2024 Q1 Form 10-Q Financial Statement

#000162828024023038 Filed on May 14, 2024

View on sec.gov

Income Statement

Concept 2024 Q1 2023 Q4
Revenue $1.014M $6.036M
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $6.404M $5.155M
YoY Change -21.84% -25.69%
% of Gross Profit
Research & Development $6.826M $9.504M
YoY Change -28.58% -44.79%
% of Gross Profit
Depreciation & Amortization $179.0K $174.0K
YoY Change 2.87% 0.58%
% of Gross Profit
Operating Expenses $13.23M $14.66M
YoY Change -25.47% -39.3%
Operating Profit -$12.22M
YoY Change -31.18%
Interest Expense $300.0K
YoY Change -57.14%
% of Operating Profit
Other Income/Expense, Net $292.0K -$870.0K
YoY Change -76.7% -139.35%
Pretax Income -$11.92M -$9.493M
YoY Change -27.72% -56.73%
Income Tax
% Of Pretax Income
Net Earnings -$11.90M -$9.493M
YoY Change -27.87% -56.73%
Net Earnings / Revenue -1173.57% -157.27%
Basic Earnings Per Share -$0.05
Diluted Earnings Per Share -$0.05 -$0.04
COMMON SHARES
Basic Shares Outstanding 257.2M shares 256.5M shares
Diluted Shares Outstanding 257.2M shares

Balance Sheet

Concept 2024 Q1 2023 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $26.38M $39.50M
YoY Change -65.62% -56.56%
Cash & Equivalents $26.40M $39.50M
Short-Term Investments $0.00
Other Short-Term Assets $3.623M $3.509M
YoY Change -52.83% -53.57%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $30.00M $42.97M
YoY Change -64.46% -56.37%
LONG-TERM ASSETS
Property, Plant & Equipment $17.65M $17.29M
YoY Change 122.01% 185.64%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $4.142M $4.286M
YoY Change 4.97% 4.87%
Total Long-Term Assets $21.80M $21.58M
YoY Change 83.19% 112.78%
TOTAL ASSETS
Total Short-Term Assets $30.00M $42.97M
Total Long-Term Assets $21.80M $21.58M
Total Assets $51.79M $64.55M
YoY Change -46.22% -40.58%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.731M $3.172M
YoY Change -78.61% -60.65%
Accrued Expenses $3.411M $3.392M
YoY Change -46.16% -65.74%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $1.296M $0.00
YoY Change 3.18%
Total Short-Term Liabilities $16.05M $17.09M
YoY Change 2.34% -7.43%
LONG-TERM LIABILITIES
Long-Term Debt $1.533M $2.800M
YoY Change 44.9% 22.32%
Other Long-Term Liabilities $536.0K $527.0K
YoY Change 73.46% 115.98%
Total Long-Term Liabilities $5.483M $6.894M
YoY Change 13.85% 12.65%
TOTAL LIABILITIES
Total Short-Term Liabilities $16.05M $17.09M
Total Long-Term Liabilities $5.483M $6.894M
Total Liabilities $21.53M $23.98M
YoY Change 5.04% -2.43%
SHAREHOLDERS EQUITY
Retained Earnings -$298.1M -$286.2M
YoY Change 29.89% 34.37%
Common Stock $2.575M $2.567M
YoY Change 13.69% 15.79%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $30.26M $40.56M
YoY Change
Total Liabilities & Shareholders Equity $51.79M $64.55M
YoY Change -46.22% -40.58%

Cashflow Statement

Concept 2024 Q1 2023 Q4
OPERATING ACTIVITIES
Net Income -$11.90M -$9.493M
YoY Change -27.87% -56.73%
Depreciation, Depletion And Amortization $179.0K $174.0K
YoY Change 2.87% 0.58%
Cash From Operating Activities -$10.60M -$11.30M
YoY Change -41.91% -33.17%
INVESTING ACTIVITIES
Capital Expenditures $2.352M $2.726M
YoY Change 45.91% 34.68%
Acquisitions
YoY Change
Other Investing Activities $0.00 $3.000K
YoY Change -100.0% -100.02%
Cash From Investing Activities -$2.352M -$2.723M
YoY Change -168.35% -82.2%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net -$145.0K
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -$145.0K 11.00K
YoY Change -102.64% -99.87%
NET CHANGE
Cash From Operating Activities -$10.60M -11.30M
Cash From Investing Activities -$2.352M -2.723M
Cash From Financing Activities -$145.0K 11.00K
Net Change In Cash -$13.09M -14.02M
YoY Change 40.66% -41.68%
FREE CASH FLOW
Cash From Operating Activities -$10.60M -$11.30M
Capital Expenditures $2.352M $2.726M
Free Cash Flow -$12.95M -$14.03M
YoY Change -34.78% -25.92%

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Nature of Business<div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Ocugen, Inc., together with its wholly owned subsidiaries ("Ocugen" or the "Company"), is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. The Company is headquartered in Malvern, Pennsylvania, and manages its business as one operating segment.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Our technology pipeline includes:</span></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:112%">•</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:112%;padding-left:14.5pt">Modifier Gene Therapy Platform </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">— Based on the use of nuclear hormone receptors ("NHRs"), the Company believes its modifier gene therapy platform has the potential to address many retinal diseases, including rare genetic diseases such as retinitis pigmentosa ("RP") (OCU400) and Leber congenital amaurosis ("LCA") (OCU400), with a gene-agnostic approach. The Company also believes its modifier gene therapy platform has the potential to address multifactorial retinal diseases including dry age-related macular degeneration ("dAMD") using OCU410, which affects millions of patients in the United States alone, and Stargardt disease (OCU410ST), which is also a rare genetic disease. The Company received clearance from FDA to initiate a Phase 3 trial for OCU400 for the treatment of RP and intends to begin dosing patients in 2Q 2024. The Company further expects to expand OCU400 Phase 3 development in LCA patients in the second half of 2024 based on Phase 1/2 study results in LCA patients and subject to alignment with the FDA. Currently both OCU410, for the treatment of geographic atrophy ("GA"), an advanced form of dAMD, and OCU410ST, for the treatment of Stargardt disease, are in Phase 1/2 clinical development. In OCU410 GA study, low and medium dose cohorts were completed to date. In OCU410ST Stargardt study, low dose cohort was completed to date.</span></div><div style="margin-top:6pt;padding-left:36pt;text-align:justify;text-indent:-18pt"><span style="color:#000000;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:700;line-height:120%;padding-left:14.5pt">Novel</span><span style="color:#000000;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:700;line-height:120%">Biologic Therapy for Retinal Diseases </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">— OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin. OCU200 possesses unique features which potentially enable it to treat vascular complications of diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. Tumstatin is the active component of OCU200 and binds to integrin receptors, which play a crucial role in disease pathogenesis. Transferrin is expected to facilitate the targeted delivery of tumstatin into the retina and choroid and potentially help increase the interaction between tumstatin and integrin receptors. The Company continues to work with the FDA to address comments to lift the clinical hold.</span></div><div style="margin-top:6pt;padding-left:36pt;text-align:justify;text-indent:-18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">•</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%;padding-left:14.5pt">Regenerative Medicine Cell Therapy Platform </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">— Our Phase 3-ready regenerative medicine cell therapy platform technology, which includes NeoCart (autologous chondrocyte-derived neocartilage), is being developed for the repair of knee cartilage injuries in adults. The Company received concurrence from the FDA on the confirmatory Phase 3 trial design and has completed renovating an existing facility into a current Good Manufacturing Practice ("GMP") facility to support clinical study and initial commercial launch. This facility is needed to generate patient-specific NeoCart implant from chondrocytes derived from knee biopsy. </span></div><div style="margin-top:6pt;padding-left:36pt;text-align:justify;text-indent:-18pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">•</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%;padding-left:14.5pt">Inhaled Mucosal Vaccine Platform</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> — The Company's next-generation, inhaled mucosal vaccine platform includes OCU500, a COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and COVID-19 vaccine. The Company is conducting IND-enabling and product development activities for OCU500. The Company is currently collaborating with the National Institute of Allergy and Infectious Diseases ("NIAID") for early clinical studies for OCU500. NIAID plans to submit an IND to initiate a Phase 1 clinical trial in mid-2024. The Company is continuing discussions with relevant government agencies as well as strategic partners regarding developmental funding for its OCU510 and OCU520 platforms.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Going Concern</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company has incurred recurring net losses since inception and has funded its operations to date through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes and debt, and grant proceeds. The Company incurred net losses of approximately $11.9 and $17.3 for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, the Company had an accumulated deficit of $298.1 million and cash and cash equivalents totaling $26.4 million. This amount will not meet the Company's capital requirements over the next 12 months after the date that the condensed consolidated financial statements are issued. The Company believes that its cash and cash equivalents will enable it to fund its operations into the fourth quarter of 2024. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and commercialization of biotechnology products, the Company may have </span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">based this estimate on assumptions that may prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the Company.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is subject to risks, expenses, and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research, development, and commercialization efforts for its product candidates, which will require significant additional funding. If the Company is unable to obtain additional funding in the future and/or its research, development, and commercialization efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company is currently exploring options to fund its operations through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sales of assets, licensing and/or collaboration arrangements with pharmaceutical companies or other institutions, funding from the government, particularly for the development of the Company's novel inhaled mucosal vaccine platform, or funding from other third parties. Such financing and funding may not be available at all, or on terms that are favorable to the Company. While Company management believes that it has a plan to fund operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital, or appropriately manage certain discretionary spending, could have a material adverse effect on the Company's ability to achieve its intended business objectives.</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">As a result of these factors, together with the anticipated continued spending that will be necessary to continue to research, develop, and commercialize the Company's product candidates, there is 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. The condensed consolidated financial statements do not contain any adjustments that might result from the resolution of any of the above uncertainties.</span></div>
CY2024Q1 us-gaap Number Of Operating Segments
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NetIncomeLoss
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CY2023Q1 us-gaap Net Income Loss
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CY2024Q1 us-gaap Use Of Estimates
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<div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of Estimates</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In preparing the condensed consolidated financial statements in conformity with GAAP, management is required 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, as well as the reported amounts of expenses during the reporting period. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include those used in the accounting for research and development contracts, including clinical trial accruals, determination of the collaborative arrangements' transaction price, calculating the progress towards the satisfaction of the performance obligations under the collaborative arrangements, and determining the value of the non-cash consideration received under collaborative arrangements.</span></div>
CY2024Q1 us-gaap Interest Income Expense Nonoperating Net
InterestIncomeExpenseNonoperatingNet
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CY2024Q1 us-gaap Concentration Risk Credit Risk
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<div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Concentration of Credit Risk</span></div><div style="margin-top:12pt;text-align:justify"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents. The Company's cash and cash equivalents are held in accounts at financial institutions that may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to significant credit risk beyond the standard credit risk associated with commercial banking relationships.</span></div>
CY2024Q1 us-gaap Cash And Cash Equivalents At Carrying Value
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CY2024Q1 us-gaap Operating Lease Liability
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EmployeeRelatedLiabilitiesCurrent
1791000 usd
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OtherAccruedLiabilitiesCurrent
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CY2024Q1 us-gaap Accrued Liabilities And Other Liabilities
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CY2024Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized
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CY2024Q1 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period For Recognition1
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P1Y7M6D
CY2024Q1 ocgn Number Of Equity Compensation Plans
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CY2023Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
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CY2023 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
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CY2023Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
337000 usd
CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Gross
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross
2632054 shares
CY2024Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Grants In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice
0.70
CY2024Q1 ocgn Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodIntrinsicValue
5000 usd
CY2024Q1 us-gaap Stock Issued During Period Shares Stock Options Exercised
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CY2024Q1 us-gaap Share Based Compensation Arrangements By Share Based Payment Award Options Exercises In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsExercisesInPeriodWeightedAverageExercisePrice
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercises In Period Total Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisesInPeriodTotalIntrinsicValue
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriod
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Forfeitures And Expirations In Period Weighted Average Exercise Price
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeituresAndExpirationsInPeriodWeightedAverageExercisePrice
3.63
CY2024Q1 ocgn Share Based Compensation Arrangement By Share Based Payment Award Options Forfeited In Period Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsForfeitedInPeriodIntrinsicValue
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price
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CY2024Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Outstanding Weighted Average Remaining Contractual Term2
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsOutstandingWeightedAverageRemainingContractualTerm2
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsOutstandingIntrinsicValue
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price
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CY2024Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Weighted Average Remaining Contractual Term1
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CY2024Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Exercisable Intrinsic Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsExercisableIntrinsicValue1
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CY2024Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
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CY2023Q1 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
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CY2023Q1 us-gaap Sharebased Compensation Arrangement By Sharebased Payment Award Options Vested In Period Fair Value1
SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1
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CY2024Q1 us-gaap Net Income Loss Available To Common Stockholders Diluted
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CY2024Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
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CY2024Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
257232636 shares
CY2023Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
225523627 shares
CY2023Q1 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
225523627 shares
CY2024Q1 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-0.05
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EarningsPerShareDiluted
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EarningsPerShareBasic
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CY2024Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2023Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2024Q1 ecd Non Rule10b51 Arr Adopted Flag
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CY2024Q1 ecd Rule10b51 Arr Adopted Flag
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NonRule10b51ArrTrmntdFlag
false
CY2024Q1 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false

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