Viveve Reports Third Quarter 2021 Financial Results and Company Update

  • Total revenue of $ 1.6M reported for Q3

  • Recruitment for the pivotal SUI PURSUIT trial nears completion – randomizations on track to be completed in Q4

ENGLEWOOD, CO / ACCESSWIRE / November 11, 2021 / Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, today released financial results for the quarter ended September 30, 2021 and will provide a company update on his conference call scheduled for 5:00 p.m. And today. The company’s 10-Q documents will be filed on Friday, November 12, 2021, when the United States Securities and Exchange Commission reopens after the Veterans Day.

“During the third quarter of 2021, we continued to make great progress in advancing our stress urinary incontinence (SUI) clinical development program. Patient enrollment in our pivotal US PURSUIT trial is nearing completion and we plan to fully randomize the trial within weeks. that follow, ”said Scott Durbin, CEO of Viveve. “We look forward to reaching the PURSUIT trial stage in the fourth quarter as we move towards a potential future indication of SUI in the United States if its results are positive. Additionally, throughout this year, we continued to successfully promote the adoption and use of the Viveve® system through core medical specialists in the US and Asia-Pacific markets. “

Third Quarter and Recent Highlights

  • Reported total revenue of $ 1.6 million for the third quarter of 2021, including sales of 16 Viveve systems and approximately 2,300 consumable treatment tips;

  • Advanced enrollment in the pivotal US PURSUIT clinical trial for SUI is nearing completion with full patient randomization expected in the fourth trimester;

  • Expanded the company’s strong intellectual property portfolio with the issuance of one SUI methods patent in Australia and one additional methods patent granted in the United States;

  • Established a potential long-term reimbursement pathway with the announcement of a Category III CPT® code for the American Medical Association’s Viveve SUI procedure and with support from key medical companies; and

  • Continued to maintain high quality service and support to customers in the United States and Asia-Pacific to drive consumable process tip volumes and procedures.

Q3 2021 Financial Results

Revenue for the quarter ended September 30, 2021 totaled $ 1.6 million from sales of 16 Viveve systems and approximately 2,300 consumable treatment tips, compared to revenue of $ 1.5 million for the same. period in 2020. As of September 30, 2021, the Company had a base of 870 Viveve systems worldwide, 455 in the United States and 415 internationally.

Total operating expenses for the third quarter of 2021 were $ 5.6 million, compared to $ 3.6 million for the same period in 2020. The increase is primarily the result of the Company’s efforts to lead and advance recruitment in our PURSUIT pivotal clinical trial in the United States.

Net loss attributable to common shareholders for the third quarter of 2021 was $ 7.0 million, or ($ 0.67) per share based on 10,591,834 weighted average shares outstanding during the period, compared at a net loss of $ 4.8 million, or ($ 2.65 per share, for the same period in 2020 based on 1,807,931 weighted average shares outstanding during the period (adjusted for the consolidation of 1 for 10 shares of the Company in December 2020).

Cash and cash equivalents were $ 22.7 million as at September 30, 2021, compared to $ 25.4 million as at June 30, 2021.

Conference Call Information

The Company will host a conference call and webcast at 5:00 p.m. ET today. The conference call can be accessed by dialing 1-833-255-2833 (national) or 1-412-902-6728 (international) or by live webcast at https://services.choruscall.com/mediaframe/webcast. html? webcastid = DIlQEEg1. Participants can also register for the conference call at https://dpregister.com/sreg/10160082/ed1ef0147c.

A recording of the webcast will be posted on the Company’s investor relations website following the call at ir.viveve.com and available online for 90 days.

About Viveve

Viveve Medical, Inc. is a medical technology company focused on the intimate health of women. Viveve is committed to providing new solutions to improve the general well-being and quality of life of women. The internationally patented Viveve system incorporates cryogen-cooled monopolar radiofrequency technology to uniformly provide volumetric heating while gently cooling surface tissues 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 authorizations have been received for vaginal laxity and / or improved indications of sexual function in 50 countries.

Viveve continues to advance its clinical development program in SUI. Viveve Receives FDA Approval for its Investigative Device Exemption (IDE) Request to Conduct the Multicenter, Randomized, Double-Blind, Sham-Controlled PURSUIT Trial for Improvement of SUI in women in July 2020 and FDA approval of its requested changes to the IDE protocol as reported on December 10, 2020. Trial initiation was reported in January 2021. If the PURSUIT trial results are positive , the results may support a future indication for SUI commercialization in the United States

For more information, visit www.viveve.com.

Safe Harbor Declaration

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. Statements forward-looking statements included in this press release about its current expectations, the information on which those expectations were based may 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 the results actual differ significantly from these statements. These risks, uncertainties and other factors include, but are not limited to, fluctuating global economic conditions, the impact of the novel coronavirus called COVID-19 on our clinical development and regulatory review and approvals, and on manufacturing, placements. and patient use. of our Viveve Systems, the performance of management and our employees, our ability to obtain financing, our assessment of strategic alternatives, our ability to obtain approval or authorization to sell our medical device for all the indications sought , competition, general economic conditions and other factors which are detailed in our periodic and current reports available for review at www.sec.gov. In addition, we operate in a highly competitive and rapidly changing environment where new and unforeseen risks may arise. Therefore, investors should not rely on forward-looking statements as a prediction of actual results. We disclaim any intention and assume no obligation to update or revise forward-looking statements to reflect events or circumstances which subsequently occur or of which we subsequently become aware, except as 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 Advisor
[email protected]

Media contact:
Bill berry
Public Relations Berry & Company
(212) 253-8881
[email protected]

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

September 30

The 31st of December,

2021

2020

ASSETS

Current assets:

Cash and cash equivalents

$

22,665

$

6 523

Accounts receivable, net

514

770

Inventory

2 150

3,254

Prepaid expenses and other current assets

2,083

2 296

Total current assets

27,412

12 843

Property and equipment, net

1,678

2 759

Investment in a limited liability company

645

833

other assets

649

195

Total assets

$

30,384

$

16,630

LIABILITIES AND EQUITY

Current liabilities :

Accounts payable

$

1,292

$

881

Liabilities payable

2,557

2,416

Instrument payable, current portion

918

Total current liabilities

3,849

4 215

Note payable, non-current portion

4,964

4,943

Other non-current liabilities

1,206

498

Total responsibilities

10,019

9 656

Equity:

Share capital and additional contributed capital

255,890

226,800

Accumulated deficit

(235,525

)

(219,826

)

Total equity for shareholders

20 365

6,974

Total liabilities and equity

$

30,384

$

16,630

VIVEVE MEDICAL, INC.
SUMMARY CONSOLIDATED EARNINGS STATEMENTS
(in thousands, excluding data per share and per share)
(unaudited)

Three months ended

Nine months ended

September 30

September 30

2021

2020

2021

2020

Returned

$

1,616

$

1,524

$

4,720

$

3,532

Cost of income

1,502

1,283

4,059

3 483

Gross profit

114

241

661

49

Operating costs :

Research and development

2,695

884

6,804

3,745

Selling, general and administrative expenses

2 911

2,761

9,423

10,476

Total operating expenses

5,606

3,645

16 227

14 221

Operating loss

(5,492

)

(3,404

)

(15,566

)

(14 172

)

Gain on forgiveness of paycheck protection program loan

1,358

Modification of warrants

(373

)

(1,838

)

Interest expense, net

(255

)

(235

)

(734

)

(668

)

Other expenses, net

(78

)

(41

)

(196

)

(159

)

Net loss of consolidated companies

(5 825

)

(3680

)

(15,511

)

(16 837

)

Loss of minority interests in the limited liability company

(33

)

(55

)

(188

)

(323

)

Overall and net loss

(5,858

)

(3,735

)

(15,699

)

(17 160

)

Series B Convertible Preferred Share Dividends

(1190

)

(1,053

)

(3,463

)

(3 064

)

Net loss attributable to common shareholders

$

(7,048

)

$

(4 788

)

(19,162)

)

(20 224

)

Net loss per common share:

Basic and diluted

$

(0.67

)

$

(2.65

)

$

(1.93

)

(14.71)

)

Weighted average stocks used in

calculation of net loss per common share:

Basic and diluted

10 591 834

1,807,931

9 916 834

1,374,800

Note: All per share and per share data has been adjusted to reflect the 1 for 10 reverse stock split which came into effect after the market close on December 1, 2020.

THE SOURCE: Viveve Medical, Inc.

See the source version on accesswire.com:
https://www.accesswire.com/672293/Viveve-Reports-Third-Quarter-2021-Financial-Results-and-Provides-Corporate-Update

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