2023 Q2 Form 10-Q Financial Statement

#000168954823000086 Filed on May 11, 2023

View on sec.gov

Income Statement

Concept 2023 Q2 2023 Q1 2022 Q1
Revenue $781.0K $683.0K $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $10.13M $13.27M $16.20M
YoY Change -38.15% -18.07% 70.67%
% of Gross Profit
Research & Development $25.61M $25.50M $52.65M
YoY Change -41.28% -51.56% 193.67%
% of Gross Profit
Depreciation & Amortization $106.0K $106.0K $93.00K
YoY Change -10.92% 13.98% 304.35%
% of Gross Profit
Operating Expenses $35.74M $38.77M $68.85M
YoY Change -40.82% -43.68% 151.1%
Operating Profit -$34.96M -$38.09M -$68.85M
YoY Change -42.11% -44.67% 151.1%
Interest Expense $648.0K $636.0K $132.0K
YoY Change 224.0% 381.82% 164.0%
% of Operating Profit
Other Income/Expense, Net $648.0K $636.0K $132.0K
YoY Change 224.0% 381.82% 186.96%
Pretax Income -$34.31M -$37.46M -$68.72M
YoY Change -43.0% -45.49% 151.04%
Income Tax
% Of Pretax Income
Net Earnings -$34.31M -$37.50M -$68.72M
YoY Change -43.0% -45.43% 151.04%
Net Earnings / Revenue -4393.34% -5490.48%
Basic Earnings Per Share -$0.49 -$0.71 -$1.51
Diluted Earnings Per Share -$0.49 -$0.71 -$1.51
COMMON SHARES
Basic Shares Outstanding 62.10M shares 52.39M shares 45.46M shares
Diluted Shares Outstanding 69.74M shares 53.10M shares 45.46M shares

Balance Sheet

Concept 2023 Q2 2023 Q1 2022 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $124.3M $85.82M $210.6M
YoY Change -24.85% -59.25% -9.12%
Cash & Equivalents $124.3M $80.84M $77.85M
Short-Term Investments $0.00 $4.983M $132.7M
Other Short-Term Assets $5.529M $8.580M $11.96M
YoY Change -45.67% -28.24% 53.29%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $129.8M $94.40M $234.5M
YoY Change -26.06% -59.74% -15.83%
LONG-TERM ASSETS
Property, Plant & Equipment $759.0K $865.0K $1.142M
YoY Change -33.07% -24.26% 947.71%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $416.0K $416.0K $416.0K
YoY Change 0.0% 0.0% 4522.22%
Total Long-Term Assets $3.669M $3.981M $5.031M
YoY Change -24.15% -20.87% 630.19%
TOTAL ASSETS
Total Short-Term Assets $129.8M $94.40M $234.5M
Total Long-Term Assets $3.669M $3.981M $5.031M
Total Assets $133.5M $98.38M $239.5M
YoY Change -26.01% -58.92% -14.23%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $8.010M $16.99M $13.27M
YoY Change -32.24% 28.01% 129.81%
Accrued Expenses $13.32M $9.352M $30.93M
YoY Change -48.32% -69.76% 318.75%
Deferred Revenue $2.039M $2.543M
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $24.43M $29.92M $45.22M
YoY Change -36.61% -33.85% 229.18%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.443M $3.999M $3.259M
YoY Change 14.39% 22.71%
Total Long-Term Liabilities $3.443M $3.999M $3.259M
YoY Change 14.39% 22.71%
TOTAL LIABILITIES
Total Short-Term Liabilities $24.43M $29.92M $45.22M
Total Long-Term Liabilities $3.443M $3.999M $3.259M
Total Liabilities $27.87M $33.92M $48.48M
YoY Change -32.91% -30.05% 252.9%
SHAREHOLDERS EQUITY
Retained Earnings -$602.4M -$568.1M -$385.3M
YoY Change 35.22% 47.44% 117.81%
Common Stock $13.00K $6.000K $5.000K
YoY Change 160.0% 20.0% 25.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares 0.000 shares
Shareholders Equity $105.6M $64.47M $191.0M
YoY Change
Total Liabilities & Shareholders Equity $133.5M $98.38M $239.5M
YoY Change -26.01% -58.92% -14.23%

Cashflow Statement

Concept 2023 Q2 2023 Q1 2022 Q1
OPERATING ACTIVITIES
Net Income -$34.31M -$37.50M -$68.72M
YoY Change -43.0% -45.43% 151.04%
Depreciation, Depletion And Amortization $106.0K $106.0K $93.00K
YoY Change -10.92% 13.98% 304.35%
Cash From Operating Activities -$31.21M -$32.85M -$54.11M
YoY Change -45.44% -39.3% 110.36%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $289.0K
YoY Change -100.0% -100.0% 7125.0%
Acquisitions
YoY Change
Other Investing Activities $5.000M $34.00M -$8.261M
YoY Change -85.71% -511.57% -94.1%
Cash From Investing Activities $5.000M $34.00M -$8.550M
YoY Change -85.67% -497.66% -93.89%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $1.368M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 69.68M $18.07M $1.209M
YoY Change 13724.4% 1394.62% 338.04%
NET CHANGE
Cash From Operating Activities -31.21M -$32.85M -$54.11M
Cash From Investing Activities 5.000M $34.00M -$8.550M
Cash From Financing Activities 69.68M $18.07M $1.209M
Net Change In Cash 43.46M $19.22M -$61.45M
YoY Change -299.23% -131.28% -62.86%
FREE CASH FLOW
Cash From Operating Activities -$31.21M -$32.85M -$54.11M
Capital Expenditures $0.00 $0.00 $289.0K
Free Cash Flow -$31.21M -$32.85M -$54.40M
YoY Change -45.33% -39.62% 111.45%

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CY2023Q1 us-gaap Nature Of Operations
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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. An end-of-Phase 2 meeting is scheduled with the U.S. Food and Drug Administration in June 2023 and the Company intends to initiate a Phase 3 study in ET in the second half of 2023. 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 and expects to initiate a Phase 2 study in focal epilepsy in the fourth quarter of 2023. For the Company's most advanced product candidate under the Solidus™ platform, PRAX-222, it expects to announce topline results from the first dose cohort of its EMBRAVE study 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 through an initial public offering, a follow-on public offering and at-the-market offerings under its shelf registration statement. From inception through March 31, 2023, the Company raised $544.1 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 </span></div><div style="margin-top:6pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the 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 $37.5 million for the three months ended March 31, 2023. In addition, as of March 31, 2023, the Company had an accumulated deficit of $568.1 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, cash equivalents and marketable securities as of March 31, 2023 may not be sufficient to fund operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements which raises substantial doubt about the Company's ability to continue as a going concern, and the Company will need to obtain additional funding. The Company expects to finance its operations through potential public or private equity financings, debt financings, collaboration agreements or other capital sources. 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><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 accompanying condensed consolidated 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 condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.</span></div>
CY2023Q1 us-gaap Proceeds From Issuance Or Sale Of Equity
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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 </span></div>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 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.
CY2023Q1 us-gaap Debt Securities Available For Sale Amortized Cost Current
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CY2023Q1 us-gaap Debt Securities Available For Sale Unrealized Loss Position
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CY2023Q1 us-gaap Common Stock Shares Authorized
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CY2022Q4 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
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CY2023Q1 us-gaap Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
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CY2023Q1 us-gaap Treasury Stock Common Shares
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CY2023Q1 us-gaap Common Stock Capital Shares Reserved For Future Issuance
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CY2022Q4 us-gaap Common Stock Capital Shares Reserved For Future Issuance
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CY2023Q1 us-gaap Preferred Stock Shares Authorized
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CY2022Q4 us-gaap Preferred Stock Shares Authorized
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
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CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
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CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
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CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
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2.97
CY2023Q1 us-gaap Stock Issued During Period Shares Stock Options Exercised
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CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
2.27
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresInPeriod
731577 shares
CY2023Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Forfeitures In Period Weighted Average Exercise Price
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10.28
CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
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11.53
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
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CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Number
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Exercise Price
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11.47
CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested And Expected To Vest Outstanding Weighted Average Remaining Contractual Term1
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Vested And Expected To Vest Outstanding Aggregate Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsVestedAndExpectedToVestOutstandingAggregateIntrinsicValue
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Risk Free Interest Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRate
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CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Fair Value Assumptions Expected Term1
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Volatility Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRate
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions Expected Dividend Rate
ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate
0
CY2023Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
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CY2022Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
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CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2022Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
8733194 shares

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