2020 Q4 Form 10-Q Financial Statement

#000162828020015862 Filed on November 06, 2020

View on sec.gov

Income Statement

Concept 2020 Q4 2020 Q3 2019 Q3
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.210M $1.700M $1.410M
YoY Change -12.65% 20.57% -41.98%
% of Gross Profit
Research & Development $1.590M $1.478M $1.305M
YoY Change -9.14% 13.22% -71.37%
% of Gross Profit
Depreciation & Amortization $40.00K $19.80K -$90.00K
YoY Change 33.33% -122.0% -190.0%
% of Gross Profit
Operating Expenses $3.810M $10.18M $2.714M
YoY Change -10.98% 275.19% -61.17%
Operating Profit -$10.18M -$2.714M
YoY Change 275.19% -61.17%
Interest Expense -$170.0K $292.0K $796.1K
YoY Change -101.02% -63.32% 4090.22%
% of Operating Profit
Other Income/Expense, Net $180.0K -$292.0K -$20.06M
YoY Change -700.0% -98.54% -212.86%
Pretax Income -$3.790M -$10.47M -$22.77M
YoY Change -130.61% -54.0% -311.03%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$3.790M -$10.47M -$22.77M
YoY Change -130.61% -54.01% -311.16%
Net Earnings / Revenue
Basic Earnings Per Share -$0.07
Diluted Earnings Per Share -$22.21K -$0.07 -$3.552M
COMMON SHARES
Basic Shares Outstanding 162.0M shares 141.6M shares 94.60M
Diluted Shares Outstanding 141.6M shares

Balance Sheet

Concept 2020 Q4 2020 Q3 2019 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $24.04M $19.11M $15.30M
YoY Change 223.12% 24.9% 194.8%
Cash & Equivalents $24.04M $19.11M $15.30M
Short-Term Investments
Other Short-Term Assets $1.840M $650.0K $7.520M
YoY Change -77.88% -91.36% 806.02%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $25.88M $19.76M $22.82M
YoY Change 64.14% -13.41% 279.26%
LONG-TERM ASSETS
Property, Plant & Equipment $633.0K $214.1K $210.0K
YoY Change 184.54% 1.95% -95.17%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $714.0K $415.6K $590.0K
YoY Change 6.93% -29.57% 57.33%
Total Long-Term Assets $1.498M $780.9K $800.0K
YoY Change 43.87% -2.39% -83.55%
TOTAL ASSETS
Total Short-Term Assets $25.88M $19.76M $22.82M
Total Long-Term Assets $1.498M $780.9K $800.0K
Total Assets $27.38M $20.54M $23.62M
YoY Change 62.88% -13.04% 117.1%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $395.0K $222.3K $5.790M
YoY Change -79.16% -96.16% 242.6%
Accrued Expenses $2.930M $2.334M $1.450M
YoY Change 29.09% 60.95% -26.51%
Deferred Revenue
YoY Change
Short-Term Debt $234.0K $1.211M $0.00
YoY Change
Long-Term Debt Due $230.0K $1.210M $20.00K
YoY Change 5950.0%
Total Short-Term Liabilities $3.614M $4.131M $35.41M
YoY Change -20.47% -88.33% 295.95%
LONG-TERM LIABILITIES
Long-Term Debt $1.823M $1.944M $1.080M
YoY Change 70.04% 80.04%
Other Long-Term Liabilities $0.00 $0.00 $220.0K
YoY Change -100.0% -100.0% -98.11%
Total Long-Term Liabilities $2.212M $1.987M $1.300M
YoY Change 77.66% 52.86% -88.8%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.614M $4.131M $35.41M
Total Long-Term Liabilities $2.212M $1.987M $1.300M
Total Liabilities $5.826M $6.118M $36.71M
YoY Change 0.64% -83.33% 78.58%
SHAREHOLDERS EQUITY
Retained Earnings -$73.30M -$69.50M
YoY Change 42.39%
Common Stock $1.841M $1.621M
YoY Change 249.03%
Preferred Stock
YoY Change
Treasury Stock (at cost) $48.00K $47.86K
YoY Change 0.28%
Treasury Stock Shares
Shareholders Equity $21.55M $14.42M -$13.09M
YoY Change
Total Liabilities & Shareholders Equity $27.38M $20.54M $23.62M
YoY Change 62.88% -13.04% 117.08%

Cashflow Statement

Concept 2020 Q4 2020 Q3 2019 Q3
OPERATING ACTIVITIES
Net Income -$3.790M -$10.47M -$22.77M
YoY Change -130.61% -54.01% -311.16%
Depreciation, Depletion And Amortization $40.00K $19.80K -$90.00K
YoY Change 33.33% -122.0% -190.0%
Cash From Operating Activities -$4.280M -$2.660M $3.400M
YoY Change -51.03% -178.24% -149.2%
INVESTING ACTIVITIES
Capital Expenditures -$250.0K -$30.00K $0.00
YoY Change 733.33% -100.0%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00 -$2.440M
YoY Change -100.0%
Cash From Investing Activities -$250.0K -$30.00K -$2.450M
YoY Change 1150.0% -98.78% -410.13%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 9.470M 6.810M 25.61M
YoY Change 940.66% -73.41% 908.27%
NET CHANGE
Cash From Operating Activities -4.280M -2.660M 3.400M
Cash From Investing Activities -250.0K -30.00K -2.450M
Cash From Financing Activities 9.470M 6.810M 25.61M
Net Change In Cash 4.940M 4.120M 26.56M
YoY Change -162.93% -84.49% -841.9%
FREE CASH FLOW
Cash From Operating Activities -$4.280M -$2.660M $3.400M
Capital Expenditures -$250.0K -$30.00K $0.00
Free Cash Flow -$4.030M -$2.630M $3.400M
YoY Change -53.73% -177.35% -144.16%

Facts In Submission

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Nature of Business<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%">Ocugen, Inc. (formerly known as Histogenics Corporation), together with its wholly owned subsidiaries (“Ocugen” or the “Company”), is a biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to cure blindness diseases. The Company is located in Malvern, Pennsylvania, and manages its business as one operating segment.</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%">Ocugen is developing a modifier gene therapy platform to generate therapies designed to fulfill unmet medical needs in the area of retinal diseases, including inherited retinal diseases ("IRDs") and dry age-related macular degeneration ("AMD"). Ocugen's modifier gene therapy platform is based on nuclear hormone receptors ("NHRs") which have the potential to restore homeostasis, the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, Ocugen believes that its gene therapy platform, through its use of NHRs, represents a novel approach in that it may address multiple retinal diseases with one product. </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%">Ocugen's first gene therapy candidate, OCU400, is being developed to treat retinitis pigmentosa ("RP"), a group of rare genetic disorders that involves a breakdown and loss of cells in the retina and can lead to visual impairment and blindness. Ocugen has received four Orphan Drug Designations ("ODDs") from the Food and Drug Administration ("FDA") for the treatment of certain disease genotypes: nuclear receptor subfamily 2 group E member 3 ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">NR2E3</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"), centrosomal protein 290 ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">CEP290</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"), rhodopsin ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">RHO</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">"), and phosphodiesterase 6B ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">PDE6B</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">") mutation-associated RP. Ocugen is planning to initiate two Phase 1/2a clinical trials for OCU400 in the second half of 2021. Ocugen's second gene therapy candidate, OCU410, is being developed to utilize the nuclear receptor genes RAR-related orphan receptor A ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">RORA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">") for the treatment of dry AMD. This candidate is currently in preclinical development. Ocugen is planning to initiate a Phase 1/2a clinical trial for OCU410 in 2022.</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%">Ocugen is also conducting preclinical development for its biologic product candidate, OCU200. OCU200 is a novel fusion protein designed to treat diabetic macular edema ("DME"), diabetic retinopathy ("DR") and wet AMD. Ocugen plans to expand the therapeutic applications of OCU200 beyond DME, DR and wet AMD to potentially include macular edema following retinal vein occlusion and myopic choroidal neovascularization. Ocugen expects to initiate Investigational New Drug ("IND") enabling preclinical studies for OCU200 in 2021 and a Phase 1/2a clinical trial for OCU200 in the first half of 2022.</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%">Ocugen was developing OCU300, a small molecule therapeutic for the treatment of symptoms associated with ocular graft versus-host disease ("oGVHD"). On June 1, 2020, Ocugen announced that it had discontinued the Phase 3 trial of OCU300 based on results of a pre-planned interim sample size analysis conducted by an independent Data Monitoring Committee, which indicated the trial was unlikely to meet its co-primary endpoints upon completion. The trial was not stopped based on safety concerns. Ocugen is no longer pursuing the development of this product candidate.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Merger with Histogenics</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%">On September 27, 2019, the Company completed its reverse merger with Ocugen OpCo, Inc. (“OpCo”) in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of April 5, 2019, by and among Histogenics Corporation ("Histogenics"), OpCo and Restore Merger Sub, Inc., a wholly owned subsidiary of Histogenics (“Merger Sub”), as amended (the “Merger Agreement”), pursuant to which Merger Sub merged with and into OpCo, with OpCo surviving as a wholly owned subsidiary of Histogenics (the “Merger”). Immediately after completion of the Merger, Histogenics changed its name to Ocugen, Inc. and the business conducted by Ocugen, Inc. became the business conducted by OpCo. OpCo is deemed to be the accounting acquirer. Accordingly, the historical financial statements of OpCo became the Company’s historical financial statements, including the comparative prior periods. See Note 3 for additional information.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Reverse Stock Split</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%">In connection with, and immediately prior to the completion of the Merger, Histogenics effected a reverse stock split of the common stock, at a ratio of 1-for-60 (the ‘‘Reverse Stock Split’’). Under the terms of the Merger Agreement, the Company issued common stock to OpCo’s stockholders at an exchange rate of 0.4794 shares of common stock, after taking into account the Reverse Stock Split, for each share of OpCo’s common stock outstanding immediately prior to the Merger.</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%">The capital structure, including the number of shares of common stock issued appearing in the condensed consolidated balance sheets for the periods presented, reflects that of Ocugen. All references in the condensed consolidated financial statements to the number of shares and per-share amounts of common stock have been retroactively restated to reflect the exchange rate.</span></div><div style="margin-top:12pt"><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"><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 losses and negative cash flows from operations since inception and has funded its operating losses through the sale of common stock, warrants to purchase common stock, the issuance of convertible notes, debt, and grant proceeds. The Company incurred net losses of approximately $18.0 million and $32.6 million for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the Company had an accumulated deficit of $69.5 million and cash, cash equivalents and restricted cash totaling $19.3 million.</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%">The Company has a limited operating history and its prospects are subject to risks, expenses and uncertainties frequently encountered by companies in its industry. The Company intends to continue its research and development efforts for its product candidates, which will require significant funding. If the Company is unable to obtain additional financing in the future or research and development efforts require higher than anticipated capital, there may be a negative impact on the financial viability of the Company. The Company plans to increase working capital by raising additional capital through public and private placements of equity and/or debt, payments from potential strategic research and development arrangements, sale of assets, and licensing and/or collaboration arrangements with pharmaceutical companies or other institutions. Such financing may not be available at all, or on terms that are favorable to the Company. While management of the Company believes that it has a plan to fund ongoing operations, its plan may not be successfully implemented. Failure to generate sufficient cash flows from operations, raise additional capital through one or more financings, 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-bottom:12pt;margin-top:12pt"><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 increase in spending that will be necessary to continue to develop 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>
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<div style="margin-top:12pt"><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"><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 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 primarily include those used in the accounting for clinical trial accruals, warrant transactions, asset held for sale, and the valuation of debt and equity instruments, including embedded derivatives and stock-based compensation.</span></div>
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LongTermDebtMaturitiesRepaymentsOfPrincipalInYearThree
0 USD
CY2020Q3 us-gaap Long Term Debt Maturities Repayments Of Principal In Year Four
LongTermDebtMaturitiesRepaymentsOfPrincipalInYearFour
0 USD
CY2020Q3 ocgn Long Term Debt Maturity After Year Four
LongTermDebtMaturityAfterYearFour
1500000 USD
CY2020Q3 us-gaap Debt Instrument Carrying Amount
DebtInstrumentCarryingAmount
3184144 USD
CY2020Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
126290 USD
CY2019Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
193005 USD
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
498012 USD
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
720014 USD
CY2020Q3 us-gaap Employee Service Share Based Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Stock Options
EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions
1300000 USD
CY2020Q3 ocgn Number Of Equity Compensation Plans
NumberOfEquityCompensationPlans
2 segment
CY2019Q4 ocgn Share Based Compensation Arrangement By Share Based Payment Award Automatic Increase In Shares To Be Issue Percentage
ShareBasedCompensationArrangementByShareBasedPaymentAwardAutomaticIncreaseInSharesToBeIssuePercentage
0.04
CY2020Q3 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
0.34
us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Grants In Period Weighted Average Grant Date Fair Value
ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageGrantDateFairValue
0.34
CY2020Q3 us-gaap Operating Lease Cost
OperatingLeaseCost
47696 USD
CY2019Q3 us-gaap Operating Lease Cost
OperatingLeaseCost
47696 USD
us-gaap Operating Lease Cost
OperatingLeaseCost
142947 USD
us-gaap Operating Lease Cost
OperatingLeaseCost
202665 USD
CY2020Q3 us-gaap Variable Lease Cost
VariableLeaseCost
21169 USD
CY2019Q3 us-gaap Variable Lease Cost
VariableLeaseCost
21284 USD
us-gaap Variable Lease Cost
VariableLeaseCost
62415 USD
us-gaap Variable Lease Cost
VariableLeaseCost
58163 USD
CY2020Q3 us-gaap Lease Cost
LeaseCost
68865 USD
CY2019Q3 us-gaap Lease Cost
LeaseCost
68980 USD
us-gaap Lease Cost
LeaseCost
205362 USD
us-gaap Lease Cost
LeaseCost
260828 USD
CY2020Q3 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
217508 USD
CY2019Q4 us-gaap Operating Lease Right Of Use Asset
OperatingLeaseRightOfUseAsset
344574 USD
CY2020Q3 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
164808 USD
CY2019Q4 us-gaap Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
172310 USD
CY2020Q3 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
42746 USD
CY2019Q4 us-gaap Operating Lease Liability Noncurrent
OperatingLeaseLiabilityNoncurrent
163198 USD
CY2020Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
207554 USD
CY2019Q4 us-gaap Operating Lease Liability
OperatingLeaseLiability
335508 USD
CY2020Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P1Y4M24D
CY2019Q3 us-gaap Operating Lease Weighted Average Remaining Lease Term1
OperatingLeaseWeightedAverageRemainingLeaseTerm1
P2Y3M18D
CY2020Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.076
CY2019Q3 us-gaap Operating Lease Weighted Average Discount Rate Percent
OperatingLeaseWeightedAverageDiscountRatePercent
0.076
CY2020Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
48056 USD
CY2020Q3 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
160909 USD
CY2020Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
11354 USD
CY2020Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
220319 USD
CY2020Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
12765 USD
CY2020Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
207554 USD
CY2018Q2 us-gaap Lessee Operating Lease Term Of Contract
LesseeOperatingLeaseTermOfContract
P5Y
CY2020Q3 us-gaap Lessee Finance Lease Discount Rate
LesseeFinanceLeaseDiscountRate
0.076
CY2020Q3 us-gaap Finance Lease Liability Payments Remainder Of Fiscal Year
FinanceLeaseLiabilityPaymentsRemainderOfFiscalYear
5964 USD
CY2020Q3 us-gaap Finance Lease Liability Payments Due Next Twelve Months
FinanceLeaseLiabilityPaymentsDueNextTwelveMonths
9941 USD
CY2020Q3 us-gaap Finance Lease Liability Payments Due
FinanceLeaseLiabilityPaymentsDue
15905 USD
CY2020Q3 us-gaap Finance Lease Liability Undiscounted Excess Amount
FinanceLeaseLiabilityUndiscountedExcessAmount
444 USD
CY2020Q3 us-gaap Finance Lease Liability
FinanceLeaseLiability
15461 USD

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