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.

 
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  

CONTACT:

Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129

Investors:
Mark Klausner
Westwicke Partners
443-213-0501
irdept@invuity.com
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