Group 1 - Ocular Therapeutix reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.24, representing an earnings surprise of -20.83% [1] - The company posted revenues of $17.08 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 2.40%, and showing an increase from $14.8 million in the same quarter last year [2] - Ocular Therapeutix shares have declined approximately 16.4% since the beginning of the year, contrasting with the S&P 500's gain of 1.2% [3] Group 2 - The earnings outlook for Ocular Therapeutix is mixed, with the current consensus EPS estimate for the upcoming quarter at -$0.27 on revenues of $16.79 million, and -$1.05 on revenues of $70.1 million for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Drugs sector is currently in the bottom 48% of over 250 Zacks industries, suggesting potential underperformance compared to the top 50% of ranked industries [8]

Clinical Trials and Product Development - AXPAXLI is currently in two Phase 3 clinical trials for wet AMD, with over 300 subjects randomized in the SOL-1 trial and 311 subjects enrolled in the SOL-R trial as of January 10, 2025[680][683]. - The SOL-1 trial's topline results are now expected in Q1 2026, with a potential for a 6-12 month dosing label for AXPAXLI[684]. - The company plans to meet with the FDA in the first half of 2025 to discuss a potential registrational clinical program for AXPAXLI targeting NPDR and DME[686]. - The company anticipates significant increases in direct research and development expenses for 2025 as it progresses with ongoing clinical trials[719]. - The company expects to continue incurring losses as it advances clinical trials for product candidates, including AXPAXLI, and increases sales and marketing resources for DEXTENZA[739]. - The company anticipates substantial expenses related to ongoing clinical trials, scaling up manufacturing processes, and expanding sales and marketing capabilities[740]. Financial Performance - Net product revenue for DEXTENZA was $63.5 million for the year ended December 31, 2024, reflecting a 9.7% increase from $57.9 million in 2023[687]. - Total revenue for 2024 was $63.7 million, reflecting a year-over-year increase of $5.3 million (9.0%) from $58.4 million in 2023[711]. - Product revenue, net for the year ended December 31, 2024 was $63.5 million, an increase of $5.6 million (9.7%) from $57.9 million in 2023, all attributable to DEXTENZA sales[711]. - Collaboration revenue decreased to $0.3 million in 2024 from $0.6 million in 2023, reflecting a decline in performance obligations under the license agreement with AffaMed[714]. - The company incurred net losses of $193.5 million, $80.7 million, and $71.0 million for the years ended December 31, 2024, 2023, and 2022, respectively[738]. Expenses and Cost Management - Research and development expenses increased significantly to $127.6 million in 2024, up $66.6 million (109.1%) from $61.1 million in 2023[716]. - Selling and marketing expenses rose to $41.6 million in 2024, an increase of $1.0 million (2.6%) compared to $40.5 million in 2023[720]. - General and administrative expenses increased to $60.7 million in 2024, reflecting a rise of $26.7 million (78.6%) from $33.9 million in 2023[722]. - Interest expense increased to $13.6 million in 2024, up $2.2 million (19.5%) from $11.3 million in 2023, driven by higher debt balances[727]. Cash Flow and Financing Activities - The company raised approximately $316.4 million in a private placement by selling 32,413,560 shares at $7.52 per share in February 2024[692]. - Net cash provided by financing activities was $332.1 million for the year ended December 31, 2024, compared to $169.8 million for 2023[750]. - Net cash provided by financing activities for the year ended December 31, 2024, was $332.1 million, an increase from $169.8 million in 2023, representing a growth of 95.5%[756][757]. - The financing activities in 2024 included proceeds from the issuance of common stock and pre-funded warrants of approximately $316.4 million, and proceeds from the exercise of stock options of $14.7 million[756]. - As of December 31, 2024, the company had cash and cash equivalents of $392.1 million and outstanding notes payable of $82.5 million under the Barings Credit Facility[732]. Market Position and Growth Potential - DEXTENZA is currently used in less than 5% of cataract procedures, indicating significant growth potential in sales to ASCs[689]. - The Medicare Statute allows for continued separate payment of DEXTENZA in the ASC setting for 2025, which may enhance its market position[688]. - The gross-to-net provisions for DEXTENZA product sales were 38.5% in 2024, up from 30.1% in 2023, indicating a shift in pricing strategy[712]. Debt and Obligations - The company has a total borrowing capacity of $82.5 million under the Barings Credit Facility, which has been fully drawn down[749]. - Total contractual obligations and commitments as of December 31, 2024, amounted to $91.2 million, with $2.7 million due within one year and $83.2 million due in 3 to 5 years[760]. - Operating lease commitments total $8.7 million, with $2.7 million due within one year and $5.3 million due in 1 to 3 years[759]. Financial Instruments and Risk Management - The company does not enter into financial instruments for trading or speculative purposes[787]. - An immediate 100 basis point change in U.S. interest rates would not materially affect the fair market value of the company's investment portfolio due to its short-term duration and low risk profile[786]. - A 10% increase or decrease in the interest rate used in the valuation model of the Royalty Fee Derivative Liability would not have a material effect on its fair value[790]. - Expected cash outflows from the secured term loan facility fluctuate based on changes in the Secured Overnight Financing Rate (SOFR)[788]. - An immediate 100 basis point increase or decrease in SOFR would not have a material effect on anticipated cash outflows from the secured term loan facility[789].

Exhibit 99.1 Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2024 Results and Business Highlights Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability Additional updates provided on SOL-R non-inferiority margin and rescue criteria Cash balance of $392.1M as of December 31, 2024, expected to fund operations into 2028 and the Company currently does not intend ...

Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability FDA approves Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76 SOL-1 trial Week 36 primary endpoint data now expected in 1Q 2026 due to requirement for masking until Week 52 to allow for re-dosing Inclusion of re-dosing in SOL-1, along with exceptional retention se ...

BEDFORD, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that the Company will participate in two investor conferences in March: TD Cowen 45th Annual Health Care Conference Presentation DetailsFireside Chat Date: Tuesday, March 4, 2025Fireside Chat Time: 11:50 AM ETPresenter: Pravin U. Dugel, MD, Executive Chairman, President and CEOLocation: Boston, MA Leerink Partners Glob ...

BEDFORD, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Monday, March 3, 2025, at 8:00 AM ET to discuss recent business progress and financial results for the fourth quarter and full year ended December 31, 2024. Conference Call and Webcast Information: Date: Monday, March 3, 2025, at 8:00 AM ET Participant Dial-In (U.S ...

BEDFORD, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today announced upcoming presentations at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025. Presentation Details: OTX-TKI From Phase 1 to Phase 3: SOL-1 and SOL-R Trials for Neovascular AMDSession: V: Imaging and Emerging Therapies for Exudative AMDPresentation Time: 2:30 PM ETPresenter: Carl J. D ...

311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmace ...

Company presentation scheduled on Monday, January 13th at 5:15 PM PT Ocular to provide enrollment update for SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, future opportunities for AXPAXLI, and a general corporate overview BEDFORD, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for re ...

I have been covering Ocular Therapeutix (NASDAQ: OCUL ) for a while now, and I have not been bullish. However, the stock has not done poorly, and their programs have progressed well. Since my last coverage inAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investors requiring h ...