Clearside Biomedical(US:CLSD)2020-05-08 20:47Financial Performance - The company has an accumulated deficit of $240.6 million as of March 31, 2020, with net losses of $2.9 million and $15.4 million for the three months ended March 31, 2020, and 2019, respectively [75]. - The company has not generated any revenue from product sales to date, relying primarily on public offerings and private placements for financing [75]. - For the three months ended March 31, 2020, the company recognized $4.1 million in revenue from license agreements, a significant increase from $45,000 in the same period in 2019 [94]. - The net loss for the three months ended March 31, 2020, was $2.9 million, a reduction of $12.5 million compared to a net loss of $15.4 million in Q1 2019 [96]. - Total operating expenses for Q1 2020 were $6.9 million, down from $15.4 million in Q1 2019, reflecting a decrease of $8.4 million [96]. - Research and development expenses decreased by $7.2 million, from $11.0 million in Q1 2019 to $3.8 million in Q1 2020, primarily due to the closure of two late-stage clinical trials [94]. - General and administrative expenses decreased by $1.3 million, from $4.4 million in Q1 2019 to $3.1 million in Q1 2020, mainly due to a shift in business strategy [98]. Product Development and Regulatory Affairs - The company expects to resubmit the New Drug Application (NDA) for XIPERE in the fourth quarter of 2020 due to delays in manufacturing activities [74]. - The company anticipates resubmitting the NDA for XIPERE in Q4 2020 due to delays caused by COVID-19 [82]. - The company is advancing its proprietary suspension of axitinib (CLS-AX) into further preclinical development, with an Investigational New Drug application expected to be submitted in mid-2020 [74]. - The company is focused on developing proprietary therapeutic formulations for use with its SCS Microinjector, targeting unmet needs in back of the eye diseases [72]. - The company is actively seeking additional license agreements to evaluate the use of its proprietary SCS Microinjector with third-party product candidates [83]. Market and Operational Context - Approximately 350,000 patients in the U.S. and over one million worldwide are affected by uveitis, with one-third developing uveitic macular edema, which XIPERE aims to treat [72]. - The company anticipates significant and increasing operating losses for the next several years, with no expected significant revenue until successful commercialization of product candidates [77]. - The impact of COVID-19 on the company's business remains uncertain, with potential disruptions to clinical trials and operations [82]. Financial Position and Capital Needs - As of March 31, 2020, the company had cash and cash equivalents of $20.9 million, down from $22.6 million as of December 31, 2019 [115]. - During the three months ended March 31, 2020, the company used net cash of $2.8 million in operating activities, a decrease from $12.7 million in the same period of 2019 [108]. - The company expects to require additional capital to fund ongoing operations and anticipates incurring additional losses until it can generate significant revenue from XIPERE [104]. - The company sold 0.5 million shares of common stock for net proceeds of $1.2 million under the at-the-market sales agreement during the three months ended March 31, 2020 [102]. - The company entered into a loan agreement with Silicon Valley Bank for $1.0 million under the Paycheck Protection Program, scheduled to mature on April 20, 2022 [99]. - The company plans to pursue a new debt facility to replace some or all of the repaid loan to meet future financial needs [99]. - The company incurred a net cash outflow of $1.1 million from a decrease in accrued liabilities during the three months ended March 31, 2020 [108]. - The company anticipates that its cash and cash equivalents will fund operations into the second quarter of 2021, based on current plans and forecasted expenses [106]. - A 100 basis point increase in the LIBOR rate would result in a $50,000 increase in annual interest expense based on the current outstanding balance under the Loan Agreement [115]. Licensing and Royalties - Bausch Health has been granted an exclusive license to develop, manufacture, and commercialize XIPERE in the United States and Canada, with an upfront payment of $5.0 million and potential milestone payments of up to $15.0 million [78]. - The Bausch License Agreement includes tiered royalties from the high-teens to twenty percent based on XIPERE achieving certain annual net sales thresholds [78].