8-K
Nuwellis, Inc. (NUWE)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 8, 2022
Nuwellis, Inc.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-35312 | No. 68-0533453 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
12988 Valley View Road, Eden Prairie, MN 55344
(Address of Principal Executive Offices) (Zip Code)
(952) 345-4200
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | NUWE | Nasdaq Capital Market |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition. |
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On November 8, 2022, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three and nine months ended September 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.
| Item 9.01 | Financial Statements and Exhibits. |
|---|---|
| (d) | Exhibits |
| --- | --- |
Exhibit No. Description
| 99.1 | Press Release, dated November 8, 2022, reporting the financial results of Nuwellis, Inc. for the three and nine months ended September 30, 2022. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 8, 2022 | NUWELLIS, INC. | |
|---|---|---|
| By: | /s/ Nestor Jaramillo, Jr. | |
| Name: | Nestor Jaramillo, Jr. | |
| Title: | President and Chief Executive Officer |
Exhibit 99.1
Nuwellis, Inc. Reports Third Quarter 2022 Financial Results
Minneapolis, MN, November 8, 2022 (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 third quarter ended September 30, 2022.
Q3 Results and Recent Highlights:
| • | Revenue of $2.1 million in the third quarter 2022, an 11% increase over the same year ago period |
|---|---|
| • | Gross margin of 61% was consistent with the same period last year |
| --- | --- |
| • | Activated three additional sites for pivotal REVERSE-HF clinical study |
| --- | --- |
| • | Announced AVOID-HF clinical study analysis demonstrating statistically superior benefit of ultrafiltration over diuretics for fluid-overloaded heart failure patients at 30 and 90 days |
| --- | --- |
| • | Announced clinical data demonstrating reduced mortality rates, with 100% survival rate in post-operative CABG patients at 30 days following use of ultrafiltration |
| --- | --- |
| • | Awarded U.S. patent for novel innovation that improves fluid balance and safety in pediatric dialysis and hemofiltration |
| --- | --- |
| • | Closed an underwritten public offering on October 18, with $11.0 million of gross proceeds |
| --- | --- |
“We made meaningful progress this quarter on the continued execution of our key strategic initiatives and achieved 11% year-over-year revenue growth. These results not only demonstrate that we are gaining traction on the sales front but also continuing to achieve key milestones toward making the Aquadex system the standard of care for restoring fluid balance. We are confident that continued expansion of our field sales team, including clinical education specialists, bolstered by our market penetration initiatives and growing body of clinical evidence, will position Nuwellis well for strong growth in 2023 and beyond,” said Nestor Jaramillo, CEO of Nuwellis.
Third Quarter 2022 Financial Results
Total revenue for the third quarter of 2022 was $2.1 million, an increase of 11% compared to the third quarter of 2021.
Gross margin was 61.0% for the third quarter of 2022 compared to 60.4% in the prior-year period.
Selling, general and administrative expenses for the third quarter of 2022 were $4.3 million, compared to $4.6 million in the prior-year period. This reduction resulted from continued spending vigilance, as well as some open positions in the current year quarter.
Third quarter research and development expenses were $0.9 million, compared to $1.7 million in the third quarter of 2021, while continuing to advance the most critical new product development initiatives.
The net loss for the third quarter of 2022 was $3.9 million, or a loss of $0.37 per basic and diluted common share, compared to a net loss of $5.3 million, or a loss of $0.75 per basic and diluted common share in the prior-year period.
Cash and cash equivalents were approximately $12.1 million at September 30, 2022. On October 18, Nuwellis closed an underwritten public offering with gross proceeds of $11.0 million. After deducting underwriting discounts and commissions on the offering, pro forma cash at the end of the third quarter would have been $21.9 million.
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 1-844-825-9789 (U.S) or 1-412-317-5180 (international) and using the conference ID: 10172214. 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 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 superior 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 healthcare provider, in an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
Forward-Looking Statements
Certain 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.
CONTACTS
INVESTORS:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com
MEDIA:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com
FINANCIAL STATEMENTS
NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| December 31,<br><br> <br>2021 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| Current assets | |||||
| Cash and cash equivalents | 12,053 | $ | 24,205 | ||
| Accounts receivable | 1,100 | 750 | |||
| Inventories | 2,919 | 2,843 | |||
| Other current assets | 368 | 328 | |||
| Total current assets | 16,440 | 28,126 | |||
| Property, plant and equipment, net | 1,027 | 1,188 | |||
| Operating lease right-of-use asset | 949 | 1,082 | |||
| Other assets | 21 | 21 | |||
| TOTAL ASSETS | 18,437 | $ | 30,417 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities | |||||
| Accounts payable | 1,561 | $ | 1,414 | ||
| Accrued compensation | 1,751 | 1,664 | |||
| Current portion of operating lease liability | 191 | 167 | |||
| Current portion of finance lease liability | 35 | 26 | |||
| Other current liabilities | 73 | 36 | |||
| Total current liabilities | 3,611 | 3,307 | |||
| Operating lease liability | 810 | 956 | |||
| Finance lease liability | — | 28 | |||
| Other long-term liability | — | 179 | |||
| Total liabilities | 4,421 | 4,470 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity | |||||
| Series A junior participating preferred stock as of September 30, 2022 and <br> December 31, 2021, par value 0.0001 per share; authorized 30,000 shares, none outstanding | — | — | |||
| Series F convertible preferred stock as of both September 30, 2022 and <br> December 31, 2021, par value 0.0001 per share; authorized 127 shares, issued and outstanding 127 shares | — | — | |||
| Preferred stock as of both September 30, 2022 and December 31, 2021, par value <br> 0.0001 per share; authorized 39,969,873 shares, none outstanding | — | — | |||
| Common stock as of September 30, 2022 and December 31, 2021, par value 0.0001 per share; authorized<br> 100,000,000 shares, issued and outstanding 10,537,606 shares | 1 | 1 | |||
| Additional paid-in capital | 279,570 | 278,873 | |||
| Accumulated other comprehensive income: | |||||
| Foreign currency translation adjustment | (10 | ) | (11 | ) | |
| Accumulated deficit | (265,545 | ) | (252,916 | ) | |
| Total stockholders’ equity | 14,016 | 25,947 | |||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 18,437 | $ | 30,417 |
All values are in US Dollars.
NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except per share amounts)
| Three months ended<br><br> <br>September 30, | Nine months ended<br><br> <br>September 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Net sales | $ | 2,065 | $ | 1,853 | $ | 6,204 | $ | 6,279 | ||||
| Cost of goods sold | 806 | 733 | 2,780 | 2,682 | ||||||||
| Gross profit | 1,259 | 1,120 | 3,424 | 3,597 | ||||||||
| Operating expenses: | ||||||||||||
| Selling, general and administrative | 4,251 | 4,645 | 12,920 | 14,945 | ||||||||
| Research and development | 928 | 1,726 | 3,141 | 3,847 | ||||||||
| Total operating expenses | 5,179 | 6,371 | 16,061 | 18,792 | ||||||||
| Loss from operations | (3,920 | ) | (5,251 | ) | (12,637 | ) | (15,195 | ) | ||||
| Other income (expense), net | 52 | (19 | ) | 14 | (22 | ) | ||||||
| Loss before income taxes | (3,868 | ) | (5,270 | ) | (12,623 | ) | (15,217 | ) | ||||
| Income tax expense | (2 | ) | (2 | ) | (6 | ) | (7 | ) | ||||
| Net loss | $ | (3,870 | ) | $ | (5,272 | ) | $ | (12,629 | ) | $ | (15,224 | ) |
| Basic and diluted loss per share | $ | (0.37 | ) | $ | (0.75 | ) | $ | (1.20 | ) | $ | (2.72 | ) |
| Weighted average shares outstanding – basic and diluted | 10,538 | 7,098 | 10,538 | 5,624 | ||||||||
| Other comprehensive loss: | ||||||||||||
| Foreign currency translation adjustments | $ | 2 | $ | — | $ | 1 | $ | (3 | ) | |||
| Total comprehensive loss | $ | (3,868 | ) | $ | (5,272 | ) | $ | (12,628 | ) | $ | (15,227 | ) |
NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
| Nine months ended<br><br> <br>September 30, | ||||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | |||||
| Operating Activities: | ||||||
| Net loss | $ | (12,629 | ) | $ | (15,224 | ) |
| Adjustments to reconcile net loss to cash flows used in operating activities: | ||||||
| Depreciation and amortization | 301 | 383 | ||||
| Stock-based compensation expense, net | 697 | 993 | ||||
| Changes in operating assets and liabilities: | ||||||
| Accounts receivable | (350 | ) | (164 | ) | ||
| Inventory | (113 | ) | (105 | ) | ||
| Other current assets | (40 | ) | (183 | ) | ||
| Other assets and liabilities | (142 | ) | 279 | |||
| Accounts payable and accrued expenses | 254 | 333 | ||||
| Net cash used in operating activities | (12,022 | ) | (13,688 | ) | ||
| Investing Activities: | ||||||
| Purchases of property and equipment | (103 | ) | (191 | ) | ||
| Net cash used in investing activities | (103 | ) | (191 | ) | ||
| Financing Activities: | ||||||
| Proceeds from public stock offerings, net | — | 27,896 | ||||
| Proceeds from warrant exercises | — | 1 | ||||
| Payments on finance lease liability | (28 | ) | (21 | ) | ||
| Net cash provided (used in) by financing activities | (28 | ) | 27,876 | |||
| Effect of exchange rate changes on cash | 1 | (3 | ) | |||
| Net increase (decrease) in cash and cash equivalents | (12,152 | ) | 13,994 | |||
| Cash and cash equivalents - beginning of period | 24,205 | 14,437 | ||||
| Cash and cash equivalents - end of period | $ | 12,053 | $ | 28,431 | ||
| Supplemental cash flow information | ||||||
| Inventory transferred to property, plant and equipment | $ | 37 | $ | 257 |