PART I [Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28unaudited%29) Unaudited consolidated financial statements for Ocular Therapeutix, Inc. as of and for the periods ended September 30, 2023, are presented [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2023, details total assets of **$162.4 million** and total liabilities of **$154.5 million** | Metric | Sep 30, 2023 ($ thousands) | Dec 31, 2022 ($ thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | 110,550 | 102,300 | | Total Assets | 162,384 | 149,289 | | Total Liabilities | 154,531 | 113,910 | | Total Stockholders' Equity | 7,853 | 35,379 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q3 2023 saw increased revenue and a significantly reduced net loss of **$0.5 million**, driven by a **$14.2 million** gain on debt extinguishment | Metric ($ thousands) | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | 14,950 | 11,913 | 43,193 | 36,555 | | Loss from operations | (19,214) | (21,544) | (62,332) | (59,293) | | Gains on extinguishment of debt, net | 14,190 | — | 14,190 | — | | Net loss | (516) | (24,188) | (51,516) | (55,496) | | Net loss per share, basic | (0.01) | (0.31) | (0.66) | (0.72) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operations was **$47.8 million**, offset by **$61.7 million** from financing activities | Cash Flow Activity (9 Months Ended Sep 30, $ thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | (47,780) | (42,645) | | Net cash used in investing activities | (5,628) | (1,565) | | Net cash provided by financing activities | 61,658 | 996 | | Net increase (decrease) in cash | 8,250 | (43,214) | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the **$82.5 million** Barings credit facility, **$14.2 million** debt extinguishment gain, and high customer concentration, with cash funding operations into 2025 - The company believes its existing cash of **$110.6 million** as of Sep 30, 2023, will fund operations into 2025, but this does not cover the completion of the SOL trial or initiation of other pivotal trials[31](index=31&type=chunk)[157](index=157&type=chunk)[217](index=217&type=chunk) - In August 2023, the company entered into an **$82.5 million** credit facility with Barings, repaid its **$25 million** MidCap facility, and amended its Convertible Notes, resulting in a net gain on debt extinguishment of **$14.2 million**[53](index=53&type=chunk)[65](index=65&type=chunk)[174](index=174&type=chunk) - For the nine months ended September 30, 2023, three specialty distributor customers accounted for **51%**, **23%**, and **11%** of the company's gross product revenue[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, DEXTENZA commercialization, AXPAXLI clinical progress, and the **$82.5 million** debt refinancing, which funds operations into 2025 - The company is a biopharmaceutical firm focused on eye disease therapies using its proprietary ELUTYX hydrogel technology, with DEXTENZA as its commercial product and AXPAXLI as its lead pipeline candidate for retinal diseases[102](index=102&type=chunk)[106](index=106&type=chunk) - The pivotal Phase 3 SOL trial for AXPAXLI in wet AMD was initiated in September 2023, with FDA agreement under a Special Protocol Assessment (SPA) received in October 2023[109](index=109&type=chunk)[115](index=115&type=chunk) - In-market unit sales for DEXTENZA exceeded **36,000 units** in Q3 2023, an increase of approximately **38%** from Q3 2022[148](index=148&type=chunk) - The company secured an **$82.5 million** credit facility with Barings in August 2023, which it believes will fund operations into 2025, though additional financing is needed to complete the SOL trial and initiate other pivotal trials[151](index=151&type=chunk)[157](index=157&type=chunk)[217](index=217&type=chunk) [Results of Operations](index=56&type=section&id=Results%20of%20Operations) Q3 2023 net product revenue grew **25.5%** to **$15.0 million**, with a significantly reduced net loss of **$0.5 million** due to a **$14.2 million** debt extinguishment gain | Metric ($ thousands) | Q3 2023 | Q3 2022 | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | 14,950 | 11,913 | 3,037 | | Research and development | 15,019 | 13,719 | 1,300 | | Selling and marketing | 9,315 | 10,186 | (871) | | Loss from operations | (19,214) | (21,544) | 2,330 | | Net loss | (516) | (24,188) | 23,672 | | Metric ($ thousands) | 9M 2023 | 9M 2022 | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | 43,193 | 36,555 | 6,638 | | Research and development | 44,860 | 39,919 | 4,941 | | Selling and marketing | 31,304 | 29,390 | 1,914 | | Loss from operations | (62,332) | (59,293) | (3,039) | | Net loss | (51,516) | (55,496) | 3,980 | - Gross-to-net deductions for DEXTENZA increased to **29.8%** of gross sales in Q3 2023 from **24.3%** in Q3 2022, and to **29.2%** for the nine-month period from **23.1%** in the prior year[183](index=183&type=chunk)[195](index=195&type=chunk) [Liquidity and Capital Resources](index=64&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company held **$110.6 million** in cash, with **$47.8 million** used in operations, and believes current cash funds operations into 2025 but requires additional financing for trials - The company had cash and cash equivalents of **$110.6 million** as of September 30, 2023[207](index=207&type=chunk) - Net cash used in operating activities for the nine months ended Sep 30, 2023 was **$47.8 million**, compared to **$42.6 million** in the prior year period[209](index=209&type=chunk) - The company believes its existing cash will fund operations into 2025 but acknowledges it is not enough to complete the SOL trial or initiate other planned pivotal trials without additional financing[217](index=217&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=74&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on cash and variable-rate debt, with two derivative liabilities valued at **$12.6 million** and **$11.4 million** - The company's main market risk is interest rate sensitivity on its cash equivalents and SOFR-based debt[226](index=226&type=chunk)[228](index=228&type=chunk) - The company accounts for two derivative liabilities at fair value: the Royalty Fee Derivative Liability (**$12.6 million**) and the Conversion Option Derivative Liability (**$11.4 million**) as of September 30, 2023[229](index=229&type=chunk)[230](index=230&type=chunk) [Controls and Procedures](index=74&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during Q3 2023 - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective at the reasonable assurance level[232](index=232&type=chunk) - There were no changes in internal control over financial reporting during Q3 2023 that materially affected, or are reasonably likely to materially affect, internal controls[233](index=233&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=77&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is it aware of any threatened against it - The company is not presently a party to any material legal proceedings[236](index=236&type=chunk) [Risk Factors](index=77&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight substantial indebtedness from the **$82.5 million** Barings Credit Agreement, including restrictive covenants and the risk of default - The company's substantial debt from the **$82.5 million** Barings Credit Facility and **$37.5 million** Convertible Notes could limit cash flow for business investment and other corporate purposes[238](index=238&type=chunk)[239](index=239&type=chunk) - The Barings Credit Agreement contains restrictive covenants, including maintaining a minimum liquidity of **$20.0 million**, and is secured by all of the company's assets, including intellectual property[239](index=239&type=chunk) - A failure to comply with debt conditions could result in an event of default and acceleration of debt repayment, which the company may not have sufficient funds to cover[243](index=243&type=chunk) [Other Information](index=77&type=section&id=Item%205.%20Other%20Information) This section is listed in the table of contents but contains no substantive information in the report body [Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section indexes exhibits filed with the Form 10-Q, including the Barings Credit Agreement, Convertible Note amendment, and officer certifications - Key exhibits filed include the new Credit and Security Agreement with Barings, an amendment to the Convertible Notes, and officer certifications required by the Sarbanes-Oxley Act[247](index=247&type=chunk)

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements for Ocular Therapeutix, Inc. as of June 30, 2023, and for the three and six months ended June 30, 2023 and 2022, highlighting a decrease in cash and stockholders' equity alongside an increase in net loss [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2023, shows a decrease in total assets and a significant reduction in stockholders' equity compared to December 31, 2022, primarily driven by a decline in cash and cash equivalents and an increase in total liabilities Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $66,606 | $102,300 | | Total current assets | $100,712 | $129,627 | | Total assets | $122,558 | $149,289 | | Total liabilities | $119,471 | $113,910 | | Total stockholders' equity | $3,087 | $35,379 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net product revenue increased year-over-year for both the three and six-month periods, but net loss also widened, particularly for the six-month period, due to higher operating expenses and a significant negative change in the fair value of its derivative liability Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2023 | Q2 2022 | H1 2023 | H1 2022 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $15,029 | $12,144 | $28,243 | $24,642 | | Total revenue, net | $15,186 | $12,266 | $28,561 | $25,453 | | Loss from operations | $(20,570) | $(19,916) | $(43,119) | $(37,748) | | Net loss | $(20,682) | $(18,766) | $(51,000) | $(31,308) | | Net loss per share, basic | $(0.26) | $(0.24) | $(0.66) | $(0.41) | - The significant increase in net loss for the six months ended June 30, 2023, was heavily impacted by a **$5.4 million loss** from the change in fair value of derivative liability, compared to a **$9.7 million gain** in the same period of 2022[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the first six months of 2023, cash used in operating activities increased compared to the prior year, driven by a larger net loss, while investing activities also consumed more cash due to equipment purchases, and financing activities provided a net inflow primarily from a stock offering Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(40,048) | $(29,476) | | Net cash used in investing activities | $(5,369) | $(771) | | Net cash provided by financing activities | $9,723 | $622 | | **Net decrease in cash** | **$(35,694)** | **$(29,625)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business focus on ophthalmology, its history of losses, and its reliance on future financing, including disclosures on licensing agreements, debt facilities, derivative liability valuation, and a new **$82.5 million credit facility** secured in August 2023 - The company has a history of losses, with an **accumulated deficit of $667.8 million** as of June 30, 2023, and expects to continue generating operating losses[31](index=31&type=chunk) - Subsequent to the quarter's end, on August 2, 2023, the company entered into a **new $82.5 million credit facility** with Barings, used the proceeds to repay its existing MidCap facility, and extended the maturity of its Convertible Notes[89](index=89&type=chunk)[90](index=90&type=chunk)[93](index=93&type=chunk) - For the six months ended June 30, 2023, three specialty distributor customers accounted for **55%**, **23%**, and **11%** of the company's gross product revenue[67](index=67&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business strategy, progress in its clinical pipeline, and commercial performance of DEXTENZA, showing revenue growth but also widening net losses due to increased R&D and S&M spending and non-cash charges, with a new credit facility secured in August 2023 expected to fund operations into 2025 [Overview](index=32&type=section&id=Overview) The company is a biopharmaceutical firm focused on eye diseases using its proprietary ELUTYX hydrogel technology, with its sole commercial product, DEXTENZA, showing strong sales growth, and its clinical pipeline advancing with key programs for wet AMD, NPDR, and glaucoma, including plans to initiate a pivotal trial for OTX-TKI in wet AMD in Q3 2023 - **DEXTENZA in-market unit sales exceeded 36,000** in Q2 2023, a **40% increase year-over-year** and a **6% increase quarter-over-quarter**[135](index=135&type=chunk) - The company plans to initiate the first of two pivotal trials for OTX-TKI in wet AMD in Q3 2023, following 12-month data showing **60% of subjects were rescue-free**[107](index=107&type=chunk)[108](index=108&type=chunk) - Enrollment was completed for the OTX-TKI Phase 1 trial in NPDR (HELIOS) and the OTX-TIC Phase 2 trial in glaucoma, with topline data for both expected in Q1 2024[110](index=110&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk) [Results of Operations](index=54&type=section&id=Results%20of%20Operations) This section provides a detailed comparison of financial results for the three and six months ended June 30, 2023, and 2022, showing that net product revenue from DEXTENZA grew 24% in Q2 2023 year-over-year, but operating expenses also rose, with R&D increasing due to clinical trial activities and S&M increasing from sales team expansion, leading to a higher net loss Q2 2023 vs Q2 2022 Expense Changes (in thousands) | Expense Category | Q2 2023 | Q2 2022 | Increase (Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $15,094 | $13,100 | $1,994 | | Selling and marketing | $11,153 | $10,140 | $1,013 | | General and administrative | $8,205 | $7,787 | $418 | H1 2023 vs H1 2022 Financial Summary (in thousands) | Metric | H1 2023 | H1 2022 | Increase (Decrease) | | :--- | :--- | :--- | :--- | | Product revenue, net | $28,243 | $24,642 | $3,601 | | Total costs and operating expenses | $71,680 | $63,201 | $8,479 | | Net loss | $(51,000) | $(31,308) | $(19,692) | [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q2 2023 with **$66.6 million** in cash, and a significant post-quarter event was securing an **$82.5 million credit facility** from Barings in August 2023, which management believes will **fund planned operations into 2025**, including the initiation of the first OTX-TKI pivotal trial, but not its completion or other pivotal trials without additional capital - As of June 30, 2023, the company had **cash and cash equivalents of $66.6 million** and an **accumulated deficit of $667.8 million**[186](index=186&type=chunk)[187](index=187&type=chunk) - In August 2023, the company secured a **new $82.5 million credit facility**, receiving **$77.8 million** in net proceeds, and used **$26.2 million** to repay its existing MidCap Credit Facility[187](index=187&type=chunk) - The company believes its existing cash and new financing will **fund planned operations into 2025**, sufficient to *initiate* the first pivotal trial for OTX-TKI for wet AMD, but additional financing is needed for completion and other pivotal trials[197](index=197&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily interest rate sensitivity affecting its cash equivalents and variable-rate debt, and notes the valuation risk of the derivative liability tied to its convertible notes, which is influenced by stock price and volatility, concluding that a 100 basis point change in interest rates would not materially impact its financial position - The company's primary market risk is interest rate sensitivity on its cash equivalents and variable-rate debt[208](index=208&type=chunk) - The derivative liability associated with the Convertible Notes was **valued at $11.8 million** as of June 30, 2023, and while its fair value is sensitive to stock price and volatility, management states a **10% change in these inputs would not have a material effect**[209](index=209&type=chunk)[210](index=210&type=chunk) [Item 4. Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2023, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[212](index=212&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[213](index=213&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings, nor is it aware of any material legal proceedings being threatened against it - The company is not presently a party to any material legal proceedings[216](index=216&type=chunk) [Item 1A. Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) This section updates previously disclosed risk factors, with a new primary focus on the substantial indebtedness incurred from the **$82.5 million Barings Credit Facility** obtained in August 2023, highlighting risks such as potential limitation on cash flow for business investment, restrictive covenants like a **$20.0 million minimum liquidity** requirement, and the consequences of a potential default - A new risk factor is the company's substantial indebtedness following the **$82.5 million Barings Credit Facility** entered into on August 2, 2023[218](index=218&type=chunk) - The debt is secured by all company assets and includes restrictive covenants, such as maintaining a **minimum liquidity of $20.0 million**, which could limit operational flexibility[219](index=219&type=chunk) - Failure to comply with the debt conditions could result in an event of default, acceleration of debt repayment, and enforcement of security interests by the lenders[223](index=223&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) This section details significant events occurring after the quarter's end, including entering into a new **$82.5 million credit facility** with Barings on August 2, 2023, using the proceeds to repay the existing MidCap facility, extending the maturity of the company's Convertible Notes, and the board ratifying certain past stock issuances that may not have been properly authorized - On August 2, 2023, the company entered into an **$82.5 million credit facility** with Barings, receiving **net proceeds of $77.8 million** after discounts and fees[224](index=224&type=chunk) - The Barings facility includes a unique "**Royalty Fee**" structure, where the company must pay an amount equal to the total facility, paid in quarterly installments equal to **3.5% of DEXTENZA net sales**[229](index=229&type=chunk) - On August 6, 2023, the board of directors ratified several past issuances of common stock under the 2014 Employee Stock Purchase Plan due to a "Failure of Authorization"[232](index=232&type=chunk) [Item 6. Exhibits](index=79&type=section&id=Item%206.%20Exhibits) This section provides an index of the exhibits filed as part of the Quarterly Report on Form 10-Q, including amendments to credit agreements, the amended 2021 Stock Incentive Plan, and the required certifications by the Principal Executive Officer and Principal Financial Officer - The report includes several exhibits, such as Amendment No. 2 to the MidCap Credit Agreement, the 2021 Stock Incentive Plan (as amended), and certifications from the CEO and CFO[238](index=238&type=chunk)

• One of most common, severe diabetes complications; leading cause of blindness in working-age population *per planned protocol dosing Sources: Eye care of the patient with diabetes mellitus. American Optometric Association, Second Edition; Market Scope - 2022 Retinal Pharmaceuticals Market Report, Global Analysis 2021-2027; Market Scope Q2-2022 US Retina Quarterly Update; AAO DR Preferred Practice Pattern; JAMA Ophthalmol. 2021;139(9):946-955 (PANORAMA); Arcadu F, et al. NPJ Digit Med. 2019;2:92. • Diabeti ...

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Ocular Therapeutix, Inc.'s unaudited condensed consolidated financial statements for Q1 2023 and prior periods [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $128.6 million, liabilities increased, and equity significantly declined to $9.7 million by Q1 2023 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $79,026 | $102,300 | | Total current assets | $107,162 | $129,627 | | Total assets | $128,573 | $149,289 | | **Liabilities & Equity** | | | | Total current liabilities | $29,715 | $31,395 | | Derivative liability | $12,914 | $6,351 | | Total liabilities | $118,862 | $113,910 | | Total stockholders' equity | $9,711 | $35,379 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss surged to $30.3 million in Q1 2023, primarily due to derivative liability changes and increased operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Product revenue, net | $13,214 | $12,498 | | Total revenue, net | $13,374 | $13,187 | | Total costs and operating expenses | $35,923 | $31,020 | | Loss from operations | $(22,549) | $(17,833) | | Change in fair value of derivative liability | $(6,563) | $6,958 | | Net loss | $(30,318) | $(12,542) | | Net loss per share, basic & diluted | $(0.39) | $(0.16) / $(0.22) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $20.0 million in Q1 2023, leading to a total cash decrease of $23.3 million Cash Flow Summary (in thousands) | Activity | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,973) | $(18,600) | | Net cash used in investing activities | $(3,379) | $(276) | | Net cash provided by financing activities | $78 | $129 | | **Net decrease in cash, cash equivalents and restricted cash** | **$(23,274)** | **$(18,747)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business, accounting policies, and financial condition, highlighting an accumulated deficit and future capital needs - The company is a biopharmaceutical firm focused on eye therapies using its proprietary ELUTYX hydrogel technology, commercializing DEXTENZA and developing product candidates like OTX-TKI and OTX-TIC[28](index=28&type=chunk)[30](index=30&type=chunk) - As of March 31, 2023, the company had an accumulated deficit of **$647.2 million** and expects continued operating losses, with existing cash of **$79.0 million** funding operations into mid-2024, excluding planned pivotal trials for OTX-TKI which require additional funding[31](index=31&type=chunk) - For Q1 2023, three specialty distributor customers accounted for **52%**, **25%**, and **13%** of gross product revenue, indicating significant customer concentration[60](index=60&type=chunk) - The fair value of the derivative liability associated with the 2026 Convertible Notes increased from **$6.4 million** at year-end 2022 to **$12.9 million** at March 31, 2023, primarily due to an increase in the company's stock price[65](index=65&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, business overview, and strategic direction, covering DEXTENZA, pipeline progress, and liquidity [Overview and Portfolio](index=27&type=section&id=Overview%20and%20Portfolio) The company develops ophthalmic therapies using ELUTYX hydrogel technology, commercializing DEXTENZA and advancing its OTX-TKI and OTX-TIC pipeline - The company's core is its ELUTYX hydrogel technology, which allows for local, programmed drug release in the eye[81](index=81&type=chunk)[82](index=82&type=chunk) - Key clinical programs include OTX-TKI (wet AMD/DR), OTX-TIC (glaucoma), OTX-DED (short-term dry eye), and OTX-CSI (chronic dry eye)[83](index=83&type=chunk)[84](index=84&type=chunk) - Interim 10-month data for the OTX-TKI Phase 1 trial in wet AMD showed the implant was well-tolerated, with **73%** of subjects remaining rescue-free and a **92%** reduction in treatment burden[88](index=88&type=chunk)[89](index=89&type=chunk) - The company plans to initiate the first of two pivotal trials for OTX-TKI in wet AMD as early as Q3 2023, contingent on securing necessary financing[94](index=94&type=chunk) - The Phase 2 trial for OTX-TIC (glaucoma) is ongoing with the 26 µg dose arm after the 5 µg arm was terminated, with topline data expected in Q4 2023[101](index=101&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) Total net revenue was flat at $13.4 million in Q1 2023, but net loss surged to $30.3 million due to higher expenses and derivative liability impact Results of Operations Comparison (in thousands) | Metric | Q1 2023 | Q1 2022 | Change | | :--- | :--- | :--- | :--- | | Total revenue, net | $13,374 | $13,187 | $187 | | Research and development | $14,747 | $13,100 | $1,647 | | Selling and marketing | $10,835 | $9,063 | $1,772 | | General and administrative | $9,127 | $7,557 | $1,570 | | Loss from operations | $(22,549) | $(17,833) | $(4,716) | | Net loss | $(30,318) | $(12,542) | $(17,776) | - Net product revenue from DEXTENZA increased to **$13.2 million** in Q1 2023 from **$12.5 million** in Q1 2022[147](index=147&type=chunk) - Gross-to-net deductions for DEXTENZA increased to **28.1%** of gross sales in Q1 2023, up from **21.9%** in Q1 2022[146](index=146&type=chunk) - The increase in R&D expenses was primarily due to a **$2.0 million** increase in clinical and preclinical program costs, particularly for OTX-TKI[149](index=149&type=chunk) - The **$13.1 million** negative change in 'Other Income (Expense), Net' was primarily due to a **$13.5 million** unfavorable change in the fair value of the derivative liability, reflecting an increase in the company's stock price[154](index=154&type=chunk) [Liquidity and Capital Resources](index=49&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2023 with $79.0 million in cash, projecting funds into mid-2024, but additional capital is needed for pivotal trials - As of March 31, 2023, the company had **$79.0 million** in cash and cash equivalents[158](index=158&type=chunk) - Existing cash is projected to fund planned operations, debt service, and capital expenditures into the middle of 2024, explicitly excluding expenses for planned pivotal clinical trials for OTX-TKI[159](index=159&type=chunk)[168](index=168&type=chunk) - Net cash used in operating activities was **$20.0 million** in Q1 2023, driven by a net loss of **$30.3 million**, partially offset by non-cash charges like a **$6.6 million** change in derivative liability value and **$4.6 million** in stock-based compensation[160](index=160&type=chunk) - The company has an Open Market Sale Agreement with Jefferies to sell up to **$100.0 million** in common stock, with no shares sold as of May 4, 2023[119](index=119&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risk is interest rate sensitivity on cash and variable-rate debt, with management concluding no material effect from rate changes - The company's primary market risk is interest rate sensitivity on its **$79.0 million** in cash and cash equivalents and its **$25.0 million** variable interest rate note payable[177](index=177&type=chunk)[181](index=181&type=chunk) - Management concludes that an immediate **100 basis point** change in interest rates would not materially affect the fair market value of its portfolio or cash outflows from its debt[177](index=177&type=chunk)[181](index=181&type=chunk) - The fair value of the derivative liability (**$12.9 million** as of March 31, 2023) is subject to market inputs, but a **10%** change in these inputs is not expected to have a material effect[179](index=179&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2023, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[182](index=182&type=chunk) - No changes occurred during Q1 2023 that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[183](index=183&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=60&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is management aware of any threatened proceedings - The company is not presently a party to any material legal proceedings[186](index=186&type=chunk) [Item 1A. Risk Factors](index=60&type=section&id=Item%201A.%20Risk%20Factors) Risk factors highlight the risk of holding cash exceeding FDIC insurance limits, citing the SVB failure as a key example - A key risk is the concentration of cash in deposit accounts at a small number of financial institutions, with balances that exceed FDIC insurance limits[188](index=188&type=chunk)[191](index=191&type=chunk) - The failure of Silicon Valley Bank (SVB) in March 2023 is cited as a direct example of this risk, as the company maintained a significant portion of its cash at SVB at the time[189](index=189&type=chunk) - While the company amended its credit agreement to allow holding up to **50%** of its cash elsewhere, the risk of concentration remains, with no assurance of government protection for uninsured deposits in future bank failures[191](index=191&type=chunk)[192](index=192&type=chunk) [Item 5. Other Information](index=62&type=section&id=Item%205.%20Other%20Information) On May 4, 2023, the company amended its Credit and Security Agreement to permit holding up to 50% of cash outside Silicon Valley Bank - On May 4, 2023, the company amended its credit agreement to allow diversification of its cash holdings, permitting up to **50%** to be held at institutions other than Silicon Valley Bank[195](index=195&type=chunk) [Item 6. Exhibits](index=62&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed as part of the Quarterly Report on Form 10-Q, including certifications and XBRL documents - Lists exhibits filed with the report, including Amendment No. 1 to the Credit and Security Agreement, CEO/CFO certifications (Rules 302 and 906), and XBRL data files[200](index=200&type=chunk)

Financial Data and Key Metrics Changes - The company reported a net loss of $15.5 million for Q4 2022, compared to a net loss of $3.9 million in Q4 2021, reflecting a significant increase in losses [2] - Total net revenue for Q4 2022 was $14.1 million, representing an 18% growth over the prior quarter and a 15% growth over the same period in 2021 [30] - For the full year 2022, the company reported a net loss of $71 million, compared to a net loss of $6.6 million in 2021 [31] Business Line Data and Key Metrics Changes - DEXTENZA net product revenue for Q4 2022 was $13.9 million, up approximately 17% sequentially and 14% year-over-year [15][30] - Total DEXTENZA net product revenue for the full year 2022 was $50.5 million, representing a growth of approximately 20% over the previous year [15] Market Data and Key Metrics Changes - The company anticipates DEXTENZA net product revenue for 2023 to be between $55 million and $60 million, indicating potential growth of approximately 10% to 20% over 2022 [24] - In-market billable units for DEXTENZA were running more than 20% ahead of 2022 levels in January and February 2023 [50] Company Strategy and Development Direction - The company plans to initiate a Phase III program for diabetic retinopathy in Q1 2024, assuming positive results from the ongoing Phase I trial [20] - The company aims to commence pivotal trials for OTX-TKI in wet AMD in Q3 2023, contingent on securing financing and FDA discussions [32][47] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of OTX-TKI to provide a durable anti-VEGF response, which could set a new standard of care for wet AMD and diabetic retinopathy [44][26] - The company is in active discussions with the FDA regarding pivotal study designs and is encouraged by the potential path forward [47][77] Other Important Information - The company reported general and administrative expenses of $8.3 million for Q4 2022, an increase from $7.5 million in Q4 2021, primarily due to personnel-related costs [58] - Research and development expenses for Q4 2022 were $13.5 million, up from $12.6 million in the same period in 2021 [71] Q&A Session Summary Question: Where do you feel you are in the process of evaluating potential partnership situations for OTX-TKI? - Management indicated they are in discussions with potential partners and are optimistic about reaching an agreement before initiating pivotal studies [4][75] Question: What factors could influence being at the low or high end of the guidance for DEXTENZA? - Management noted that customer capacity and market access coverage would play significant roles in achieving revenue targets [7][64] Question: How much financing would be needed to progress the program for TKI in both wet AMD and DR? - Management stated it would be premature to specify the amount needed until an approved protocol is in place [66]

PART I [Item 1. Business](index=10&type=section&id=Item%201.%20Business) Ocular Therapeutix, Inc. is a biopharmaceutical company focused on ophthalmic therapies, leveraging its bioresorbable hydrogel technology for commercial products like DEXTENZA and a pipeline including OTX-TKI and OTX-TIC - The company's core focus is on developing and commercializing innovative eye therapies using its proprietary bioresorbable hydrogel-based formulation technology[25](index=25&type=chunk) Product & Pipeline Overview | PROGRAM | THERAPEUTIC FOCUS | STAGE | NEXT MILESTONES | | :--- | :--- | :--- | :--- | | **DEXTENZA®** | Post-surgical inflammation & pain; Allergic conjunctivitis | FDA Approved | Continue commercialization | | **OTX-TKI** | Wet AMD | Pivotal Trial Prep | Initiate pivotal trial as early as Q3 2023 | | **OTX-TKI** | Diabetic Retinopathy | Phase 1 | Initiate pivotal trial as early as Q1 2024 | | **OTX-TIC** | Glaucoma & ocular hypertension | Phase 2 | Topline data in Q4 2023 | | **OTX-DED** | Episodic dry eye disease | Phase 2 | Initiate trial for placebo comparator in Q2 2023 | | **OTX-CSI** | Dry eye disease | Phase 2 | Initiate trial for placebo comparator in Q2 2023 | - The company's strategy includes growing DEXTENZA revenues, advancing its clinical pipeline with a focus on OTX-TKI and OTX-TIC, and leveraging its commercial infrastructure for future ophthalmology products[32](index=32&type=chunk) [Clinical Portfolio](index=19&type=section&id=Clinical%20Portfolio) The clinical portfolio focuses on major ophthalmology markets, with OTX-TKI for retinal diseases, OTX-TIC for glaucoma, and OTX-DED/OTX-CSI for dry eye disease, all in various stages of clinical development - OTX-TKI (axitinib intravitreal implant) is being developed for wet AMD and diabetic retinopathy; for wet AMD, the company aims to initiate a pivotal trial in Q3 2023, subject to FDA discussions and financing, with interim 10-month data from the U.S. Phase 1 trial showing stable vision and a **92% reduction in treatment burden**[61](index=61&type=chunk)[74](index=74&type=chunk)[77](index=77&type=chunk) - OTX-TIC (travoprost intracameral implant) is being developed for glaucoma, with a U.S.-based Phase 2 trial ongoing, comparing OTX-TIC 26 µg to DURYSTA, and topline data expected in **Q4 2023**[87](index=87&type=chunk)[91](index=91&type=chunk)[93](index=93&type=chunk) - The dry eye program includes OTX-DED and OTX-CSI; following Phase 2 trials where the vehicle hydrogel placebo performed more like an active comparator, the company plans to initiate a small trial in **H1 2023** to identify a more appropriate placebo (e.g., collagen plugs) for future pivotal studies[115](index=115&type=chunk) [Commercial Portfolio and Collaborations](index=39&type=section&id=Commercial%20Portfolio%20and%20Collaborations) The commercial portfolio is led by DEXTENZA, an FDA-approved intracanalicular insert for ocular inflammation/pain and allergic conjunctivitis, complemented by a strategic collaboration with AffaMed Therapeutics for Asian markets - DEXTENZA is the first FDA-approved intracanalicular insert delivering dexamethasone for up to **30 days** to treat post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis[133](index=133&type=chunk)[143](index=143&type=chunk) - Production of ReSure Sealant was suspended in **Q4 2021** to prioritize manufacturing resources for DEXTENZA, and the product is not currently commercially available in the U.S.[149](index=149&type=chunk) - The company has a license and collaboration agreement with AffaMed Therapeutics for the development and commercialization of DEXTENZA and OTX-TIC in key Asian markets, including an upfront payment of **$12 million**, up to **$91 million** in potential milestones, and tiered royalties[150](index=150&type=chunk) [Manufacturing, Intellectual Property, and Competition](index=45&type=section&id=Manufacturing%2C%20Intellectual%20Property%2C%20and%20Competition) The company manages its manufacturing in-house, protects its innovations through owned and licensed patents, and navigates a competitive landscape with established pharmaceutical companies and generic alternatives - The company manufactures its products and clinical trial materials at its cGMP facility in Bedford, Massachusetts, which it believes provides flexibility and control over the manufacturing process[157](index=157&type=chunk)[159](index=159&type=chunk) - The intellectual property portfolio consists of owned and licensed patents, with key patents for OTX-TKI expiring in **2041**, and DEXTENZA, OTX-TIC, OTX-CSI, and OTX-DED patents expiring between **2030** and **2041**[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk) - A significant portion of the core hydrogel technology and patent rights for DEXTENZA, ReSure Sealant, and product candidates are exclusively licensed from Incept, LLC[176](index=176&type=chunk) - The company faces competition from established anti-VEGF drugs for OTX-TKI, approved glaucoma treatments like DURYSTA for OTX-TIC, and numerous therapies for dry eye for OTX-CSI and OTX-DED[197](index=197&type=chunk)[199](index=199&type=chunk)[200](index=200&type=chunk) [Government Regulation](index=59&type=section&id=Government%20Regulation) The company's products and operations are subject to extensive regulation by the FDA and international authorities, covering all stages from development and manufacturing to marketing, pricing, and data privacy - The company's products are subject to extensive regulation by the FDA in the U.S. and other global authorities, covering all stages from preclinical studies to post-market surveillance[204](index=204&type=chunk)[205](index=205&type=chunk) - The company plans to submit New Drug Applications (NDAs) for its product candidates under the Section 505(b)(2) pathway, which allows reliance on existing FDA data for previously approved drugs, potentially streamlining the approval process[239](index=239&type=chunk)[240](index=240&type=chunk) - Sales and marketing activities are subject to strict healthcare laws, including the federal Anti-Kickback Statute and False Claims Act, which regulate relationships with healthcare providers and payors[566](index=566&type=chunk)[568](index=568&type=chunk) - The business is impacted by healthcare reform and drug pricing legislation, such as the Inflation Reduction Act (IRA), which could affect reimbursement rates and impose new pricing pressures on pharmaceutical products[577](index=577&type=chunk)[581](index=581&type=chunk) [Item 1A. Risk Factors](index=119&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of net losses, the need for substantial additional funding, dependence on DEXTENZA and pipeline success, single-site manufacturing vulnerability, and exposure to unfavorable pricing regulations and intense competition - The company has a history of significant losses, with a net loss of **$71.0 million** for the year ended December 31, 2022, and an accumulated deficit of **$616.8 million**, expecting to incur operating losses for the next several years[394](index=394&type=chunk) - Substantial additional funding is required to advance research, development, and commercialization efforts, without which the company may be forced to delay, reduce, or eliminate programs[404](index=404&type=chunk) - The company's success is heavily dependent on the commercial success of DEXTENZA and the successful development and approval of its pipeline candidates, particularly OTX-TKI and OTX-TIC[452](index=452&type=chunk) - Operations rely on a single-site manufacturing facility, making the company vulnerable to disruptions that could impact clinical trial supply and commercial inventory[492](index=492&type=chunk) - The company faces risks related to unfavorable pricing regulations, third-party reimbursement practices, and healthcare reform, which could harm the commercial viability of its products[479](index=479&type=chunk) [Item 2. Properties](index=195&type=section&id=Item%202.%20Properties) The company leases approximately 121,000 square feet of office, laboratory, and manufacturing space in Bedford, Massachusetts, with leases expiring between 2024 and 2028 - The company's facilities consist of approximately **121,000 square feet** of leased office, lab, and manufacturing space in Bedford, MA, with lease expirations in July **2027**, March **2024**, and an extended lease through July **2028**[630](index=630&type=chunk) [Item 3. Legal Proceedings](index=195&type=section&id=Item%203.%20Legal%20Proceedings) As of the filing date, the company is not a party to any material legal proceedings, nor is management aware of any material legal proceedings threatened against it - The company is not currently a party to any material legal proceedings[631](index=631&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=197&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'OCUL', has approximately 12 record holders, has never paid cash dividends, and did not sell unregistered securities or repurchase equity in 2022 - The company's common stock is traded on the Nasdaq Global Market under the symbol **"OCUL"**[636](index=636&type=chunk) - The company has never declared or paid cash dividends and does not anticipate doing so in the foreseeable future[638](index=638&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=198&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For FY2022, total net revenue increased to $51.5 million, but the net loss widened to $71.0 million due to a smaller derivative liability gain, with operating expenses rising to $130.1 million, and cash of $102.3 million expected to fund operations into mid-2024 Results of Operations (2022 vs. 2021) | Metric | 2022 (in thousands) | 2021 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | **Total revenue, net** | **$51,494** | **$43,522** | **$7,972** | | Cost of product revenue | $4,540 | $4,406 | $134 | | Research and development | $53,462 | $50,083 | $3,379 | | Selling and marketing | $39,922 | $35,190 | $4,732 | | General and administrative | $32,224 | $31,880 | $344 | | **Total costs and operating expenses** | **$130,148** | **$121,559** | **$8,589** | | **Loss from operations** | **($78,654)** | **($78,037)** | **($617)** | | Change in fair value of derivative liability | $13,841 | $78,121 | ($64,280) | | **Net loss** | **($71,038)** | **($6,553)** | **($64,485)** | - As of December 31, 2022, the company had **$102.3 million** in cash and cash equivalents, projected to fund planned operations into the middle of **2024**, excluding the costs of planned pivotal trials for OTX-TKI[659](index=659&type=chunk)[721](index=721&type=chunk) - Net cash used in operating activities was **$59.6 million** for the year ended December 31, 2022, compared to **$65.6 million** in 2021[722](index=722&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=229&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its $102.3 million cash equivalents and $25.0 million variable-rate debt, though a 100 basis point rate change is not expected to be material - The company's primary market risk is interest rate sensitivity on its cash equivalents (**$102.3 million**) and variable-rate debt (**$25.0 million**)[758](index=758&type=chunk)[761](index=761&type=chunk) - Management concluded that an immediate **100 basis point (1%)** change in interest rates would not materially affect the fair market value of its investment portfolio or cash outflows from its debt[759](index=759&type=chunk)[761](index=761&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=231&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the consolidated financial statements and the independent auditor's report, which highlights the valuation of derivative liability as a critical audit matter and emphasizes the need for additional financing - The report from the independent auditor, PricewaterhouseCoopers LLP, highlights the valuation of the derivative liability related to the 2026 convertible notes as a Critical Audit Matter, noting the significant judgment required by management in its fair value estimation[812](index=812&type=chunk)[813](index=813&type=chunk)[816](index=816&type=chunk) - The auditor's report also includes an "Emphasis of Matter" paragraph, drawing attention to the company's need to secure additional financing to fund future operations[808](index=808&type=chunk) [Item 9A. Controls and Procedures](index=231&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, with no material changes reported in Q4 2022 - Based on their evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2022[764](index=764&type=chunk) - Management assessed the effectiveness of internal control over financial reporting using the COSO framework and concluded that it was effective as of December 31, 2022[768](index=768&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=234&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, corporate governance, and the audit committee is incorporated by reference from the 2023 Proxy Statement, noting the adoption of a code of conduct and the identification of an audit committee financial expert - Information required for this item is incorporated by reference from the company's 2023 Proxy Statement[774](index=774&type=chunk) - The company has adopted a code of business conduct and ethics applicable to all directors, officers, and employees[776](index=776&type=chunk) [Item 11. Executive Compensation](index=234&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive compensation is incorporated by reference from the company's definitive Proxy Statement for the 2023 Annual Meeting of Stockholders - Information required for this item is incorporated by reference from the company's 2023 Proxy Statement[780](index=780&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=234&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership of certain beneficial owners, management, and related stockholder matters is incorporated by reference from the company's definitive Proxy Statement for the 2023 Annual Meeting of Stockholders - Information required for this item is incorporated by reference from the company's 2023 Proxy Statement[781](index=781&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=236&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive Proxy Statement for the 2023 Annual Meeting of Stockholders - Information required for this item is incorporated by reference from the company's 2023 Proxy Statement[782](index=782&type=chunk) [Item 14. Principal Accounting Fees and Services](index=236&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information regarding principal accounting fees and services is incorporated by reference from the company's definitive Proxy Statement for the 2023 Annual Meeting of Stockholders - Information required for this item is incorporated by reference from the company's 2023 Proxy Statement[783](index=783&type=chunk) PART IV [Item 15. Exhibits, Financial Statement Schedules](index=237&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K, with financial statement schedules omitted as not applicable or required - This section lists the financial statements and exhibits filed with the 10-K report[786](index=786&type=chunk)[787](index=787&type=chunk)

Financial Data and Key Metrics Changes - Net revenue for Q3 2022 was $12 million, representing a 2% decrease compared to the same period in 2021 [51] - DEXTENZA net product revenue was $11.9 million, flat year-over-year and down approximately 2% sequentially [52] - The company recorded a net loss of $24.2 million or a loss of $0.31 per share, compared to a net income of $2.6 million or $0.03 per share in the same period in 2021 [54] Business Line Data and Key Metrics Changes - DEXTENZA sales were essentially flat year-over-year, which was considered disappointing by management [17] - Research and development expenses increased to $13.7 million from $12.7 million in the comparable period of 2021, driven by higher personnel and preclinical development activity [53] - Selling and marketing expenses rose to $10.2 million from $9.6 million in the same period of 2021, reflecting an increase in field force personnel [53] Market Data and Key Metrics Changes - The company noted that ambulatory surgical centers (ASCs) and hospital outpatient departments (HOPDs) are facing staffing shortages, impacting DEXTENZA's performance [18][20] - Changes in the reimbursement landscape for the procedure code CPT 68841 have also affected volume due to reduced physician payment [21] Company Strategy and Development Direction - The company aims to establish itself as a leader in ophthalmology, focusing on both front and back of the eye treatments [10] - Plans to initiate a Phase 2/3 trial for OTX-TKI in wet AMD in Q3 2023 and a Phase 1 trial for diabetic retinopathy in Q1 2023 [16][49] - The company is working on improving the value proposition for DEXTENZA and addressing reimbursement issues to reignite growth [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for OTX-TKI to become a differentiated product in the treatment of wet AMD and diabetic retinopathy [32] - The company adjusted its full-year net revenue guidance to between $48 million and $52 million, reflecting a growth of 10% to 20% over the prior year [26] - Management highlighted a strong start to Q4 2022, with record monthly sales for DEXTENZA in October [25][59] Other Important Information - The company had $121 million in cash and cash equivalents as of September 30, 2022, sufficient to fund operations through 2023 [56] - Non-cash charges through stock-based compensation and depreciation were $4.7 million in Q3 2022, compared to $4.4 million in the same quarter of 2021 [54] Q&A Session Summary Question: Why is the diabetic retinopathy study moving forward under an exploratory IND? - Management explained that using an exploratory IND allows for a sufficient number of patients while moving forward with the current formulation [63] Question: What is the priority for DEXTENZA in office or ambulatory surgical centers? - The focus is on reigniting growth in the surgical setting, which is the company's primary business area [69] Question: Can you elaborate on the cause of staffing shortages? - Staffing shortages are attributed to post-pandemic issues affecting various industries, including ASCs and hospitals [78] Question: What kind of sales boost for DEXTENZA is expected in 2023? - Management expects to capture some volume from DEXYCU as it loses its pass-through status, but specific guidance will be provided later [81] Question: Can you comment on the diabetic retinopathy patient journey? - Management noted that many patients with diabetic retinopathy do not realize they have the condition until vision changes occur, making treatment challenging [86] Question: What is the timeline for seeing results from the Phase 2/3 trial? - Management indicated that they expect to collapse the Phase 2 and Phase 3 trials, aiming for efficient data collection and NDA filing [95]

Ocular Therapeutix, Inc. (NASDAQ:OCUL) Q2 2022 Earnings Conference Call August 8, 2022 4:30 PM ET Company Participants Donald Notman - CFO Antony Mattessich - President, CEO & Director Rabia Ozden - Chief Medical Officer Conference Call Participants Jonathan Wolleben - JMP Securities Stacy Ku - Cowen and Company Yi Chen - H.C. Wainwright & Co. Joseph Catanzaro - Piper Sandler & Co. Operator Good afternoon, ladies and gentlemen. Thank you for standing by, and welcome to the Ocular Therapeutix Second Quarter ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36554 Ocular Therapeutix, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdic ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36554 Ocular Therapeutix, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...