8-K
false000100604500010060452023-05-112023-05-11

 

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

 

May 11, 2023

 

(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 May 11, 2023, IRIDEX Corporation issued a press release discussing its financial results for its first fiscal quarter of fiscal year 2023, which ended on April 1, 2023. 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 May 11, 2023.

 

 

 

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: May 11, 2023

 

 

 

 

-3-


EX-99.1

 

Exhibit 99.1

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Iridex Reports First Quarter 2023 Financial Results

 

MOUNTAIN VIEW, Calif., May 11, 2023 -- 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 first quarter ended April 1, 2023.

 

First Quarter 2023 Highlights

Generated total revenue of $13.7 million, an increase of 2% year-over-year
Cyclo G6® product family revenue of $3.7 million increased 4% year-over-year
o
61 Cyclo G6 Glaucoma Laser Systems sold, compared to 56 in the prior year period
o
Cyclo G6 probe revenue increased 6% year-over-year on decreased unit sales of 13,800 probes
Retina product revenue of $7.2 million was essentially flat year-over-year
Received FDA clearance in February for the new single-spot laser platform for the Iridex 532 and Iridex 577 systems
Cash and cash equivalents totaled approximately $11.0 million as of April 1, 2023

 

“In addition to receiving FDA clearance in February for our second key laser platform, we were pleased to achieve 19% year-over-year growth in U.S. G6 probe revenue,” said David Bruce, President and CEO. “Although we experienced a modest decline in year-over-year glaucoma probe unit sales resulting from continued international distributor order volatility after a record fourth quarter, we saw strength in international purchases of glaucoma systems. We remain confident in our activities to drive adoption and utilization of our Cyclo G6 glaucoma treatment platform. By leveraging our Sweep Management software and increasing awareness of effective dosing recommendations, we expect clinicians to experience strong clinical outcomes and consistency, leading to increased utilization throughout the year.”

 

First Quarter 2023 Financial Results

 

Revenue for the three months ended April 1, 2023 was $13.7 million compared to $13.4 million during the same period of the prior year. Total product revenue from the Cyclo G6 glaucoma product group was $3.7 million, an increase of 4% compared to the first quarter of 2022, driven by strong probe ASP growth in the U.S. Retina product revenue in the first quarter was $7.2 million compared to $7.3 million in the prior year, a decrease of 1%. Other revenue, which includes royalties, services, and other legacy products, increased 11% to $2.8 million in the first quarter of 2023 compared to the prior year, primarily driven by higher revenue from Other legacy products.

 

Gross profit for the first quarter of 2023 remained essentially unchanged at $5.9 million or a 43.3% gross margin, compared to $6.0 million, or a 44.6% gross margin, in the same period of the prior year. The lower gross margin was the result of higher production overhead.

 

Operating expenses for the first quarter of 2023 were flat at $8.3 million for both the first quarter of 2023 and in the same period of the prior year.

 

Net loss for the first quarter of 2023 was $2.1 million, or $0.13 per share, compared to a net loss of $2.4 million, or $0.15 per share, in the same period of the prior year.

 

Cash and cash equivalents totaled $11.0 million as of April 1, 2023. Cash use of $2.9 million in the first quarter included items unique to the first quarter and cash usage is expected to decrease significantly in the remaining quarters of 2023 as inventory levels decrease.

 


Guidance for Full Year 2023

Iridex reiterated its financial outlook for 2023, expecting Cyclo G6 probe sales of 65,000 to 67,000 representing approximately 9% to 12% growth over 2022 and to expand the Cyclo G6 systems installed base by 225 to 250 systems. Total revenue for the full year is expected to be $57 million to $59 million. 2023 total revenue guidance represents growth of approximately 3% to 6% after adjusting for an approximate $1.5 million reduction of Other Revenue royalty income resulting from the expiration of licensed patents.

 

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. Investors interested in listening to the conference call may do so by accessing the live and recorded webcast on the “Event Calendar” page of 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission for the fiscal year ended December 31, 2022. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

 

Investor Relations Contact

Philip Taylor

Gilmartin Group

investors@iridex.com

 

 


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IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(unaudited)

 

Three Months Ended

April 1,

April 2,

2023

2022

Total revenues

$

13,706

$

13,387

Cost of revenues

7,768

7,410

Gross profit

5,938

5,977

Operating expenses:

Research and development

1,749

2,116

Sales and marketing

4,283

4,300

 

General and administrative

 

 

2,250

 

 

 

1,838

 

   Total operating expenses

8,282

8,254

Loss from operations

(2,344

)

(2,277

)

Other income (expense), net

266

 

(94

)

Loss from operations before provision for income taxes

(2,078

)

(2,371

)

Provision for income taxes

12

 

20

 

Net loss

$

(2,090

)

$

(2,391

)

Net loss per share:

    Basic

$

(0.13

)

$

(0.15

)

    Diluted

$

(0.13

)

$

(0.15

)

 

Weighted average shares used in computing net loss per share:

    Basic

16,001

15,881

    Diluted

16,001

15,881

 

 


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IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

 

April 1,

December 31,

 

2023

2022

Assets

Current assets:

Cash and cash equivalents

$

11,048

$

13,922

Accounts receivable, net

10,759

9,768

Inventories

11,241

10,608

Prepaid expenses and other current assets

1,650

1,468

Total current assets

34,698

35,766

Property and equipment, net

449

462

Intangible assets, net

1,894

1,977

Goodwill

965

965

Operating lease right-of-use assets, net

 

 

1,423

 

 

 

1,665

 

Other long-term assets

1,551

1,455

Total assets

$

40,980

$

42,290

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

3,669

$

3,873

Accrued compensation

2,813

2,448

Accrued expenses

2,132

1,548

Other current liabilities

 

 

882

 

 

 

968

 

Accrued warranty

196

168

Deferred revenue

2,424

2,411

Operating lease liabilities

 

 

1,046

 

 

 

1,037

 

Total current liabilities

13,162

12,453

Long-term liabilities:

Accrued warranty

 

 

124

 

 

 

106

 

Deferred revenue

 

 

11,312

 

 

 

11,742

 

Operating lease liabilities

 

 

472

 

 

 

732

 

Other long-term liabilities

26

26

Total liabilities

25,096

25,059

Stockholders' equity:

Common stock

169

169

Additional paid-in capital

87,312

86,802

Accumulated other comprehensive loss

 

 

(35

)

 

 

(24

)

Accumulated deficit

(71,562

)

(69,716

)

Total stockholders' equity

15,884

17,231

Total liabilities and stockholders' equity

$

40,980

$

42,290