Financial Performance - Nuwellis, Inc. reported a quarterly loss of $0.65 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.43, representing an earnings surprise of -51.16% [1] - The company's revenues for the quarter ended December 2024 were $2.32 million, missing the Zacks Consensus Estimate by 7.12%, and down from $2.55 million in the same quarter last year [2] - The current consensus EPS estimate for the upcoming quarter is -$0.30 on revenues of $2.65 million, and for the current fiscal year, it is -$0.89 on revenues of $12.13 million [7] Stock Performance - Nuwellis shares have increased approximately 13.5% since the beginning of the year, contrasting with a decline of -4.5% in the S&P 500 [3] - The company currently holds a Zacks Rank 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] Industry Outlook - The Medical - Instruments industry, to which Nuwellis belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Nuwellis' stock performance [5]

Nuwellis (NUWE) Q4 2024 Earnings Call March 11, 2025 09:00 AM ET Company Participants Vivian Cervantes - Managing DirectorJohn Erb - Chairman, Interim President & CEORob Scott - CFOAnthony Vendetti - Executive Managing Director Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good morning, and welcome to the Nuelles Earnings Conference Call for the Fourth Quarter and Full Year Ended 12/31/2024. All participants will be in a listen only mode. After today's p ...

Financial Performance - Fourth quarter 2024 revenue was $2.3 million, a 9% decrease compared to the prior year quarter[5] - Net loss attributable to common shareholders for Q4 2024 was $1.5 million, significantly improved from a net loss of $7.9 million in the prior year quarter[11] - Net loss for 2024 was $11,165 million, a decrease from $20,209 million in 2023, indicating improved financial performance[23] - Net cash used in operating activities decreased to $9,591 million in 2024 from $17,937 million in 2023, reflecting better cash flow management[23] Cost Management - The company achieved a full year operating cost reduction of $5.9 million, or 26%, compared to the previous year[7] - Total operating expenses for Q4 2024 were $3.7 million, a 25% decrease compared to $5.0 million in the prior year quarter[9] - Research and development expenses decreased to $831 thousand in Q4 2024, down from $1.4 million in the prior year quarter[9] Cash Position - The company had cash and cash equivalents of approximately $5.1 million as of December 31, 2024[12] - Cash and cash equivalents at the end of the period increased to $5,095 million from $3,800 million, showing a positive cash position[23] - Net cash provided by financing activities rose significantly to $10,962 million in 2024 compared to $3,683 million in 2023, highlighting strong capital raising efforts[23] - Proceeds from April 2024 common stock offerings amounted to $2,403 million, up from $2,109 million in the previous year, indicating robust investor interest[23] Inventory and Liabilities - Inventory net decreased to $279 million in 2024 from $697 million in 2023, reflecting improved inventory management[23] - Accounts payable and accrued expenses improved to $(626) million in 2024 from $(1,500) million in 2023, indicating better payment practices[23] Other Financial Metrics - Gross margin improved to 58.4% in Q4 2024, up from 54.4% in the prior year quarter[6] - The company reported a significant one-time gain of $900,000 from the termination of the SeaStar Medical distribution agreement[11] - The company recorded a change in fair value of warrant liability of $(4,615) million in 2024, compared to $(758) million in 2023, suggesting increased volatility in warrant valuations[23] - Depreciation and amortization expenses decreased to $310 million in 2024 from $362 million in 2023, indicating potential asset efficiency improvements[23] Revenue Growth - Consumables utilization grew by 21% year-over-year, while revenue in the Critical Care customer category increased by 35%[4] - A four-fold payment increase to $1,639 for Aquadex Ultrafiltration Therapy in the outpatient setting is effective January 1, 2025[7]

Nuwellis (NUWE) Q4 2024 Earnings Call March 11, 2025 09:00 AM ET Company Participants Vivian Cervantes - Managing DirectorJohn Erb - Chairman, Interim President & CEORob Scott - CFOAnthony Vendetti - Executive Managing Director Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Good morning, and welcome to the Nuelles Earnings Conference Call for the Fourth Quarter and Full Year Ended 12/31/2024. All participants will be in a listen only mode. After today's p ...

Core Insights - Nuwellis, Inc. reported a 9% decrease in revenue for Q4 2024, totaling $2.3 million, primarily due to a decline in US console and international sales, despite a 21% increase in consumables utilization [4][10] - The company achieved a 35% revenue growth in its Critical Care customer category, indicating strong demand for its Aquadex system [3][10] - A significant improvement in gross margin to 58.4% was noted, up from 54.4% in the prior year, driven by higher manufacturing volumes and lower fixed overhead costs [5][10] Financial Performance - Total operating expenses for Q4 2024 decreased by 25% to $3.7 million, down from $5.0 million in the prior year, reflecting cost-saving initiatives [7][10] - The operating loss for Q4 2024 was reduced to $2.4 million from $3.6 million in the previous year [8] - The net loss attributable to common shareholders improved significantly to $1.5 million, or $0.44 per share, compared to a net loss of $7.9 million, or $54.48 per share, in the prior year [9][10] Strategic Developments - The company anticipates growth in 2025, supported by increased awareness of clinical evidence for the Aquadex system and favorable changes in CMS reimbursement policies [3][10] - A four-fold increase in CMS payment for Aquadex Ultrafiltration Therapy to $1,639 in the outpatient setting is expected to create new expansion opportunities [10] - The company reported a full-year operating cost reduction of $5.9 million, or 26%, compared to the previous year [10] Balance Sheet Highlights - As of December 31, 2024, Nuwellis had cash and cash equivalents of approximately $5.1 million and no debt [11] - Total assets increased slightly to $9.864 million from $9.770 million in the prior year [18][19] - Current liabilities decreased to $2.559 million from $3.172 million, indicating improved financial health [18][19]

Company Leadership Change - Nestor Jaramillo, Jr. has retired as President and CEO of Nuwellis, effective February 18, 2025, with John Erb appointed as Interim President and CEO [1][2] - John Erb has been with Nuwellis since September 2012, serving as a director and chairman of the board, and previously held the role of president and CEO from November 2015 to January 2021 [2] Company Overview - Nuwellis, Inc. is a commercial-stage medical device company focused on addressing fluid overload in patients through innovative solutions [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - The Aquadex SmartFlow system is designed for ultrafiltration therapy, effectively removing excess fluid from patients suffering from hypervolemia [4] - The system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4]

Core Insights - Nuwellis, Inc. has highlighted promising findings from the updated analysis of the AVOID-HF study, indicating that Aquadex® SmartFlow ultrafiltration therapy led to a 60% reduction in heart failure events compared to standard diuretic therapy [1][2][3] Group 1: Study Findings - The updated AVOID-HF study included a broader dataset, allowing for a more comprehensive analysis of patient outcomes, which suggests potential improvements in patient management strategies [2][4] - The reanalysis demonstrated significant clinical advantages of ultrafiltration therapy, supporting its broader clinical adoption [4] Group 2: Expert Commentary - Dr. Sean P. Pinney emphasized the compelling evidence supporting ultrafiltration over conventional diuretics, highlighting the need for further investigation to validate the therapy's benefits [3] - Megan Cotts, Vice President of Clinical Research and Reimbursement at Nuwellis, noted that the updated results contribute valuable insights into the Aquadex SmartFlow system's role in heart failure therapy [3] Group 3: Future Research and Development - Nuwellis plans to continue research efforts under the current REVERSE-HF trial to further establish the clinical and economic benefits of ultrafiltration therapy compared to conventional IV diuretics [3][5] - The complete analysis of the AVOID-HF study will be published in the February 2025 issue of JACC: Heart Failure, reinforcing the company's commitment to advancing patient care [3][4]

Company Overview - Nuwellis, Inc. is a commercial-stage medical technology company focused on transforming the lives of patients suffering from fluid overload through innovation and collaboration [3] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland [3] Product Information - Nuwellis is focused on commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy to remove excess fluid from patients with hypervolemia [3][4] - The Aquadex SmartFlow system is indicated for temporary use (up to 8 hours) or extended use (longer than 8 hours) in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [4] Financial Results Announcement - Nuwellis will release its financial results for the fourth quarter and full year 2024 on March 11, 2025 [1] - A conference call and webcast will be held at 9:00 AM ET to discuss the financial results and provide a general business update [1]

Core Insights - Nuwellis, Inc. has announced a new partnership with a nationally ranked pediatric hospital in Utah, marking its 44th pediatric account, to utilize the Aquadex SmartFlow system for treating fluid overload in children [1][2][3] - The Aquadex SmartFlow system is designed to provide advanced therapy for fluid management, particularly beneficial for pediatric patients suffering from severe kidney and heart conditions [2][3] - Since receiving FDA clearance in 2020, Nuwellis has significantly expanded its accounts from 13 to 44, demonstrating strong growth in its pediatric business [1][3] Company Overview - Nuwellis, Inc. is a medical technology company focused on transforming the lives of patients suffering from fluid overload through innovative solutions like the Aquadex SmartFlow system [5] - The company is headquartered in Minneapolis and has a wholly owned subsidiary in Ireland, emphasizing its commitment to expanding access to its therapies for both pediatric and adult patients [5][4] Product Details - The Aquadex SmartFlow system is an ultrafiltration therapy device that safely and predictably removes excess fluid from patients, helping them regain fluid balance in critical care situations [3][6] - It is indicated for temporary or extended use in patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics [6]

Core Points - Nuwellis, Inc. has regained compliance with Nasdaq's minimum bid price and stockholders' equity requirements, allowing its common stock to continue trading on the Nasdaq Capital Market under the symbol "NUWE" [1][2][3] - The company improved its balance sheet by raising $5.1 million in gross proceeds from warrant exercises and a warrant inducement transaction, and it now exceeds the equity requirement of at least $2.5 million [2][3] - A reverse stock split of 1:35 was implemented on June 26, 2024, as part of the company's compliance efforts [3] Company Overview - Nuwellis, Inc. is a medical device company focused on transforming the lives of patients suffering from fluid overload through innovative therapies [4] - The company is commercializing the Aquadex SmartFlow® system, which is designed for ultrafiltration therapy in patients with hypervolemia [5] - The Aquadex SmartFlow system is indicated for temporary or extended use in adult and pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management [5]