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8-K - 8-K - Invuity, Inc.f8-k.htm

 

 

 

Exhibit 99.1

cid:5327A1A0-F9B9-49C0-A5E8-10F0E7F125E3@lan

NEWS RELEASE

 

 

INVUITY REPORTS 2017 SECOND QUARTER, SIX-MONTH FINANCIAL RESULTS

Achieves revenue growth of 19% over prior year quarter 

Updates 2017 revenue guidance

 

 

SAN FRANCISCO, July 25, 2017 - Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today reported financial results for the three months and six months ended June 30, 2017.

 

Q2 2017 Highlights

 

·

Revenue grew 19% to $9.8 million compared to revenue of $8.2 million in the 2016 second quarter.

·

Approximately 825 hospitals purchased Invuity devices in the second quarter of 2017, up from 620 hospitals in the second quarter of 2016.

·

Approximately 300,000 procedures have been performed using Invuity devices.

 

"We continued to experience positive underlying trends in our overall business during the second quarter as we added new accounts to our installed base and drove increased disposable usage. The PhotonBlade received an enthusiastic market reception during its trial commercialization phase, which supports our conviction regarding its future,” said President and CEO Philip Sawyer.  “During the quarter, we initiated a voluntary withdrawal of PhotonBlade to enhance the design of the product prior to full commercial launch, which we anticipate will occur by the end of the third quarter. This withdrawal from the market has delayed our commercialization plans and as a result we are adjusting our guidance. We remain confident that we have a solid platform to drive long-term shareholder value.”

 

Financial Results

 

Revenue was $9.8 million in the second quarter of 2017, up 19% from revenue of $8.2 million in the second quarter of 2016 driven by an increase in active accounts.

 

Gross margin for the second quarter was 69.1%, which was negatively impacted by approximately 3.5% due to the voluntary recall of the PhotonBlade. Gross margin was 74.6% for the same period in 2016.

 

Total operating expenses for the second quarter were $16.6 million, compared to $15.8 million in the prior year period.

 

The net loss for the second quarter of 2017 was $10.4 million, or $0.61 loss per share, compared to a net loss of $10.1 million, or $0.76 loss per share, for the second quarter of 2016.

 

The Company's balance sheet as of June 30, 2017 included total cash, cash equivalents and short-


 

term investments of $26.3 million.

 

Business Outlook

 

Invuity is adjusting its revenue guidance for 2017 to $40 million to $42 million from its previous revenue guidance of $42 million to $44 million.

 

Conference Call

 

Invuity's management will discuss the Company's financial results for the second quarter ended June 30, 2017, 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 25, 2017. To join the live call, participants may dial 1-877- 556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 51160313. 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, expectations for the launch of PhotonBlade, 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 complete successfully the redesign and relaunch of PhotonBlade; 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 Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 

 

Six Months Ended June 30, 

 

 

    

2017

    

2016

    

2017

    

2016

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

    

$

9,768

    

$

8,223

 

$

18,791

    

$

14,627

 

Cost of goods sold

 

 

3,015

 

 

2,091

 

 

5,114

 

 

4,196

 

Gross profit

 

 

6,753

 

 

6,132

 

 

13,677

 

 

10,431

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

2,410

 

 

2,340

 

 

4,839

 

 

4,941

 

Selling, general and administrative

 

 

14,204

 

 

13,429

 

 

29,057

 

 

26,750

 

Total operating expenses

 

 

16,614

 

 

15,769

 

 

33,896

 

 

31,691

 

Loss from operations

 

 

(9,861)

 

 

(9,637)

 

 

(20,219)

 

 

(21,260)

 

Interest expense

 

 

(527)

 

 

(505)

 

 

(1,014)

 

 

(1,009)

 

Interest income

 

 

53

 

 

 —

 

 

110

 

 

 —

 

Other income (expense), net

 

 

(52)

 

 

13

 

 

(178)

 

 

30

 

Loss on extinguishment of debt

 

 

 —

 

 

 —

 

 

(2,303)

 

 

 —

 

Net loss and comprehensive loss

 

$

(10,387)

 

$

(10,129)

 

$

(23,604)

 

$

(22,239)

 

Net loss per common share, basic and diluted

 

$

(0.61)

 

$

(0.76)

 

$

(1.39)

 

$

(1.66)

 

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

 

 

16,986,074

 

 

13,404,007

 

 

16,972,280

 

 

13,399,775

 

 

 

 

 

 

 

 


 

Condensed Balance Sheets

as of June 30, 2017 and December 31, 2016

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30, 

 

December 31, 

 

    

2017

    

2016

 

Assets

 

 

 

 

 

 

    

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

16,795

 

$

28,300

 

Short-term investments

 

 

9,475

 

 

10,737

 

Restricted cash - current

 

 

181

 

 

181

 

Accounts receivable, net

 

 

5,602

 

 

5,782

 

Inventory

 

 

5,560

 

 

5,052

 

Prepaid expenses and other current assets

 

 

702

 

 

1,088

 

Total current assets

 

 

38,315

 

 

51,140

 

Restricted cash

 

 

909

 

 

909

 

Property and equipment, net

 

 

7,821

 

 

8,286

 

Other long-term assets

 

 

250

 

 

 —

 

Total assets

 

$

47,295

 

$

60,335

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

2,891

 

$

2,192

 

Accrued and other current liabilities

 

 

6,056

 

 

6,351

 

Short-term debt

 

 

3,518

 

 

1,362

 

Total current liabilities

 

 

12,465

 

 

9,905

 

Deferred rent

 

 

2,650

 

 

2,721

 

Long-term debt

 

 

19,364

 

 

13,261

 

Total liabilities

 

 

34,479

 

 

25,887

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.001 par value—10,000,000 shares authorized at June 30, 2017 and December 31, 2016, no shares issued and outstanding at June 30, 2017 and December 31, 2016

 

 

 —

 

 

 —

 

Common stock, $0.001 par value—100,000,000 shares authorized at June 30, 2017 and December 31, 2016 17,041,158 and 16,950,940 shares issued and outstanding at June 30, 2017 and December 31, 2016

 

 

17

 

 

17

 

Additional paid-in capital

 

 

182,619

 

 

180,647

 

Accumulated deficit

 

 

(169,820)

 

 

(146,216)

 

Total stockholders’ equity

 

 

12,816

 

 

34,448

 

Total liabilities and stockholders’ equity

 

$

47,295

 

$

60,335

 

 

 

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