8-K

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): May 10, 2018

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: (720) 696-8100

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 Condition.

On May 10, 2018, Viveve Medical, Inc. (the “Company”) issued a press release announcing its results for the quarter ended March 31, 2017. 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, and in Exhibit 99.2, 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 5.02 Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers.

Scott Durbin Appointed as Chief Executive Officer and Director

On May 10, 2018, the Company also issued a press release (the “Press Release”) announcing that on May 9, 2018, upon recommendation of the Nominating and Corporate Governance Committee, the Board of Directors (the “Board”), of the Company, appointed Scott Durbin to serve as the Company’s Chief Executive Officer and Principal Executive Officer, effective May 10, 2018 (the “Effective Date”).  Mr. Durbin, who has served as the Company’s Chief Financial Officer, Secretary and Principal Financial and Accounting Officer since 2014, has also been appointed to serve on the Board as a Class I director. Mr. Durbin resigned as the Company’s Chief Financial Officer, Secretary and Principal Financial and Accounting Officer as of the Effective Date.

Mr. Durbin, 49, joined Viveve, Inc., a wholly owned subsidiary of the Company, as its Chief Financial Officer in February 2013 and was appointed as the Chief Financial Officer and Secretary of the Company on September 23, 2014. From June 2012 to January 2013, he served as an advisor and Acting Chief Financial Officer for Viveve, Inc. Prior to joining Viveve, Inc., from June 2010 to October 2011, he was Chief Financial Officer of Aastrom Biosciences, (now known as Vericel Corporation) (“Aastrom”), a publicly traded, cardiovascular cell therapy company. Before Aastrom, he spent six years as Chief Operating and Financial Officer for Prescient Medical (“Prescient”) from May 2004 to June 2010, a privately held company that developed diagnostic imaging catheters and coronary stents designed to reduce deaths from heart attacks. Prior to Prescient, from January 2003 to April 2004, he spent several years as a financial consultant for two publicly traded biotech companies, Scios Inc., a Johnson & Johnson company, and Alteon Inc. Mr. Durbin began his career in corporate finance as an investment banker in the Healthcare and M&A groups at Lehman Brothers Inc. from August 1999 to January 2003, where he focused on mergers and acquisitions and financings for the life science industry. At Lehman, he successfully executed over $5 billion in transactions for medical device and biotechnology companies. He began his career as a Director of Neurophysiology for Biotronic, Inc. Mr. Durbin received a B.S. from the University of Michigan and an M.P.H. in Health Management with Honors from the Yale University School of Medicine and School of Management. The Board determined that Mr. Durbin should serve as a director because of his extensive experience in the healthcare industry.

Mr. Durbin has entered into the Company’s standard form of indemnification agreement, which is filed as Exhibit 10.52 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Mr. Durbin is not a party to any transaction with the Company that would require disclosure under Item 404(a) of Regulation S-K, and there are no arrangements or understandings between Mr. Durbin and any other persons pursuant to which he was selected as Chief Executive Officer.

Patricia Scheller Resigned as Chief Executive Officer; Continues as Senior Advisor and Director

The Company announced in the Press Release that Patricia Scheller resigned from her position as Chief Executive Officer of the Company and from all positions she held as an officer of the Company or its subsidiaries, as of the Effective Date. Ms. Scheller will remain on the Board as a Class III director and will continue as a Senior Advisor to the Company. Ms. Scheller's resignation as Chief Executive Officer was not due to any disagreement relating to the operations, policies or practices of the Company.

Debora Jorn Appointed as Senior Advisor

The Company also announced in the Press Release that Ms. Debora Jorn was appointed to serve as a Senior Advisor to the Chief Executive Officer, as of the Effective Date. Ms. Jorn will remain on the Board as a Class II director.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release issued by the Company on May 10, 2018 announcing results for the quarter ended March 31, 2018, furnished herewith.
99.2	Press Release issued by the Company on May 10, 2018 announcing the appointment of Scott Durbin as Chief Executive Officer, furnished herewith

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: May 10, 2018	Viveve Medical, Inc.
	By:	/s/ Scott Durbin
		Scott Durbin
		Chief Executive Officer

EX-99.1

Exhibit 99.1

Viveve Reports First Quarter 2018 Financial Results

Continued quarter-over-quarter annual revenue growth and rapid expansion into stress urinary incontinence market planned for Viveve® System

ENGLEWOOD, CO – May 10, 2018 -- Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today reported its financial results for the quarter ended March 31, 2018.

“For the first quarter of 2018, Viveve recorded sales of $3.7 million demonstrating strong global demand and increasing enthusiasm from physicians for our innovative cryogen-cooled monopolar radiofrequency technology and its clinical applications. We also reached a number of significant milestones that support our global commercialization strategy and set the stage for continuing global adoption of the Viveve® System through the remainder of 2018,” said Scott Durbin, chief executive officer and director of Viveve.

Q1 2018 Business Highlights

● Received U.S. Food and Drug Administration (FDA) approval of an Investigational Exemption Device (IDE) to conduct VIVEVE II, a multicenter randomized double blinded sham-controlled trial using the Viveve System for the improvement of sexual function;

● Announced expansion of its cryogen-cooled monopolar radiofrequency (CMRF) technology platform into the Stress Urinary Incontinence (SUI) market;

● Reported positive 12-month results from the SUI pilot study conducted by Dr. Bruce Allan in Calgary, Alberta;

● Announced plans to conduct clinical registration studies to further assess the safety and efficacy of the Viveve System in the treatment SUI;

● Received regulatory approvals in three Latin America countries;

● Secured financing of approximately $32.4 million in a February common stock offering.

Q1 2018 Financial Results

Revenue for the first quarter of 2018 totaled $3,699,000 from the sale of 53 Viveve systems, 38 of which were sold in North America through direct sales, and approximately 5,400 disposable treatment tips making the company’s current global installed base as of March 31, 2018 – 497 systems, compared to revenue of $3,041,000 for the same period in 2017, a 22% year-over-year quarterly revenue growth.

Gross profit for the first quarter of 2018 was $1,347,000, or 36% of revenue, compared to gross profit of $1,422,000 or 47% of revenue, for the same period in 2017. The decrease was primarily due to the change in the mix of products sold in the first quarter of 2018.

Total operating expenses for the first quarter of 2018 were $12,687,000, up from $7,838,000 in the same period in 2017, mainly a result of increased costs to support commercialization in North America markets, product development efforts, regulatory and clinical study activities, strategies to protect Viveve’s intellectual property and other general corporate expenses.

Net loss for the first quarter of 2018 was $12,669,000, or ($0.49) per share, compared to a net loss of $6,695,000, or ($0.57) per share, for the same period in 2017.

Cash and cash equivalents were $38,378,000 as of March 31, 2018, which includes the recent equity financing that concluded in February 2018.

2018 Financial Guidance

Viveve continues to anticipate rapid commercial growth and reiterates its 2018 guidance for annual revenue of $22 million to $24 million.

Conference Call Information

The company will host a live conference call at 5:00 pm ET today. The conference call may be accessed by dialing 1-866-777-2509 (domestic) or 1-412-317-5413 (international) or via live webcast at http://services.choruscall.com/links/vive180510.html. Participants may also pre-register for the conference call at http://dpregister.com/10119472.

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

About Viveve

Viveve Medical, Inc. is a women's intimate health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System, that delivers the Viveve treatment, incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single 30-minute in-office session.

International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Viveve received approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018 to proceed with VIVEVE II, a multicenter, randomized, double-blind, sham-controlled study to assess improvement of sexual function in women following childbirth. Initiation of the trial is expected to begin in the second quarter of 2018 and if successful, could support a marketing application for a new U.S. commercial indication. Currently, in the United States, the Viveve System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis. 

Viveve has submitted an Investigational Trial Application to the Canadian Ministry of Health and plans to submit an IDE to the FDA to conduct two independent multicenter randomized registration trials (LIBERATE-International and LIBERATE-U.S. respectively) for use of the CMRF device in stress urinary incontinence treatment.

InControl Products by Viveve are FDA cleared medical devices that treat stress, urge, and mixed incontinence conditions and products to improve pelvic floor strength. Viveve exclusively distributes InControl Medical's products to healthcare providers in the United States.

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. 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 fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, 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.

Viveve is a registered trademark of Viveve, Inc.

Investor Relations contacts:

Sarah McCabe

Stern Investor Relations, Inc.

(212) 362-1200

sarah@sternir.com

Amato and Partners, LLC

Investor Relations Counsel

admin@amatoandpartners.com

Media contact:

Kelly Wakelee

Berry & Company Public Relations

(212) 253-8881

kwakelee@berrypr.com

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

	March 31,			December 31,
	2018			2017
ASSETS
Current assets:
Cash and cash equivalents	$	38,378		$	20,730
Accounts receivable, net		6,999			6,213
Inventory		3,828			2,390
Prepaid expenses and other current assets		3,302			2,741
Total current assets		52,507			32,074
Property and equipment, net		1,674			1,303
Investment in limited liability company		2,251			2,500
Other assets		204			202
Total assets	$	56,636		$	36,079
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	3,865		$	4,799
Accrued liabilities		4,257			4,605
Total current liabilities		8,122			9,404
Note payable, noncurrent portion		29,334			28,948
Other noncurrent liabilities		218			327
Total liabilities		37,674			38,679
Stockholders’ equity (deficit):
Common stock and additional paid-in capital		137,035			102,981
Accumulated deficit		(118,073	)		(105,581	)
Total stockholders’ equity (deficit)		18,962			(2,600	)
Total liabilities and stockholders’ equity (deficit)	$	56,636		$	36,079

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

	Three Months Ended
	March 31,
	2018			2017
Revenue	$	3,699		$	3,041
Cost of revenue		2,352			1,619
Gross profit		1,347			1,422
Operating expenses:
Research and development		3,756			2,388
Selling, general and administrative		8,931			5,450
Total operating expenses		12,687			7,838
Loss from operations		(11,340	)		(6,416	)
Interest expense, net		(1,070	)		(263	)
Other expense, net		(10	)		(16	)
Net loss from consolidated companies		(12,420	)		(6,695	)
Loss from minority interest		(249	)		-
Net loss	$	(12,669	)	$	(6,695	)
Net loss per share:
Basic and diluted	$	(0.49	)	$	(0.57	)
Weighted average shares used in computing net loss per common share:
Basic and diluted		25,846,724			11,663,765

EX-99.2

Exhibit 99.2

Viveve Appoints Scott Durbin as Chief Executive Officer

ENGLEWOOD, CO, May 10, 2018 -- Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced that Scott Durbin has been appointed as the company’s Chief Executive Officer, effective immediately. Mr. Durbin, a seasoned healthcare executive and the company’s former Chief Financial Officer, will also join the Board of Directors.

Mr. Durbin’s appointment follows Patricia Scheller’s decision to step down from her position as Chief Executive Officer to pursue other personal and business opportunities. Ms. Scheller will remain on the Viveve Board of Directors.

The company also named Debora Jorn, a director at Viveve since May 2016, as Senior Advisor to the CEO. Ms. Jorn led the successful launch of a major brand for the treatment of incontinence for Pharmacia and has over 30 years of commercial experience building global pharmaceutical, aesthetics and OTC businesses.

Dan Janney, Chairman of the Board, said, “Scott is uniquely qualified to lead Viveve into the next stage of growth given his significant operational and clinical experience, and 5-year tenure as the company’s Chief Financial Officer. We are extremely pleased to promote Scott at this important juncture for Viveve, as the company continues to solidify its position as a leader in women’s intimate health and develop its innovative CMRF technology for the treatment of Stress Urinary Incontinence. We are also delighted that Debora Jorn will be taking an active advisory role in supporting Scott as the company advances toward a potential launch in the large, unsatisfied incontinence market.”

Mr. Janney went on to say, “The Board and I want to thank Patricia Scheller for her many contributions to Viveve. She established the company and product branding, built a strong management team and led its initial development into a global business. We support her decision to step down and agree this is the opportune time for Scott to lead Viveve into its next phase of commercial growth.”

Mr. Durbin said, “I am extremely excited and honored to be chosen to lead Viveve into this next phase of growth. Viveve’s commitment to improve the intimate health and wellness of women around the world is one I continue to passionately share with our employees and stakeholders. I look forward to working more closely with Debora, the Board and the entire organization to drive the growth of the current business while rapidly advancing our development and commercialization programs in female sexual function and SUI.”

About Viveve 

Viveve Medical, Inc. is a women's intimate health company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System incorporates clinically-proven cryogen-cooled, monopolar radiofrequency (CMRF) technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in a single, in-office session.

International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications from over 55 countries. Viveve received approval of an Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) in March of 2018 to proceed with VIVEVE II, a multicenter, randomized, double-blind, sham-controlled study to assess improvement of sexual function in women following childbirth. Initiation of the trial is expected to begin in the second quarter of 2018 and if successful, could support a marketing application for a new US commercial indication. Currently, in the United States, the Viveve® System is cleared by the FDA for use in general surgical procedures for electrocoagulation and hemostasis.

InControl Products by Viveve are FDA-cleared medical devices that treat stress, urge, and mixed incontinence conditions and that improve pelvic floor strength. Viveve exclusively distributes InControl Medical's products to healthcare providers in the United States.

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. 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 fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, 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.

Viveve is a registered trademark of Viveve, Inc.
Geneveve is a trademark of Viveve, Inc.

Investor Relations contacts:

Sarah McCabe

Stern Investor Relations, Inc.

(212) 362-1200

sarah@sternir.com

Amato and Partners, LLC

Investor Relations Counsel

admin@amatoandpartners.com

Media contact:

Kelly Wakelee

Berry & Company Public Relations

(212) 253-8881

kwakelee@berrypr.com