Total revenue of $1.6 million in Q1 including sale of 2,750 consumable treatment tips
PURSUIT trial top-line results anticipated at end of 2022
Conference call to be hosted by Company at 5:00 PM ET today
ENGLEWOOD, CO / ACCESSWIRE / May 12, 2022 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women's intimate health, today reported financial results for the quarter ended March 31, 2022, and will provide a corporate update on its scheduled conference call at 5:00 PM ET today.
"During the first quarter of 2022, we continued the focus on advancing our stress urinary incontinence (SUI) clinical development program. We remain on track to complete all patient follow-up visits and monitoring by the end of the year," said Scott Durbin, Viveve's chief executive officer. "We are also pleased with our commercial progress during the first quarter and will continue our efforts to increase adoption of the Viveve® System by core medical specialists in urology, urogynecology and gynecology in the U.S. and Asia Pacific regions."
First Quarter and Recent Business Highlights
- Reported $1.6 million total revenue for the first quarter 2022, increasing the installed base of Viveve® Systems to 895 systems worldwide;
- Sold approximately 2,750 single-use consumable treatment tips worldwide;
- Advanced 12-month follow-up visits in pivotal U.S. PURSUIT clinical trial for SUI;
- Continued to provide high-quality service and support to existing customers; and
- Advanced market development and procedure utilization efforts with key physicians in targeted Asia Pacific countries and core urology, urogynecology, and gynecology practitioners in the U.S.
Q1 2022 Financial Results
Revenue for the quarter ended March 31, 2022 totaled $1.6 million from the placement of 11 Viveve Systems and approximately 2,750 consumable treatment tips, compared to revenue of $1.5 million for the same period in 2021. As of March 31, 2022, the Company had an installed base of 895 Viveve Systems worldwide, 468 in the U.S. and 427 internationally.
Gross profit for the first quarter of 2022 was $0.3 million, or 20% of revenue, compared to gross profit of $0.4 million or 26% of revenue, for the same period in 2021.
Total operating expenses for the first quarter of 2022 were $5.8 million, compared to $5.5 million for the same period in 2021. The increase is mainly a result of the Company's efforts to advance our SUI development program for our fully enrolled PURSUIT clinical trial and increased engineering and development work related to our next generation products.
Net loss attributable to common stockholders for the first quarter of 2022 was $7.2 million, or ($0.67) per share based on 10,620,076 weighted average shares outstanding during the period, compared to a net loss of $6.9 million, or ($0.80) per share, for the same period in 2021 based on 8,636,120 weighted average shares outstanding during the period.
Cash and cash equivalents were $14.0 million as of March 31, 2022, compared to $19.2 million as of December 31, 2021.
Conference Call Information
The Company will host a conference call and webcast at 5:00 PM ET today. The conference call may be accessed by dialing 1-833-255-2833 (domestic) or 1-412-902-6728 (international) or via live webcast at https://services.choruscall.com/mediaframe/webcast.html?webcastid=kTDfnY3F. Participants may also register for the conference call at https://dpregister.com/sreg/10166270/f26eb67fd6.
A recording of the webcast will be posted on the Company's investor relations website following the call at ir.viveve.com and will be available for 90 days.
About Viveve
Viveve Medical, Inc. is a medical technology company focused on women's intimate health. Viveve is committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. In the United States, the Viveve® System is cleared by the Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in 50 countries.
Viveve continues to advance its clinical development program in stress urinary incontinence (SUI). Viveve received FDA approval of its Investigational Device Exemption (IDE) application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020 and FDA approval of its requested amendments to the IDE protocol in December 2020. Initiation of the trial was reported in January 2021 and completion of subject enrollment was announced on December 14, 2021. Topline results are anticipated at the end of 2022. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.
For more information visit Viveve's website at www.viveve.com.
Safe Harbor Statement
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including, without limitation, implied and express statements regarding Viveve Medical, Inc.'s plans, timelines or presumptions of results for the PURSUIT trial, the anticipated future impact of the new Category III CPT® code, including any potential reimbursement for Viveve's dual-energy endovaginal procedure for SUI, and our anticipated cash runway. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the timing, progress and results of our clinical trials, the fluctuation of global economic conditions, the impact of the novel coronavirus termed COVID-19 on our clinical development and regulatory review and clearances and on the manufacturing, placements and patient utilization of our Viveve Systems, the performance of management and our employees, our ability to obtain financing, our evaluation of strategic alternatives, our ability to obtain approval or clearance for sale of our medical device for all indications sought, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware, unless required by law.
Viveve is a registered trademark of Viveve, Inc.
CPT is a registered trademark of the American Medical Association.
Investor Relations contacts:
Amato and Partners, LLC
Investor Relations Counsel
[email protected]
Media contact:
Bill Berry
Berry & Company Public Relations
(212) 253-8881
[email protected]
| VIVEVE MEDICAL, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) | ||||||||
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 14,045 | $ | 19,162 | ||||
Accounts receivable, net | 509 | 549 | ||||||
Inventory | 1,552 | 1,472 | ||||||
Prepaid expenses and other current assets | 1,393 | 1,055 | ||||||
Total current assets | 17,499 | 22,238 | ||||||
Property and equipment, net | 1,351 | 1,554 | ||||||
Investment in limited liability company | 455 | 577 | ||||||
Other assets | 1,379 | 1,544 | ||||||
Total assets | $ | 20,684 | $ | 25,913 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,602 | $ | 1,480 | ||||
Accrued liabilities | 3,376 | 3,053 | ||||||
Note payable, current portion | 5,285 | - | ||||||
Total current liabilities | 10,263 | 4,533 | ||||||
Note payable, noncurrent portion | - | 5,124 | ||||||
Other noncurrent liabilities | 265 | 1,190 | ||||||
Total liabilities | 10,528 | 10,847 | ||||||
Stockholders' equity: | ||||||||
Capital stock and additional paid-in capital | 257,895 | 256,919 | ||||||
Accumulated deficit | (247,739 | ) | (241,853 | ) | ||||
Total stockholders' equity | 10,156 | 15,066 | ||||||
Total liabilities and stockholders' equity | $ | 20,684 | $ | 25,913 | ||||
| VIVEVE MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
Revenue | $ | 1,641 | $ | 1,450 | ||||
Cost of revenue | 1,321 | 1,068 | ||||||
Gross profit | 320 | 382 | ||||||
Operating expenses: | ||||||||
Research and development | 2,140 | 1,930 | ||||||
Selling, general and administrative | 3,653 | 3,581 | ||||||
Total operating expenses | 5,793 | 5,511 | ||||||
Loss from operations | (5,473 | ) | (5,129 | ) | ||||
Modification of warrants | - | (287 | ) | |||||
Interest expense, net | (270 | ) | (234 | ) | ||||
Other expense, net | (21 | ) | (65 | ) | ||||
Net loss from consolidated companies | (5,764 | ) | (5,715 | ) | ||||
Loss from investment in unconsolidated limited liability company | (122 | ) | (76 | ) | ||||
Comprehensive and net loss | (5,886 | ) | (5,791 | ) | ||||
Series B convertible preferred stock dividends | (1,266 | ) | (1,119 | ) | ||||
Net loss attributable to common stockholders | $ | (7,152 | ) | $ | (6,910 | ) | ||
Net loss per share of common stock: | ||||||||
Basic and diluted | $ | (0.67 | ) | $ | (0.80 | ) | ||
Weighted average shares used in | ||||||||
computing net loss per common share: | ||||||||
Basic and diluted | 10,620,076 | 8,636,120 | ||||||
SOURCE: Viveve Medical, Inc.