Third Quarter Revenue Increased Over 38% Year-Over-Year
Expects to Benefit from Increased OSA Testing, Opening of Live Training Facility, Expansion of Marketing Programs, Additional FDA Approval and Positive Study Results
Management to Host Conference Call Today at 5:00 pm ET
Colorado, November 15, 2021
Vivos Therapeutics, Inc. (“Vivos” or the “Company”) (NASDAQ: VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from mild to moderate obstructive sleep apnea (OSA) and snoring in adults, today reported financial results and operating highlights for the third quarter and nine months ended September 30, 2021.
Financial and Operating Highlights:
- Revenue increased over 38% to $4.5 million for the third quarter of 2021 and was $12.5 million for the nine months ended September 30, 2021, compared to $3.3 million and $9.8 million for the three and nine months ended September 30, 2020, respectively, as Vivos benefited from increased appliance sales and additional sources of revenue including Billing Intelligence Services and MyoCorrect myofunctional therapy;
- Appliance sales increased to 2,996 total oral appliance arches, a 33% increase for the third quarter of 2021 compared to 2,245 the same period in 2020, and rose to 8,648 total oral appliance arches, a 54% increase for the nine months ended September 30, 2021 versus 5,610 for the same period in 2020;
- Dentist enrollments in the Vivos Integrated Practice (VIP) program decreased somewhat in 2021 due in part to the COVID-19 Delta variant resurgence (56 and 162 enrollments, respectively and net of cancellations, for the three and nine months ended September 30, 2021, versus 64 and 194 respectively for the same periods in 2020), while VIP enrollment revenue overall increased due to enrollment revenue recognition from prior periods;
- Gross profit was $3.2 million for the third quarter of 2021 and $9.5 million for the nine months ended September 30, 2021, compared to gross profit of $2.6 million and $7.7 million for the comparable periods in 2020, respectively;
- Gross margin was 70% for the third quarter of 2021, compared to 78% for the third quarter of 2020, and was 76% for the first nine months of 2021, compared to 79% for the first nine months of 2020, reflecting higher costs associated with VIP enrollments;
- Cash and cash equivalents were $28.5 million at September 30, 2021;
- Operational highlights during the third quarter and October of 2021 included:
- Vivos surpassed 22,000 total patients treated with the Vivos System, compared to just over 13,000 as of the third quarter of 2020. Vivos has also trained over 1,350 dentists in the use of the Vivos System and other related value-added services, compared to just over 1,000 as of the third quarter of 2020.
- Vivos announced the U.S. Food and Drug Administration granted 510(k) market clearance to Vivos’ mmRNA device for treating mild to moderate OSA, sleep-disordered breathing and snoring in adults.
- Vivos announced the positive results from an independent patient survey and separate clinical study related to its proprietary Vivos treatment.
- Vivos announced the opening of The Vivos Institute, an international training center in Denver, Colorado.
- Vivos announced a new cooperative relationship with Empower Sleep to provide critical diagnostic and medical consultation services to people across North America who suffer from OSA.
- Vivos announced the formation of the Vivos Medical Consortium, a group of renowned physicians from prominent academic institutions in the U.S. and Canada, who will collaborate to advance Vivos’ OSA technology capabilities.
- Vivos and Candid Care Co., a digital platform for oral healthcare, announced a new collaboration that will seek to provide patients with a comprehensive, whole-mouth solution to diagnose and treat OSA in adult patients and provide orthodontic treatment from the same provider network.
VIVOS THERAPEUTICS, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Balance Sheets
|September 30, 2021||December 31, 2020
|Cash and cash equivalents||$||28,534,535||$||18,205,668|
|Accounts receivable, net||3,833,095||1,430,890|
|Current portion of note receivable – related party||61,864||84,696|
|Prepaid expenses and other current assets||1,601,974||673,061|
|Total current assets||34,031,468||20,394,315|
|Property and equipment, net||2,601,042||871,597|
|Intangible assets, net||350,585||270,121|
|Note receivable, net – related party||842,290||810,635|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable – related party||–||1,500,000|
|Current portion of long-term debt||1,265,067||866,972|
|Total current liabilities||8,195,017||7,823,049|
|Long-term debt, net of current portion||–||423,095|
|Commitments and contingencies (Note 12)|
|Convertible Redeemable Series A Preferred Stock – $0.0001 par value, 50,000,000 shares authorized, none issued and outstanding at September 30, 2021 and December 31, 2020, respectively||–||–|
|Preferred Stock Series B, nonvoting – $0.0001 par value, 1,200,000 authorized, none issued and outstanding at September 30, 2021 and December 31, 2020, respectively||–||–|
|Common Stock $0.0001 par value, 200,000,000 shares authorized, 23,012,119 and 18,209,452 issued and outstanding at September 30, 2021 and December 31, 2020, respectively||2,302||1,821|
|Additional paid-in capital||80,696,658||52,250,266|
|Total stockholders’ equity||32,469,189||(16,917,359)|
|Total liabilities and stockholders’ equity||$||41,024,206||$||25,327,469|
VIVOS THERAPEUTICS, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Operations
|Three months ended
|Nine months ended
|Cost of sales (exclusive of depreciation and amortization shown separately below)||1,363,170||709,184||2,993,817||2,034,486|
|General and administrative||6,516,631||3,788,996||17,668,299||11,482,808|
|Sales and marketing||1,976,247||431,704||4,234,457||1,493,730|
|Depreciation and amortization||192,504||178,933||564,770||540,540|
|Total operating expenses||8,685,382||4,399,633||22,467,526||13,517,078|
|Preferred stock accretion||–||(250,000)||–||(750,000)|
|Net loss attributable to Common Stockholders||$||(5,453,273)||$||(2,063,168)||$||(12,895,044)||$||(6,557,407)|
|Net loss per share attributable to Common Stockholders (basic and diluted)||$||(0.26)||$||(0.17)||$||(0.62)||$||(0.52)|
|Weighted average number of shares of Common Stock outstanding (basic and diluted)||20,826,499||12,488,952||20,634,092||12,557,943|
Cautionary Note Regarding Forward-Looking Statements
This press release 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, particularly with respect to the public offering described herein. Words such as “aim,” “may,” “could,” “expects,” “projects,” “intends,” “plans,” “believes,” “predicts,” “anticipates,” “hopes,” “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve 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 anticipated benefits of Australian regulatory approval described here on the Company’s sales and ability to obtain regulatory approvals in other countries) may differ materially 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, the risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at 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.