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Mar 31, 2021
Tvardi Therapeutics Q1 2021 Earnings Report
Reported financial results and operational highlights for the first quarter ended March 31, 2021.
Key Takeaways
Cara Therapeutics reported a net loss of $23.3 million, or $0.47 per share, for the first quarter of 2021. Total revenue was $1.9 million, primarily consisting of license and milestone fees. Cash, cash equivalents, and marketable securities totaled $228.3 million as of March 31, 2021.
FDA accepted the NDA filing for KORSUVA Injection for hemodialysis patients with Priority Review, with an expected PDUFA target action date of August 23, 2021.
Potential U.S. commercial launch of KORSUVA Injection could take place in the second half of 2021, if approved.
EMA accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients.
Company plans to initiate Phase 3 programs for Oral KORSUVA in pre-dialysis CKD patients and atopic dermatitis patients by year-end 2021.
Forward Guidance
Cara expects that its existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of March 31, 2021 will be sufficient to fund its currently anticipated operating expenses and capital expenditures into 2023, without giving effect to any potential milestone payments or potential product revenue under existing collaborations.
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