Ocular Therapeutix Reports $193.5 Million Net Loss for 2024, Increases DEXTENZA Sales by 9.7%

Ocular Therapeutix, Inc. reported a net loss of $193.5 million for the year ended December 31, 2024, compared to a net loss of $80.7 million in 2023. The company's accumulated deficit reached $891.1 million as of December 31, 2024. Net product revenue, primarily from DEXTENZA sales, increased by 9.7% year-over-year to $63.5 million. This increase was partially offset by a rise in gross-to-net provisions from 30.1% in 2023 to 38.5% in 2024, attributed to increased off-invoice discounts. Collaboration revenue decreased from $1.0 million in 2023 to $0.3 million in 2024.

Research and development expenses surged to $127.6 million in 2024, a $66.6 million increase compared to 2023, primarily due to the advancement of AXPAXLI clinical trials (SOL-1 and SOL-R) and the completion of the HELIOS trial. Selling and marketing expenses increased slightly to $41.6 million, while general and administrative expenses rose to $60.7 million, reflecting increases in personnel costs and professional fees. The company completed a private placement in February 2024, raising approximately $316.4 million in net proceeds, and the holders of its convertible notes converted them in March 2024, resulting in the issuance of common stock.

Significant operational developments included the completion of randomization in the SOL-1 trial for AXPAXLI in wet AMD and continued enrollment in the SOL-R trial. The company intends to meet with the FDA in the first half of 2025 to discuss a potential registrational clinical program for AXPAXLI in NPDR and DME. The company also completed a strategic restructuring in May 2024, resulting in a reduction of 37 full-time employees. DEXTENZA sales increased, but the company anticipates continued operating losses over the next several years. The company submitted data to the FDA for DEXTENZA's pediatric labeling, anticipating a decision in the second quarter of 2025.

The company's cash and cash equivalents totaled $392.1 million as of December 31, 2024, with outstanding debt of $82.5 million under the Barings Credit Facility. The company projects sufficient funding through 2028 based on current assumptions, but acknowledges that future capital requirements will depend on various factors, including clinical trial outcomes, regulatory approvals, and commercialization efforts. The company's financial statements and supplementary data are included in the filing. No unresolved staff comments or disagreements with accountants were reported.

The company's management assessed the effectiveness of its disclosure controls and procedures and internal control over financial reporting as of December 31, 2024, concluding that both were effective at the reasonable assurance level. The company's independent registered public accounting firm, PricewaterhouseCoopers LLP, audited the effectiveness of its internal control over financial reporting. The company disclosed its exposure to market risk related to interest rate changes and outlined its risk management policies. No material legal proceedings were pending as of the filing date.