Motus GI Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
Motus GI Holdings, Inc. (NASDAQ: MOTS) reported its Q4 and 2022 financial results, highlighting a revenue increase to $109,000 in Q4 2022, up from $99,000 in Q4 2021. Full-year revenues reached $592,000, a rise from $391,000 in 2021. The net loss for Q4 2022 was $3.7 million ($0.79 per share), an improvement from a $4.8 million loss a year prior. For the full year, net loss was $18.6 million ($5.74 per share) compared to $25.2 million in 2021. The company continues to develop its Pure-Vu EVS Gastro device, expecting FDA submission by year-end 2023. A strategic restructuring is in progress, aiming for a 35% reduction in quarterly operating costs and exploring financing alternatives to maximize shareholder value.
- Q4 2022 revenue increased to $109,000, up from $99,000 YoY.
- 2022 revenue rose to $592,000, compared to $391,000 in 2021.
- Net loss narrowed to $3.7 million in Q4 2022 from $4.8 million YoY.
- Net loss decreased to $18.6 million for the full year from $25.2 million in 2021.
- Expected FDA submission for Pure-Vu EVS Gastro by end of 2023, indicating product advancement.
- Continued net losses indicate ongoing financial challenges.
- Significant restructuring costs of $1.0 to 2.0 million expected in Q1 2023.
- Limited cash reserves of $14.0 million as of December 31, 2022, down from $22.6 million in 2021.
- The Company continues its exploration process to target strategic and financing alternatives aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value
- The Company is actively supporting its existing installed customer base and pipeline opportunities in contracted health systems
- The Company is advancing its development of Pure-Vu EVS Gastro, designed for Upper GI bleeding procedures, and expects submission to FDA by the end of 2023
FORT LAUDERDALE, Fla., March 31, 2023 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today reported its financial results for the fourth quarter and year ended December 31, 2022, and provided a corporate update.
“As previously announced, we initiated the ongoing evaluation of strategic and financing alternatives with the goal of identifying opportunities to accelerate our commercialization of the Pure-Vu System while also maximizing shareholder value. In the meantime, we have also implemented a restructuring process to further reduce our costs, while maintaining the ability to support our customers and targeted commercial activities,” commented Tim Moran, Chief Executive Officer.
“We remain on track to achieve our previously communicated timeline for submission of our Pure-Vu Gastro Upper GI product to the FDA in the second half of 2023. New enhancements in this device will be incorporated into the current Pure-Vu colon device, which will reduce our overall cost-of-goods by approximately
Fourth Quarter and Recent Business Highlights
- The Company’s commercial program continues providing sales and support to hospitals across the United States that have implemented Pure-Vu EVS, as well as pipeline opportunities in contracted health systems.
- The Company recently announced it had initiated a process of exploring a range of strategic and financing alternatives focused on maximizing stockholder value and accelerating commercialization of the Pure-Vu System. Potential strategic alternatives that may be considered by the Company as part of this process include an acquisition, merger, reverse merger, other business combination, sale of assets, licensing, and other strategic transactions. The Company intends to continue to pursue this process, however, there can be no assurance that it will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful.
- In January 2023, the Company began implementing a strategic restructuring program, including a reduction in workforce, with the objective of preserving capital by initially reducing quarterly operating costs by approximately
35% on a go forward basis. The Company expects to incur a non-recurring charge of approximately$1.0 t o 2.0 million in the first quarter of 2023 related to the restructuring.
◼ Product Innovation
- Motus GI continues to advance the development of the Pure-Vu EVS Gastro device, which is on track to be submitted to the FDA before the end of this year via the 510(k) process. This device brings upper GI capabilities to the new Pure-Vu EVS platform through key enhancements, including a larger and more powerful suction channel, more efficient irrigation jets, and a smaller profile distal tip that offers enhanced flexibility during insertion. In addition, several of the design enhancements will result in a significant reduction in cost-of-goods compared to the EVS colon device that is currently on the market. In parallel the Company is working on incorporating the improvements developed for the Pure-Vu EVS Gastro into the device for the colon, which should achieve approximately a
50% reduction in the cost-of-goods to be better positioned for strategic relationships. - The Company believes the Upper GI application and removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat a bleed source. Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. The mortality rate of this condition can reach up to approximately
13% , as noted in Thad Wilkins, MD, et al., American Family Physician (2012).
◼ Outpatient Reimbursement Strategy
- The Company has designed a large, multi-center trial designed to show a significant reduction in the number of aborted or poor-quality exams that lead to an early repeat procedure as defined by the Gastroenterology Tri-Society guidelines. The study’s aim is to generate data quantifying the percentage of patients with inadequate prep and showing the Pure Vu Systems ability to achieve a substantial clinical improvement in those patients compared to the standard of care in a large multicenter trial. The results from this study are expected to support applications seeking reimbursement of the Pure-Vu System when used in certain outpatient colonoscopies, a market representing approximately 4.7 million procedures per year.
Financial Results for the Quarter and Year Ended December 31, 2022
The Company reported revenue of
For the three months ended December 31, 2022, the Company reported a net loss attributable to common shareholders of
For the year ended December 31, 2022, the Company reported a net loss attributable to common shareholders of
During the fourth quarter of 2022, net cash used in operating activities and for the purchase of fixed assets was
Net cash used in operating activities and for the purchase of fixed assets during the year ended December 31, 2022 totaled
The Company reported
Motus GI Holdings, Inc. and Subsidiaries Condensed Consolidated Balance Sheets Highlights (unaudited, in thousands) | ||||||||
As of | ||||||||
December 31, 2022 | December 31, 2021 | |||||||
Cash | $ | 14,042 | $ | 22,563 | ||||
Working capital | 10,571 | 20,629 | ||||||
Total assets | 17,647 | 26,089 | ||||||
Total shareholders’ equity | 2,977 | 9,657 | ||||||
About Motus GI
Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions.
For more information, visit www.motusgi.com and connect with the Company on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains certain forward-looking statements. Forward-looking statements are based on the Company’s current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms, including without limitation, risks related to the continued impact of the COVID-19 pandemic, risks inherent in the development and commercialization of potential products, possible or assumed future results of operations, business strategies, potential grow opportunities, uncertainty in the timing and results of clinical trials or regulatory approvals, maintenance of intellectual property rights or other risks discussed in the Company’s quarterly and annual reports filed with the Securities and Exchange Commission, and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor Contact:
Troy Williams
LifeSci Advisors
(518) 221-0106
twilliams@lifesciadvisors.com
Motus GI Holdings, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | ||||||||
December 31, | ||||||||
2022 | 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 14,042 | $ | 22,563 | ||||
Accounts receivable | 59 | 109 | ||||||
Inventory, current | 488 | 496 | ||||||
Prepaid expenses and other current assets | 781 | 793 | ||||||
Total current assets | 15,370 | 23,961 | ||||||
Fixed assets, net | 1,325 | 1,428 | ||||||
Inventory, non-current | 511 | - | ||||||
Right-of-use assets | 428 | 687 | ||||||
Other non-current assets | 13 | 13 | ||||||
Total assets | $ | 17,647 | $ | 26,089 | ||||
Liabilities and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued expenses | $ | 1,969 | $ | 2,584 | ||||
Operating lease liabilities - current | 245 | 307 | ||||||
Other current liabilities | 53 | 10 | ||||||
Current portion of long-term debt, net of unamortized debt discount of | 2,532 | 431 | ||||||
Total current liabilities | 4,799 | 3,332 | ||||||
Contingent royalty obligation | 1,212 | 1,760 | ||||||
Operating lease liabilities - non-current | 178 | 385 | ||||||
Convertible note, net of unamortized debt discount of | 3,892 | 3,834 | ||||||
Long-term debt, net of unamortized debt discount of | 4,589 | 7,121 | ||||||
Total liabilities | 14,670 | 16,432 | ||||||
Commitments and contingent liabilities (Note 9) | ||||||||
Shareholders’ equity | ||||||||
Preferred stock | - | - | ||||||
Common stock | - | 5 | ||||||
Additional paid-in capital | 144,328 | 132,406 | ||||||
Accumulated deficit | (141,351 | ) | (122,754 | ) | ||||
Total shareholders’ equity | 2,977 | 9,657 | ||||||
Total liabilities and shareholders’ equity | $ | 17,647 | $ | 26,089 | ||||
Motus GI Holdings, Inc. and Subsidiaries Condensed Consolidated Statements of Comprehensive Loss (Unaudited, in thousands, except share and per share amounts) | ||||||||||||||||
Three Months Ended December 31, | Twelve months Ended December 31, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue | $ | 109 | $ | 99 | $ | 592 | $ | 391 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of revenue - sales | 32 | 46 | 198 | 181 | ||||||||||||
Cost of revenue - impairment of inventory | 439 | 257 | 598 | 443 | ||||||||||||
Research and development | 1,350 | 1,301 | 5,611 | 5,341 | ||||||||||||
Sales and marketing | 872 | 881 | 4,425 | 3,077 | ||||||||||||
General and administrative | 1,444 | 2,169 | 7,611 | 9,273 | ||||||||||||
Total costs and expenses | 4,137 | 4,654 | 18,443 | 18,315 | ||||||||||||
Operating loss | (4,028 | ) | (4,555 | ) | (17,851 | ) | (17,924 | ) | ||||||||
Gain (loss) on change in estimated fair value of contingent royalty obligation | 577 | 9 | 548 | (143 | ) | |||||||||||
Loss on extinguishment of debt | - | (267 | ) | - | (237 | ) | ||||||||||
Finance expense, net | (251 | ) | (216 | ) | (1,252 | ) | (717 | ) | ||||||||
Other income | - | - | - | 5 | ||||||||||||
Foreign currency gain (loss) | 19 | (5 | ) | (42 | ) | (17 | ) | |||||||||
Net loss | (3,683 | ) | (4,818 | ) | (18,597 | ) | (19,033 | ) | ||||||||
Deemed dividends from warrant issuance | - | - | - | (6,145 | ) | |||||||||||
Net loss attributable to common shareholders | $ | (3,683 | ) | $ | (4,818 | ) | $ | (18,597 | ) | $ | (25,178 | ) | ||||
Basic and diluted loss per common share: | ||||||||||||||||
Net loss attributable to common shareholders | $ | (0.79 | ) | $ | (1.99 | ) | $ | (5.74 | ) | $ | (10.74 | ) | ||||
Weighted average number of common shares outstanding, basic and diluted | 4,646,834 | 2,415,315 | 3,237,952 | 2,344,759 | ||||||||||||
FAQ
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