Cara Therapeutics(US:CARA)2020-02-28 01:56Financial Data and Key Metrics Changes - For the year ended December 31, 2019, the company reported a net loss of $106.4 million or $2.49 per share, compared to a net loss of $74 million or $2.06 per share for 2018 [35] - For Q4 2019, the net loss was $28.6 million or $0.61 per share, compared to a net loss of $20.7 million or $0.52 per share for the same quarter in 2018 [36] - Revenues for the year were $19.9 million, up from $13.5 million in 2018, primarily related to a license agreement with Vifor Fresenius [36][37] - Cash, cash equivalents, and marketable securities totaled $218.2 million as of December 31, 2019, compared to $182.8 million at the end of 2018 [42] Business Line Data and Key Metrics Changes - The company advanced the late-stage clinical development of KORSUVA, with positive topline results from the KALM-1 Phase 3 trial in hemodialysis patients [7][8] - The oral KORSUVA program expanded into two new pruritic indications: atopic dermatitis and chronic liver disease associated pruritus, with Phase 2 trials initiated in 2019 [9][10] - The KALM-2 trial was fully enrolled to a target of 430 patients, a 20% increase from the original target, with topline data expected in Q2 2020 [18] Market Data and Key Metrics Changes - There are over 500,000 dialysis patients in the U.S., with 60% reporting some level of pruritus, indicating a significant unmet need in this market [20] - The company has established commercial license agreements in major markets including Japan, South Korea, and the European Union, enhancing its market reach [21] Company Strategy and Development Direction - The company plans to commercialize KORSUVA injection in the U.S. and has established a co-promotion and profit-sharing agreement with Vifor Fresenius [21][22] - The strategy includes advancing KORSUVA to an NDA filing in the second half of 2020, pending positive KALM-2 results, while also initiating pre-commercial activities [22][33] - The company aims to leverage its clinical data to support a broader label for KORSUVA across various pruritic conditions [70] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about multiple major clinical data readouts and regulatory advancements expected in 2020 [11] - The company anticipates that its current cash position will fund operations into the second half of 2021, allowing for continued clinical development [43] - Management acknowledged the challenges of placebo responses in clinical trials and outlined strategies to mitigate these in future studies [54][90] Other Important Information - The company reported a significant increase in R&D expenses, totaling $113.8 million for the year, primarily due to clinical trial costs and stock compensation [38] - General and administrative expenses were $17.7 million for the year, reflecting increases in various operational costs [40] Q&A Session Summary Question: What alignment does the company hope to achieve with the FDA regarding the CKD oral program? - The company aims to propose a 3-point responder analysis as the primary endpoint for the CKD oral study, based on previous consultations with the FDA [50][51] Question: How does the company plan to control the placebo response in future trials? - The company plans to use de novo sites without prior experience with the drug and may incorporate a longer run-in period to identify consistent patient responses [58][59] Question: What is the rationale for increasing the sample size in the atopic dermatitis trial? - The increase was based on maintaining high statistical power to detect a treatment effect, informed by historical placebo rates and treatment effects observed in previous trials [61][76] Question: How will the company approach commercialization for atopic dermatitis and liver disease? - The company is capable of running late-stage trials independently but may consider partnerships for commercialization in these areas [68][70] Question: What are the expected milestones from the collaboration with Vifor Fresenius? - The company anticipates $30 million in regulatory milestones and $430 million in commercial milestones, with further guidance to be provided as timelines for launch and approval become clearer [101]