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): July 19, 2016
INVUITY, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-37417 |
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04-3803169 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On July 19, 2016, Invuity, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 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 9.01 |
Financial Statements and Exhibits. |
(d) |
Exhibits. |
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Exhibit No. |
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Description |
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99.1 |
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Press release issued by Invuity, Inc. dated July 19, 2016. |
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.
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INVUITY, INC. |
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Date: July 19, 2016 |
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By: |
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/s/ Philip Sawyer |
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Philip Sawyer |
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President and Chief Executive Officer |
Exhibit 99.1
NEWS RELEASE
INVUITY REPORTS 2016 SECOND QUARTER AND SIX-MONTH FINANCIAL RESULTS
Achieves 73 percent year-over-year revenue growth
SAN FRANCISCO, July 19, 2016 - Invuity, Inc. (NASDAQ:IVTY), a leading surgical photonics company, today reported financial results for the second quarter and six months ended June 30, 2016.
Q2 2016 Highlights
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Revenue grew 73 percent to $8.2 million compared to revenue of $4.7 million in the 2015 second quarter. |
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Gross margin expansion continued to 74.6 percent compared to 61.0 percent for the 2015 second quarter. |
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Approximately 610 customers purchased Invuity devices in the second quarter of 2016, up from 445 customers in the second quarter of 2015. |
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Approximately 186,000 procedures have been performed using Invuity devices. |
"We had a strong second quarter highlighted by 73 percent revenue growth and continued execution on our development plans to expand our advanced photonics technology to additional complementary surgical procedures and modalities,” said President and CEO Philip Sawyer. “We are pleased with our progress to date and excited about our momentum towards the widespread adoption of our unique devices and technologies, which provide meaningful clinical and economic value to surgeons and hospitals.”
Financial Results
Revenue was $8.2 million for the second quarter 2016, compared to $4.7 million for the second quarter in 2015, driven by an increase in active accounts and an increase in the revenue per active account.
Gross margin for the 2016 second quarter was 74.6 percent, compared to 61.0 percent for the same period in 2015. Gross margin has benefited from the recent introduction of our non-conductive polymer based retractors, and from overhead efficiencies due to increased sales volumes.
Total operating expenses for the 2016 second quarter were $15.8 million, compared to $11.8 million in the prior year period. We have continued to invest in our commercial platform consistent with our stated objectives, including the continued ramp up in sales reps and increased product development efforts in support of our new product pipeline.
The net loss for the second quarter of 2016 was $10.1 million, or $0.76 loss per share, compared to a net loss of $9.3 million, or $3.20 loss per share, for the second quarter of 2015.
The Company's balance sheet as of June 30, 2016 showed total cash and cash equivalents of $25.5 million.
Conference Call
Invuity's management will discuss the Company's financial results for the second quarter ended June 30, 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, July 19, 2016. To join the live call, participants may dial 1-877-556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 47469934. 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, visitwww.invuity.com.
Forward-Looking Statements
This announcement contains forward-looking statements that involve risks and uncertainties, including statements regarding financial results, future product introductions, 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.
CONTACT:
Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129
Investors:
Mark Klausner
Westwicke Partners
443-213-0501
irdept@invuity.com
Condensed Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2016 |
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2015 |
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2016 |
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2015 |
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Revenue |
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$ |
8,223 |
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$ |
4,747 |
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$ |
14,627 |
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$ |
9,189 |
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Cost of goods sold |
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2,091 |
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1,849 |
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4,196 |
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3,571 |
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Gross profit |
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6,132 |
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2,898 |
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10,431 |
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5,618 |
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Operating expenses: |
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Research and development |
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2,340 |
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1,857 |
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4,941 |
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3,757 |
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Selling, general and administrative |
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13,429 |
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9,907 |
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26,750 |
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18,840 |
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Total operating expenses |
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15,769 |
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11,764 |
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31,691 |
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22,597 |
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Loss from operations |
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(9,637 |
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(8,866 |
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(21,260 |
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(16,979 |
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Interest expense |
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(505 |
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(504 |
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(1,009 |
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(873 |
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Interest and other income (expense), net |
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13 |
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24 |
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30 |
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(526 |
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Net loss and comprehensive loss |
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$ |
(10,129 |
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$ |
(9,346 |
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$ |
(22,239 |
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$ |
(18,378 |
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Net loss per common share, basic and diluted |
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$ |
(0.76 |
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$ |
(3.20 |
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$ |
(1.66 |
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$ |
(10.11 |
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Weighted-average shares used to compute net loss per common share, basic and diluted |
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13,404,007 |
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2,919,823 |
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13,399,775 |
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1,817,673 |
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Balance Sheet
as of June 30, 2016 and December 31, 2015
(In thousands, except share and per share amounts)
(Unaudited)
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June 30, 2016 |
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December 31, 2015 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
25,456 |
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$ |
46,296 |
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Accounts receivable, net |
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4,514 |
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3,619 |
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Inventory |
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5,450 |
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5,182 |
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Prepaid expenses and other current assets |
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572 |
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923 |
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Total current assets |
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35,992 |
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56,020 |
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Restricted Cash |
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1,090 |
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1,090 |
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Property and equipment, net |
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8,752 |
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9,195 |
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Other non-current assets |
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285 |
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— |
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Total assets |
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$ |
46,119 |
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$ |
66,305 |
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Liabilities, Preferred Stock and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
2,369 |
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$ |
2,458 |
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Accrued and other current liabilities |
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4,951 |
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4,214 |
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Short-term debt—related party |
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750 |
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— |
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Total current liabilities |
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8,070 |
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6,672 |
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Deferred rent |
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2,771 |
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2,810 |
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Long-term debt—related party |
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13,801 |
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14,480 |
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Total liabilities |
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24,642 |
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23,962 |
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Commitments and contingencies |
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Stockholders’ equity : |
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Preferred stock, $0.001 par value—10,000,000 shares authorized at June 30, 2016 and December 31, 2015, respectively; no shares issued and outstanding at June 30, 2016 and December 31, 2015 |
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— |
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— |
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Common stock, $0.001 par value—100,000,000 shares authorized at June 30, 2016 and December 31, 2015, respectively;13,444,818 and 13,392,358 shares issued and outstanding at June 30, 2016 and December 31, 2015, respectively |
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13 |
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13 |
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Additional paid-in capital |
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149,309 |
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147,937 |
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Accumulated deficit |
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(127,845 |
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(105,607 |
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Total stockholders’ equity |
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21,477 |
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42,343 |
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Total liabilities and stockholders’ equity |
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$ |
46,119 |
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$ |
66,305 |
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