0001437749-22-026886.txt : 20221110 0001437749-22-026886.hdr.sgml : 20221110 20221110160355 ACCESSION NUMBER: 0001437749-22-026886 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20221110 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20221110 DATE AS OF CHANGE: 20221110 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VIVEVE MEDICAL, INC. CENTRAL INDEX KEY: 0000879682 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 043153858 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11388 FILM NUMBER: 221376971 BUSINESS ADDRESS: STREET 1: 345 INVERNESS DRIVE SOUTH STREET 2: BUILDING B, SUITE 250 CITY: ENGLEWOOD STATE: CO ZIP: 80112 BUSINESS PHONE: 4085301900 MAIL ADDRESS: STREET 1: 345 INVERNESS DRIVE SOUTH STREET 2: BUILDING B, SUITE 250 CITY: ENGLEWOOD STATE: CO ZIP: 80112 FORMER COMPANY: FORMER CONFORMED NAME: PLC SYSTEMS INC DATE OF NAME CHANGE: 19930328 8-K 1 vive20221108_8k.htm FORM 8-K vive20221108_8k.htm
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): November 10, 2022
 
VIVEVE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
 
 
Delaware
 
1-11388
 
04-3153858
(State or other jurisdiction of
incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
 
 
345 Inverness Drive South, Building B, Suite 250
Englewood, Colorado
 
80112
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (720696-8100
 
 
Securities registered pursuant to Section 12(b) of the Act:
 
 
Title of each class
Trading symbol(s)
Name of each exchange on which
registered
 
 
Common Stock
VIVE
Nasdaq Capital Market
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
 
Emerging growth company    
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐
 
 

 
Item 2.02.
 Results of Operations and Financial Conditions.
 
On November 10, 2022, Viveve Medical, Inc. (the “Company”) issued a press release announcing its results for the fiscal quarter ended September 30, 2022. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
 
The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such a filing, except as shall be expressly set forth by specific reference in such a filing.
 
 

 
Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit
No.
 
Description
   
99.1
 
104
 
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: November 10, 2022
Viveve Medical, Inc.
 
 
 
By:  
/s/ Scott Durbin
 
   
Scott Durbin 
 
   
Chief Executive Officer
 
 
 
EX-99.1 2 ex_444223.htm EXHIBIT 99.1 ex_444223.htm

Exhibit 99.1

 

Viveve Reports Third Quarter 2022 Financial Results and Provides Corporate Update

 

Total revenue of $1.7 million in Q3 including sale of 3,100 disposable treatment tips

 

PURSUIT clinical trial completion expected by year-end

 

Conference call to be hosted by Company at 5:00 PM ET today

 

 

ENGLEWOOD, CO November 10, 2022 – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's health and the treatment of female stress urinary incontinence (SUI), today reported financial results for the quarter ended September 30, 2022, and will provide a corporate update on its scheduled conference call at 5:00 PM ET today.

 

"During the third quarter of 2022, we continued to make great progress in the final phase of our pivotal U.S. PURSUIT clinical trial for the treatment of female stress urinary incontinence. We remain on track to complete patient follow-up visits by the end of the year with topline results expected shortly thereafter," said Scott Durbin, Viveve's chief executive officer. "We are also pleased with our commercial results during the third quarter as we continue our ongoing efforts to increase adoption and utilization of the Viveve® System by core medical specialists in urology, urogynecology, and gynecology in the U.S. and Asia Pacific regions."

 

Third Quarter and Recent Business Highlights

Reported total revenue of $1.7 million for the third quarter 2022, increasing the installed base of Viveve® Systems to 915 worldwide;

Sold approximately 3,100 single-use disposable treatment tips worldwide;

Advanced 12-month follow-up visits in pivotal U.S. PURSUIT clinical trial for SUI targeting completion of final follow visits by the end of 2022 and reporting of topline data thereafter; and

Expanded the Company's intellectual property estate with the reported Notice of Allowance for a second SUI Method Patent from the U.S. Patent and Trademark Office.

 

Q3 2022 Financial Results

Revenue for the quarter ended September 30, 2022, totaled $1.7 million from the sale of 11 Viveve Systems and approximately 3,100 disposable treatment tips, compared to revenue of $1.6 million for the same period in 2021. As of September 30, 2022, the Company had an installed base of 915 Viveve Systems worldwide, 479 in the U.S. and 436 internationally.

 

Gross profit for the third quarter of 2022 was $0.5 million, or 32% of revenue, compared to gross profit of $0.1 million, or 7% of revenue, for the same period in 2021.

 

Total operating expenses for the third quarter of 2022 were $5.2 million, compared to $5.6 million for the same period in 2021. The decrease is primarily due to reduced clinical study costs in the period as we advanced our fully enrolled PURSUIT clinical trial. Operating expense reductions were partially offset by costs associated with increased engineering and development work related to our next generation products and strategic planning efforts in anticipation of the PURSUIT clinical trial completion.

 

 

 

Net loss attributable to common stockholders for the third quarter of 2022 was $6.3 million, or ($0.59) per share based on 10,655,410 weighted average shares outstanding during the period, compared to a net loss attributable to common stockholders of $7.0 million, or ($0.67) per share, for the same period in 2021 based on 10,591,834 weighted average shares outstanding during the period.

 

Cash and cash equivalents were $5.9 million as of September 30, 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://event.choruscall.com/mediaframe/webcast.html?webcastid=N8zzMVtv. Participants may also register for the conference call at https://dpregister.com/sreg/10172049/f4c100901f.

 

A webcast recording 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. (Viveve), is a women's health company focused on the treatment of female SUI. Based in Englewood, Colorado, the Company is conducting a pivotal U.S. clinical trial called PURSUIT, using its novel, dual-energy treatment for SUI in women. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency technology to uniformly provide an endovaginal treatment that is non-ablative. In the U.S., 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 and/or urinary incontinence. Viveve's current commercial and market development efforts focus on the U.S. and Asia Pacific regions targeting urogynecology, urology, and gynecology core specialties.

 

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 IDE protocol amendments in December 2020. The clinical trial was initiated in January 2021, and completion of subject enrollment was announced on December 14, 2021. Completion of subject follow-up visits is anticipated by the end of 2022, and topline results will be reported shortly thereafter. If positive, results from the PURSUIT clinical trial may support a new SUI indication in the U.S.

 

For more information visit 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. 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.

 

Investor Relations contacts:
Amato and Partners, LLC
Investor Relations Counsel

admin@amatoandpartners.com

 

Media contact:
Bill Berry
Berry & Company Public Relations
(212) 253-8881

bberry@berrypr.com

 

 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

  

   

September 30,

   

December 31,

 
   

2022

   

2021

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 5,907     $ 19,162  

Accounts receivable, net

    860       549  

Inventory

    1,615       1,472  

Prepaid expenses and other current assets

    1,222       1,055  

Total current assets

    9,604       22,238  

Property and equipment, net

    1,009       1,554  

Investment in unconsolidated limited liability company

    -       577  

Other assets

    1,541       1,544  

Total assets

  $ 12,154     $ 25,913  

LIABILITIES AND STOCKHOLDERS' EQUITY

               

Current liabilities:

               

Accounts payable

  $ 1,108     $ 1,480  

Accrued liabilities

    4,101       3,053  

Note payable, current portion

    5,628       -  

Total current liabilities

    10,837       4,533  

Note payable, noncurrent portion

    -       5,124  

Other noncurrent liabilities

    133       1,190  

Total liabilities

    10,970       10,847  

Stockholders’ equity:

               

Capital stock and additional paid-in capital

    259,698       256,919  

Accumulated deficit

    (258,514 )     (241,853 )

Total stockholders’ equity

    1,184       15,066  

Total liabilities and stockholders’ equity

  $ 12,154     $ 25,913  

 

 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

  

   

Three Months Ended

   

Nine Months Ended

 
   

September 30,

   

September 30,

 
   

2022

   

2021

   

2022

   

2021

 
                                 

Revenue

  $ 1,684     $ 1,616     $ 5,120     $ 4,720  

Cost of revenue

    1,138       1,502       3,960       4,059  

Gross profit

    546       114       1,160       661  
                                 

Operating expenses:

                               

Research and development

    1,800       2,695       5,861       6,804  

Selling, general and administrative

    3,408       2,911       10,454       9,423  

Total operating expenses

    5,208       5,606       16,315       16,227  

Loss from operations

    (4,662 )     (5,492 )     (15,155 )     (15,566 )

Gain on forgiveness of Paycheck Protection Program loan

    -       -       -       1,358  

Modification of warrants

    -       -       -       (373 )

Interest expense, net

    (292 )     (255 )     (846 )     (734 )

Other expense, net

    (22 )     (78 )     (83 )     (196 )

Net loss from consolidated companies

    (4,976 )     (5,825 )     (16,084 )     (15,511 )

Impairment loss on investment in unconsolidated limited liability company

    -       -       (455 )     -  

Loss from minority interest in unconsolidated limited liability company

    -       (33 )     (122 )     (188 )

Comprehensive and net loss

    (4,976 )     (5,858 )     (16,661 )     (15,699 )

Series B convertible preferred stock dividends

    (1,347 )     (1,190 )     (3,918 )     (3,463 )

Net loss attributable to common stockholders

  $ (6,323 )   $ (7,048 )   $ (20,579 )   $ (19,162 )
                                 

Net loss per share of common stock:

                               

Basic and diluted

  $ (0.59 )   $ (0.67 )   $ (1.93 )   $ (1.93 )
                                 

Weighted average shares used in computing net loss per share of common stock:

                               

Basic and diluted

    10,665,410       10,591,834       10,642,263       9,916,834  

 

 
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