2024 Q2 Form 10-K Financial Statement

#000162828024016378 Filed on April 16, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2023 Q4 2023
Revenue $1.141M $6.036M $6.036M
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $7.688M $5.155M $31.99M
YoY Change -19.62% -25.69% -8.88%
% of Gross Profit
Research & Development $8.902M $9.504M $39.57M
YoY Change -37.17% -44.79% -20.47%
% of Gross Profit
Depreciation & Amortization $578.0K $174.0K $704.0K
YoY Change 232.18% 0.58% 46.67%
% of Gross Profit
Operating Expenses $16.59M $14.66M $71.57M
YoY Change -30.1% -39.3% -15.67%
Operating Profit -$15.45M -$65.53M
YoY Change -34.9% -22.78%
Interest Expense $200.0K $2.500M
YoY Change -60.0% 78.57%
% of Operating Profit
Other Income/Expense, Net $169.0K -$870.0K $2.453M
YoY Change -79.08% -139.35% -30.25%
Pretax Income -$15.28M -$9.493M -$63.08M
YoY Change -33.35% -56.73% -22.46%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$15.28M -$9.493M -$63.10M
YoY Change -33.35% -56.73% -22.43%
Net Earnings / Revenue -1339.18% -157.27% -1045.39%
Basic Earnings Per Share -$0.04 -$0.26
Diluted Earnings Per Share -$0.04 -$0.04 -$0.26
COMMON SHARES
Basic Shares Outstanding 257.3M shares 256.5M shares 244.3M shares
Diluted Shares Outstanding 257.4M shares 244.3M shares

Balance Sheet

Concept 2024 Q2 2023 Q4 2023
SHORT-TERM ASSETS
Cash & Short-Term Investments $15.70M $39.50M $39.46M
YoY Change -77.77% -56.56% -56.6%
Cash & Equivalents $15.70M $39.50M $39.46M
Short-Term Investments $0.00 $0.00
Other Short-Term Assets $2.920M $3.509M $3.509M
YoY Change 1.6% -53.57% -53.57%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $18.62M $42.97M $42.97M
YoY Change -74.65% -56.37% -56.37%
LONG-TERM ASSETS
Property, Plant & Equipment $17.47M $17.29M $21.23M
YoY Change 49.1% 185.64% 113.13%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $4.149M $4.286M $342.0K
YoY Change 9.07% 4.87% 93.22%
Total Long-Term Assets $21.93M $21.58M $21.58M
YoY Change 41.23% 112.78% 112.78%
TOTAL ASSETS
Total Short-Term Assets $18.62M $42.97M $42.97M
Total Long-Term Assets $21.93M $21.58M $21.58M
Total Assets $40.54M $64.55M $64.55M
YoY Change -54.43% -40.58% -40.58%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.391M $3.172M $3.172M
YoY Change -12.63% -60.65% -60.65%
Accrued Expenses $4.495M $3.392M $3.392M
YoY Change -45.93% -65.74% -67.38%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $1.306M $0.00
YoY Change 3.16%
Total Short-Term Liabilities $17.97M $17.09M $17.09M
YoY Change 33.52% -7.43% -7.43%
LONG-TERM LIABILITIES
Long-Term Debt $1.552M $2.800M $2.800M
YoY Change 5.43% 22.32% 22.32%
Other Long-Term Liabilities $545.0K $527.0K $4.094M
YoY Change 19.78% 115.98% 6.87%
Total Long-Term Liabilities $5.643M $6.894M $6.894M
YoY Change 7.79% 12.65% 12.65%
TOTAL LIABILITIES
Total Short-Term Liabilities $17.97M $17.09M $17.09M
Total Long-Term Liabilities $5.643M $6.894M $6.894M
Total Liabilities $23.62M $23.98M $23.98M
YoY Change 26.32% -2.43% -2.43%
SHAREHOLDERS EQUITY
Retained Earnings -$313.4M -$286.2M
YoY Change 24.17% 34.37%
Common Stock $2.576M $2.567M
YoY Change 0.39% 15.79%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $16.93M $40.56M $40.56M
YoY Change
Total Liabilities & Shareholders Equity $40.54M $64.55M $64.55M
YoY Change -54.43% -40.58% -40.58%

Cashflow Statement

Concept 2024 Q2 2023 Q4 2023
OPERATING ACTIVITIES
Net Income -$15.28M -$9.493M -$63.10M
YoY Change -33.35% -56.73% -22.43%
Depreciation, Depletion And Amortization $578.0K $174.0K $704.0K
YoY Change 232.18% 0.58% 46.67%
Cash From Operating Activities -$9.911M -$11.30M -$62.05M
YoY Change -47.3% -33.17% 3.29%
INVESTING ACTIVITIES
Capital Expenditures $513.0K $2.726M $10.48M
YoY Change -81.53% 34.68% 135.05%
Acquisitions
YoY Change
Other Investing Activities $0.00 $3.000K $13.55M
YoY Change -100.0% -100.02% -208.34%
Cash From Investing Activities -$513.0K -$2.723M $3.077M
YoY Change -108.96% -82.2% -118.14%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $20.80M
YoY Change -65.07%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 45.00K 11.00K $20.88M
YoY Change -99.71% -99.87% -64.89%
NET CHANGE
Cash From Operating Activities -9.911M -11.30M -$62.05M
Cash From Investing Activities -513.0K -2.723M $3.077M
Cash From Financing Activities 45.00K 11.00K $20.88M
Net Change In Cash -10.38M -14.02M -$38.10M
YoY Change -547.18% -41.68% 117.15%
FREE CASH FLOW
Cash From Operating Activities -$9.911M -$11.30M -$62.05M
Capital Expenditures $513.0K $2.726M $10.48M
Free Cash Flow -$10.42M -$14.03M -$72.53M
YoY Change -51.7% -25.92% 12.39%

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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="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">Modifier Gene Therapy Platform </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">— 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 diseases such as retinitis pigmentosa ("RP") (OCU400) and Leber congenital amaurosis ("LCA") (OCU400), with a gene-agnostic approach. We also believe our modifier gene therapy platform has the potential to address many retinal diseases, including a multifactorial dry age-related macular degeneration ("dAMD") using OCU410, which the Company believes has the potential to treat millions of patients, and Stargardt disease (OCU410ST), which is also a rare 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 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 GA patients, and OCU410ST, for the treatment of Stargardt patients, programs are in Phase 1/2 clinical development.</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.</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 our OCU500 product and planning to submit an IND in 2024. The Company is currently collaborating with the National Institute of Allergy and Infectious Diseases ("NIAID") for early clinical studies for the OCU500 program. The Company expects OCU500 clinical trials to begin mid-2024. The Company is continuing discussions with relevant government agencies regarding developmental funding for our 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 $63.1 million and $86.8 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had an accumulated deficit of $286.2 million and cash and cash equivalents totaling $39.5 million. This amount will not meet the Company's capital requirements over the next 12 months after the date that the 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 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 consolidated financial statements are issued. The 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;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 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>
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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>
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