8-K
0001006045false00010060452022-11-102022-11-10

 

UNITED STATES
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

 

November 10, 2022

 

(Date of Report (date of earliest event reported)

 

IRIDEX CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware

000-27598

77-0210467

(State or other jurisdiction of
incorporation or organization)

(Commission File Number)

(I.R.S. Employer
Identification Number)

1212 Terra Bella Avenue
Mountain View, California 94043

(Address of principal executive offices, including zip code)

 

(650) 940-4700

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

 

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 (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Securities registered pursuant to Section 12(b) of the Act:

Title of Class

 

Trading

Symbol

 

Name of Exchange on Which Registered

Common Stock, par value $0.01 per share

 

IRIX

 

Nasdaq Global Market

 

 


 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 10, 2022, IRIDEX Corporation issued a press release discussing its financial results for its third fiscal quarter of fiscal year 2022, which ended on October 1, 2022. The press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

 

This information 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

 

Exhibit No.

 

Description

 

 

99.1

 

Press Release dated November 10, 2022.

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

-2-


 

SIGNATURES

 

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.

 

 

 

 

IRIDEX CORPORATION

 

 

 

 

 

By:

 

/s/David I. Bruce

 

 

 

David I. Bruce

 

 

 

President and Chief Executive Officer

 

 

 

 

Date: November 10, 2022

 

 

 

 

-3-


EX-99.1

 

Exhibit 99.1

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Iridex Announces Record Third Quarter 2022 Financial Results

 

Company Announces FDA Clearance of new Iridex Pascal® Scanning Laser Platform

 

MOUNTAIN VIEW, Calif., November 10, 2022 -- Iridex Corporation (Nasdaq: IRIX), a provider of innovative ophthalmic laser-based medical products for the treatment of glaucoma and retinal diseases, today reported financial results for the third quarter ended October 1, 2022.

 

Third Quarter 2022 Highlights

Total revenue of $14.6 million, a record third quarter revenue, and an increase of 10% over the prior year period
Gross Margin was 44.1% compared to 43.6% in the prior year period
Cyclo G6® product family revenue of $3.5 million, an increase of 10% year-over-year
o
13,680 Cyclo G6 probes sold, a 2% increase year-over-year
o
54 Cyclo G6 Glaucoma Laser Systems sold, compared to 42 in the prior year quarter
Retina product revenue increased to $8.8 million or 13% year-over-year
Net Cash use of $2.1 million resulting in cash balance on October 1, 2022 of $15.9 million
Introduced Sweep Management software for Cyclo G6, privately previewed new suite of laser systems for the treatment of retinal disease and hosted eight physician presentations highlighting the benefits of IRIDEX’s product portfolio at the American Academy of Ophthalmology annual meeting
Received FDA Clearance of next -generation Iridex Pascal Scanning Laser System

 

“Our third quarter results were driven by continued gains in our retina laser portfolio plus a rebound in glaucoma systems placements, demonstrating increased clinical appetite for adoption of our non-incisional laser procedures,” said David Bruce, President and CEO. “We are especially pleased with our retina results, which clearly demonstrate that the investments we have made over the last two years in product and sales improvements are clearly bearing fruit by creating value in the retina business segment. Now, with FDA clearance of our new Pascal platform, we have strengthened our competitive and clinical position even further. We look forward to our first shipments this fourth quarter, and sharing more information in the weeks ahead.

 

In glaucoma, we are encouraged that the U.S. growth rate increased to 6% and are working to improve our international glaucoma probe utilization, which has lagged our expectations for a second half rebound. We continue to focus on key initiatives to drive utilization globally including increasing awareness of our updated dosing guidance and Sweep Management software, educating clinicians on the benefits of the use of MPTLT earlier in the glaucoma treatment algorithm, adding new users at existing surgery centers, broadening clinical evidence and advancing the China Cyclo G6 launch. We are confident execution of these initiatives can accelerate growth in the U.S. and internationally.”

 

Third Quarter 2022 Financial Results

Revenue for the three months ended October 1, 2022, increased 10% to $14.6 million from $13.3 million during the same period of the prior year.

 

Total product revenue from the Cyclo G6 glaucoma product family was $3.5 million, 10% higher than the third quarter of 2021. The year-over-year increase was driven by higher G6 systems sold in the U.S. and OUS and an increase in U.S. probe sales.

 


Retina product revenue in the third quarter was $8.8 million compared to $7.8 million in the prior year, an increase of 13%, driven by strength in both medical retina and Pascal® system sales. Other revenue, which includes royalties, services, and other legacy products, increased 4% to $2.4 million in the third quarter of 2022 compared to the prior year.

 

Gross profit for the third quarter of 2022 increased 12% to $6.5 million, or a 44.1% gross margin, compared to $5.8 million and 43.6% gross margin in the same period of the prior year.

 

Operating expenses for the third quarter of 2022 increased 3% to $8.2 million compared to $7.9 million in the same period of the prior year. The increase is the result of the expansion of sales and marketing programs.

 

Net loss for the third quarter of 2022 was $1.8 million, or $0.11 per share, compared to a net loss of $2.2 million or $0.14 per share, in the same period of the prior year.

 

Cash and cash equivalents as of October 1, 2022 totaled $15.9 million. Cash reduction during the quarter of $2.1 million includes net $0.5 million increase in inventories and related pre-orders to mitigate potential supply-chain issues.

 

Updated Guidance for Full Year 2022

Iridex continues to expect total revenue for fiscal year 2022 to range from $56 million to $58 million, reflecting growth of 4% to 8% over fiscal year 2021. The Company continues to expect Glaucoma Laser System installed base to expand by 225 to 250 systems in 2022. Cyclo G6 probe unit sales are expected to be about 60,000 versus the previous guidance of 61,000 to 63,000.

 

Webcast and Conference Call Information

Iridex’s management team will host a conference call today beginning at 2:00 p.m. PT / 5:00 p.m. ET. Individuals interested in listening to the conference call may do so by registering here (https://register.vevent.com/register/BIc617990f00854409a04f03f01d3647db). Participants are required to register at a minimum 15 minutes before the start of the call. To listen to the live webcast and a replay, please visit the “Investors” section of the Company’s website at: www.iridex.com.

 

About Iridex

Iridex Corporation is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers a differentiated treatment that provides safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used for the treatment of glaucoma and diabetic macular edema (DME) and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.

 

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical and commercial momentum, market adoption and expansion, demand for and utilization of the Company's products, financial guidance and results and expected sales volumes. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 15, 2022.

 

Investor Relations Contact

Philip Taylor

investors@iridex.com

 

 


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IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

October 1,

 

 

October 2,

 

 

October 1,

 

 

October 2,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

14,635

 

 

$

13,264

 

 

$

41,777

 

 

$

38,649

 

Cost of revenues

 

 

8,175

 

 

 

7,482

 

 

 

23,073

 

 

 

21,820

 

Gross profit

 

 

6,460

 

 

 

5,782

 

 

 

18,704

 

 

 

16,829

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,687

 

 

 

1,788

 

 

 

5,725

 

 

 

4,625

 

Sales and marketing

 

 

4,445

 

 

 

3,914

 

 

 

13,352

 

 

 

10,542

 

General and administrative

 

 

2,023

 

 

 

2,237

 

 

 

5,759

 

 

 

 6,798

 

   Total operating expenses

 

 

8,155

 

 

 

7,939

 

 

 

24,836

 

 

 

21,965

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(1,695

)

 

 

(2,157

)

 

 

(6,132

)

 

 

(5,136

)

Other (expense) income, net

 

 

(58

)

 

 

-

 

 

 

(216

)

 

 

2,378

 

Loss from operations before provision for income taxes

 

 

(1,753

)

 

 

(2,157

)

 

 

(6,348

)

 

 

(2,758

)

Provision for income taxes

 

 

14

 

 

 

8

 

 

 

51

 

 

 

24

 

Net loss

 

$

(1,767

)

 

$

(2,165

)

 

$

(6,399

)

 

$

(2,782

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

$

(0.11

)

 

$

(0.14

)

 

$

(0.40

)

 

$

(0.18

)

    Diluted

 

$

(0.11

)

 

$

(0.14

)

 

$

(0.40

)

 

$

(0.18

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares used in computing net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

 

15,986

 

 

 

15,824

 

 

 

15,921

 

 

 

15,272

 

    Diluted

 

 

15,986

 

 

 

15,824

 

 

 

15,921

 

 

 

15,272

 

 

 


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IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

 

 

 

October 1,

 

 

January 1,

 

 

 

2022

 

 

2022

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

15,856

 

 

$

23,852

 

Accounts receivable, net

 

 

9,744

 

 

 

9,716

 

Inventories

 

 

10,765

 

 

 

7,614

 

Prepaid expenses and other current assets

 

 

1,984

 

 

 

1,071

 

Total current assets

 

 

38,349

 

 

 

42,253

 

Property and equipment, net

 

 

435

 

 

 

428

 

Intangible assets, net

 

 

2,061

 

 

 

2,205

 

Goodwill

 

 

965

 

 

 

965

 

Operating lease right-of-use assets, net

 

 

1,862

 

 

 

2,565

 

Other long-term assets

 

 

1,287

 

 

 

271

 

Total assets

 

$

44,959

 

 

$

48,687

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,640

 

 

$

3,399

 

Accrued compensation

 

 

2,862

 

 

 

3,192

 

Accrued expenses

 

 

1,705

 

 

 

1,575

 

Other current liabilities

 

 

841

 

 

 

1,098

 

Accrued warranty

 

 

142

 

 

 

100

 

Deferred revenue

 

 

2,431

 

 

 

2,355

 

Operating lease liabilities

 

 

1,012

 

 

 

927

 

Total current liabilities

 

 

13,633

 

 

 

12,646

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Accrued warranty

 

 

91

 

 

 

58

 

Deferred revenue

 

 

12,172

 

 

 

10,930

 

Operating lease liabilities

 

 

961

 

 

 

1,729

 

Other long-term liabilities

 

 

27

 

 

 

25

 

Total liabilities

 

 

26,884

 

 

 

25,388

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock

 

 

169

 

 

 

168

 

Additional paid-in capital

 

 

86,286

 

 

 

85,255

 

Accumulated other comprehensive income

 

 

188

 

 

 

45

 

Accumulated deficit

 

 

(68,568

)

 

 

(62,169

)

Total stockholders' equity

 

 

18,075

 

 

 

23,299

 

Total liabilities and stockholders' equity

 

$

44,959

 

 

$

48,687