Viveve Reports Second Quarter 2022 Financial Results and Provides Company Updates – Yahoo Finance | Vette Leader

Total revenue of $1.8 million for the second quarter, including the sale of 2,850 disposable treatment tips

PURSUIT clinical study follow-up visit expected to be completed by year-end

Conference call hosted by the company today at 5:00 p.m. ET

ENGLEWOOD, CO / ACCESSWIRE / Aug 11, 2022 / Viveve Medical, Inc. (NASDAQ:VIVE), a medical technology company focused on women’s health and the treatment of stress urinary incontinence (SUI), today released financial results for the quarter ended June 30, 2022 and will become a corporate Update to release its scheduled conference call today at 5:00 p.m. ET.

“During the second quarter of 2022, we continued to advance our clinical development program in Stress Urinary Incontinence (SUI). We remain on track to complete follow-up of patients from our pivotal US clinical trial PURSUIT by the end of the year and will report topline results shortly thereafter,” said Scott Durbin, Chief Executive Officer of Viveve. “We are also pleased with our business results in the second quarter and will continue our ongoing efforts to increase acceptance of the Viveve® System by core urology, urogynecology and gynecology physicians in the United States and Asia Pacific.”

Second Quarter Highlights and Recent Operations

  • Reported total revenue of $1.8 million for the second quarter of 2022, increasing the installed base of Viveve® systems to 905 worldwide;

  • Approximately 2,850 disposable treatment tips sold worldwide;

  • Advanced 12-Month Follow-up in Pivotal US PURSUIT Clinical Trial in SUI; and

  • Expansion of the company’s intellectual property through a new patent grant in Taiwan.

Financial results Q2 2022

Revenue for the quarter ended June 30, 2022 totaled $1.8 million from the sale of 14 Viveve systems and approximately 2,850 single-use treatment tips compared to revenue of $1.7 million for the same period Year 2021 period. As of June 30, 2022, the Company had an installed base of 905 Viveve systems worldwide, 473 in the US and 432 internationally.

Gross profit for the second quarter of 2022 was $0.3 million, or 16% of revenue, compared to gross profit of $0.2 million, or 10% of revenue, for the same period in 2021.

Total operating expenses for the second quarter of 2022 were $5.3 million compared to $5.1 million for the same period in 2021. The increase is a result of the Company’s continued efforts to improve our SUI development program for our fully registered PURSUIT clinical trial, and increased engineering and development work related to our next generation products.

Net loss attributable to common shareholders for the second quarter of 2022 was $7.1 million, or ($0.67) per share, based on 10,640,806 weighted average shares outstanding during the period, compared to a net loss of 5, $2 million or ($0.49) per share for the same period in 2021 based on 10,501,057 weighted average shares outstanding during the period.

Cash and cash equivalents were $9.4 million as of June 30, 2022 compared to $19.2 million as of December 31, 2021.

Information about the conference call

The company will host a conference call and webcast today at 5:00 p.m. ET. The conference call can be accessed at 1-833-255-2833 (Domestic) or 1-412-902-6728 (International) or via live webcast at https://event.choruscall.com/mediaframe/webcast.html? webcastid=edZnKiaV. Participants can also register for the conference call at https://dpregister.com/sreg/10169095/f3a2e624b3.

A replay of the webcast will be posted to the Company’s Investor Relations website at ir.viveve.com following the call and will be available online for 90 days.

About Viveve

Viveve Medical, Inc. is a medical technology company focused on women’s health and the treatment of Stress Urinary Incontinence (SUI). Viveve is committed to developing new solutions to improve women’s overall well-being and quality of life. The internationally patented Viveve® system incorporates cryogenically cooled monopolar radiofrequency technology to deliver uniform volumetric heating while gently cooling surface tissue to create 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 in 48 countries for the indications of vaginal laxity and/or enhancement of sexual function.

Viveve continues to advance its clinical development program in SUI. In July 2020, Viveve received FDA approval for its Investigational Device Exemption (IDE) application to conduct the multi-center, randomized, double-blind, sham-controlled PURSUIT study in improvement of SUI in women and FDA approval for the pending application IDE protocol changes in December 2020. Study initiation was reported in January 2021 and completion of subject enrollment was announced on December 14, 2021. Completion of the subjects’ follow-up is expected in late 2022, and top-line results will be reported shortly thereafter. If positive, the results of the PURSUIT clinical trial could support a new SUI indication in the US

For more information, visit Viveve’s website at www.viveve.com.

Safe Harbor Declaration

All statements in this press release that are not historical facts 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, but not limited to, implied and statements of the Viveve Medical, Inc. plans, schedules or guesses of results for the PURSUIT Clinical Trial. While management has based any forward-looking statements contained in this press release based on its current expectations, the information on which such expectations were based is subject to change. These forward-looking statements are based on a number of assumptions about future events and are subject to a number of risks, uncertainties and other factors, many of which are beyond our control, which could cause actual results to differ materially from these statements. These risks, uncertainties and other factors include, but are not limited to, the timing, progress and results of our clinical trials, fluctuations in global economic conditions, the impact of the novel coronavirus known as COVID-19 on our clinical development and regulatory reviews and clearances and from the manufacture, placement and patient use 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, any indications sought, competition, general economic conditions and other factors detailed in our periodic and current reports, which can be viewed at www.sec.gov. In addition, we operate in a highly competitive and rapidly changing environment where new and unexpected risks may arise. Accordingly, investors should not rely on any forward-looking statement as a prediction of actual results. We disclaim any intention or obligation to update or revise any forward-looking statements to reflect events or circumstances that later occur or become known to us, except as required by law.

Viveve is a registered trademark of Viveve, Inc.

Investor Relations contacts:
Amato and Partners, LLC
Investor Relations Advisor
admin@amatoandpartners.com

Media contact:
Bill Berry
Berry & Company Public Relations
(212) 253-8881
bberry@berrypr.com

VIVEVE MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEET
(in thousands)
(unaudited)

June 30th

December 31,

2022

2021

FINANCIAL ASSETS

current assets:

Cash and cash equivalents

$

9,431

$

19,162

receivables, net

801

549

inventory

1,599

1,472

Prepaid expenses and other current assets

1.407

1,055

total current assets

13,238

22,238

property, plant and equipment, net

1.114

1,554

Participation in a limited liability company

577

Other assets

1.136

1,544

total assets

$

15,488

$

25,913

LIABILITIES AND SHAREHOLDERS EQUITY

Current liabilities:

Accounts Payable

$

904

$

1,480

Accrued Liabilities

3,655

3,053

Promissory note loan, short-term portion

5,453

Total current liabilities

10.012

4,533

Promissory note loan, long-term part

5.124

Other non-current burdens

200

1,190

Total Liabilities

10.212

10,847

Equity capital:

share capital and capital reserve

258,814

256,919

Cumulative deficit

(253,538

)

(241,853

)

Total Equity

5.276

15,066

Total Liabilities and Equity

$

15,488

$

25,913

VIVEVE MEDICAL, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except share and per share data)
(unaudited)

Three months ended

Six months ended

June 30th

June 30th

2022

2021

2022

2021

revenue

$

1,795

$

1,654

$

3,436

$

3.104

cost of sales

1,501

1,489

2,822

2,557

gross profit

294

165

614

547

Operating expenses:

Research and Development

1,921

2,180

4,061

4.110

Sales General and administration

3,393

2,930

7,046

6,511

business expenses

5.314

5.110

11.107

10,621

loss from operations

(5.020

)

(4,945

)

(10,493

)

(10,074

)

Paycheck Protection Program Loan Forgiveness Gain

1,358

1,358

Modification of Arrest Warrants

(86

)

(373

)

Interest expense, net

(284

)

(245

)

(554

)

(479

)

Other costs, net

(40

)

(53

)

(61

)

(118

)

Net loss for the year from consolidated companies

(5.344

)

(3,971

)

(11.108

)

(9,686

)

Impairment loss on interest in unconsolidated limited liability company

(455

)

(455

)

Loss of a minority interest in a limited liability company

(79

)

(122

)

(155

)

Total and Net Loss

(5,799

)

(4,050

)

(11,685

)

(9,841

)

Dividends on Series B Convertible Preferred Stock

(1.305

)

(1.119

)

(2,571

)

(2.273

)

Net Loss Attributable to Common Shareholders

$

(7.104

)

$

(5.169

)

$

(14.256

)

$

(12.114

)

Net loss per common share:

Basic and diluted

$

(0.67

)

$

(0.49

)

$

(1.34

)

$

(1.27

)

Weighted average proportions used in

Calculation of net loss per common share:

Basic and diluted

10,640,806

10.501.057

10,630,498

9,573,740

SOURCE: Viveve Medical, Inc.

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