2021 Q4 Form 10-K Financial Statement

#000156459022009929 Filed on March 14, 2022

View on sec.gov

Income Statement

Concept 2021 Q4 2021 2020 Q4
Revenue $11.54M $36.94M $7.130M
YoY Change 61.91% 7.27% -17.42%
Cost Of Revenue $3.033M $8.177M $2.460M
YoY Change 23.29% 40.5% 86.36%
Gross Profit $8.511M $28.76M $4.670M
YoY Change 82.25% 0.53% -36.11%
Gross Profit Margin 73.73% 77.86% 65.5%
Selling, General & Admin $17.03M $53.08M $11.59M
YoY Change 46.92% 16.83% 0.35%
% of Gross Profit 200.07% 184.54% 248.18%
Research & Development $8.918M $28.50M $5.210M
YoY Change 71.17% 63.61% 26.15%
% of Gross Profit 104.78% 99.09% 111.56%
Depreciation & Amortization $698.0K $311.0K $660.0K
YoY Change 5.76% 64.55% 3.13%
% of Gross Profit 8.2% 1.08% 14.13%
Operating Expenses $26.56M $84.04M $17.40M
YoY Change 52.65% 17.16% 6.75%
Operating Profit -$18.05M -$55.28M -$12.73M
YoY Change 41.79% 48.23% 41.68%
Interest Expense -$1.382M $5.498M -$1.830M
YoY Change -24.48% -24.24% 27.97%
% of Operating Profit
Other Income/Expense, Net -$3.141M
YoY Change -61.24%
Pretax Income -$19.43M -$58.42M -$15.47M
YoY Change 25.61% 28.69% 48.61%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$19.43M -$58.42M -$15.47M
YoY Change 25.61% 28.69% 48.61%
Net Earnings / Revenue -168.33% -158.14% -216.97%
Basic Earnings Per Share -$2.03
Diluted Earnings Per Share -$593.4K -$2.031M -$1.066M
COMMON SHARES
Basic Shares Outstanding 28.76M
Diluted Shares Outstanding 28.76M

Balance Sheet

Concept 2021 Q4 2021 2020 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $211.6M $211.6M $44.91M
YoY Change 371.16% 371.18% 102.29%
Cash & Equivalents $178.6M $178.6M $44.91M
Short-Term Investments $33.00M $32.97M $0.00
Other Short-Term Assets $4.217M $4.217M $3.400M
YoY Change 24.03% 24.03% -43.33%
Inventory $3.616M $3.616M $5.337M
Prepaid Expenses $3.372M
Receivables $18.35M $18.35M $9.500M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $237.7M $237.7M $63.12M
YoY Change 276.67% 276.77% 51.3%
LONG-TERM ASSETS
Property, Plant & Equipment $476.0K $2.728M $630.0K
YoY Change -24.44% -14.75% 76.47%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $150.0K $150.0K $200.0K
YoY Change -25.0% -25.0% 0.0%
Total Long-Term Assets $25.63M $25.63M $28.60M
YoY Change -10.39% -10.4% -8.49%
TOTAL ASSETS
Total Short-Term Assets $237.7M $237.7M $63.12M
Total Long-Term Assets $25.63M $25.63M $28.60M
Total Assets $263.4M $263.4M $91.72M
YoY Change 187.16% 187.21% 25.69%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.385M $7.385M $4.811M
YoY Change 53.5% 53.85% 14.77%
Accrued Expenses $14.42M $15.07M $8.445M
YoY Change 70.78% 67.41% 23.61%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $137.0K $137.0K $100.0K
YoY Change 37.0% 37.0%
Total Short-Term Liabilities $23.66M $23.66M $14.89M
YoY Change 58.91% 58.78% 29.24%
LONG-TERM LIABILITIES
Long-Term Debt $36.56M $36.60M $37.98M
YoY Change -3.73% -3.69% -19.58%
Other Long-Term Liabilities $2.352M $18.74M $2.365M
YoY Change -0.55% -7.25% -21.17%
Total Long-Term Liabilities $38.91M $55.33M $40.34M
YoY Change -3.54% -4.92% -19.67%
TOTAL LIABILITIES
Total Short-Term Liabilities $23.66M $23.66M $14.89M
Total Long-Term Liabilities $38.91M $55.33M $40.34M
Total Liabilities $78.99M $78.99M $73.18M
YoY Change 7.95% 7.91% 13.2%
SHAREHOLDERS EQUITY
Retained Earnings -$569.1M -$510.7M
YoY Change 11.44% 9.76%
Common Stock $752.6M $528.4M
YoY Change 42.44% 11.76%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $184.4M $184.4M $18.54M
YoY Change
Total Liabilities & Shareholders Equity $263.4M $263.4M $91.72M
YoY Change 187.16% 187.21% 25.69%

Cashflow Statement

Concept 2021 Q4 2021 2020 Q4
OPERATING ACTIVITIES
Net Income -$19.43M -$58.42M -$15.47M
YoY Change 25.61% 28.69% 48.61%
Depreciation, Depletion And Amortization $698.0K $311.0K $660.0K
YoY Change 5.76% 64.55% 3.13%
Cash From Operating Activities -$16.67M -$50.10M $5.890M
YoY Change -382.99% 247.05% -151.26%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $156.0K -$190.0K
YoY Change -100.0% -56.91%
Acquisitions
YoY Change
Other Investing Activities -$32.97M -$32.97M
YoY Change
Cash From Investing Activities -$32.97M -$33.12M -$190.0K
YoY Change 17250.0% 9049.45%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net $0.00
YoY Change -100.0%
Cash From Financing Activities 108.5M 216.9M 10.48M
YoY Change 935.46% 478.53% 440.21%
NET CHANGE
Cash From Operating Activities -16.67M -50.10M 5.890M
Cash From Investing Activities -32.97M -33.12M -190.0K
Cash From Financing Activities 108.5M 216.9M 10.48M
Net Change In Cash 58.88M 133.7M 16.18M
YoY Change 263.92% 489.05% -269.42%
FREE CASH FLOW
Cash From Operating Activities -$16.67M -$50.10M $5.890M
Capital Expenditures $0.00 $156.0K -$190.0K
Free Cash Flow -$16.67M -$50.25M $6.080M
YoY Change -374.14% 239.62% -152.92%

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45059000
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CY2021 us-gaap Nature Of Operations
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<div style="align:left;"> <table border="0" cellpadding="0" cellspacing="0" style="border-collapse:collapse; width:100%;"> <tr> <td style="width:4.54%;white-space:nowrap" valign="top"> <p style="margin-bottom:0pt;margin-top:10pt;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><span style="font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1.</span></p></td> <td valign="top"> <p style="margin-bottom:0pt;margin-top:10pt;font-weight:bold;font-style:normal;text-transform:none;font-variant: normal;font-family:Times New Roman;font-size:10pt;"><span style="font-weight:normal;"/>Operations</p></td></tr></table></div> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">EyePoint Pharmaceuticals, Inc. (together with its subsidiaries, the “Company”), incorporated in Delaware, is<span style="Background-color:#FFFFFF;"> a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders. The Company’s pipeline leverages its proprietary Durasert</span><sup style="font-size:85%;line-height:120%;vertical-align:top">® </sup><span style="Background-color:#FFFFFF;">technology for sustained intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF treatment initially targeting wet age-related macular degeneration (“wet AMD”), the leading cause of vision loss among people 50 years of age and older in the United States. The Company’s product candidate pipeline also includes YUTIQ 50, a potential six-month treatment for non-infectious uveitis affecting the posterior segment of the eye, one of the leading causes of blindness under a supplemental New Drug Application (“sNDA”) strategy. The Company also has two commercial products: YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup>, a once every three-year treatment for chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup>, a single dose treatment for postoperative inflammation following ocular surgery.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Local drug delivery for treating ocular diseases is a significant challenge due to the effectiveness of the blood-eye barrier. This barrier makes it difficult for systemically-administered drugs to reach the eye in sufficient quantities to have a beneficial effect without causing unacceptable adverse side effects to other organs. The Company’s validated Durasert technology, which has already been included in four products approved for marketing by the U.S. Food and Drug Administration (“FDA”), is designed to provide consistent, sustained delivery of small molecule drugs over a period of months to years through a single intravitreal injection. </p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The Company’s lead product candidate, EYP-1901, combines a bioerodible formulation of its proprietary Durasert sustained-release technology with vorolanib, a tyrosine kinase inhibitor (“TKI”) that has demonstrated anti-VEGF activity. Current FDA approved anti-VEGF treatments for wet AMD require monthly or bi-monthly intravitreal injections in a physician’s office. The Company is currently evaluating EYP-1901 in a Phase 1 clinical trial as a potential six-month sustained delivery treatment for wet AMD and reported positive six-month interim safety and efficacy data in November 2021. In February 2022, the Company updated the results of the DAVIO clinical trial through 8-months reporting continued positive safety and efficacy results. The Company expects to initiate a Phase 2 clinical trial in wet AMD in the third quarter of 2022 and a Phase 2 clinical trial in diabetic retinopathy later in the second half of 2022.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">YUTIQ<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> (fluocinolone acetonide intravitreal implant) 0.18 mg for intravitreal injection, is a non-erodible intravitreal implant containing fluocinolone acetonide (“FA”) lasting for up to 36 months and is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. This disease affects between 60,000 to 100,000 people each year in the U.S. causes approximately 30,000 new cases of blindness every year and is the third leading cause of blindness. YUTIQ utilizes the Company’s proprietary Durasert<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> sustained-release drug delivery technology platform.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">DEXYCU<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> (dexamethasone intraocular suspension) 9%, for intraocular administration, is indicated for the treatment of post-operative ocular inflammation, with the Company’s primary focus on its use immediately following cataract surgery as a single dose treatment. DEXYCU utilizes the Company’s proprietary Verisome<sup style="font-size:85%;line-height:120%;vertical-align:top">®</sup> drug-delivery technology. In December 2021, the Company announced that its commercial alliance partner, ImprimisRx, assumed responsibility for all sales and marketing activity for DEXYCU effective January 1, 2022.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The Company is also developing YUTIQ 50 as a potential six-month intravitreal treatment for chronic non-infectious uveitis affecting the posterior segment of the eye. The Company dosed the first patient in a Phase 3 clinical trial in November 2021.</span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The</span> Company is also seeking to potentially identify and advance additional product candidates through clinical and regulatory development. This may be accomplished through internal discovery efforts, potential research collaborations and/or in-licensing arrangements with partner molecules and potential acquisition of additional ophthalmic products, product candidates or technologies that complement the Company’s current product portfolio.</p> <p style="Background-color:#FFFFFF;margin-bottom:0pt;margin-top:10pt;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;">Effects of the COVID-19 Coronavirus Pandemic<span style="Background-color:#FFFFFF;"> </span></p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The</span><span style="color:#000000;"> ongoing COVID-19 coronavirus pandemic</span><span style="Background-color:#FFFFFF;color:#000000;"> (the “Pandemic”)</span><span style="color:#000000;"> has had a material and adverse impact on the Company’s business, including as a result of measures that the Company, other businesses, and government have taken and will likely continue to take. This includes a significant impact on cash flows from expected revenues due to the closure of ambulatory surgery centers for DEXYCU and a significant reduction in physician office visits impacting YUTIQ in 2020. The ongoing Pandemic continued to have an adverse impact on the Company’s revenues, financial condition and cash flows through 2021. For the year ended December 31, 2021, the Company recorded impairment charges of $1.2 million to cost of sales, excluding amortization of acquired intangible assets and $0.1 million to sales and marketing expense, respectively, associated with the write-off of obsolete inventory of DEXYCU units and DEXYCU sample units, respectively, whose inventory levels were higher than the Company’s updated forecasts of future demand </span></p> <p style="margin-top:10pt;margin-bottom:0pt;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="color:#000000;">for those units. </span><span style="color:#000000;">Additionally, the emergence of </span><span style="color:#000000;">the Omicron </span><span style="color:#000000;">variant has </span><span style="color:#000000;">continued to have an adverse impact on the Company’s revenues, financial condition and cash flows into the first quarter of 2022</span><span style="color:#000000;"> and may continue to cause intermittent or prolonged periods of reduced patient services at the Company’s customers’ facilities, which may negatively affect customer demand. The progression of the Pandemic and its effects on the Company’s business and operations are uncertain at this time. Depending on the future developments that are uncertain and difficult to predict, including new information that may emerge concerning the Pandemic, the Company’s revenues, financial condition and cash flows may be adversely affected in the future as well.</span><span style="color:#000000;"> </span><span style="color:#000000;">The Company is </span><span style="color:#000000;">continuously </span><span style="color:#000000;">monitoring the Pandemic and its potential effect on the Company’s financial position, results of operations and cash flows. This uncertainty could have an impact in future periods on certain estimates used in the preparation of the Company’s periodic financial results, including reserves for variable consideration related to product sales, realizability of certain receivables, assessment for excess or obsolete inventory, and impairment of long-lived assets. </span><span style="Background-color:#FFFFFF;color:#000000;">Uncertainty around the extent and duration of the Pandemic, and any future related financial impact cannot be reasonably estimated at this time.</span><span style="Background-color:#FFFFFF;color:#000000;"> </span></p> <p style="margin-bottom:0pt;margin-top:10pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Liquidity</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><span style="Background-color:#FFFFFF;">The</span><span style="color:#000000;"> Company had cash, cash equivalents, and investments in marketable securities of $211.6</span><span style="font-size:12pt;"> </span><span style="color:#000000;">million at December 31, 2021. </span><span style="Background-color:#FFFFFF;color:#000000;">The Company has a history of operating losses and has not had significant recurring cash inflows from revenue.</span><span style="color:#000000;"> The Company’s operations have been financed primarily from sales of its equity securities, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from its collaboration partners. The Company anticipates that it will continue to incur losses as it continues the research and development of its product candidates and the Company does not expect revenues from its product sales to generate sufficient funding to sustain its operations in the near-term. The Company expects to continue fulfilling its funding needs through cash inflows from revenues of its product sales, licensing and research collaboration transactions, additional equity capital raises and other arrangements. The Company believes that its cash, cash equivalents, and investments in marketable securities of $211.6</span><span style="font-size:12pt;"> </span><span style="color:#000000;">million at December 31, 2021, coupled with expected cash inflows from its product sales will enable the Company to fund its current and planned operations for </span><span style="Background-color:#FFFFFF;color:#000000;">at least the next twelve months from the date these consolidated financial statements were issued. A</span><span style="color:#000000;">ctual cash requirements could differ from management’s projections due to many factors, including the continued effect of the Pandemic on the Company’s business and the medical community, </span><span style="Background-color:#FFFFFF;color:#000000;">the timing and results of the Company’s clinical trials for EYP-1901, </span><span style="color:#000000;">additional </span><span style="Background-color:#FFFFFF;color:#000000;">investments</span><span style="color:#000000;"> in research and development programs, the success of ongoing </span><span style="Background-color:#FFFFFF;color:#000000;">commercialization</span><span style="color:#000000;"> efforts for YUTIQ and DEXYCU, the actual costs of these ongoing commercialization efforts, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.</span></p>
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<p style="margin-bottom:0pt;margin-top:10pt;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-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates and assumptions that affect the reported amounts and disclosure of assets and liabilities at the date of the consolidated financial statements and the reported amounts and disclosure of revenues and expenses during the reporting periods. Significant management estimates and assumptions include, among others, those related to reserves for variable consideration related to product sales, revenue recognition for multiple-deliverable arrangements, recognition of expense in outsourced clinical trial agreements, recording of excess or obsolete inventory write-offs and reserves, and realization of deferred tax assets. Actual results could differ from these and other estimates and there may be changes to the Company’s estimates in future periods. </p>
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CY2021 us-gaap Concentration Risk Credit Risk
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<p style="margin-bottom:0pt;margin-top:10pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Concentrations of Credit Risk </p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, and investments in marketable securities. At December 31, 2021, a total of $155.6 million, or 90.4% of the Company’s interest-bearing cash equivalent balances, were concentrated in one U.S. Government institutional money market fund that had investments consisting primarily of U.S. Government Agency debt, U.S. Treasury debt, U.S. Treasury Repurchase Agreements and U.S. Government Agency Repurchase Agreements. $16.5 million, or 9.6% of the Company’s interest-bearing cash equivalent balances consisted of investment-grade commercial paper. Generally, these investments may be sold upon demand and, therefore, the Company believes they have minimal risk. The Company had investments of $33.0 million and $0 in marketable securities at December 31, 2021 and 2020, respectively. The Company’s investment policy, approved by the Company’s Board of Directors, includes guidelines relative to diversification and maturities designed to preserve principal and liquidity. </p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of December 31, 2021, accounts receivable from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 54.7% and 38.3% of total accounts receivable, respectively. For the year ended December 31, 2021, revenues from McKesson Specialty Care Distribution LLC and ASD Specialty Healthcare LLC accounted for 46.6% and 43.1% of total revenues, respectively.</p> <p style="margin-top:10pt;margin-bottom:0pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As of December 31, 2020, accounts receivable from ASD Specialty Healthcare LLC and McKesson Specialty Care Distribution LLC accounted for 56.0% and 37.0% of total accounts receivable, respectively. For the year ended December 31, 2020, revenues from ASD Specialty Healthcare LLC, Ocumension Therapeutics, and McKesson Specialty Care Distribution LLC accounted for 39.0%, 33.0%, and 18.0% of total revenues, respectively.</p>
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CY2020Q4 us-gaap Finance Lease Right Of Use Asset
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CY2021Q4 us-gaap Finance Lease Liability
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CY2020Q4 us-gaap Finance Lease Liability
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CY2021 us-gaap Income Tax Reconciliation Change In Deferred Tax Assets Valuation Allowance
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CY2021Q4 us-gaap Deferred Tax Assets Tax Credit Carryforwards Research
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CY2020Q4 us-gaap Deferred Tax Assets Tax Credit Carryforwards Research
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CY2021Q4 us-gaap Deferred Tax Assets Other
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CY2020Q4 us-gaap Deferred Tax Assets Other
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CY2020Q4 us-gaap Deferred Tax Liabilities Goodwill And Intangible Assets Intangible Assets
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CY2021 us-gaap Income Tax Reconciliation Change In Enacted Tax Rate
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