Ocular Therapeutix(OCUL) - 2022 Q4 - Earnings Call Transcript

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