2021 Q4 Form 10-K Financial Statement

#000162828022004522 Filed on March 01, 2022

View on sec.gov

Income Statement

Concept 2021 Q4 2021 2020 Q4
Revenue $59.61M $213.6M $56.70M
YoY Change 5.12% -27.68% -18.53%
Cost Of Revenue $42.37M $153.4M $63.23M
YoY Change -33.0% -48.16% 65.76%
Gross Profit $17.24M $60.18M -$300.0K
YoY Change -5845.33% -10113.98% -100.76%
Gross Profit Margin 28.92% 28.18% -0.53%
Selling, General & Admin $44.83M $174.2M $40.30M
YoY Change 11.23% 13.13% -10.24%
% of Gross Profit 260.07% 289.38%
Research & Development $29.56M $147.9M $37.60M
YoY Change -21.39% -32.33% -53.23%
% of Gross Profit 171.48% 245.67%
Depreciation & Amortization $9.453M $1.927M $7.730M
YoY Change 22.29% -7.13% -20.23%
% of Gross Profit 54.84% 3.2%
Operating Expenses $83.39M $325.5M $78.87M
YoY Change 5.73% -13.39% -37.55%
Operating Profit -$66.16M -$265.3M -$85.40M
YoY Change -22.54% -29.52% -10.0%
Interest Expense -$5.083M -$19.94M -$2.300M
YoY Change 121.0% 124.73% 187.5%
% of Operating Profit
Other Income/Expense, Net $560.0K $2.414M -$1.597M
YoY Change -135.07% 30.06% 18.82%
Pretax Income -$70.68M -$282.8M -$87.00M
YoY Change -18.76% -26.24% -9.56%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$70.68M -$282.8M -$87.00M
YoY Change -18.76% -26.24% -7.92%
Net Earnings / Revenue -118.58% -132.43% -153.44%
Basic Earnings Per Share -$1.70
Diluted Earnings Per Share -$404.7K -$1.70 -$599.2K
COMMON SHARES
Basic Shares Outstanding 175.0M shares 165.9M shares 144.5M shares
Diluted Shares Outstanding 165.9M shares

Balance Sheet

Concept 2021 Q4 2021 2020 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $149.8M $149.8M $268.7M
YoY Change -44.25% -44.25% 81.93%
Cash & Equivalents $149.8M $149.8M $228.7M
Short-Term Investments $0.00 $0.00 $40.00M
Other Short-Term Assets $33.14M $33.14M $14.90M
YoY Change 122.42% 122.42% 125.76%
Inventory $38.20M $38.20M $61.02M
Prepaid Expenses
Receivables $50.88M $50.88M $26.85M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $272.0M $272.0M $371.4M
YoY Change -26.77% -26.76% 20.0%
LONG-TERM ASSETS
Property, Plant & Equipment $6.754M $40.61M $8.622M
YoY Change -21.67% 14.38% -16.94%
Goodwill $55.10M $55.10M
YoY Change 0.0% 0.0%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $49.75M $49.75M $37.98M
YoY Change 31.0% 30.93% -50.02%
Total Long-Term Assets $253.5M $253.5M $272.7M
YoY Change -7.03% -7.03% -40.93%
TOTAL ASSETS
Total Short-Term Assets $272.0M $272.0M $371.4M
Total Long-Term Assets $253.5M $253.5M $272.7M
Total Assets $525.6M $525.5M $644.1M
YoY Change -18.41% -18.41% -16.48%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $33.59M $33.59M $41.31M
YoY Change -18.69% -18.67% 5.33%
Accrued Expenses $104.5M $104.5M $130.6M
YoY Change -20.03% -20.02% 1.2%
Deferred Revenue $20.91M $15.21M
YoY Change 37.41% -61.8%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $97.54M $97.54M $0.00
YoY Change
Total Short-Term Liabilities $256.5M $256.5M $187.1M
YoY Change 37.06% 37.09% -10.08%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $96.38M
YoY Change -100.0% -100.0% 27.14%
Other Long-Term Liabilities $82.53M $192.6M $60.61M
YoY Change 36.16% 70.44% 100.55%
Total Long-Term Liabilities $82.53M $192.6M $157.0M
YoY Change -47.43% -8.02% 48.06%
TOTAL LIABILITIES
Total Short-Term Liabilities $256.5M $256.5M $187.1M
Total Long-Term Liabilities $82.53M $192.6M $157.0M
Total Liabilities $449.1M $449.1M $396.5M
YoY Change 13.26% 13.26% 5.33%
SHAREHOLDERS EQUITY
Retained Earnings -$1.460B -$1.178B
YoY Change 24.02% 48.29%
Common Stock $1.537B $1.425B
YoY Change 7.84% 19.88%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $76.46M $76.46M $247.6M
YoY Change
Total Liabilities & Shareholders Equity $525.6M $525.5M $644.1M
YoY Change -18.41% -18.41% -16.48%

Cashflow Statement

Concept 2021 Q4 2021 2020 Q4
OPERATING ACTIVITIES
Net Income -$70.68M -$282.8M -$87.00M
YoY Change -18.76% -26.24% -7.92%
Depreciation, Depletion And Amortization $9.453M $1.927M $7.730M
YoY Change 22.29% -7.13% -20.23%
Cash From Operating Activities -$62.81M -$253.0M -$30.78M
YoY Change 104.05% 129.16% -66.59%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $59.00K -$320.0K
YoY Change -100.0% -81.39% 45.45%
Acquisitions
YoY Change
Other Investing Activities $0.00 $40.00M $60.00M
YoY Change -100.0% -200.78% 166.67%
Cash From Investing Activities $0.00 $39.94M $59.69M
YoY Change -100.0% -199.84% 167.91%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 5.403M $133.7M 30.51M
YoY Change -82.29% -42.29% -67.69%
NET CHANGE
Cash From Operating Activities -62.81M -$253.0M -30.78M
Cash From Investing Activities 0.000 $39.94M 59.69M
Cash From Financing Activities 5.403M $133.7M 30.51M
Net Change In Cash -57.41M -$79.29M 59.42M
YoY Change -196.61% -197.5% 141.84%
FREE CASH FLOW
Cash From Operating Activities -$62.81M -$253.0M -$30.78M
Capital Expenditures $0.00 $59.00K -$320.0K
Free Cash Flow -$62.81M -$253.0M -$30.46M
YoY Change 106.2% 128.56% -66.86%

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Nature of Organization and Operations<div style="margin-top:6pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a biopharmaceutical company with the purpose of bettering the lives of people living with kidney disease. Akebia’s lead investigational product candidate, vadadustat, is an oral therapy for the treatment of anemia due to chronic kidney disease, or CKD. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase, or HIF-PH inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, or HIF, which stimulates erythropoietin, or EPO, production and can lead to red blood cell, or RBC, production and improved oxygen delivery to tissues. The Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for vadadustat in March of 2021 for the treatment of anemia due to CKD in adult patients with CKD on dialysis, or DD-CKD, and adult patients with CKD not on dialysis, or NDD-CKD. The Company's NDA submission was accepted for filing by the FDA in May 2021 and</span><span style="background-color:#ffffff;color:#373737;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> the FDA has indicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> for vadadustat. The FDA also assigned the application standard review and a Prescription Drug User Fee Act, or PDUFA, target action date of March 29, 2022. The Company’s collaboration partner, Otsuka Pharmaceutical Co. Ltd., submitted a Marketing Authorization Application, or MAA, for vadadustat for the treatment of anemia due to CKD in both DD-CKD and NDD-CKD adult patients to the European Medicines Agency, or EMA, in October 2021</span><span style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Vadadustat is approved and marketed in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients under the trade name Vafseo</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;position:relative;top:-3.5pt;vertical-align:baseline">TM</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">. In addition, the Company has a commercial product, Auryxia</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;position:relative;top:-3.5pt;vertical-align:baseline">®</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> (ferric citrate), which is currently approved by the U.S. Food and Drug Administration, or FDA, and marketed for two indications in the United States, the control of serum phosphorus levels in adult patients with CKD on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD. Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate).</span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities and commercializing Auryxia, and providing general and administrative support for these operations. The Company began recording revenue from the U.S. sales of Auryxia and revenue from sublicensing rights to Auryxia in Japan to the Company’s Japanese partners Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively JT and Torii, on December 12, 2018 following the consummation of the Merger with Keryx. Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation, or MTPC, from the sale of Vafseo in August 2020. In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 for additional information). The Company has not generated a profit to date and may never generate profits from product sales. Vadadustat and the Company’s other potential product candidates are subject to long development cycles, and the Company may be unsuccessful in its efforts to develop, obtain marketing approval for or market vadadustat and its other potential product candidates. If the Company does not successfully commercialize Auryxia, vadadustat or any other potential product candidate, it may be unable to achieve profitability.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Going Concern </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">As of December 31, 2021, the Company had cash and cash equivalents of approximately $149.8 million. The Company expects its cash resources to fund its current operating plan for at least twelve months from the date of this filing. However, the potential timely regulatory approval of vadadustat and the receipt of associated regulatory milestones is an important source of funding of our cash runway, which is outside of the Company’s control. There can be no assurance that the current operating plan, including with respect to vadadustat, if approved, will be achieved in the time frame anticipated by the Company, or that its cash resources will fund the Company’s operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to the Company, or at all. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">In addition, on February 18, 2022, the Company and BioPharma Credit PLC, or the Collateral Agent, BPCR Limited Partnership, as a Lender, and BioPharma Credit Investments V (Master) LP. as a Lender, entered into the First Amendment and Waiver, or the First Amendment and Waiver, which amends and waives certain provisions of the Loan Agreement, dated November 11, 2019 (see Note 18). Pursuant to the Loan Agreement, as amended, the Company’s filings of Form 10-Q for fiscal quarters ending June 30, 2022 and September 30, 2022, and its future Annual Reports on Form 10-K, must not be subject to any qualification as to going concern. If the Company does not satisfy the covenant as to going concern in any of these filings, the Company will be in default under the Loan Agreement. If an event of default occurs and is continuing under the Loan </span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">Agreement, the Collateral Agent is entitled to take enforcement action, including acceleration of amounts due under the Loan Agreement, which the Company may not have the available cash resources to repay at such time. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">The Company's management completed its going concern assessment in accordance with ASC 205-40, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:107%">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">, or ASC 205-40. Pursuant to the requirements of ASC 205-40, the Company’s management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">When substantial doubt exists under this methodology, the Company’s management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of the Company’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan through at least the next twelve months from the filing of the Company’s 2021 Annual Report on Form 10-K. However, as certain elements of the Company’s operating plan are outside of the Company’s control, including the potential timely regulatory approval of vadadustat and the receipt of associated regulatory milestones, they cannot be considered probable under ASC 205-40. There also is uncertainty as to whether or not the Company will meet our quarterly and annual debt covenants.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. The Company will require additional capital to fund its operating plan beyond the next twelve months, including pursuing development and commercial activities related to Auryxia and vadadustat, if approved, or any additional products and product candidates, including those that may be in-licensed or acquired. The Company expects to finance future cash needs through product revenue Management’s plans to alleviate the conditions that raise substantial doubt include raising additional funding through product revenue, earning milestone payments pursuant to the Company’s collaboration agreements, public or private equity or debt transactions, payments from its collaborators, strategic transactions, or a combination of these approaches. However, adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital in sufficient amounts when needed or on attractive terms, it may not be able to pursue development and commercial activities related to Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired. for the Company to continue as a going concern for a period of twelve months from the date the financial statements are issued. The Company has concluded the likelihood that its plan to obtain sufficient funding from one or more of these sources will be successful, while reasonably possible, is less than probable. Accordingly, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least twelve months from the date of issuance of these financial statements. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:107%">The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities, other than obligations under the Loan Agreement classified as current, that might result from the outcome of the uncertainties described above.</span></div>
CY2021Q4 us-gaap Cash And Cash Equivalents At Carrying Value
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149800000 USD
CY2021 us-gaap Number Of Operating Segments
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1 segment
CY2021 us-gaap Use Of Estimates
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<div style="margin-top:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Use of Estimates</span></div><div style="margin-top:6pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ 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 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. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, other non-current liabilities, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible assets and goodwill. The Company has made estimates of the impact of COVID-19 within the consolidated financial statements and there may be changes to those estimates in future periods including changes to sales, payer mix, reserves and allowances, intangible assets and goodwill. </span></div>Although the Company regularly assesses these estimates, actual results could differ materially from these estimates. Changes in estimates are recorded in the period they become known. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances.
CY2021Q4 us-gaap Cash And Cash Equivalents At Carrying Value
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CY2020Q4 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
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CY2019Q4 us-gaap Cash And Cash Equivalents At Carrying Value
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CY2021Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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CY2020Q4 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
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CY2021 us-gaap Concentration Risk Credit Risk
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<div style="margin-top:18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Concentrations of Credit Risk and Off-Balance Sheet Risk</span></div><div style="margin-top:6pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Cash, cash equivalents, investments, and accounts receivable are the only financial instruments that potentially subject the Company to concentrations of credit risk. The Company maintains its cash, cash equivalents, and investments with high quality, accredited financial institutions and, accordingly, such funds are subject to minimal credit risk. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Accounts receivable represent amounts due from the Company’s customers and collaboration partners. As part of its credit management policy, the Company performs ongoing credit evaluations of its Customers and generally does not require collateral from any customer. The Company also monitors economic conditions of its collaboration partners to identify facts or circumstances that may indicate that any of its accounts receivable are at risk of collection.</span></div>
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CY2021 us-gaap Depreciation
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CY2021Q1 akba Contractual Arrangement Royalties Agreement Maximum Aggregate Royalty Payout Capacity
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0.85
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CY2020Q4 us-gaap Cash And Cash Equivalents At Carrying Value
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CY2020Q4 us-gaap Inventory Finished Goods Net Of Reserves
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CY2021 us-gaap Inventory Write Down
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CY2020 us-gaap Inventory Write Down
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CY2021Q4 us-gaap Goodwill
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CY2020Q4 us-gaap Accrued Liabilities Current
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130624000 USD
CY2021Q4 us-gaap Long Term Debt Maturities Repayments Of Principal In Year Three
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CY2021Q4 us-gaap Long Term Debt Maturities Repayments Of Principal In Year Five
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0 USD
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CY2021Q4 us-gaap Debt Instrument Carrying Amount
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100000000 USD
CY2021Q4 us-gaap Debt Instrument Unamortized Discount Premium And Debt Issuance Costs Net
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2457000 USD
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