2019 Q1 Form 10-K Financial Statement

#000156459019008830 Filed on March 22, 2019

View on sec.gov

Income Statement

Concept 2019 Q1 2018 Q4 2018
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue $900.0K
YoY Change
Gross Profit -$900.0K
YoY Change
Gross Profit Margin
Selling, General & Admin $2.930M $2.150M $10.20M
YoY Change 4.27% -19.48% 8.74%
% of Gross Profit
Research & Development $3.793M $3.330M $10.32M
YoY Change 15.43% -1.19% -33.69%
% of Gross Profit
Depreciation & Amortization $14.60K $90.00K $49.62K
YoY Change -91.51% -74.29% -96.77%
% of Gross Profit
Operating Expenses $4.841M $5.470M $16.14M
YoY Change -20.55% -9.29% -35.31%
Operating Profit -$4.841M -$16.14M
YoY Change -20.55% -35.31%
Interest Expense $695.5K $7.420M $3.751M
YoY Change 1779.65% -1039.24% 2698.98%
% of Operating Profit
Other Income/Expense, Net -$1.472M -$40.00K -$2.079M
YoY Change -83.16% -233.33% 42.02%
Pretax Income -$9.420M -$820.0K -$8.503M
YoY Change -36.48% -87.94% -67.64%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$6.313M -$820.0K -$18.20M
YoY Change -57.44% -87.94% -31.1%
Net Earnings / Revenue
Basic Earnings Per Share -$0.23
Diluted Earnings Per Share -$7.030M -$828.3K -$0.79
COMMON SHARES
Basic Shares Outstanding 94.60M 36.40M
Diluted Shares Outstanding 37.09M

Balance Sheet

Concept 2019 Q1 2018 Q4 2018
SHORT-TERM ASSETS
Cash & Short-Term Investments $7.380M $15.54M $15.54M
YoY Change -52.42% 94.71% 94.74%
Cash & Equivalents $308.7K $1.628M $15.54M
Short-Term Investments $0.00 $0.00
Other Short-Term Assets $760.0K $172.0K $860.0K
YoY Change -11.63% 40.98% 352.63%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $8.140M $1.942M $16.40M
YoY Change -50.27% -76.25% 100.49%
LONG-TERM ASSETS
Property, Plant & Equipment $135.0K $245.8K $140.0K
YoY Change -96.97% -90.97% -94.85%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $6.426M $116.3K $890.0K
YoY Change 1160.0% -16.91% 535.71%
Total Long-Term Assets $6.698M $512.6K $1.030M
YoY Change 35.04% -82.08% -63.99%
TOTAL ASSETS
Total Short-Term Assets $8.140M $1.942M $16.40M
Total Long-Term Assets $6.698M $512.6K $1.030M
Total Assets $14.84M $2.454M $17.43M
YoY Change -30.44% -77.76% 57.88%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.100M $3.278M $1.590M
YoY Change -19.12% 322.36% 103.85%
Accrued Expenses $99.00K $1.403M $1.000M
YoY Change -94.31% -48.14% -63.1%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $7.484M $0.00
YoY Change
Long-Term Debt Due $0.00 $0.00
YoY Change -100.0% -100.0%
Total Short-Term Liabilities $2.317M $14.11M $2.870M
YoY Change -72.48% 270.82% -24.67%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $1.017M $0.00
YoY Change
Other Long-Term Liabilities $18.05M $37.46K $15.01M
YoY Change -45.27% -99.8% -18.86%
Total Long-Term Liabilities $18.05M $1.054M $15.01M
YoY Change -45.27% -94.3% -18.86%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.317M $14.11M $2.870M
Total Long-Term Liabilities $18.05M $1.054M $15.01M
Total Liabilities $20.37M $15.16M $17.89M
YoY Change -50.8% -32.01% -19.78%
SHAREHOLDERS EQUITY
Retained Earnings -$226.2M $31.24M
YoY Change -115.0%
Common Stock $220.7M $215.9M
YoY Change 9.64%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$18.61M -$12.71M -$460.0K
YoY Change
Total Liabilities & Shareholders Equity $14.84M $2.454M $17.43M
YoY Change -30.44% -77.76% 57.88%

Cashflow Statement

Concept 2019 Q1 2018 Q4 2018
OPERATING ACTIVITIES
Net Income -$6.313M -$820.0K -$18.20M
YoY Change -57.44% -87.94% -31.1%
Depreciation, Depletion And Amortization $14.60K $90.00K $49.62K
YoY Change -91.51% -74.29% -96.77%
Cash From Operating Activities -$2.667M -$6.940M -$11.63M
YoY Change -181.17% 60.65% -49.48%
INVESTING ACTIVITIES
Capital Expenditures $10.58K -$70.00K $77.41K
YoY Change -99.16% -53.33% -71.95%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00 $900.0K
YoY Change -100.0% -100.0% -194.74%
Cash From Investing Activities -$10.58K -$70.00K -$77.41K
YoY Change -97.02% -109.33% -93.71%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $0.00
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $1.359M 17.36M $7.185M
YoY Change -75.27% -11673.33% -1345.16%
NET CHANGE
Cash From Operating Activities -$2.667M -6.940M -$11.63M
Cash From Investing Activities -$10.58K -70.00K -$77.41K
Cash From Financing Activities $1.359M 17.36M $7.185M
Net Change In Cash -$1.319M 10.35M -$4.523M
YoY Change -115.66% -378.23% -81.78%
FREE CASH FLOW
Cash From Operating Activities -$2.667M -$6.940M -$11.63M
Capital Expenditures $10.58K -$70.00K $77.41K
Free Cash Flow -$2.678M -$6.870M -$11.71M
YoY Change -231.85% 64.75% -49.74%

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<div align="left"> <table border="0" cellspacing="0" cellpadding="0" style="border-collapse:collapse; width:100%;"> <tr> <td valign="top" style="width:5.24%;white-space:nowrap"> <p style="margin-bottom:0pt;margin-top:12pt;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1.</font></p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:12pt;font-weight:bold;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;">NATURE OF BUSINESS </p></td></tr></table></div> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Organization</p> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Histogenics Corporation (the &#8220;Company&#8221;) was incorporated under the laws of the Commonwealth of Massachusetts on June&#160;28, 2000 and has its principal operations in Waltham, Massachusetts. In 2006, the Company&#8217;s board of directors approved a corporate reorganization pursuant to which the Company incorporated as a Delaware corporation. The Company historically focused on the development of restorative cell therapies (RCTs). RCTs refer to a new class of products that are designed to offer patients rapid-onset pain relief and restored function through the repair of damaged or worn tissue. The Company&#8217;s lead product, NeoCart<sup style="font-size:85%; vertical-align:top">&#174;</sup>, is an innovative cell therapy designed to treat tissue injury in the field of orthopedics, specifically cartilage damage in the knee. In the third quarter of 2018, the Company announced that its Phase 3 clinical trial of NeoCart did&#160;not meet the primary endpoint in the Phase 3 clinical trial. Histogenics subsequently initiated a dialogue with the United States Food and Drug Administration (FDA) to discuss the regulatory path forward for NeoCart with a goal of determining whether the FDA would accept a submission of a Biologics License Application (BLA) for NeoCart without data from an additional Phase 3 clinical trial. In December 2018, the Company received final feedback from the FDA indicating the need for an additional Phase 3 clinical trial prior to the FDA&#8217;s acceptance of a NeoCart BLA submission. However, considering the time and funding required to conduct such a trial, the Company discontinued the development of NeoCart and is not planning to submit a BLA. In addition, the Company initiated a process to evaluate strategic alternatives to maximize value for all of its stakeholders. The process is being conducted with the assistance of financial and legal advisors and is evaluating the full range of potential strategic alternatives, including but not limited to, acquisitions, business combinations, joint ventures, public and private capital raises and recapitalization and sale transaction options, including a sale of assets or intellectual property. Since these efforts may not be successful and given our limited cash reserves, we are also considering other possible alternatives, including a wind-down of operations, or Chapter 11 bankruptcy protection to complete or execute a restructuring transaction or liquidation.&nbsp;&nbsp;</p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On May&#160;13, 2011, the Company completed the acquisition of ProChon Biotech Ltd. (&#8220;ProChon&#8221;), a privately-held biotechnology company focused on modulating the fibroblast growth factor system for consideration of $2.2 million to enable it to create more effective solutions for tissue regeneration. ProChon&#8217;s products combine cell regeneration technologies with proprietary growth factors and biocompatible scaffolds to restore injured or chronically damaged tissues. The acquisition led to the initial recognition of goodwill, which was subsequently written off in 2011, and intangible assets including IPR&amp;D and a licensing agreement which were fully impaired in 2016 as discussed in Note 2. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On September&#160;29, 2016, the Company closed a private placement of common stock, preferred stock and warrants, contemplated by a securities purchase agreement dated September&#160;15, 2016, with certain institutional and accredited investors. The net proceeds after deducting placement agent fees and other transaction-related expenses were $27.6 million. See Note 8, Capital Stock, for further discussion of the private placement. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In January 2018, the Company closed a registered direct offering where the Company issued 2,691,494 shares of<font style="font-weight:bold;"> </font>common stock at a price of $2.35 per share.&nbsp;&nbsp;The underwriter option to purchase additional shares of 351,064 were fully exercised.&nbsp;&nbsp;The total net proceeds of the offering were approximately $5.9 million after deducting underwriting discounts and commissions.</p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In March 2018, the Company entered into an equity distribution agreement (&#8220;ATM Agreement&#8221;) with Canaccord Genuity Inc. (&#8220;Canaccord&#8221;), pursuant to which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $10.0 million (the &#8220;Shares&#8221;) through Canaccord, as sales agent. During the year ended December 31, 2018, the Company sold an aggregate of 6,633,903 shares of common stock and received $4.5 million after deducting commissions related to the ATM Agreement and other offering costs. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In October 2018, the Company closed an underwritten public offering of 26,155,000 shares of its common stock and warrants to purchase up to 19,616,250 shares of common stock, at a combined purchase price of&#160;$0.65&#160;per share of common stock and accompanying warrant. The gross proceeds to&#160;Histogenics&#160;from this offering were&#160;$17.0 million, before deducting underwriting discounts and commissions, and offering expenses payable by the Company.&#160; The warrants are exercisable immediately upon issuance at a price of&#160;$0.70&#160;per share of common stock and have a term of five years commencing on the date of issuance.&#160;</p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Since its inception, the Company has devoted substantially all of its efforts to product development, recruiting management and technical staff, raising capital, starting up production and building infrastructure and has not yet generated product revenues. Expenses have primarily been for research and development and related administrative costs. </p> <p style="margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is subject to a number of risks including the successful development of therapeutics, the ability to obtain adequate financing, the ability to obtain FDA approval and reimbursement for any products we may develop, protection of intellectual property, fluctuations in operating results, dependence on key personnel and collaborative partners, rapid technological changes inherent in the target markets of any products the Company may develop, the introduction of substitute products and competition from larger companies.&nbsp;&nbsp;</p> <p style="margin-top:18pt;margin-bottom:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Liquidity</p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements, the Company has incurred losses and cash flow deficits from operations since inception, resulting in an accumulated deficit at December 31, 2018 of $216.8 million. The Company has financed operations to date primarily through public and private placements of equity securities, and borrowings under debt agreements. The Company anticipates that it will continue to incur net losses for the foreseeable future. The Company believes that its existing cash, cash equivalents and marketable securities will only be sufficient to fund its projected cash needs into the middle of 2019. Accordingly, these factors, among others, raise substantial doubt about the Company&#8217;s ability to continue as a going concern. <font style="color:#000000;">To meet future capital needs, the Company would need to raise additional capital through debt or equity financing or other strategic transactions.</font> However, any such financing may not be on favorable terms or available to the Company.<font style="color:#000000;"> The failure of the Company to obtain sufficient funds on commercially acceptable terms when needed will have a material adverse effect on the Company&#8217;s business, results of operations and financial condition. The forecast of cash resources is forward-looking information that involves risks and uncertainties, and the actual amount of our expenses could vary materially and adversely as a result of a number of factors. The Company has based its estimates on assumptions that may prove to be wrong, and the Company&#8217;s expenses could prove to be significantly higher than it currently anticipates.</font></p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;">&nbsp;</p>
CY2018 us-gaap Use Of Estimates
UseOfEstimates
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Use of Estimates </p> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The preparation of the Company&#8217;s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company&#8217;s consolidated financial statements and accompanying notes. The most significant estimates in the Company&#8217;s consolidated financial statements relate to the valuation of equity awards, warrant liability, recoverability of deferred tax assets, estimated useful lives of fixed assets. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company recorded in 2018 a loss on impairment of fixed assets. See Note 5 Property and Equipment. The Company&#8217;s actual results may differ from these estimates under different assumptions or conditions. </p>
CY2018 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Concentration of Credit Risk </p> <p style="margin-bottom:0pt;margin-top:6pt;text-indent:0%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Financial instruments, which potentially subject the Company to significant concentration of credit risk, consist primarily of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company has not experienced any losses in such accounts and management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has no financial instruments with off-balance sheet risk of loss. </p>
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CY2018 us-gaap Convertible Preferred Stock Terms Of Conversion
ConvertiblePreferredStockTermsOfConversion
The Series A Preferred Stock shall not be converted if, after giving effect to the conversion, the holder and its affiliated persons would own beneficially more than 4.99% of our common stock (subject to adjustment up to 9.99% solely at the holder’s discretion upon 61 days’ prior notice to us or, solely as to a holder, if such limitation is waived by such holder upon execution of the private placement agreement).
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CY2017 us-gaap Share Based Goods And Nonemployee Services Transaction Valuation Method Expected Dividend Rate
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CY2017 us-gaap Income Loss From Continuing Operations Before Income Taxes Foreign
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CY2018 us-gaap Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments
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CY2017 us-gaap Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments
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CY2017 us-gaap Effective Income Tax Rate Reconciliation At Federal Statutory Income Tax Rate
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0.337
CY2018 us-gaap Effective Income Tax Rate Reconciliation State And Local Income Taxes
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CY2017 us-gaap Effective Income Tax Rate Reconciliation State And Local Income Taxes
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CY2018 hsgx Effective Income Tax Rate Reconciliation Permanent Differences
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0.000
CY2018 us-gaap Effective Income Tax Rate Reconciliation Change In Enacted Tax Rate
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CY2018 hsgx Effective Income Tax Rate Reconciliation R And D Credit Limitation
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-0.985
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-0.004
CY2018 us-gaap Effective Income Tax Rate Continuing Operations
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0.000
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4878000
CY2018Q4 us-gaap Deferred Tax Assets Tax Deferred Expense Reserves And Accruals Accrued Liabilities
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141000
CY2018Q4 hsgx Deferred Tax Assets Capitalized Start Up Costs
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9143000
CY2018Q4 us-gaap Deferred Tax Assets Tax Credit Carryforwards Research
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312000
CY2018Q4 us-gaap Deferred Tax Assets Other
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1155000
CY2018 hsgx Tax Cuts And Jobs Act Of2017 Limitation Of Net Operating Loss Deduction Percentage Of Annual Taxable Income
TaxCutsAndJobsActOf2017LimitationOfNetOperatingLossDeductionPercentageOfAnnualTaxableIncome
0.80
CY2018 hsgx Tax Cuts And Jobs Act Of2017 Change In Tax Rate Income Tax Expense Benefit
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0
CY2017Q4 us-gaap Unrecognized Tax Benefits
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303000
CY2018 us-gaap Unrecognized Tax Benefits Income Tax Penalties And Interest Expense
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0
CY2017Q4 us-gaap Significant Change In Unrecognized Tax Benefits Is Reasonably Possible Amount Of Unrecorded Benefit
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0
CY2016Q4 us-gaap Unrecognized Tax Benefits
UnrecognizedTaxBenefits
562000
CY2018 us-gaap Unrecognized Tax Benefits Decreases Resulting From Current Period Tax Positions
UnrecognizedTaxBenefitsDecreasesResultingFromCurrentPeriodTaxPositions
0
CY2017 us-gaap Unrecognized Tax Benefits Decreases Resulting From Current Period Tax Positions
UnrecognizedTaxBenefitsDecreasesResultingFromCurrentPeriodTaxPositions
123000
CY2018 hsgx Unrecognized Tax Benefits Federal Rate Revision
UnrecognizedTaxBenefitsFederalRateRevision
0
CY2017 hsgx Unrecognized Tax Benefits Federal Rate Revision
UnrecognizedTaxBenefitsFederalRateRevision
136000
CY2018Q4 us-gaap Unrecognized Tax Benefits
UnrecognizedTaxBenefits
303000
CY2018Q4 us-gaap Unrecognized Tax Benefits Income Tax Penalties And Interest Accrued
UnrecognizedTaxBenefitsIncomeTaxPenaltiesAndInterestAccrued
0
CY2018 us-gaap Income Tax Examination Description
IncomeTaxExaminationDescription
The Company is subject to U.S. federal, state and local income tax examinations by tax authorities for years 2001 through present. Carryforward attributes that were generated in earlier periods remain subject to examination to the extent the year in which they were used or will be used remains open for examination. The tax years which remain subject to examination by tax authorities in Israel, as of December 31, 2018, include years 2014 through the present.
CY2018 us-gaap Defined Contribution Plan Employer Discretionary Contribution Amount
DefinedContributionPlanEmployerDiscretionaryContributionAmount
0

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0001564590-19-008830.txt Edgar Link pending
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