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): August 11, 2015

 

 

INVUITY, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-37417   04-3803169

(State or other jurisdiction

of incorporation)

 

(Commission

File No.)

 

(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 2.02 Results of Operations and Financial Condition.

On August 11, 2015, Invuity, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2015. In the press release, the Company also announced that it would be holding a conference call on August 11, 2015 to discuss its financial results for the quarter ended June 30, 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 August 11, 2015.


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: August 11, 2015      
     

By: /s/ Philip Sawyer

      Philip Sawyer
      President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit No.    Description
99.1    Press release issued by Invuity, Inc. dated August 11, 2015.


Exhibit 99.1

 

LOGO

INVUITY REPORTS 2015 SECOND QUARTER,

SIX-MONTH FINANCIAL RESULTS

Second Quarter Revenue Increased 69 Percent Over Prior Year Period

SAN FRANCISCO, August 11, 2015 - Invuity, Inc. (NASDAQ:IVTY), a medical technology company, today reported financial results for the second quarter and six-months ended June 30, 2015.

Q2 2015 Highlights

 

    Revenue grew 69 percent to $4.7 million compared to revenue of $2.8 million in the 2014 second quarter.

 

    Revenue would have been $5.0 million, without the impact of a $300,000 adjustment.

 

    Invuity sold its devices to approximately 450 hospitals in the second quarter of 2015.

 

    In June 2015, Invuity closed its initial public offering (IPO) of 4,600,000 shares of common stock (including 600,000 shares purchased by the underwriters pursuant to an option to purchase additional shares) at the public offering price of $12.00 per share, netting $47.2 million after all banker fees and issuance costs.

Financial Results

Revenue was $4.7 million in the second quarter of 2015, compared to $2.8 million in the second quarter of 2014 and $4.4 million in the first quarter of 2015. Revenue in the second quarter of 2015 would have totaled $5.0 million without the impact of an approximately $300,000 reversal of revenue that was originally recorded in the fourth quarter of 2014.

For the first six months of 2015, revenue was $9.2 million, up 85 percent from revenue of $5.0 million in the first six months of 2014.

“Invuity has the unique opportunity to further expand its platform technology to enable new and emerging surgical procedures,” said President and CEO Philip Sawyer. “We have built strong commercial momentum in our initial clinical areas and will continue to deliver devices and technologies that address additional specialties and new high volume procedures.”

Gross margin for the second quarter and first six months of 2015 was 59 percent and 60 percent, respectively, compared to 55 percent and 59 percent for the same periods in 2014.

Total operating expenses for the 2015 second quarter and first six months were $11.7 million and $22.5 million, respectively, compared to $6.6 million and $12.4 million in the prior year periods.


The net loss for the second quarter of 2015 was $9.3 million, or $3.20 loss per share, compared to a net loss of $5.5 million, or $8.40 loss per share, for the second quarter of 2014. The net loss for the first half of 2015 was $18.4 million, or $10.11 loss per share, compared to $10.2 million, or $15.75 loss per share, for the first half of 2014.

The Company’s balance sheet as of June 30, 2015 showed total cash and cash equivalents of $65.8 million, including proceeds from the IPO in June.

Conference Call

Invuity’s management will discuss the Company’s financial results for the second quarter and six months ended June 30, 2015, and provide a general business update during a conference call beginning at 5:00 p.m. Eastern Time today, August 11, 2015. 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 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:

Media:

Miranda Duncan

Waggener Edstrom

415-342-9430

media@invuity.com

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
June 30,
    Six Months Ended
June 30,
 
     2015     2014     2015     2014  

Revenue

   $ 4,747      $ 2,816      $ 9,189      $ 4,970   

Cost of goods sold

     1,936        1,280        3,668        2,027   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     2,811        1,536        5,521        2,943   
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Selling, general and administrative

     9,820        5,339        18,743        9,913   

Research and development

     1,857        1,310        3,757        2,513   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     11,677        6,649        22,500        12,426   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (8,866     (5,113     (16,979     (9,483

Interest expense

     (504     (352     (873     (722

Interest and other income (expense), net

     24        9        (526     37   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (9,346   $ (5,456   $ (18,378   $ (10,168
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share, basic and diluted

   $ (3.20   $ (8.40   $ (10.11   $ (15.75
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     2,919,823        649,511        1,817,673        645,681   
  

 

 

   

 

 

   

 

 

   

 

 

 


Balance Sheet

as of June 30, 2015 (unaudited)

(In thousands, except share and per share amounts)

 

     June 30,
2015
    December 31,
2014
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 65,755      $ 6,048   

Accounts receivable, net

     3,237        2,798   

Inventory

     4,826        4,271   

Prepaid expenses and other current assets

     1,115        2,486   
  

 

 

   

 

 

 

Total current assets

     74,933        15,603   

Restricted cash

     1,125        1,125   

Property and equipment, net

     9,037        8,541   

Other non-current assets

     —          55   
  

 

 

   

 

 

 

Total assets

   $ 85,095      $ 25,324   
  

 

 

   

 

 

 

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

    

Current liabilities:

    

Accounts payable

   $ 2,022      $ 1,075   

Accrued and other current liabilities

     5,094        4,162   
  

 

 

   

 

 

 

Total current liabilities

     7,116        5,237   

Deferred rent

     2,831        2,676   

Convertible preferred stock warrant liability

     —          136   

Long-term debt—related party

     14,418        9,347   
  

 

 

   

 

 

 

Total liabilities

     24,365        17,396   
  

 

 

   

 

 

 

Commitments and contingencies

    

Convertible preferred stock, $0.001 par value—0 and 6,207,320 shares authorized at June 30, 2015 and December 31, 2014, respectively; 0 and 6,056,403 shares issued and outstanding at June 30, 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 June 30, 2015 and December 31, 2014, respectively; no shares issued and outstanding at June 30, 2015 and December 31, 2014

     —          —     

Common stock, $0.001 par value—100,000,000 and 9,189,189 shares authorized at June 30, 2015 and December 31, 2014, respectively; 13,305,015 and 711,249 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively

     13        1   

Additional paid-in capital

     147,132        2,209   

Accumulated deficit

     (86,415     (68,037
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     60,730        (65,827
  

 

 

   

 

 

 

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

   $ 85,095      $ 25,324   
  

 

 

   

 

 

 

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