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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 ANNOUNCES FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS

 

SAN FRANCISCO, February 13th, 2018 - Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today announces financial results for the three months and year ended December 31, 2017.

 

Q4 and full year 2017 Highlights

 

·

Fourth quarter 2017 revenue grew 20% to $11.2 million compared to revenue of $9.4 million in the fourth quarter of 2016.

·

Full year 2017 revenue grew 22% to $39.6 million compared to revenue of $32.5 million in 2016.

·

Disposable revenue in the fourth quarter of 2017 grew 30% to $9.5 million compared to $7.3 million in the fourth quarter of 2016.

·

Disposable revenue in the full year 2017 grew 32% to $32.3 million compared to revenue of $24.5 million in 2016.  

·

PhotonBlade® revenue, which is a component of disposable revenue, was $1.3 million in the fourth quarter.

 

“We saw a strong debut of PhotonBlade in its first full quarter of launch, which combined with the growth of our other disposable products, resulted in 30% growth in disposable revenue. In addition, I am pleased to report that we made our first commercial sales of the Adapt Waveguide™ in the quarter. The Adapt is a flexible waveguide that can be used in conjunction with a variety of specialized retractors, increasing the number of procedures available to us and broadening our appeal in key surgical specialties, particularly gynecology,” said President and Chief Executive Officer Philip Sawyer. “We believe we are well positioned for strong growth in 2018.”

 

Financial Results

 

Revenue was $11.2 million in the fourth quarter of 2017, up 20% from revenue of $9.4 million in the fourth quarter of 2016 driven by strong market acceptance of PhotonBlade and continued growth of the company’s other disposable products. For the 2017 full year, revenue was $39.6 million, an increase of 22% over revenue of $32.5 million in 2016.

 

Disposable revenue was $9.5 million in the fourth quarter of 2017, up 30% from revenue of $7.3 million in the fourth quarter of 2016. For the 2017 full year, revenue was $32.3 million, a 32% increase over revenue of $24.5 million in 2016. Disposable revenue comes from the sale of our single use devices; waveguides that are attached to our retractors, illuminated aspirators – both Yankauer and Frazier designs – and most recently the addition of PhotonBlade. These revenues are driven by per procedure adoption and represent the primary driver of our growth.

 


 

Gross margin for the fourth quarter was 66.7%. This is in line with the expectations we set on our last conference call when we discussed the impact that meaningful PhotonBlade sales and ongoing limited sales of PhotonVue® would have on gross margin. Gross margin was 74.3% for the same period in 2016. For the 2017 full year, gross margin was 70.5% in 2017, compared to 72.8% in 2016.

 

Total operating expenses for the fourth quarter and full year 2017 were $14.1 million and $63.1 million, respectively compared to $16.0 million and $62.3 million in the prior year periods.

 

The net loss for the fourth quarter of 2017 was $7.4 million, or $0.43 loss per share, compared to a net loss of $9.6 million, or $0.56 loss per share, for the fourth quarter of 2016. The net loss for full-year 2017 was $39.9 million, or $2.34 loss per share, compared to $40.6 million, or $2.73 loss per share, for 2016. 

 

The Company's balance sheet as of December 31, 2017, included total cash, cash equivalents and short-term investments of $21.0 million.

 

Business Outlook

 

For fiscal 2018 Invuity expects revenue to exceed $46 million. The Company expects disposable revenue to grow in excess of 25% in 2018.

 

Conference Call

Invuity's management will discuss the Company's financial results for the fourth quarter ended and full year ended December 31, 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, February 13, 2018. To join the live call, participants may dial 1-877- 556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 4988156. 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 2018.  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; the adequacy of the Company’s existing cash resources and funding requirements; 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 December 31, 

 

Year Ended December 31, 

 

    

2017

    

2016

    

2017

 

2016

 

 

 

 

 

 

 

 

 

 

Revenue

 

$

11,228

    

$

9,356

 

$

39,619

    

$

32,461

    

Cost of goods sold

 

 

3,739

 

 

2,409

 

 

11,741

 

 

8,824

 

Gross profit

 

 

7,489

 

 

6,947

 

 

27,878

 

 

23,637

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,853

 

 

2,496

 

 

9,018

 

 

9,908

 

Selling, general and administrative

 

 

12,272

 

 

13,524

 

 

54,119

 

 

52,409

 

Total operating expenses

 

 

14,125

 

 

16,020

 

 

63,137

 

 

62,317

 

Loss from operations

 

 

(6,636)

 

 

(9,073)

 

 

(35,259)

 

 

(38,680)

 

Interest expense

 

 

(811)

 

 

(505)

 

 

(2,370)

 

 

(2,018)

 

Interest income

 

 

61

 

 

42

 

 

222

 

 

133

 

Other income (expense), net

 

 

(21)

 

 

(14)

 

 

(208)

 

 

(44)

 

Loss on extinguishment of debt

 

 

 —

 

 

 —

 

 

(2,303)

 

 

 —

 

Net loss and comprehensive loss

 

$

(7,407)

 

$

(9,550)

 

$

(39,918)

 

$

(40,609)

 

Net loss per common share, basic and diluted

 

$

(0.43)

 

$

(0.56)

 

$

(2.34)

 

$

(2.73)

 

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

 

 

17,154,060

 

 

16,930,612

 

 

17,051,037

 

 

14,868,501

 

 


 

Condensed Balance Sheets

as of December 31, 2017 and December 31, 2016

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

December 31, 

 

 

2017

 

2016

 

 

(In thousands, except per share data)

 

Assets

 

 

    

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

$

17,962

 

$

28,300

 

Short-term investments

 

3,040

 

 

10,737

 

Restricted cash - current

 

181

 

 

181

 

Accounts receivable, net

 

7,421

 

 

5,782

 

Inventory

 

7,436

 

 

5,052

 

Prepaid expenses and other current assets

 

1,274

 

 

1,088

 

Total current assets

 

37,314

 

 

51,140

 

Restricted cash

 

727

 

 

909

 

Property and equipment, net

 

7,169

 

 

8,286

 

Other long-term assets

 

285

 

 

 —

 

Total assets

$

45,495

 

$

60,335

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

$

3,598

 

$

2,192

 

Accrued and other current liabilities

 

5,179

 

 

6,351

 

Short-term debt

 

5,859

 

 

1,362

 

Total current liabilities

 

14,636

 

 

9,905

 

Deferred rent

 

2,569

 

 

2,721

 

Deferred Revenue - LT

 

36

 

 

 —

 

Long-term debt

 

29,116

 

 

13,261

 

Total liabilities

 

46,357

 

 

25,887

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

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

 

 —

 

 

 —

 

Common stock, $0.001 par value—100,000,000 shares authorized at December 31, 2017 and December 31, 2016 17,179,258 and 16,950,940 shares issued and outstanding at December 31, 2017 and December 31, 2016

 

17

 

 

17

 

Additional paid-in capital

 

185,255

 

 

180,647

 

Accumulated deficit

 

(186,134)

 

 

(146,216)

 

Total stockholders’ equity

 

(862)

 

 

34,448

 

Total liabilities and stockholders’ equity

$

45,495

 

$

60,335