Nuwellis, Inc. Announces Third Quarter 2024 Financial Results and Recent Highlights
Nuwellis (NUWE) reported Q3 2024 financial results with revenue of $2.4 million, showing a 2% decrease from the prior year. Notable highlights include a 297% CMS reimbursement increase to $1,639 for Aquadex facility fee effective January 2025, 28% growth in pediatrics revenue, and improved gross margin of 70% compared to 57.3% last year. The company achieved a 30% reduction in operating costs and reported net income of $2.4 million. A new study showed significant reduction in Heart Failure readmissions using Aquadex. The company added three new pediatric and two new adult accounts, while receiving $5.1 million through warrant exercises.
Nuwellis (NUWE) ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato di $2,4 milioni, mostrando una diminuzione del 2% rispetto all'anno precedente. Tra i punti salienti si segnala un aumento del 297% nei rimborsi CMS, portando la tariffa per l'impianto Aquadex a $1.639, efficace a partire da gennaio 2025, una crescita del 28% nel fatturato pediatrico e un margine lordo migliorato del 70% rispetto al 57,3% dell'anno scorso. L'azienda ha raggiunto una riduzione del 30% nei costi operativi e ha riportato un reddito netto di $2,4 milioni. Un nuovo studio ha mostrato una significativa riduzione delle readmissioni per insufficienza cardiaca utilizzando Aquadex. L'azienda ha aggiunto tre nuovi conti pediatrici e due nuovi conti per adulti, ricevendo $5,1 milioni attraverso l'esercizio di warrant.
Nuwellis (NUWE) informó los resultados financieros del tercer trimestre de 2024, con ingresos de $2.4 millones, mostrando una disminución del 2% con respecto al año anterior. Los puntos destacados incluyen un aumento del 297% en reembolsos de CMS, llevando la tarifa de instalación de Aquadex a $1,639, efectivo a partir de enero de 2025, un crecimiento del 28% en ingresos pediátricos y un margen bruto mejorado del 70% en comparación con el 57.3% del año pasado. La empresa logró una reducción del 30% en costos operativos y reportó un ingreso neto de $2.4 millones. Un nuevo estudio mostró una reducción significativa en las readmisiones por insuficiencia cardíaca utilizando Aquadex. La compañía añadió tres nuevas cuentas pediátricas y dos nuevas cuentas para adultos, mientras recibía $5.1 millones a través de ejercicios de opciones.
Nuwellis (NUWE)는 2024년 3분기 재무 실적을 보고했으며, 수익은 $2.4 million으로 전년 대비 2% 감소했습니다. 주요 하이라이트로는 2025년 1월부터 Aquadex 시설 요금에 대해 297%의 CMS 환급 증가가 $1,639으로 적용되고, 소아청소년 수익이 28% 성장했으며, 지난해 57.3% 대비 개선된 총 마진 70%을 기록했습니다. 회사는 운영 비용을 30% 줄였고, $2.4 million의 순이익을 보고했습니다. 새로운 연구에서는 Aquadex을 사용한 심부전 재입원이 상당히 감소한 것으로 나타났습니다. 회사는 세 개의 새로운 소아 및 두 개의 새로운 성인 계좌를 추가했으며, 워런트 실행을 통해 $5.1 million을 받았습니다.
Nuwellis (NUWE) a publié les résultats financiers du troisième trimestre 2024, avec un chiffre d'affaires de $2,4 millions, montrant une baisse de 2% par rapport à l'année précédente. Parmi les faits marquants, on note une augmentation de 297% des remboursements CMS, portant les frais d'installation d'Aquadex à $1.639, en vigueur à partir de janvier 2025, une croissance de 28% des revenus pédiatriques et un taux de marge brute amélioré de 70% contre 57,3% l'année dernière. L'entreprise a réussi à réaliser une réduction de 30% des coûts d'exploitation et a déclaré un revenu net de $2,4 millions. Une nouvelle étude a montré une réduction significative des réadmissions pour insuffisance cardiaque en utilisant Aquadex. L'entreprise a ajouté trois nouveaux comptes pédiatriques et deux nouveaux comptes pour adultes, tout en recevant $5,1 millions par le biais de l'exercice de bons de souscription.
Nuwellis (NUWE) hat die Finanzergebnisse für das dritte Quartal 2024 veröffentlicht, mit Einnahmen von $2,4 Millionen, was einem Rückgang von 2% gegenüber dem Vorjahr entspricht. Zu den bemerkenswerten Highlights zählt ein 297%iger Anstieg der CMS-Rückerstattung auf $1.639 für die Aquadex-Einrichtungsgebühr, die ab Januar 2025 gilt, ein Wachstum von 28% im Bereich der Pädiatrie und eine verbesserte Bruttomarge von 70% im Vergleich zu 57,3% im letzten Jahr. Das Unternehmen erzielte eine 30%ige Reduktion der Betriebskosten und meldete einen Nettogewinn von $2,4 Millionen. Eine neue Studie zeigte eine signifikante Reduzierung der Wiederaufnahmen bei Herzinsuffizienz durch die Nutzung von Aquadex. Das Unternehmen hat drei neue pädiatrische und zwei neue erwachsene Konten hinzugefügt und erhielt $5,1 Millionen durch die Ausübung von Warrants.
- 297% increase in CMS reimbursement to $1,639 per day starting January 2025
- 28% growth in pediatrics revenue year-over-year
- Gross margin improvement to 70% from 57.3%
- 30% reduction in operating expenses to $3.2 million
- Net income of $2.4 million compared to prior year loss
- $5.1 million raised through warrant exercises
- 2% decrease in overall revenue to $2.4 million
- Decrease in consumables utilization
- Low cash position of $1.9 million
- Potential Nasdaq listing compliance issues
Insights
The Q3 results present a mixed financial picture for Nuwellis. While revenue slightly declined by
The most notable development is the
The company's financial position includes
The newly published study in Current Problems in Cardiology demonstrating statistically significant reduction in Heart Failure readmissions at 60 days using Aquadex therapy represents a important clinical validation. This evidence, combined with expanding pediatric adoption (three new accounts) and adult market penetration (two new accounts), strengthens Aquadex's position as a potential standard of care for fluid removal in diuretic-resistant cases.
The
MINNEAPOLIS, Nov. 11, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical device company focused on transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2024.
Recent Highlights:
- Received a
297% CMS reimbursement increase to$1,639 for Aquadex facility fee, effective January 1, 2025. - Revenue of
$2.4 million . - Pediatrics revenue growth of
28% compared to the prior year quarter. - Gross margin of
70% , compared to57.3% in the prior-year quarter. - Total operating cost reduction of
30% compared to the prior-year quarter. - New study published in Current Problems in Cardiology highlighted statistically significant reduction in Heart Failure readmissions at 60 days when using Aquadex.
- Added three new pediatric accounts and two new adult accounts.
- Received
$5.1 million in gross proceeds through the November exercise of outstanding warrants.
“We commend the hard work and dedication of the Nuwellis team, fueling steady market adoption of our Aquadex ultrafiltration therapy, with revenue in the third quarter 2024 led by console sales and new account wins in our Pediatric customer category, which posted
Third Quarter 2024 Financial Results
Revenue for the third quarter of 2024 was
Gross margin was
Selling, general and administrative expenses (SG&A) for the third quarter of 2024 decreased to
Third quarter research and development (R&D) expenses were
Total operating expenses for the third quarter of 2024 were
Operating loss for the third quarter of 2024 decreased to
Net income attributable to common shareholders for the third quarter of 2024 was
As of September 30, 2024, the Company had no debt, cash and cash equivalents of approximately
Webcast and Conference Call Information
The Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Company’s performance.
To access the live webcast, please visit the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-445-7795 (U.S) or 1-785-424-1789 (international) and using the conference ID: NUWEQ3. An audio archive of the webcast will be available following the call on the Investors page at https://ir.nuwellis.com.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit ir.nuwellis.com or visit us on LinkedIn or X.
About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
CONTACTS
INVESTORS:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
| NUWELLIS, INC. AND SUBSIDIARY | |||||||||||||||||||||
| Condensed Consolidated Balance Sheets | |||||||||||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||||||||
| September 30, 2024 | December 31, 2023 | ||||||||||||||||||||
| ASSETS | (Unaudited) | ||||||||||||||||||||
| Current assets | |||||||||||||||||||||
| Cash and cash equivalents | $ | 1,907 | $ | 3,800 | |||||||||||||||||
| Accounts receivable | 1,293 | 1,951 | |||||||||||||||||||
| Inventories, net | 1,864 | 1,997 | |||||||||||||||||||
| Other current assets | 430 | 461 | |||||||||||||||||||
| Total current assets | 5,494 | 8,209 | |||||||||||||||||||
| Property, plant and equipment, net | 551 | 728 | |||||||||||||||||||
| Operating lease right-of-use asset | 563 | 713 | |||||||||||||||||||
| Other assets | 120 | 120 | |||||||||||||||||||
| TOTAL ASSETS | $ | 6,728 | $ | 9,770 | |||||||||||||||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | |||||||||||||||||||||
| Current liabilities | |||||||||||||||||||||
| Accounts payable and accrued liabilities | $ | 1,822 | $ | 2,380 | |||||||||||||||||
| Accrued compensation | 597 | 525 | |||||||||||||||||||
| Current portion of operating lease liability | 232 | 216 | |||||||||||||||||||
| Other current liabilities | 50 | 51 | |||||||||||||||||||
| Total current liabilities | 2,701 | 3,172 | |||||||||||||||||||
| Common stock warrant liability | 480 | 2,843 | |||||||||||||||||||
| Operating lease liability | 368 | 544 | |||||||||||||||||||
| Total liabilities | 3,549 | 6,559 | |||||||||||||||||||
| Commitments and contingencies | |||||||||||||||||||||
| Mezzanine Equity | |||||||||||||||||||||
| Series J Convertible Preferred Stock as of September 30, 2024 and December 31, 2023, par value | 2 | 221 | |||||||||||||||||||
| Stockholders’ equity | |||||||||||||||||||||
| Series A junior participating preferred stock as of September 30, 2024 and December 31, 2023, par value | — | — | |||||||||||||||||||
| Series F convertible preferred stock as of September 30, 2024 and December 31, 2023, par value | — | — | |||||||||||||||||||
| Preferred stock as of September 30, 2024 and December 31, 2023, par value | — | — | |||||||||||||||||||
| Common stock as of September 30, 2024 and December 31, 2023, par value | — | — | |||||||||||||||||||
| Additional paid-in capital | 300,546 | 290,647 | |||||||||||||||||||
| Accumulated other comprehensive income: Foreign currency translation adjustment | (46 | ) | (31 | ) | |||||||||||||||||
| Accumulated deficit | (297,323 | ) | (287,626 | ) | |||||||||||||||||
| Total stockholders’ equity | 3,177 | 2,990 | |||||||||||||||||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | $ | 6,728 | $ | 9,770 | |||||||||||||||||
| NUWELLIS, INC. AND SUBSIDIARY | |||||||||||||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||
| (in thousands, except per share amounts and weighted average shares outstanding) | |||||||||||||||||||||||||||
| Three months ended September 30 | Nine months ended September 30 | ||||||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||
| Net sales | $ | 2,367 | $ | 2,412 | $ | 6,418 | $ | 6,313 | |||||||||||||||||||
| Cost of goods sold | 711 | 1,031 | 2,097 | 2,718 | |||||||||||||||||||||||
| Gross profit | 1,656 | 1,381 | 4,321 | 3,595 | |||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||||
| Selling, general and administrative | 2,702 | 3,428 | 10,544 | 13,582 | |||||||||||||||||||||||
| Research and development | 486 | 1,117 | 2,378 | 4,050 | |||||||||||||||||||||||
| Total operating expenses | 3,188 | 4,545 | 12,922 | 17,632 | |||||||||||||||||||||||
| Loss from operations | (1,532 | ) | (3,164 | ) | (8,601 | ) | (14,037 | ) | |||||||||||||||||||
| Other income (expense), net | 8 | (204 | ) | (87 | ) | 98 | |||||||||||||||||||||
| Financing Expense | — | — | (5,607 | ) | — | ||||||||||||||||||||||
| Change in fair value of warrant liability | 3,882 | — | 4,602 | (755 | ) | ||||||||||||||||||||||
| Income (loss) before income taxes | 2,358 | (3,368 | ) | (9,693 | ) | (14,694 | ) | ||||||||||||||||||||
| Income tax expense | — | (2 | ) | (4 | ) | (6 | ) | ||||||||||||||||||||
| Net income (loss) | $ | 2,358 | $ | (3,370 | ) | $ | (9,697 | ) | $ | (14,700 | ) | ||||||||||||||||
| Deemed dividend attributable to Series J Convertible Preferred Stock | — | — | 541 | — | |||||||||||||||||||||||
| Net income (loss) attributable to common shareholders | $ | 2,358 | ) | $ | (3,370 | ) | $ | (9,156 | ) | $ | (14,700 | ) | |||||||||||||||
| Basic and diluted net income (loss) per share | $ | 1.74 | $ | (63.27 | ) | $ | (14.99 | ) | $ | (357.42 | ) | ||||||||||||||||
| Weighted average shares outstanding – basic and diluted | 1,351,939 | 53,265 | 647,079 | 41,128 | |||||||||||||||||||||||
| Other comprehensive loss: | |||||||||||||||||||||||||||
| Foreign currency translation adjustments | $ | (4 | ) | $ | — | $ | (15 | ) | $ | (6 | ) | ||||||||||||||||
| Total comprehensive income (loss) | $ | 2,354 | $ | (3,370 | ) | $ | (9,171 | ) | $ | (14,706 | ) | ||||||||||||||||
| NUWELLIS, INC. AND SUBSIDIARY | |||||||||||||||||||||||||||||||
| Condensed Consolidated Statements of Cash Flows | |||||||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||||||||||
| Nine months ended September 30 | |||||||||||||||||||||||||||||||
| 2024 | 2023 | ||||||||||||||||||||||||||||||
| Operating Activities: | |||||||||||||||||||||||||||||||
| Net loss | $ | (9,697 | ) | $ | (14,700 | ) | |||||||||||||||||||||||||
| Adjustments to reconcile net loss to cash flows used in operating activities: | |||||||||||||||||||||||||||||||
| Depreciation and amortization | 227 | 253 | |||||||||||||||||||||||||||||
| Stock-based compensation expense | 374 | 513 | |||||||||||||||||||||||||||||
| Change in fair value of warrant liability | (4,602 | ) | 755 | ||||||||||||||||||||||||||||
| Warrant financing costs | 5,607 | — | |||||||||||||||||||||||||||||
| Net realized gain on marketable securities | — | (65 | ) | ||||||||||||||||||||||||||||
| Changes in operating assets and liabilities: | |||||||||||||||||||||||||||||||
| Accounts receivable | 658 | (19 | ) | ||||||||||||||||||||||||||||
| Inventory, net | 120 | 325 | |||||||||||||||||||||||||||||
| Other current assets | (275 | ) | (551 | ) | |||||||||||||||||||||||||||
| Other assets and liabilities | (13 | ) | (16 | ) | |||||||||||||||||||||||||||
| Accounts payable and accrued expenses | (486 | ) | (1,678 | ) | |||||||||||||||||||||||||||
| Net cash used in operating activities | (8,087 | ) | (15,183 | ) | |||||||||||||||||||||||||||
| Investing Activities: | |||||||||||||||||||||||||||||||
| Proceeds from sale of marketable securities | — | 578 | |||||||||||||||||||||||||||||
| Additions to intangible assets | — | (99 | ) | ||||||||||||||||||||||||||||
| Purchases of property and equipment | (37 | ) | (185 | ) | |||||||||||||||||||||||||||
| Net cash provided by (used in) investing activities | (37 | ) | 294 | ||||||||||||||||||||||||||||
| Financing Activities: | |||||||||||||||||||||||||||||||
| Issuance of common stock from offering | 2,403 | — | |||||||||||||||||||||||||||||
| Proceeds from the exercise of Series J Convertible Preferred Warrants | 501 | — | |||||||||||||||||||||||||||||
| Proceeds from the exercise of April 2024 Warrants | 1,182 | — | |||||||||||||||||||||||||||||
| Issuance of July and August 2024 Common Stock and Warrants | 2,160 | — | |||||||||||||||||||||||||||||
| Proceeds from ATM stock offerings, net | — | 2,108 | |||||||||||||||||||||||||||||
| Payments on finance lease liability | — | (20 | ) | ||||||||||||||||||||||||||||
| Net cash provided by financing activities | 6,246 | 2,088 | |||||||||||||||||||||||||||||
| Effect of exchange rate changes on cash | (15 | ) | (6 | ) | |||||||||||||||||||||||||||
| Net decrease in cash and cash equivalents | (1,893 | ) | (12,807 | ) | |||||||||||||||||||||||||||
| Cash and cash equivalents - beginning of period | 3,800 | 17,737 | |||||||||||||||||||||||||||||
| Cash and cash equivalents - end of period | $ | 1,907 | $ | 4,930 | |||||||||||||||||||||||||||
FAQ
What was Nuwellis (NUWE) revenue in Q3 2024?
How much did Nuwellis (NUWE) CMS reimbursement increase for 2025?
What was Nuwellis (NUWE) gross margin in Q3 2024?
How much did Nuwellis (NUWE) pediatric revenue grow in Q3 2024?
