Cara Therapeutics(US:CARA)2024-11-14 21:10Clinical Program Updates - The company announced a decision to discontinue the clinical program in notalgia paresthetica after the KOURAGE-1 study showed no meaningful clinical benefit from oral difelikefalin compared to placebo [170]. - R&D expenses are expected to significantly decrease in the future as the company focuses on strategic alternatives following the discontinuation of its NP program [245]. - The company anticipates focusing expenses on the discontinuation of its clinical program for oral difelikefalin and exploring strategic alternatives to maximize shareholder value [294]. Financial Performance - As of September 30, 2024, the company had shareholders' equity of $0.7 million, failing to meet the Nasdaq requirement of at least $2.5 million [178]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $56.9 million, compared to $74.7 million for the same period in 2023 [317]. - The company incurred net losses of $63.2 million compared to $86.2 million for the same period in 2023, indicating a reduction in losses [293]. - Total revenue for Q3 2024 was $2.6 million, a decrease of 47% from $4.9 million in Q3 2023, and for the nine months ended September 30, 2024, it was $5.7 million, down 68% from $18.0 million in the same period of 2023 [263]. Shareholder Equity and Compliance - The company received an extension from Nasdaq until January 27, 2025, to regain compliance with the minimum closing bid price requirement of $1.00 per share [177]. - The company is assessing options to regain compliance with Nasdaq's Shareholders' Equity Requirement [178]. - The company has not yet implemented a reverse stock split, which was approved by stockholders, and the decision remains at the discretion of the Board of Directors [179]. Revenue and Sales - KORSUVA injection recorded net sales of approximately $3.0 million in the U.S. for the three months ended September 30, 2024, down from $4.4 million in the same period of 2023, resulting in a profit share of $1.3 million compared to $1.9 million [185]. - For the nine months ended September 30, 2024, KORSUVA injection net sales in the U.S. were approximately $2.1 million, significantly lower than $21.5 million for the same period in 2023, primarily due to higher rebates and chargebacks [185]. - Collaborative revenue from KORSUVA injection for the nine months ended September 30, 2024, was $2.1 million, a decrease from $10.1 million in the same period of 2023 [191]. Strategic Alternatives and Workforce Reduction - The company is exploring strategic alternatives to maximize shareholder value amid substantial uncertainties [164]. - A streamlined operating plan was approved, which includes a workforce reduction of approximately 70%, completed by June 30, 2024 [170]. - In January 2024, the company announced a workforce reduction of up to 50% to reduce operating expenses [251]. Milestone Payments and Agreements - The company is eligible for up to $440.0 million in commercial milestone payments based on sales and tiered double-digit royalty payments from CSL Vifor for KORSUVA injection [212]. - The company received a non-refundable upfront license fee of $15.0 million from Maruishi and is eligible for up to $10.5 million in clinical development and regulatory milestones [216]. - The company plans to achieve a $2.5 million milestone payment upon reaching a 2024 sales milestone for KORSUVA in Japan, expected in Q4 2024 [202]. Cost Management and Expenses - G&A expenses are anticipated to decrease due to workforce reductions, but may still include costs related to remaining personnel and strategic alternatives exploration [249]. - The decrease in R&D expenses was primarily due to the discontinuation of several oral difelikefalin programs and reductions in workforce [270]. - General and administrative expenses for Q3 2024 were $6.5 million, a decrease of 4% from $6.8 million in Q3 2023, and for the nine months ended September 30, 2024, they were $19.7 million, down 7% from $21.2 million in the same period of 2023 [272]. Cash Flow and Investments - The company expects to fund its capital requirements primarily with current unrestricted cash and cash equivalents [289]. - The company has raised an aggregate of $943.8 million to fund operations, including $447.4 million from public offerings and $258.8 million from license and supply agreements [299]. - As of September 30, 2024, the company had invested $5.0 million in marketable securities with a yield of approximately 0.90% [330]. Regulatory and Market Approvals - The IV formulation of oral difelikefalin is approved for treating moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis in the U.S., EU, and multiple other countries [171]. - Difelikefalin, the active ingredient in KORSUVA, is approved for treating moderate-to-severe pruritus associated with advanced CKD in multiple countries, including the U.S., EU, and Japan [186]. - The final CY 2024 rule from CMS established a post-TDAPA add-on payment of 65% for KORSUVA injection, effective April 1, 2024, but the unfavorable reimbursement has led to a lack of sequential revenue growth since the product's launch [185].