2020 Q1 Form 10-K Financial Statement

#000162828020004221 Filed on March 27, 2020

View on sec.gov

Income Statement

Concept 2020 Q1 2019 2018 Q4
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $2.280M $6.080M $2.150M
YoY Change -22.18% -40.39% -19.48%
% of Gross Profit
Research & Development $1.652M $8.086M $3.330M
YoY Change -56.44% -21.66% -1.19%
% of Gross Profit
Depreciation & Amortization $18.00K $100.0K $90.00K
YoY Change 23.25% 101.52% -74.29%
% of Gross Profit
Operating Expenses $3.929M $14.16M $5.470M
YoY Change -18.84% -12.25% -9.29%
Operating Profit -$3.929M -$14.16M
YoY Change -18.84% -12.25%
Interest Expense $15.00K $1.768M $7.420M
YoY Change -97.84% -52.86% -1039.24%
% of Operating Profit
Other Income/Expense, Net -$15.00K -$6.080M -$40.00K
YoY Change -98.98% 192.43% -233.33%
Pretax Income -$3.940M -$20.20M -$820.0K
YoY Change -58.17% 137.56% -87.94%
Income Tax $0.00 $0.00
% Of Pretax Income
Net Earnings -$3.944M -$20.24M -$820.0K
YoY Change -37.52% 11.23% -87.94%
Net Earnings / Revenue
Basic Earnings Per Share -$1.46
Diluted Earnings Per Share -$74.86K -$1.46 -$828.3K
COMMON SHARES
Basic Shares Outstanding 52.63M shares 13.89M shares
Diluted Shares Outstanding 13.89M shares

Balance Sheet

Concept 2020 Q1 2019 2018 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $3.190M $7.440M $15.54M
YoY Change -56.78% -52.12% 94.71%
Cash & Equivalents $3.193M $7.440M $1.628M
Short-Term Investments $0.00
Other Short-Term Assets $8.170M $8.320M $172.0K
YoY Change 975.0% 867.44% 40.98%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $11.36M $15.77M $1.942M
YoY Change 39.59% -3.84% -76.25%
LONG-TERM ASSETS
Property, Plant & Equipment $249.0K $220.0K $245.8K
YoY Change 84.44% 57.14% -90.97%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $551.2K $820.0K $116.3K
YoY Change -91.42% -7.87% -16.91%
Total Long-Term Assets $951.3K $1.040M $512.6K
YoY Change -85.8% 0.97% -82.08%
TOTAL ASSETS
Total Short-Term Assets $11.36M $15.77M $1.942M
Total Long-Term Assets $951.3K $1.040M $512.6K
Total Assets $12.31M $16.81M $2.454M
YoY Change -17.01% -3.56% -77.76%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.548M $1.900M $3.278M
YoY Change 40.76% 19.5% 322.36%
Accrued Expenses $1.384M $2.440M $1.403M
YoY Change 1297.63% 144.0% -48.14%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $7.484M
YoY Change
Long-Term Debt Due $0.00 $0.00
YoY Change -100.0%
Total Short-Term Liabilities $3.315M $4.540M $14.11M
YoY Change 43.07% 58.19% 270.82%
LONG-TERM LIABILITIES
Long-Term Debt $1.581M $1.070M $1.017M
YoY Change
Other Long-Term Liabilities $3.940K $170.0K $37.46K
YoY Change -99.98% -98.87% -99.8%
Total Long-Term Liabilities $1.702M $1.240M $1.054M
YoY Change -90.57% -91.74% -94.3%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.315M $4.540M $14.11M
Total Long-Term Liabilities $1.702M $1.240M $1.054M
Total Liabilities $5.017M $5.790M $15.16M
YoY Change -75.37% -67.64% -32.01%
SHAREHOLDERS EQUITY
Retained Earnings -$55.40M $31.24M
YoY Change -75.51% -115.0%
Common Stock $527.5K $215.9M
YoY Change -99.76% 9.64%
Preferred Stock
YoY Change
Treasury Stock (at cost) $47.86K
YoY Change
Treasury Stock Shares
Shareholders Equity $7.297M $11.02M -$12.71M
YoY Change
Total Liabilities & Shareholders Equity $12.31M $16.81M $2.454M
YoY Change -17.01% -3.56% -77.76%

Cashflow Statement

Concept 2020 Q1 2019 2018 Q4
OPERATING ACTIVITIES
Net Income -$3.944M -$20.24M -$820.0K
YoY Change -37.52% 11.23% -87.94%
Depreciation, Depletion And Amortization $18.00K $100.0K $90.00K
YoY Change 23.25% 101.52% -74.29%
Cash From Operating Activities -$4.686M -$16.89M -$6.940M
YoY Change 75.69% 45.25% 60.65%
INVESTING ACTIVITIES
Capital Expenditures $53.00K $30.00K -$70.00K
YoY Change 400.9% -61.25% -53.33%
Acquisitions
YoY Change
Other Investing Activities -$2.330M $0.00
YoY Change -358.89% -100.0%
Cash From Investing Activities -$53.00K -$2.357M -$70.00K
YoY Change 400.9% 2944.67% -109.33%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $0.00 -$1.135M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $488.0K $25.07M 17.36M
YoY Change -64.09% 248.89% -11673.33%
NET CHANGE
Cash From Operating Activities -$4.686M -$16.89M -6.940M
Cash From Investing Activities -$53.00K -$2.357M -70.00K
Cash From Financing Activities $488.0K $25.07M 17.36M
Net Change In Cash -$4.251M $5.816M 10.35M
YoY Change 222.22% -228.59% -378.23%
FREE CASH FLOW
Cash From Operating Activities -$4.686M -$16.89M -$6.940M
Capital Expenditures $53.00K $30.00K -$70.00K
Free Cash Flow -$4.739M -$16.92M -$6.870M
YoY Change 76.97% 44.54% 64.75%

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CY2019 us-gaap Nature Of Operations
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Nature of Business<div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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 clinical-stage biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to treat the whole eye. The Company is located in Malvern, Pennsylvania.</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">Ocugen has a late-stage, Phase 3 program, OCU300, which has received Orphan Drug Designation ("ODD") from the U.S. Food and Drug Administration ("FDA"). OCU300 is a small molecule therapeutic currently in Phase 3 clinical development for patients with ocular redness and discomfort stemming from ocular graft-versus-host disease (“oGVHD”). Ocugen is the first and only company to receive ODD for the treatment of symptoms associated with oGVHD and is the only company conducting Phase 3 studies in this patient population. OCU300 is formulated using the Company’s proprietary nanoemulsion technology, OcuNanoE—Ocugen’s ONE Platform™ (“OcuNanoE™”).</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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 for unmet medical needs in the area of retinal diseases, including inherited retinal diseases (“IRDs”). Ocugen’s modifier gene therapy platform is novel in that it targets nuclear hormone receptors (“NHRs”), which have the potential to restore homeostasis to the retina and may target multiple genes that are associated with a range of IRDs. Unlike single-gene replacement therapies, which only target one genetic mutation, the Company believes that its gene therapy platform, through its targeting of NHRs, may impact multiple genes that are associated with a range of genetically diverse diseases. Ocugen’s first gene therapy candidate, OCU400, has received ODD from the FDA, for the treatment of nuclear receptor subfamily 2 group E member 3 ("</span><span style="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">")</span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;"> </span><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">mutation-associated retinal diseases and centrosomal protein 290 ("</span><span style="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">") mutation-associated retinal diseases. Ocugen’s second gene therapy product candidate, OCU410, is targeted for dry age-related macular degeneration (“AMD”) and is currently in preclinical development. Currently, there are no FDA-approved therapies to treat this disease.</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;">Ocugen is also developing OCU200, a novel fusion protein for the treatment of wet AMD, diabetic retinopathy (“DR”) and diabetic macular edema (“DME”), which is in preclinical development. Ocugen expects to initiate a Phase 1/2 clinical trial for OCU200 within the next two years. Ocugen plans to expand the therapeutic applications of OCU200 beyond DME, DR and wet AMD to potentially include macular edema following retinal vein occlusion (“RVO”) and myopic choroidal neovascularization (“mCNV”).</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);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. (formerly known as Ocugen, Inc. (“Former Ocugen”)) in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of April 5, 2019, by and among Histogenics, Former Ocugen 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 Former Ocugen, with Former Ocugen 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 Former Ocugen. Former Ocugen is deemed to be the accounting acquirer. Accordingly, the historical financial statements of Former Ocugen 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="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);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 Former Ocugen’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 Former Ocugen’s common stock outstanding immediately prior to the Merger.</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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 consolidated balance sheets for the periods presented, reflects that of Ocugen. All references in the 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="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);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, and debt. The Company incurred net losses of approximately $20.2 million and $18.2 million for the year ended December 31, 2019 and 2018, respectively, and had an accumulated deficit of $51.5 million as of December 31, 2019. As of December 31, 2019, the Company had cash, cash equivalents and restricted cash totaling $7.6 million.</span></div><div style="margin-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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-top:12pt;"><span style="background-color:rgb(255,255,255, 0.0);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 products, there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these audited consolidated financial statements are issued. The audited 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="background-color:rgb(255,255,255, 0.0);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="background-color:rgb(255,255,255, 0.0);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 and the valuation of share-based payment arrangements, warrants, and embedded conversion features on the convertible notes.</span></div>
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CY2018Q4 us-gaap Unrecognized Tax Benefits
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0 USD
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303050 USD
CY2019 us-gaap Unrecognized Tax Benefits Increases Resulting From Current Period Tax Positions
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0 USD
CY2019 us-gaap Unrecognized Tax Benefits Decreases Resulting From Settlements With Taxing Authorities
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0 USD
CY2019 us-gaap Unrecognized Tax Benefits Reductions Resulting From Lapse Of Applicable Statute Of Limitations
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0 USD
CY2019Q4 us-gaap Unrecognized Tax Benefits
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303050 USD
CY2019Q4 us-gaap Unrecognized Tax Benefits
UnrecognizedTaxBenefits
300000 USD

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