$OCGN
Ocugen, Inc.

2024 Q3 Form 10-Q Financial Statement

#000162828024035822 Filed on August 08, 2024

View on sec.gov

Income Statement

Concept 2024 Q3 2024 Q2
Revenue $1.136M $1.141M
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $6.280M $7.688M
YoY Change -30.84% -19.62%
% of Gross Profit
Research & Development $8.108M $8.902M
YoY Change 27.85% -37.17%
% of Gross Profit
Depreciation & Amortization $613.0K $578.0K
YoY Change 240.56% 232.18%
% of Gross Profit
Operating Expenses $14.39M $16.59M
YoY Change -6.72% -30.1%
Operating Profit -$13.25M -$15.45M
YoY Change -14.08% -34.9%
Interest Expense $300.0K $200.0K
YoY Change -57.14% -60.0%
% of Operating Profit
Other Income/Expense, Net $282.0K $169.0K
YoY Change -77.65% -79.08%
Pretax Income -$12.97M -$15.28M
YoY Change -8.4% -33.35%
Income Tax
% Of Pretax Income
Net Earnings -$12.97M -$15.28M
YoY Change -8.42% -33.35%
Net Earnings / Revenue -1141.73% -1339.18%
Basic Earnings Per Share -$0.04
Diluted Earnings Per Share -$0.05 -$0.04
COMMON SHARES
Basic Shares Outstanding 287.9M shares 257.3M shares
Diluted Shares Outstanding 257.4M shares

Balance Sheet

Concept 2024 Q3 2024 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $38.70M $15.70M
YoY Change -27.67% -77.77%
Cash & Equivalents $39.00M $15.70M
Short-Term Investments
Other Short-Term Assets $1.977M $2.920M
YoY Change -36.23% 1.6%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $40.67M $18.62M
YoY Change -28.09% -74.65%
LONG-TERM ASSETS
Property, Plant & Equipment $17.13M $17.47M
YoY Change 18.39% 49.1%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.828M $4.149M
YoY Change 4.59% 9.07%
Total Long-Term Assets $21.26M $21.93M
YoY Change 17.29% 41.23%
TOTAL ASSETS
Total Short-Term Assets $40.67M $18.62M
Total Long-Term Assets $21.26M $21.93M
Total Assets $61.94M $40.54M
YoY Change -17.07% -54.43%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.494M $3.391M
YoY Change -48.85% -12.63%
Accrued Expenses $4.833M $4.495M
YoY Change -29.96% -45.93%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $1.316M $1.306M
YoY Change 3.13% 3.16%
Total Short-Term Liabilities $15.76M $17.97M
YoY Change 41.54% 33.52%
LONG-TERM LIABILITIES
Long-Term Debt $1.571M $1.552M
YoY Change 5.08% 5.43%
Other Long-Term Liabilities $554.0K $545.0K
YoY Change 11.47% 19.78%
Total Long-Term Liabilities $5.544M $5.643M
YoY Change 7.53% 7.79%
TOTAL LIABILITIES
Total Short-Term Liabilities $15.76M $17.97M
Total Long-Term Liabilities $5.544M $5.643M
Total Liabilities $21.31M $23.62M
YoY Change 30.78% 26.32%
SHAREHOLDERS EQUITY
Retained Earnings -$326.3M -$313.4M
YoY Change 22.39% 24.17%
Common Stock $2.904M $2.576M
YoY Change 13.17% 0.39%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $40.63M $16.93M
YoY Change
Total Liabilities & Shareholders Equity $61.94M $40.54M
YoY Change -17.07% -54.43%

Cashflow Statement

Concept 2024 Q3 2024 Q2
OPERATING ACTIVITIES
Net Income -$12.97M -$15.28M
YoY Change -8.42% -33.35%
Depreciation, Depletion And Amortization $613.0K $578.0K
YoY Change 240.56% 232.18%
Cash From Operating Activities -$11.27M -$9.911M
YoY Change -17.72% -47.3%
INVESTING ACTIVITIES
Capital Expenditures $507.0K $513.0K
YoY Change -84.91% -81.53%
Acquisitions
YoY Change
Other Investing Activities $0.00 $0.00
YoY Change -100.0%
Cash From Investing Activities -$507.0K -$513.0K
YoY Change -84.91% -108.96%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 34.79M 45.00K
YoY Change -116053.33% -99.71%
NET CHANGE
Cash From Operating Activities -11.27M -9.911M
Cash From Investing Activities -507.0K -513.0K
Cash From Financing Activities 34.79M 45.00K
Net Change In Cash 23.01M -10.38M
YoY Change -234.62% -547.18%
FREE CASH FLOW
Cash From Operating Activities -$11.27M -$9.911M
Capital Expenditures $507.0K $513.0K
Free Cash Flow -$11.78M -$10.42M
YoY Change -30.96% -51.7%

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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 dosed its first patient in June 2024</span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">. After completion of Phase 1/2 for OCU400 for the treatment of LCA, the Company will discuss alignment for Phase 3 strategy with the FDA. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">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, with OCU410 initiating Phase 2 dosing.</span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%"> In OCU410 GA study, low, medium, and high dose cohorts were completed to date. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In OCU410ST Stargardt study, low and medium dose cohorts were completed to date, and the Company is proceeding to dose with the high dose in the dose-escalation phase of the trial.</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 on its IND application for OCU200.</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 Cell Therapy 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 Phase 3-ready regenerative 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 has completed IND-enabling studies and GMP manufacturing of clinical trial material 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 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 $27.2 million and $40.4 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, the Company had an accumulated deficit of $313.4 million and cash, cash equivalents, and restricted cash totaling $16.0 million. This amount plus the amounts raised subsequent to June 30, 2024, as discussed in Note 14, 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 as of June 30, 2024, as well as the amount raised subsequent to June 30, 2024, are expected to enable it to fund its operations into the third quarter of 2025. Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development, and </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%">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 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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