Nuwellis, Inc. Announces Second Quarter 2024 Financial Results
2024年8月13日 - 9:00PM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, today
reported financial results for the second quarter ended June 30,
2024.
Highlights:
- Revenue of $2.2 million, a 6%
increase over the second quarter of 2023.
- Critical Care revenue growth of 28%
compared to the prior year quarter; Heart Failure consumables
utilization growth of 35% over the prior-year quarter.
- Gross margin of 67.2%, compared to
55.3% in the prior-year quarter.
- Total operating cost reduction of
38% compared to the prior-year quarter.
- Expanded Aquadex® to pediatric
patients at one of the largest hospital networks in Florida.
- Announced purchase agreement with a
50-hospital network in Texas for Aquadex Ultrafiltration
Therapy.
“Our second quarter 2024 results continue to
demonstrate market traction for our Aquadex ultrafiltration
therapy, with revenue growth driven by steady increases in
consumables utilization, particularly in Critical Care and Heart
Failure, supported by our growing body of clinical evidence that
highlights the benefits of Aquadex for patients experiencing fluid
overload who have not responded to traditional diuretic treatments.
Of note, our higher margin consumables business continues to fuel
manufacturing efficiencies, resulting in strong gross margin gains
compared to the year ago period,” said Nestor Jaramillo, President
and CEO of Nuwellis. “Bolstering our positive momentum in 2024, we
are also excited to now expand our Pediatric product offerings with
QUELIMMUNE™, providing our growing Pediatric network with a new
therapy for acute kidney injury (AKI) and sepsis. This novel
therapy comes to Nuwellis from our exclusive license and
distribution agreement with SeaStar Medical Holding
Corporation.”
Second Quarter 2024 Financial
Results
Revenue for the second quarter of 2024 was $2.2
million, a 6% increase compared to the prior-year quarter. The
year-over-year increase is attributable to a 30% increase in heart
failure and critical care consumables utilization. Pediatrics had a
25% decline in utilization due to patient census.
Gross margin was 67.2% for the second quarter of
2024, compared to 55.3% in the prior-year quarter. The increase was
primarily due to higher manufacturing volumes of consumables in the
current year period and lower fixed overhead manufacturing
expenses.
Selling, general and administrative expenses
(SG&A) for the second quarter of 2024 decreased to $3.2
million, compared to $4.7 million in the prior-year quarter. The
decrease in SG&A expense was primarily realized through
efficiency initiatives enacted in the second half of
2023.
Second quarter research and development
(R&D) expenses were $558 thousand, compared to $1.5 million in
the prior-year quarter. The decrease in R&D expense was
primarily due to reduced consulting fees and compensation-related
expenses.
Total operating expenses for the second quarter
of 2024 were $3.8 million, a 38% decrease compared to $6.2 million
in the prior-year quarter as we continue to realize savings from
operating efficiency initiatives enacted in the second half of
2023.
Operating loss for the second quarter of 2024
decreased to $2.3 million compared to an operating loss of $5.0
million in the prior-year quarter.
Net loss attributable to common shareholders for
the second quarter of 2024 was $7.7 million, or a loss of $18.85
per basic and diluted common share, compared to a net loss
attributable to common shareholders of $4.8 million, or a loss of
$127.65 per basic and diluted common share in the prior-year
quarter.
As of June 30, 2024, the Company had no debt,
cash and cash equivalents of approximately $1.0 million, and
approximately 516 thousand common shares outstanding. On July 25,
Nuwellis closed a registered direct offering and concurrent private
placement with gross proceeds of $2.0 million before deducting
placement agent fees and other offering expenses.
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
1-800-267-6316 (U.S) or 1-203-518-9783 (international) and using
the conference ID: NUWEQ2. 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
technology 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
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 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 CervantesGilmartin Group
ir@nuwellis.com
| |
|
NUWELLIS, INC. AND SUBSIDIARYCondensed
Consolidated Balance Sheets(in thousands, except share and
per share amounts) |
| |
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
| Current
assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
1,023 |
|
$ |
3,800 |
|
|
|
Accounts receivable |
|
1,292 |
|
|
1,951 |
|
|
|
Inventories, net |
|
1,967 |
|
|
1,997 |
|
|
|
Other current assets |
|
544 |
|
|
461 |
|
|
| Total
current assets |
|
4,826 |
|
|
8,209 |
|
|
|
Property, plant and equipment, net |
|
630 |
|
|
728 |
|
|
|
Operating lease right-of-use asset |
|
613 |
|
|
713 |
|
|
|
Other assets |
|
120 |
|
|
120 |
|
|
| TOTAL
ASSETS |
$ |
6,189 |
|
$ |
9,770 |
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY (DEFICIT) |
|
|
|
|
|
|
|
| Current
liabilities |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
$ |
3,028 |
|
$ |
2,380 |
|
|
|
Accrued compensation |
|
706 |
|
|
525 |
|
|
|
Current portion of operating lease liability |
|
226 |
|
|
216 |
|
|
|
Other current liabilities |
|
56 |
|
|
51 |
|
|
| Total
current liabilities |
|
4,016 |
|
|
3,172 |
|
|
|
Common stock warrant liability |
|
8,579 |
|
|
2,843 |
|
|
|
Operating lease liability |
|
428 |
|
|
544 |
|
|
|
Total liabilities |
|
13,023 |
|
|
6,559 |
|
|
| Commitments and
contingencies |
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
| Mezzanine
Equity |
|
|
|
|
|
|
|
| Series J
Convertible Preferred Stock as of June 30, 2024 and December 31,
2023, par value $0.0001 per share; authorized 600,000 shares,
issued and outstanding 88 and 11,950, respectively |
|
2 |
|
|
221 |
|
|
| |
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit) |
|
|
|
|
|
|
|
| Series A junior
participating preferred stock as of June 30, 2024 and December 31,
2023, par value $0.0001 per share; authorized 30,000 shares, none
outstanding |
|
— |
|
|
— |
|
|
| Series F
convertible preferred stock as of June 30, 2024 and December 31,
2023, par value $0.0001 per share; authorized 18,000 shares, issued
and outstanding 127 shares |
|
— |
|
|
— |
|
|
| Preferred stock as
of June 30, 2024 and December 31, 2023, par value $0.0001 per
share; authorized 39,352,000 shares, none outstanding |
|
— |
|
|
— |
|
|
| Common stock as of
June 30, 2024 and December 31, 2023, par value $0.0001 per share;
authorized 100,000,000 shares, issued and outstanding 515,744 and
162,356, respectively |
|
— |
|
|
— |
|
|
| Additional paid‑in
capital |
|
292,887 |
|
|
290,647 |
|
|
| Accumulated other
comprehensive income: |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(42 |
) |
|
(31 |
) |
|
| Accumulated
deficit |
|
(299,681 |
) |
|
(287,626 |
) |
|
| Total
stockholders’ equity (deficit) |
|
(6,836 |
) |
|
2,990 |
|
|
| TOTAL
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
$ |
6,189 |
|
$ |
9,770 |
|
|
|
|
|
|
|
|
|
|
NUWELLIS, INC. AND SUBSIDIARYCondensed
Consolidated Statements of Operations and Comprehensive
Loss(Unaudited)(in thousands, except per
share amounts and weighted average shares outstanding) |
|
|
|
|
| |
|
|
Three months ended June 30 |
Six months endedJune 30 |
| |
|
|
2024 |
|
2023 |
|
|
2024 |
2023 |
|
|
Net sales |
|
$ |
2,194 |
|
$ |
2,075 |
|
$ |
4,051 |
|
$ |
3,901 |
|
|
|
Cost of goods sold |
|
|
720 |
|
|
928 |
|
|
1,386 |
|
|
1,687 |
|
|
|
Gross profit |
|
|
1,474 |
|
|
1,147 |
|
|
2,665 |
|
|
2,214 |
|
|
| Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
3,236 |
|
|
4,664 |
|
|
7,842 |
|
|
10,154 |
|
|
|
Research and development |
|
|
558 |
|
|
1,505 |
|
|
1,892 |
|
|
2,933 |
|
|
|
Total operating expenses |
|
|
3,794 |
|
|
6,169 |
|
|
9,734 |
|
|
13,087 |
|
|
|
Loss from operations |
|
|
(2,320 |
) |
|
(5,022 |
) |
|
(7,069 |
) |
|
(10,873 |
) |
|
| Other income
(expense), net |
|
|
6 |
|
|
179 |
|
|
(95 |
) |
|
302 |
|
|
| Financing
Expense |
|
|
(5,607 |
) |
|
— |
|
|
(5,607 |
|
|
— |
|
|
| Change in
fair value of warrant liability |
|
|
198 |
|
|
— |
|
|
720 |
|
|
(755 |
) |
|
|
Loss before income taxes |
|
|
(7,723 |
) |
|
(4,843 |
) |
|
(12,051 |
) |
|
(11,326 |
) |
|
|
Income tax expense |
|
|
(2 |
) |
|
(2 |
) |
|
(4 |
) |
|
(4 |
) |
|
|
Net loss |
|
$ |
(7,725 |
) |
$ |
(4,845 |
) |
$ |
(12,055 |
) |
$ |
(11,330 |
) |
|
| Deemed dividend
attributable to Series J Convertible Preferred Stock |
|
|
— |
|
|
— |
|
|
541 |
|
|
— |
|
|
|
Net loss attributable to common shareholders |
|
$ |
(7,725 |
) |
$ |
(4,845 |
) |
$ |
(11,514 |
) |
$ |
(11,330 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and
diluted loss per share |
|
$ |
(18.85 |
) |
$ |
(127.65 |
) |
$ |
(40.91 |
) |
$ |
(323.15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average
shares outstanding – basic and diluted |
|
|
409,690 |
|
|
37,949 |
|
|
294,649 |
|
|
35,060 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
$ |
(2 |
) |
$ |
1 |
|
$ |
(11 |
) |
$ |
(6 |
) |
|
| Total
comprehensive loss |
|
$ |
(7,727 |
) |
$ |
(4,844 |
) |
$ |
(12,066 |
) |
$ |
(11,336 |
) |
|
| |
| |
|
NUWELLIS, INC. AND SUBSIDIARYCondensed
Consolidated Statements of Cash
Flows(Unaudited)(in thousands) |
| |
|
|
|
Six months endedJune 30 |
|
|
|
|
2024 |
|
|
2023 |
|
|
Operating Activities: |
|
|
|
|
|
Net loss |
$ |
(12,055 |
) |
$ |
(11,330 |
) |
|
| Adjustments to reconcile net
loss to cash flows used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
151 |
|
|
169 |
|
|
|
Stock-based compensation expense |
|
273 |
|
|
378 |
|
|
|
Change in fair value of warrant liability |
|
(720 |
) |
|
755 |
|
|
|
Warrant financing costs |
|
5,607 |
|
|
— |
|
|
|
Net realized gain on marketable securities |
|
— |
|
|
(65 |
) |
|
| Changes in operating assets
and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
659 |
|
|
230 |
|
|
|
Inventory, net |
|
30 |
|
|
(72 |
) |
|
|
Other current assets |
|
(395 |
) |
|
(547 |
) |
|
|
Other assets and liabilities |
|
5 |
|
|
(20 |
) |
|
|
Accounts payable and accrued expenses |
|
829 |
|
|
(856 |
) |
|
| Net cash used in
operating activities |
|
(5,616 |
) |
|
(11,358 |
) |
|
| |
|
|
|
|
|
|
|
| Investing
Activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of marketable securities |
|
— |
|
|
578 |
|
|
|
Additions to intangible assets |
|
— |
|
|
(99 |
) |
|
|
Purchases of property and equipment |
|
(53 |
) |
|
(64 |
) |
|
| Net cash provided by
(used in) investing activities |
|
(53 |
) |
|
415 |
|
|
| |
|
|
|
|
|
|
|
| Financing
Activities: |
|
|
|
|
|
|
|
|
Issuance of common stock from offering |
|
2,403 |
|
|
— |
|
|
|
Proceeds from the exercise of Series J
Convertible Preferred Warrants |
|
500 |
|
|
— |
|
|
|
Proceeds from ATM stock offerings, net |
|
— |
|
|
2,108 |
|
|
| Net cash provided by
financing activities |
|
2,903 |
|
|
2,108 |
|
|
| |
|
|
|
|
|
|
|
| Effect of exchange rate
changes on cash |
|
(11 |
) |
|
(6 |
) |
|
| Net decrease in cash and cash
equivalents |
|
(2,777 |
) |
|
(8,841 |
) |
|
| Cash and cash equivalents -
beginning of period |
|
3,800 |
|
|
17,737 |
|
|
| Cash and cash
equivalents - end of period |
$ |
1,023 |
|
$ |
8,896 |
|
|
|
|
|
|
|
|
|
|
|
| |
Supplemental cash flow information
| |
Issuance of Series J Preferred Stock for exercise of Warrants |
$ |
1,857 |
|
$ |
— |
|
|
| |
Issuance of Common Stock for
conversion of Series J Preferred Stock |
$ |
1,535 |
|
$ |
— |
|
|
| |
Deemed dividend on Series J
Preferred Stock |
$ |
(541 |
) |
$ |
— |
|
|
| |
Common stock offering costs
included in prepaids |
$ |
306 |
|
$ |
— |
|
|
Newellis (NASDAQ:NUWE)
過去 株価チャート
から 10 2024 まで 11 2024
Newellis (NASDAQ:NUWE)
過去 株価チャート
から 11 2023 まで 11 2024
