Exhibit 10.1

 

SECOND AMENDMENT TO

 

THE NUWELLIS, INC.

 

2021 INDUCEMENT PLAN

 

The Nuwellis, Inc. 2021 Inducement Plan, as amended (the “Plan”) is hereby amended in the following respects, effective February 23, 2023, in accordance with Section 2(b)(vi) of the Plan.

 

The first sentence of Section 3(a) of the Plan is deleted in its entirety and replaced with the following sentence:

 

“Subject to Section 9(a) relating Capitalization Adjustments, the aggregate number of shares of Common Stock that may be issued pursuant to Awards will not exceed 46,928 shares (the “Share Reserve”).”

 

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Nuwellis, Inc. Announces Fourth Quarter and Full Year 2022 Financial Results

Q4 Revenue Up 42%; Expansion of Clinical Evidence Sets Stage for 2023 Growth

Minneapolis, MN, February 28, 2023 (GLOBE NEWSWIRE) -- 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.

“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.

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 Nuwellis

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 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 Cervantes

Gilmartin Group

MEDIA:

Annika Parish

Health+Commerce

		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

		Three months ended December 31,								Twelve months ended December 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	)