Nuwellis(US:NUWE)2022-11-08 16:52Financial Data and Key Metrics Changes - Revenue for Q3 2022 was $2.1 million, representing an 11% year-over-year growth but a 7% decline compared to Q2 2022. Compared to Q3 2019, revenue grew by 65% [12][39] - Gross margin increased to 61% for Q3 2022, up from 60.4% in the prior year [40] - Net loss for Q3 2022 was $3.9 million or $0.37 per share, compared to a net loss of $5.3 million or $0.75 per share in Q3 2021 [46] Business Line Data and Key Metrics Changes - Pediatric customer segment revenue grew 106% year-over-year, while critical care segment declined by 9% and heart failure segment remained flat [39][15] - Revenue mix for Q3 2022 was 42% from critical care, 37% from pediatric, and 21% from heart failure [14] Market Data and Key Metrics Changes - The company added three new accounts and reactivated five accounts in Q3 2022, selling a total of 17 consoles compared to 14 in the prior year [16] - The pediatric segment's growth reflects the company's strategic focus on this patient population, indicating a successful market penetration [13] Company Strategy and Development Direction - The company aims to make the Aquadex system the standard of care for fluid management, focusing on clinical education and a targeted sales strategy [9][36] - Key strategic initiatives include targeting outpatient clinics, expanding clinical evidence, and developing new products, particularly a pediatric continuous renal replacement therapy device [22][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the company, emphasizing the importance of clinical evidence in driving product acceptance and utilization [38][63] - The company is committed to investing in strategic initiatives while maintaining cost vigilance, with a focus on expanding its clinical education team and product pipeline [45][47] Other Important Information - The company ended Q3 2022 with $12.1 million in cash and cash equivalents, and after a public offering, the pro forma cash balance was approximately $22 million [46] - The company is on track to submit an IDE for the pediatric device by early 2024, indicating ongoing product development efforts [34] Q&A Session Summary Question: Can you discuss the placements and consoles? - Growth in console placements is driven by opening new accounts and expanding utilization in existing accounts, with customers upgrading to the smart flow system [55] Question: Can you talk about FTEs and new hires? - The company has fully staffed territories except for one account manager position, with all clinical education specialists in place [57] Question: Update on the HF trial and enrollment? - Currently, five sites are enrolling patients, with adjustments being made to the protocol to ensure proper patient enrollment [58] Question: Utilization of Aquadex in heart failure and cabbage patients? - Most utilization occurs post-procedure, with some accounts starting to use Aquadex pre-transplant [59] Question: Why is acceptance of ultrafiltration products taking time? - The main reason has been the lack of direct clinical evidence supporting the reduction in readmissions, but new data is expected to drive increased sales [62][63]