2017 Q4 Form 10-Q Financial Statement
#000143853317000034 Filed on November 07, 2017
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% |
Facts In Submission
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CommonStockSharesIssued
|
39280702 | shares |
CY2016Q4 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
37906669 | shares |
CY2017Q3 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
39280702 | shares |
CY2016Q4 | us-gaap |
Common Stock Value
CommonStockValue
|
4000 | USD |
CY2017Q3 | us-gaap |
Common Stock Value
CommonStockValue
|
4000 | USD |
CY2016Q3 | us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-36788000 | USD |
us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-39678000 | USD | |
CY2017Q3 | us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-17813000 | USD |
us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-42218000 | USD | |
CY2017Q3 | us-gaap |
Contractual Obligation
ContractualObligation
|
85457000 | USD |
CY2016Q4 | us-gaap |
Convertible Debt
ConvertibleDebt
|
44422000 | USD |
CY2017Q3 | us-gaap |
Convertible Debt
ConvertibleDebt
|
44911000 | USD |
CY2017Q3 | us-gaap |
Convertible Debt Fair Value Disclosures
ConvertibleDebtFairValueDisclosures
|
71700000 | USD |
CY2016Q3 | us-gaap |
Cost Of Goods Sold
CostOfGoodsSold
|
1573000 | USD |
us-gaap |
Cost Of Goods Sold
CostOfGoodsSold
|
3351000 | USD | |
CY2017Q3 | us-gaap |
Cost Of Goods Sold
CostOfGoodsSold
|
925000 | USD |
us-gaap |
Cost Of Goods Sold
CostOfGoodsSold
|
2431000 | USD | |
us-gaap |
Deferred Income Tax Expense Benefit
DeferredIncomeTaxExpenseBenefit
|
-10999000 | USD | |
us-gaap |
Deferred Income Tax Expense Benefit
DeferredIncomeTaxExpenseBenefit
|
-7811000 | USD | |
CY2016Q4 | us-gaap |
Deferred Tax Assets Liabilities Net
DeferredTaxAssetsLiabilitiesNet
|
0 | USD |
CY2017Q3 | us-gaap |
Deferred Tax Assets Liabilities Net
DeferredTaxAssetsLiabilitiesNet
|
4848000 | USD |
CY2016Q4 | us-gaap |
Deferred Tax Liabilities
DeferredTaxLiabilities
|
6425000 | USD |
CY2017Q3 | us-gaap |
Deferred Tax Liabilities
DeferredTaxLiabilities
|
0 | USD |
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
11953000 | USD | |
us-gaap |
Depreciation Depletion And Amortization
DepreciationDepletionAndAmortization
|
13336000 | USD | |
CY2016Q4 | us-gaap |
Derivative Liabilities Current
DerivativeLiabilitiesCurrent
|
22440000 | USD |
CY2017Q3 | us-gaap |
Derivative Liabilities Current
DerivativeLiabilitiesCurrent
|
20140000 | USD |
CY2016Q3 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-1.00 | |
CY2017Q3 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-0.46 | |
us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-1.10 | ||
CY2016Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-1.00 | |
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-1.07 | ||
CY2017Q3 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.46 | |
us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-1.10 | ||
CY2016Q3 | us-gaap |
Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
|
-0.211 | |
us-gaap |
Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
|
0.132 | ||
CY2017Q3 | us-gaap |
Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
|
0.064 | |
us-gaap |
Effective Income Tax Rate Continuing Operations
EffectiveIncomeTaxRateContinuingOperations
|
0.110 | ||
CY2017Q3 | us-gaap |
Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate
|
0.35 | |
us-gaap |
Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate
|
0.35 | ||
CY2016Q3 | us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
10126000 | USD |
us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
4849000 | USD | |
CY2017Q3 | us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
8901000 | USD |
us-gaap |
Fair Value Adjustment Of Warrants
FairValueAdjustmentOfWarrants
|
8921000 | USD | |
CY2016Q4 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
33497000 | USD |
CY2017Q3 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
46680000 | USD |
CY2016Q4 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
215540000 | USD |
CY2017Q3 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
226249000 | USD |
CY2016Q4 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
182043000 | USD |
CY2017Q3 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
179569000 | USD |
us-gaap |
Foreign Currency Transaction Gain Loss Before Tax
ForeignCurrencyTransactionGainLossBeforeTax
|
0 | USD | |
us-gaap |
Foreign Currency Transaction Gain Loss Before Tax
ForeignCurrencyTransactionGainLossBeforeTax
|
1074000 | USD | |
CY2016Q3 | us-gaap |
Foreign Currency Transaction Gain Loss Realized
ForeignCurrencyTransactionGainLossRealized
|
17000 | USD |
us-gaap |
Foreign Currency Transaction Gain Loss Realized
ForeignCurrencyTransactionGainLossRealized
|
19000 | USD | |
CY2017Q3 | us-gaap |
Foreign Currency Transaction Gain Loss Realized
ForeignCurrencyTransactionGainLossRealized
|
-102000 | USD |
us-gaap |
Foreign Currency Transaction Gain Loss Realized
ForeignCurrencyTransactionGainLossRealized
|
-361000 | USD | |
us-gaap |
Gain Loss Related To Litigation Settlement
GainLossRelatedToLitigationSettlement
|
-5212000 | USD | |
us-gaap |
Gain Loss Related To Litigation Settlement
GainLossRelatedToLitigationSettlement
|
0 | USD | |
CY2016Q4 | us-gaap |
Goodwill
Goodwill
|
936000 | USD |
CY2017Q3 | us-gaap |
Goodwill
Goodwill
|
936000 | USD |
CY2016Q3 | us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-30646000 | USD |
us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-45294000 | USD | |
CY2017Q3 | us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-19017000 | USD |
us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-47325000 | USD | |
CY2016Q3 | us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
6467000 | USD |
us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-5994000 | USD | |
CY2017Q3 | us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-1200000 | USD |
CY2017Q3 | us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-1223000 | USD |
us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-5212000 | USD | |
us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-5200000 | USD | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
3278000 | USD | |
us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
425000 | USD | |
us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
2544000 | USD | |
us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
-4064000 | USD | |
us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
712000 | USD | |
us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
319000 | USD | |
us-gaap |
Increase Decrease In Other Operating Assets
IncreaseDecreaseInOtherOperatingAssets
|
937000 | USD | |
us-gaap |
Increase Decrease In Other Operating Assets
IncreaseDecreaseInOtherOperatingAssets
|
3747000 | USD | |
us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
3879000 | USD | |
us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
2561000 | USD | |
CY2016Q3 | us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-299000 | USD |
us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-609000 | USD | |
CY2017Q3 | us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-65000 | USD |
us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-855000 | USD | |
CY2016Q4 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
1490000 | USD |
CY2017Q3 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
1552000 | USD |
CY2016Q4 | us-gaap |
Inventory Net
InventoryNet
|
2826000 | USD |
CY2017Q3 | us-gaap |
Inventory Net
InventoryNet
|
4318000 | USD |
CY2016Q4 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
1336000 | USD |
CY2017Q3 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
2766000 | USD |
CY2016Q4 | us-gaap |
Inventory Valuation Reserves
InventoryValuationReserves
|
600000 | USD |
CY2017Q3 | us-gaap |
Inventory Valuation Reserves
InventoryValuationReserves
|
500000 | USD |
CY2016Q4 | us-gaap |
Liabilities
Liabilities
|
217515000 | USD |
CY2017Q3 | us-gaap |
Liabilities
Liabilities
|
215990000 | USD |
CY2016Q4 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
525282000 | USD |
CY2017Q3 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
520510000 | USD |
CY2016Q4 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
83262000 | USD |
CY2017Q3 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
83904000 | USD |
CY2016Q3 | us-gaap |
Litigation Settlement Expense
LitigationSettlementExpense
|
5212000 | USD |
us-gaap |
Litigation Settlement Expense
LitigationSettlementExpense
|
5212000 | USD | |
CY2017Q3 | us-gaap |
Litigation Settlement Expense
LitigationSettlementExpense
|
0 | USD |
us-gaap |
Litigation Settlement Expense
LitigationSettlementExpense
|
2000000 | USD | |
CY2016Q4 | us-gaap |
Marketable Securities
MarketableSecurities
|
214871000 | USD |
CY2017Q3 | us-gaap |
Marketable Securities
MarketableSecurities
|
204882000 | USD |
us-gaap |
Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
|
1195000 | USD | |
us-gaap |
Net Cash Provided By Used In Financing Activities Continuing Operations
NetCashProvidedByUsedInFinancingActivitiesContinuingOperations
|
4084000 | USD | |
us-gaap |
Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
|
-20100000 | USD | |
us-gaap |
Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
|
45705000 | USD | |
us-gaap |
Net Cash Provided By Used In Operating Activities Continuing Operations
NetCashProvidedByUsedInOperatingActivitiesContinuingOperations
|
5052000 | USD | |
us-gaap |
Net Cash Provided By Used In Operating Activities Continuing Operations
NetCashProvidedByUsedInOperatingActivitiesContinuingOperations
|
8257000 | USD | |
CY2016Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-37113000 | USD |
us-gaap |
Net Income Loss
NetIncomeLoss
|
-39300000 | USD | |
CY2017Q3 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-17794000 | USD |
us-gaap |
Net Income Loss
NetIncomeLoss
|
-42113000 | USD | |
CY2016Q3 | us-gaap |
Net Income Loss Attributable To Parent Diluted
NetIncomeLossAttributableToParentDiluted
|
-37113000 | USD |
us-gaap |
Net Income Loss Attributable To Parent Diluted
NetIncomeLossAttributableToParentDiluted
|
-39300000 | USD | |
CY2017Q3 | us-gaap |
Net Income Loss Attributable To Parent Diluted
NetIncomeLossAttributableToParentDiluted
|
-17794000 | USD |
us-gaap |
Net Income Loss Attributable To Parent Diluted
NetIncomeLossAttributableToParentDiluted
|
-42113000 | USD | |
CY2016Q3 | us-gaap |
Nonoperating Income Expense
NonoperatingIncomeExpense
|
-10274000 | USD |
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
1437000 | USD | |
us-gaap |
Nonoperating Income Expense
NonoperatingIncomeExpense
|
-5302000 | USD | |
CY2017Q3 | us-gaap |
Nonoperating Income Expense
NonoperatingIncomeExpense
|
-8409000 | USD |
us-gaap |
Nonoperating Income Expense
NonoperatingIncomeExpense
|
-8711000 | USD | |
CY2016Q4 | us-gaap |
Notes And Loans Receivable Net Current
NotesAndLoansReceivableNetCurrent
|
46849000 | USD |
CY2017Q3 | us-gaap |
Notes And Loans Receivable Net Current
NotesAndLoansReceivableNetCurrent
|
0 | USD |
CY2017Q3 | us-gaap |
Notes And Loans Receivable Net Current
NotesAndLoansReceivableNetCurrent
|
0 | USD |
CY2016Q3 | us-gaap |
Operating Expenses
OperatingExpenses
|
54317000 | USD |
us-gaap |
Operating Expenses
OperatingExpenses
|
136257000 | USD | |
CY2017Q3 | us-gaap |
Operating Expenses
OperatingExpenses
|
50948000 | USD |
us-gaap |
Operating Expenses
OperatingExpenses
|
151374000 | USD | |
CY2016Q3 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-20372000 | USD |
us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-39992000 | USD | |
CY2017Q3 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-10608000 | USD |
us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-38614000 | USD | |
CY2017Q3 | us-gaap |
Operating Leases Future Minimum Payments Due
OperatingLeasesFutureMinimumPaymentsDue
|
17015000 | USD |
CY2017Q3 | us-gaap |
Operating Leases Future Minimum Payments Due In Rolling After Year Five
OperatingLeasesFutureMinimumPaymentsDueInRollingAfterYearFive
|
4862000 | USD |
CY2017Q3 | us-gaap |
Operating Leases Future Minimum Payments Due In Rolling Year Four And Five
OperatingLeasesFutureMinimumPaymentsDueInRollingYearFourAndFive
|
5010000 | USD |
CY2017Q3 | us-gaap |
Operating Leases Future Minimum Payments Due In Rolling Year Two And Three
OperatingLeasesFutureMinimumPaymentsDueInRollingYearTwoAndThree
|
4817000 | USD |
CY2017Q3 | us-gaap |
Operating Leases Future Minimum Payments Next Rolling Twelve Months
OperatingLeasesFutureMinimumPaymentsNextRollingTwelveMonths
|
2326000 | USD |
CY2016Q4 | us-gaap |
Other Assets Noncurrent
OtherAssetsNoncurrent
|
7364000 | USD |
CY2017Q3 | us-gaap |
Other Assets Noncurrent
OtherAssetsNoncurrent
|
7101000 | USD |
CY2016Q3 | us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
308000 | USD |
us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
-397000 | USD | |
CY2017Q3 | us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
83000 | USD |
us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
256000 | USD | |
CY2016Q4 | us-gaap |
Other Liabilities Current
OtherLiabilitiesCurrent
|
1842000 | USD |
CY2017Q3 | us-gaap |
Other Liabilities Current
OtherLiabilitiesCurrent
|
4048000 | USD |
CY2016Q4 | us-gaap |
Other Liabilities Noncurrent
OtherLiabilitiesNoncurrent
|
4010000 | USD |
CY2017Q3 | us-gaap |
Other Liabilities Noncurrent
OtherLiabilitiesNoncurrent
|
3808000 | USD |
us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
11000 | USD | |
us-gaap |
Other Noncash Income Expense
OtherNoncashIncomeExpense
|
-95000 | USD | |
CY2016Q3 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
151000 | USD |
us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
156000 | USD | |
CY2017Q3 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
557000 | USD |
us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
1065000 | USD | |
us-gaap |
Payment For Contingent Consideration Liability Financing Activities
PaymentForContingentConsiderationLiabilityFinancingActivities
|
4339000 | USD | |
us-gaap |
Payment For Contingent Consideration Liability Financing Activities
PaymentForContingentConsiderationLiabilityFinancingActivities
|
5006000 | USD | |
CY2017Q3 | us-gaap |
Payments For Restructuring
PaymentsForRestructuring
|
0 | USD |
us-gaap |
Payments For Restructuring
PaymentsForRestructuring
|
898000 | USD | |
us-gaap |
Payments To Acquire Available For Sale Securities
PaymentsToAcquireAvailableForSaleSecurities
|
152016000 | USD | |
us-gaap |
Payments To Acquire Available For Sale Securities
PaymentsToAcquireAvailableForSaleSecurities
|
67552000 | USD | |
us-gaap |
Payments To Acquire Businesses Net Of Cash Acquired
PaymentsToAcquireBusinessesNetOfCashAcquired
|
500000 | USD | |
us-gaap |
Payments To Acquire Businesses Net Of Cash Acquired
PaymentsToAcquireBusinessesNetOfCashAcquired
|
0 | USD | |
us-gaap |
Payments To Acquire Intangible Assets
PaymentsToAcquireIntangibleAssets
|
7632000 | USD | |
us-gaap |
Payments To Acquire Intangible Assets
PaymentsToAcquireIntangibleAssets
|
9632000 | USD | |
us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
61000 | USD | |
CY2016Q4 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
CY2017Q3 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.001 | |
CY2016Q4 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
20000000 | shares |
CY2017Q3 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
20000000 | shares |
CY2016Q4 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2017Q3 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2016Q4 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2017Q3 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2016Q4 | us-gaap |
Preferred Stock Value
PreferredStockValue
|
0 | USD |
CY2017Q3 | us-gaap |
Preferred Stock Value
PreferredStockValue
|
0 | USD |
CY2016Q4 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
4831000 | USD |
CY2017Q3 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
2605000 | USD |
CY2016Q4 | us-gaap |
Prepaid Taxes
PrepaidTaxes
|
3463000 | USD |
CY2017Q3 | us-gaap |
Prepaid Taxes
PrepaidTaxes
|
0 | USD |
us-gaap |
Proceeds From Issuance Of Warrants
ProceedsFromIssuanceOfWarrants
|
5998000 | USD | |
us-gaap |
Proceeds From Issuance Of Warrants
ProceedsFromIssuanceOfWarrants
|
3645000 | USD | |
us-gaap |
Proceeds From Payments For Other Financing Activities
ProceedsFromPaymentsForOtherFinancingActivities
|
-439000 | USD | |
us-gaap |
Proceeds From Payments For Other Financing Activities
ProceedsFromPaymentsForOtherFinancingActivities
|
0 | USD | |
us-gaap |
Proceeds From Sale Of Available For Sale Securities
ProceedsFromSaleOfAvailableForSaleSecurities
|
92609000 | USD | |
us-gaap |
Proceeds From Sale Of Available For Sale Securities
ProceedsFromSaleOfAvailableForSaleSecurities
|
76826000 | USD | |
us-gaap |
Proceeds From Sale Of Intangible Assets
ProceedsFromSaleOfIntangibleAssets
|
47500000 | USD | |
us-gaap |
Proceeds From Sale Of Intangible Assets
ProceedsFromSaleOfIntangibleAssets
|
47500000 | USD | |
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
2225000 | USD | |
us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
7695000 | USD | |
CY2017Q3 | us-gaap |
Proceeds From Warrant Exercises
ProceedsFromWarrantExercises
|
3600000 | USD |
us-gaap |
Proceeds From Warrant Exercises
ProceedsFromWarrantExercises
|
3600000 | USD | |
CY2016Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
2587000 | USD |
CY2017Q3 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
2717000 | USD |
us-gaap |
Provision For Doubtful Accounts
ProvisionForDoubtfulAccounts
|
58000 | USD | |
us-gaap |
Provision For Doubtful Accounts
ProvisionForDoubtfulAccounts
|
321000 | USD | |
CY2017Q3 | us-gaap |
Purchase Obligation
PurchaseObligation
|
387000 | USD |
us-gaap |
Repayments Of Other Debt
RepaymentsOfOtherDebt
|
750000 | USD | |
us-gaap |
Repayments Of Other Debt
RepaymentsOfOtherDebt
|
750000 | USD | |
CY2016Q3 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
18414000 | USD |
us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
50758000 | USD | |
CY2017Q3 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
19610000 | USD |
us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
58592000 | USD | |
CY2017Q3 | us-gaap |
Restructuring And Related Cost Expected Cost Remaining1
RestructuringAndRelatedCostExpectedCostRemaining1
|
1400000 | USD |
CY2016Q3 | us-gaap |
Restructuring Charges
RestructuringCharges
|
396000 | USD |
us-gaap |
Restructuring Charges
RestructuringCharges
|
481000 | USD | |
CY2017Q1 | us-gaap |
Restructuring Charges
RestructuringCharges
|
498000 | USD |
CY2017Q2 | us-gaap |
Restructuring Charges
RestructuringCharges
|
981000 | USD |
CY2017Q3 | us-gaap |
Restructuring Charges
RestructuringCharges
|
1132000 | USD |
us-gaap |
Restructuring Charges
RestructuringCharges
|
2611000 | USD | |
CY2017Q3 | us-gaap |
Restructuring Costs
RestructuringCosts
|
1131000 | USD |
us-gaap |
Restructuring Costs
RestructuringCosts
|
2611000 | USD | |
CY2016Q4 | us-gaap |
Restructuring Reserve
RestructuringReserve
|
893000 | USD |
CY2016Q3 | us-gaap |
Sales Revenue Goods Net
SalesRevenueGoodsNet
|
33945000 | USD |
CY2017Q2 | us-gaap |
Restructuring Reserve
RestructuringReserve
|
1420000 | USD |
CY2017Q3 | us-gaap |
Restructuring Reserve
RestructuringReserve
|
2551000 | USD |
CY2017Q3 | us-gaap |
Restructuring Reserve Accrual Adjustment1
RestructuringReserveAccrualAdjustment1
|
0 | USD |
us-gaap |
Restructuring Reserve Accrual Adjustment1
RestructuringReserveAccrualAdjustment1
|
-55000 | USD | |
CY2016Q4 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-113056000 | USD |
CY2017Q3 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-160037000 | USD |
us-gaap |
Sales Revenue Goods Net
SalesRevenueGoodsNet
|
96265000 | USD | |
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
36728911 | shares | |
CY2017Q3 | us-gaap |
Sales Revenue Goods Net
SalesRevenueGoodsNet
|
40340000 | USD |
us-gaap |
Sales Revenue Goods Net
SalesRevenueGoodsNet
|
112760000 | USD | |
CY2016Q3 | us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
|
23466000 | USD |
us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
|
65714000 | USD | |
CY2017Q3 | us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
|
24852000 | USD |
us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
|
74683000 | USD | |
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
22034000 | USD | |
us-gaap |
Share Based Compensation
ShareBasedCompensation
|
21292000 | USD | |
CY2017Q3 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
|
4300000 | shares |
CY2017Q3 | us-gaap |
Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
|
15.64 | |
CY2016Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
307767000 | USD |
CY2017Q3 | us-gaap |
Stockholders Equity
StockholdersEquity
|
304520000 | USD |
CY2016Q4 | us-gaap |
Taxes Payable Current
TaxesPayableCurrent
|
0 | USD |
CY2017Q3 | us-gaap |
Taxes Payable Current
TaxesPayableCurrent
|
1152000 | USD |
CY2016Q4 | us-gaap |
Unrecognized Tax Benefits
UnrecognizedTaxBenefits
|
1500000 | USD |
CY2017Q3 | us-gaap |
Unrecognized Tax Benefits
UnrecognizedTaxBenefits
|
1500000 | USD |
CY2017Q3 | us-gaap |
Unrecognized Tax Benefits Income Tax Penalties And Interest Expense
UnrecognizedTaxBenefitsIncomeTaxPenaltiesAndInterestExpense
|
0 | USD |
CY2016Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
36980356 | shares |
CY2017Q3 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
38654086 | shares |
us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
38301893 | shares | |
CY2016Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
36980356 | shares |
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
36728911 | shares | |
CY2017Q3 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
38654086 | shares |
us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
38301893 | shares | |
us-gaap |
Basis Of Accounting
BasisOfAccounting
|
<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 (“GAAP”) for interim financial information, the instructions for Form 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. The </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">December 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;"> </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 conform to the current period presentation.</font></div></div> | ||
us-gaap |
Nature Of Operations
NatureOfOperations
|
<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 “we”, “our”, “us”, “Retrophin” and the “Company” 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 (“PKAN”). 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 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;"> 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 (“ARB”), as well as a selective endothelin receptor antagonist (“ERA”), 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 (“NS”). 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.  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’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 Cooperative Research and Development Agreement ("CRADA") </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">with the National Institutes of Health’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;">•</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">®</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;">•</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">®</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;">•</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">®</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> |