Core Insights - Ocular Therapeutix has received FDA agreement on the registrational trial design for AXPAXLI targeting non-proliferative diabetic retinopathy (NPDR) [1][2] - The company plans to present its clinical trial design and development strategy for NPDR and diabetic macular edema (DME) at an Investor Day on September 30, 2025 [1][2] Company Overview - Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience with its investigational product AXPAXLI, a bioresorbable intravitreal hydrogel incorporating axitinib [3][8] - AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) and is being evaluated for diabetic retinopathy and DME [8] Market Opportunity - Diabetic retinopathy affects nearly 9 million people in the U.S., with a significant portion of patients not receiving treatment despite the availability of effective therapies [2][6] - The potential for AXPAXLI to provide annual dosing could transform treatment approaches, shifting from reactive to proactive disease management [2][6] Clinical Trial Insights - In the Phase 1 HELIOS trial, AXPAXLI demonstrated no disease progression or vision-threatening complications in NPDR patients at 48 weeks, compared to 25% worsening in the control group [2][6] - The treatment showed improvement in all patients with non-center involved DME, indicating its potential to reshape proactive care in diabetic eye disease [2][6] Public Health Impact - With 6.4 million Americans living with NPDR and fewer than 1% currently treated, AXPAXLI's long-acting treatment could significantly reduce vision-threatening complications from diabetes [2][6][7]

Core Viewpoint - Ocular Therapeutix reported a significant widening of net loss in Q2 2025 due to increased research and marketing investments, alongside a decline in commercial revenue from its only marketed product, DEXTENZA [1][5][6] Financial Performance - Revenue (GAAP) for Q2 2025 was $13.5 million, slightly above expectations of $13.46 million, but down 18.1% from $16.4 million in Q2 2024 [2][5] - Net loss per share (GAAP) was $(0.39), missing analyst estimates by 8.4% and representing a 50% increase from $(0.26) in Q2 2024 [2][5] - Research and Development (R&D) expenses rose 76.9% to $51.1 million, driven by costs associated with two major Phase 3 trials [2][6] - Selling and Marketing expenses increased 37% to $13.7 million, reflecting pre-commercialization activities for AXPAXLI [2][6] - Cash and cash equivalents stood at $391.1 million as of June 30, 2025, with management indicating this provides a runway into 2028 [2][9] Product and Market Overview - DEXTENZA, the company's FDA-approved ocular implant, faced reimbursement challenges, leading to an 18.1% decline in net revenue despite a 5% increase in unit sales [5][8] - The company is focusing on advancing late-stage clinical trials for AXPAXLI, an ocular implant targeting wet age-related macular degeneration (AMD) [4][7] Clinical Development - The SOL-1 and SOL-R trials for AXPAXLI are progressing on schedule, with topline data from SOL-1 expected in Q1 2026 and primary endpoint data from SOL-R anticipated in the first half of 2027 [7] - Positive feedback was received from the FDA regarding potential designs for future studies in non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME) [7] Strategic Focus and Future Outlook - The company did not provide specific financial guidance for the upcoming quarter but emphasized the importance of advancing AXPAXLI's pivotal trials and maintaining cash reserves [10][11] - Future performance will depend on managing DEXTENZA's reimbursement pressures and executing late-stage clinical programs [11]

Financial Performance - Ocular Therapeutix reported a quarterly loss of $0.39 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.35, and compared to a loss of $0.24 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $13.46 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 0.7%, and down from $16.44 million in the same quarter last year [2] - Over the last four quarters, Ocular Therapeutix has not surpassed consensus EPS estimates and has topped revenue estimates only once [2] Stock Performance - Ocular Therapeutix shares have increased by approximately 44.6% since the beginning of the year, significantly outperforming the S&P 500's gain of 7.6% [3] - The stock currently holds a Zacks Rank 5 (Strong Sell), indicating expectations of underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $14.99 million, and for the current fiscal year, it is -$1.42 on revenues of $56.55 million [7] - The estimate revisions trend for Ocular Therapeutix was unfavorable ahead of the earnings release, which may impact future stock movements [6] Industry Context - The Medical - Drugs industry, to which Ocular Therapeutix belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a relatively strong industry performance [8] - Another company in the same industry, Plus Therapeutics, is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year change of +87.3%, with revenues projected to be $1.7 million, up 32.8% from the previous year [9]

Financial Data and Key Metrics Changes - The company ended the second quarter with over $390 million in cash and cash equivalents, having raised approximately $97 million through its existing at-the-market facility [28][29] - The company expects a financial runway into 2028, which is well beyond anticipated top-line data readouts for both SOLO-one and SOLAR [29][34] Business Line Data and Key Metrics Changes - The registrational program for expaxly includes the SOLO-one and SOLAR studies, which are designed to address key questions regarding durability and flexibility in treating wet AMD [7][21] - The company reported exceptional retention rates in both SOLO-one and SOLAR trials, reinforcing confidence in the quality of data being generated [31] Market Data and Key Metrics Changes - The company aims to address the critical needs of millions of patients worldwide suffering from wet AMD, where nearly 40% of patients in the U.S. discontinue treatment within the first year [6][30] - The company is preparing to expand its reach towards diabetic eye diseases, having received positive FDA feedback on its proposed trial design for patients with diabetic retinopathy [25][34] Company Strategy and Development Direction - The company is focused on advancing expaxly as a treatment designed to offer best-in-class durability and meaningful efficacy, with the potential to be the first product for wet AMD with a superiority claim [7][30] - Plans include incorporating a long-term open-label extension study for both SOLO trials to generate valuable real-world insights and long-term safety data [15][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing trials and the potential for expaxly to redefine treatment standards in retinal diseases, particularly in wet AMD and diabetic eye diseases [30][34] - The company is committed to delivering a long-lasting, flexible, and non-pulsatile solution that could improve long-term visual outcomes for patients [16][34] Other Important Information - The company will host an Investor Day on September 30 in New York City to provide deeper insights into the SOLO trials and its diabetic eye disease strategy [27][34] - The company has strategically modified the rescue criteria for the SOLAR trial to enhance its clinical relevance and adoption potential [19][20] Q&A Session Summary Question: When do you expect to complete randomization of the 555 patients required for the SOLAR trial? - Management stated that enrollment has been completed and trial conduct is going superbly [38] Question: What drove the change in the rescue criteria for the SOLAR study? - The change was made purely for strategic advantage and was not required by the FDA, reflecting confidence based on the data observed [39][40] Question: How do you think removing the 10-letter loss requirement for the rescue criteria will impact the primary endpoint? - Management confirmed that the modification will not impact the primary endpoint and is aimed at making the drug more adoptable [50][56] Question: What is the rationale for starting the open-label extensions now? - The decision was based on logistics and the desire to answer clinically relevant questions regarding the drug's long-term benefits [99] Question: How should investors think about the interplay of the eventual time to market for expaxly with a potential superior label? - Management emphasized that a superiority label would provide a significant competitive advantage, allowing for better patient care and outcomes [96][97]

[FORWARD-LOOKING STATEMENTS](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section outlines the forward-looking nature of statements within the report, cautioning readers about inherent risks and uncertainties - The report contains forward-looking statements regarding the company's strategy, future operations, financial position, revenues, costs, and management objectives, identified by words like "anticipate," "believe," "expect," and "intend"[8](index=8&type=chunk) - Key forward-looking statements include ongoing clinical trials for AXPAXLI (wet AMD, NPDR, DME) and OTX-TIC (OAG/OHT), commercialization efforts for DEXTENZA, manufacturing capabilities, regulatory approvals, future revenue estimates, and plans for additional capital raising[9](index=9&type=chunk)[14](index=14&type=chunk) - Readers are cautioned not to place undue reliance on these statements, as actual results may differ materially due to various risks and uncertainties, particularly those detailed in the "Risk Factors" section of the Annual Report on Form 10-K[11](index=11&type=chunk) PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, cash flows, and stockholders' equity, along with detailed notes explaining the company's business, accounting policies, financial instruments, and other relevant disclosures for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $391,134 | $392,102 | $(968) | -0.25% | | Total current assets | $433,375 | $440,987 | $(7,612) | -1.73% | | Total assets | $451,333 | $457,935 | $(6,602) | -1.44% | | Total current liabilities | $42,931 | $41,354 | $1,577 | 3.81% | | Total liabilities | $145,417 | $142,591 | $2,826 | 1.98% | | Total stockholders' equity | $305,916 | $315,344 | $(9,428) | -2.99% | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (3 Months Ended) (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Product revenue, net | $13,395 | $16,379 | $(2,984) | -18.22% | | Collaboration revenue | $64 | $62 | $2 | 3.23% | | Total revenue, net | $13,459 | $16,441 | $(2,982) | -18.14% | | R&D expenses | $51,081 | $28,857 | $22,224 | 77.08% | | S&M expenses | $13,729 | $9,994 | $3,735 | 37.37% | | G&A expenses | $14,346 | $19,671 | $(5,325) | -27.07% | | Total operating expenses | $81,100 | $60,031 | $21,069 | 35.09% | | Loss from operations | $(67,641) | $(43,590) | $(24,051) | 55.18% | | Net loss | $(67,814) | $(43,777) | $(24,037) | 54.91% | | Net loss per share, basic | $(0.39) | $(0.26) | $(0.13) | 50.00% | Condensed Consolidated Statements of Operations and Comprehensive Loss (6 Months Ended) (in thousands) | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | % Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Product revenue, net | $24,028 | $31,094 | $(7,066) | -22.73% | | Collaboration revenue | $128 | $121 | $7 | 5.79% | | Total revenue, net | $24,156 | $31,215 | $(7,059) | -22.61% | | R&D expenses | $93,938 | $49,592 | $44,346 | 89.42% | | S&M expenses | $27,877 | $20,177 | $7,700 | 38.16% | | G&A expenses | $30,694 | $33,818 | $(3,124) | -9.24% | | Total operating expenses | $155,715 | $106,422 | $49,293 | 46.32% | | Loss from operations | $(131,559) | $(75,207) | $(56,352) | 74.93% | | Net loss | $(131,867) | $(108,625) | $(23,242) | 21.40% | | Net loss per share, basic | $(0.77) | $(0.73) | $(0.04) | 5.48% | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | | Net cash used in operating activities | $(99,909) | $(58,689) | $(41,220) | | Net cash used in investing activities | $(3,048) | $(997) | $(2,051) | | Net cash provided by financing activities | $101,989 | $323,419 | $(221,430) | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(968) | $263,733 | $(264,701) | | Cash, cash equivalents and restricted cash at end of period | $392,748 | $461,304 | $(68,556) | [Condensed Consolidated Statements of Stockholders' Equity](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Condensed Consolidated Statements of Stockholders' Equity (in thousands, except shares) | Metric (in thousands, except shares) | December 31, 2024 | June 30, 2025 | Change | | :----------------------------------- | :---------------- | :------------ | :----- | | Common Stock Shares | 157,749,490 | 172,925,389 | 15,175,899 | | Common Stock Par Value | $16 | $17 | $1 | | Additional Paid-in Capital | $1,206,412 | $1,328,850 | $122,438 | | Accumulated Deficit | $(891,084) | $(1,022,951) | $(131,867) | | Total Stockholders' Equity | $315,344 | $305,916 | $(9,428) | - The increase in common stock shares and additional paid-in capital was primarily driven by the issuance of common stock from public offerings, exercise of stock options, and employee stock purchase plans[23](index=23&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) - The accumulated deficit increased by **$131.867 million**, reflecting the net loss incurred during the six months ended June 30, 2025[23](index=23&type=chunk)[19](index=19&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) [1. Nature of the Business](index=14&type=section&id=1.%20Nature%20of%20the%20Business) - Ocular Therapeutix, Inc. is an integrated biopharmaceutical company focused on redefining the retina experience, leveraging its ELUTYX proprietary bioresorbable hydrogel-based formulation technology[27](index=27&type=chunk) - Key product candidates include AXPAXLI (axitinib intravitreal hydrogel) in Phase 3 clinical trials for wet AMD (SOL-1 and SOL-R) and completed Phase 1 for NPDR (HELIOS), with plans for NPDR and DME. The commercial product DEXTENZA is FDA-approved for ocular inflammation/pain and allergic conjunctivitis. OTX-TIC (travoprost intracameral hydrogel) is in a Phase 2 clinical trial for OAG/OHT[27](index=27&type=chunk)[28](index=28&type=chunk) - The company has an accumulated deficit of **$1,022,951 thousand** as of June 30, 2025, and expects to fund operations through existing cash and cash equivalents of **$391,134 thousand** for at least the next 12 months, while observing a minimum liquidity covenant of **$20,000 thousand**[30](index=30&type=chunk) [2. Summary of Significant Accounting Policies](index=16&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited condensed consolidated financial statements are prepared in conformity with GAAP, consistent with policies described in the Annual Report on Form 10-K for December 31, 2024[34](index=34&type=chunk) - Stock-based compensation is measured at fair value on the grant date and expensed over the requisite service period, net of estimated forfeitures. The company uses estimates for variable consideration, collaboration revenue, derivative fair values, and deferred tax assets[35](index=35&type=chunk)[39](index=39&type=chunk) - Recently issued ASUs (2023-09 Income Taxes and 2024-03 Disaggregation of Income Statement Expenses) are not expected to have a significant impact on the consolidated financial statements[42](index=42&type=chunk)[43](index=43&type=chunk) [3. Licensing Agreements and Deferred Revenue](index=18&type=section&id=3.%20Licensing%20Agreements%20and%20Deferred%20Revenue) - The company has an exclusive worldwide license with Incept, LLC for ophthalmic technology, incurring low single-digit royalties on net sales of commercial products[44](index=44&type=chunk) Incept Royalties (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Incept Royalties | $319 | $441 | $830 | $882 | - Collaboration revenue of **$64 thousand** (Q2 2025) and **$128 thousand** (YTD Q2 2025) was recognized from the AffaMed License Agreement for a Phase 2 clinical trial of OTX-TIC, with the performance obligation substantially satisfied as of June 30, 2025[50](index=50&type=chunk)[51](index=51&type=chunk) Deferred Revenue (in thousands) | Metric (in thousands) | Amount | | :-------------------- | :----- | | Deferred revenue at December 31, 2024 | $14,128 | | Amounts recognized into revenue | $(128) | | Deferred revenue at June 30, 2025 | $14,000 | [4. Cash Equivalents and Restricted Cash](index=20&type=section&id=4.%20Cash%20Equivalents%20and%20Restricted%20Cash) Cash, Cash Equivalents and Restricted Cash (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | | :-------------------- | :------------ | :------------ | | Cash and cash equivalents | $391,134 | $459,690 | | Restricted cash | $1,614 | $1,614 | | Total cash, cash equivalents and restricted cash | $392,748 | $461,304 | - Restricted cash is held as security deposits for real estate leases[53](index=53&type=chunk) [5. Inventory](index=20&type=section&id=5.%20Inventory) Inventory (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Raw materials | $219 | $214 | | Work-in-process | $1,736 | $1,489 | | Finished goods | $1,084 | $1,337 | | Total Inventory | $3,039 | $3,040 | [6. Expenses](index=22&type=section&id=6.%20Expenses) Accrued Expenses and Other Current Liabilities (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Accrued payroll and related expenses | $10,189 | $14,272 | | Accrued rebates and programs | $5,686 | $5,265 | | Accrued professional fees | $2,917 | $1,879 | | Accrued research and development expenses | $13,173 | $11,054 | | Accrued interest payable on Barings Credit Facility | $736 | $592 | | Accrued other | $1,716 | $2,055 | | Total Accrued expenses and other current liabilities | $34,417 | $35,117 | [7. Financial Liabilities](index=22&type=section&id=7.%20Financial%20Liabilities) - The company has a Barings Credit Facility of **$82,474 thousand**, maturing in 2029, with interest based on SOFR plus 6.75%. A Barings Royalty Fee Obligation (3.5% of DEXTENZA net sales) is embedded and accounted for as a freestanding derivative[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) Notes Payable, Net (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Barings Credit Facility | $82,474 | $82,474 | | Less: unamortized discount | $(12,568) | $(13,969) | | Total Notes Payable, net | $69,906 | $68,505 | - The Convertible Notes (**$37,500 thousand** principal) were converted on March 28, 2024, resulting in the issuance of 5,769,232 common shares and a net loss on extinguishment of **$27,950 thousand**[62](index=62&type=chunk)[64](index=64&type=chunk) [8. Derivative Liability](index=24&type=section&id=8.%20Derivative%20Liability) - The Barings Royalty Fee Obligation is accounted for as a Royalty Fee Derivative Liability, measured at fair value using a "with-and-without" method and Monte Carlo simulation[65](index=65&type=chunk) Royalty Fee Derivative Liability (in thousands) | Metric (in thousands) | Amount | | :-------------------- | :----- | | Balance at December 31, 2024 | $13,246 | | Change in fair value | $778 | | Balance at June 30, 2025 | $14,024 | - The Conversion Option Derivative Liability related to the Convertible Notes was extinguished in March 2024 upon conversion[67](index=67&type=chunk) [9. Risks and Fair Value](index=26&type=section&id=9.%20Risks%20and%20Fair%20Value) - The company faces concentration of credit risk in cash and cash equivalents (held at three institutions) and accounts receivable (three specialty distributors)[68](index=68&type=chunk)[69](index=69&type=chunk) Customer Revenue and Accounts Receivable Concentration | Customer | 3 Months Ended June 30, 2025 Revenue % | 3 Months Ended June 30, 2024 Revenue % | June 30, 2025 Accounts Receivable % | December 31, 2024 Accounts Receivable % | | :--------- | :------------------------------------- | :------------------------------------- | :------------------------------------ | :------------------------------------ | | Customer 1 | 40% | 42% | 45% | 46% | | Customer 2 | 26% | 24% | 28% | 28% | | Customer 3 | 10% | 12% | 10% | 8% | Change in Fair Value of Derivative Liabilities (in thousands) | Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Change in fair value of Royalty Fee Derivative Liability | $(172) | $(2,454) | $(778) | $(9,689) | | Barings Royalty Fee | $(469) | $(573) | $(841) | $(1,088) | | Total Change in fair value of derivative liabilities | $(641) | $(3,027) | $(1,619) | $(8,179) | - The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation, with key unobservable inputs being revenue volatility (**65.2%** as of June 30, 2025) and revenue discount rate (**15.4%** as of June 30, 2025)[73](index=73&type=chunk)[76](index=76&type=chunk) [10. Equity](index=30&type=section&id=10.%20Equity) - During the three and six months ended June 30, 2025, the company sold 11,548,364 common shares under the 2021 Sales Agreement, generating net proceeds of **$94,025 thousand**[77](index=77&type=chunk) - In February 2024, a private placement of common stock and pre-funded warrants generated approximately **$316,353 thousand** in net proceeds. As of June 30, 2025, 9,713,684 pre-funded warrants remained outstanding after 1,092,148 shares were exercised via cashless exercise[78](index=78&type=chunk) - In June 2024, authorized common stock shares were increased by 200,000,000 to 400,000,000[79](index=79&type=chunk) [11. Stock-Based Awards](index=32&type=section&id=11.%20Stock-Based%20Awards) - The company operates under the 2021 Stock Incentive Plan, 2019 Inducement Stock Incentive Plan, and 2014 Employee Stock Purchase Plan (ESPP). Stockholders approved amendments in June 2025 to increase shares issuable under the 2021 Plan by 8,750,000 and the ESPP by 2,000,000[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) Stock-Based Awards Granted | Award Type | 3 Months Ended June 30, 2025 | 6 Months Ended June 30, 2025 | | :----------- | :--------------------------- | :--------------------------- | | Stock Options Granted | 3,243,075 | 6,466,301 | | RSUs Granted | 156,683 | 2,470,579 | | PSUs Granted | 1,500,000 | 1,500,000 | Total Stock-Based Compensation Expense (in thousands) | Expense Category (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $3,350 | $2,345 | $6,368 | $3,798 | | Selling and marketing | $1,068 | $689 | $2,245 | $1,526 | | General and administrative | $5,260 | $8,259 | $11,521 | $13,947 | | Total Stock-based compensation expense | $9,678 | $11,293 | $20,134 | $19,271 | [12. Income Taxes](index=34&type=section&id=12.%20Income%20Taxes) - No income taxes were provided for the periods presented due to a valuation allowance for the full amount of net deferred tax assets, as realization of future benefits is not likely[94](index=94&type=chunk) - The One Big Beautiful Bill Act (OBBB) signed on July 4, 2025, includes tax reform provisions, but the company does not anticipate a significant impact on its consolidated financial statements[95](index=95&type=chunk) [13. Net Loss Per Share](index=35&type=section&id=13.%20Net%20Loss%20Per%20Share) Net Loss Per Share (in thousands, except per share amounts) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :----- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss attributable to common stockholders (in thousands) | $(67,814) | $(43,777) | $(131,867) | $(108,625) | | Weighted average common shares outstanding, basic | 172,594,662 | 165,824,778 | 171,004,629 | 148,922,937 | | Net loss per share - basic | $(0.39) | $(0.26) | $(0.77) | $(0.73) | - Diluted net loss per share was the same as basic net loss per share due to the anti-dilutive impact of potentially issuable common shares, including options, RSUs, and PSUs[96](index=96&type=chunk)[97](index=97&type=chunk) [14. Segment Reporting](index=35&type=section&id=14.%20Segment%20Reporting) - The company operates as a single operating segment focused on developing and commercializing therapies for retinal diseases and other eye conditions using its ELUTYX technology[98](index=98&type=chunk) - The Chief Operating Decision Maker (CODM), collectively the CEO and CFO/COO, allocates resources and assesses performance based on Net Loss[99](index=99&type=chunk) [15. Commitments and Contingencies](index=36&type=section&id=15.%20Commitments%20and%20Contingencies) - The company enters into indemnification agreements in the ordinary course of business but has not incurred any material costs to date[101](index=101&type=chunk) [16. Related Party Transactions](index=36&type=section&id=16.%20Related%20Party%20Transactions) - The company incurred fees for clinical development services from Boston Image Reading Center LLC (BIRC), where its CMO is a Director, totaling **$4 thousand** (Q2 2025) and **$25 thousand** (YTD Q2 2025)[102](index=102&type=chunk) - Fees and expenses related to services from i2Vision, affiliated with the CSO and CDO, were **$43 thousand** (Q2 2025) and a net credit of **$(121) thousand** (YTD Q2 2025)[103](index=103&type=chunk) - The consulting agreement with Heier Consulting, LLC was terminated in February 2024 upon Dr. Heier's employment as Chief Scientific Officer[107](index=107&type=chunk) [17. Subsequent Events](index=38&type=section&id=17.%20Subsequent%20Events) - No subsequent events were noted by the company[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, detailing key business developments, a breakdown of financial performance components, and a comparison of financial results for the three and six months ended June 30, 2025, and 2024. It also covers liquidity, capital resources, and critical accounting policies [Overview](index=39&type=section&id=Overview) - The company is an integrated biopharmaceutical company focused on retinal diseases, utilizing its ELUTYX hydrogel technology[110](index=110&type=chunk) - Key product candidates include AXPAXLI for wet AMD, NPDR, and DME, and OTX-TIC for OAG/OHT. DEXTENZA is the commercial product for ocular inflammation/pain and allergic conjunctivitis[110](index=110&type=chunk)[111](index=111&type=chunk) [Key Business and Financial Developments](index=39&type=section&id=Key%20Business%20and%20Financial%20Developments) [AXPAXLI for wet AMD](index=39&type=section&id=AXPAXLI%20for%20wet%20AMD) - The SOL-1 trial, a Phase 3 superiority trial for wet AMD, completed randomization of 344 subjects in December 2024. Topline results are expected in Q1 2026. An FDA-agreed SPA amendment allows for repeat dosing at Week 52 and Week 76 to support a 6-12 month dosing label[112](index=112&type=chunk)[113](index=113&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk) - The SOL-R trial, a Phase 3 non-inferiority trial for wet AMD, was initiated in June 2024 and completed enrollment. Topline results are expected in H1 2027. Rescue criteria were modified in June 2025 to align with real-world clinical practice[118](index=118&type=chunk)[120](index=120&type=chunk) - The company plans a long-term, open-label extension study for both SOL trials to gather long-term safety data and further inform the AXPAXLI treatment paradigm, with details expected in Q3 2025[122](index=122&type=chunk)[123](index=123&type=chunk) - Favorable results from SOL-1 and SOL-R could lead to an NDA submission via the 505(b)(2) pathway, potentially resulting in a superiority label and infrequent dosing (e.g., every 12 months)[124](index=124&type=chunk) [AXPAXLI for NPDR and DME](index=43&type=section&id=AXPAXLI%20for%20NPDR%20and%20DME) - The HELIOS trial for NPDR has been completed. The FDA provided positive written feedback on the design of a potential registrational clinical trial for AXPAXLI for NPDR in H1 2025[125](index=125&type=chunk) - Further details on the clinical strategy for AXPAXLI for NPDR and DME are expected in Q3 2025[125](index=125&type=chunk) [OTX-TIC for OAG or OHT](index=43&type=section&id=OTX-TIC%20for%20OAG%20or%20OHT) - A pilot repeat-dose sub-study is ongoing in the Phase 2 clinical trial to evaluate the safety of a repeat sustained-release dose of OTX-TIC 26 μg for OAG or OHT[126](index=126&type=chunk) - Upon completion of the sub-study, the company plans to evaluate an end-of-Phase 2 meeting with the FDA to determine next steps[126](index=126&type=chunk) [Commercial](index=43&type=section&id=Commercial) Net Product Revenue (DEXTENZA) (in millions) | Metric (in millions) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | % Change | | :------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Net product revenue (DEXTENZA) | $13.4 | $16.4 | $(3.0) | -18.3% | Net Product Revenue (DEXTENZA) (in millions) | Metric (in millions) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | % Change | | :------------------- | :--------------------------- | :--------------------------- | :----- | :------- | | Net product revenue (DEXTENZA) | $24.0 | $31.1 | $(7.1) | -22.8% | - The decrease in net product revenue is attributed to pricing strategy, distributor stocking patterns, buying patterns, and the negative impact of DEXTENZA's inclusion in the MIPS cost performance category for 2025[129](index=129&type=chunk) - In-Market Sales for DEXTENZA increased to approximately **44,000 units** in Q2 2025, up **2,000 units** YoY and **4,000 units** QoQ, indicating growing demand as clinicians adjust to MIPS and increased sales efforts towards HOPDs[130](index=130&type=chunk) - A supplemental NDA for DEXTENZA was approved on April 7, 2025, expanding its label for pediatric use in ocular inflammation/pain and allergic conjunctivitis, though significant revenue from this expansion is not expected[132](index=132&type=chunk) [Other Developments](index=45&type=section&id=Other%20Developments) - The company does not anticipate a significant adverse effect on its business or operations from current tariffs, changes in trade policies, or the recently signed One Big Beautiful Bill Act (OBBB)[133](index=133&type=chunk)[134](index=134&type=chunk) [Components of our Financial Performance](index=45&type=section&id=Components%20of%20our%20Financial%20Performance) [Revenue](index=45&type=section&id=Revenue) - Product revenue from DEXTENZA sales is recorded net of gross-to-net (GTN) provisions, including discounts, chargebacks, rebates, distribution fees, and returns[135](index=135&type=chunk) [Operating Expenses](index=45&type=section&id=Operating%20Expenses) [Cost of Product Revenue](index=45&type=section&id=Cost%20of%20Product%20Revenue) - Cost of product revenue for DEXTENZA includes direct materials, royalties, direct labor (salaries, benefits, stock-based compensation), manufacturing overhead, transportation, and cost of scrap material[137](index=137&type=chunk) [Research and Development Expenses](index=45&type=section&id=Research%20and%20Development%20Expenses) - R&D expenses primarily consist of costs for clinical trials (investigative sites, CROs), employee-related expenses, regulatory activities, pre-commercial manufacturing, ongoing core technology development, facility expenses, and preclinical activities[136](index=136&type=chunk)[138](index=138&type=chunk)[142](index=142&type=chunk) - Direct R&D expenses are tracked program-by-program, while unallocated costs (employee/contractor, ELUTYX technology, manufacturing, facility) are deployed across multiple programs[140](index=140&type=chunk) - The successful development and commercialization of products are highly uncertain, with costs and timing dependent on clinical trial outcomes, regulatory approvals, market acceptance, and government regulation[141](index=141&type=chunk)[143](index=143&type=chunk) [Selling and Marketing Expenses](index=49&type=section&id=Selling%20and%20Marketing%20Expenses) - Selling and marketing expenses primarily include salaries and related costs (including stock-based compensation) for personnel, as well as consulting, advertising, and promotion costs[146](index=146&type=chunk) [General and Administrative Expenses](index=49&type=section&id=General%20and%20Administrative%20Expenses) - General and administrative expenses mainly comprise salaries and related costs (including stock-based compensation) for executive, finance, IT, HR, and administrative functions, along with insurance, facility costs, and professional fees[147](index=147&type=chunk) [Other Income (Expense)](index=49&type=section&id=Other%20Income%20(Expense)) - Interest income is primarily from investments in money market funds. Interest expense is incurred on debt, including the Barings Credit Facility[148](index=148&type=chunk)[149](index=149&type=chunk) - Changes in the fair value of derivative liabilities (Barings Credit Agreement's embedded royalty fee and the extinguished Convertible Notes' conversion option) are recorded as net gains or losses[150](index=150&type=chunk) - A loss on extinguishment of debt was recognized in March 2024 due to the conversion of the Convertible Notes[151](index=151&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) [Comparison of the Three Months Ended June 30, 2025 and 2024](index=50&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) Financial Performance (3 Months Ended) (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | Product Revenue, net | $13,395 | $16,379 | $(2,984) | -18.22% | | Collaboration Revenue | $64 | $62 | $2 | 3.23% | | R&D Expenses | $51,081 | $28,857 | $22,224 | 77.08% | | S&M Expenses | $13,729 | $9,994 | $3,735 | 37.37% | | G&A Expenses | $14,346 | $19,671 | $(5,325) | -27.07% | | Interest Income | $3,455 | $6,036 | $(2,581) | -42.76% | | Interest Expense | $(3,016) | $(3,196) | $180 | -5.63% | | Change in Fair Value of Derivative Liabilities | $(641) | $(3,027) | $2,386 | -78.82% | | Net Loss | $(67,814) | $(43,777) | $(24,037) | 54.91% | - Product revenue decreased due to pricing strategy, distributor stocking, and MIPS impact, with GTN Provisions increasing to **51.7%** of gross sales (from 39.6% in Q2 2024)[153](index=153&type=chunk)[154](index=154&type=chunk) - R&D expenses significantly increased by **$22.2 million**, primarily driven by the progression of the SOL-1 and initiation/progression of the SOL-R clinical trials for AXPAXLI[157](index=157&type=chunk)[159](index=159&type=chunk) - G&A expenses decreased by **$5.4 million**, mainly due to lower personnel-related costs following a strategic reduction in force and executive departures in Q2 2024[165](index=165&type=chunk)[166](index=166&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=56&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) Financial Performance (6 Months Ended) (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | Product Revenue, net | $24,028 | $31,094 | $(7,066) | -22.73% | | Collaboration Revenue | $128 | $121 | $7 | 5.79% | | R&D Expenses | $93,938 | $49,592 | $44,346 | 89.42% | | S&M Expenses | $27,877 | $20,177 | $7,700 | 38.16% | | G&A Expenses | $30,694 | $33,818 | $(3,124) | -9.24% | | Interest Income | $7,282 | $9,958 | $(2,676) | -26.87% | | Interest Expense | $(6,000) | $(7,247) | $1,247 | -17.21% | | Change in Fair Value of Derivative Liabilities | $(1,619) | $(8,179) | $6,560 | -80.21% | | Loss on Extinguishment of Debt | $0 | $(27,950) | $27,950 | -100.00% | | Net Loss | $(131,867) | $(108,625) | $(23,242) | 21.40% | - Product revenue decreased by **$7.1 million**, with GTN Provisions increasing to **50.7%** of gross sales (from 38.0% in YTD Q2 2024) due to increased WAC and OID[172](index=172&type=chunk)[173](index=173&type=chunk) - R&D expenses increased by **$44.3 million**, primarily due to the progression of SOL-1, initiation/progression of SOL-R, and completion of the HELIOS trial[176](index=176&type=chunk)[178](index=178&type=chunk) - Interest expense decreased by **$1.2 million**, mainly due to lower average debt balances after the conversion of Convertible Notes in March 2024[188](index=188&type=chunk) - A non-cash loss on extinguishment of debt of **$28.0 million** was recognized in YTD Q2 2024 due to the Convertible Notes conversion[190](index=190&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) [Sources of Liquidity](index=62&type=section&id=Sources%20of%20Liquidity) - As of June 30, 2025, the company had **$391.1 million** in cash and cash equivalents and **$82.5 million** in outstanding notes payable under the Barings Credit Facility[192](index=192&type=chunk) - In June 2025, the company sold 11,548,364 common shares under the 2021 Sales Agreement, generating **$94.0 million** in net proceeds[193](index=193&type=chunk) - In February 2024, a private placement of common stock and pre-funded warrants yielded approximately **$316.4 million** in net proceeds[194](index=194&type=chunk) [Funding Requirements](index=62&type=section&id=Funding%20Requirements) - The company has a history of significant operating losses, with a net loss of **$131.9 million** for the six months ended June 30, 2025, and an accumulated deficit of **$1,023.0 million**[196](index=196&type=chunk) - Substantial expenses are anticipated for ongoing clinical trials (SOL-1, SOL-R), potential new trials (AXPAXLI for NPDR/DME, long-term extension), manufacturing scale-up, commercialization efforts, and intellectual property protection[198](index=198&type=chunk)[199](index=199&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk) - Existing cash and cash equivalents are expected to fund planned operating expenses, debt service, and capital expenditures into 2028, excluding expenses for AXPAXLI for NPDR/DME and the long-term extension for wet AMD[201](index=201&type=chunk) - Future capital requirements depend on various factors, and additional financing may be sought through equity offerings, debt financings, or collaborations, which could dilute ownership or impose restrictive covenants[203](index=203&type=chunk)[205](index=205&type=chunk) [Cash Flows](index=66&type=section&id=Cash%20Flows) Cash Flow Activities (in thousands) | Cash Flow Activity | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | Change (in thousands) | | :----------------- | :------------------------------------------ | :------------------------------------------ | :-------------------- | | Operating Activities | $(99,909) | $(58,689) | $(41,220) | | Investing Activities | $(3,048) | $(997) | $(2,051) | | Financing Activities | $101,989 | $323,419 | $(221,430) | - Net cash used in operating activities increased by **$41.2 million**, primarily due to a higher net loss, partially offset by non-cash adjustments and favorable changes in operating assets and liabilities[209](index=209&type=chunk) - Net cash provided by financing activities decreased by **$221.4 million**, mainly due to significant proceeds from a private placement in 2024 that did not recur in 2025, partially offset by proceeds from a public offering in 2025[212](index=212&type=chunk) [Contractual Obligations and Commitments](index=68&type=section&id=Contractual%20Obligations%20and%20Commitments) Contractual Obligations and Commitments (in thousands) | Obligation (in thousands) | Total | Less Than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | | :------------------------ | :---- | :--------------- | :----------- | :----------- | :---------------- | | Operating lease commitments | $8,371 | $3,480 | $4,789 | $102 | — | | Barings Credit Agreement | $82,474 | — | — | $82,474 | — | | Total | $90,845 | $3,480 | $4,789 | $82,576 | — | - The table includes enforceable and legally binding obligations, but excludes cancelable contracts for R&D activities and unquantifiable royalty payments to Incept, LLC[215](index=215&type=chunk)[216](index=216&type=chunk)[219](index=219&type=chunk) - Future interest payments on the Barings Credit Agreement and royalty fees on DEXTENZA sales are not estimable at this time[218](index=218&type=chunk)[219](index=219&type=chunk) [Off-Balance Sheet Arrangements](index=70&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have any off-balance sheet arrangements during the periods presented[220](index=220&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=71&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - Critical accounting policies, including revenue recognition and derivative liabilities, are detailed in the Annual Report on Form 10-K[222](index=222&type=chunk) - The preparation of financial statements requires management to make subjective estimates and judgments that affect reported amounts, which are periodically reviewed[223](index=223&type=chunk) [Recently Issued Accounting Pronouncements](index=71&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) - Information regarding new accounting pronouncements is included in Note 2 to the condensed consolidated financial statements[224](index=224&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=71&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) - The company is exposed to market risk from changes in interest rates, particularly affecting its **$391.1 million** in cash and cash equivalents invested in short-term money market funds[225](index=225&type=chunk) - The Barings Credit Facility (**$82.5 million** principal) has interest payments tied to SOFR, but an immediate 100 basis point change in SOFR is not expected to materially affect cash outflows[227](index=227&type=chunk) - The Royalty Fee Derivative Liability, valued at **$14.0 million** as of June 30, 2025, is subject to fair value changes, but a 10% change in the interest rate used in its valuation model would not materially affect its fair value[228](index=228&type=chunk) [Item 4. Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[229](index=229&type=chunk) - No changes in internal control over financial reporting occurred during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[230](index=230&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is not presently a party to any material legal proceedings, nor are any material legal proceedings threatened against it[233](index=233&type=chunk) [Item 1A. Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the comprehensive discussion of risk factors in the company's Annual Report on Form 10-K for the year ended December 31, 2024 - The company is subject to various risks that could materially and adversely affect its business, financial condition, and results of operations, as identified in the "Risk Factors" section of its Annual Report on Form 10-K[234](index=234&type=chunk) [Item 5. Other Information](index=73&type=section&id=Item%205.%20Other%20Information) This section addresses director and officer trading arrangements, confirming compliance with insider trading policies and Rule 10b5-1, and reporting no new or terminated trading arrangements during the quarter - Director and officer trading arrangements are made in accordance with the company's insider trading policy and Rule 10b5-1 to avoid concerns about trading on material nonpublic information[235](index=235&type=chunk)[236](index=236&type=chunk) - During the three months ended June 30, 2025, none of the company's directors and officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement[237](index=237&type=chunk) [Item 6. Exhibits](index=73&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed as part of this Quarterly Report on Form 10-Q - The report includes an Exhibit Index listing various documents, such as the Certificate of Amendment of Restated Certificate of Incorporation, amended Stock Incentive Plans, Employment Agreements, and certifications[238](index=238&type=chunk)[240](index=240&type=chunk) [SIGNATURES](index=77&type=section&id=SIGNATURES) This section confirms the official signing of the report by the company's principal financial and accounting officer - The report was signed on August 5, 2025, by Donald Notman, Chief Financial Officer and Chief Operating Officer (Principal Financial and Accounting Officer), on behalf of Ocular Therapeutix, Inc[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk)

Executive Summary & Business Highlights [Company Overview and Strategic Vision](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Vision) Ocular Therapeutix is entering a pivotal phase, focusing on redefining retina treatment with AXPAXLI™, which aims for a powerful and differentiated clinical profile, potentially securing an unprecedented superiority label in wet AMD with long-term dosing flexibility. The company maintains a strong financial position with a cash runway into 2028 - AXPAXLI™ is expected to achieve a powerful and highly differentiated clinical profile, with the potential to secure an unprecedented superiority label in wet AMD[2](index=2&type=chunk) - The SOL program is anticipated to enable AXPAXLI™ dosing every 6 months to as infrequently as every 12 months[2](index=2&type=chunk) Cash Balance as of June 30, 2025 | Metric | Amount (Millions) | | :----- | :---------------- | | Cash Balance | $391 | - Expected cash runway extends into **2028**, well beyond anticipated topline data for SOL-1 and SOL-R[1](index=1&type=chunk) [Recent Achievements and Upcoming Milestones](index=2&type=section&id=Recent%20Achievements%20and%20Upcoming%20Milestones) Ocular Therapeutix reported significant progress in its AXPAXLI™ clinical trials for wet AMD, including SOL-1 remaining on track for 1Q 2026 topline data and streamlined rescue criteria for SOL-R, with data expected in 1H 2027. The company also plans a long-term extension study, received positive FDA feedback for NPDR and DME programs, raised $97 million, and will host an Investor Day in September 2025 [AXPAXLI™ Clinical Development](index=2&type=section&id=AXPAXLI%E2%84%A2%20Clinical%20Development) - SOL-1 (Phase 3, wet AMD) topline data remains on track for **1Q 2026**, with exceptional patient retention and protocol adherence[3](index=3&type=chunk) - SOL-R (Phase 3, wet AMD) rescue criteria were streamlined and simplified to align with real-world clinical decision-making (criteria: >5-letter loss in visual acuity plus ≥75-micron increase in central subfield thickness). Topline data is expected in **1H 2027**[3](index=3&type=chunk) - New Drug Application (NDA) filing for AXPAXLI™ is planned shortly after SOL-R topline results, utilizing the 505(b)(2) pathway for potentially shorter review[3](index=3&type=chunk) - A single long-term, open-label extension study is planned for patients completing either SOL-1 or SOL-R to provide long-term safety data and inform the AXPAXLI™ treatment paradigm[4](index=4&type=chunk) [Pipeline Expansion (NPDR, DME)](index=3&type=section&id=Pipeline%20Expansion%20(NPDR%2C%20DME)) - Received written feedback from FDA supporting a registrational trial for AXPAXLI™ in non-proliferative diabetic retinopathy (NPDR)[4](index=4&type=chunk) - Actively defining clinical strategy for AXPAXLI™ in NPDR and diabetic macular edema (DME), with more details to be shared at Investor Day[4](index=4&type=chunk) [Corporate and Financial Updates](index=3&type=section&id=Corporate%20and%20Financial%20Updates) - Raised gross proceeds of approximately **$97 million** in June 2025 through an existing at-the-market (ATM) facility, extending financial flexibility and cash runway into **2028**[4](index=4&type=chunk) - Ocular will host an Investor Day on Tuesday, **September 30, 2025**, in New York City, to discuss SOL trials, the extension study, NPDR/DME strategy, and the global commercial opportunity for AXPAXLI™[4](index=4&type=chunk) - Unveiled new corporate branding in June 2025, reflecting the company's transformation to a retina-focused entity committed to redefining the retina experience[4](index=4&type=chunk) Financial Performance (Q2 2025) [Key Financial Highlights](index=4&type=section&id=Key%20Financial%20Highlights) As of June 30, 2025, Ocular Therapeutix reported total cash and cash equivalents of $391.1 million, which is projected to fund operations into 2028, well beyond the anticipated topline data for its key clinical trials Cash and Cash Equivalents (as of June 30, 2025) | Metric | Amount (Millions) | | :----- | :---------------- | | Cash and cash equivalents | $391.1 | - Current cash balance is sufficient to support planned expenses, debt service, and capital expenditure requirements into **2028**[5](index=5&type=chunk) [Revenue Analysis](index=4&type=section&id=Revenue%20Analysis) Total net revenue for Q2 2025 decreased by 18.1% year-over-year to $13.5 million, primarily due to a challenging reimbursement environment for DEXTENZA. Despite this, DEXTENZA end-user unit sales increased by 5% YoY, and net product revenue grew by 26.0% quarter-over-quarter Total Net Revenue (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----- | :----------------- | :----------------- | :--------- | | Total Net Revenue | $13.5 | $16.4 | -18.1% | - DEXTENZA end-user unit sales increased by **5%** compared to Q2 2024[7](index=7&type=chunk) - DEXTENZA net product revenue increased by **26.0%** compared to Q1 2025[7](index=7&type=chunk) - The reduction in net revenue was attributed to an evolving and significantly more challenging reimbursement environment for DEXTENZA in 2025[7](index=7&type=chunk) [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Research and development expenses significantly increased by 76.8% YoY to $51.1 million in Q2 2025, driven by increased clinical activities for the SOL-1 and SOL-R trials. Selling and marketing expenses also rose by 37.0% to $13.7 million due to pre-commercialization efforts for AXPAXLI™. General and administrative expenses decreased by 27.4% to $14.3 million, primarily due to one-time costs in the prior year Operating Expenses (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :--------------- | :----------------- | :----------------- | :--------- | | R&D Expenses | $51.1 | $28.9 | +76.8% | | S&M Expenses | $13.7 | $10.0 | +37.0% | | G&A Expenses | $14.3 | $19.7 | -27.4% | - Increase in R&D expenses reflects higher overall clinical expenses associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services[8](index=8&type=chunk) - Increase in S&M expenses primarily reflects higher personnel-related costs and professional fees for AXPAXLI™ pre-commercialization activities[9](index=9&type=chunk) - Decrease in G&A expenses was primarily due to lower personnel-related costs, as Q2 2024 included one-time costs for departed employees and restructuring[10](index=10&type=chunk) [Net Loss and EPS](index=4&type=section&id=Net%20Loss%20and%20EPS) Ocular Therapeutix reported a net loss of $(67.8) million, or $(0.39) per share, for Q2 2025, an increase from $(43.8) million, or $(0.26) per share, in the comparable quarter of 2024, primarily driven by increased operating expenses Net Loss and EPS (Q2 2025 vs Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | YoY Change | | :----- | :----------------- | :----------------- | :--------- | | Net Loss | $(67.8) | $(43.8) | +54.8% | | Net Loss per Share (Basic & Diluted) | $(0.39) | $(0.26) | +50.0% | - Outstanding shares as of August 1, 2025, were approximately **174.0 million**[12](index=12&type=chunk) Product and Disease Background [About AXPAXLI™](index=5&type=section&id=About%20AXPAXLI%E2%84%A2) AXPAXLI™ (OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel that incorporates axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic properties. It is currently being evaluated for the treatment of wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases - AXPAXLI™ (OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel[13](index=13&type=chunk) - It incorporates axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties[13](index=13&type=chunk) - AXPAXLI™ is being evaluated for wet AMD, diabetic retinopathy, diabetic macular edema, and other retinal diseases[13](index=13&type=chunk) [About SOL-1 Study](index=5&type=section&id=About%20SOL-1%20Study) The SOL-1 trial is a registrational Phase 3 superiority study evaluating AXPAXLI™ against aflibercept (2 mg) in 344 treatment-naïve wet AMD subjects. The primary endpoint is the proportion of subjects maintaining visual acuity at Week 36, with durability evaluated up to Week 52. The study is conducted under an FDA Special Protocol Assessment (SPA) - SOL-1 is a registrational Phase 3, multi-center, double-masked, randomized (1:1), parallel group superiority study[14](index=14&type=chunk)[15](index=15&type=chunk) - The trial completed randomization of **344** evaluable treatment-naïve subjects with wet AMD[14](index=14&type=chunk) - The primary endpoint is the proportion of subjects who maintain visual acuity (loss of <15 ETDRS letters of BCVA) at Week 36[16](index=16&type=chunk) - The study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA[16](index=16&type=chunk) [About SOL-R Study](index=6&type=section&id=About%20SOL-R%20Study) The SOL-R trial is a registrational Phase 3 non-inferiority study designed to evaluate AXPAXLI™ in approximately 555 wet AMD subjects. The primary endpoint is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI™ and on-label aflibercept (2 mg) arms at Week 56, with a pre-specified non-inferiority margin of -4.5 letters - SOL-R is a registrational Phase 3, multi-center, double-masked, randomized (2:2:1), three-arm non-inferiority study[17](index=17&type=chunk)[19](index=19&type=chunk) - The trial intends to randomize approximately **555** subjects who are treatment-naïve or recently diagnosed with wet AMD[17](index=17&type=chunk) - The primary endpoint is to demonstrate non-inferiority in mean BCVA change from baseline between the AXPAXLI™ and on-label aflibercept (2 mg) arms at Week 56[19](index=19&type=chunk) - The non-inferiority margin for the lower bound is **-4.5 letters** of mean BCVA, as agreed with the FDA[19](index=19&type=chunk) - Pre-specified rescue criteria include a >5-letter loss in visual acuity plus a ≥75-micron increase in central subfield thickness (CSFT)[18](index=18&type=chunk) [About Wet AMD](index=6&type=section&id=About%20Wet%20AMD) Wet age-related macular degeneration (wet AMD) is a leading cause of severe, irreversible vision loss, affecting millions globally. It is characterized by abnormal blood vessel growth and hyperpermeability, primarily stimulated by VEGF. Current treatments involve frequent intraocular injections, which often lead to patient discontinuation and undertreatment, highlighting the need for more sustainable solutions - Wet AMD affects approximately **14.5 million** individuals globally and **1.8 million** in the United States[20](index=20&type=chunk) - It causes vision loss due to abnormal new blood vessel growth and hyperpermeability in the macula, primarily stimulated by vascular endothelial growth factor (VEGF)[20](index=20&type=chunk) - Challenges with current therapies include pulsatile, repeated intraocular injections, treatment-related adverse events, and up to **40%** patient discontinuation within one year, leading to undertreatment and lack of long-term vision improvement[20](index=20&type=chunk) Corporate Information [About Ocular Therapeutix, Inc.](index=7&type=section&id=About%20Ocular%20Therapeutix%2C%20Inc.) Ocular Therapeutix is an integrated biopharmaceutical company focused on redefining the retina experience through its proprietary ELUTYX™ bioresorbable hydrogel technology. Its pipeline includes AXPAXLI™ (Phase 3 for wet AMD), the commercial product DEXTENZA (for ocular inflammation/pain/itching), and OTX-TIC (Phase 2 for open-angle glaucoma/ocular hypertension) - Ocular Therapeutix is an integrated biopharmaceutical company committed to redefining the retina experience[21](index=21&type=chunk) - The company leverages its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology[21](index=21&type=chunk) - Key products and candidates include AXPAXLI™ (Phase 3 for wet AMD), DEXTENZA (FDA-approved for ocular inflammation, pain, and allergic conjunctivitis), and OTX-TIC (Phase 2 for open-angle glaucoma or ocular hypertension)[21](index=21&type=chunk)[22](index=22&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) This section outlines that statements regarding future expectations, plans, and prospects are forward-looking and subject to substantial risks and uncertainties. Actual results may differ materially from those indicated, and the company disclaims any obligation to update these statements unless required by law - Statements about future expectations, plans, and prospects constitute forward-looking statements[24](index=24&type=chunk) - Actual results may differ materially from forward-looking statements due to various important factors, risks, and uncertainties[24](index=24&type=chunk) - The company disclaims any obligation to update these forward-looking statements, except as required by law[24](index=24&type=chunk) [Investor Relations](index=8&type=section&id=Investor%20Relations) This section provides contact information for investor and media inquiries - Contact for Investors & Media: Bill Slattery, Vice President, Investor Relations[25](index=25&type=chunk) Financial Statements [Consolidated Balance Sheets](index=9&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheets present the company's financial position as of June 30, 2025, and December 31, 2024, detailing assets, liabilities, and stockholders' equity. Total assets slightly decreased from $457.9 million to $451.3 million, while total liabilities increased from $142.6 million to $145.4 million, and total stockholders' equity decreased from $315.3 million to $305.9 million Consolidated Balance Sheets (Selected Data in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | **Assets** | | | | Cash and cash equivalents | $391,134 | $392,102 | | Total current assets | $433,375 | $440,987 | | Total assets | $451,333 | $457,935 | | **Liabilities** | | | | Total current liabilities | $42,931 | $41,354 | | Total liabilities | $145,417 | $142,591 | | **Stockholders' Equity** | | | | Total stockholders' equity | $305,916 | $315,344 | [Consolidated Statements of Operations and Comprehensive Loss](index=10&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The Consolidated Statements of Operations and Comprehensive Loss detail the company's financial performance for the three and six months ended June 30, 2025, and 2024. For Q2 2025, total net revenue was $13.5 million, operating expenses were $81.1 million, resulting in a net loss of $(67.8) million, or $(0.39) per share. This represents an increased net loss compared to Q2 2024 Consolidated Statements of Operations (Selected Data in thousands, except per share) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue, net | $13,459 | $16,441 | $24,156 | $31,215 | | Total costs and operating expenses | $81,100 | $60,031 | $155,715 | $106,422 | | Loss from operations | $(67,641) | $(43,590) | $(131,559) | $(75,207) | | Net loss | $(67,814) | $(43,777) | $(131,867) | $(108,625) | | Net loss per share, basic | $(0.39) | $(0.26) | $(0.77) | $(0.73) | | Weighted average common shares outstanding, basic | 172,594,662 | 165,824,778 | 171,004,629 | 148,922,937 |

Core Insights - Ocular Therapeutix is advancing its clinical trials for AXPAXLI, targeting wet age-related macular degeneration (AMD) with significant milestones expected in 2026 and 2027 [1][2][3] Clinical Trials and Development - SOL-1 trial is on track for topline data in Q1 2026, while SOL-R trial is expected to report topline data in H1 2027 [1][3] - A long-term extension study for both SOL trials is planned to follow patients after completion, aiming to gather additional safety and efficacy data [1][6] - SOL-R has streamlined rescue criteria to align with real-world clinical practices, enhancing its relevance and applicability [3][4] Financial Performance - As of June 30, 2025, the company reported a cash balance of $391.1 million, sufficient to support operations into 2028 [5][6] - Total net revenue for Q2 2025 was $13.5 million, an 18.1% decrease from $16.4 million in Q2 2024, attributed to a challenging reimbursement environment [7][8] - Research and development expenses increased to $51.1 million in Q2 2025, reflecting the costs associated with ongoing clinical trials [9] Strategic Initiatives - The company raised approximately $97 million in gross proceeds through an at-the-market facility in June 2025, enhancing financial flexibility [5][6] - An Investor Day is scheduled for September 30, 2025, to discuss the clinical strategy and commercial outlook for AXPAXLI [5][6] Market Context - Wet AMD affects approximately 14.5 million individuals globally, highlighting a significant market opportunity for innovative treatments like AXPAXLI [22] - Current therapies face challenges such as treatment burden and high patient discontinuation rates, indicating a need for more sustainable treatment options [22]

Core Viewpoint - Ocular Therapeutix, Inc. is set to discuss its recent business progress and financial results for Q2 2025 in an upcoming conference call on August 5, 2025 [1]. Group 1: Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company focused on redefining the retina experience [3]. - The company is developing AXPAXLI™ (OTX-TKI), an investigational product for retinal disease, currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD) [3]. - Ocular's pipeline includes DEXTENZA, an FDA-approved corticosteroid for treating ocular inflammation and pain post-surgery, and OTX-TIC, an investigational product in Phase 2 trials for open-angle glaucoma or ocular hypertension [4]. Group 2: Conference Call Details - The conference call and webcast will take place on August 5, 2025, at 8:00 AM ET [2]. - Participants can join via U.S. dial-in at 1-877-407-9039 or international dial-in at 1-201-689-8470 [2]. - The live and archived webcast will be accessible on the Ocular Therapeutix website for at least 30 days [2].

Core Insights - Ocular Therapeutix, Inc. is actively participating in several scientific conferences in July and August 2025, showcasing its commitment to advancing retinal therapies [1] Conference Participation - Ocular Therapeutix will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, focusing on drug delivery, with Sanjay Nayak as the presenter [2] - At the American Society of Retinal Specialists (ASRS) 2025 Annual Scientific Meeting on July 31, 2025, Ocular will present research on diabetic retinopathy, including a study on Axitinib Hydrogel [3] - The company will also present a poster at the Women in Ophthalmology (WIO) 2025 conference on August 9-10, 2025, discussing macular fluid volume and retinal vascular leakage [4] Product Pipeline - Ocular Therapeutix is developing AXPAXLI™ (OTX-TKI), an investigational axitinib intravitreal hydrogel for retinal diseases, currently in Phase 3 trials for wet age-related macular degeneration [5] - The company’s pipeline includes DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain, and OTX-TIC, a travoprost intracameral hydrogel in Phase 2 trials for open-angle glaucoma [6][7]

Core Insights - Ocular Therapeutix has launched a new corporate branding and website, marking a significant transformation towards becoming a retina-focused company [1][8] - The new branding reflects the company's innovative vision and commitment to redefining the retina experience, particularly in the treatment of retinal diseases [3][6] Company Overview - Ocular Therapeutix, Inc. is a biopharmaceutical company dedicated to redefining the retina experience, with a focus on innovative treatments for retinal diseases [9] - The investigational therapy AXPAXLI™ (OTX-TKI) is an axitinib hydrogel designed for intravitreal injection, aimed at improving treatment durability and long-term outcomes for patients with wet age-related macular degeneration (wet AMD) [7][9] Market Context - Wet AMD affects approximately 1.8 million people in the U.S., and current treatment options often require up to 12 injections per year, leading to patient burden and potential treatment discontinuation [6] - The company aims to disrupt existing treatment paradigms for retinal diseases, addressing the high burden associated with current pulsatile treatments [6][3] Product Pipeline - Ocular's pipeline includes AXPAXLI™, currently in Phase 3 clinical trials for wet AMD, and DEXTENZA, an FDA-approved corticosteroid for ocular inflammation and pain [10] - The investigational product OTX-TIC is in Phase 2 clinical trials for open-angle glaucoma or ocular hypertension, leveraging the company's proprietary ELUTYX™ technology [10]