Nuwellis, Inc. Announces First Quarter 2022 Financial Results
May 10 2022 - 7:00AM
Nuwellis, Inc. (Nasdaq: NUWE) announced today its results for the
first quarter ended March 31, 2022, which included the following
highlights:
- Generated $1.9 million in total
revenue for the first quarter 2022, up 17% sequentially from the
fourth quarter of 2021
- Received a Category III CPT Code
effective January 1, 2022, specifically for the use of therapeutic
ultrafiltration, thereby increasing reimbursement to professionals
and facilities, an important step in advancing Aquadex to standard
of care
- On track to enroll first patients
in REVERSE-HF, a randomized controlled multi-center clinical trial
designed to validate clinical outcomes and the economic value of
Aquadex therapy
- First quarter 2022 cash flow from
operations improved $0.6 million compared to the prior-year
period
“I am very pleased with the resilient
performance in the quarter,” said Nestor Jaramillo, CEO of
Nuwellis. “Going forward, we expect to continue benefiting from the
successful execution of our strategy and rollout of our new sales
management system.”
First Quarter 2022 Financial
Results
Total revenue for the first quarter of 2022 was
$1.9 million, an increase of 17% compared to the fourth quarter of
2021 and even with the prior-year period. Growth in the quarter was
fueled by higher sales of consumables. Capital equipment sales
increased sequentially but were below the prior year, while total
monthly year-on-year sales comparisons improved as the business
advanced through the quarter.
Gross margin was 57.2% for the first quarter
2022, compared to 50.4% in the prior-year period, with the increase
driven primarily by favorable product sales mix and reduced
inventory revaluation expense.
Selling, general and administrative expenses for
the first quarter of 2022 were $4.4 million, representing a 16%
reduction compared to the prior-year period. This reduction
resulted from continued cost vigilance and certain non-recurring
administrative costs in the prior-year period.
First-quarter research and development expenses
were $1.1 million dollars, compared to $0.9 million dollars in the
first quarter of 2021. This increase reflects investment in our
dedicated pediatric device.
The net loss for the first quarter of 2022 was
$4.5 million, compared to a net loss of $5.2 million in the
prior-year period. This resulted in $0.6 million lower net cash
used in operating activities.
Cash and cash equivalents were approximately
$19.3 million as of March 31, 2022.
Webcast and Conference Call
InformationThe 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 http://ir.nuwellis.com. Alternatively, you
may access the live conference call by dialing (877) 303-9826
(U.S.) or (224) 357-2194 (international) and using conference ID:
6092276. An audio archive of the webcast will be available
following the call at http://ir.nuwellis.com.
About NuwellisNuwellis,
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 developing, manufacturing and commercializing the
Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is
headquartered in Minneapolis, MN, with a wholly owned subsidiary in
Ireland.
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 are
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 2022 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.
NUWELLIS, INC. AND
SUBSIDIARYConsolidated Statements of Operations and
Comprehensive Loss (Unaudited)(In thousands, except per share
amounts)
|
|
Three months endedMarch 31, |
|
|
|
|
2022 |
|
|
2021 |
|
|
Net sales |
$ |
1,926 |
|
$ |
1,918 |
|
Cost of goods sold |
|
824 |
|
|
952 |
|
Gross profit |
|
1,102 |
|
|
966 |
|
Operating
expenses: |
|
|
|
|
|
|
Selling, general and administrative |
|
4,412 |
|
|
5,237 |
|
Research and development |
|
1,106 |
|
|
947 |
|
Total operating expenses |
|
5,518 |
|
|
6,184 |
|
Loss from operations |
|
(4,416 |
) |
|
(5,218 |
) |
Other income (expense),
net |
|
(55 |
) |
|
(1 |
) |
Loss before income taxes |
|
(4,471 |
) |
|
(5,219 |
) |
Income tax expense |
|
(2 |
) |
|
(2 |
) |
Net loss |
$ |
(4,473 |
) |
$ |
(5,221 |
) |
|
|
|
|
|
|
|
Basic and diluted loss
per share |
$ |
(0.42 |
) |
$ |
(1.62 |
) |
|
|
|
|
|
|
|
Weighted average shares
outstanding – basic and diluted |
|
10,538 |
|
|
3,242 |
|
|
|
|
|
|
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
Unrealized foreign currency translation adjustments |
$ |
(2 |
) |
$ |
(3 |
) |
Total comprehensive
loss |
$ |
(4,475 |
) |
$ |
(5,224 |
) |
NUWELLIS, INC. AND
SUBSIDIARY Consolidated Balance Sheets(In thousands,
except share and per share amounts)
|
|
March 31,2022 |
|
|
December 31,2021 |
ASSETS |
|
(unaudited) |
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
19,300 |
|
|
$ |
24,205 |
|
Accounts receivable |
|
951 |
|
|
|
750 |
|
Inventories |
|
3,294 |
|
|
|
2,843 |
|
Other current assets |
|
350 |
|
|
|
328 |
|
Total current
assets |
|
23,895 |
|
|
|
28,126 |
|
Property, plant and equipment, net |
|
1,153 |
|
|
|
1,188 |
|
Operating lease right-of-use asset |
|
1,038 |
|
|
|
1,082 |
|
Other assets |
|
21 |
|
|
|
21 |
|
TOTAL
ASSETS |
$ |
26,107 |
|
|
$ |
30,417 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
1,797 |
|
|
$ |
1,414 |
|
Accrued compensation |
|
1,335 |
|
|
|
1,664 |
|
Current portion of operating lease liability |
|
181 |
|
|
|
167 |
|
Current portion of finance lease liability |
|
24 |
|
|
|
26 |
|
Other current liabilities |
|
55 |
|
|
|
36 |
|
Total current
liabilities |
|
3,392 |
|
|
|
3,307 |
|
Operating lease liability |
|
909 |
|
|
|
956 |
|
Finance lease liability |
|
22 |
|
|
|
28 |
|
Other long-term liability |
|
71 |
|
|
|
179 |
|
Total
liabilities |
|
4,394 |
|
|
|
4,470 |
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
Series A junior participating
preferred stock as of March 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 both March 31, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 127 shares, issued and outstanding
127 shares |
|
— |
|
|
|
— |
|
Preferred stock as of both
March 31, 2022 and December 31, 2021, par value $0.0001 per share;
authorized 39,969,873 shares, none outstanding |
|
— |
|
|
|
— |
|
Common stock as of March 31,
2022 and December 31, 2021, par value $0.0001 per share; authorized
100,000,000 shares, issued and outstanding 10,537,606 shares |
|
1 |
|
|
|
1 |
|
Additional paid-in
capital |
|
279,114 |
|
|
|
278,873 |
|
Accumulated other
comprehensive income: |
|
|
|
|
|
Foreign currency translation adjustment |
|
(13 |
) |
|
|
(11 |
) |
Accumulated deficit |
|
(257,389 |
) |
|
|
(252,916 |
) |
Total stockholders’
equity |
|
21,713 |
|
|
|
25,947 |
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
26,107 |
|
|
$ |
30,417 |
|
NUWELLIS, INC. AND
SUBSIDIARYCondensed Consolidated Statements of Cash
Flows(Unaudited)(in thousands)
|
|
Three months ended March
31, |
|
|
2022 |
|
|
2021 |
|
Operating Activities: |
|
|
|
|
|
|
Net loss |
$ |
(4,473 |
) |
$ |
(5,221 |
) |
Adjustments to reconcile net loss
to cash flows used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
105 |
|
|
126 |
|
Stock-based compensation expense, net |
|
241 |
|
|
355 |
|
Changes in operating assets and
liabilities: |
|
|
|
|
|
|
Accounts receivable |
|
(201 |
) |
|
(14 |
) |
Inventory |
|
(451 |
) |
|
(89 |
) |
Other current assets |
|
(22 |
) |
|
(132 |
) |
Other assets and liabilities |
|
(80 |
) |
|
24 |
|
Accounts payable and accrued expenses |
|
54 |
|
|
(431 |
) |
Net cash used in
operating activities |
|
(4,827 |
) |
|
(5,382 |
) |
|
|
|
|
|
|
|
Investing
Activities: |
|
|
|
|
|
|
Purchases of property and equipment |
|
(70 |
) |
|
(56 |
) |
Net cash used in
investing activities |
|
(70 |
) |
|
(56 |
) |
|
|
|
|
|
|
|
Financing
Activities: |
|
|
|
|
|
|
Proceeds from public stock offerings, net |
|
— |
|
|
18,902 |
|
Proceeds from warrant exercises |
|
— |
|
|
1 |
|
Payments on finance lease liability |
|
(6 |
) |
|
(6 |
) |
Net cash provided (used
in) by financing activities |
|
(6 |
) |
|
18,897 |
|
|
|
|
|
|
|
|
Effect of exchange rate changes
on cash |
|
(2 |
) |
|
(3 |
) |
Net increase in cash and cash
equivalents |
|
(4,905 |
) |
|
13,456 |
|
Cash and cash equivalents -
beginning of period |
|
24,205 |
|
|
14,437 |
|
Cash and cash equivalents
- end of period |
$ |
19,300 |
|
$ |
27,893 |
|
|
|
|
|
|
|
|
Supplemental cash flow
information |
|
|
|
|
|
|
Inventory transferred to property, plant and equipment |
$ |
— |
|
$ |
89 |
|
INVESTOR CONTACTS:
George Montague, CFAChief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com
Matt Bacso, CFAGilmartin Group Matt.Bacso@gilmartinir.com
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