Nuwellis, Inc. Announces Fourth Quarter and Full Year 2022 Financial Results
01 March 2023 - 12:00AM
Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused
on transforming the lives of people with fluid overload, today
reported financial results for the fourth quarter and full year
ended December 31, 2022.
- Revenue of $2.3 million for the
fourth quarter 2022, a 42% increase over the prior-year period.
Full year revenue of $8.5 million, an 8% increase over 2021.
- Gross margin of 56.9% in the fourth
quarter 2022, an increase of 250 basis points from the same period
last year. Full year 2022 gross margin of 55.7%, a decrease of 100
basis points from 2021.
- By segment, fourth quarter 2022
revenue was led by Pediatrics, followed by Heart Failure and
Critical Care, which increased approximately 92%, 47%, and 24% over
the same period last year, respectively. Full year 2022 revenue by
segment was led by Pediatrics and Heart Failure, which increased
approximately 28% and 9%, respectively.
- Entered into an exclusive U.S.
license and distribution agreement for SeaStar Medical’s Selective
Cytopheretic Device (SCD) for pediatric Acute Kidney Injury (AKI).
Approximately 4,000 children with AKI who are at high risk of
mortality require therapy annually.
- Announced peer-reviewed publication
of results from a 10-year, real-world retrospective study
supporting lower heart failure hospitalizations and readmissions
with Aquadex. Data demonstrated 81% lower heart failure
hospitalizations per year and a 48% decrease in rehospitalizations
at 30 days from the national average.
- Announced peer-reviewed data
demonstrating 71% survival with kidney replacement therapy using
Aquadex in low birth-weight preterm neonates.
- Announced AVOID-HF clinical study
analysis demonstrating clinical data that strongly favored
adjustable ultrafiltration using Aquadex over adjustable IV
diuretics in reducing cardiovascular mortality and subsequent HF
events when patients are unresponsive to diuretics treatment.
- Continued site activations for the
Company’s REVERSE-HF clinical trial, with nine sites activated to
date, on track to complete twelve activations by the end of first
quarter 2023.
- Appointed Chief Medical Officer,
John Jefferies, M.D., and Chief Financial Officer, Lynn Blake, to
the Executive Leadership team.
- Cash, cash equivalents, and marketable securities of $18.3
million and no debt as of December 31, 2022.
“2022 proved to be a year of growth for
Nuwellis, with 42% year-over-year revenue growth in the fourth
quarter and 8% revenue growth for the full year. In 2023, we remain
focused on the execution of our key strategic growth initiatives,
with targeted expansion of our commercial team, investments in
market penetration initiatives, and leverage of our growing body of
clinical evidence to drive continued sales momentum. We are
committed to making Aquadex the standard of care for patients with
fluid overload who are not responsive to diuretics and driving
increased utilization of ultrafiltration therapy in 2023 and
beyond,” said Nestor Jaramillo, President and CEO of Nuwellis.
Fourth Quarter 2022 Financial
Results
Revenue for the fourth quarter of 2022 was $2.3
million, compared to $1.6 million in the prior-year period.
Gross margin was 56.9% for the fourth quarter of
2022, compared to 54.4% in the prior-year period, an increase of
250 basis points, resulting from increased sales volume.
Selling, general and administrative expenses for
the fourth quarter of 2022 were $4.7 million, compared to $4.1
million in the prior-year period. The increase in SG&A was
primarily due to higher professional service fees and variable
compensation expense, balanced with continued spending
vigilance.
Fourth quarter research and development expenses
were $1.2 million, compared to $1.1 million in the fourth quarter
of 2021, reflecting a slight increase in product development
expenses.
Net loss for the fourth quarter of 2022 was $1.9
million, or a loss of $5.00 per basic and diluted common share,
compared to a net loss of $4.3 million, or a loss of $41.09 per
basic and diluted common share in the prior-year period. The
current period net loss includes $2.6 million of Other Income
related to the year-end revaluation of warrants issued in
conjunction with the Company’s October financing.
At December 31, 2022, the Company had cash, cash
equivalents, and marketable securities of approximately $18.3
million and no debt. Outstanding shares as of February 24 were
approximately 1.2 million, reflecting the Company’s December
reverse stock split and the exercise of warrants issued in
conjunction with the Company’s October financing.
Webcast and Conference Call
Information
The Company will host a conference call and
webcast at 8:30 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
1-844-825-9789 (U.S) or 1-412-317-5180 (international) and using
the conference ID: 10175088. An audio archive of the webcast will
be available following the call on the Investors page at
https://ir.nuwellis.com.
About NuwellisNuwellis,
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 www.nuwellis.com or visit
us on LinkedIn.
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 2023 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 impact of the COVID-19
pandemic, 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 as a result of new
information, future events or otherwise.
CONTACTS
INVESTORS: Vivian CervantesGilmartin Group
ir@nuwellis.com
MEDIA: Annika
ParishHealth+Commerceannika@healthandcommerce.com
NUWELLIS, INC. AND SUBSIDIARYCondensed
Consolidated Balance Sheets(In thousands, except share and per
share amounts) |
|
|
|
December 31,2022 |
|
December 31, 2021 |
|
ASSETS |
|
(unaudited) |
|
|
|
|
Current
assets |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
17,737 |
|
$ |
8,742 |
|
Marketable securities |
|
569 |
|
|
15,463 |
|
Accounts receivable |
|
1,406 |
|
|
750 |
|
Inventories, net |
|
2,661 |
|
|
2,843 |
|
Other current assets |
|
396 |
|
|
328 |
|
Total current
assets |
|
22,769 |
|
|
28,126 |
|
Property, plant and equipment, net |
|
980 |
|
|
1,188 |
|
Operating lease right-of-use asset |
|
903 |
|
|
1,082 |
|
Other assets |
|
21 |
|
|
21 |
|
TOTAL
ASSETS |
$ |
24,673 |
|
$ |
30,417 |
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Accounts payable |
$ |
2,245 |
|
$ |
1,414 |
|
Accrued compensation |
|
2,161 |
|
|
1,664 |
|
Current portion of operating lease liability |
|
196 |
|
|
167 |
|
Current portion of finance lease liability |
|
28 |
|
|
26 |
|
Other current liabilities |
|
58 |
|
|
36 |
|
Total current
liabilities |
|
4,688 |
|
|
3,307 |
|
Common stock warrant liability |
|
6,868 |
|
|
— |
|
Operating lease liability |
|
760 |
|
|
956 |
|
Finance lease liability |
|
— |
|
|
28 |
|
Other long-term liability |
|
— |
|
|
179 |
|
Total
liabilities |
|
12,316 |
|
|
4,470 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
Series A junior participating
preferred stock as of December 31, 2022 and December 31, 2021, par
value $0.0001 per share; authorized 30,000 shares, none
outstanding |
|
— |
|
|
— |
|
Series F convertible preferred
stock as of December 31, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 127 shares, issued and outstanding
127 shares |
|
— |
|
|
— |
|
Series I convertible preferred
stock as of December 31, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 1,049,280 and none, issued and
outstanding 1,049,280 and none, respectively |
|
— |
|
|
— |
|
Preferred stock as of December
31, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 39,969,873 shares, none outstanding |
|
— |
|
|
— |
|
Common stock as of December
31, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 100,000,000 shares, issued and outstanding 536,394 and
105,376, respectively |
|
— |
|
|
— |
|
Additional paid-in
capital |
|
279,736 |
|
|
278,874 |
|
Accumulated other
comprehensive income: |
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(18 |
) |
|
(11 |
) |
Unrealized gain (loss) on marketable securities |
|
56 |
|
|
(24 |
) |
Accumulated deficit |
|
(267,417 |
) |
|
(252,892 |
) |
|
Total stockholders’
equity |
|
12,357 |
|
|
25,947 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
24,673 |
|
$ |
30,417 |
|
|
|
|
|
|
|
|
NUWELLIS, INC. AND SUBSIDIARYCondensed
Consolidated Statements of Operations and Comprehensive
Loss (In thousands, except per share amounts) |
|
|
|
Three months ended December
31, |
Twelve months endedDecember
31, |
|
|
|
2022 |
2021 |
2022 |
2021 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
sales |
$ |
2,339 |
|
$ |
1,642 |
|
$ |
8,543 |
|
$ |
7,921 |
|
|
Cost of goods sold |
|
1,008 |
|
|
748 |
|
|
3,788 |
|
|
3,430 |
|
|
Gross profit |
|
1,331 |
|
|
894 |
|
|
4,755 |
|
|
4,491 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
4,664 |
|
|
4,094 |
|
|
17,584 |
|
|
19,039 |
|
|
Research and development |
|
1,201 |
|
|
1,131 |
|
|
4,342 |
|
|
4,978 |
|
|
Total operating expenses |
|
5,865 |
|
|
5,225 |
|
|
21,926 |
|
|
24,017 |
|
|
Loss from operations |
|
(4,534 |
) |
|
(4,331 |
) |
|
(17,171 |
) |
|
(19,526 |
) |
|
Other income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
61 |
|
|
3 |
|
|
75 |
|
|
(19 |
) |
|
Financing expense |
|
(9,247 |
) |
|
|
— |
|
|
(9,247 |
) |
|
|
— |
|
|
Change in fair value of warrant liability |
|
11,827 |
|
|
— |
|
|
11,827 |
|
|
— |
|
|
Loss before income taxes |
|
(1,893 |
) |
|
(4,328 |
) |
|
(14,516 |
) |
|
(19,545 |
) |
|
Income tax expense |
|
(3 |
) |
|
(2 |
) |
|
(9 |
) |
|
(9 |
) |
|
Net loss |
$ |
(1,896 |
) |
$ |
(4,330 |
) |
$ |
(14,525 |
) |
$ |
(19,554 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share |
$ |
(5.00 |
) |
$ |
(41.09 |
) |
$ |
(83.55 |
) |
$ |
(285.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding – basic and diluted |
|
379 |
|
|
105 |
|
|
174 |
|
|
69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
6 |
|
|
(24) |
|
|
80 |
|
|
(24 |
) |
|
Foreign currency translation adjustments |
$ |
(7 |
) |
|
$ |
— |
|
$ |
(7 |
) |
|
$ |
(4 |
) |
Total comprehensive
loss |
$ |
(1,897 |
) |
$ |
(4,354 |
) |
$ |
(14,452 |
) |
$ |
(19,582 |
) |
|
NUWELLIS, INC. AND
SUBSIDIARYCondensed Consolidated Statements of
Cash Flows(In thousands) |
|
|
|
For the years ended December 31, |
|
|
2022 |
|
2021 |
|
|
|
Operating Activities |
|
(unaudited) |
|
|
|
|
|
|
Net loss |
|
$ |
(14,525 |
) |
|
$ |
(19,554 |
) |
|
|
Adjustments to
reconcile net loss to cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
372 |
|
|
|
488 |
|
|
|
Stock-based compensation expense, net |
|
|
862 |
|
|
|
1,314 |
|
|
|
Change in fair value of warrant liability |
|
|
(11,827 |
) |
|
|
— |
|
|
|
Financing expense |
|
|
9,247 |
|
|
|
— |
|
|
|
Net realized and unrealized gains on marketable securities |
|
|
124 |
|
|
|
13 |
|
|
|
Changes in
operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(656 |
) |
|
|
155 |
|
|
|
Inventory |
|
|
140 |
|
|
|
(143 |
) |
|
|
Other current assets |
|
|
(68 |
) |
|
|
(91 |
) |
|
|
Other assets and liabilities |
|
|
(96 |
) |
|
|
186 |
|
|
|
Accounts payable and accrued expenses |
|
|
1,278 |
|
|
|
(211 |
) |
|
|
Net cash
used in operations |
|
|
(15,149 |
) |
|
|
(17,843 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing
activities: |
|
|
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
|
— |
|
|
|
(18,850 |
) |
|
|
Proceeds from sales of marketable securities |
|
|
14,850 |
|
|
|
3,350 |
|
|
|
Purchase of property and equipment |
|
|
(122 |
) |
|
|
(219 |
) |
|
|
Net cash
provided (used) in investing activities |
|
|
14,728 |
|
|
|
(15,719 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing
activities: |
|
|
|
|
|
|
|
|
|
|
Proceeds from public stock offerings, net |
|
|
9,449 |
|
|
|
27,896 |
|
|
|
Proceeds from warrant exercises |
|
|
— |
|
|
|
1 |
|
|
|
Payments on finance lease liability |
|
|
(26 |
) |
|
|
(26 |
) |
|
|
Net cash
provided by financing activities |
|
|
9,423 |
|
|
|
27,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange
rate changes on cash |
|
|
(7 |
) |
|
|
(4 |
) |
|
|
Net increase in
cash and cash equivalents |
|
|
8,995 |
|
|
|
(5,695 |
) |
|
|
Cash and cash
equivalents—beginning of year |
|
|
8,742 |
|
|
|
14,437 |
|
|
|
Cash and
cash equivalents—end of year |
|
$ |
17,737 |
|
|
$ |
8,742 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash activities |
|
|
|
|
|
|
|
|
|
|
Inventory transferred to property, plant and equipment |
|
$ |
42 |
|
|
$ |
257 |
|
|
|
Operating right-of-use asset recorded as an operating lease
liability |
|
$ |
— |
|
|
$ |
901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information |
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes |
|
$ |
9 |
|
|
$ |
11 |
|
|
|
|
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