Cara Therapeutics(US:CARA)2024-08-14 20:10Clinical 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[131]. - The decision to discontinue the clinical program for oral difelikefalin in neuropathic pruritus was made on June 12, 2024, due to lack of meaningful clinical benefit[156]. - R&D expenses are expected to significantly decrease in the future as the company focuses on strategic alternatives after discontinuing the NP program[194]. Financial Performance - For the three months ended June 30, 2024, CSL Vifor recorded net sales of KORSUVA injection in the United States of approximately negative $2.7 million, compared to $11.4 million for the same period in 2023, representing a significant decline[144][153]. - For the six months ended June 30, 2024, CSL Vifor recorded net sales of KORSUVA injection of approximately negative $0.9 million, down from $17.1 million in the same period of 2023[144][153]. - Total revenue for the three months ended June 30, 2024 was $991,000, an 86% decrease from $6.9 million in 2023; for the six months, total revenue was $3.1 million, down 76% from $13.1 million[211]. - The company reported net losses of $20.0 million and $31.5 million for the three months ended June 30, 2024 and 2023, respectively, and $50.7 million and $58.1 million for the six months ended June 30, 2024[233]. Revenue Sources and Changes - Collaborative revenue from KORSUVA injection was $0.8 million for the six months ended June 30, 2024, a decrease of 90.2% compared to $8.2 million for the same period in 2023[150]. - Royalty revenue from Kapruvia was approximately $123,000 and $248,000 for the three and six months ended June 30, 2023, respectively, with no royalty revenue recorded for the same periods in 2024 due to the HCR Agreement[151][152]. - The anticipated unfavorable CMS reimbursement has resulted in a lack of sequential revenue growth for KORSUVA injection since its launch[187]. Strategic Decisions and Workforce Changes - A streamlined operating plan was approved, which includes a reduction in workforce by approximately 70%, completed by June 30, 2024[131]. - The company announced a workforce reduction of up to 50% in January 2024, followed by an additional reduction of approximately 70% by June 30, 2024[200]. - The company is exploring strategic alternatives to maximize shareholder value, with substantial uncertainties regarding the identification and implementation of these alternatives[127]. Regulatory and Compliance Updates - The company has received an extension from Nasdaq until January 27, 2025, to regain compliance with the minimum closing bid price requirement[137]. - The Centers for Medicare & Medicaid Services (CMS) granted a post-TDAPA add-on payment set at 65% of total trailing 12-month expenditure levels for KORSUVA injection, effective April 1, 2024[143]. Agreements and Milestones - The HCR Agreement includes an initial payment of $17.5 million and an additional $20.0 million upon achieving a milestone event for pricing in Germany[158]. - The company has out-licensed KORSUVA injection commercialization in Japan to Maruishi, which received manufacturing and marketing approval in September 2023[147]. - The company is eligible for up to $440.0 million in commercial milestone payments from CSL Vifor, all of which are sales-related[165]. Cash Flow and Investments - Net cash used in operating activities for the six months ended June 30, 2024, was $50.7 million, with a net loss contributing significantly to this figure[253]. - Net cash provided by investing activities was $41.2 million for the six months ended June 30, 2024, primarily from maturities of marketable securities[256]. - The company expects its current cash and cash equivalents will be sufficient to fund operations for at least the next 12 months, despite uncertainties[252]. Cost Management and Expenses - General and administrative expenses for the three months ended June 30, 2024 were $6.4 million, a 15% decrease from $7.5 million in 2023; for the six months, G&A expenses were $13.2 million, down 8% from $14.4 million[218]. - Restructuring expenses for the three months ended June 30, 2024 were $2.6 million, related to the discontinuation of the oral program and associated workforce reduction[221]. - Stock-based compensation expense decreased significantly, with an 83% reduction for the three months ended June 30, 2024 compared to 2023[214].