2020 Q4 Form 10-K Financial Statement

#000162828021005124 Filed on March 19, 2021

View on sec.gov

Income Statement

Concept 2020 Q4 2019 Q4
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.210M $2.530M
YoY Change -12.65% 17.67%
% of Gross Profit
Research & Development $1.590M $1.750M
YoY Change -9.14% -47.45%
% of Gross Profit
Depreciation & Amortization $40.00K $30.00K
YoY Change 33.33% -66.67%
% of Gross Profit
Operating Expenses $3.810M $4.280M
YoY Change -10.98% -21.76%
Operating Profit
YoY Change
Interest Expense -$170.0K $16.69M
YoY Change -101.02% 124.93%
% of Operating Profit
Other Income/Expense, Net $180.0K -$30.00K
YoY Change -700.0% -25.0%
Pretax Income -$3.790M $12.38M
YoY Change -130.61% -1609.76%
Income Tax
% Of Pretax Income
Net Earnings -$3.790M $12.38M
YoY Change -130.61% -1609.76%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$22.21K $325.3K
COMMON SHARES
Basic Shares Outstanding 162.0M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q4 2019 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $24.04M $7.440M
YoY Change 223.12% -52.12%
Cash & Equivalents $24.04M $7.444M
Short-Term Investments
Other Short-Term Assets $1.840M $8.320M
YoY Change -77.88% 4737.21%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $25.88M $15.77M
YoY Change 64.14% 712.01%
LONG-TERM ASSETS
Property, Plant & Equipment $633.0K $222.5K
YoY Change 184.54% -9.49%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $714.0K $667.7K
YoY Change 6.93% 474.0%
Total Long-Term Assets $1.498M $1.041M
YoY Change 43.87% 103.13%
TOTAL ASSETS
Total Short-Term Assets $25.88M $15.77M
Total Long-Term Assets $1.498M $1.041M
Total Assets $27.38M $16.81M
YoY Change 62.88% 584.83%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $395.0K $1.896M
YoY Change -79.16% -42.16%
Accrued Expenses $2.930M $2.270M
YoY Change 29.09% 61.83%
Deferred Revenue
YoY Change
Short-Term Debt $234.0K $0.00
YoY Change -100.0%
Long-Term Debt Due $230.0K $0.00
YoY Change
Total Short-Term Liabilities $3.614M $4.544M
YoY Change -20.47% -67.8%
LONG-TERM LIABILITIES
Long-Term Debt $1.823M $1.072M
YoY Change 70.04% 5.45%
Other Long-Term Liabilities $0.00 $9.755K
YoY Change -100.0% -73.96%
Total Long-Term Liabilities $2.212M $1.245M
YoY Change 77.66% 18.11%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.614M $4.544M
Total Long-Term Liabilities $2.212M $1.245M
Total Liabilities $5.826M $5.789M
YoY Change 0.64% -61.82%
SHAREHOLDERS EQUITY
Retained Earnings -$73.30M -$51.48M
YoY Change 42.39% -264.8%
Common Stock $1.841M $527.5K
YoY Change 249.03% -99.76%
Preferred Stock
YoY Change
Treasury Stock (at cost) $48.00K $47.86K
YoY Change 0.28%
Treasury Stock Shares
Shareholders Equity $21.55M $11.02M
YoY Change
Total Liabilities & Shareholders Equity $27.38M $16.81M
YoY Change 62.88% 584.83%

Cashflow Statement

Concept 2020 Q4 2019 Q4
OPERATING ACTIVITIES
Net Income -$3.790M $12.38M
YoY Change -130.61% -1609.76%
Depreciation, Depletion And Amortization $40.00K $30.00K
YoY Change 33.33% -66.67%
Cash From Operating Activities -$4.280M -$8.740M
YoY Change -51.03% 25.94%
INVESTING ACTIVITIES
Capital Expenditures -$250.0K -$30.00K
YoY Change 733.33% -57.14%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change
Cash From Investing Activities -$250.0K -$20.00K
YoY Change 1150.0% -71.43%
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 910.0K
YoY Change 940.66% -94.76%
NET CHANGE
Cash From Operating Activities -4.280M -8.740M
Cash From Investing Activities -250.0K -20.00K
Cash From Financing Activities 9.470M 910.0K
Net Change In Cash 4.940M -7.850M
YoY Change -162.93% -175.85%
FREE CASH FLOW
Cash From Operating Activities -$4.280M -$8.740M
Capital Expenditures -$250.0K -$30.00K
Free Cash Flow -$4.030M -$8.710M
YoY Change -53.73% 26.78%

Facts In Submission

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<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., together with its wholly owned subsidiaries (“Ocugen” or the “Company”), is a biopharmaceutical company focused on developing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. The Company is located in Malvern, Pennsylvania.</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 co-developing COVAXIN, a whole-virion inactivated COVID-19 vaccine candidate, with Bharat Biotech International Limited ("Bharat Biotech") for the U.S. market. COVAXIN is being developed to prevent COVID-19 infection in humans and is formulated with the inactivated SARS-CoV-2 virus, an antigen, and an adjuvant. In February 2021, the Company entered into a Co-Development, Supply and Commercialization Agreement (the "Covaxin Agreement") with Bharat Biotech, pursuant to which the Company obtained an exclusive right and license under certain of Bharat Biotech's intellectual property rights, with the right to grant sublicenses to develop, manufacture, and commercialize COVAXIN for the prevention of COVID-19 in humans in the United States, its territories and possessions (the “Ocugen Covaxin Territory”). COVAXIN has been granted approval for emergency use in India. A Phase 3 clinical trial is ongoing in India. The Company is currently evaluating the clinical and regulatory path for COVAXIN in the United States including obtaining Emergency Use Authorization ("EUA") from the U.S. Food and Drug Administration (the "FDA") and, eventually, biologic license application (“BLA”) approval in the U.S. market, as well as the Company's commercialization strategy, if authorized or approved. See Note 16 for additional information about the terms, rights, and obligations under the Covaxin Agreement.</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 breakthrough 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%">OCU400 is the Company's first product candidate being developed with the Company's modifier gene therapy platform. OCU400 is a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including retinitis pigmentosa ("RP") and leber congenital amaurosis ("LCA"). OCU400 has received four Orphan Drug Designations from the 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%">PDE6ß</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">") mutation-associated inherited retinal degenerations. Ocugen is planning to initiate two Phase 1/2a clinical trials for OCU400 in the United States in the second half of 2021. OCU400 additionally received Orphan Medicinal Product Designation from the European Commission, based on the recommendation of the European Medicines Agency, for RP and LCA in February 2021, which Ocugen believes further supports the broad spectrum application of OCU400 to treat many IRDs. Ocugen is currently evaluating options to commence OCU400 clinical trials in Europe in 2022. 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, diabetic retinopathy, and wet AMD. Ocugen had a pre-Investigational New Drug ("IND") meeting with the FDA in November 2020 and received guidance on IND-enabling preclinical studies to support the Phase 1/2a study. Ocugen expects to initiate IND-enabling preclinical studies for OCU200 in 2021. Ocugen plans to initiate a Phase 1/2a clinical trial for OCU200 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 was developing OCU300, a small molecule therapeutic for the treatment of symptoms associated with ocular graft-versus-host disease. The Phase 3 clinical trial for OCU300 was discontinued in 2020 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. 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, which was formerly known as Histogenics Corporation ("Histogenics"), completed a reverse merger (the "Merger") with Ocugen OpCo, Inc. ("OpCo") in accordance with the terms of the Agreement and Plan of </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%">Merger and Reorganization, dated as of April 5, 2019, by and among OpCo, Restore Merger Sub, Inc., the Company's wholly owned subsidiary ("Merger Sub"), and the Company, as amended (the "Merger Agreement") pursuant to which Merger Sub merged with and into OpCo, with OpCo surviving as the Company's wholly owned subsidiary. Immediately after completion of the Merger, the Company changed its name to Ocugen, Inc. and the business previously conducted by OpCo became the business conducted by the Company. 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%">Going Concern Consideration</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 audited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) assuming the Company will continue as a going concern. As of December 31, 2020, the Company had cash, cash equivalents, and restricted cash of approximately $24.2 million, and since that date the Company has received net proceeds of $4.8 million from the sale of the Company's common stock in an at-the-market offering (“ATM") commenced in August 2020 and net proceeds of $21.2 million from the sale of the Company's common stock in a registered direct offering (the "Registered Direct Offering"). See Note 9 for additional information about the August 2020 ATM. See Note 16 for additional information about the Registered Direct Offering. As a result of the Company's cash, cash equivalents, and restricted cash balance as of December 31, 2020 and the net proceeds received subsequent to December 31, 2020 from the August 2020 ATM and the Registered Direct Offering, the Company believes that its cash, cash equivalents, and restricted cash will enable the Company to fund its operating expenses and capital expenditure requirements through at least one year from the date the audited consolidated financial statements are issued.</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 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 include those used in the estimation of 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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