Positive Business Momentum and Sales Pipeline Growth Following FDA 510(k) Clearance of Vivos’ Proprietary Oral Medical Devices to Treat Severe Obstructive Sleep Apnea
Annual Operating Expenses Declined 27% Due to Success of Cost Cutting Initiatives
Management to Host Conference Call Today at
Fourth Quarter and Full Year 2023 Financial and Operating Summary
- Revenue was
$3.2 million for the fourth quarter of 2023 and$13.8 million for the full year endedDecember 31, 2023 , compared to$4.0 million and$16.0 million for the fourth quarter and full year endedDecember 31, 2022 , respectively, mainly due to lower appliance revenue and Vivos Integrated Provider (VIP) enrollments, offset by increased revenue from home sleep testing services and seminars conducted at theVivos Institute inDenver . Importantly, Vivos believes that governmental investigations of unrelated third parties with non-FDA approved products in the sleep apnea treatment space adversely impacted new Vivos case starts and VIP enrollments during 2023. - Gross profit was
$2.1 million for the fourth quarter of 2023 and$8.3 million for the full year endedDecember 31, 2023 , compared to$2.4 million and$10.0 million for the comparable periods in 2022, respectively, attributable primarily to the decrease in revenue; - Gross margin was 64% and 60% for the fourth quarters of 2023 and 2022, respectively. For the full year ended
December 31, 2023 , gross margin was 60%, compared 63% for the full year endedDecember 31, 2022 ; - Operating expenses for the fourth quarter of 2023 decreased by a significant amount (
$2.2 million , or 26%) versus the fourth quarter of 2022, reflecting Vivos’ previously announced cost-cutting initiatives including personnel and related expenses. For the full year endedDecember 31, 2023 operating expenses decreased by$9.5 million or 27%, compared to the full year 2022; - Vivos’ cost-cutting initiatives also led to significant year-over-year reductions of net loss of
$1.8 million , or a 30% reduction, and$10.3 million , or a 43% reduction, for the fourth quarter and full year endedDecember 31, 2023 , respectively, compared to the same periods in 2022. Vivos plans to utilize its cost reductions to help achieve cash flow positive operations by the end of 2024 should revenue increase as planned; - Cash and cash equivalents were
$1.6 million atDecember 31, 2023 . Subsequent to year end, inFebruary 2024 , an outstanding common stock purchase warrant held by an institutional investor to purchase an aggregate of 980,393 shares of Vivos common stock was exercised for gross proceeds of approximately$4.0 million ; - As of
December 31, 2023 , patients treated with Vivos’ patented oral appliances totaled over 42,000 worldwide, compared to over 33,000 as of the end of 2022. Vivos has also trained more than 1,900 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to over 1,700 as of the end of 2022; - In
October 2023 , Vivos announced two key strategic agreements with Ormco, a division of publicly-traded Envista Holdings Corporation, and On Demand Orthodontist (ODO), offering Vivos’ national network of providers access to Spark™ Clear Aligners. The agreements will expand Vivos’ current product line and are expected to create near term additional revenue opportunities; - Also in October, Vivos announced an exclusive distribution agreement with NOUM DMCC (“Noum”), a
Dubai -based company focused on diagnostic testing and treatment product distribution for healthcare providers and hospital networks treating obstructive sleep apnea patients throughout theMiddle East -North Africa (MENA) region. Subject to regulatory approvals, Vivos could see revenue from this collaboration in 2024; - Later in October, Vivos announced that its flagship daytime-nighttime appliance (DNA) will be tested in a clinical trial at Stanford Medicine. The protocol has been finalized and participant enrollment will begin in 2024. Study participants with moderate to severe OSA will be randomly assigned to either treatment with Vivos’ DNA appliance or CPAP (continuous positive airway pressure) machine, the current industry standard for OSA treatment. Sleep studies will be performed prior to and following a course of treatment using in-lab polysomnography to assess changes in the patients’ apnea-hypopnea index (AHI);
- On
October 27, 2023 , Vivos effected a 1-for-25 reverse stock split of its issued and outstanding common stock. The reverse stock split was approved at Vivos’ 2023 Annual Meeting of Stockholders onSeptember 22, 2023 ; - In
November 2023 , Vivos amended its national distribution agreement with Lincare, a leading supplier of in-home respiratory therapy products and services for approximately 1.8 million patients, giving Lincare a six-month exclusivity period to distribute certain designated Vivos devices. The agreement follows the successful conclusion of a distribution pilot with Lincare, and marks an important milestone in Vivos’ strategy to engage with leading durable medical equipment (DME) companies inthe United States ; and - Later in November, Vivos was granted 510(k) clearance from the
U.S. Food and Drug Administration (FDA) for treating severe OSA in adults using the Vivos’ removableCARE (Complete Airway Repositioning and/or Expansion) oral appliances. Vivos’CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance. This represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.
“We also took actions to strengthen our capital structure and improve our liquidity. Last year, we effected a 1-for-25 reverse stock split to come back into compliance with Nasdaq’s minimum bid requirement. More recently, we completed a
“In addition, throughout 2023 we established a number of key relationships to expand our product line and extend our international presence into the
“Perhaps most important, in November, we received FDA 510(k) clearance for our
“As we move through the new year, macroeconomic trends exiting 2023 and in early 2024 give us optimism that the larger environment is improving. At the same time, we are seeing increased interest from dentists and medical professionals related to our growing portfolio of products, driven by our new FDA clearance for severe OSA. The FDA clearance to treat severe OSA has provided the credibility we have needed for medical doctors to recommend Vivos oral medical devices to their patients. Given all this, the key relationships we’ve established, our success in managing costs and reducing our cash burn, our increased liquidity and enhanced capital structure, we are extremely excited about our prospects for this year. We believe we have all the necessary tools in place to implement our growth plans, drive increased revenues and achieve cash flow positive operations and profitability in the foreseeable future, and we remain committed to doing so,”
Vivos encourages investors and other interested parties to join its conference call today at
In addition, further information on Vivos’ financial results is included on the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Vivos’ financial performance are provided in the Vivos’ Annual Report on Form 10-K for the twelve months ended
Conference Call
To access Vivos’ investor conference call, please dial (888) 886-7786, or for international callers, (416) 764-8658. A replay will be available shortly after the call and can be accessed by dialing (844) 512-2921, or for international callers, (412) 317-6671. The passcode for the live call and the replay is 27185528. The replay will be available until
A live webcast of the conference call can be accessed on Vivos’ website at https://vivos.com/investor-relations. An online archive of the webcast will be available on the Company’s website for 30 days following the call.
About
The Vivos Method includes treatment regimens that employ the proprietary
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward-Looking Statements
This press release, the conference call referred to herein, and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, the results of the Company’s sales and marketing initiatives and results of operations) may differ materially and adversely from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to implement revenue, sales, marketing, collaboration and other strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos’ products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financing on reasonable terms when needed, if at all, or maintain its Nasdaq listing and (v) other risk factors described in Vivos’ filings with the
Vivos Investor Relations and Media Contact:
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com
-Tables Follow-
Unaudited Condensed Consolidated Balance Sheets
(In Thousands, Except Per Share Amounts)
2023 | 2022 | |||||||
Current assets | ||||||||
Cash and cash equivalents | $ | 1,643 | $ | 3,519 | ||||
Accounts receivable, net of allowance of | 202 | 457 | ||||||
Prepaid expenses and other current assets | 616 | 1,448 | ||||||
Total current assets | 2,461 | 5,424 | ||||||
Long-term assets | ||||||||
2,843 | 2,843 | |||||||
Property and equipment, net | 3,314 | 3,082 | ||||||
Operating lease right-of-use asset | 1,385 | 1,695 | ||||||
Intangible assets, net | 420 | 302 | ||||||
Deposits and other | 307 | 374 | ||||||
Total assets | $ | 10,730 | $ | 13,720 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities | ||||||||
Accounts payable | $ | 2,145 | $ | 1,411 | ||||
Accrued expenses | 2,334 | 1,912 | ||||||
Current portion of contract liabilities | 2,138 | 2,926 | ||||||
Current portion of operating lease liability | 474 | 419 | ||||||
Other current liabilities | 198 | 145 | ||||||
Total current liabilities | 7,289 | 6,813 | ||||||
Long-term liabilities | ||||||||
Contract liabilities, net of current portion | 289 | 112 | ||||||
Employee retention credit liability | 1,220 | - | ||||||
Operating lease liability, net of current portion | 1,521 | 1,994 | ||||||
Total liabilities | 10,319 | 8,919 | ||||||
Commitments and contingencies | - | - | ||||||
Stockholders’ equity | ||||||||
Preferred Stock, | - | - | ||||||
Common Stock, | - | - | ||||||
Additional paid-in capital | 93,462 | 84,269 | ||||||
Accumulated deficit | (93,051 | ) | (79,468 | ) | ||||
Total stockholders’ equity | 411 | 4,801 | ||||||
Total liabilities and stockholders’ equity | $ | 10,730 | $ | 13,720 | ||||
Unaudited Condensed Consolidated Statements of Operations
Years Ended
(In Thousands, Except Per Share Amounts)
2023 | 2022 | |||||||
Revenue | ||||||||
Product revenue | $ | 6,270 | $ | 8,381 | ||||
Service revenue | 7,531 | 7,643 | ||||||
Total revenue | 13,801 | 16,024 | ||||||
Cost of sales (exclusive of depreciation and amortization shown separately below) | 5,530 | 6,005 | ||||||
Gross profit | 8,271 | 10,019 | ||||||
Operating expenses | ||||||||
General and administrative | 22,479 | 29,041 | ||||||
Sales and marketing | 2,467 | 5,340 | ||||||
Depreciation and amortization | 621 | 669 | ||||||
Total operating expenses | 25,567 | 35,050 | ||||||
Operating loss | (17,296 | ) | (25,031 | ) | ||||
Non-operating income (expense) | ||||||||
Other expense | (212 | ) | (190 | ) | ||||
PPP loan forgiveness | - | 1,287 | ||||||
Excess warrant fair value | (6,453 | ) | - | |||||
Change in fair value of warrant liability, net of issuance costs of | 10,231 | - | ||||||
Other income | 147 | 89 | ||||||
Loss before income taxes | (13,583 | ) | (23,845 | ) | ||||
Net loss | $ | (13,583 | ) | $ | (23,845 | ) | ||
Net loss per share (basic and diluted) | $ | (11.14 | ) | $ | (25.90 | ) | ||
Weighted average number of shares of Common Stock outstanding (basic and diluted) | 1,219,381 | 920,592 |
Source:
2024 GlobeNewswire, Inc., source