2017 Q4 Form 10-Q Financial Statement

#000143853317000034 Filed on November 07, 2017

View on sec.gov

Income Statement

Concept 2017 Q4 2017 Q3 2016 Q4
Revenue $42.00K $40.00K $37.33M
YoY Change -99.89% -99.88% 22.6%
Cost Of Revenue $1.170M $925.0K $1.200M
YoY Change -2.5% -41.2% 57.89%
Gross Profit $41.00M -$885.0K $36.12M
YoY Change 13.51% -102.73% 21.66%
Gross Profit Margin 97619.05% -2212.5% 96.77%
Selling, General & Admin $22.40M $24.85M $22.58M
YoY Change -0.8% 5.91% 19.16%
% of Gross Profit 54.63% 62.51%
Research & Development $19.49M $19.61M $20.00M
YoY Change -2.55% 6.5% 30.12%
% of Gross Profit 47.54% 55.37%
Depreciation & Amortization $4.460M $4.620M $4.190M
YoY Change 6.44% 12.96% 5.54%
% of Gross Profit 10.88% 11.6%
Operating Expenses $57.35M $50.95M $55.55M
YoY Change 3.25% -6.2% 21.68%
Operating Profit -$15.18M -$10.61M -$18.22M
YoY Change -16.71% -47.93% 19.85%
Interest Expense -$4.230M -$660.0K -$1.290M
YoY Change 227.91% 120.74% -69.36%
% of Operating Profit
Other Income/Expense, Net $4.139M -$8.409M -$5.935M
YoY Change -169.74% -181.85% -368.55%
Pretax Income -$11.04M -$19.02M -$12.29M
YoY Change -10.17% -37.95% -5.44%
Income Tax $6.580M -$1.223M -$3.684M
% Of Pretax Income
Net Earnings -$17.62M -$17.79M -$8.603M
YoY Change 104.79% -52.05% 248.44%
Net Earnings / Revenue -41947.62% -44485.0% -23.05%
Basic Earnings Per Share -$0.45 -$0.46 -$0.23
Diluted Earnings Per Share -$0.55 -$0.46 -$0.39
COMMON SHARES
Basic Shares Outstanding 39.31M shares 38.65M shares 37.73M shares
Diluted Shares Outstanding 38.65M shares

Balance Sheet

Concept 2017 Q4 2017 Q3 2016 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $222.7M $303.9M $255.9M
YoY Change -12.98% 10.78% 11.44%
Cash & Equivalents $99.39M $98.99M $41.00M
Short-Term Investments $123.3M $204.9M $214.9M
Other Short-Term Assets $6.000M $2.600M $8.300M
YoY Change -27.71% -27.78% -20.95%
Inventory $5.351M $4.318M $2.826M
Prepaid Expenses
Receivables $13.87M $14.54M $18.51M
Other Receivables $0.00 $0.00 $46.90M
Total Short-Term Assets $325.8M $325.3M $332.4M
YoY Change -1.97% -5.04% 10.08%
LONG-TERM ASSETS
Property, Plant & Equipment $3.230M $2.717M $2.587M
YoY Change 24.86% 611.26% 504.44%
Goodwill $936.0K $936.0K $936.0K
YoY Change 0.0% 0.0% 0.0%
Intangibles $184.8M $182.0M
YoY Change 1.52% 12.7%
Long-Term Investments $0.00
YoY Change
Other Assets $5.556M $7.101M $7.364M
YoY Change -24.55% 259.73% 296.13%
Total Long-Term Assets $194.5M $195.2M $192.9M
YoY Change 0.83% 2.81% -8.27%
TOTAL ASSETS
Total Short-Term Assets $325.8M $325.3M $332.4M
Total Long-Term Assets $194.5M $195.2M $192.9M
Total Assets $520.3M $520.5M $525.3M
YoY Change -0.94% -2.24% 2.54%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $18.94M $7.370M $7.522M
YoY Change 151.77% 140.38% -1.53%
Accrued Expenses $36.02M $32.25M $33.31M
YoY Change 8.14% -20.12% 39.83%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $85.67M $83.90M $83.26M
YoY Change 2.89% -2.43% -4.28%
LONG-TERM LIABILITIES
Long-Term Debt $45.10M $44.90M $44.40M
YoY Change 1.58% 1.35% 1.37%
Other Long-Term Liabilities $2.472M $3.808M $4.010M
YoY Change -38.35% 54.73% 30.79%
Total Long-Term Liabilities $2.472M $3.808M $4.010M
YoY Change -38.35% 54.73% 30.79%
TOTAL LIABILITIES
Total Short-Term Liabilities $85.67M $83.90M $83.26M
Total Long-Term Liabilities $2.472M $3.808M $4.010M
Total Liabilities $227.2M $216.0M $217.5M
YoY Change 4.46% -3.93% 2.46%
SHAREHOLDERS EQUITY
Retained Earnings -$177.7M -$160.0M -$113.1M
YoY Change 57.14% 53.21% 73.52%
Common Stock $471.8M $465.2M $421.3M
YoY Change 11.98% 12.8% 15.17%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $293.1M $304.5M $307.8M
YoY Change
Total Liabilities & Shareholders Equity $520.3M $520.5M $525.3M
YoY Change -0.94% -2.24% 2.54%

Cashflow Statement

Concept 2017 Q4 2017 Q3 2016 Q4
OPERATING ACTIVITIES
Net Income -$17.62M -$17.79M -$8.603M
YoY Change 104.79% -52.05% 248.44%
Depreciation, Depletion And Amortization $4.460M $4.620M $4.190M
YoY Change 6.44% 12.96% 5.54%
Cash From Operating Activities -$860.0K $6.200M -$8.490M
YoY Change -89.87% 33.91% 139.15%
INVESTING ACTIVITIES
Capital Expenditures -$2.940M -$3.740M -$4.230M
YoY Change -30.5% 34.53% 145.93%
Acquisitions
YoY Change
Other Investing Activities $2.840M $1.540M $34.70M
YoY Change -91.82% -147.09% -135.14%
Cash From Investing Activities -$110.0K -$2.180M $30.47M
YoY Change -100.36% -63.97% -130.33%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.370M 5.830M -5.050M
YoY Change -127.13% 44.31% -510.57%
NET CHANGE
Cash From Operating Activities -860.0K 6.200M -8.490M
Cash From Investing Activities -110.0K -2.180M 30.47M
Cash From Financing Activities 1.370M 5.830M -5.050M
Net Change In Cash 400.0K 9.850M 16.93M
YoY Change -97.64% 275.95% -116.47%
FREE CASH FLOW
Cash From Operating Activities -$860.0K $6.200M -$8.490M
Capital Expenditures -$2.940M -$3.740M -$4.230M
Free Cash Flow $2.080M $9.940M -$4.260M
YoY Change -148.83% 34.14% 132.79%

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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-bottom:13px;padding-top:12px;font-size:13pt;"><font style="font-family:Arial;font-size:13pt;color:#000000;font-style:normal;font-weight:bold;text-decoration:none;">BASIS OF PRESENTATION</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the 2016 10-K filed with the SEC on March 1, 2017. 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 for 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;The </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">December&#160;31, 2016</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> balance sheet information was derived from the audited financial statements as of that date.</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;font-style:italic;">&#160;</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Certain reclassifications have been made to the prior period consolidated financial statements to&#160;conform&#160;to&#160;the current period presentation.</font></div></div>
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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-bottom:13px;padding-top:12px;font-size:13pt;"><font style="font-family:Arial;font-size:13pt;color:#000000;font-style:normal;font-weight:bold;text-decoration:none;">DESCRIPTION OF BUSINESS</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:16px;font-size:12pt;"><font style="font-family:Arial;font-size:12pt;color:#006ebf;font-style:normal;font-weight:bold;text-decoration:none;">Organization and Description of Business</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">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. Retrophin is a fully integrated biopharmaceutical company headquartered in San Diego, California focused on the development, acquisition and commercialization of therapies for the treatment of serious 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 or rare diseases and that we believe offer attractive growth characteristics. </font></div><div style="line-height:120%;padding-bottom:8px;padding-top:12px;font-size:10.5pt;"><font style="font-family:Arial;font-size:10.5pt;color:#666666;font-style:italic;font-weight:bold;text-decoration:none;">Research and Development Programs:</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Fosmetpantotenate, also known as 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. Fosmetpantotenate (RE-024) is a phosphopantothenate replacement therapy that aims to restore levels of this key substrate in PKAN patients. Certain international health regulators have approved the initiation of dosing fosmetpantotenate (RE-024) in PKAN patients under physician-initiated studies in accordance with local regulations in their respective countries. The Company filed a U.S. Investigational New Drug ("IND") for fosmetpantotenate (RE-024) with the FDA in the first quarter of 2015 to support the commencement of a Company-sponsored Phase 1 study, which was successfully completed during 2015. The FDA granted fosmetpantotenate (RE-024) orphan drug designation in May 2015 and fast track designation in June 2015. In February 2016, the Company announced fosmetpantotenate (RE-024) was granted orphan drug designation by the European Commission. In November 2016, the Company announced that it had reached an agreement with the&#160;FDA under the Special Protocol Assessment (SPA) process for a Phase 3 clinical trial evaluating fosmetpantotenate (RE-024) for PKAN. The Company </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">has reviewed the study design with the </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> European Medicines Agency ("EMA") </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">and we expect it to support registration in Europe.</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> In July 2017, we</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">&#160;announced that the first patient had been dosed in the FORT (FOsmetpantotenate Replacement Therapy) Study.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Sparsentan, 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. The Company has secured a license to sparsentan from Ligand Pharmaceuticals, Inc. and Bristol-Myers Squibb Company (who referred to it as DARA). The Company is developing sparsentan as a treatment for focal segmental glomerulosclerosis ("FSGS"), which is a leading cause of end-stage renal disease and nephrotic syndrome (&#8220;NS&#8221;). Sparsentan was granted orphan drug designation in the United States and the European Union in January 2015 and November 2015, respectively. In the third quarter of 2016, the Company announced positive top-line data from the Phase 2 DUET study of sparsentan for the treatment of FSGS. In early 2017, we had</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;font-weight:bold;"> </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">an End of Phase 2 meeting with the U.S. Food and Drug Administration (the "FDA") regarding the regulatory pathway for sparsentan as a treatment for FSGS.&#160; Following the meeting and our receipt of confirmatory meeting minutes, we announced our plans to initiate a single Phase 3 clinical trial to serve as the basis of a New Drug Application ("NDA") filing for sparsentan for the treatment of FSGS. During the third quarter of 2017, we </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">submitted the Phase 3 protocol for review to the FDA, and on November 6, 2017, we received feedback from the FDA requesting additional quantitative analyses to support the trial design&#8217;s eligibility for the Subpart H accelerated approval pathway. Study start-up activities continue and we anticipate initiating the pivotal trial in 2018.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">N-glycanase deficiency, or NGLY1 deficiency, is an extremely rare genetic disorder believed to be caused by a deficiency in an enzyme called N-glycanase-1, which is encoded by the gene NGLY1. The condition has been characterized by symptoms such as developmental delays, seizures, complex hyperkinetic movement disorders, diminished reflexes and an inability to produce tears. There are no approved therapeutic options for NGLY1 deficiency, and current therapeutic strategies are limited to symptom management.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">In September 2017, we announced that we entered a three-way&#160;Cooperative Research&#160;and Development Agreement ("CRADA") </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">with the National Institutes of Health&#8217;s National Center for Advancing Translational Sciences (NCATS) and patient advocacy foundation NGLY1.org</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> to collaborate on research efforts aimed at the identification of potential small molecule therapeutics for NGLY1 deficiency.</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> </font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Liquid ursodeoxycholic acid ("L-UDCA") is a liquid formulation of ursodeoxycholic acid being developed for the treatment of a rare liver disease called primary biliary cholangitis ("PBC"). We obtained rights to L-UDCA during 2016 with the intention of making L-UDCA commercially available to the subset of PBC patients who have difficulty swallowing. </font></div><div style="line-height:120%;padding-bottom:8px;padding-top:12px;text-align:justify;font-size:10.5pt;"><font style="font-family:Arial;font-size:10.5pt;color:#666666;font-style:italic;font-weight:bold;text-decoration:none;">Products on the Market:</font></div><table cellpadding="0" cellspacing="0" style="padding-top:4px;padding-bottom:8px;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:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Chenodal</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">&#174;</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (chenodiol) 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 has been the standard of care for cerebrotendinous xanthomatosis ("CTX") 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:4px;padding-bottom:8px;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:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Cholbam</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">&#174;</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (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><table cellpadding="0" cellspacing="0" style="padding-top:4px;padding-bottom:8px;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:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Thiola</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">&#174;</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (tiopronin) is approved in the United States for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria.</font></div></td></tr></table></div>

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