Nuwellis, Inc. Announces Third Quarter 2024 Financial Results and Recent Highlights
NUWE 11.11.2024
Drug:Aquadex-001 Aquadex
Recent Highlights:
- Received a 297% CMS reimbursement increase to
$1,639 for Aquadex facility fee, effectiveJanuary 1, 2025 . - Revenue of
$2.4 million . - Pediatrics revenue growth of 28% compared to the prior year quarter.
- Gross margin of 70%, compared to 57.3% 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 28% annual growth,” said
Third Quarter 2024 Financial Results
Revenue for the third quarter of 2024 was
Gross margin was 70% for the third quarter of 2024, compared to 57.3% in the prior-year quarter. The increase was primarily driven by higher manufacturing volumes of consumables and lower fixed overhead manufacturing expenses.
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
Webcast and Conference Call Information
The Company will host a conference call and webcast at
To access the live webcast, please visit the Investors page of the Nuwellis website athttps://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-800-445-7795 (
About Nuwellis
About the Aquadex SmartFlow®SystemThe 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 StatementsCertain 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
CONTACTS
INVESTORS:
| Condensed Consolidated Balance Sheets | |||||||||||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||||||||
| 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 | 2 | 221 | |||||||||||||||||||
| Stockholders’ equity | |||||||||||||||||||||
| Series A junior participating preferred stock as of | — | — | |||||||||||||||||||
| Series F convertible preferred stock as of | — | — | |||||||||||||||||||
| Preferred stock as of | — | — | |||||||||||||||||||
| Common stock as of | — | — | |||||||||||||||||||
| 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 | |||||||||||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||
| (in thousands, except per share amounts and weighted average shares outstanding) | |||||||||||||||||||||||||||
| Three months ended | Nine months ended | ||||||||||||||||||||||||||
| 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 | ) | ||||||||||||||||
| Condensed Consolidated Statements of Cash Flows | |||||||||||||||||||||||||||||||
| (Unaudited) | |||||||||||||||||||||||||||||||
| (in thousands) | |||||||||||||||||||||||||||||||
| Nine months ended | |||||||||||||||||||||||||||||||
| 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 | 1,182 | — | |||||||||||||||||||||||||||||
| Issuance of July and | 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 | |||||||||||||||||||||||||||
Source: Nuwellis, Inc.