2015 Q4 Form 10-Q Financial Statement

#000162828015008436 Filed on November 06, 2015

View on sec.gov

Income Statement

Concept 2015 Q4 2015 Q3 2014 Q4
Revenue $30.45M $28.01M $14.09M
YoY Change 116.17% 235.47%
Cost Of Revenue $760.0K $513.0K $340.0K
YoY Change 123.53% 159.09%
Gross Profit $29.69M $27.49M $13.75M
YoY Change 115.93% 237.33%
Gross Profit Margin 97.51% 98.17% 97.62%
Selling, General & Admin $18.95M $22.31M $18.46M
YoY Change 2.65% 28.41% 152.88%
% of Gross Profit 63.83% 81.14% 134.25%
Research & Development $15.37M $14.06M $14.19M
YoY Change 8.32% 11.21% 185.51%
% of Gross Profit 51.77% 51.16% 103.2%
Depreciation & Amortization $3.970M $3.880M $1.860M
YoY Change 113.44% 109.73% 3000.0%
% of Gross Profit 13.37% 14.11% 13.53%
Operating Expenses $45.65M $48.50M $32.78M
YoY Change 39.26% 60.52% 176.12%
Operating Profit -$15.20M -$20.50M -$18.70M
YoY Change -18.68% -6.27% 57.49%
Interest Expense -$4.210M -$695.0K -$10.33M
YoY Change -59.24% -73.56% 549.69%
% of Operating Profit
Other Income/Expense, Net $2.210M $164.8M -$10.33M
YoY Change -121.39% 4140.67% 1081.52%
Pretax Income -$12.99M $144.3M -$29.03M
YoY Change -55.23% -902.78% 127.73%
Income Tax -$10.53M $38.76M $0.00
% Of Pretax Income 26.85%
Net Earnings -$2.469M $105.6M -$29.03M
YoY Change -91.49% -687.2% 126.38%
Net Earnings / Revenue -8.11% 377.0% -206.08%
Basic Earnings Per Share -$0.07 $2.95 -$1.10
Diluted Earnings Per Share -$0.14 $1.78 -$1.10
COMMON SHARES
Basic Shares Outstanding 36.15M shares 35.74M shares
Diluted Shares Outstanding 42.75M shares

Balance Sheet

Concept 2015 Q4 2015 Q3 2014 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $229.6M $235.3M $27.76M
YoY Change 727.1% 522.43% 355.08%
Cash & Equivalents $37.81M $140.6M $18.20M
Short-Term Investments $191.8M $94.68M $9.556M
Other Short-Term Assets $10.50M $2.000M $800.0K
YoY Change 1212.5% -13.04% -42.86%
Inventory $2.536M $2.650M $801.0K
Prepaid Expenses
Receivables $12.46M $13.50M $7.960M
Other Receivables $46.80M $46.50M $0.00
Total Short-Term Assets $301.9M $300.0M $37.33M
YoY Change 708.73% 560.69% 397.7%
LONG-TERM ASSETS
Property, Plant & Equipment $428.0K $478.0K $671.0K
YoY Change -36.21% -20.33% 426.58%
Goodwill $936.0K $936.0K $936.0K
YoY Change 0.0%
Intangibles $161.5M
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.859M $2.006M $2.265M
YoY Change -17.92% -12.78% 655.0%
Total Long-Term Assets $210.3M $211.7M $98.14M
YoY Change 114.32% 110.62% 655.04%
TOTAL ASSETS
Total Short-Term Assets $301.9M $300.0M $37.33M
Total Long-Term Assets $210.3M $211.7M $98.14M
Total Assets $512.3M $511.6M $135.5M
YoY Change 278.14% 250.67% 560.87%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.639M $4.893M $7.124M
YoY Change 7.23% -56.7% 100.47%
Accrued Expenses $23.82M $22.32M $27.88M
YoY Change -14.57% 90.75% 471.21%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $40.50M
YoY Change -100.0%
Long-Term Debt Due $1.000M $1.000M
YoY Change -33.33% -37.5%
Total Short-Term Liabilities $86.98M $101.9M $107.5M
YoY Change -19.12% 107.63% 194.1%
LONG-TERM LIABILITIES
Long-Term Debt $43.80M $43.70M $43.30M
YoY Change 1.15% 1.39%
Other Long-Term Liabilities $3.066M $13.92M $1.617M
YoY Change 89.61% -78.16% 61.7%
Total Long-Term Liabilities $3.066M $13.92M $1.617M
YoY Change 89.61% -86.97% 61.7%
TOTAL LIABILITIES
Total Short-Term Liabilities $86.98M $101.9M $107.5M
Total Long-Term Liabilities $3.066M $13.92M $1.617M
Total Liabilities $212.3M $220.6M $172.7M
YoY Change 22.91% 41.33% 330.02%
SHAREHOLDERS EQUITY
Retained Earnings -$65.15M -$62.68M -$179.2M
YoY Change -63.64% 162.58%
Common Stock $365.8M $353.8M $140.9M
YoY Change 159.71% 7593107.55%
Preferred Stock
YoY Change
Treasury Stock (at cost) $0.00 $0.00 $3.215M
YoY Change -100.0% 235.85%
Treasury Stock Shares 0.000 shares 0.000 shares 379.6K shares
Shareholders Equity $300.0M $291.0M -$37.25M
YoY Change
Total Liabilities & Shareholders Equity $512.3M $511.6M $135.5M
YoY Change 278.14% 250.67% 560.87%

Cashflow Statement

Concept 2015 Q4 2015 Q3 2014 Q4
OPERATING ACTIVITIES
Net Income -$2.469M $105.6M -$29.03M
YoY Change -91.49% -687.2% 126.38%
Depreciation, Depletion And Amortization $3.970M $3.880M $1.860M
YoY Change 113.44% 109.73% 3000.0%
Cash From Operating Activities -$3.550M $1.590M -$9.090M
YoY Change -60.95% -110.26% 11.53%
INVESTING ACTIVITIES
Capital Expenditures -$1.720M -$3.880M -$80.00K
YoY Change 2050.0% 2486.67% -33.33%
Acquisitions
YoY Change
Other Investing Activities -$98.74M $55.01M $2.050M
YoY Change -4916.59% -2995.26% 48.55%
Cash From Investing Activities -$100.5M $51.12M $1.970M
YoY Change -5199.49% -2581.55% 56.35%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.230M -39.87M -530.0K
YoY Change -332.08% -1226.27% 0.0%
NET CHANGE
Cash From Operating Activities -3.550M 1.590M -9.090M
Cash From Investing Activities -100.5M 51.12M 1.970M
Cash From Financing Activities 1.230M -39.87M -530.0K
Net Change In Cash -102.8M 12.84M -7.650M
YoY Change 1243.53% -191.58% 3.1%
FREE CASH FLOW
Cash From Operating Activities -$3.550M $1.590M -$9.090M
Capital Expenditures -$1.720M -$3.880M -$80.00K
Free Cash Flow -$1.830M $5.470M -$9.010M
YoY Change -79.69% -135.64% 12.2%

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513000 USD
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us-gaap Dilutive Securities Effect On Basic Earnings Per Share Other
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518000 USD
us-gaap Dilutive Securities Effect On Basic Earnings Per Share Other
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us-gaap Fair Value Adjustment Of Warrants
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us-gaap Foreign Currency Transaction Gain Loss Realized
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us-gaap Foreign Currency Transaction Gain Loss Realized
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us-gaap Gain Loss On Disposition Of Assets1
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us-gaap Increase Decrease In Accrued Income Taxes Payable
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us-gaap Gain Loss On Disposition Of Assets1
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140004000 USD
us-gaap Gain Loss On Sale Of Property Plant Equipment
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us-gaap Gain Loss On Sale Of Property Plant Equipment
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us-gaap Gain Loss Related To Litigation Settlement
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0 USD
CY2015Q3 us-gaap Gain Loss Related To Litigation Settlement
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us-gaap Gain Loss Related To Litigation Settlement
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us-gaap Gains Losses On Extinguishment Of Debt
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us-gaap Gains Losses On Extinguishment Of Debt
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us-gaap Impairment Of Intangible Assets Finitelived
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4710000 USD
us-gaap Impairment Of Intangible Assets Finitelived
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4710000 USD
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us-gaap Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
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144339000 USD
us-gaap Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
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us-gaap Income Tax Expense Benefit
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200000 USD
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us-gaap Increase Decrease In Prepaid Deferred Expense And Other Assets
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us-gaap Incremental Common Shares Attributable To Conversion Of Debt Securities
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us-gaap Incremental Common Shares Attributable To Conversion Of Debt Securities
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us-gaap Net Income Loss Attributable To Parent Diluted
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us-gaap Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
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4372000 USD
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2252000 USD
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4977000 USD
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0 USD
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us-gaap Proceeds From Stock Options Exercised
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478000 USD
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45000000 USD
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us-gaap Repayments Of Notes Payable
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us-gaap Research And Development Expense
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32899000 USD
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69444000 USD
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us-gaap Selling General And Administrative Expense
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22308000 USD
us-gaap Selling General And Administrative Expense
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us-gaap Share Based Compensation
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us-gaap Share Based Compensation
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CY2015Q1 us-gaap Stock Issued During Period Shares New Issues
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us-gaap Basis Of Accounting
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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"></font><font style="font-family:inherit;font-size:10pt;font-weight:bold;text-decoration:underline;">BASIS OF PRESENTATION</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company&#8217;s Annual Report on Form 10-K for the year ended </font><font style="font-family:inherit;font-size:10pt;">December&#160;31, 2014</font><font style="font-family:inherit;font-size:10pt;"> (the &#8220;2014 10-K&#8221;) filed with the Securities and Exchange Commission (the &#8220;SEC&#8221;) on March 11, 2015, and amended on March 13, 2015. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (&#8220;GAAP&#8221;) for interim financial information, the instructions to Form&#160;10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for annual financial statements, but reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of the results that may be expected for any future periods.&#160;&#160;The </font><font style="font-family:inherit;font-size:10pt;">December&#160;31, 2014</font><font style="font-family:inherit;font-size:10pt;"> balance sheet information was derived from the audited financial statements as of that date.</font></div></div>
us-gaap Nature Of Operations
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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"></font><font style="font-family:inherit;font-size:10pt;font-weight:bold;text-decoration:underline;">DESCRIPTION OF BUSINESS</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br clear="none"/></font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Organization and Description of Business</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">In this Quarterly Report on Form 10-Q, unless the context requires otherwise, the terms &#8220;we&#8221;, &#8220;our&#8221;, &#8220;us&#8221;, &#8220;Retrophin&#8221; and the &#8220;Company&#8221; refer to Retrophin, Inc., a Delaware corporation, as well as our direct and indirect subsidiaries. We are a fully integrated biopharmaceutical company with approximately </font><font style="font-family:inherit;font-size:10pt;">126</font><font style="font-family:inherit;font-size:10pt;"> employees headquartered in San Diego, California focused on the development, acquisition and commercialization of therapies for the treatment of serious, catastrophic or rare diseases. We regularly evaluate and, where appropriate, act on opportunities to expand our product pipeline through licenses and acquisitions of products in areas that will serve patients with serious, catastrophic or rare diseases and that we believe offer attractive growth characteristics.</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">We currently sell the following three products:</font></div><table cellpadding="0" cellspacing="0" style="padding-top:12px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:24px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Chenodal</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> (chenodeoxycholic acid) is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. Chenodal</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> has been the standard of care for cerebrotendinous xanthomatosis (&#8220;CTX&#8221;) patients for more than three decades and the Company is currently pursuing adding this indication to the label.</font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-top:12px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:24px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Thiola</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> (tiopronin) is approved in the United States for the prevention of cysteine (kidney) stone formation in patients with cystinuria.</font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-top:12px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:24px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Cholbam</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> (cholic acid) is approved in the United States for the treatment of bile acid synthesis disorders due to single enzyme defects and is further indicated for adjunctive treatment of patients with peroxisomal disorders.</font></div></td></tr></table><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br clear="none"/></font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Sparsentan</font><font style="font-family:inherit;font-size:10pt;font-style:italic;">,</font><font style="font-family:inherit;font-size:10pt;"> also known as RE-021, is an investigational therapeutic agent which acts as both a potent angiotensin receptor blocker (&#8220;ARB&#8221;), as well as a selective endothelin receptor antagonist (&#8220;ERA&#8221;), with in vitro selectivity toward endothelin receptor type A. We are developing sparsentan as a treatment for focal segmental glomerulosclerosis (&#8220;FSGS&#8221;), which is a leading cause of end-stage renal disease. We are currently enrolling patients for the DUET Phase 2 clinical study of sparsentan for the treatment of FSGS. Based on the robustness of the data obtained in the DUET study, we may be able to support an application for accelerated approval for sparsentan on the basis of proteinuria as a surrogate endpoint. In the first quarter of 2015, sparsentan received orphan drug designation from the U.S. Food and Drug Administration (&#8220;FDA&#8221;).</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">RE-024, a novel small molecule, is being developed as a potential treatment for pantothenate kinase-associated neurodegeneration (&#8220;PKAN&#8221;). PKAN is a genetic neurodegenerative disorder that is typically diagnosed in the first decade of life. Consequences of PKAN include parkinsonism, dystonia, and other severe systemic manifestations. There are currently no viable treatment options for patients with PKAN.&#160; RE-024 is a phosphopantothenate prodrug therapy that aims to restore levels of this key substrate in PKAN patients.&#160; Certain ex-US health regulators have approved the initiation of dosing RE-024 in PKAN under physician-initiated studies in accordance with local regulations in their respective countries.&#160;&#160; The Company filed a U.S. IND for RE-024 with the FDA in the first quarter of 2015 to support the commencement of a Company-sponsored Phase 1 study, which initiated in April 2015. RE-024 was granted orphan drug designation from the FDA on May 5, 2015 and was granted fast track designation on June 4, 2015.</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">RE-034 is a synthetic hormone analog of the first 24 amino acids of the 39 amino acids contained in adrenocorticotropic hormone (&#8220;ACTH&#8221;) incorporated into a novel formulation developed by the Company. &#160;RE-034 exhibits similar physiological actions as endogenous ACTH by binding to melanocortin receptors, resulting in its anti-inflammatory and immunomodulatory effects. The Company has successfully manufactured RE-034 at proof-of-concept scale using a novel formulation that allows modulation of the release of the active ingredient from the site of administration. &#160;The Company intends to continue preclinical development of RE-034 to enable multiple strategic options.</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;">Voucher Sale</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The FDA granted Asklepion Pharmaceuticals, LLC (&#8220;Asklepion&#8221;) a Rare Pediatric Disease Priority Review Voucher ("Pediatric PRV"), awarded to encourage development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. A Pediatric PRV is transferable and provides the bearer with FDA priority review classification for a new drug application. The Pediatric PRV was transferred to Retrophin under the terms of the asset purchase agreement between the Company and Asklepion dated January 12, 2015 pursuant to which the Company acquired Cholbam</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;">.</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On July&#160;2, 2015, the Company sold and transferred the Pediatric PRV to Sanofi.&#160; Pursuant to the Company&#8217;s agreement with Sanofi, the Company will receive </font><font style="font-family:inherit;font-size:10pt;">$245 million</font><font style="font-family:inherit;font-size:10pt;">; </font><font style="font-family:inherit;font-size:10pt;">$150.0 million</font><font style="font-family:inherit;font-size:10pt;"> was received upon closing, and </font><font style="font-family:inherit;font-size:10pt;">$47.5 million</font><font style="font-family:inherit;font-size:10pt;"> is due on each of the first and second anniversaries of the closing. The asset value of the Pediatric PRV recorded in the financial statements as of June 30, 2015 was </font><font style="font-family:inherit;font-size:10pt;">$96.3 million</font><font style="font-family:inherit;font-size:10pt;">. In accordance with accounting principles generally accepted in the United States ("GAAP"), the Company recorded the future short term and long term payments at their present value of </font><font style="font-family:inherit;font-size:10pt;">$46.2 million</font><font style="font-family:inherit;font-size:10pt;"> and </font><font style="font-family:inherit;font-size:10pt;">$44.9 million</font><font style="font-family:inherit;font-size:10pt;">, respectively, at the date of the sale. The incremental gain from the sale of the asset was approximately </font><font style="font-family:inherit;font-size:10pt;">$140.0 million</font><font style="font-family:inherit;font-size:10pt;"> during the three months ended September 30, 2015, net of </font><font style="font-family:inherit;font-size:10pt;">$4.9 million</font><font style="font-family:inherit;font-size:10pt;"> in fees contractually due as part of the Cholbam</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> acquisition.</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On June 11, 2015, the General Court of the European Union annulled the marketing authorization (&#8220;MA&#8221;) for Kolbam (bottled and branded name of Cholbam</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">&#174;</sup></font><font style="font-family:inherit;font-size:10pt;"> in Europe) in recognition of the orphan market exclusivity afforded to Orphacol. This was the result of a lawsuit brought by a competitor product against the awarding of the MA for Kolbam by the EU Commission, citing similarities in the efficacy statements in a section of the labelling, and the competitor claimed circumvention of market exclusivity attached to Orphacol. The competitor product received its MA and orphan designation before Kolbam&#8217;s MA, which purportedly entitled it to 10 years of market exclusivity. The EU Court ruled in favor of the competitor, and Kolbam&#8217;s MA was withdrawn. The withdrawal of the MA was solely based on market exclusivity, and not for safety or efficacy reasons. At the time of the EU Court&#8217;s ruling, the product was launched in one EU country, France.</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Kolbam is currently available in Europe only through nationally approved Named Patient Programs.</font></div><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">&#160;</font></div><div style="line-height:120%;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On September 24, 2015, the European Committee for Medical Products for Human Use adopted an opinion recommending the Company be granted a MA for Kolbam. We anticipate a ruling from the EU Commission on the issuance of a new MA with revised labeling by the end of the year</font></div></div>

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