0001558370-17-000592.txt : 20170214 0001558370-17-000592.hdr.sgml : 20170214 20170214160046 ACCESSION NUMBER: 0001558370-17-000592 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170214 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170214 DATE AS OF CHANGE: 20170214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Invuity, Inc. CENTRAL INDEX KEY: 0001393020 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: CA FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37417 FILM NUMBER: 17608420 BUSINESS ADDRESS: STREET 1: 444 DE HARO STREET CITY: San Francisco STATE: CA ZIP: 94107 BUSINESS PHONE: 415-655-2100 MAIL ADDRESS: STREET 1: 444 DE HARO STREET CITY: San Francisco STATE: CA ZIP: 94107 FORMER COMPANY: FORMER CONFORMED NAME: Spotlight Surgical Inc DATE OF NAME CHANGE: 20070313 8-K 1 ivty-20170214x8k.htm 8-K ivty_Current_Folio_8K

 

 

 

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):  February 14, 2017

 


 

INVUITY, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware

001-37417

04-3803169

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

 

444 De Haro Street

San Francisco, CA 94107

(Address of principal executive offices)

 

(650) 655-2100

(Registrant’s telephone number, including area code)

 


 

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))

 

 

 

 

 


 

Item 2.02Results of Operations and Financial Condition.

 

On February 14, 2017, Invuity, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2016. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This information is intended to be furnished under Item 2.02 of Form 8-K, “Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01Financial Statements and Exhibits.

(d)Exhibits.

 

 

 

 

Exhibit No.

    

Description

 

 

 

99.1

 

Press release issued by Invuity, Inc. dated February 14, 2017.

 

 


 

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.

 

 

INVUITY, INC.

Date:  February 14, 2017

 

 

 

By:

  /s/ Philip Sawyer

 

 

  Philip Sawyer

 

 

  President and Chief Executive Officer

 


EX-99.1 2 ivty-20170214ex991affd47.htm EX-99.1 Exhibit_991

Exhibit 99.1

 

 

Picture 1

NEWS RELEASE

 

 

INVUITY REPORTS 2016 FOURTH QUARTER, ANNUAL FINANCIAL RESULTS

Achieves revenue growth of 50% and gross margin expansion over prior year’s fourth quarter

 

 

SAN FRANCISCO, February 14, 2017 - Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today reported financial results for the three months and year ended December 31, 2016.

 

Q4 2016 Highlights

 

·

Revenue grew 50% to $9.4 million compared to revenue of $6.2 million in the 2015 fourth quarter.

·

Gross margin expansion continued to 74.3% compared to 65.9% in the 2015 fourth quarter.

·

Approximately 745 hospitals purchased Invuity devices in the fourth quarter of 2016, up from 530 hospitals in the fourth quarter of 2015.

·

Approximately 240,000 procedures have been performed using Invuity devices.

 

‘We finished 2016 on a strong note, delivering 50% year-over-year growth in the fourth quarter,” said President and CEO Philip Sawyer. “In 2017, we will continue to drive toward our goal of leadership in minimal access surgery through consistent execution of our commercial strategies coupled with the introduction of innovative, disruptive products.”

 

Financial Results

 

Revenue was $9.4 million in the fourth quarter of 2016, up 50% from revenue of $6.2 million in the fourth quarter of 2015 driven by an increase in active accounts and an increase in revenue per account. For the 2016 full year, revenue was $32.5 million, an increase of 54% over revenue of $21.0 million in 2015.

 

Gross margin for the fourth quarter and full-year 2016 was 74.3% and 72.8%, respectively, compared to 65.9% and 63.2% for the same periods in 2015. Gross margin expansion has been helped by the introduction of our non-conductive polymer based retractors, and by overhead efficiencies created as a result of increased sales volumes.

 

Total operating expenses for the fourth quarter and full-year 2016 were $16.0 million and $62.3 million, respectively, compared to $13.7 million and $48.5 million in the prior year periods. The increase in operating expenses is due to continued investment in our commercial platform, new product development costs and related increases in corporate infrastructure.

 

The net loss for the fourth quarter of 2016 was $9.6 million, or $0.56 loss per share, compared to a net loss of $10.1 million, or $0.76 loss per share, for the fourth quarter of 2015. The net loss for full-year 2016 was $40.6 million, or $2.73 loss per share, compared to $37.6 million, or $4.94 loss per share, for 2015.


 

 

The Company's balance sheet as of December 31, 2016, included total cash, cash equivalents and short term investments of $39.0 million.

 

Business Outlook

 

Invuity is reiterating its revenue guidance for 2017 in the range of $42 million to $44 million.

 

Conference Call

 

Invuity's management will discuss the Company's financial results for the fourth quarter ended December 31, 2016, and provide a general business update during a conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time today, February 14, 2017. To join the live call, participants may dial 1-877- 556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 59656880.  To listen to the live call via Invuity's website, go to www.invuity.com, in the Events & Presentations section. A webcast replay of the call will be available following the conclusion of the call for a period of 90 days in the Events & Presentations section of the website.

 

About Invuity®

 

Invuity, Inc. is a leading medical technology company focused on developing and marketing advanced surgical devices to improve the ability of physicians to perform minimal access surgery through smaller and hidden incisions. The company's patented Intelligent Photonics™ technology delivers enhanced visualization which facilitates surgical precision, efficiency and safety. In addition, the company utilizes comprehensive strategic marketing programs to create stronger institutional partnerships. Clinical applications include women’s health, encompassing breast cancer and breast reconstruction surgery, gynecology and thyroid surgery.  Additional applications include procedures for electrophysiology, spine, orthopedic, cardiothoracic, and general surgery. Invuity is headquartered in San Francisco, CA. For more information, visit www.invuity.com.

 

Forward-Looking Statements

 

This announcement contains forward-looking statements that involve risks and uncertainties, including statements regarding financial projections for 2017, future product introductions, future sales and marketing initiatives, and market opportunities. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including, but not limited to: fluctuations in demand or failure to gain market acceptance for the Company's devices; the Company's ability to demonstrate to and gain approval from hospitals to use the Company's devices; the highly competitive business environment for surgical medical devices; the Company's ability to sell its devices at prices that support its current business strategies; difficulty forecasting future financial performance; protection of the Company's intellectual property; and compliance with necessary regulatory clearances or approvals. The Company undertakes no obligation to update the forward-looking information in this release. More information about potential factors that could affect the Company's business and financial results is included in its filings with the Securities and Exchange Commission, including, without limitation, under the captions: "Management's Discussion and Analysis of Financial Condition and Results of Operations," and "Risk Factors," which are on file with the Securities and Exchange Commission.

 


 

 

CONTACT:

 

Company Contact:

Jim Mackaness

Chief Financial Officer

Invuity, Inc.

415-655-2129

 

Investors:

Mark Klausner

Westwicke Partners

443-213-0501

irdept@invuity.com 

 

 


 

 

INVUITY, INC.

Condensed Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31, 

 

Year Ended December 31, 

 

    

2016

    

2015

    

2016

 

2015

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

9,356

    

$

6,246

 

$

32,461

    

$

21,031

    

Cost of goods sold

 

 

2,409

 

 

2,127

 

 

8,824

 

 

7,733

 

Gross profit

 

 

6,947

 

 

4,119

 

 

23,637

 

 

13,298

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,496

 

 

2,069

 

 

9,908

 

 

7,869

 

Selling, general and administrative

 

 

13,524

 

 

11,617

 

 

52,409

 

 

40,636

 

Total operating expenses

 

 

16,020

 

 

13,686

 

 

62,317

 

 

48,505

 

Loss from operations

 

 

(9,073)

 

 

(9,567)

 

 

(38,680)

 

 

(35,207)

 

Interest expense

 

 

(505)

 

 

(505)

 

 

(2,018)

 

 

(1,881)

 

Interest and other income (expense), net

 

 

28

 

 

17

 

 

89

 

 

(482)

 

Net loss

 

$

(9,550)

 

$

(10,055)

 

$

(40,609)

 

$

(37,570)

 

Net loss per common share, basic and diluted

 

$

(0.56)

 

$

(0.76)

 

$

(2.73)

 

$

(4.94)

 

Weighted-average shares used to compute net loss per common share, basic and diluted

 

 

16,930,612

 

 

13,307,031

 

 

14,868,501

 

 

7,606,172

 

 

 

 

 


 

 

Condensed Balance Sheets

as of December 31, 2016 and December 31, 2015

(In thousands, except share and per share amounts)

(Unaudited) 

 

 

 

 

 

 

 

 

 

 

December 31, 

 

 

    

2016

 

2015

 

Assets

 

 

 

    

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,300

 

$

46,296

 

Short-Term Investments

 

 

10,737

 

 

 —

 

Restricted cash - Current

 

 

181

 

 

 —

 

Accounts receivable, net

 

 

5,782

 

 

3,619

 

Inventory

 

 

5,052

 

 

5,182

 

Prepaid expenses and other current assets

 

 

1,088

 

 

923

 

Total current assets

 

 

51,140

 

 

56,020

 

Restricted cash

 

 

909

 

 

1,090

 

Property and equipment, net

 

 

8,286

 

 

9,195

 

Other non-current assets

 

 

 —

 

 

 —

 

Total assets

 

$

60,335

 

$

66,305

 

Liabilities, Stock and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

2,192

 

$

2,458

 

Accrued and other current liabilities

 

 

6,351

 

 

4,214

 

Short-term debt—related party

 

 

1,362

 

 

 —

 

Total current liabilities

 

 

9,905

 

 

6,672

 

Deferred rent

 

 

2,721

 

 

2,810

 

Long-term debt—related party

 

 

13,261

 

 

14,480

 

Total liabilities

 

 

25,887

 

 

23,962

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.001 par value—10,000,000 shares authorized at December 31, 2016 and December 31, 2015, respectively; no shares issued and outstanding at December 31, 2016 and December 31, 2015

 

 

 —

 

 

 —

 

Common stock, $0.001 par value—200,000,000  shares authorized at December 31, 2016 and December 31, 2015 respectively; 16,950,940 and 13,392,358 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively

 

 

17

 

 

13

 

Additional paid-in capital

 

 

180,647

 

 

147,937

 

Accumulated deficit

 

 

(146,216)

 

 

(105,607)

 

Total stockholders’ equity

 

 

34,448

 

 

42,343

 

Total liabilities and stockholders’ equity

 

$

60,335

 

$

66,305

 

 

###

 

 

 

 

 

 


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