EX-99.1 2 exhibit_991.htm EX-99.1 Exhibit_99.1

 

 

     Exhibit 99.1  

 

          

Picture 1NEWS RELEASE

 

 

 

INVUITY REPORTS 2016 THIRD QUARTER, NINE-MONTH FINANCIAL RESULTS

Updates 2016 revenue guidance and introduces 2017 revenue guidance

Received FDA 510(k) clearance for PhotonBlade™

 

SAN FRANCISCO, November 3, 2016 - Invuity, Inc. (NASDAQ:IVTY), a leading surgical photonics company, today reported financial results for the third quarter and nine-months ended September 30, 2016.

 

Q3 2016 Highlights

 

·

Revenue grew 52% to $8.5 million compared to revenue of $5.6 million in the 2015 third quarter.

·

Gross margin expansion continued to 73.8% compared to 63.6% in the 2015 third quarter.

·

Approximately 700 hospitals purchased Invuity devices in the third quarter of 2016, up from 465 hospitals in the third quarter of 2015.

·

Approximately 212,000 procedures have been performed using Invuity devices.

·

Received FDA 510(k) clearance for PhotonBlade, a novel device that integrates Intelligent Photonics™ technology into our high-value advanced energy device used for cutting and coagulation of soft-tissue during surgical procedures.

 

"While we achieved 52% revenue growth in the third quarter, results were lower than our expectations due to seasonality and lower than anticipated revenue per account. Although we have moderated our our near-term growth expectations, we remain quite confident in the long-term growth prospects of the business,” said President and CEO Philip Sawyer.  “On the product development front, we are thrilled that the FDA has cleared our PhotonBlade technology.  PhotonBlade is a major milestone for Invuity as we continue to execute on our strategy to leverage our expertise in advanced photonics into the development of novel high value medical devices for use in minimal access surgery.”

 

Financial Results

 

Revenue was $8.5 million in the third quarter of 2016, up 52% from revenue of $5.6 million in the third quarter of 2015 driven by an increase in active accounts.

 

For the first nine months of 2016, revenue was $23.1 million, up 56% from revenue of $14.8 million in the first nine months of 2015.

 

Gross margin for the third quarter and first nine months of 2016 was 73.8% and 72.2%, respectively, compared to 63.6% and 62.1% 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 third quarter and first nine months of 2016 were $14.6 million and $46.3 million, respectively, compared to $12.2 million and $34.8 million in the prior year periods. The increase in operating expenses is due to investment in our commercial platform. This is consistent with our stated objectives of increasing the size of our sales force and accelerating our product development efforts.

 

The net loss for the third quarter of 2016 was $8.8 million, or $0.56 loss per share, compared to a net loss of $9.1 million, or $0.69 loss per share, for the third quarter of 2015. The net loss for the first nine months of 2016 was $31.1 million, or $2.19 loss per share, compared to $27.5 million, or $4.84 loss per share, for the first nine months of 2015.

 

The Company's balance sheet as of September 30, 2016, showed total cash and cash equivalents of $47.7 million.

 

PhotonBlade

 

In September the Company received Food and Drug Administration 510(k) clearance for PhotonBlade, a single use device that integrates the Company’s proprietary Intelligent Photonics™ technology into our high value advanced energy device used for cutting and coagulation of soft-tissue during general surgical procedures.  PhotonBlade’s novel energy platform, developed by Invuity, consists of a proprietary shielded blade for precise cutting and coagulation of tissue, with minimal collateral effect, while the integrated Photonics delivers directed, thermally cool illumination at the precise point of surgical treatment.  This ground breaking combination of illumination and advanced energy enables low thermal damage, vascularity preservation and use in a wet surgical field with superior visualization thus improving surgical efficiency and outcomes.  

 

Business Outlook

 

Invuity now expects revenue for 2016 to range from $32 million to $32.5 million, as compared to prior guidance of $35 million to $37 million. Our current guidance represents annual growth of approximately 50% over 2015.

 

The Company is introducing 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 third quarter ended September 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, November 3, 2016. To join the live call, participants may dial 1-877-556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 969511601.  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 and future product introductions. 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 September 30, 

 

Nine Months Ended September 30, 

 

 

    

2016

    

2015

    

2016

    

2015

    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

    

$
8,478

    

$
5,595

 

$
23,106

    

$
14,784

 

Cost of goods sold

 

 
2,219

 

 
2,035

 

 
6,416

 

 
5,605

 

Gross profit

 

 
6,259

 

 
3,560

 

 
16,690

 

 
9,179

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 
2,471

 

 
2,042

 

 
7,412

 

 
5,799

 

Selling, general and administrative

 

 
12,134

 

 
10,180

 

 
38,885

 

 
29,020

 

Total operating expenses

 

 
14,605

 

 
12,222

 

 
46,297

 

 
34,819

 

Loss from operations

 

 
(8,346)

 

 
(8,662)

 

 
(29,607)

 

 
(25,640)

 

Interest expense

 

 
(505)

 

 
(504)

 

 
(1,514)

 

 
(1,377)

 

Interest and other income (expense), net

 

 
30

 

 
28

 

 
61

 

 
(499)

 

Net loss and comprehensive loss

 

$
(8,821)

 

$
(9,138)

 

$
(31,060)

 

$
(27,516)

 

Net loss per common share, basic and diluted

 

$
(0.56)

 

$
(0.69)

 

$
(2.19)

 

$
(4.84)

 

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

 

 
15,690,785

 

 
13,292,849

 

 
14,173,534

 

 
5,684,755

 

 

 

 

 

 

 

 

Balance Sheet

as of September 30, 2016 and December 31, 2015

(In thousands, except share and per share amounts)

(Unaudited) 

 

 

 

 

 

 

 

 

 

 

September 30, 

 

December 31, 

 

 

    

2016

    

2015

    

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$
47,709

 

$
46,296

 

Accounts receivable, net

 

 
5,149

 

 
3,619

 

Inventory

 

 
5,120

 

 
5,182

 

Prepaid expenses and other current assets

 

 
952

 

 
923

 

Total current assets

 

 
58,930

 

 
56,020

 

Restricted cash

 

 
1,090

 

 
1,090

 

Property and equipment, net

 

 
8,538

 

 
9,195

 

Other non-current assets

 

 
170

 

 

 —

 

Total assets

 

$
68,728

 

$
66,305

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$
2,800

 

$
2,458

 

Accrued and other current liabilities

 

 
5,283

 

 
4,214

 

Short-term debt—related party

 

 
1,125

 

 

 —

 

Total current liabilities

 

 
9,208

 

 
6,672

 

Deferred rent

 

 
2,751

 

 
2,810

 

Long-term debt—related party

 

 
13,462

 

 
14,480

 

Total liabilities

 

 
25,421

 

 
23,962

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Preferred stock, $0.001 par value—10,000,000  shares authorized at September 30, 2016 and December 31, 2015, respectively; no shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively

 

 

 —

 

 

 —

 

Common stock, $0.001 par value—100,000,000  shares authorized at September 30, 2016 and December 31, 2015, respectively; 16,905,103 and 13,392,358 shares issued and outstanding at September 30, 2016 and December 31, 2015, respectively

 

 
14

 

 
13

 

Additional paid-in capital

 

 
179,960

 

 
147,937

 

Accumulated deficit

 

 
(136,667)

 

 
(105,607)

 

Total stockholders’ equity

 

 
43,307

 

 
42,343

 

Total liabilities, convertible preferred stock and stockholders’ equity

 

$
68,728

 

$
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