Ocular Therapeutix(US:OCUL)2022-11-08 01:45Financial Data and Key Metrics Changes - Net revenue for Q3 2022 was $12 million, representing a 2% decrease compared to the same period in 2021 [51] - DEXTENZA net product revenue was $11.9 million, flat year-over-year and down approximately 2% sequentially [52] - The company recorded a net loss of $24.2 million or a loss of $0.31 per share, compared to a net income of $2.6 million or $0.03 per share in the same period in 2021 [54] Business Line Data and Key Metrics Changes - DEXTENZA sales were essentially flat year-over-year, which was considered disappointing by management [17] - Research and development expenses increased to $13.7 million from $12.7 million in the comparable period of 2021, driven by higher personnel and preclinical development activity [53] - Selling and marketing expenses rose to $10.2 million from $9.6 million in the same period of 2021, reflecting an increase in field force personnel [53] Market Data and Key Metrics Changes - The company noted that ambulatory surgical centers (ASCs) and hospital outpatient departments (HOPDs) are facing staffing shortages, impacting DEXTENZA's performance [18][20] - Changes in the reimbursement landscape for the procedure code CPT 68841 have also affected volume due to reduced physician payment [21] Company Strategy and Development Direction - The company aims to establish itself as a leader in ophthalmology, focusing on both front and back of the eye treatments [10] - Plans to initiate a Phase 2/3 trial for OTX-TKI in wet AMD in Q3 2023 and a Phase 1 trial for diabetic retinopathy in Q1 2023 [16][49] - The company is working on improving the value proposition for DEXTENZA and addressing reimbursement issues to reignite growth [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for OTX-TKI to become a differentiated product in the treatment of wet AMD and diabetic retinopathy [32] - The company adjusted its full-year net revenue guidance to between $48 million and $52 million, reflecting a growth of 10% to 20% over the prior year [26] - Management highlighted a strong start to Q4 2022, with record monthly sales for DEXTENZA in October [25][59] Other Important Information - The company had $121 million in cash and cash equivalents as of September 30, 2022, sufficient to fund operations through 2023 [56] - Non-cash charges through stock-based compensation and depreciation were $4.7 million in Q3 2022, compared to $4.4 million in the same quarter of 2021 [54] Q&A Session Summary Question: Why is the diabetic retinopathy study moving forward under an exploratory IND? - Management explained that using an exploratory IND allows for a sufficient number of patients while moving forward with the current formulation [63] Question: What is the priority for DEXTENZA in office or ambulatory surgical centers? - The focus is on reigniting growth in the surgical setting, which is the company's primary business area [69] Question: Can you elaborate on the cause of staffing shortages? - Staffing shortages are attributed to post-pandemic issues affecting various industries, including ASCs and hospitals [78] Question: What kind of sales boost for DEXTENZA is expected in 2023? - Management expects to capture some volume from DEXYCU as it loses its pass-through status, but specific guidance will be provided later [81] Question: Can you comment on the diabetic retinopathy patient journey? - Management noted that many patients with diabetic retinopathy do not realize they have the condition until vision changes occur, making treatment challenging [86] Question: What is the timeline for seeing results from the Phase 2/3 trial? - Management indicated that they expect to collapse the Phase 2 and Phase 3 trials, aiming for efficient data collection and NDA filing [95]