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Clearside Biomedical(CLSD) - 2020 Q3 - Earnings Call Transcript
2020-11-11 04:11
Clearside Biomedical, Inc. (NASDAQ:CLSD) Q3 2020 Earnings Conference Call November 11, 2020 4:30 PM ET Company Participants Jenny Kobin - Head, Investor Relations George Lasezkay - President & Chief Executive Officer Thomas Ciulla - Chief Medical Officer & Chief Development Officer Charles Deignan - Chief Financial Officer Conference Call Participants Zegbeh Jallah - Roth Capital Partners Annabel Samimy - Stifle Jonathan Wolleben - JMP Securities Operator Ladies and gentlemen thank you standing by and welco ...
Clearside Biomedical(CLSD) - 2020 Q3 - Quarterly Report
2020-11-10 22:15
Financial Performance - The company reported a net loss of $2.4 million for the three months ended September 30, 2020, compared to a net loss of $6.5 million for the same period in 2019, indicating a reduction in losses [75]. - The net loss for the nine months ended September 30, 2020, was $11.1 million, compared to a net loss of $27.7 million in 2019, an improvement of $16.6 million [93]. - The net loss decreased to $11.1 million for the nine months ended September 30, 2020, from $27.7 million for the same period in 2019, attributed to the discontinuation of certain clinical trials [102]. Revenue Generation - The company has not generated any revenue from drug sales and primarily relies on license agreements for revenue generation [78]. - License and other revenue for the three months ended September 30, 2020, was $3.4 million, a significant increase from $141,000 in the same period of 2019, representing a change of $3.3 million [89]. - For the nine months ended September 30, 2020, license and other revenue was $7.9 million, compared to $231,000 in 2019, marking a period-to-period change of $7.7 million [93]. Research and Development - The company expects to resubmit the New Drug Application (NDA) for XIPERE no later than the first half of 2021, with the FDA expected to review it within six months of resubmission [69]. - The company is advancing its proprietary suspension of axitinib (CLS-AX) into further preclinical development, with plans to initiate a Phase 1/2a clinical trial by the end of 2020 [71]. - Research and development expenses for the three months ended September 30, 2020, increased to $3.5 million from $2.7 million in 2019, primarily due to costs related to the initiation of the CLS-AX Phase 1/2a clinical trial [89]. - Research and development expenses for the nine months ended September 30, 2020, decreased to $10.6 million from $14.4 million in 2019, a reduction of $3.8 million [93]. Operating Expenses - General and administrative expenses decreased to $2.4 million for the three months ended September 30, 2020, down from $3.8 million in 2019, reflecting a $0.8 million reduction in marketing-related expenses [89]. - General and administrative expenses for the nine months ended September 30, 2020, were $8.1 million, down from $13.2 million in 2019, a decrease of $5.1 million [93]. Cash Flow and Capital Resources - As of September 30, 2020, the company had cash and cash equivalents of $14.8 million [94]. - The company incurred a net cash outflow of $8.7 million from operating activities for the nine months ended September 30, 2020, compared to $28.8 million for the same period in 2019, primarily due to lower research and development expenses [102]. - The company expects to require additional capital to fund ongoing operations and mitigate going concern risks, with plans to raise funds through equity or debt financings [100]. - The company anticipates that its cash and cash equivalents will fund operating expenses into the third quarter of 2021, based on current plans and forecasted expenses [100]. - The company has no committed external sources of funds and may face challenges in raising additional capital due to global economic conditions and market volatility [100]. Collaborations and Agreements - The company has entered into a license agreement with Arctic Vision for the commercialization of XIPERE in China, Hong Kong, Macau, Taiwan, and South Korea [74]. - The company is collaborating with Bausch Health for the commercialization of XIPERE in the United States and Canada, with an option for Bausch to develop XIPERE in additional regions [72]. Other Financial Information - The company incurred costs related to being a public entity, including board fees, audit fees, and compliance expenses [99]. - The company does not have any off-balance sheet arrangements as defined under SEC rules [106]. - The company received $3.0 million in milestone payments under the REGENXBIO agreement in September 2020 [94]. - The company used $55,000 in investing activities for equipment purchases during the nine months ended September 30, 2020, compared to a net cash inflow of $32.9 million in 2019 from short-term investments [102]. - Financing activities provided $1.0 million in net cash during the nine months ended September 30, 2020, primarily from the sale of common stock and a PPP loan [102].
Clearside Biomedical(CLSD) - 2020 Q2 - Earnings Call Transcript
2020-08-11 01:14
Clearside Biomedical, Inc. (NASDAQ:CLSD) Q2 2020 Earnings Conference Call August 10, 2020 4:30 PM ET Company Participants Jenny Kobin - Head, Investor Relations George Lasezkay - President & Chief Executive Officer Thomas Ciulla - Chief Medical Officer & Chief Development Officer Charles Deignan - Chief Financial Officer Conference Call Participants Boris Peaker - Cowen Jonathan Wolleben - JMP Securities Zegbeh Jallah - Roth Capital Partners Operator Good afternoon ladies and gentlemen and welcome to the Cl ...
Clearside Biomedical(CLSD) - 2020 Q2 - Quarterly Report
2020-08-10 20:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------|---------- ...
Clearside Biomedical(CLSD) - 2020 Q1 - Quarterly Report
2020-05-08 20:47
Financial 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].
Clearside Biomedical(CLSD) - 2019 Q4 - Annual Report
2020-03-13 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fi ...
Clearside Biomedical(CLSD) - 2019 Q4 - Earnings Call Transcript
2020-03-12 01:08
Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2019 Earnings Conference Call March 11, 2020 4:30 PM ET Company Participants Jenny Kobin - Head, Investor Relations George Lasezkay - President & Chief Executive Officer Thomas Ciulla - Chief Medical Officer Charles Deignan - Chief Financial Officer Conference Call Participants Liana Moussatos - Wedbush Securities Annabel Samimy - Stifel Esther Hong - Janney Montgomery Scott Boris Peaker - Cowen Serge Belanger - Needham and Company Operator Ladies and gentlemen, t ...
Clearside Biomedical(CLSD) - 2019 Q3 - Quarterly Report
2019-11-08 21:16
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | |------------------------------------------------------------------------------------------------------------------------------------|----- ...
Clearside Biomedical(CLSD) - 2019 Q2 - Quarterly Report
2019-08-08 20:16
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 | --- | --- | |---------------------------------------------------------------------------------|-------------------------------| | Clearsid ...
Clearside Biomedical(CLSD) - 2019 Q1 - Quarterly Report
2019-05-10 20:16
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-2437375 (State or other jurisdiction of incor ...