Ocular Therapeutix(US:OCUL)2022-08-08 20:14Product Development - The company has one FDA-approved product, DEXTENZA®, which treats post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis, with a single administration effect lasting up to 30 days [99][104]. - DEXTENZA was commercially launched in the U.S. in July 2019 and has a dedicated sales force for ophthalmology and optometric offices, supporting future product candidates [104]. - The company is conducting a Phase 3 clinical trial for DEXTENZA in pediatric patients, aiming to enroll approximately 60 subjects to evaluate its safety and efficacy [106]. - The company has four core pipeline assets in clinical development, including OTX-TKI for wet AMD, OTX-TIC for glaucoma, OTX-DED for dry eye disease, and OTX-CSI for chronic dry eye disease [101]. - OTX-TKI has shown a duration of activity of six months or more in over 60% of subjects in clinical trials, indicating a promising drug profile [113]. - OTX-TIC demonstrated a clinically meaningful decrease in intraocular pressure for six months or longer, with a favorable safety profile [117]. - OTX-DED achieved its primary endpoint in a Phase 2 clinical trial, showing a statistically significant change in bulbar conjunctival hyperemia compared to vehicle hydrogel [119]. - The company plans to conduct a trial to evaluate OTX-DED against biodegradable collagen plugs to better understand placebo performance in clinical trials [120]. - The trial results for OTX-CSI did not show statistically significant improvements compared to the placebo, indicating a need for further formulation work [122]. Financial Performance - The net loss for the six months ended June 30, 2022, was $31.3 million, compared to a net loss of $5.4 million for the same period in 2021 [131]. - Total costs and operating expenses for the six months ended June 30, 2022, were $63.2 million, including $9.6 million in non-cash stock-based compensation [132]. - Product revenue for the three months ended June 30, 2022, was $12.1 million, an increase of $0.4 million from $11.7 million in the same period of 2021 [159]. - Total revenue for the three months ended June 30, 2022, was $12.3 million, compared to $11.7 million for the same period in 2021, reflecting an increase of $0.5 million [159]. - Total net revenue for the six months ended June 30, 2022, was $25.5 million, an increase of 33.5% from $19.1 million in the same period of 2021 [171]. - Product revenue from DEXTENZA accounted for $24.6 million, while collaboration revenue contributed $0.8 million during the six months ended June 30, 2022 [171]. - Gross-to-net deductions for DEXTENZA product sales were 22.5% for the six months ended June 30, 2022, down from 25.4% in 2021 [170]. - The total gross-to-net provisions for DEXTENZA product sales were 23.1% for the three months ended June 30, 2022, compared to 23.9% for the same period in 2021 [160]. - The company recognized $0.1 million in collaboration revenue for the three months ended June 30, 2022, related to a Phase 2 clinical trial, with no collaboration revenue reported in the same period of 2021 [163]. Expenses and Cash Flow - Research and development expenses decreased to $13.1 million for the three months ended June 30, 2022, from $13.9 million in the same period of 2021, a reduction of $0.8 million [164]. - Selling and marketing expenses increased to $10.1 million for the three months ended June 30, 2022, compared to $8.4 million in the same period of 2021, an increase of $1.7 million [165]. - General and administrative expenses decreased to $7.8 million for the three months ended June 30, 2022, from $8.6 million in the same period of 2021, a decrease of $0.8 million [167]. - Research and development expenses increased to $26.2 million for the six months ended June 30, 2022, compared to $24.8 million in 2021, primarily due to a $5.6 million rise in unallocated expenses [172]. - Selling and marketing expenses rose to $19.2 million for the six months ended June 30, 2022, up from $16.5 million in 2021, driven by increased personnel costs and professional fees [173]. - General and administrative expenses decreased to $15.3 million for the six months ended June 30, 2022, from $16.3 million in 2021, mainly due to lower professional fees [175]. - Cash used in operating activities was $29.5 million for the six months ended June 30, 2022, a decrease from $37.4 million in 2021 [186]. - The company expects to incur substantial sales and marketing expenses for the ongoing commercialization of DEXTENZA [132]. - The company anticipates substantial expenses related to the commercialization of DEXTENZA and ongoing clinical trials for product candidates OTX-TKI and OTX-TIC [193]. Funding and Financial Position - The existing cash and cash equivalents of $134.5 million as of June 30, 2022, are expected to fund operations through 2023 [138]. - The company has financed operations through product sales and public offerings, resulting in net proceeds of $641.4 million [134]. - The company plans to fund its cash needs through equity offerings, debt financings, and collaborations, with no committed external sources of funds currently available [201]. - As of June 30, 2022, the company had cash and cash equivalents of $134.5 million, primarily in money market funds [208]. - The company had a variable interest rate-based note payable with a principal amount of $25.0 million as of June 30, 2022, with cash outflows fluctuating based on the U.S. dollar-denominated LIBOR index [211]. - The company received an upfront payment of $12 million from AffaMed for a license agreement and is eligible for up to $91 million in milestone payments [124]. Future Outlook - The company plans to continue the commercialization of DEXTENZA and advance clinical trials for other product candidates, including OTX-TKI and OTX-TIC [178]. - The company expects to continue incurring losses as it advances clinical trials and increases sales and marketing resources for DEXTENZA, pending FDA approval [192]. - The company is focused on expanding its manufacturing processes and capabilities to support sales and clinical trials for its product candidates [197]. - The company is actively seeking to identify and develop additional product candidates and expand its intellectual property portfolio [197].