Vivos Therapeutics Reports First Quarter 2024 Financial Results and Provides Operational Update
Vivos Therapeutics (NASDAQ: VVOS) reported Q1 2024 financial results, highlighting a 22% reduction in operating expenses and a gross margin of 57%. Revenue for Q1 2024 was $3.4 million, down from $3.8 million in Q1 2023, due to lower VIP enrollments and CARE appliance revenue. However, revenue from pediatric and lifeline appliances and home sleep testing services increased. Gross profit was $1.9 million. Despite revenue decline, cost-cutting initiatives reduced operating loss by 24% year-over-year. Cash and cash equivalents were $2.6 million. Over 42,600 patients have been treated with Vivos' devices, and regulatory approvals for Medicare reimbursement were obtained in April 2024. The company expects positive cash flow by end-2024, driven by new strategic revenue initiatives and improved market conditions.
- Operating expenses decreased by 22% year-over-year.
- Operating loss reduced by 24% compared to Q1 2023.
- Over 42,600 patients treated with Vivos devices, up from 35,000.
- Regulatory approvals obtained for Medicare reimbursement for CARE devices.
- Anticipates positive cash flow by end of 2024.
- Significant milestone achieved in regulatory approvals.
- Revenue for Q1 2024 was $3.4 million, down from $3.8 million in Q1 2023.
- Gross profit decreased to $1.9 million from $2.3 million in Q1 2023.
- Gross margin declined from 61% to 57% year-over-year.
- Lower Vivos Integrated Provider enrollments and CARE appliance revenue.
Insights
Vivos Therapeutics' first quarter of 2024 financial results provide a mixed bag of insights. The company reported revenue of
It’s noteworthy that the company's cost-cutting initiatives have been highly effective, marking the seventh consecutive quarter of year-over-year improvement in operating expenses. This demonstrates strong fiscal discipline and management’s commitment to lean operations. Additionally, a one-time exercise of stock purchase warrants provided a liquidity boost of
From a market perspective, the approval for Medicare reimbursement of Vivos' CARE oral devices is a significant development. This opens up access to millions of Medicare beneficiaries and could potentially drive substantial increases in patient counts and utilization rates. Given that this approval aligns with broader industry shifts—such as United Healthcare's new policy favoring oral appliance therapy—Vivos is well-positioned to harness this growing market opportunity. Additionally, the suspension of CPAP shipments by Phillips Respironics could see a shift in patient preferences towards alternative treatments like those offered by Vivos.
This regulatory milestone is indicative of a potentially increased market share and improved competitive positioning for Vivos. Yet, the company's ability to convert this expanded access into sustainable revenue growth remains to be seen. Investors should focus on monitoring the uptake of these devices within the Medicare population and the impact on the company's revenues in the next few quarters to gauge the full impact of this development.
From a clinical standpoint, Vivos Therapeutics continues to make strides with its treatment solutions for sleep-related breathing disorders. The company now claims that their methods are potentially effective in approximately
The company's operational strategy to diversify its product portfolio to include pediatric and Lifeline appliances also shows a proactive approach to broadening patient demographics and treatment options. This could mitigate revenue volatility associated with VIP enrollments and provide a more stable revenue base moving forward. However, the real-world efficacy and compliance of these new devices will be critical in determining their market success, so investors should keep an eye on forthcoming clinical and user feedback data.
Vivos Expanding its Revenue Generating Initiatives
As Operating Expenses Decrease
Year Over Year Improvement Due to Successful Cost Cutting Initiatives
Management to Host Conference Call Today at 5:00 pm ET
LITTLETON, Colo., May 14, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA) in adults), today reported financial results and operating highlights for the first quarter ended March 31, 2024.
First Quarter 2024 Financial and Operating Summary
| ● | Revenue was | |
| ● | Gross profit was | |
| ● | Gross margin was | |
| ● | Operating expenses for the first quarter of 2024 decreased by a significant amount ( | |
| ● | Vivos’ cost-cutting initiatives also led to a significant year-over-year reduction in operating loss ( | |
| ● | In February 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 | |
| ● | Cash and cash equivalents were | |
| ● | As of March 31, 2024, patients treated with Vivos’ patented oral appliances totaled over 42,600 worldwide, compared to over 35,000 as of the first quarter of 2023. Vivos has also trained more than 1,950 dentists in the use of The Vivos Method and Vivos’ related value-added services, compared to over 1,750 as of the first quarter 2023; and | |
| ● | In April 2024, Vivos received all required regulatory approvals to enable Medicare reimbursement for its CARE oral devices. This milestone achievement allows millions of Medicare beneficiaries coverage and reimbursement for allowable charges billable to Medicare. The Vivos Method is estimated to be indicated and potentially effective (within the scope of the FDA cleared uses) in approximately |
Kirk Huntsman, Vivos’ Chairman and Chief Executive Officer, stated, “We are proud of the prudent way we have managed our costs and our cash resources as well as our successful efforts to expand our product offerings, gain unprecedented regulatory approvals and obtain Medicare reimbursement for our CARE oral devices. That said, we recognize that our revenues have not grown as we would have liked. To that end, we are announcing today the anticipated launch of a new strategic revenue initiative based on collaborations to better align our interests with referring medical professionals, which we expect to materially broaden the number of OSA patients who have access to our products, make our revenue less reliant of VIP enrollments, and build on the initiatives we’ve been implementing over the past year. We look forward to providing some additional details on our investor call today and in the coming weeks. All of these initiatives are intended to increase our ability to take advantage of what we see as steadily improving market conditions in OSA and open Vivos up for greater revenue opportunities. By doing this, we expect to position Vivos for long-term, sustainable revenue growth and ultimate profitability.”
“Some of the progress we’ve already made on the expense side is evident in our first quarter financial results. During the first quarter, we once again reduced our operating expenses by a substantial amount, over
“During the first quarter, we also continued to broaden our regulatory approvals for Vivos’ products and services. In April, our company achieved a significant milestone when we were granted all required regulatory approvals to enable Medicare reimbursement for Vivos’ CARE oral medical devices. Now, patients across the nation will have coverage and reimbursement for allowable charges billable to Medicare. This means Vivos’ CARE oral medical devices can now be utilized by millions of Medicare beneficiaries as an integral part of treatment regiments for moderate to severe OSA. I cannot understate the importance of this recent development, which we believe has the potential to drive increased patient count and utilization of our Vivos devices and methods.”
“Taking into consideration these favorable developments and our progress in improving internal efficiencies, we are positive about our prospects for the rest of this year and into 2025. Since the end of 2023, we have seen positive market developments, including the announcement by Phillips Respironics they were suspending CPAP shipments into the U.S., which has contributed to an increasing number of patients seeing CPAP alternatives, including oral appliance therapy. Additionally, United Healthcare announced a new policy that now mandates oral appliance therapy prior to approval of neurostimulation implant surgery for adult patients with OSA. We expect these shifts in patient needs will spur greater demand for our products and services. With our full line of OSA treatment options across a range of price points, increased regulatory approvals and the success of our cost cutting measures, we are well placed to meet this anticipated demand and deliver on the considerable promise our technology holds. Doing this, we expect to drive revenue growth as we continue on the path to becoming cash flow positive from operations,” Mr. Huntsman concluded.
Vivos encourages investors and other interested parties to join its conference call today at 5:00 p.m. Eastern time (details below), where management will discuss further details on topics including: (i) Vivos’ new collaboration initiatives described herein, expanded product line and revenue potential, (ii) an update on Vivos’ durable medical equipment and other sales and marketing efforts; (ii) additional programs for dentists to enroll with Vivos, and (iv) Vivos’ current cash position and actions taken to reduce expenses and remain compliant with Nasdaq listing standards.
In addition, further information on Vivos’ financial results is included on the attached unaudited condensed consolidated balance sheets and statements of operations, and additional explanations of Vivos’ financial performance are provided in the Vivos’ Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which will be filed with the Securities and Exchange Commission (“SEC”). The full 10-Q report will be available on the SEC Filings section of the Investor Relations section of Vivos’ website at https://vivos.com/investor-relations.
Conference Call
To access Vivos’ investor conference call, please dial (800) 717-1738, or for international callers, (646) 307-1865. 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 1180952. The replay will be available until May 28, 2024.
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 Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to severe OSA. It has proven effective in over 42,600 patients treated worldwide by more than 1,950 trained dentists.
The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The three Vivos CARE devices open airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
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 the actual results of the initiatives described herein on Vivos’ future revenues 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 generate additional revenue from its receipt of the Medicare reimbursement code described herein or from other strategies aimed at increasing 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 SEC. Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
Vivos Investor Relations and Media Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com
| -Tables Follow- | ||||||||
| VIVOS THERAPEUTICS INC. Unaudited Condensed Consolidated Balance Sheets (In Thousands, Except Per Share Amounts) | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 2,611 | $ | 1,643 | ||||
| Accounts receivable, net of allowance of | 525 | 202 | ||||||
| Prepaid expenses and other current assets | 475 | 616 | ||||||
| Total current assets | 3,611 | 2,461 | ||||||
| Long-term assets | ||||||||
| Goodwill | 2,843 | 2,843 | ||||||
| Property and equipment, net | 3,332 | 3,314 | ||||||
| Operating lease right-of-use asset | 1,302 | 1,385 | ||||||
| Intangible assets, net | 408 | 420 | ||||||
| Deposits and other | 308 | 307 | ||||||
| Total assets | $ | 11,804 | $ | 10,730 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,499 | $ | 2,145 | ||||
| Accrued expenses | 2,466 | 2,334 | ||||||
| Current portion of contract liabilities | 2,398 | 2,138 | ||||||
| Current portion of operating lease liability | 483 | 474 | ||||||
| Other current liabilities | 224 | 198 | ||||||
| Total current liabilities | 8,070 | 7,289 | ||||||
| Long-term liabilities | ||||||||
| Contract liabilities, net of current portion | 533 | 289 | ||||||
| Employee retention tax credit liability | 1,220 | 1,220 | ||||||
| Operating lease liability, net of current portion | 1,399 | 1,521 | ||||||
| Total liabilities | 11,222 | 10,319 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred Stock, | - | - | ||||||
| Common Stock, | - | - | ||||||
| Additional paid-in capital | 97,396 | 93,462 | ||||||
| Accumulated deficit | (96,814 | ) | (93,051 | ) | ||||
| Total stockholders’ equity | 582 | 411 | ||||||
| Total liabilities and stockholders’ equity | $ | 11,804 | $ | 10,730 | ||||
| VIVOS THERAPEUTICS INC. Unaudited Condensed Consolidated Statements of Operations (In Thousands, Except Per Share Amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenue | ||||||||
| Product revenue | $ | 1,674 | $ | 1,772 | ||||
| Service revenue | 1,745 | 2,085 | ||||||
| Total revenue | 3,419 | 3,857 | ||||||
| Cost of sales (exclusive of depreciation and amortization shown separately below) | 1,482 | 1,520 | ||||||
| Gross profit | 1,937 | 2,337 | ||||||
| Operating expenses | ||||||||
| General and administrative | 4,921 | 6,537 | ||||||
| Sales and marketing | 655 | 630 | ||||||
| Depreciation and amortization | 146 | 175 | ||||||
| Total operating expenses | 5,722 | 7,342 | ||||||
| Operating loss | (3,785 | ) | (5,005 | ) | ||||
| Non-operating income (expense) | ||||||||
| Other expense | (1 | ) | 51 | |||||
| Excess warrant fair value | - | (6,453 | ) | |||||
| Change in fair value of warrant liability, net of issuance costs of | - | 9,628 | ||||||
| Other income | 23 | 76 | ||||||
| Loss before income taxes | (3,763 | ) | (1,703 | ) | ||||
| Net loss | $ | (3,763 | ) | $ | (1,703 | ) | ||
| Net loss per share (basic and diluted) | $ | (1.63 | ) | $ | (1.72 | ) | ||
| Weighted average number of shares of Common Stock outstanding (basic and diluted) | 2,308,154 | 990,669 | ||||||
FAQ
What were Vivos Therapeutics' Q1 2024 revenues?
How much did Vivos Therapeutics reduce its operating expenses in Q1 2024?
What was Vivos Therapeutics' gross margin in Q1 2024?
How many patients have been treated with Vivos devices as of Q1 2024?
Did Vivos Therapeutics receive Medicare reimbursement approvals in Q1 2024?
What is the expected cash flow status of Vivos Therapeutics by the end of 2024?
What was the cash and cash equivalents position of Vivos Therapeutics at the end of Q1 2024?
