Cara Therapeutics, Inc. (NASDAQ:CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2021.
"Cara Therapeutics made excellent progress in 2021 executing on our strategic priorities, underscored by our first FDA approval -- KORSUVA™ (difelikefalin) injection, the first and only therapy approved for the treatment of pruritus associated with chronic kidney disease in adults undergoing hemodialysis," said Christopher Posner, president and CEO of Cara Therapeutics. "We have been collaborating with our partner Vifor Pharma to optimize the U.S. commercial launch, which is on track for April 2022. To that end, Vifor has been conducting an extensive array of pre-launch activities and we have a clear path to reimbursement.
"With the planned imminent U.S. launch of KORSUVA injection, an Oral KORSUVA (difelikefalin) pipeline with significant market opportunity and a firm financial foundation, we believe we are poised to make substantial progress in 2022 that will position us for long-term growth," Posner continued.
Fourth Quarter and Full Year 2021 Financial Results
Cash, cash equivalents and marketable securities at December 31, 2021 totaled $236.8 million compared to $251.5 million at December 31, 2020.
Total revenue was $0.8 million for the three months ended December 31, 2021, compared to $112.1 million during the same period of 2020. For the full year ended December 31, 2021, total revenue was $23.0 million, compared to $135.1 million for the full year ended December 31, 2020.
Research and Development (R&D) Expenses were $22.8 million for the three months ended December 31, 2021 compared to $27.1 million in the same period of 2020. R&D Expenses were $82.7 million for the full year ended December 31, 2021 compared to $107.9 million for the full year ended December 31, 2020.
General and Administrative (G&A) Expenses were $11.5 million for the three months ended December 31, 2021 compared to $6.7 million in the same period of 2020. G&A Expenses were $29.4 million for the full year ended December 31, 2021 compared to $21.8 million for the full year ended December 31, 2020.
For the fourth quarter of 2021, net loss was $33.4 million, or $(0.63) per basic and diluted share, compared to net income of $78.9 million, or $1.60 per basic and $1.59 per diluted share, for the same period in 2020. For the full year ended December 31, 2021, net loss was $88.4 million, or $(1.74) per basic and diluted share, compared to net income of $8.4 million, or $0.18 per basic and diluted share for the full year ended December 31, 2020.
Financial Guidance
Based on timing expectations and projected costs for current clinical development plans, Cara expects that its existing unrestricted cash and cash equivalents and available-for-sale marketable securities as of December 31, 2021 will be sufficient to fund its currently anticipated operating expenses and capital requirements through 2023, without giving effect to any potential milestone payments under existing collaborations or product revenue from the commercialization of KORSUVA injection.
Image By Ilona Szentivanyi.