2018 Q3 Form 10-Q Financial Statement

#000156459018028054 Filed on November 07, 2018

View on sec.gov

Income Statement

Concept 2018 Q3 2018 Q2 2017 Q3
Revenue $5.306M $40.03M $1.336M
YoY Change 297.16% 510.04% 968.8%
Cost Of Revenue $517.0K $3.900M $700.0K
YoY Change -26.14% 64900.0% 3081.82%
Gross Profit $4.789M $36.20M $700.0K
YoY Change 584.14% 452.17% 579.61%
Gross Profit Margin 90.26% 90.43% 52.4%
Selling, General & Admin $9.000M $8.300M $9.400M
YoY Change -4.26% 29.69% 51.61%
% of Gross Profit 187.93% 22.93% 1342.86%
Research & Development $18.51M $21.49M $12.52M
YoY Change 47.85% 54.39% -0.33%
% of Gross Profit 386.47% 59.35% 1788.29%
Depreciation & Amortization $1.000M $900.0K $700.0K
YoY Change 42.86% 28.57% 250.0%
% of Gross Profit 20.88% 2.49% 100.0%
Operating Expenses $18.51M $21.49M $12.52M
YoY Change 47.85% 54.39% -0.33%
Operating Profit -$22.73M $6.350M -$11.82M
YoY Change 92.29% -142.18% -36.69%
Interest Expense $2.200M $8.100M $600.0K
YoY Change 266.67% 1250.0% 20.0%
% of Operating Profit 127.56%
Other Income/Expense, Net $603.0K
YoY Change 17.32%
Pretax Income -$20.50M $14.40M -$20.70M
YoY Change -0.97% -199.31% 13.74%
Income Tax -$1.300M $3.850M
% Of Pretax Income 26.74%
Net Earnings -$19.20M $10.59M -$20.71M
YoY Change -7.26% -173.2% 14.06%
Net Earnings / Revenue -361.89% 26.46% -1549.85%
Basic Earnings Per Share -$0.56 $0.33 -$0.67
Diluted Earnings Per Share -$0.56 $0.30 -$0.67
COMMON SHARES
Basic Shares Outstanding 33.99M 32.08M 30.89M
Diluted Shares Outstanding 33.99M 35.27M

Balance Sheet

Concept 2018 Q3 2018 Q2 2017 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $372.6M $286.5M $166.7M
YoY Change 123.52% 76.74% 81.59%
Cash & Equivalents $142.4M $106.9M $60.11M
Short-Term Investments $230.2M $179.6M $106.8M
Other Short-Term Assets $11.10M $6.000M $4.600M
YoY Change 141.3% 379.23% 9.52%
Inventory
Prepaid Expenses
Receivables $2.600M $700.0K $900.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $386.4M $293.3M $172.2M
YoY Change 124.39% 76.88% 78.26%
LONG-TERM ASSETS
Property, Plant & Equipment $19.90M $16.70M $11.50M
YoY Change 73.04% 44.91% 98.28%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $102.3M $19.80M $24.50M
YoY Change 317.55% -57.33% -73.68%
Other Assets $1.650M $1.700M $1.100M
YoY Change 50.0% 332.57% 120.0%
Total Long-Term Assets $128.6M $42.70M $37.10M
YoY Change 246.59% -27.08% -62.68%
TOTAL ASSETS
Total Short-Term Assets $386.4M $293.3M $172.2M
Total Long-Term Assets $128.6M $42.70M $37.10M
Total Assets $515.0M $336.0M $209.3M
YoY Change 146.05% 49.75% 6.79%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.214M $4.200M $2.600M
YoY Change 100.54% 6.38% -51.85%
Accrued Expenses $12.20M $9.600M $10.80M
YoY Change 12.96% 28.0% 20.0%
Deferred Revenue $600.0K $600.0K
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $19.12M $16.90M $13.40M
YoY Change 42.69% 47.44% -6.94%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $691.0K $720.0K $1.200M
YoY Change -42.42% -40.0% -14.29%
Total Long-Term Liabilities $691.0K $720.0K $1.200M
YoY Change -42.42% -40.0% -14.29%
TOTAL LIABILITIES
Total Short-Term Liabilities $19.12M $16.90M $13.40M
Total Long-Term Liabilities $691.0K $720.0K $1.200M
Total Liabilities $19.81M $18.80M $14.60M
YoY Change 35.69% 48.28% -7.01%
SHAREHOLDERS EQUITY
Retained Earnings
YoY Change
Common Stock
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $494.1M $317.2M $194.7M
YoY Change
Total Liabilities & Shareholders Equity $515.0M $336.0M $209.3M
YoY Change 146.06% 49.75% 6.79%

Cashflow Statement

Concept 2018 Q3 2018 Q2 2017 Q3
OPERATING ACTIVITIES
Net Income -$19.20M $10.59M -$20.71M
YoY Change -7.26% -173.2% 14.06%
Depreciation, Depletion And Amortization $1.000M $900.0K $700.0K
YoY Change 42.86% 28.57% 250.0%
Cash From Operating Activities -$19.50M $70.20M -$17.20M
YoY Change 13.37% -838.95% 45.76%
INVESTING ACTIVITIES
Capital Expenditures -$3.400M -$2.700M -$500.0K
YoY Change 580.0% 58.82% -77.27%
Acquisitions
YoY Change
Other Investing Activities -$133.4M -$35.70M $19.20M
YoY Change -794.79% 49.37% 58.68%
Cash From Investing Activities -$136.7M -$38.40M $18.80M
YoY Change -827.13% 50.0% 91.84%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 191.9M 3.100M 600.0K
YoY Change 31883.33% -71.3% 500.0%
NET CHANGE
Cash From Operating Activities -19.50M 70.20M -17.20M
Cash From Investing Activities -136.7M -38.40M 18.80M
Cash From Financing Activities 191.9M 3.100M 600.0K
Net Change In Cash 35.70M 34.90M 2.200M
YoY Change 1522.73% -243.62% -215.79%
FREE CASH FLOW
Cash From Operating Activities -$19.50M $70.20M -$17.20M
Capital Expenditures -$3.400M -$2.700M -$500.0K
Free Cash Flow -$16.10M $72.90M -$16.70M
YoY Change -3.59% -1034.62% 73.96%

Facts In Submission

Frame Concept Type Concept / XBRL Key Value Unit
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AccruedPurchasesOfPropertyAndEquipment
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us-gaap Income Tax Expense Benefit
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us-gaap Earnings Per Share Basic
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us-gaap Increase Decrease In Other Current Assets
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us-gaap Increase Decrease In Accounts Payable Trade
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us-gaap Increase Decrease In Accounts Payable Trade
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us-gaap Increase Decrease In Accrued Liabilities And Other Operating Liabilities
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us-gaap Increase Decrease In Contract With Customer Liability
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rgnx Increase Decrease In Deferred Rent Payable
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us-gaap Nature Of Operations
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<div> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:10pt;font-style:normal;text-transform:none;font-variant: normal;">1. Nature of Business</p> <p style="margin-top:6pt;margin-bottom:0pt;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:4.54%;">REGENXBIO Inc. (the Company) is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. The Company&#8217;s proprietary adeno-associated virus (AAV) gene delivery platform (NAV Technology Platform) consists of exclusive rights to over 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. The Company&#8217;s NAV&#174; Technology Platform is being applied by the Company, as well as by third-party licensees (NAV Technology Licensees), in the development of product candidates for a variety of&#160;diseases with unmet needs. The Company was formed in 2008 in the State of Delaware and is headquartered in Rockville, Maryland.</p> <p style="margin-top:18pt;margin-bottom:0pt;margin-left:4.54%;text-indent:0%;font-weight:bold;font-style:italic;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Liquidity and Risks </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In August 2018, the Company completed a follow-on public offering of 3,105,000 shares of its common stock (inclusive of 405,000 shares pursuant to the full exercise by the underwriters of their option to purchase additional shares) at a price of $65.00 per share. The aggregate net proceeds received by the Company from the offering, inclusive of the underwriters&#8217; option exercise, were $189.1 million, net of underwriting discounts and commissions and offering expenses payable by the Company.</p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of September 30, 2018, the Company had generated an accumulated deficit of $87.3 million since inception. As the Company has incurred cumulative losses since inception, transition to recurring profitability is dependent upon the successful development, approval and commercialization of its product candidates and achieving a level of revenues adequate to support the Company&#8217;s cost structure. The Company may never achieve recurring profitability, and unless and until it does, the Company will continue to need to raise additional capital.<font style="color:#000000;"> As of September 30, 2018, the Company had cash, cash equivalents and marketable securities of $474.9 million, which management believes is sufficient to fund operations for at least the next 12 months from the date these consolidated financial statements were issued.</font></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:4.54%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, development by the Company or its competitors of technological innovations, risks of failure of clinical trials, dependence on key personnel, protection of proprietary technology, compliance with government regulations and ability to transition from clinical manufacturing to the commercial production of products.</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;;font-size:9pt;">&nbsp;</p></div>
us-gaap Use Of Estimates
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<div> <p style="margin-top:18pt;margin-bottom:0pt;margin-left:4.54%;text-indent:0%;font-weight:bold;font-style:italic;font-family:Times New Roman;font-size:10pt;text-transform:none;font-variant: normal;">Use of Estimates</p> <p style="margin-top:6pt;margin-bottom:0pt;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:4.54%;">The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these consolidated financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the consolidated financial statements. Estimates are used in the following areas, among others: revenue, stock-based compensation expense, accrued research and development expenses and other accrued expenses, income taxes and the fair value of financial instruments.</p></div>
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CY2017Q4 us-gaap Available For Sale Securities Continuous Unrealized Loss Position Twelve Months Or Longer Fair Value
AvailableForSaleSecuritiesContinuousUnrealizedLossPositionTwelveMonthsOrLongerFairValue
17124000
CY2017Q4 us-gaap Debt Securities Available For Sale Continuous Unrealized Loss Position12 Months Or Longer Accumulated Loss
DebtSecuritiesAvailableForSaleContinuousUnrealizedLossPosition12MonthsOrLongerAccumulatedLoss
102000
CY2017Q4 us-gaap Available For Sale Securities Continuous Unrealized Loss Position Fair Value
AvailableForSaleSecuritiesContinuousUnrealizedLossPositionFairValue
126362000
CY2017Q4 us-gaap Debt Securities Available For Sale Unrealized Loss Position Accumulated Loss
DebtSecuritiesAvailableForSaleUnrealizedLossPositionAccumulatedLoss
282000
CY2018Q3 us-gaap Debt Securities Available For Sale Unrealized Loss Position Number Of Positions
DebtSecuritiesAvailableForSaleUnrealizedLossPositionNumberOfPositions
106
us-gaap Other Than Temporary Impairment Loss Debt Securities Available For Sale
OtherThanTemporaryImpairmentLossDebtSecuritiesAvailableForSale
0
CY2017 us-gaap Other Than Temporary Impairment Loss Debt Securities Available For Sale
OtherThanTemporaryImpairmentLossDebtSecuritiesAvailableForSale
0
CY2018Q3 us-gaap Fair Value Assets Level1 To Level2 Transfers Amount
FairValueAssetsLevel1ToLevel2TransfersAmount
0
CY2018Q3 us-gaap Fair Value Assets Level2 To Level1 Transfers Amount
FairValueAssetsLevel2ToLevel1TransfersAmount
0
CY2018Q3 rgnx Non Marketable Equity Securities Carrying Value
NonMarketableEquitySecuritiesCarryingValue
400000
CY2017Q4 rgnx Non Marketable Equity Securities Carrying Value
NonMarketableEquitySecuritiesCarryingValue
400000
CY2018Q3 rgnx Impairment Losses On Non Marketable Equity Securities
ImpairmentLossesOnNonMarketableEquitySecurities
0
rgnx Impairment Losses On Non Marketable Equity Securities
ImpairmentLossesOnNonMarketableEquitySecurities
0
CY2017Q3 rgnx Impairment Losses On Non Marketable Equity Securities
ImpairmentLossesOnNonMarketableEquitySecurities
0
rgnx Impairment Losses On Non Marketable Equity Securities
ImpairmentLossesOnNonMarketableEquitySecurities
0
CY2018Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
25782000
CY2017Q4 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
17254000
CY2018Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
5926000
CY2017Q4 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
3277000
CY2015Q3 us-gaap Payments For Proceeds From Tenant Allowance
PaymentsForProceedsFromTenantAllowance
400000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Remainder Of Fiscal Year
OperatingLeasesFutureMinimumPaymentsRemainderOfFiscalYear
660000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Due In Two Years
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2946000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Due In Three Years
OperatingLeasesFutureMinimumPaymentsDueInThreeYears
2975000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Due In Four Years
OperatingLeasesFutureMinimumPaymentsDueInFourYears
2335000
CY2017Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2734000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
11755000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
7809000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Due In Five Years
OperatingLeasesFutureMinimumPaymentsDueInFiveYears
621000
CY2018Q3 us-gaap Operating Leases Future Minimum Payments Due Thereafter
OperatingLeasesFutureMinimumPaymentsDueThereafter
479000
us-gaap Loss Contingency Damages Paid Value
LossContingencyDamagesPaidValue
0
us-gaap Loss Contingency Accrual Provision
LossContingencyAccrualProvision
0
CY2017 us-gaap Loss Contingency Accrual Provision
LossContingencyAccrualProvision
0
rgnx Milestone Fee Payments Upon Commencement Of Clinical Trials
MilestoneFeePaymentsUponCommencementOfClinicalTrials
27400000
rgnx Milestone Fee Payments Upon Submission Of Regulatory Approval Filings
MilestoneFeePaymentsUponSubmissionOfRegulatoryApprovalFilings
45500000
rgnx Milestone Fee Payments Upon Approval Of Commercial Products
MilestoneFeePaymentsUponApprovalOfCommercialProducts
111500000
rgnx Milestone Fee Payments Upon Achievement Of Specified Sales Targets
MilestoneFeePaymentsUponAchievementOfSpecifiedSalesTargets
172000000
CY2018Q2 us-gaap Accounts Receivable Net
AccountsReceivableNet
5224000
CY2018Q3 rgnx Increase Decrease In Accounts Receivable Current And Noncurrent
IncreaseDecreaseInAccountsReceivableCurrentAndNoncurrent
2002000
CY2018Q3 us-gaap Accounts Receivable Net
AccountsReceivableNet
7226000
CY2018Q3 rgnx Increase Decrease In Contract With Customer Asset Current
IncreaseDecreaseInContractWithCustomerAssetCurrent
2000000
CY2018Q3 us-gaap Contract With Customer Asset Net Current
ContractWithCustomerAssetNetCurrent
2000000
CY2018Q2 us-gaap Contract With Customer Liability Current
ContractWithCustomerLiabilityCurrent
600000
CY2017Q4 us-gaap Accounts Receivable Net
AccountsReceivableNet
5850000
rgnx Increase Decrease In Accounts Receivable Current And Noncurrent
IncreaseDecreaseInAccountsReceivableCurrentAndNoncurrent
1376000
CY2017Q4 us-gaap Contract With Customer Asset Net Current
ContractWithCustomerAssetNetCurrent
350000
rgnx Increase Decrease In Contract With Customer Asset Current
IncreaseDecreaseInContractWithCustomerAssetCurrent
1650000
rgnx Increase Decrease In Contract With Customer Liability Current
IncreaseDecreaseInContractWithCustomerLiabilityCurrent
600000
us-gaap Capitalized Contract Cost Impairment Loss
CapitalizedContractCostImpairmentLoss
0
us-gaap Revenue Information Used To Determine Transaction Price
RevenueInformationUsedToDetermineTransactionPrice
Upon its execution, the transaction price of the January 2018 Amendment was $132.1 million, which was fully recognized as license revenue upon the delivery of the modified license in January 2018. In May 2018, as a result of the acquisition of AveXis by Novartis, the transaction price was increased by $40.0 million to account for the acceleration of the sale-based milestone which was previously excluded from the transaction price. The $40.0 million increase in the transaction price was recognized as license revenue upon the completion of the change of control in May 2018 since the amended license had been fully delivered to AveXis. Additionally, due to the acceleration of the two $30.0 million payments originally due in January 2019 and January 2020, the Company recognized $6.1 million of interest income from licensing upon the completion of the change of control of AveXis, which represents the remaining present value discount on such payments as of the date of the change of control of AveXis. The transaction price of $172.1 million as of September 30, 2018 includes the following fixed consideration: (i) the $80.0 million payment in January 2018, (ii) the present value, as of the date of the January 2018 Amendment, of the two $30.0 million payments originally due in January 2019 and January 2020 and (iii) the $40.0 million sales-based milestone which was accelerated upon the change of control in May 2018. Variable consideration under the January 2018 Amendment, which has been excluded from the transaction price, includes the remaining sales-based milestone payment of $80.0 million, as well as any potential sublicense fees or royalties on sales of licensed products, which will be recognized in the period of the underlying sales or sublicenses, if any.
CY2018Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4483000
CY2018Q3 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognized
40800000
us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period For Recognition1
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1
P2Y8M12D
CY2018Q3 us-gaap Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate
0.21
us-gaap Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
EffectiveIncomeTaxRateReconciliationAtFederalStatutoryIncomeTaxRate
0.21
CY2018Q3 us-gaap Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
-19202000
CY2017Q3 us-gaap Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
-20706000
us-gaap Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
95631000
us-gaap Net Income Loss Available To Common Stockholders Diluted
NetIncomeLossAvailableToCommonStockholdersDiluted
-57172000
CY2018Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5215000
CY2017Q3 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5669000
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
1132000
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5669000
CY2018Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
6381000
CY2017Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
5789000
CY2018Q3 rgnx Accrued External Research And Development Expenses
AccruedExternalResearchAndDevelopmentExpenses
3136000
CY2017Q4 rgnx Accrued External Research And Development Expenses
AccruedExternalResearchAndDevelopmentExpenses
2072000
CY2018Q3 rgnx Accrued External General And Administrative Expenses
AccruedExternalGeneralAndAdministrativeExpenses
1228000
CY2017Q4 rgnx Accrued External General And Administrative Expenses
AccruedExternalGeneralAndAdministrativeExpenses
1078000
CY2018Q3 us-gaap Accrued Income Taxes Current
AccruedIncomeTaxesCurrent
1140000
CY2017Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
236000
CY2018Q3 rgnx Accrued Licensing Costs
AccruedLicensingCosts
646000

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