2023 Q3 Form 10-Q Financial Statement

#000168954823000128 Filed on August 09, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2
Revenue $468.0K $781.0K
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $8.720M $10.13M
YoY Change -37.04% -38.15%
% of Gross Profit
Research & Development $17.26M $25.61M
YoY Change -43.3% -41.28%
% of Gross Profit
Depreciation & Amortization $110.0K $106.0K
YoY Change 7.84% -10.92%
% of Gross Profit
Operating Expenses $25.98M $35.74M
YoY Change -41.33% -40.82%
Operating Profit -$25.52M -$34.96M
YoY Change -42.39% -42.11%
Interest Expense $880.0K $648.0K
YoY Change 155.07% 224.0%
% of Operating Profit
Other Income/Expense, Net $884.0K $648.0K
YoY Change 156.23% 224.0%
Pretax Income -$24.63M -$34.31M
YoY Change -43.95% -43.0%
Income Tax
% Of Pretax Income
Net Earnings -$24.63M -$34.31M
YoY Change -43.95% -43.0%
Net Earnings / Revenue -5263.25% -4393.34%
Basic Earnings Per Share -$0.18 -$0.49
Diluted Earnings Per Share -$0.18 -$0.49
COMMON SHARES
Basic Shares Outstanding 128.5M shares 62.10M shares
Diluted Shares Outstanding 135.6M shares 69.74M shares

Balance Sheet

Concept 2023 Q3 2023 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $101.1M $124.3M
YoY Change -18.3% -24.85%
Cash & Equivalents $101.1M $124.3M
Short-Term Investments $0.00 $0.00
Other Short-Term Assets $2.200M $5.529M
YoY Change -74.34% -45.67%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $103.3M $129.8M
YoY Change -21.91% -26.06%
LONG-TERM ASSETS
Property, Plant & Equipment $700.0K $759.0K
YoY Change -35.0% -33.07%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $416.0K $416.0K
YoY Change 0.0% 0.0%
Total Long-Term Assets $3.398M $3.669M
YoY Change -25.97% -24.15%
TOTAL ASSETS
Total Short-Term Assets $103.3M $129.8M
Total Long-Term Assets $3.398M $3.669M
Total Assets $106.7M $133.5M
YoY Change -22.04% -26.01%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.166M $8.010M
YoY Change -29.2% -32.24%
Accrued Expenses $6.979M $13.32M
YoY Change -60.98% -48.32%
Deferred Revenue $1.552M $2.039M
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $16.79M $24.43M
YoY Change -42.06% -36.61%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.200M $3.443M
YoY Change 16.11% 14.39%
Total Long-Term Liabilities $3.200M $3.443M
YoY Change 16.11% 14.39%
TOTAL LIABILITIES
Total Short-Term Liabilities $16.79M $24.43M
Total Long-Term Liabilities $3.200M $3.443M
Total Liabilities $19.97M $27.87M
YoY Change -37.08% -32.91%
SHAREHOLDERS EQUITY
Retained Earnings -$627.0M -$602.4M
YoY Change 28.09% 35.22%
Common Stock $13.00K $13.00K
YoY Change 160.0% 160.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $86.76M $105.6M
YoY Change
Total Liabilities & Shareholders Equity $106.7M $133.5M
YoY Change -22.04% -26.01%

Cashflow Statement

Concept 2023 Q3 2023 Q2
OPERATING ACTIVITIES
Net Income -$24.63M -$34.31M
YoY Change -43.95% -43.0%
Depreciation, Depletion And Amortization $110.0K $106.0K
YoY Change 7.84% -10.92%
Cash From Operating Activities -$23.22M -$31.21M
YoY Change -48.31% -45.44%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00
YoY Change -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $5.000M
YoY Change -100.0% -85.71%
Cash From Investing Activities $0.00 $5.000M
YoY Change -100.0% -85.67%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 0.000 69.68M
YoY Change -100.0% 13724.4%
NET CHANGE
Cash From Operating Activities -23.22M -31.21M
Cash From Investing Activities 0.000 5.000M
Cash From Financing Activities 0.000 69.68M
Net Change In Cash -23.22M 43.46M
YoY Change -462.76% -299.23%
FREE CASH FLOW
Cash From Operating Activities -$23.22M -$31.21M
Capital Expenditures $0.00 $0.00
Free Cash Flow -$23.22M -$31.21M
YoY Change -48.26% -45.33%

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Nature of the Business<div style="margin-top:6pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Praxis Precision Medicines, Inc. (“Praxis” or the “Company”) is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and both rare and more prevalent neurological disorders. The Company is applying genetic insights to the discovery and development of therapies for neurological disorders through two proprietary platforms, using its understanding of shared biological targets and circuits in the brain. Each platform has multiple programs currently, with significant potential for additional program and indication expansion: </span></div><div style="margin-top:9pt;padding-left:36pt;text-indent:-18pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">•</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%;padding-left:13.8pt">Cerebrum</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">™, the Company's small molecule platform, utilizes deep understanding of neuronal excitability and neuronal networks and applies a series of computational and experimental tools to develop orally available precision therapies </span></div><div style="margin-top:9pt;padding-left:36pt;text-indent:-18pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">•</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%;padding-left:14.5pt">Solidus</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">™, the Company's antisense oligonucleotide, or ASO, platform, is an efficient, targeted precision medicine discovery and development engine anchored on a proprietary, computational methodology </span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company's platforms utilize a deliberate, pragmatic and patient-guided approach, leveraging a suite of translational tools, including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients. Through this approach, the Company has established a diversified, multimodal CNS portfolio with four clinical-stage product candidates across movement disorders and epilepsy. For the Company's most advanced product candidate under the Cerebrum™ platform, ulixacaltamide (also known as PRAX-944), topline results from the Phase 2b Essential1 clinical trial in essential tremor ("ET"), were announced in the first quarter of 2023. The Company intends to initiate two Phase 3 studies in ET in the fourth quarter of 2023, with topline results expected in the second half of 2024. The Company initiated</span><span style="color:#ff0000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%"> </span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">its PRAX-562 Phase 2 EMBOLD study in the first quarter of 2023 and expects to announce topline results in the fourth quarter of 2023. The Company also announced positive results from its PRAX-628 Phase 1 study in May 2023. In June 2023, the Company initiated a Phase 2 proof of concept study evaluating PRAX-628 in patients with a Photo Paroxysmal Response ("PPR"), with results anticipated by year-end 2023. Upon completion of the PPR study, Praxis plans to initiate a Phase 2 study of PRAX-628 in focal epilepsy in the first half of 2024. For the Company's most advanced product candidate under the Solidus™ platform, PRAX-222, it initiated the first dose cohort of its EMBRAVE study in the second quarter of 2023 and expects to announce topline results in the second half of 2023. </span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Praxis was incorporated in 2015 and commenced operations in 2016. The Company has funded its operations primarily with proceeds from the issuance of redeemable convertible preferred stock, and from the sale of common stock and pre-funded warrants through an initial public offering, follow-on public offerings and at-the-market offerings under its shelf registration statement. From inception through June 30, 2023, the Company raised $613.6 million in aggregate cash proceeds from these transactions, net of issuance costs. </span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Liquidity</span></div><div style="margin-top:6pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2014-15, </span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, the Company has evaluated whether there are conditions and 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 that these condensed consolidated financial statements are issued.</span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company has incurred recurring losses since its inception, including a net loss of $71.8 million for the six months ended June 30, 2023. In addition, as of June 30, 2023, the Company had an accumulated deficit of $602.4 million. The Company expects to continue to generate operating losses for the foreseeable future.</span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company expects that its cash and cash equivalents as of June 30, 2023 of $124.3 million will be sufficient to fund the operating expenditures and capital expenditure requirements necessary to advance its research efforts and clinical trials for at least one year from the date of issuance of these condensed consolidated financial statements. The analysis included consideration of the Company's current financial needs and ongoing research and development plans, which are limited to advancing product candidates through, but not beyond, their current clinical trials and the ulixacaltamide Phase 3 clinical trials in ET. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.</span></div>
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<div style="margin-top:12pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of Estimates</span></div><div style="margin-top:6pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, accrued and prepaid research and development expense, collaboration revenue, stock-based compensation expense and the recoverability of the </span></div>Company’s net deferred tax assets and related valuation allowance. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates.
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CY2022Q4 prax Accrued External Research And Development Expenses Current
AccruedExternalResearchAndDevelopmentExpensesCurrent
10734000 usd
CY2023Q2 prax Accrued Milestone Expense Current
AccruedMilestoneExpenseCurrent
6937000 usd
CY2022Q4 prax Accrued Milestone Expense Current
AccruedMilestoneExpenseCurrent
0 usd
CY2023Q2 prax Accrued Personnel Related Expenses Current
AccruedPersonnelRelatedExpensesCurrent
1617000 usd
CY2022Q4 prax Accrued Personnel Related Expenses Current
AccruedPersonnelRelatedExpensesCurrent
2803000 usd
CY2023Q2 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
791000 usd
CY2022Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
2313000 usd
CY2023Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
13317000 usd
CY2022Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
15850000 usd
CY2022Q4 us-gaap Common Stock Shares Authorized
CommonStockSharesAuthorized
150000000 shares
CY2023Q2 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
0.0001
CY2022Q4 us-gaap Treasury Stock Common Shares
TreasuryStockCommonShares
0 shares
CY2023Q2 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
21096649 shares
CY2022Q4 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
12072855 shares
CY2023Q2 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000 shares
CY2022Q4 us-gaap Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
10000000 shares
CY2022Q4 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.0001
CY2023Q2 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.0001
CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
8838028 shares
CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
13.93
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
2813641 shares
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
83000 usd
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
1492830 shares
us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsForfeituresInPeriodWeightedAverageExercisePrice
11.87
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingNumber
10114195 shares
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingWeightedAverageExercisePrice
11.20
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
P8Y10D
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
68000 usd
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
4922220 shares
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice
13.13
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableWeightedAverageRemainingContractualTerm1
P7Y3M10D
CY2023Q2 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
34000 usd
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingNumber
10114195 shares
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageExercisePrice
11.20
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Remaining Contractual Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingWeightedAverageRemainingContractualTerm1
P8Y10D
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Aggregate Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingAggregateIntrinsicValue
68000 usd
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
0.0384
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
0.0353
CY2023Q2 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1
P6Y
us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1
P6Y
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
0.8843
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
0.8823
CY2023Q2 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2023Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5775000 usd
CY2022Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
7611000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
13368000 usd
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
15497000 usd
CY2023Q2 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
10932939 shares
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
10738203 shares
CY2022Q2 us-gaap Restructuring And Related Cost Incurred Cost
RestructuringAndRelatedCostIncurredCost
1000000.0 usd
us-gaap Restructuring And Related Cost Incurred Cost
RestructuringAndRelatedCostIncurredCost
1000000.0 usd

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exhibit31120230630.htm Edgar Link pending
exhibit31220230630.htm Edgar Link pending
exhibit32120230630.htm Edgar Link pending
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