2016 Q2 Form 10-Q Financial Statement

#000162828016018545 Filed on August 05, 2016

View on sec.gov

Income Statement

Concept 2016 Q2 2015 Q2
Revenue $33.31M $24.07M
YoY Change 38.4% 319.16%
Cost Of Revenue $1.021M $637.0K
YoY Change 60.28% 1492.5%
Gross Profit $32.29M $23.43M
YoY Change 37.81% 310.35%
Gross Profit Margin 96.93% 97.35%
Selling, General & Admin $23.21M $19.69M
YoY Change 17.84% 137.25%
% of Gross Profit 71.86% 84.04%
Research & Development $17.68M $10.56M
YoY Change 67.33% -19.12%
% of Gross Profit 54.74% 45.08%
Depreciation & Amortization $3.970M $3.760M
YoY Change 5.59% 141.03%
% of Gross Profit 12.29% 16.05%
Operating Expenses $44.69M $31.01M
YoY Change 44.11% 35.28%
Operating Profit -$11.38M -$6.944M
YoY Change 63.87% -59.59%
Interest Expense -$147.0K -$2.922M
YoY Change -94.97% -111.2%
% of Operating Profit
Other Income/Expense, Net $9.416M -$18.57M
YoY Change -150.71% -170.17%
Pretax Income -$20.80M -$25.51M
YoY Change -18.49% -374.91%
Income Tax -$7.392M $15.00K
% Of Pretax Income
Net Earnings -$13.40M -$25.53M
YoY Change -47.49% -316.24%
Net Earnings / Revenue -40.24% -106.06%
Basic Earnings Per Share -$0.37 -$0.73
Diluted Earnings Per Share -$0.37 -$0.73
COMMON SHARES
Basic Shares Outstanding 36.68M shares 34.96M shares
Diluted Shares Outstanding 36.68M shares 34.96M shares

Balance Sheet

Concept 2016 Q2 2015 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $221.5M $133.6M
YoY Change 65.8% 207.83%
Cash & Equivalents $21.16M $127.7M
Short-Term Investments $200.4M $5.900M
Other Short-Term Assets $11.90M $97.70M
YoY Change -87.82% 5042.11%
Inventory $2.713M $2.000M
Prepaid Expenses
Receivables $16.57M $11.50M
Other Receivables $47.50M $0.00
Total Short-Term Assets $300.2M $244.7M
YoY Change 22.66% 358.24%
LONG-TERM ASSETS
Property, Plant & Equipment $381.0K $500.0K
YoY Change -23.8% 0.0%
Goodwill $936.0K
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $1.859M $10.70M
YoY Change -82.63% 365.22%
Total Long-Term Assets $233.8M $180.4M
YoY Change 29.61% 76.69%
TOTAL ASSETS
Total Short-Term Assets $300.2M $244.7M
Total Long-Term Assets $233.8M $180.4M
Total Assets $534.0M $425.1M
YoY Change 25.61% 173.38%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $6.285M $4.800M
YoY Change 30.94% -54.72%
Accrued Expenses $23.16M $20.30M
YoY Change 14.08% 181.94%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $41.10M
YoY Change -100.0%
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $80.07M $172.4M
YoY Change -53.56% 259.17%
LONG-TERM LIABILITIES
Long-Term Debt $44.10M $43.60M
YoY Change 1.15% 1.4%
Other Long-Term Liabilities $2.548M $58.40M
YoY Change -95.64% -7.89%
Total Long-Term Liabilities $2.548M $102.0M
YoY Change -97.5% -4.14%
TOTAL LIABILITIES
Total Short-Term Liabilities $80.07M $172.4M
Total Long-Term Liabilities $2.548M $102.0M
Total Liabilities $219.6M $274.4M
YoY Change -19.97% 77.61%
SHAREHOLDERS EQUITY
Retained Earnings -$67.34M
YoY Change
Common Stock $381.7M
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $314.4M $150.8M
YoY Change
Total Liabilities & Shareholders Equity $534.0M $425.1M
YoY Change 25.61% 173.38%

Cashflow Statement

Concept 2016 Q2 2015 Q2
OPERATING ACTIVITIES
Net Income -$13.40M -$25.53M
YoY Change -47.49% -316.24%
Depreciation, Depletion And Amortization $3.970M $3.760M
YoY Change 5.59% 141.03%
Cash From Operating Activities $3.990M $7.900M
YoY Change -49.49% -169.0%
INVESTING ACTIVITIES
Capital Expenditures -$2.310M -$1.410M
YoY Change 63.83% -59.71%
Acquisitions
YoY Change
Other Investing Activities -$1.980M $0.00
YoY Change -100.0%
Cash From Investing Activities -$4.290M -$1.400M
YoY Change 206.43% -76.9%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -1.910M 1.070M
YoY Change -278.5% -98.01%
NET CHANGE
Cash From Operating Activities 3.990M 7.900M
Cash From Investing Activities -4.290M -1.400M
Cash From Financing Activities -1.910M 1.070M
Net Change In Cash -2.210M 7.570M
YoY Change -129.19% -79.08%
FREE CASH FLOW
Cash From Operating Activities $3.990M $7.900M
Capital Expenditures -$2.310M -$1.410M
Free Cash Flow $6.300M $9.310M
YoY Change -32.33% -217.11%

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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:#4c4c4c;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;text-align:justify;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 Company&#8217;s Annual Report on Form 10-K for the year ended </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">December&#160;31, 2015</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (the &#8220;2015 10-K&#8221;) filed with the Securities and Exchange Commission (the &#8220;SEC&#8221;) on February 26, 2016, and amended on March 2, 2016. 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, 2015</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:#4c4c4c;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:justify;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. We are a fully integrated biopharmaceutical company with approximately </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">130</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> employees headquartered in San Diego, California </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">dedicated to delivering life-changing therapies to people living with rare diseases who have few, if any, treatment options. Our approach centers on our pipeline, featuring clinical-stage assets and pre-clinical discovery programs targeting rare diseases with significant unmet medical needs. Our research and development efforts are supported by revenues from the Company's marketed products, 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;">, 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;">and 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;">. </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">In addition 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%;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;">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;"> (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 has also 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: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 cysteine (kidney) stone formation in patients with cystinuria.</font></div></td></tr></table><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;">Product Candidates:</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Sparsentan</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;font-style:italic;">,</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> 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;), </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">with in vitro selectivity toward endothelin receptor type A</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">. We have secured a license to sparsentan from Ligand Pharmaceuticals, Inc. and Bristol-Myers Squibb Company (who referred to it as DARA). We are developing sparsentan as a treatment for </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">focal segmental glomerulosclerosis ("FSGS")</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">, which is a leading cause of end-stage renal disease and Nephrotic Syndrome (&#8220;NS&#8221;). There are no U.S. Food and Drug Administration ("FDA") approved pharmacological treatments for FSGS and the off-label armamentarium is limited to ACE/ARBs, steroids, and immunosuppressant agents, which are effective in only a subset of patients. We estimate that there are at least </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">40,000</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> FSGS patients in the United States. We have completed enrollment for our DUET Phase 2 clinical study of sparsentan for the treatment of FSGS and we anticipate having a top line data read out in the third quarter of 2016. Depending 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. Sparsentan was granted orphan drug designation in the U.S. and EU in January and November 2015, respectively.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">We are developing RE-024, a novel small molecule, as a potential treatment for </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">pantothenate kinase-associated neurodegeneration ("</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">PKAN"). PKAN is a genetic neurodegenerative disorder that is typically diagnosed in the first decade of life. Consequences of PKAN include dystonia, dysarthria, rigidity, retinal degeneration, and severe digestive problems. PKAN is estimated to affect 1 to 3 persons per million. There are currently no viable treatment options for patients with PKAN. RE-024 is a phosphopantothenate prodrug therapy that aims to restore levels of this key substrate in PKAN patients. Certain international health regulators have approved the initiation of dosing RE-024 in PKAN patients under physician-initiated studies in accordance with local regulations in their respective countries. The Company filed a Investigational New Drug application ("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 was successfully completed during 2015. RE-024 was granted orphan drug designation by the FDA in May 2015 and was granted fast track designation by the FDA in June 2015. On February 24, 2016, we announced RE-024 was granted orphan drug designation from the European Commission. The Company continues discussions with the FDA and the European Medicines Agency ("EMA") regarding the initiation of a potential registration-enabling efficacy trial in PKAN patients.</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;">L-UDCA is a liquid formulation of ursodeoxycholic acid being developed for the treatment of a rare liver disease called primary biliary cholangitis (PBC). Retrophin expects to file a New Drug Application with the FDA in 2017 and, if approved, plans to make L-UDCA commercially available to the subset of PBC patients who have difficulty swallowing. There are no liquid formulations of ursodeoxycholic acid currently approved by the FDA.</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;">RE-034 is a synthetic hormone analog of the first 24 amino acids of the 39 amino acids contained in adrenocorticotropic hormone ("ACTH") incorporated into a novel formulation developed by the Company. RE-034 exhibits similar physiological actions as endogenous ACTH by binding to all five melanocortin receptors (pan-MCR), resulting in its anti-inflammatory and immunomodulatory effects. Retrophin has successfully manufactured RE-034 at proof-of-concept scale using a novel formulation process that allows modulation of the release of the active ingredient from the site of administration. The Company is exploring strategic options for development of RE-034, including the evaluation of external partnership and out-licensing opportunities.</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;">Preclinical:</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:8px;font-size:10pt;"><font style="font-family:Arial Narrow;font-size:10pt;color:#006ebf;font-style:normal;font-weight:bold;text-decoration:none;">NGLY1</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 Company entered into a research collaboration with the Grace Science Foundation and the Warren Family Research Center for Drug Discovery and Development at the University of Notre Dame for the development of a novel therapeutic for patients with NGLY1 deficiency, a rare genetic disorder. NGLY1 deficiency is believed to be caused by a deficiency in an enzyme called N-glycanase-1, which is encoded by the gene NGLY1. The condition is characterized by a variety of symptoms, including global developmental delay, movement disorder, seizures, and ocular abnormalities. Under this collaboration, the Grace Science Foundation will provide support and funding to Retrophin to enable discovery efforts that aim to validate and address a new molecular target that may be relevant to NGLY1 deficiency. The Warren Family Research Center for Drug Discovery and Development at the University of Notre Dame will provide funding and in-kind research support to help Retrophin advance this program.</font></div></div>

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