Cara Therapeutics(US:CARA)2025-03-11 20:10Financial Performance - Total revenue for the year ended December 31, 2024, was $7.137 million, a decrease of 66% compared to $20.968 million in 2023[678]. - Collaborative revenue decreased to $2.086 million in 2024 from $12.936 million in 2023, representing an 84% decline[678]. - Research and development expenses for 2024 were $32.805 million, down from $108.510 million in 2023, a reduction of 70%[678]. - The net loss for 2024 was $70.867 million, compared to a net loss of $118.513 million in 2023, indicating a 40% improvement[678]. - The company reported an operating loss of $58.383 million for 2024, compared to an operating loss of $121.495 million in 2023, reflecting a 52% improvement[678]. - Basic and diluted net loss per share for 2024 was $15.53, compared to $26.26 in 2023, showing a 41% reduction[678]. - The net loss for the year ended December 31, 2024, was $70,867,000, a decrease from the net loss of $118,513,000 in 2023 and $85,474,000 in 2022[682]. - The Company recognized net losses of $70.9 million, $118.5 million, and $85.5 million for the years ended December 31, 2024, 2023, and 2022, respectively[697]. Assets and Liabilities - Cash and cash equivalents decreased to $37.903 million as of December 31, 2024, down from $51.775 million in 2023, a decline of 27%[677]. - Total current assets dropped significantly to $43.827 million in 2024 from $116.158 million in 2023, a decrease of 62%[677]. - Total stockholders' equity turned negative at $(4.593) million in 2024, down from $57.085 million in 2023[677]. - The Company had unrestricted cash and cash equivalents of $37.9 million and an accumulated deficit of $755.6 million as of December 31, 2024[697]. - The liability related to sales of future royalties and milestones increased to $44.448 million in 2024 from $37.079 million in 2023, a rise of 20%[677]. - Accounts payable and accrued expenses totaled $3,972 as of December 31, 2024, down from $25,592 as of December 31, 2023, a decrease of approximately 84%[815]. Investments and Securities - As of December 31, 2023, the company had invested $49.0 million in available-for-sale marketable securities with a yield of approximately 4.41%[658]. - The aggregate unrealized losses on available-for-sale marketable securities were $0.3 million as of December 31, 2023[661]. - The company has no available-for-sale marketable securities as of December 31, 2024, indicating a shift in investment strategy[659]. - The Company reviews available-for-sale marketable securities for unrealized losses at each balance sheet date and whenever circumstances indicate that the amortized cost basis may not be recoverable[718]. - The assessment of unrealized losses includes qualitative factors such as credit downgrades and the intent to sell the security, which may change based on new developments[720]. - If the Company intends to sell a security or is likely to be forced to sell it, the entire unrealized loss is recognized as a credit loss in net loss[721]. - The Company had an insignificant allowance for credit losses as of December 31, 2024 and 2023, indicating low credit risk associated with its licensing partners[733]. Revenue Recognition - Revenue is recognized based on the consideration expected in exchange for the transfer of goods or services, following a five-step process[747]. - The Company recognizes revenue when it satisfies a performance obligation by transferring a promised good or service to a customer, with revenue from licenses recognized when the customer has legal title and can direct the use of the license[755]. - Collaborative revenue includes the Company's share of profits from CSL Vifor's sale of KORSUVA injection, recognized in the period the product sales are earned[759]. - Commercial supply revenue is recognized when CSL Vifor obtains control of KORSUVA injection, typically upon receipt after passing quality testing[763]. - License and milestone fees include upfront and milestone payments associated with license agreements, recognized based on relative standalone selling prices[764]. - Royalty revenue from net sales of Kapruvia in Europe will not be recognized until the Company fulfills its obligations under the HCR Agreement starting October 1, 2023[765]. Strategic Initiatives - The company is exploring strategic alternatives to maximize shareholder value if the proposed merger with Tvardi Therapeutics does not consummate[12]. - The company entered into a merger agreement with Tvardi Therapeutics, Inc. on December 17, 2024, which is subject to stockholder approval[685]. - The Company plans to sell certain assets and rights related to difelikefalin to CSL Vifor for a purchase price of $900,000, subject to adjustments[686]. - The Company is subject to risks related to the completion of the merger with Tvardi, which could materially affect its financial results and stock price[19]. Workforce and Operations - The company underwent a workforce reduction of approximately 70% in June 2024 as part of a streamlined operating plan[684]. - G&A expenses consist primarily of salaries and related costs for personnel across various functions, with ongoing costs related to remaining personnel and consultants despite workforce reductions[770][771]. - The Company recognized restructuring expenses related to the discontinuation of oral programs in atopic dermatitis and chronic kidney disease, with workforce reductions planned throughout 2024[778]. Clinical Development - Difelikefalin injection, marketed as KORSUVA, received FDA approval in August 2021 and began commercial launch in the U.S. in April 2022[687]. - Difelikefalin injection was approved in multiple countries, including the EU and the UK, with commercial launches commencing in various member states[689]. - The company discontinued the clinical program for notalgia paresthetica on June 12, 2024, after failing to demonstrate meaningful clinical benefit in trials[684]. - The Company is responsible for clinical and non-clinical development, including R&D services, at its own cost[844]. Stock and Equity - The company increased its authorized common stock from 100 million shares to 200 million shares as of June 7, 2024, which may affect earnings per share and voting rights[822]. - Cara Therapeutics approved a one-for-twelve reverse stock split, reducing authorized shares from 200 million to 16.67 million[824]. - As of December 31, 2024, there were 4,571,229 shares of common stock issued and outstanding[824]. - The Company entered into a reverse stock split of 1-for-12, effective December 31, 2024, to help regain compliance with Nasdaq listing requirements[701]. - The Company is subject to potential delisting from Nasdaq due to non-compliance with bid price requirements, having received an extension until January 27, 2025, to regain compliance[699].