | 11,492,475 |
RETROPHIN, INC. AND SUBSIDIARIES
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RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
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CERTAIN LINE ITEMS AND OTHER INFORMATION
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(Unaudited)
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Three Months
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June 30, 2014
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June 30, 2013
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GAAP
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Non-GAAP
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GAAP
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Non-GAAP
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Reported
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Adjustments
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Adjusted*
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Reported
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Adjustments
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Adjusted*
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Net product sales
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$ | 5,741,734 | $ | - | $ | 5,741,734 | $ | - | $ | - | $ | - | ||||||||||||||
Cost of goods sold
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1,207,395 | - | 1,207,395 | - | - | - | ||||||||||||||||||||
Research and development
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13,697,991 | (1,115,330 | ) |
(a)
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12,582,661 | 605,203 | (36,683 | ) |
(a)
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568,520 | ||||||||||||||||
Selling, general and
administrative
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11,340,071 | (5,681,491 | ) |
(b)
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5,658,580 | 4,494,699 | (2,489,268 | ) |
(b)
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2,005,431 | ||||||||||||||||
Operating loss
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(20,503,723 | ) | 6,796,821 | (13,706,902 | ) | (5,099,902 | ) | 2,525,951 | (2,573,951 | ) | ||||||||||||||||
Interest income (expense), net
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(2,178,937 | ) | 2,178,937 | - | 5 | - | 5 | |||||||||||||||||||
Finance expense
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(4,708,280 | ) | 4,708,280 | - | - | - | - | |||||||||||||||||||
Realized gain on sale of
marketable securities, net
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370,177 | - | 370,177 | - | - | - | ||||||||||||||||||||
Change in fair value of derivative instruments
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32,978,586 | (32,978,586 | ) | - | 56,041 | (56,041 | ) | - | ||||||||||||||||||
Loss on transaction denominated in foreign currencies
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- | - | - | (4,657 | ) | - | (4,657 | ) | ||||||||||||||||||
Income (loss) before provision for income taxes
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5,957,823 | (19,294,548 | ) | (13,336,725 | ) | (5,048,513 | ) | 2,469,910 | (2,578,603 | ) | ||||||||||||||||
Income tax benefit
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$ | 2,525,124 | (2,525,124 | ) | - | $ | - | - | - | |||||||||||||||||
Net income (loss)
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$ | 8,482,947 | $ | (21,819,672 | ) | $ | (13,336,725 | ) | $ | (5,048,513 | ) | $ | 2,469,910 | $ | (2,578,603 | ) | ||||||||||
Net income (loss) per common share, basic
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$ | 0.33 | $ | (0.52 | ) | $ | (0.41 | ) | $ | (0.21 | ) | |||||||||||||||
Net loss per common share, diluted
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$ | (0.90 | ) | $ | (0.52 | ) | $ | (0.41 | ) | $ | (0.21 | ) | ||||||||||||||
Weighted average
common shares
outstanding, basic
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25,635,277 | 25,635,277 | 12,253,599 | 12,253,599 | ||||||||||||||||||||||
Weighted average common shares outstanding, diluted
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27,326,442 | 25,635,277 | 12,253,599 | 12,253,599 |
RETROPHIN, INC. AND SUBSIDIARIES
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RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
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CERTAIN LINE ITEMS AND OTHER INFORMATION
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(Unaudited)
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Six Months
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June 30, 2014
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June 30, 2013
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GAAP
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Non-GAAP
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GAAP
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Non-GAAP
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Reported
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Adjustments
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Adjusted*
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Reported
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Adjustments
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Adjusted*
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Net product sales
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$ | 5,769,634 | $ | - | $ | 5,769,634 | $ | - | $ | - | $ | - | ||||||||||||||
Cost of goods sold
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1,208,295 | - | 1,208,295 | - | - | - | ||||||||||||||||||||
Research and development
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20,584,717 | (1,561,978 | ) |
(a)
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19,022,739 | 713,937 | (36,683 | ) |
(a)
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677,254 | ||||||||||||||||
Selling, general and
administrative
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21,432,093 | (11,278,024 | ) |
(c)
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10,154,069 | 6,636,449 | (2,815,641 | ) |
(c)
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3,820,808 | ||||||||||||||||
Operating loss
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(37,455,471 | ) | 12,840,002 | (24,615,469 | ) | (7,350,386 | ) | 2,852,324 | (4,498,062 | ) | ||||||||||||||||
Interest income (expense), net
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(2,178,401 | ) | 2,178,401 | - | (41,558 | ) | 41,558 | - | ||||||||||||||||||
Finance expense
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(4,708,280 | ) | 4,708,280 | - | - | - | - | |||||||||||||||||||
Realized gain on sale of
marketable securities, net
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374,841 | - | 374,841 | - | - | - | ||||||||||||||||||||
Change in fair value of derivative instruments
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(20,635,216 | ) | 20,635,216 | - | (2,395,618 | ) | 2,395,618 | - | ||||||||||||||||||
Loss on transaction denominated in foreign currencies
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- | - | - | (3,873 | ) | - | (3,873 | ) | ||||||||||||||||||
Net loss before provision for income taxes
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(64,602,527 | ) | 40,361,899 | (24,240,628 | ) | (9,791,435 | ) | 5,289,500 | (4,501,935 | ) | ||||||||||||||||
Income tax benefit
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$ | 2,459,748 | (2,459,748 | ) | - | $ | - | - | - | |||||||||||||||||
Net loss
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$ | (62,142,779 | ) | $ | 37,902,151 | $ | (24,240,628 | ) | $ | (9,791,435 | ) | $ | 5,289,500 | $ | (4,501,935 | ) | ||||||||||
Net loss per common share, basic and diluted
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$ | (2.54 | ) | $ | (0.99 | ) | $ | (0.85 | ) | $ | (0.39 | ) | ||||||||||||||
Weighted average common
shares outstanding, basic and
diluted
|
$ | 24,491,477 | $ | 24,491,477 | $ | 11,492,475 | $ | 11,492,475 |
(a)
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Share-based compensation expense.
|
(b)
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Share-based compensation expense of $3,892,942 and $91,705, intangible amortization and depreciation expense of $392,985 and $53,139, transaction and license fees of $1,068,356 and $125,000 and legal settlements of $327,208 and $2,219,424.
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(c)
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Share-based compensation expense of $8,452,649 and $250,910, intangible amortization and depreciation expense of $520,171 and $105,307, transaction and license fees of $1,977,996 and $225,000 and legal settlements of $327,208 and $2,234,424.
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RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2015 FINANCIAL GUIDANCE
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(In thousands, except per share amounts)
|
||
(Unaudited)
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GAAP net loss
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$(15,000) - $(6,000)
|
Intangible asset amortization and depreciation
|
6,000 - 7,000
|
Stock-based compensation expense
|
15,000 - 18,000
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Transaction costs and license fees
|
4,500
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Interest expense
|
10,000 - 12,000
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Non-GAAP adjusted net income
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$20,500 - $35,500
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GAAP net loss per common share, basic and diluted
|
$(0.54) - $(0.21)
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Non-GAAP adjusted net income per common share, basic and diluted
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$0.75 - $1.25
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Weighted-average common shares used in per share computations
|
27,500 - 28,500
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