Ocugen(OCGN) - 2023 Q1 - Quarterly Report

PART I—FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's analysis for the quarter ended March 31, 2023 Item 1. Financial Statements (Unaudited) This section presents Ocugen, Inc.'s unaudited condensed consolidated financial statements for the quarter ended March 31, 2023, including balance sheets, statements of operations and comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and specific financial line items Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of March 31, 2023, and December 31, 2022 Key Metrics for Condensed Consolidated Balance Sheets | Metric | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $68,259 | $77,563 | | Marketable securities | $8,462 | $13,371 | | Total current assets | $84,401 | $98,492 | | Total assets | $96,299 | $108,632 | | Total current liabilities | $15,683 | $18,460 | | Total liabilities | $20,499 | $24,580 | | Total stockholders' equity | $75,800 | $84,052 | | Accumulated deficit | $(229,516) | $(213,018) | - Total assets decreased from $108.6 million at December 31, 2022, to $96.3 million at March 31, 2023, primarily driven by a reduction in cash and cash equivalents and marketable securities[19] Condensed Consolidated Statements of Operations and Comprehensive Loss This section details the company's financial performance, including revenues, expenses, and net loss for the three months ended March 31, 2023, and 2022 Key Metrics for Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Three months ended March 31, 2023 (in thousands) | Three months ended March 31, 2022 (in thousands) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | | Research and development | $9,558 | $7,915 | | General and administrative | $8,193 | $10,119 | | Total operating expenses | $17,751 | $18,034 | | Loss from operations | $(17,751) | $(18,034) | | Other income (expense), net | $1,253 | $15 | | Net loss | $(16,498) | $(18,019) | | Net loss per share | $(0.07) | $(0.09) | - Net loss decreased to $16.5 million for the three months ended March 31, 2023, from $18.0 million in the prior year period, primarily due to increased other income and reduced general and administrative expenses[22] - Research and development expenses increased by $1.6 million, while general and administrative expenses decreased by $1.9 million year-over-year[22] Condensed Consolidated Statements of Stockholders' Equity This section outlines changes in the company's equity accounts, including common stock, additional paid-in capital, and accumulated deficit, for the three months ended March 31, 2023, and 2022 Key Metrics for Condensed Consolidated Statements of Stockholders' Equity | Metric | December 31, 2022 (in thousands) | March 31, 2023 (in thousands) | | :-------------------------- | :----------------------------- | :---------------------------- | | Total Stockholders' Equity | $84,052 | $75,800 | | Additional Paid-in Capital | $294,874 | $303,073 | | Accumulated Deficit | $(213,018) | $(229,516) | | Common Stock Shares Issued | 221,721,182 | 226,548,693 | - Total stockholders' equity decreased from $84.1 million to $75.8 million, primarily due to the net loss incurred during the quarter, partially offset by capital raises[25] - Additional paid-in capital increased by $8.2 million, reflecting $2.7 million from stock-based compensation expense and $5.5 million from common stock issuance for capital raises[25] Condensed Consolidated Statements of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2023, and 2022 Key Metrics for Condensed Consolidated Statements of Cash Flows | Cash Flow Activity | Three months ended March 31, 2023 (in thousands) | Three months ended March 31, 2022 (in thousands) | | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net cash used in operating activities | $(18,240) | $(15,066) | | Net cash provided by (used in) investing activities | $3,441 | $(223) | | Net cash provided by financing activities | $5,496 | $50,102 | | Net (decrease) increase in cash | $(9,304) | $34,813 | | Cash, cash equivalents, and restricted cash at end of period | $68,259 | $129,922 | - Net cash used in operating activities increased to $18.2 million in Q1 2023 from $15.1 million in Q1 2022, driven by increased operating expenses[27][114] - Investing activities shifted from a net cash outflow of $0.2 million in Q1 2022 to a net cash inflow of $3.4 million in Q1 2023, primarily due to proceeds from marketable securities maturities[27][115] - Cash provided by financing activities significantly decreased from $50.1 million in Q1 2022 to $5.5 million in Q1 2023, reflecting lower proceeds from common stock issuances[27][116] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements Note 1. Nature of Business Ocugen, Inc. is a biotechnology company focused on gene and cell therapies and vaccines. The company is developing a modifier gene therapy platform for retinal diseases (OCU400, OCU410, OCU410ST), a regenerative medicine cell therapy (NeoCart), and an inhaled mucosal vaccine platform (OCU500, OCU510, OCU520). The company has discontinued development of its intramuscular COVID-19 vaccine (COVAXIN) in North America due to commercial viability concerns. Ocugen faces substantial doubt about its ability to continue as a going concern beyond Q1 2024 without additional funding - Ocugen is a biotechnology company focused on gene and cell therapies and vaccines, managing its business as one operating segment[30] - The modifier gene therapy platform includes OCU400 for inherited retinal diseases (RP, LCA), OCU410 for dry AMD, and OCU410ST for Stargardt disease. OCU400 showed positive preliminary Phase 1/2 data in RP patients, with plans for pediatric enrollment in Q2 2023 and a Phase 3 trial by end of 2023[31][32][33][34] - NeoCart, a Phase 3-ready regenerative medicine cell therapy for knee cartilage repair, received RMAT designation from the FDA, with a Phase 3 trial intended to initiate in 2024[35][36] - The company is refocusing its vaccine efforts on an inhaled mucosal vaccine platform (OCU500, OCU510, OCU520) and has discontinued COVAXIN development in North America due to commercial viability concerns following FDA's cancellation of monovalent vaccine EUAs[37][38][39] - OCU200, a novel biologic therapy for diabetic macular edema (DME), diabetic retinopathy (DR), and wet AMD, is on clinical hold by the FDA for its Phase 1 trial due to CMC information requests[40] - Ocugen has incurred recurring net losses and had an accumulated deficit of $229.5 million as of March 31, 2023. Current cash, cash equivalents, and investments of $76.7 million are expected to fund operations only into Q1 2024, raising substantial doubt about its ability to continue as a going concern[41][43] Note 2. Summary of Significant Accounting Policies This note outlines the significant accounting policies used in preparing the condensed consolidated financial statements, including the basis of presentation, use of estimates, accounting for cash and cash equivalents, fair value measurements, marketable securities, concentration of credit risk, leases, and stock-based compensation. It also details the recent adoption of ASU No. 2016-13 (Credit Losses) and the expected non-material impact of ASU No. 2020-06 (Convertible Instruments) - The condensed consolidated financial statements are prepared in conformity with GAAP and SEC rules for interim reporting, including normal recurring adjustments[44] - The company classifies highly liquid investments with maturities of three months or less as cash equivalents and accounts for marketable debt securities as available-for-sale[46][49] - The adoption of ASU No. 2016-13 (Credit Losses) on January 1, 2023, did not have a material impact on the financial statements[61] - The company does not expect the adoption of ASU No. 2020-06 (Convertible Instruments) on January 1, 2024, to have a material impact[62] Note 3. Fair Value Measurements This note provides a summary of the fair value measurements for financial assets, categorizing them by Level 1 and Level 2 inputs. As of March 31, 2023, total assets measured at fair value were $76.7 million, with cash and cash equivalents primarily in Level 1 and marketable securities (U.S. government agency securities, treasuries, and commercial paper) in Level 2 Key Metrics for Note 3. Fair Value Measurements | Asset Category | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents (Level 1) | $68,259 | $76,564 | | Marketable securities (Level 2) | $8,462 | $13,371 | | Total assets at fair value | $76,721 | $90,934 | - The fair value of marketable securities, including U.S. government agency securities, treasuries, and commercial paper, is determined using Level 2 inputs[63] Note 4. Marketable Securities The company's marketable securities, classified as available-for-sale, consist of U.S. government agency securities, treasuries, and commercial paper. As of March 31, 2023, the fair value of these securities was $8.46 million, a decrease from $13.37 million at December 31, 2022. All marketable securities mature within one year Key Metrics for Note 4. Marketable Securities | Security Type | March 31, 2023 Fair Value (in thousands) | December 31, 2022 Fair Value (in thousands) | | :-------------------------------- | :------------------------------------ | :------------------------------------ | | U.S. government agency securities and treasuries | $4,478 | $7,433 | | Commercial paper | $3,984 | $5,938 | | Total marketable securities | $8,462 | $13,371 | - All marketable securities held by the company are classified as available-for-sale and mature within one year[65] Note 5. Property and Equipment Property and equipment, net, increased to $7.95 million as of March 31, 2023, from $6.05 million at December 31, 2022. This increase is primarily driven by a significant rise in construction in progress, reflecting ongoing investments in facilities Key Metrics for Note 5. Property and Equipment | Component | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Furniture and fixtures | $337 | $337 | | Machinery and equipment | $1,783 | $1,685 | | Leasehold improvements | $1,907 | $1,603 | | Construction in progress | $4,712 | $3,049 | | Total property and equipment, net | $7,952 | $6,053 | - Construction in progress increased by $1.66 million, indicating significant capital expenditures for facility development[66] Note 6. Operating Leases Ocugen has operating lease commitments for office, laboratory, and future manufacturing space in Malvern, Pennsylvania. The total present value of minimum lease payments is $3.96 million, with future minimum base rent payments extending through 2027 and thereafter Key Metrics for Note 6. Operating Leases | Year Ending December 31, | Amount (in thousands) | | :----------------------- | :-------------------- | | Remainder of 2023 | $574 | | 2024 | $787 | | 2025 | $810 | | 2026 | $834 | | 2027 | $834 | | Thereafter | $978 | | Total | $4,817 | | Less: present value adjustment | $(856) | | Present value of minimum lease payments | $3,961 | - Lease terms are approximately seven years, with extension options excluded from lease liabilities as they are not reasonably certain to be exercised[67] Note 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities decreased to $5.82 million as of March 31, 2023, from $9.90 million at December 31, 2022. This reduction was primarily driven by decreases in clinical and employee-related accruals Key Metrics for Note 7. Accrued Expenses and Other Current Liabilities | Component | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,286 | $1,894 | | Clinical | $117 | $3,310 | | Professional fees | $615 | $437 | | Employee-related | $1,592 | $2,752 | | Other | $2,213 | $1,507 | | Total accrued expenses and other current liabilities | $5,823 | $9,900 | - Clinical accruals saw a significant decrease from $3.31 million to $0.12 million, and employee-related accruals decreased from $2.75 million to $1.59 million[69] Note 8. Debt The company has an EB-5 Loan Agreement providing up to $10.0 million in borrowings, secured by most of its assets excluding intellectual property. As of March 31, 2023, the carrying value of the debt was $2.31 million, with $2.0 million in principal outstanding at a fixed interest rate of 4.0% per annum. An additional $0.5 million was borrowed subsequent to March 31, 2023 Key Metrics for Note 8. Debt | Component | March 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :----------------------------- | :----------------------------- | | Principal outstanding | $2,000 | $2,000 | | Accrued interest | $327 | $307 | | Unamortized debt issuance costs | $(13) | $(18) | | Carrying value, net | $2,314 | $2,289 | | Current portion of long term debt | $(1,256) | $0 | | Long term debt, net of current portion | $1,058 | $2,289 | - Borrowings under the EB-5 Loan Agreement carry a fixed interest rate of 4.0% per annum, with each borrowing due upon its seventh anniversary[72] - Subsequent to March 31, 2023, the company borrowed an additional $0.5 million under the EB-5 Loan Agreement[71][94] Note 9. Equity This note details the company's equity activities, including common stock offerings and the Series B Convertible Preferred Stock. During Q1 2023, Ocugen sold 4.5 million common shares through an At-the-Market Offering, generating $5.6 million net proceeds. The Series B Convertible Preferred Stock, issued to Bharat Biotech as an advance payment for COVAXIN, is being re-evaluated for accounting implications following the discontinuation of COVAXIN development in North America - During the three months ended March 31, 2023, Ocugen sold 4.5 million shares of common stock through an At-the-Market Offering, generating net proceeds of $5.6 million[74] - The Series B Convertible Preferred Stock, issued to Bharat Biotech, had a remaining short-term asset balance of $4.1 million as of March 31, 2023, for the advanced payment for COVAXIN supply[79] - The company is evaluating the accounting implications of discontinuing COVAXIN development in North America on the Series B preferred stock and the related short-term asset[80] Note 10. Warrants Ocugen has outstanding Canada Warrants and OpCo Warrants. The Canada Warrants, issued in connection with Canadian operations and COVAXIN milestones, are being re-evaluated due to the discontinuation of COVAXIN development in North America. As of March 31, 2023, 0.6 million OpCo Warrants were outstanding with a weighted-average exercise price of $6.23 per share - As of March 31, 2023, all 0.2 million Canada Warrants were outstanding and unvested, with an exercise price of $6.36 per share[81] - The company is evaluating the implications of the FDA's decision regarding monovalent vaccines on the Canada Consulting Agreement and Canada Warrants[81] - As of March 31, 2023, 0.6 million OpCo Warrants were outstanding with a weighted-average exercise price of $6.23 per share, expiring between 2026 and 2027[82] Note 11. Stock-Based Compensation Stock-based compensation expense decreased to $2.69 million for the three months ended March 31, 2023, from $3.30 million in the prior year period. The company had $17.8 million of unrecognized stock-based compensation expense as of March 31, 2023, expected to be recognized over a weighted-average period of 2.0 years Key Metrics for Note 11. Stock-Based Compensation | Expense Category | Three months ended March 31, 2023 (in thousands) | Three months ended March 31, 2022 (in thousands) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | | General and administrative | $1,952 | $2,216 | | Research and development | $737 | $1,083 | | Total | $2,689 | $3,299 | - The weighted average grant date fair value of stock options granted decreased significantly from $3.61 in Q1 2022 to $1.01 in Q1 2023[85] - As of March 31, 2023, 13.7 million stock options and 3.5 million RSUs were outstanding[85][86] Note 12. Net Loss Per Share of Common Stock The basic and diluted net loss per common share for the three months ended March 31, 2023, was $(0.07), an improvement from $(0.09) in the prior year period. Potentially dilutive securities, including stock options, RSUs, and warrants, were excluded from diluted EPS calculation as their inclusion would have been antidilutive Key Metrics for Note 12. Net Loss Per Share of Common Stock | Metric | Three months ended March 31, 2023 | Three months ended March 31, 2022 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss — basic and diluted | $(16,498) (in thousands) | $(18,019) (in thousands) | | Shares used in calculating net loss per common share | 225,523,627 | 205,693,498 | | Net loss per common share — basic and diluted | $(0.07) | $(0.09) | - Approximately 18.6 million potentially dilutive securities were excluded from the diluted EPS calculation for Q1 2023 due to their antidilutive effect[89] Note 13. Commitments and Contingencies Ocugen has commitments under various agreements, including licensing, leases, debt, and consulting. The company is also involved in securities class action and stockholder derivative lawsuits related to COVAXIN statements. While a motion to dismiss the securities class action was granted, the lead plaintiff has appealed. The company believes these lawsuits are without merit and has not accrued for any potential losses - Commitments include annual payments, milestone payments, and royalties under license and development agreements, as well as future payments under lease and debt agreements[90] - The U.S. District Court granted Ocugen's motion to dismiss with prejudice in the consolidated securities class action lawsuits in March 2023, but the lead plaintiff has appealed[91] - Stockholder derivative lawsuits are stayed pending resolution of the appeal in the securities class action lawsuits[92] Note 14. Subsequent Events Subsequent to March 31, 2023, Ocugen borrowed an additional $0.5 million under the EB-5 Loan Agreement - An additional $0.5 million was borrowed under the EB-5 Loan Agreement after March 31, 2023[94] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Ocugen's financial condition and operational results for the three months ended March 31, 2023. It reiterates the company's biotechnology focus and pipeline, analyzes changes in operating expenses and net loss, and discusses liquidity challenges, including the need for significant additional funding to continue operations beyond Q1 2024 Overview This section provides a high-level summary of Ocugen's biotechnology focus, pipeline developments, and strategic shifts in its gene therapy, cell therapy, and vaccine programs - Ocugen is a biotechnology company developing gene and cell therapies and vaccines, with a pipeline including a modifier gene therapy platform (OCU400, OCU410, OCU410ST), a regenerative medicine cell therapy (NeoCart), and an inhaled mucosal vaccine platform (OCU500, OCU510, OCU520)[97][98][99] - OCU400's Phase 1/2 trial for RP and LCA showed positive preliminary safety and visual improvement data, with pediatric enrollment approved and a Phase 3 trial planned for late 2023[100] - NeoCart, a Phase 3-ready therapy for knee cartilage injuries, received RMAT designation, with Phase 3 trial initiation targeted for 2024[101] - The company is prioritizing its inhaled mucosal vaccine platform and has ceased development of the intramuscular COVID-19 vaccine (COVAXIN) in North America due to commercial viability concerns[102][103][104] - OCU200, a novel biologic for retinal diseases, is currently on clinical hold for its Phase 1 IND application due to FDA requests for additional CMC information[105] Results of Operations This section analyzes the company's financial performance, detailing changes in research and development, general and administrative expenses, and net loss for the three months ended March 31, 2023, compared to the prior year Key Metrics for Results of Operations | Operating Expense | Three months ended March 31, 2023 (in thousands) | Three months ended March 31, 2022 (in thousands) | Change (in thousands) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | :-------------------- | | Research and development | $9,558 | $7,915 | $1,643 | | General and administrative | $8,193 | $10,119 | $(1,926) | | Total operating expenses | $17,751 | $18,034 | $(283) | | Net loss | $(16,498) | $(18,019) | $1,521 | - Research and development expense increased by $1.6 million, primarily due to higher employee-related expenses, technical service costs for the modifier gene therapy platform, and preclinical activities for the inhaled mucosal vaccine platform[107] - General and administrative expense decreased by $1.9 million, mainly due to reductions in professional services and pre-commercialization activities[108] - Other income (expense), net, increased by $1.2 million, primarily driven by $0.7 million in interest earned on cash, cash equivalents, and investments[109] Liquidity and Capital Resources This section discusses the company's cash position, historical funding, and future capital requirements, highlighting the need for additional funding to sustain operations beyond Q1 2024 - As of March 31, 2023, Ocugen had $76.7 million in cash, cash equivalents, and investments, which is insufficient to meet capital requirements for the next 12 months[110][119] - The company expects its current capital to fund operations only into the first quarter of 2024[119] - Ocugen has an accumulated deficit of $229.5 million as of March 31, 2023, and has historically funded operations through equity and debt sales[112] - The company plans to seek additional funding through public/private placements of equity/debt, strategic R&D arrangements, asset sales, licensing, or government funding, particularly for its vaccine platform[119] - There is substantial doubt about the company's ability to continue as a going concern within one year due to anticipated increased spending and the need for significant additional funding[120] Contractual Obligations This section confirms that no material changes to contractual obligations were reported compared to the previous annual report - No material changes to contractual obligations were reported compared to the 2022 Annual Report, which include licensing, development, lease, debt, and consulting agreements[117] Funding Requirements This section outlines the significant future funding needs dependent on clinical trial progress, regulatory approvals, and commercialization efforts - Future funding requirements are significant and depend on clinical trial progress, regulatory approvals, manufacturing, commercialization, intellectual property costs, infrastructure expansion, and personnel recruitment[118][119] - Failure to secure additional funding could lead to delays, scaling back, or elimination of R&D programs and commercialization efforts, or even cessation of operations[119] Off-Balance Sheet Arrangements This section confirms that the company did not have any off-balance sheet arrangements during the reported periods - The company did not have any off-balance sheet arrangements during the reported periods[121] Critical Accounting Policies and Significant Judgments and Estimates This section states that no material changes to critical accounting policies and estimates were reported compared to the previous annual report - No material changes to critical accounting policies and estimates were reported compared to the 2022 Annual Report[122] Recently Adopted Accounting Pronouncements This section refers to Note 2 for details on recently adopted accounting pronouncements - Refer to Note 2 for a discussion of recently adopted accounting pronouncements[123] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[125] Item 4. Controls and Procedures Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2023. There were no material changes in internal control over financial reporting during the period - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2023[126] - No material changes in internal control over financial reporting occurred during the period[127] PART II—OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings This section refers to Note 13 of the financial statements for a discussion of legal proceedings, which include securities class action and stockholder derivative lawsuits - Legal proceedings are detailed in Note 13 to the condensed consolidated financial statements[130] Item 1A. Risk Factors This section highlights a new material risk factor: the potential delisting of Ocugen's common stock from Nasdaq due to failure to meet the minimum $1.00 bid price requirement. The company received a deficiency notice on May 1, 2023, and has until October 30, 2023, to regain compliance - No material changes to risk factors were reported, except for a new risk regarding potential Nasdaq delisting[131] - Ocugen received a Nasdaq deficiency letter on May 1, 2023, for failing to meet the minimum $1.00 bid price requirement for 30 consecutive business days[133] - The company has 180 calendar days, until October 30, 2023, to regain compliance by having its stock close above $1.00 for a minimum of 10 consecutive trading days[133] - A delisting could reduce stock liquidity, impair capital raising, and negatively impact investor and employee confidence[134] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities or purchases of equity securities by the company that were not previously reported during the period - No unregistered sales of equity securities or un-reported purchases of equity securities occurred during the period[135] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - There were no defaults upon senior securities[136] Item 4. Mine Safety Disclosures This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[137] Item 5. Other Information No other information was reported in this section - No other information was reported[138] Item 6. Exhibits This section lists the exhibits filed or incorporated by reference in the Quarterly Report on Form 10-Q, including amendments to license agreements, executive employment agreements, and certifications required by the Sarbanes-Oxley Act - Exhibits include the First Amendment to the Exclusive License Agreement with The Washington University, an Executive Employment Agreement with Quan Vu, and certifications (302 and 1350) from the CEO and CFO[139]