2023 Q3 Form 10-Q Financial Statement

#000162828023030128 Filed on August 21, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2 2022 Q2
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $9.080M $9.564M $10.56M
YoY Change 21.12% -9.41% 56.25%
% of Gross Profit
Research & Development $6.342M $14.17M $9.007M
YoY Change -59.4% 57.31% -52.23%
% of Gross Profit
Depreciation & Amortization $180.0K $174.0K $90.00K
YoY Change 27.66% 93.33% 69.81%
% of Gross Profit
Operating Expenses $15.42M $23.73M $19.57M
YoY Change -33.28% 21.3% -23.6%
Operating Profit -$15.42M -$23.73M -$19.57M
YoY Change -33.28% 21.3% -23.6%
Interest Expense $700.0K $500.0K $100.0K
YoY Change 40.0% 400.0% 400.0%
% of Operating Profit
Other Income/Expense, Net $1.262M $808.0K $94.00K
YoY Change 5.43% 759.57% -127.49%
Pretax Income -$14.16M -$22.93M -$19.47M
YoY Change -35.41% 17.74% -24.97%
Income Tax
% Of Pretax Income
Net Earnings -$14.16M -$22.93M -$19.47M
YoY Change -35.4% 17.74% -24.97%
Net Earnings / Revenue
Basic Earnings Per Share -$0.06 -$0.10 -$0.09
Diluted Earnings Per Share -$0.06 -$0.10 -$0.09
COMMON SHARES
Basic Shares Outstanding 256.5M shares 226.4M shares 215.9M shares
Diluted Shares Outstanding 256.5M shares 238.3M shares 215.9M shares

Balance Sheet

Concept 2023 Q3 2023 Q2 2022 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $53.50M $70.60M $115.0M
YoY Change -47.34% -38.61% -0.55%
Cash & Equivalents $53.50M $70.60M $115.0M
Short-Term Investments $0.00 $0.00 $0.00
Other Short-Term Assets $3.100M $2.874M $7.564M
YoY Change -47.41% -62.0% 26.4%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $56.56M $73.45M $122.6M
YoY Change -47.39% -40.07% 0.78%
LONG-TERM ASSETS
Property, Plant & Equipment $14.47M $11.72M $3.153M
YoY Change 220.32% 271.71% 234.0%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.660M $3.804M $4.366M
YoY Change -13.37% -12.87% 185.36%
Total Long-Term Assets $18.13M $15.52M $7.519M
YoY Change 107.38% 106.46% 186.44%
TOTAL ASSETS
Total Short-Term Assets $56.56M $73.45M $122.6M
Total Long-Term Assets $18.13M $15.52M $7.519M
Total Assets $74.69M $88.98M $130.1M
YoY Change -35.75% -31.6% 4.7%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $2.921M $3.881M $5.921M
YoY Change -54.78% -34.45% 638.28%
Accrued Expenses $6.900M $8.313M $4.103M
YoY Change -13.79% 102.61% 1.61%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $1.276M $1.266M $0.00
YoY Change
Total Short-Term Liabilities $11.14M $13.46M $10.34M
YoY Change -25.3% 30.2% 113.6%
LONG-TERM LIABILITIES
Long-Term Debt $1.495M $1.472M $1.750M
YoY Change -34.0% -15.89% 4.54%
Other Long-Term Liabilities $497.0K $455.0K $3.892M
YoY Change -86.8% -88.31% 193.07%
Total Long-Term Liabilities $5.156M $5.235M $5.642M
YoY Change -14.48% -7.21% 87.94%
TOTAL LIABILITIES
Total Short-Term Liabilities $11.14M $13.46M $10.34M
Total Long-Term Liabilities $5.156M $5.235M $5.642M
Total Liabilities $16.29M $18.70M $15.98M
YoY Change -22.18% 16.99% 103.77%
SHAREHOLDERS EQUITY
Retained Earnings -$266.6M -$252.4M -$169.2M
YoY Change 39.52% 49.17% 59.17%
Common Stock $2.566M $2.566M $2.163M
YoY Change 18.36% 18.63% 8.8%
Preferred Stock
YoY Change
Treasury Stock (at cost) $48.00K $48.00K
YoY Change 0.0% 0.0%
Treasury Stock Shares
Shareholders Equity $58.40M $70.28M $114.1M
YoY Change
Total Liabilities & Shareholders Equity $74.69M $88.98M $130.1M
YoY Change -35.75% -31.6% 4.7%

Cashflow Statement

Concept 2023 Q3 2023 Q2 2022 Q2
OPERATING ACTIVITIES
Net Income -$14.16M -$22.93M -$19.47M
YoY Change -35.4% 17.74% -24.97%
Depreciation, Depletion And Amortization $180.0K $174.0K $90.00K
YoY Change 27.66% 93.33% 69.81%
Cash From Operating Activities -$13.70M -$18.81M -$13.80M
YoY Change -4.21% 36.3% -36.72%
INVESTING ACTIVITIES
Capital Expenditures $3.360M $2.777M -$1.366M
YoY Change -498.1% -303.29% 417.42%
Acquisitions
YoY Change
Other Investing Activities $0.00 $8.500M $0.00
YoY Change -100.0% -100.0%
Cash From Investing Activities -$3.360M $5.723M -$1.366M
YoY Change 3948.19% -518.96% 34.71%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -30.00K 15.40M 236.0K
YoY Change -103.12% 6427.12% -99.75%
NET CHANGE
Cash From Operating Activities -13.70M -18.81M -13.80M
Cash From Investing Activities -3.360M 5.723M -1.366M
Cash From Financing Activities -30.00K 15.40M 236.0K
Net Change In Cash -17.09M 2.321M -14.93M
YoY Change 27.32% -115.55% -121.07%
FREE CASH FLOW
Cash From Operating Activities -$13.70M -$18.81M -$13.80M
Capital Expenditures $3.360M $2.777M -$1.366M
Free Cash Flow -$17.06M -$21.58M -$12.43M
YoY Change 26.76% 73.62% -42.29%

Facts In Submission

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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, biologics, 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-style:italic;font-weight:700;line-height:120%">Modifier Gene Therapy Platform</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 developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal diseases ("IRDs"), such as retinitis pigmentosa ("RP"), Leber congenital amaurosis ("LCA"), and Stargardt disease, as well as dry age-related macular degeneration ("AMD") with a gene-agnostic therapy. The Company's modifier gene therapy platform is based on the use of 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, the Company believes that its modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential both to address multiple retinal diseases caused by mutations in multiple genes with a gene-agnostic therapy and to address complex diseases that are potentially caused by imbalances in multiple gene networks.</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 believes that OCU400 has the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs, including RP and LCA. OCU400 has received Orphan Drug Designation ("ODD") from the United States Food and Drug Administration ("FDA") and Orphan Medicinal Product Designation ("OMPD") from the European Commission ("EC") for the treatment of RP and LCA.</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 conducting a Phase 1/2 trial to assess the safety and efficacy of unilateral subretinal administration of OCU400 in patients with 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%">and 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%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-related RP and 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%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-related LCA in the United States. The Company has completed dosing adult RP patients in the dose-escalation portion of the trial, which enrolled 10 patients to receive a low, medium, or high dose of OCU400 in the subretinal space. Additionally, the Company completed dosing eight adult RP patients with the high dose, which was determined to be the maximum tolerable dose from the dose-escalation portion of the trial. The Company is continuing to enroll adult LCA patients to receive the medium dose based on the nature of the disease for this subset of the patient population. In April 2023, the Company announced positive preliminary data among adult RP patients treated in the first two cohorts of the Phase 1/2 trial. In Cohorts 1 and 2 of the trial, seven participants with severe vision impairment due to RP associated with the </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 </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%"> gene mutations received a unilateral subretinal injection of either a low dose or a medium dose of OCU400, respectively. The preliminary results showed a favorable safety profile and visual improvements after treatment with OCU400 as measured by multi-luminance mobility testing ("MLMT") and best corrected visual acuity assessment ("BCVA"). Additionally, the Company is continuing to enroll pediatric patients in the ongoing Phase 1/2 trial for the treatment of RP and LCA. The Company also intends to initiate a Phase 3 trial for OCU400 for the treatment of RP and LCA near the end of 2023/early 2024, subject to the outcome of the ongoing Phase 1/2 trial and discussions with the FDA on the proposed Phase 3 trial plan.</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 also developing OCU410 and OCU410ST, utilizing 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%">"</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">),</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 and Stargardt disease, respectively. OCU410 is a potential one-time, curative therapy with a single sub-retinal injection. OCU410ST has received ODD from the FDA for the treatment of </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">ABCA4</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">-associated retinopathies, including Stargardt disease. The Company submitted Investigational New Drug ("IND") applications to the FDA for both OCU410 and OCU410ST in the second quarter of 2023. The FDA cleared the Company's IND applications, and the Company intends to initiate Phase 1/2 trials by the end of 2023.</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%">Regenerative Medicine Cell Therapy Platform</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%">NeoCart is a Phase 3-ready, regenerative medicine cell therapy technology that combines breakthroughs in bioengineering and cell processing to enhance the autologous cartilage repair process. NeoCart is a three-dimensional tissue-engineered disc of new cartilage that is manufactured by growing chondrocytes, the cells responsible for maintaining cartilage health. The chondrocytes are derived from the patient on a unique scaffold. In this therapy, healthy cartilage tissue is grown and implanted in the patient. Cartilage defects often lead to osteoarthritis if left untreated. Current surgical and nonsurgical treatment options are limited in </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%">their efficacy and durability. NeoCart has the potential to accelerate healing, reduce pain, and provide regenerative native-like cartilage strength with durable benefits post transplantation. The FDA granted a regenerative medicine advanced therapy ("RMAT") designation to NeoCart for the repair of full-thickness lesions of knee cartilage injuries in adults. Additionally, the Company received concurrence from the FDA on the confirmatory Phase 3 trial design. The Company is renovating an existing facility into a current Good Manufacturing Practice ("GMP") facility in accordance with the FDA's regulations in support of NeoCart manufacturing for personalized Phase 3 trial material. The Company intends to initiate the Phase 3 trial in the second half of 2024.</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%">Inhaled Mucosal Vaccine Platform</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 developing a next-generation, inhalation-based mucosal vaccine platform based on the ChAd vector, which includes OCU500, a bivalent COVID-19 vaccine; OCU510, a seasonal quadrivalent flu vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 vaccine. The Company's inhaled mucosal vaccine platform is driven by its conviction to serve a public health concern, which requires the endorsement and support of government funding, both domestically and with respect to in-licensed territories abroad, in order to develop and ultimately commercialize its vaccine candidates. As these vaccine candidates are being developed to be administered via inhalation, the Company believes they have the potential to generate rapid local immunity in the upper airways and lungs, where viruses enter and infect the body. The Company believes this unique delivery method may help reduce or prevent infection and transmission as well as provide protection against new virus variants. The Company is continuing the internal development of its inhaled mucosal vaccine platform to achieve IND readiness and intends to submit an IND application in 2024, provided it receives government funding. The Company has submitted multiple proposals to obtain government funding and is continuing discussions with relevant government agencies regarding developmental funding for its inhaled mucosal vaccine platform.</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%">Novel Biologic Therapy for Retinal Diseases</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 developing OCU200, which is a novel fusion protein containing parts of human transferrin and tumstatin. OCU200 is designed to treat diabetic macular edema ("DME"), diabetic retinopathy ("DR"), and wet AMD. The Company has completed the technology transfer of manufacturing processes to its contract development and manufacturing organization ("CDMO") and has produced trial materials to initiate a Phase 1 trial. In April 2023, the FDA placed the Company's IND application to initiate a Phase 1 trial targeting DME on clinical hold, as part of the FDA's request for additional information related to CMC. The Company is working to provide the FDA with the requested information as promptly as possible and does not currently expect the clinical hold to impact the anticipated overall timing of the OCU200 clinical development program.</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 $39.4 million and $37.5 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, the Company had an accumulated deficit of $252.4 million and cash and cash equivalents totaling $70.6 million. This amount will not meet the Company's capital requirements for the next 12 months after the date that the condensed consolidated financial statements are issued. 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 plans 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>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.
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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;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 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 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, and the fair value measurement of equity instruments.</span></div>
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CY2022Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
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