2019 Q2 Form 10-Q Financial Statement
#000107008119000028 Filed on May 02, 2019
Income Statement
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| Revenue | $85.52M | $53.58M | $56.06M |
| YoY Change | 24.41% | -4.42% | 111.18% |
| Cost Of Revenue | $3.211M | $2.376M | $3.045M |
| YoY Change | 24.84% | -21.97% | 7707.69% |
| Gross Profit | $82.31M | $51.21M | $53.02M |
| YoY Change | 24.39% | -3.41% | 100.0% |
| Gross Profit Margin | 96.25% | 95.57% | 94.57% |
| Selling, General & Admin | $49.22M | $40.54M | $32.97M |
| YoY Change | 46.71% | 22.98% | 29.29% |
| % of Gross Profit | 59.79% | 79.18% | 62.19% |
| Research & Development | $59.98M | $52.57M | $31.36M |
| YoY Change | 83.95% | 67.61% | 14.62% |
| % of Gross Profit | 72.87% | 102.65% | 59.16% |
| Depreciation & Amortization | $7.700M | $7.059M | $6.022M |
| YoY Change | 23.79% | 17.22% | 883.99% |
| % of Gross Profit | 9.35% | 13.79% | 11.36% |
| Operating Expenses | $124.3M | $122.7M | $72.81M |
| YoY Change | 67.23% | 68.56% | 37.62% |
| Operating Profit | -$38.76M | -$69.14M | -$16.74M |
| YoY Change | 595.34% | 312.95% | -36.47% |
| Interest Expense | -$2.074M | -$2.288M | -$3.303M |
| YoY Change | -28.09% | -30.73% | 48.85% |
| % of Operating Profit | |||
| Other Income/Expense, Net | -$183.0K | -$109.0K | $1.004M |
| YoY Change | -72.81% | -110.86% | -415.72% |
| Pretax Income | -$41.02M | -$71.54M | -$19.04M |
| YoY Change | 349.18% | 275.68% | -34.09% |
| Income Tax | $774.0K | $576.0K | $221.0K |
| % Of Pretax Income | |||
| Net Earnings | -$41.79M | -$72.11M | -$19.26M |
| YoY Change | 338.96% | 274.36% | -33.71% |
| Net Earnings / Revenue | -48.86% | -134.58% | -34.36% |
| Basic Earnings Per Share | |||
| Diluted Earnings Per Share | -$747.8K | -$1.290M | -$463.9K |
| COMMON SHARES | |||
| Basic Shares Outstanding | 58.43M shares | 58.40M shares | 41.80M shares |
| Diluted Shares Outstanding |
Balance Sheet
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| SHORT-TERM ASSETS | |||
| Cash & Short-Term Investments | $363.5M | $407.2M | $178.3M |
| YoY Change | 22.76% | 128.38% | -11.99% |
| Cash & Equivalents | $136.1M | $201.1M | $97.68M |
| Short-Term Investments | $227.4M | $206.0M | $80.60M |
| Other Short-Term Assets | $17.40M | $9.300M | $5.800M |
| YoY Change | 176.19% | 60.34% | 26.09% |
| Inventory | $16.90M | $16.22M | $12.36M |
| Prepaid Expenses | |||
| Receivables | $77.10M | $46.40M | $45.60M |
| Other Receivables | $0.00 | $0.00 | $0.00 |
| Total Short-Term Assets | $475.0M | $479.1M | $242.0M |
| YoY Change | 26.44% | 97.97% | 0.53% |
| LONG-TERM ASSETS | |||
| Property, Plant & Equipment | $15.39M | $14.54M | $8.302M |
| YoY Change | 87.31% | 75.14% | 17.61% |
| Goodwill | $82.30M | $82.34M | |
| YoY Change | |||
| Intangibles | $702.7M | $695.0M | $127.6M |
| YoY Change | 456.44% | 444.79% | |
| Long-Term Investments | |||
| YoY Change | |||
| Other Assets | $5.800M | $2.300M | $1.500M |
| YoY Change | 262.5% | 53.33% | 66.67% |
| Total Long-Term Assets | $816.6M | $804.8M | $137.4M |
| YoY Change | 499.89% | 485.69% | 1635.48% |
| TOTAL ASSETS | |||
| Total Short-Term Assets | $475.0M | $479.1M | $242.0M |
| Total Long-Term Assets | $816.6M | $804.8M | $137.4M |
| Total Assets | $1.292B | $1.284B | $379.4M |
| YoY Change | 152.37% | 238.4% | 52.59% |
| SHORT-TERM LIABILITIES | |||
| YoY Change | |||
| Accounts Payable | $10.22M | $9.786M | $3.104M |
| YoY Change | 134.17% | 215.27% | -13.27% |
| Accrued Expenses | $35.70M | $24.00M | $9.200M |
| YoY Change | 174.62% | 160.87% | 21.05% |
| Deferred Revenue | $8.005M | $5.497M | |
| YoY Change | |||
| Short-Term Debt | $0.00 | $0.00 | $0.00 |
| YoY Change | |||
| Long-Term Debt Due | $20.00M | $16.67M | |
| YoY Change | 1100.48% | ||
| Total Short-Term Liabilities | $174.0M | $143.0M | $72.72M |
| YoY Change | 101.17% | 96.72% | 60.1% |
| LONG-TERM LIABILITIES | |||
| Long-Term Debt | $135.7M | $138.5M | $146.9M |
| YoY Change | -7.83% | -5.73% | 47.03% |
| Other Long-Term Liabilities | $8.416M | $8.770M | $209.0K |
| YoY Change | 5400.65% | 4096.17% | -32.8% |
| Total Long-Term Liabilities | $144.1M | $147.2M | $147.1M |
| YoY Change | -2.21% | 0.1% | 46.78% |
| TOTAL LIABILITIES | |||
| Total Short-Term Liabilities | $174.0M | $143.0M | $72.72M |
| Total Long-Term Liabilities | $144.1M | $147.2M | $147.1M |
| Total Liabilities | $802.9M | $771.0M | $229.1M |
| YoY Change | 228.55% | 236.52% | 54.99% |
| SHAREHOLDERS EQUITY | |||
| Retained Earnings | -$1.053B | -$1.011B | -$830.1M |
| YoY Change | 25.39% | 21.79% | 8.63% |
| Common Stock | $58.00K | $58.00K | $42.00K |
| YoY Change | 23.4% | 38.1% | 23.53% |
| Preferred Stock | |||
| YoY Change | |||
| Treasury Stock (at cost) | |||
| YoY Change | |||
| Treasury Stock Shares | |||
| Shareholders Equity | $488.7M | $512.9M | $150.3M |
| YoY Change | |||
| Total Liabilities & Shareholders Equity | $1.292B | $1.284B | $379.4M |
| YoY Change | 152.37% | 238.4% | 52.59% |
Cashflow Statement
| Concept | 2019 Q2 | 2019 Q1 | 2018 Q1 |
|---|---|---|---|
| OPERATING ACTIVITIES | |||
| Net Income | -$41.79M | -$72.11M | -$19.26M |
| YoY Change | 338.96% | 274.36% | -33.71% |
| Depreciation, Depletion And Amortization | $7.700M | $7.059M | $6.022M |
| YoY Change | 23.79% | 17.22% | 883.99% |
| Cash From Operating Activities | -$30.52M | -$42.41M | -$15.88M |
| YoY Change | 167.09% | -45.06% | |
| INVESTING ACTIVITIES | |||
| Capital Expenditures | -$1.980M | $2.865M | $479.0K |
| YoY Change | 178.87% | 498.12% | 112.89% |
| Acquisitions | |||
| YoY Change | |||
| Other Investing Activities | -$36.19M | -$147.6M | -$1.170M |
| YoY Change | -528.28% | 12517.95% | -104.75% |
| Cash From Investing Activities | -$38.17M | -$150.5M | -$1.648M |
| YoY Change | -592.52% | 9032.16% | -106.75% |
| FINANCING ACTIVITIES | |||
| Cash Dividend Paid | |||
| YoY Change | |||
| Common Stock Issuance & Retirement, Net | $224.4M | $0.00 | |
| YoY Change | |||
| Debt Paid & Issued, Net | |||
| YoY Change | |||
| Cash From Financing Activities | 2.850M | $225.7M | $1.136M |
| YoY Change | -97.66% | 19769.89% | 71.34% |
| NET CHANGE | |||
| Cash From Operating Activities | -30.52M | -$42.41M | -$15.88M |
| Cash From Investing Activities | -38.17M | -$150.5M | -$1.648M |
| Cash From Financing Activities | 2.850M | $225.7M | $1.136M |
| Net Change In Cash | -65.84M | $31.65M | -$16.39M |
| YoY Change | -150.89% | -293.08% | 328.95% |
| FREE CASH FLOW | |||
| Cash From Operating Activities | -$30.52M | -$42.41M | -$15.88M |
| Capital Expenditures | -$1.980M | $2.865M | $479.0K |
| Free Cash Flow | -$28.54M | -$45.27M | -$16.36M |
| YoY Change | -4119.72% | 176.79% | -43.84% |
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Contract With Customer Liability
ContractWithCustomerLiability
|
14350000 | USD |
| CY2018Q1 | us-gaap |
Contract With Customer Liability Change In Timeframe Performance Obligation Satisfied Revenue Recognized
ContractWithCustomerLiabilityChangeInTimeframePerformanceObligationSatisfiedRevenueRecognized
|
0 | USD |
| CY2019Q1 | us-gaap |
Contract With Customer Liability Change In Timeframe Performance Obligation Satisfied Revenue Recognized
ContractWithCustomerLiabilityChangeInTimeframePerformanceObligationSatisfiedRevenueRecognized
|
0 | USD |
| CY2018Q1 | us-gaap |
Contract With Customer Liability Cumulative Catch Up Adjustment To Revenue Change In Measure Of Progress
ContractWithCustomerLiabilityCumulativeCatchUpAdjustmentToRevenueChangeInMeasureOfProgress
|
-3937000 | USD |
| CY2019Q1 | us-gaap |
Contract With Customer Liability Cumulative Catch Up Adjustment To Revenue Change In Measure Of Progress
ContractWithCustomerLiabilityCumulativeCatchUpAdjustmentToRevenueChangeInMeasureOfProgress
|
0 | USD |
| CY2018Q4 | us-gaap |
Contract With Customer Liability Current
ContractWithCustomerLiabilityCurrent
|
3716000 | USD |
| CY2019Q1 | us-gaap |
Contract With Customer Liability Current
ContractWithCustomerLiabilityCurrent
|
5497000 | USD |
| CY2018Q4 | us-gaap |
Contract With Customer Liability Noncurrent
ContractWithCustomerLiabilityNoncurrent
|
9722000 | USD |
| CY2019Q1 | us-gaap |
Contract With Customer Liability Noncurrent
ContractWithCustomerLiabilityNoncurrent
|
8853000 | USD |
| CY2018Q1 | us-gaap |
Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
|
55981000 | USD |
| CY2018Q1 | us-gaap |
Contract With Customer Performance Obligation Satisfied In Previous Period
ContractWithCustomerPerformanceObligationSatisfiedInPreviousPeriod
|
0 | USD |
| CY2019Q1 | us-gaap |
Contract With Customer Performance Obligation Satisfied In Previous Period
ContractWithCustomerPerformanceObligationSatisfiedInPreviousPeriod
|
0 | USD |
| CY2018Q1 | us-gaap |
Cost Of Goods And Services Sold
CostOfGoodsAndServicesSold
|
3045000 | USD |
| CY2019Q1 | us-gaap |
Cost Of Goods And Services Sold
CostOfGoodsAndServicesSold
|
2376000 | USD |
| CY2018Q1 | us-gaap |
Cumulative Effect Of New Accounting Principle In Period Of Adoption
CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption
|
3266000 | USD |
| CY2018Q4 | us-gaap |
Debt Securities Available For Sale Continuous Unrealized Loss Position12 Months Or Longer Accumulated Loss
DebtSecuritiesAvailableForSaleContinuousUnrealizedLossPosition12MonthsOrLongerAccumulatedLoss
|
3000 | USD |
| CY2019Q1 | us-gaap |
Debt Securities Available For Sale Continuous Unrealized Loss Position12 Months Or Longer Accumulated Loss
DebtSecuritiesAvailableForSaleContinuousUnrealizedLossPosition12MonthsOrLongerAccumulatedLoss
|
0 | USD |
| CY2018Q4 | us-gaap |
Debt Securities Available For Sale Continuous Unrealized Loss Position Less Than12 Months Accumulated Loss
DebtSecuritiesAvailableForSaleContinuousUnrealizedLossPositionLessThan12MonthsAccumulatedLoss
|
8000 | USD |
| CY2019Q1 | us-gaap |
Debt Securities Available For Sale Continuous Unrealized Loss Position Less Than12 Months Accumulated Loss
DebtSecuritiesAvailableForSaleContinuousUnrealizedLossPositionLessThan12MonthsAccumulatedLoss
|
47000 | USD |
| CY2017 | us-gaap |
Debt Securities Available For Sale Realized Gain Loss
DebtSecuritiesAvailableForSaleRealizedGainLoss
|
0 | USD |
| CY2019Q1 | us-gaap |
Debt Securities Available For Sale Realized Gain Loss
DebtSecuritiesAvailableForSaleRealizedGainLoss
|
0 | USD |
| CY2018Q4 | us-gaap |
Debt Securities Available For Sale Unrealized Loss Position Accumulated Loss
DebtSecuritiesAvailableForSaleUnrealizedLossPositionAccumulatedLoss
|
11000 | USD |
| CY2019Q1 | us-gaap |
Debt Securities Available For Sale Unrealized Loss Position Accumulated Loss
DebtSecuritiesAvailableForSaleUnrealizedLossPositionAccumulatedLoss
|
47000 | USD |
| CY2018Q4 | us-gaap |
Deferred Tax Liabilities Noncurrent
DeferredTaxLiabilitiesNoncurrent
|
122032000 | USD |
| CY2019Q1 | us-gaap |
Deferred Tax Liabilities Noncurrent
DeferredTaxLiabilitiesNoncurrent
|
122032000 | USD |
| CY2018Q1 | us-gaap |
Depreciation
Depreciation
|
6022000 | USD |
| CY2019Q1 | us-gaap |
Depreciation
Depreciation
|
7059000 | USD |
| CY2018Q1 | us-gaap |
Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-0.46 | |
| CY2019Q1 | us-gaap |
Earnings Per Share Basic And Diluted
EarningsPerShareBasicAndDiluted
|
-1.29 | |
| CY2018Q1 | us-gaap |
Effect Of Exchange Rate On Cash And Cash Equivalents
EffectOfExchangeRateOnCashAndCashEquivalents
|
2273000 | USD |
| CY2019Q1 | us-gaap |
Effect Of Exchange Rate On Cash And Cash Equivalents
EffectOfExchangeRateOnCashAndCashEquivalents
|
-1169000 | USD |
| CY2018Q4 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
27629000 | USD |
| CY2019Q1 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
13277000 | USD |
| CY2019Q1 | us-gaap |
Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized
|
100000000 | USD |
| CY2019Q1 | us-gaap |
Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period For Recognition1
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1
|
P3Y2M27D | |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Asset Useful Life
FiniteLivedIntangibleAssetUsefulLife
|
P7Y | |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Remainder Of Fiscal Year
FiniteLivedIntangibleAssetsAmortizationExpenseRemainderOfFiscalYear
|
18207000 | USD |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Year Four
FiniteLivedIntangibleAssetsAmortizationExpenseYearFour
|
24276000 | USD |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Year Three
FiniteLivedIntangibleAssetsAmortizationExpenseYearThree
|
24277000 | USD |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Assets Amortization Expense Year Two
FiniteLivedIntangibleAssetsAmortizationExpenseYearTwo
|
24277000 | USD |
| CY2019Q1 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
118455000 | USD |
| CY2018Q1 | us-gaap |
Foreign Currency Transaction Gain Loss Unrealized
ForeignCurrencyTransactionGainLossUnrealized
|
1300000 | USD |
| CY2019Q1 | us-gaap |
Foreign Currency Transaction Gain Loss Unrealized
ForeignCurrencyTransactionGainLossUnrealized
|
-865000 | USD |
| CY2018Q4 | us-gaap |
Goodwill
Goodwill
|
82341000 | USD |
| CY2019Q1 | us-gaap |
Goodwill
Goodwill
|
82341000 | USD |
| CY2018Q4 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionFairValue
|
26310000 | USD |
| CY2019Q1 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionFairValue
|
67793000 | USD |
| CY2018Q4 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Less Than Twelve Months Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionLessThanTwelveMonthsFairValue
|
16223000 | USD |
| CY2019Q1 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Less Than Twelve Months Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionLessThanTwelveMonthsFairValue
|
67793000 | USD |
| CY2018Q4 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Twelve Months Or Longer Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionTwelveMonthsOrLongerFairValue
|
10087000 | USD |
| CY2019Q1 | us-gaap |
Held To Maturity Securities Continuous Unrealized Loss Position Twelve Months Or Longer Fair Value
HeldToMaturitySecuritiesContinuousUnrealizedLossPositionTwelveMonthsOrLongerFairValue
|
0 | USD |
| CY2018Q1 | us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-19042000 | USD |
| CY2019Q1 | us-gaap |
Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest
IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest
|
-71537000 | USD |
| CY2018Q1 | us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
221000 | USD |
| CY2019Q1 | us-gaap |
Income Tax Expense Benefit
IncomeTaxExpenseBenefit
|
-576000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
-28653000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
1409000 | USD |
| CY2018Q1 | us-gaap |
Income Taxes Paid Net
IncomeTaxesPaidNet
|
326000 | USD |
| CY2019Q1 | us-gaap |
Income Taxes Paid Net
IncomeTaxesPaidNet
|
537000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Accounts Payable And Accrued Liabilities
IncreaseDecreaseInAccountsPayableAndAccruedLiabilities
|
-6810000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
574000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Deposit Other Assets
IncreaseDecreaseInDepositOtherAssets
|
308000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Deposit Other Assets
IncreaseDecreaseInDepositOtherAssets
|
10754000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
1446000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
334000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
-475000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
|
8065000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-958000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
191000 | USD |
| CY2018Q1 | us-gaap |
Increase Decrease In Receivables
IncreaseDecreaseInReceivables
|
4223000 | USD |
| CY2019Q1 | us-gaap |
Increase Decrease In Receivables
IncreaseDecreaseInReceivables
|
-20786000 | USD |
| CY2019Q1 | us-gaap |
Indefinitelived Intangible Assets Acquired
IndefinitelivedIntangibleAssetsAcquired
|
576500000 | USD |
| CY2018Q4 | us-gaap |
Intangible Assets Net Excluding Goodwill
IntangibleAssetsNetExcludingGoodwill
|
701031000 | USD |
| CY2019Q1 | us-gaap |
Intangible Assets Net Excluding Goodwill
IntangibleAssetsNetExcludingGoodwill
|
694955000 | USD |
| CY2018Q1 | us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-3303000 | USD |
| CY2019Q1 | us-gaap |
Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
|
-2288000 | USD |
| CY2018Q1 | us-gaap |
Interest Paid Net
InterestPaidNet
|
3023000 | USD |
| CY2019Q1 | us-gaap |
Interest Paid Net
InterestPaidNet
|
3111000 | USD |
| CY2018Q4 | us-gaap |
Inventory Finished Goods
InventoryFinishedGoods
|
5362000 | USD |
| CY2019Q1 | us-gaap |
Inventory Finished Goods
InventoryFinishedGoods
|
6508000 | USD |
| CY2018Q4 | us-gaap |
Inventory Net
InventoryNet
|
16117000 | USD |
| CY2019Q1 | us-gaap |
Inventory Net
InventoryNet
|
16219000 | USD |
| CY2018Q4 | us-gaap |
Inventory Raw Materials
InventoryRawMaterials
|
1431000 | USD |
| CY2019Q1 | us-gaap |
Inventory Raw Materials
InventoryRawMaterials
|
1333000 | USD |
| CY2018Q4 | us-gaap |
Inventory Work In Process
InventoryWorkInProcess
|
9324000 | USD |
| CY2019Q1 | us-gaap |
Inventory Work In Process
InventoryWorkInProcess
|
8378000 | USD |
| CY2019Q1 | us-gaap |
Lease Cost
LeaseCost
|
1008000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
|
11921000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
|
2152000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
|
2478000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
|
2995000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
|
2130000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
|
1126000 | USD |
| CY2019Q1 | us-gaap |
Lessee Operating Lease Renewal Term
LesseeOperatingLeaseRenewalTerm
|
P10Y | |
| CY2018Q4 | us-gaap |
Liabilities
Liabilities
|
768495000 | USD |
| CY2019Q1 | us-gaap |
Liabilities
Liabilities
|
770969000 | USD |
| CY2018Q4 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
1119222000 | USD |
| CY2019Q1 | us-gaap |
Liabilities And Stockholders Equity
LiabilitiesAndStockholdersEquity
|
1283911000 | USD |
| CY2018Q4 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
166796000 | USD |
| CY2019Q1 | us-gaap |
Liabilities Current
LiabilitiesCurrent
|
143046000 | USD |
| CY2018Q4 | us-gaap |
Long Term Debt Current
LongTermDebtCurrent
|
11667000 | USD |
| CY2019Q1 | us-gaap |
Long Term Debt Current
LongTermDebtCurrent
|
16667000 | USD |
| CY2018Q4 | us-gaap |
Long Term Debt Noncurrent
LongTermDebtNoncurrent
|
141347000 | USD |
| CY2019Q1 | us-gaap |
Long Term Debt Noncurrent
LongTermDebtNoncurrent
|
138468000 | USD |
| CY2019Q1 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
206018000 | USD |
| CY2018Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
1136000 | USD |
| CY2018Q4 | us-gaap |
Marketable Securities Current
MarketableSecuritiesCurrent
|
58088000 | USD |
| CY2019Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
225722000 | USD |
| CY2018Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-1648000 | USD |
| CY2019Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-150498000 | USD |
| CY2018Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-15878000 | USD |
| CY2019Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-42409000 | USD |
| CY2018Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-19263000 | USD |
| CY2019Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-72113000 | USD |
| CY2018Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Basic
NetIncomeLossAvailableToCommonStockholdersBasic
|
-19263000 | USD |
| CY2019Q1 | us-gaap |
Net Income Loss Available To Common Stockholders Basic
NetIncomeLossAvailableToCommonStockholdersBasic
|
-72113000 | USD |
| CY2019Q1 | us-gaap |
Number Of Operating Segments
NumberOfOperatingSegments
|
1 | segment |
| CY2018Q1 | us-gaap |
Operating Expenses
OperatingExpenses
|
72805000 | USD |
| CY2019Q1 | us-gaap |
Operating Expenses
OperatingExpenses
|
122723000 | USD |
| CY2018Q1 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-16743000 | USD |
| CY2019Q1 | us-gaap |
Operating Income Loss
OperatingIncomeLoss
|
-69140000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Cost
OperatingLeaseCost
|
812000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Liability
OperatingLeaseLiability
|
10795000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
2025000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
|
8770000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Payments
OperatingLeasePayments
|
732000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
|
10700000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
|
11300000 | USD |
| CY2019Q1 | us-gaap |
Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
|
0.0702 | |
| CY2019Q1 | us-gaap |
Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
|
P4Y8M16D | |
| CY2018Q4 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
16437000 | USD |
| CY2019Q1 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
4022000 | USD |
| CY2018Q1 | us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
-123000 | USD |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent
|
59000 | USD |
| CY2018Q1 | us-gaap |
Other Comprehensive Income Foreign Currency Transaction And Translation Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeForeignCurrencyTransactionAndTranslationAdjustmentNetOfTaxPortionAttributableToParent
|
1107000 | USD |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Foreign Currency Transaction And Translation Adjustment Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeForeignCurrencyTransactionAndTranslationAdjustmentNetOfTaxPortionAttributableToParent
|
-716000 | USD |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Loss Before Reclassifications Net Of Tax
OtherComprehensiveIncomeLossBeforeReclassificationsNetOfTax
|
-657000 | USD |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Loss Net Of Tax
OtherComprehensiveIncomeLossNetOfTax
|
-657000 | USD |
| CY2018Q1 | us-gaap |
Other Comprehensive Income Loss Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeLossNetOfTaxPortionAttributableToParent
|
984000 | USD |
| CY2019Q1 | us-gaap |
Other Comprehensive Income Loss Net Of Tax Portion Attributable To Parent
OtherComprehensiveIncomeLossNetOfTaxPortionAttributableToParent
|
-657000 | USD |
| CY2018Q4 | us-gaap |
Other Liabilities Current
OtherLiabilitiesCurrent
|
3814000 | USD |
| CY2019Q1 | us-gaap |
Other Liabilities Current
OtherLiabilitiesCurrent
|
3132000 | USD |
| CY2018Q4 | us-gaap |
Other Liabilities Noncurrent
OtherLiabilitiesNoncurrent
|
58000 | USD |
| CY2019Q1 | us-gaap |
Other Liabilities Noncurrent
OtherLiabilitiesNoncurrent
|
8770000 | USD |
| CY2018Q1 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
1004000 | USD |
| CY2019Q1 | us-gaap |
Other Nonoperating Income Expense
OtherNonoperatingIncomeExpense
|
-109000 | USD |
| CY2018Q1 | us-gaap |
Paid In Kind Interest
PaidInKindInterest
|
1780000 | USD |
| CY2019Q1 | us-gaap |
Paid In Kind Interest
PaidInKindInterest
|
1982000 | USD |
| CY2018Q1 | us-gaap |
Payments To Acquire Marketable Securities
PaymentsToAcquireMarketableSecurities
|
22683000 | USD |
| CY2019Q1 | us-gaap |
Payments To Acquire Marketable Securities
PaymentsToAcquireMarketableSecurities
|
165723000 | USD |
| CY2018Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
479000 | USD |
| CY2019Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
2865000 | USD |
| CY2018Q4 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
9247000 | USD |
| CY2019Q1 | us-gaap |
Prepaid Expense And Other Assets Current
PrepaidExpenseAndOtherAssetsCurrent
|
9348000 | USD |
| CY2019Q1 | us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
224400000 | USD |
| CY2018Q1 | us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
0 | USD |
| CY2019Q1 | us-gaap |
Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
|
224441000 | USD |
| CY2018Q1 | us-gaap |
Proceeds From Sale And Maturity Of Marketable Securities
ProceedsFromSaleAndMaturityOfMarketableSecurities
|
21514000 | USD |
| CY2019Q1 | us-gaap |
Proceeds From Sale And Maturity Of Marketable Securities
ProceedsFromSaleAndMaturityOfMarketableSecurities
|
18090000 | USD |
| CY2018Q1 | us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
1136000 | USD |
| CY2019Q1 | us-gaap |
Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
|
1281000 | USD |
| CY2018Q4 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
12694000 | USD |
| CY2019Q1 | us-gaap |
Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
|
14540000 | USD |
| CY2018Q4 | us-gaap |
Receivables Net Current
ReceivablesNetCurrent
|
67907000 | USD |
| CY2019Q1 | us-gaap |
Receivables Net Current
ReceivablesNetCurrent
|
46350000 | USD |
| CY2019Q1 | us-gaap |
Reclassification From Aoci Current Period Net Of Tax Attributable To Parent
ReclassificationFromAociCurrentPeriodNetOfTaxAttributableToParent
|
0 | USD |
| CY2018Q1 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
31363000 | USD |
| CY2019Q1 | us-gaap |
Research And Development Expense
ResearchAndDevelopmentExpense
|
52566000 | USD |
| CY2018Q4 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-938923000 | USD |
| CY2019Q1 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-1011036000 | USD |
| CY2019Q1 | us-gaap |
Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
|
-1011000000 | USD |
| CY2018Q1 | us-gaap |
Revenue From Contract With Customer Including Assessed Tax
RevenueFromContractWithCustomerIncludingAssessedTax
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56062000 | USD |
| CY2019Q1 | us-gaap |
Revenue From Contract With Customer Including Assessed Tax
RevenueFromContractWithCustomerIncludingAssessedTax
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53583000 | USD |
| CY2018Q1 | us-gaap |
Right Of Use Asset Obtained In Exchange For Operating Lease Liability
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0 | USD |
| CY2019Q1 | us-gaap |
Right Of Use Asset Obtained In Exchange For Operating Lease Liability
RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability
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11314000 | USD |
| CY2018Q1 | us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
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32969000 | USD |
| CY2019Q1 | us-gaap |
Selling General And Administrative Expense
SellingGeneralAndAdministrativeExpense
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40544000 | USD |
| CY2018Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
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7748000 | USD |
| CY2019Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
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9263000 | USD |
| CY2019Q1 | us-gaap |
Share Price
SharePrice
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30.20 | |
| CY2019Q1 | us-gaap |
Short Term Lease Cost
ShortTermLeaseCost
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53000 | USD |
| CY2019Q1 | us-gaap |
Stock Issued During Period Shares New Issues
StockIssuedDuringPeriodSharesNewIssues
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7563725 | shares |
| CY2019Q1 | us-gaap |
Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
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224441000 | USD |
| CY2018Q1 | us-gaap |
Stock Issued During Period Value Restricted Stock Award Net Of Forfeitures
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0 | USD |
| CY2019Q1 | us-gaap |
Stock Issued During Period Value Restricted Stock Award Net Of Forfeitures
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0 | USD |
| CY2018Q1 | us-gaap |
Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
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1136000 | USD |
| CY2019Q1 | us-gaap |
Stock Issued During Period Value Stock Options Exercised
StockIssuedDuringPeriodValueStockOptionsExercised
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1281000 | USD |
| CY2017Q4 | us-gaap |
Stockholders Equity
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156437000 | USD |
| CY2018Q1 | us-gaap |
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150308000 | USD |
| CY2018Q4 | us-gaap |
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350727000 | USD |
| CY2019Q1 | us-gaap |
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StockholdersEquity
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512942000 | USD |
| CY2019Q1 | us-gaap |
Variable Lease Cost
VariableLeaseCost
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143000 | USD |
| CY2018Q1 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
WeightedAverageNumberOfShareOutstandingBasicAndDiluted
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41626617 | shares |
| CY2019Q1 | us-gaap |
Weighted Average Number Of Share Outstanding Basic And Diluted
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55855111 | shares |
| CY2019Q1 | 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-weight:bold;">The Company</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">PTC Therapeutics, Inc. (the “Company” or “PTC”) is a science-led global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. The Company’s ability to globally commercialize products is the foundation that drives its continued investment in a robust pipeline of transformative medicines and its mission to provide access to best-in-class treatments for patients who have an unmet medical need.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company has </font><font style="font-family:inherit;font-size:10pt;">two</font><font style="font-family:inherit;font-size:10pt;"> products, Translarna</font><font style="font-family:inherit;font-size:8pt;">™ </font><font style="font-family:inherit;font-size:10pt;">(ataluren) and Emflaza™ (deflazacort), for the treatment of Duchenne muscular dystrophy, or DMD, a rare, life threatening disorder. Translarna received marketing authorization from the European Commission in August 2014 for the treatment of nonsense mutation Duchenne muscular dystrophy, or nmDMD, in ambulatory patients aged five years and older in the </font><font style="font-family:inherit;font-size:10pt;">31</font><font style="font-family:inherit;font-size:10pt;"> member states of the European Economic Area, or EEA. In July 2018, the European Commission approved a label-extension request to the marketing authorization for Translarna in the EEA to include patients from two to up to five years of age. Emflaza is approved in the United States for the treatment of DMD in patients five years and older. </font></div><div style="line-height:120%;padding-bottom:6px;padding-top:6px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company has a pipeline of gene therapy product candidates, including PTC-AADC for the treatment of Aromatic L-Amino Acid Decarboxylase, or AADC, deficiency, or AADC deficiency. The Company is preparing a biologics license application, or BLA, for PTC-AADC for the treatment of AADC deficiency in the United States, which it anticipates submitting to the U.S. Food and Drug Administration, or FDA, in late 2019, with anticipated commercial launch in the United States in 2020, subject to approval. The Company is also preparing a marketing authorization application, or MAA, for PTC-AADC for the treatment of AADC deficiency in the European Union, or EU, for submission to the European Medicines Agency, or EMA, which will follow its BLA submission to the FDA. </font></div><div style="line-height:120%;padding-bottom:6px;padding-top:6px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company holds the rights for the commercialization of Tegsedi™ (inotersen) and Waylivra™ (volanesorsen) for the treatment of rare diseases in countries in Latin America and the Caribbean. Tegsedi has received marketing authorization in the U.S., EU and Canada for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hATTR amyloidosis. The Company filed for marketing authorization with ANVISA, the Brazilian health regulatory authority, which granted priority review. It expects approval in Brazil by the end of 2019. Waylivra is currently under regulatory review in the EU for the treatment of familial chylomicronemia syndrome, or FCS. Waylivra has received a positive opinion recommending conditional marketing authorization from the Committee for Medicinal Products for Human Use, or CHMP, of the EMA. The positive opinion will be referred to the European Commission for consideration. </font></div><div style="line-height:120%;padding-bottom:6px;padding-top:6px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company also has a spinal muscular atrophy (SMA) collaboration with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., referred to collectively as Roche, and the Spinal Muscular Atrophy Foundation, or SMA Foundation. Currently, its collaboration has two pivotal clinical trials ongoing to evaluate the safety and effectiveness of risdiplam (RG7916, RO7034067), the lead compound in the SMA program. Roche is preparing an NDA and a MAA for risdiplam for the treatment of SMA in the United States and the EU, respectively, which Roche anticipates submitting to the FDA and the EMA in the second half of 2019. In addition, the Company has a pipeline of product candidates and discovery programs that are in early clinical, pre-clinical and research and development stages focused on the development of new treatments for multiple therapeutic areas, including rare diseases and oncology.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company’s marketing authorization for Translarna in the EEA is subject to annual review and renewal by the European Commission following reassessment by the EMA of the benefit-risk balance of the authorization, which the Company refers to as the annual EMA reassessment. This marketing authorization is further subject to the specific obligation to conduct and submit the results of a multi-center, randomized, double-blind, 18-month, placebo-controlled trial, followed by an 18-month open-label extension, according to an agreed protocol, in order to confirm the efficacy and safety of Translarna. The final report on the trial and open-label extension is to be submitted by the Company to the EMA by the end of the third quarter of 2021. Due to enrollment at a slower pace in certain countries than initially expected, in its February 2019 marketing authorization renewal request, the Company asked the EMA to extend the timeframe for submission of the results of Study 041 to the EMA to the end of the third quarter of 2022. The Company refers to the trial and open-label extension together as Study 041.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The marketing authorization in the EEA was last renewed in July 2018 and is effective, unless extended, through August 5, 2019. The renewal was based on the Company’s commitment to conduct Study 041 and the totality of the clinical data available from its trials and studies of Translarna for the treatment of nmDMD, including the safety and efficacy results of the Phase 2b and Phase 3 clinical trials. The primary efficacy endpoint was not achieved in either trial within the pre-specified level of statistical significance. </font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">In June 2014, the Company initiated reimbursed early access programs, or EAP programs, for Translarna for nmDMD patients in selected territories in the EEA and recorded its first sales of Translarna in the third quarter of 2014 pursuant to an EAP program. In December 2014, the Company recorded its first commercial sales in Germany. As of </font><font style="font-family:inherit;font-size:10pt;">March 31, 2019</font><font style="font-family:inherit;font-size:10pt;">, Translarna was available in over </font><font style="font-family:inherit;font-size:10pt;">40</font><font style="font-family:inherit;font-size:10pt;"> countries on a commercial basis or pursuant to an EAP program. The Company expects to expand its commercial activities across the EEA pursuant to the marketing authorization granted by the EMA throughout 2019 and future years, subject to continued renewal of its marketing authorization following annual EMA reassessments and successful completion of pricing and reimbursement negotiations. Concurrently, the Company plans to continue to pursue EAP programs in select countries where those mechanisms exist, both within the EEA and in other countries that will reference the marketing authorization in the EEA.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Translarna is an investigational new drug in the United States. During the first quarter of 2017, the Company filed a New Drug Application, or NDA, over protest with the FDA, for which the FDA granted a standard review. In October 2017, the Office of Drug Evaluation I of the FDA issued a complete response letter for the NDA, stating that it was unable to approve the application in its current form. In response, the Company filed a formal dispute resolution request with the Office of New Drugs of the FDA. In February 2018, the Office of New Drugs of the FDA denied PTC’s appeal of the Complete Response Letter. In its response, the Office of New Drugs recommended a possible path forward for the ataluren NDA submission based on the accelerated approval pathway. This would involve a re-submission of an NDA containing the current data on effectiveness of ataluren with new data to be generated on dystrophin production in nmDMD patients’ muscles. The Company intends to follow the FDA’s recommendation and will collect, using newer technologies via procedures and methods that the Company designed, such dystrophin data in a new study, Study 045, which the Company initiated in the fourth quarter of 2018. The Company expects that a potential re-submission of an NDA could occur in 2020. Additionally, should a re-submission of an NDA receive accelerated approval, the Office of New Drugs stated that Study 041, which is currently enrolling, could serve as the confirmatory post-approval trial required in connection with the accelerated approval framework.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On April 20, 2017, the Company completed its acquisition of all rights to Emflaza, or the Transaction. Emflaza is approved in the United States for the treatment of DMD in patients five years and older. The Transaction was completed pursuant to an asset purchase agreement, dated March 15, 2017, as amended on April 20, 2017, (the "Asset Purchase Agreement"), by and between the Company and Marathon Pharmaceuticals, LLC (now known as Complete Pharma Holdings, LLC), or Marathon. The Transaction was accounted for as an asset acquisition. The assets acquired by the Company in the Transaction include intellectual property rights related to Emflaza, inventories of Emflaza, and certain contractual rights related to Emflaza. The Company assumed certain liabilities and obligations in the Transaction arising out of, or relating to, the assets acquired in the Transaction. </font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Upon the closing of the Transaction, the Company paid to Marathon total upfront consideration comprised of </font><font style="font-family:inherit;font-size:10pt;">$75.0 million</font><font style="font-family:inherit;font-size:10pt;"> in cash, funded through cash on hand, and </font><font style="font-family:inherit;font-size:10pt;">6,683,598</font><font style="font-family:inherit;font-size:10pt;"> shares of the Company’s common stock. The number of shares of common stock issued at closing was determined by dividing </font><font style="font-family:inherit;font-size:10pt;">$65.0 million</font><font style="font-family:inherit;font-size:10pt;"> by the volume-weighted average price per share of the Company’s common stock on the Nasdaq Stock Market for the </font><font style="font-family:inherit;font-size:10pt;">15</font><font style="font-family:inherit;font-size:10pt;"> trading-day period ending on the third trading day immediately preceding the closing. Marathon is entitled to receive contingent payments from the Company based on annual net sales of Emflaza, up to a specified aggregate maximum amount over the expected commercial life of the asset, and a single </font><font style="font-family:inherit;font-size:10pt;">$50.0 million</font><font style="font-family:inherit;font-size:10pt;"> sales-based milestone, in each case subject to the terms and conditions of the Asset Purchase Agreement.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">On August 23, 2018, the Company completed its acquisition of Agilis Biotherapeutics, Inc., or Agilis, pursuant to an Agreement and Plan of Merger, dated as of July 19, 2018 (the “Merger Agreement”), by and among the Company, Agility Merger Sub, Inc., a Delaware corporation and the Company's wholly owned, indirect subsidiary, Agilis and, solely in its capacity as the representative, agent and attorney-in-fact of the equityholders of Agilis, Shareholder Representative Services LLC (the "Merger"). </font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Upon the closing of the Merger, the Company paid to Agilis equityholders total upfront consideration comprised of </font><font style="font-family:inherit;font-size:10pt;">$49.2 million</font><font style="font-family:inherit;font-size:10pt;"> in cash and </font><font style="font-family:inherit;font-size:10pt;">3,500,907</font><font style="font-family:inherit;font-size:10pt;"> shares of the Company’s common stock (the “Closing Stock Consideration”). The Closing Stock Consideration was determined by dividing </font><font style="font-family:inherit;font-size:10pt;">$150.0 million</font><font style="font-family:inherit;font-size:10pt;"> by the volume-weighted average price per share of the Company’s common stock on the Nasdaq Global Select Market for the </font><font style="font-family:inherit;font-size:10pt;">10</font><font style="font-family:inherit;font-size:10pt;"> consecutive trading-day period ending on the second trading-day immediately preceding the closing of the Merger. Agilis equityholders may become entitled to receive contingent payments from the Company based on the achievement of certain development, regulatory and net sales milestones as well as based upon a percentage of net sales of certain products. Under the Merger Agreement, the Company is required to pay </font><font style="font-family:inherit;font-size:10pt;">$40.0 million</font><font style="font-family:inherit;font-size:10pt;"> of the development milestone payments no later than the second anniversary of the closing of the Merger, regardless of whether the applicable milestones have been achieved.</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">As of </font><font style="font-family:inherit;font-size:10pt;">March 31, 2019</font><font style="font-family:inherit;font-size:10pt;">, the Company had an accumulated deficit of approximately </font><font style="font-family:inherit;font-size:10pt;">$1,011.0 million</font><font style="font-family:inherit;font-size:10pt;">. The Company has financed its operations to date primarily through the private offering in August 2015 of </font><font style="font-family:inherit;font-size:10pt;">3.0%</font><font style="font-family:inherit;font-size:10pt;"> convertible senior notes due 2022 (see Note 10), public offerings of common stock in February 2014, October 2014, April 2018 and January 2019, its initial public offering of common stock in June 2013, private placements of its convertible preferred stock, collaborations, bank debt, convertible debt financings, grant funding and clinical trial support from governmental and philanthropic organizations and patient advocacy groups in the disease area addressed by the Company’s product candidates. Since 2014, the Company has also relied on revenue generated from net sales of Translarna for the treatment of nmDMD in territories outside of the United States, and since May 2017, the Company has generated revenue from net sales of Emflaza for the treatment of DMD in the United States. The Company expects that cash flows from the sales of its products, together with the Company’s cash, cash equivalents and marketable securities, will be sufficient to fund its operations for at least the next twelve months.</font></div></div> | |
| CY2019Q1 | us-gaap |
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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;">Use of estimates</font></div><div style="line-height:120%;padding-bottom:10px;padding-top:10px;text-align:justify;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant estimates in these consolidated financial statements have been made in connection with the calculation of net product sales, certain accruals related to the Company’s research and development expenses, stock-based compensation, valuation procedures for the convertible notes, allowance for doubtful accounts, inventory, acquired intangible assets, fair value of the contingent consideration, and the provision for or benefit from income taxes. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.</font></div></div> |
