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): March 15, 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 March 15, 2018, Viveve Medical, Inc. (the “Company”) issued a press release announcing its results for the quarter and fiscal year ended December 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, 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	Press Release issued by the Company on March 15, 2018.

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: March 15, 2018	Viveve Medical, Inc.
	By:	/s/ Scott Durbin
		Scott Durbin
		Chief Financial Officer

EX-99.1

Exhibit 99.1

Viveve Reports Fourth Quarter and Full Year 2017 Financial Results

Company achieves record performance with 114% year-over-year revenue growth and projects $22 - $24 million in revenue for 2018

ENGLEWOOD, CO -- March 15, 2018 -- Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today reported financial results for the three months and year ended December 31, 2017.

“Our successful fourth-quarter results completed a remarkable year for Viveve, underscoring the scope of our commercial opportunity and the outstanding execution delivered by our team in every area of our operations throughout the year. During 2017 we rigorously pursued and achieved several key milestones supporting our global commercialization goals,” said Ms. Patricia Scheller, chief executive officer and director of Viveve. “We believe these achievements further solidify our position as a leader in technologies to support women’s intimate health and will allow us to capitalize on the increasing demand, rapid adoption, and expanded utilization of our products in 2018.”

2017 Business Highlights

● Achieved total revenue of $15.3 million from the sale of 227 systems and over 10,800 disposable treatment tips worldwide, representing a 114% year-over-year revenue increase.

● Launched a U.S. commercial sales team in February and expanded the Viveve sales organization to a total of 23 at the end of the fourth quarter, including building a direct sales team in Canada.

● Received international regulatory clearances in 10 countries for new or expanded indications, the majority for treatment of vaginal laxity and/or improvement of sexual function.

● Strengthened balance sheet with approximately $65 million in gross proceeds from debt and equity financings to support continued global expansion and commercial operations.

● Announced publication of VIVEVE I study results and sub-analysis of validated Female Sexual Function Index domains in two peer-reviewed journals, Journal of Sexual Medicine and Journal of Women’s Health.

● Supported numerous investigator sponsored studies that generated additional differentiating clinical data for expanded applications.

● Opened new corporate headquarters in Englewood, Colorado, supporting expansion of team to nearly 100 full-time employees.

● Completed exclusive distribution agreement for sale of InControl Products by Viveve to U.S. healthcare providers for the treatment of various incontinence conditions.

● Expanded and continued the protection of the Viveve global IP portfolio.

● Selected for inclusion in the 2017 Russell 2000 Index and Deloitte’s Technology Fast 500 list.

“With the sale of 227 systems in 2017, Viveve now has a commercial installed base of 444 systems worldwide. We anticipate continued momentum in system sales and consumable utilization in 2018 as we advance our global commercial strategy,” said Scott Durbin, Viveve’s chief financial officer. "Based on the physician response to the U.S. launch of our cryogen-cooled monopolar radiofrequency (CMRF) technology platform and continued international momentum, we believe we are well positioned to build on our 2017 success and project revenue between $22 million and $24 million for 2018.”

Q4 2017 Financial Results

Revenue for the fourth quarter of 2017 totaled $5,101,000 from the sale of 80 Viveve Systems and approximately 2,600 treatment tips, compared to revenue of $2,452,000 for the same period in 2016, representing a 108% increase over the fourth quarter of 2016.

Gross profit for the fourth quarter of 2017 was $2,772,000, or 54% of revenue, compared to gross profit of $956,000, or 39% of revenue in the fourth quarter of 2016.

Total operating expense for the fourth quarter of 2017 was $12,201,000 compared to operating expense of $6,485,000 in the same period in 2016. The increase was primarily the result of increased efforts to support commercialization of Viveve’s products in the U.S.

Spending on research and development during the fourth quarter of 2017 was $3,051,000 compared to $2,052,000 in the fourth quarter of 2016. The increase was due to costs associated with additional engineering and development work with the company’s contract manufacturer related to product line expansion efforts.

Selling, general and administrative expenses for the fourth quarter of 2017 were $9,150,000 compared to $4,433,000 in the fourth quarter 2016. The increase was mainly attributable to increased sales and marketing efforts to support Viveve’s commercialization efforts, marketing expenses to build brand and market awareness, and expenses associated with being a public company.

Net loss for the fourth quarter of 2017 was $10,224,000, or a net loss of $0.53 per share based on 19,435,347 weighted average shares outstanding during the period.

Cash and cash equivalents were approximately $20.7 million as of December 31, 2017.

Full Year 2017 Financial Results

Revenue for 2017 totaled $15,288,000 from the sale of 227 Viveve Systems and approximately 10,800 treatment tips, compared to revenue of $7,141,000 for the full year of 2016, an increase of 114% year-over-year.

Gross profit for 2017 was $7,444,000, or 49% of revenue, compared to gross profit of $2,529,000, or 35% of revenue for the full year of 2016.

Total operating expense for 2017 was approximately $41,174,000 compared to $21,233,000 for the full year of 2016.

Spending on research and development for 2017 was $12,343,000 compared to $8,365,000 in 2016 and increased due to costs associated with engineering and development work with the company’s contract manufacturer related to product line improvement and expansion efforts.

Selling, general and administrative (SG&A) expenses during 2017 were $28,831,000 versus $12,868,000 in 2016. The increase in SG&A was primarily the result of increased costs associated with Viveve’s U.S. launch, mid-year expansion of the commercial sales organization, marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts.

Net loss for 2017 was $36,959,000, or a net loss of $2.11 per share, compared with a net loss of $20,111,000, or a net loss of $2.18 per share for 2016 based on 17,496,942 weighted average shares outstanding during the period.

Conference Call Information

The company will host a live conference call at 5:00 p.m. ET today. Registration to participate in the conference call can be accessed at http://dpregister.com/10117329. The dial-in telephone number will be provided upon registration either in advance of or at the time of the conference call. To view/listen only to the live webcast please use the following link: http://services.choruscall.com/links/vive171109.html. The conference call will be archived on the company’s website at http://ir.viveve.com.

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 GENEVEVE™ 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, 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. Consistent with these approvals, Viveve is seeking an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to conduct a pivotal study on use of the device for improvement in sexual function. Currently, in the United States, the Viveve System is cleared by the FDA for 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 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.
Geneveve is a trademark of Viveve, Inc.

Investor Relations contact:
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)

	December 31,			December 31,
	2017			2016
ASSETS
Current assets:
Cash and cash equivalents	$	20,730		$	8,086
Accounts receivable, net		6,213			2,091
Inventory		2,390			2,687
Prepaid expenses and other current assets		2,741			1,066
Total current assets		32,074			13,930
Property and equipment, net		1,303			483
Investment in limited liability company		2,500			-
Other assets		202			136
Total assets	$	36,079		$	14,549
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable	$	4,799		$	3,086
Accrued liabilities		4,605			2,186
Note payable, current portion		-			1,867
Total current liabilities		9,404			7,139
Note payable, noncurrent portion		28,948			7,762
Other noncurrent liabilities		327			53
Total liabilities		38,679			14,954
Stockholders’ deficit:
Common stock and additional paid-in capital		102,981			68,217
Accumulated deficit		(105,581	)		(68,622	)
Total stockholders' deficit		(2,600	)		(405	)
Total liabilities and stockholders’ deficit	$	36,079		$	14,549

VIVEVE MEDICAL, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

	Three Months Ended						Year Ended
	December 31,						December 31,
	2017			2016			2017			2016
Revenue	$	5,101		$	2,452		$	15,288		$	7,141
Cost of revenue		2,329			1,496			7,844			4,612
Gross profit		2,772			956			7,444			2,529
Operating expenses:
Research and development		3,051			2,052			12,343			8,365
Selling, general and administrative		9,150			4,433			28,831			12,868
Total operating expenses		12,201			6,485			41,174			21,233
Loss from operations		(9,429	)		(5,529	)		(33,730	)		(18,704	)
Interest expense, net		(784	)		(276	)		(3,169	)		(1,370	)
Other expense, net		(11	)		(15	)		(60	)		(37	)
Net loss	$	(10,224	)	$	(5,820	)	$	(36,959	)	$	(20,111	)
Net loss per share:
Basic and diluted	$	(0.53	)	$	(0.55	)	$	(2.11	)	$	(2.18	)
Weighted average shares used in computing net loss per common share
Basic and diluted		19,435,347			10,653,943			17,496,942			9,222,348