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, 2024 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 ...

Exhibit 99.1 "Ocular's excellent progress in 2024 has put the Company on track to becoming a leading retinal care company. We have substantially enriched the organization with the appointment of recognized leaders in retinal care and clinical development; have completed a successful financing of $325 million in gross proceeds from existing and new top-tier healthcare investors; and have progressed our Phase 3 program for AXPAXLI™ in wet AMD," said Pravin U. Dugel, MD, Executive Chairman, President and Chief ...

BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL) ("Ocular"), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it has agreed to grant inducement awards to (i) its newly appointed Vice President, Head of Programming & Data Ope ...

BEDFORD, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular", the "Company"))), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that it will participate at two investor conferences in May: Citizens JMP Life Sciences Conference Fire ...

BEDFORD, Mass., May 03, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular", the "Company"))), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, announced multiple presentations at the Ophthalmology Innovation Source (OIS) Retina 2024 (May 4th) and the Association ...

First quarter 2024 financial results to be reported on Tuesday, May 7, 2024 Investor Day to replace first quarter 2024 earnings conference call; quarterly calls to resume regular cadence with second quarter 2024 financial results BEDFORD, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL, "Ocular", the "Company"))), a biopharmaceutical company committed to enhancing people's vision and quality of life through the development and commercialization of innovative therapies for wet a ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 (781) 357-4000 (Registrant's telephone number, including area code) | Securities registered pursuant to Secti ...

[Overview and Business Highlights](index=1&type=section&id=Overview%20and%20Business%20Highlights) Ocular Therapeutix has strategically advanced its retinal care pipeline, marked by key appointments, successful financing, and upcoming clinical data [Recent Achievements & Strategic Direction](index=1&type=section&id=Recent%20Achievements%20%26%20Strategic%20Direction) Ocular Therapeutix has made significant strategic moves to position itself as a leader in retinal care, highlighted by key leadership appointments, including **Pravin Dugel, MD** as Executive Chairman. The company successfully initiated the **Phase 3 SOL-1 trial** for its lead candidate, **AXPAXLI™** in **wet AMD**, and secured over **$440 million** in gross proceeds from recent financings to fund its clinical development programs - Appointed key strategic and clinical experts, including **Pravin Dugel, MD**, as Executive Chairman, to lead the company's focus on retinal care[3](index=3&type=chunk) - Initiated the **Phase 3 SOL-1 trial** for **AXPAXLI™** in **wet AMD**, with the first subjects screened[1](index=1&type=chunk)[3](index=3&type=chunk) - Raised over **$440 million** in gross proceeds from two recent financings to fund clinical development for **AXPAXLI™** in **wet AMD** and **diabetic retinopathy**[2](index=2&type=chunk)[3](index=3&type=chunk) [Anticipated Milestones](index=2&type=section&id=Anticipated%20Upcoming%20Milestones) The company anticipates several key clinical data readouts in the second quarter of 2024, including topline results for **PAXTRAVA™** in **glaucoma** and **Phase 1 results** for **AXPAXLI™** in **diabetic retinopathy**. An Investor Day is also planned for Q2 2024 to outline the updated corporate strategy - Topline results from the Phase 2 trial of **PAXTRAVA™** in **glaucoma** are expected at ASCRS on April 5-8[11](index=11&type=chunk) - Topline **Phase 1 results** from the HELIOS trial for **AXPAXLI™** in **diabetic retinopathy** are expected in Q2 2024[1](index=1&type=chunk)[11](index=11&type=chunk) - The company plans to host an Investor Day in Q2 2024 to provide updates on its corporate strategy[1](index=1&type=chunk)[2](index=2&type=chunk)[11](index=11&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) The company reported increased revenue for FY2023, a widened net loss, and a strengthened cash position, detailed in its consolidated financial statements [Fourth Quarter and Full Year 2023 Performance](index=2&type=section&id=Fourth%20Quarter%20and%20Year%20End%20December%2031%2C%202023%20Financial%20Results) Ocular Therapeutix reported a 13.4% increase in total net revenue for the full year 2023, reaching $58.4 million, driven by DEXTENZA sales. The company's net loss widened to $(80.7) million for the year, influenced by increased R&D spending on clinical trials. The company ended 2023 with a strong cash position of $195.8 million, further bolstered by a $325 million financing in February 2024, providing a cash runway into at least 2028 - Cash and cash equivalents were **$195.8 million** at year-end 2023. A subsequent financing in February 2024 added **$325 million** in gross proceeds, extending the cash runway into at least 2028[1](index=1&type=chunk)[4](index=4&type=chunk) | Metric | Q4 2023 (in millions) | Q4 2022 (in millions) | YoY Change | FY 2023 (in millions) | FY 2022 (in millions) | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Total Net Revenue | $14.8M | $14.1M | +5.0% | $58.4M | $51.5M | +13.4% | | R&D Expenses | $16.2M | $13.5M | +20.0% | $61.1M | $53.5M | +14.2% | | Net Loss | $(29.2)M | $(15.5)M | +88.4% | $(80.7)M | $(71.0)M | +13.7% | | Net Loss per Share (basic) | $(0.35) | $(0.20) | - | $(1.01) | $(0.92) | - | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements detail the company's financial position and performance. The balance sheet shows a significant increase in total assets to $252.1 million in 2023 from $149.3 million in 2022, primarily due to a rise in cash. The statement of operations reflects revenue growth alongside increased operating expenses and a larger net loss for the full year 2023 compared to 2022 [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, the company's balance sheet strengthened significantly, with cash and cash equivalents nearly doubling to $195.8 million. Total assets grew to $252.1 million, while total liabilities increased to $160.9 million, driven by changes in derivative liabilities and notes payable. Total stockholders' equity rose to $91.1 million from $35.4 million in the prior year | Balance Sheet Item (in thousands) | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $195,807 | $102,300 | | Total current assets | $232,235 | $129,627 | | Total assets | $252,060 | $149,289 | | Total liabilities | $160,929 | $113,910 | | Total stockholders' equity | $91,131 | $35,379 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the full year 2023, total net revenue increased by 13.4% to $58.4 million. However, total costs and operating expenses also rose to $140.8 million, leading to a loss from operations of $(82.4) million. The net loss for 2023 was $(80.7) million, or $(1.01) per basic share, compared to a net loss of $(71.0) million, or $(0.92) per basic share, in 2022 | Statement of Operations (in thousands) | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Total revenue, net | $58,443 | $51,494 | | Total costs and operating expenses | $140,825 | $130,148 | | Loss from operations | $(82,382) | $(78,654) | | Net loss | $(80,736) | $(71,038) | | Net loss per share, basic | $(1.01) | $(0.92) | [Company and Product Information](index=3&type=section&id=Company%20and%20Product%20Information) Ocular Therapeutix is a biopharmaceutical company focused on eye disease therapies using its ELUTYX™ technology, including its commercial product DEXTENZA [About Ocular Therapeutix, Inc.](index=3&type=section&id=About%20Ocular%20Therapeutix%2C%20Inc.) Ocular Therapeutix is a biopharmaceutical company focused on developing and commercializing therapies for eye diseases using its proprietary **ELUTYX™ bioresorbable hydrogel technology**. Its clinical pipeline is led by **AXPAXLI™** for **wet AMD** and **diabetic retinopathy**, and **PAXTRAVA™** for **glaucoma**. The company also has several other clinical and preclinical programs - The company's lead product candidate for retinal disease is **AXPAXLI™**, which is currently in **Phase 3 trials** for **wet AMD** and a **Phase 1 trial** for **diabetic retinopathy**[13](index=13&type=chunk) - The clinical portfolio also includes **PAXTRAVA™** for primary open-angle **glaucoma** or ocular hypertension, currently in a **Phase 2 trial**[13](index=13&type=chunk) - The company's proprietary **ELUTYX™ bioresorbable hydrogel technology** is the foundation for its product candidates and its commercial product, **DEXTENZA®**[13](index=13&type=chunk)[14](index=14&type=chunk) [About DEXTENZA](index=3&type=section&id=About%20DEXTENZA) **DEXTENZA** is an **FDA-approved** corticosteroid intracanalicular insert for treating ocular inflammation and pain after ophthalmic surgery and ocular itching from allergic conjunctivitis. It is designed to deliver **dexamethasone** for up to **30 days** and resorbs naturally without needing removal - **DEXTENZA** is **FDA-approved** for treating ocular inflammation and pain post-ophthalmic surgery and for ocular itching associated with allergic conjunctivitis[14](index=14&type=chunk)[16](index=16&type=chunk) - It is a preservative-free insert that delivers **dexamethasone** to the ocular surface for up to **30 days** and resorbs without requiring removal[16](index=16&type=chunk)

Financial Data and Key Metrics Changes - The company reported a net loss of $0.5 million for Q3 2023, a significant improvement compared to a net loss of $24.2 million in Q3 2022 [76] - Total net revenue for Q3 2023 was $15.1 million, representing a 26% increase from $12 million in Q3 2022 [85] - Research and development expenses increased to $15 million in Q3 2023 from $13.7 million in Q3 2022, driven by clinical trial costs and personnel-related expenses [75] Business Line Data and Key Metrics Changes - DEXTENZA net product revenue reached $15 million in Q3 2023, a 26% increase from $11.9 million in Q3 2022 [14][86] - Units sold for DEXTENZA increased by 38% year-over-year, totaling 36,902 units in Q3 2023 [45] - The company anticipates DEXTENZA's full-year net product revenue to be at the upper end of the $55 million to $60 million range [15][79] Market Data and Key Metrics Changes - The company noted a significant increase in customer order sizes, with 49% of DEXTENZA orders being for 30 or more units in Q3 2023, compared to 29% in Q3 2022 [46] - The FDA's new draft guidance is expected to impact the development of treatments in wet AMD, particularly for products like AXPAXLI that demonstrate extended durability [12][26] Company Strategy and Development Direction - The company is focused on the commercialization of AXPAXLI, an axitinib-containing implant for wet AMD, and has received FDA agreement on a special protocol assessment for its pivotal trial [9][10] - AXPAXLI is positioned to potentially change the standard of care in the wet AMD market, which is valued in the billions [11] - The company is also advancing its OTX-TIC program for glaucoma treatment, aiming to improve patient compliance and outcomes [38][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory of DEXTENZA, citing clinical efficacy and safety as key drivers [63] - The company remains confident in its long-term prospects despite CMS's decision not to change the status indicator for DEXTENZA's insertion procedure [72] - Management highlighted the importance of strong endorsements from the retina community for AXPAXLI's success [14] Other Important Information - The company had $110.6 million in cash and cash equivalents as of September 30, 2023, providing a runway into 2025 [77] - The company plans to share topline data from the HELIOS trial for AXPAXLI in Q2 2024 [37] Q&A Session Summary Question: What is the plan for enrolling patients with 20/20 vision? - Management confirmed that the plan remains to enroll patients who achieve 20/20 vision after induction with ILEA, and they believe there is a sizable population available for enrollment [49] Question: What data is needed to move forward with the Phase 3 trial for diabetic retinopathy? - Management expects to see a trend in improvement in the DRSS score to proceed with the Phase 3 trial [54] Question: How does the new formulation of AXPAXLI compare to the previous one? - The new formulation has a lower drug load of 450 micrograms but is designed to release the drug faster, matching the delivery seen in earlier trials [102] Question: What percentage of the wet AMD population fits the current enrollment criteria? - Management indicated that the current criteria are designed to capture a significant portion of the treatment-naive wet AMD population [117] Question: What are the expectations for the safety profile of the new formulation? - Management expressed confidence that the safety profile will remain consistent with previous formulations, as the delivery rates are within the safety window [135]

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)