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)

February 24, 2016

 

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 No.)

 

444 De Haro Street

San Francisco, CA 94107

(Address of principal executive offices, including zip code)

(650) 655-2500

(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 (see General Instructions A.2. below):

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

 

 


 

Item 2.02

Results of Operations and Financial Condition. 

On February 24, 2016, Invuity, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and fiscal year ended December 31, 2015. In the press release, the Company also announced that it would be holding a conference call on February 24, 2016 to discuss its financial results for the fourth quarter and fiscal year ended December 31, 2015. 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 9.01

Financial Statements and Exhibits.

(d)

Exhibits.

 

 

 

 

Exhibit No.

 

Description

 

 

 

99.1

  

Press release issued by Invuity, Inc. dated February 24, 2016.

 

 


 

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.

 

 

By:

 

/s/ Philip Sawyer

 

 

Philip Sawyer

 

 

President and Chief Executive Officer

Date:  February 24, 2016

 

 


 

EXHIBIT INDEX

 

Exhibit No.

  

Description

 

 

 

99.1

  

Press release issued by Invuity, Inc. dated February 24, 2016.

 

 



 

Exhibit 99.1

 

 

NEWS RELEASE

INVUITY REPORTS 2015 FOURTH QUARTER,

YEAR-END FINANCIAL RESULTS

SAN FRANCISCO, February 24, 2016 - Invuity, Inc. (NASDAQ:IVTY), an advanced medical technology company, today reported financial results for the fourth quarter and year ended December 31, 2015.

Q4 2015 Highlights

 

·

Revenue grew 42 percent to $6.2 million compared to revenue of $4.4 million in the 2014 fourth quarter.

 

·

Revenue for the 2015 full year increased 61 percent to $21.0 million from $13.1 million in the prior year period.

 

·

In the fourth quarter of 2015, approximately 530 hospitals purchased Invuity devices, up from 370 hospitals in the fourth quarter of 2014.

 

·

Approximately 145,000 procedures have been performed using Invuity devices.  

“The year finished on a strong note as we grew our customer base and further penetrated existing hospital accounts by expanding the use of our advanced photonics technology into adjacent surgical procedures and new specialties” said President and CEO Philip Sawyer. “It is extremely encouraging to have generated such strong momentum and growth while scaling our sales force so dramatically during the year.  We believe that increasing the depth and capabilities of our sales force, expanding the use of our products into new surgical procedures and implementing new, innovative marketing programs will support continued sales momentum in 2016.”

Financial Results

Revenue was $6.2 million in the fourth quarter of 2015, compared to $4.4 million in the fourth quarter of 2014.  For the 2015 full year, revenue was $21.0 million, an increase of 61 percent from revenue of $13.1 million in 2014, driven by both organic growth in existing accounts and the addition of new accounts.

Gross margin for the 2015 fourth quarter was 65.9 percent, and was 63.2 percent for the 2015 full year.

Total operating expenses for the 2015 fourth quarter and full year were $13.7 million and $48.5 million, respectively, compared to $8.4 million and $28.2 million in the prior year periods.

The net loss for the fourth quarter of 2015 was $10.1 million, or $0.76 loss per share, compared to a net loss of $5.2 million, or $7.78 loss per share, for the fourth quarter of 2014.  The net loss for 2015 was $37.6 million, or $4.94 loss per share, compared to $20.7 million, or $31.63 loss per share, for 2014.

Conference Call

Invuity’s management will discuss the Company’s financial results for the fourth quarter and year ended December 31, 2015, and provide a general business update during a conference call beginning at 5:00 p.m. Eastern Time today, February 24, 2016.  To join the live call, participants may dial 1-855-539-0900 (U.S.) or 1-412-455-6044 (International).  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 medical technology company focused on developing and marketing advanced photonics devices to improve the ability of surgeons to illuminate and visualize the surgical cavity during open minimally invasive and minimal access surgery. The company's patented Intelligent Photonics™ technology enables enhanced surgical precision, efficiency and safety by providing superior visualization. Clinical applications include breast and thyroid oncology, plastic reconstructive, spine, orthopedic, cardiothoracic and general surgery among others. 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 results, future marketing initiatives, market opportunities and potential results from future new initiatives. 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.

- TABLES FOLLOW -

CONTACTS:

Company Contact:

Jim Mackaness

Chief Financial Officer

Invuity, Inc.

415-655-2129

Investors:

Matt Clawson

Pure Communications

949-370-8500

irdept@invuity.com

 


 

INVUITY, INC.

Condensed Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

Three Months Ended

December 31,

 

 

Twelve Months Ended

December 31,

 

 

2015

 

 

2014

 

 

2015

 

 

2014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

$

6,246

 

 

$

4,409

 

 

$

21,031

 

 

$

13,103

 

Cost of goods sold

 

2,128

 

 

 

1,399

 

 

 

7,733

 

 

 

4,630

 

Gross profit

 

4,118

 

 

 

3,010

 

 

 

13,298

 

 

 

8,473

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

11,617

 

 

 

6,977

 

 

 

40,636

 

 

 

23,043

 

Research and development

 

2,069

 

 

 

1,381

 

 

 

7,869

 

 

 

5,181

 

Total operating expenses

 

13,686

 

 

 

8,358

 

 

 

48,505

 

 

 

28,224

 

Loss from operations

 

(9,568

)

 

 

(5,348

)

 

 

(35,207

)

 

 

(19,751

)

Interest expense

 

(488

)

 

 

(320

)

 

 

(1,853

)

 

 

(1,351

)

Interest and other income (expense), net

 

1

 

 

 

464

 

 

 

(510

)

 

 

440

 

Net loss

$

(10,055

)

 

$

(5,204

)

 

$

(37,570

)

 

$

(20,662

)

Net loss per common share, basic and diluted

$

(0.76

)

 

$

(7.78

)

 

$

(4.94

)

 

$

(31.63

)

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

    and diluted

 

13,307,031

 

 

 

669,202

 

 

 

7,606,172

 

 

 

653,195

 

 


 

Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

December 31,

2015

 

 

December 31,

2014

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

46,296

 

 

$

6,048

 

Accounts receivable, net

 

3,619

 

 

 

2,798

 

Inventory

 

5,182

 

 

 

4,271

 

Prepaid expenses and other current assets

 

889

 

 

 

2,486

 

Total current assets

 

55,986

 

 

 

15,603

 

Restricted cash

 

1,090

 

 

 

1,125

 

Property and equipment, net

 

9,195

 

 

 

8,541

 

Other non-current assets

 

34

 

 

 

55

 

Total assets

$

66,305

 

 

$

25,324

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

2,458

 

 

$

1,075

 

Accrued and other current liabilities

 

4,213

 

 

 

4,162

 

Total current liabilities

 

6,671

 

 

 

5,237

 

Deferred rent

 

2,811

 

 

 

2,676

 

Convertible preferred stock warrant liability

 

 

 

136

 

Long-term debt—related party

 

14,479

 

 

 

9,347

 

Total liabilities

 

23,961

 

 

 

17,396

 

Commitments and contingencies

 

 

 

 

 

 

 

Convertible preferred stock, $0.001 par value—0 and 6,207,320 shares authorized

    at December 31, 2015 and December 31, 2014, respectively; 0 and 6,056,403

    shares issued and outstanding at December 31, 2015 and December 31, 2014,

    respectively

 

 

 

 

73,755

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

Preferred stock, $0.001 par value—10,000,000 and no shares authorized at

    December 31, 2015 and December 31, 2014, respectively; no shares issued

    and outstanding at December 31, 2015 and December 31, 2014

 

 

 

 

 

Common stock, $0.001 par value—100,000,000 and 9,189,189 shares

    authorized at December 31, 2015 and December 31, 2014, respectively;

    13,392,358 and 711,249 shares issued and outstanding at December 31, 2015

    and December 31, 2014, respectively

 

13

 

 

 

1

 

Additional paid-in capital

 

147,937

 

 

 

2,209

 

Accumulated deficit

 

(105,606

)

 

 

(68,037

)

Total stockholders’ equity (deficit)

 

42,344

 

 

 

(65,827

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

$

66,305

 

 

$

25,324

 

 

###

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