8-K
0001006045false00010060452023-03-092023-03-09

 

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

 

March 9, 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 March 9, 2023, IRIDEX Corporation issued a press release discussing its financial results for its fourth fiscal quarter and fiscal year ended December 31, 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 March 9, 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: March 9, 2023

 

 

 

 

-3-


EX-99

 

Exhibit 99.1

https://cdn.kscope.io/1f91e4a886314497a7ab9ea342fed9b4-img156381773_0.jpg 

Iridex Reports Fourth Quarter and Full Year 2022 Financial Results

 

Achieves Record Quarterly Glaucoma Probe Sales and 6% Full Year Revenue Growth

 

MOUNTAIN VIEW, Calif., March 9, 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 fourth quarter and year ended December 31, 2022 and issued 2023 financial guidance.

 

Fourth Quarter 2022 & Recent Highlights

Generated total revenue of $15.2 million, essentially unchanged from the prior year period
Cyclo G6® product family revenue of $4.2 million, an increase of 9% year-over-year
o
16,400 Cyclo G6 probes sold, a quarterly record and 8% increase year-over-year
o
79 Cyclo G6 Glaucoma Laser Systems sold, compared to 90 in the prior year period
Retina product revenue decreased 11% year-over-year to $8.1 million
Received FDA Clearance for the next-generation Iridex Pascal® scanning laser platform in November 2022 and announces FDA clearance of its new single-spot laser platform for the Iridex 532 and the Iridex 577 systems in February 2023
Cash and cash equivalents totaled approximately $13.9 million as of December 31, 2022

 

Full Year 2022 Highlights

Generated total revenue of $57.0 million, an increase of 6% compared to 2021
Cyclo G6 product family revenue of $14.7 million, an increase of 5% year-over-year
Sold 59,800 Cyclo G6 probes, compared to 58,200 in the prior year
Expanded Cyclo G6 Glaucoma Laser Systems installed base by 237 compared to 243 in the prior year, bringing the total global installed base to over 2,300 systems
Retina product revenue increased 2% year-over-year to $31.7 million

 

“The highlight of our fourth quarter results were record Cyclo G6 probe sales. We are pleased with our commercial and operational execution in the second half of the year resulting in improvements in gross margins and declining operating loss,” said David Bruce, President and CEO of Iridex. “In 2022 we continued to reestablish the foundation for customer adoption and market penetration with our Cyclo G6 glaucoma treatment platform. The broadening use of sweep management software combined with the establishment of the updated dosing recommendations published by our clinical consensus panel, have led users to report improved clinical outcomes and consistency with MPTLT. When coupled with the launch of our new Iridex Pascal platform in the U.S. to be followed by our new single-spot platform just cleared by FDA, we are well-positioned to build momentum in 2023.”

 

Fourth Quarter 2022 Financial Results

 

Revenue for the three months ended December 31, 2022 was $15.2 million compared to $15.3 million during the same period of the prior year. Total product revenue from the Cyclo G6 glaucoma product group was $4.2 million, 9% higher than the fourth quarter of 2021 driven by higher Cyclo G6 probe sales. Retina product revenue in the fourth quarter was $8.1 million compared to $9.1 million in the prior year, a decrease of 11%, primarily driven by weaker international capital equipment sales due to strength in the U.S. dollar. Other revenue, which includes royalties, services, and other legacy products, increased 26% to $2.9 million in the fourth quarter of 2022 compared to the prior year, primarily driven by strength in each category.

 


Gross profit for the fourth quarter of 2022 increased to $6.7 million, or a 43.9% gross margin, compared to $6.0 million, or a 39.3% gross margin, in the same period of the prior year. The higher gross margin was the result of higher Cyclo G6 probe sales and higher product mix of U.S. laser systems sales.

 

Operating expenses for the fourth quarter of 2022 decreased 4% to $8.1 million compared to $8.4 million in the same period of the prior year.

 

Net loss for the fourth quarter of 2022 was $1.1 million, or $0.07 per share, compared to a net loss of $2.4 million, or $0.15 per share, in the same period of the prior year.

 

Full Year 2022 Financial Results

 

Revenue for the year ended December 31, 2022 increased 6% to $57.0 million from $53.9 million in 2021. Total product revenue from the Cyclo G6 glaucoma product family was $14.7 million, 5% higher than fiscal year 2021 driven by higher Cyclo G6 system and probe sales in the US. Retina product revenue was $31.7 million compared to $31.1 million in the prior year, an increase of 2%, driven by strong capital equipment sales in the U.S., that was partially offset by lower international sales due to the strong U.S. dollar. Other revenue increased 20% to $10.6 million in 2022 compared to the prior year primarily driven by full year revenue recognition from the sale of distribution rights and higher legacy probe sales.

 

Gross profit for the full year 2022 was $25.4 million on higher revenue and favorable product mix, representing 44.5% gross margin, compared to $22.8 million, or 42.4% gross margin, during the prior year.

 

Operating expenses for 2022 increased 8% to $32.9 million compared to $30.4 million in the prior year. This increase in operating expenses is primarily a result of broader sales and marketing investments plus additional R&D investments in the PASCAL product line and other new product development initiatives.

 

Net loss for 2022 increased to $7.5 million, or $0.47 per share, compared to a net loss of $5.2 million, or $0.34 per share in the prior year, which included PPP loan forgiveness of $2.5 million in 2021.

 

Cash and cash equivalents as of December 31, 2022 totaled $13.9 million. Cash reduction during the year was $10.0 million, which includes approximately $3.5 million increase in inventories and related pre-orders to mitigate potential supply-chain issues, which are expected to substantially unwind throughout 2023.

 

Guidance for Full Year 2023

Iridex projects 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2022 and our Annual Report on Form 10-K to be 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

 

 


https://cdn.kscope.io/1f91e4a886314497a7ab9ea342fed9b4-img156381773_1.jpg 

IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(unaudited)

 

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

 

December 31,

 

 

January 1,

 

 

December 31,

 

 

January 1,

 

 

 

2022

 

 

2022

 

 

2022

 

 

2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

15,195

 

 

$

15,254

 

 

$

56,972

 

 

$

53,903

 

Cost of revenues

 

 

8,531

 

 

 

9,252

 

 

 

31,604

 

 

 

31,072

 

Gross profit

 

 

6,664

 

 

 

6,002

 

 

 

25,368

 

 

 

22,831

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,450

 

 

 

2,243

 

 

 

7,175

 

 

 

6,868

 

Sales and marketing

 

 

4,826

 

 

 

4,095

 

 

 

18,178

 

 

 

14,637

 

General and administrative

 

 

1,798

 

 

 

2,061

 

 

 

7,557

 

 

 

 8,859

 

   Total operating expenses

 

 

8,074

 

 

 

8,399

 

 

 

32,910

 

 

 

30,364

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(1,410

)

 

 

(2,397

)

 

 

(7,542

)

 

 

(7,533

)

Other income (expense), net

 

 

276

 

 

 

(30

)

 

 

60

 

 

 

2,348

 

Loss from operations before provision for income taxes

 

 

(1,134

)

 

 

(2,427

)

 

 

(7,482

)

 

 

(5,185

)

Provision for income taxes

 

 

14

 

 

 

16

 

 

 

65

 

 

 

40

 

Net loss

 

$

(1,148

)

 

$

(2,443

)

 

$

(7,547

)

 

$

(5,225

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

$

(0.07

)

 

$

(0.15

)

 

$

(0.47

)

 

$

(0.34

)

    Diluted

 

$

(0.07

)

 

$

(0.15

)

 

$

(0.47

)

 

$

(0.34

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares used in computing net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

 

15,990

 

 

 

15,867

 

 

 

15,938

 

 

 

15,421

 

    Diluted

 

 

15,990

 

 

 

15,867

 

 

 

15,938

 

 

 

15,421

 

 

 


https://cdn.kscope.io/1f91e4a886314497a7ab9ea342fed9b4-img156381773_1.jpg 

IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

 

 

 

December 31,

 

 

January 1,

 

 

 

2022

 

 

2022

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

13,922

 

 

$

23,852

 

Accounts receivable, net

 

 

9,768

 

 

 

9,716

 

Inventories

 

 

10,608

 

 

 

7,614

 

Prepaid expenses and other current assets

 

 

1,468

 

 

 

1,071

 

Total current assets

 

 

35,766

 

 

 

42,253

 

Property and equipment, net

 

 

462

 

 

 

428

 

Intangible assets, net

 

 

1,977

 

 

 

2,205

 

Goodwill

 

 

965

 

 

 

965

 

Operating lease right-of-use assets, net

 

 

1,665

 

 

 

2,565

 

Other long-term assets

 

 

1,455

 

 

 

271

 

Total assets

 

$

42,290

 

 

$

48,687

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,873

 

 

$

3,399

 

Accrued compensation

 

 

2,448

 

 

 

3,192

 

Accrued expenses

 

 

1,548

 

 

 

1,575

 

Other current liabilities

 

 

968

 

 

 

1,098

 

Accrued warranty

 

 

168

 

 

 

100

 

Deferred revenue

 

 

2,411

 

 

 

2,355

 

Operating lease liabilities

 

 

1,037

 

 

 

927

 

Total current liabilities

 

 

12,453

 

 

 

12,646

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Accrued warranty

 

 

106

 

 

 

58

 

Deferred revenue

 

 

11,742

 

 

 

10,930

 

Operating lease liabilities

 

 

732

 

 

 

1,729

 

Other long-term liabilities

 

 

26

 

 

 

25

 

Total liabilities

 

 

25,059

 

 

 

25,388

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock

 

 

169

 

 

 

168

 

Additional paid-in capital

 

 

86,802

 

 

 

85,255

 

Accumulated other comprehensive (loss) income

 

 

(24)

 

 

 

45

 

Accumulated deficit

 

 

(69,716

)

 

 

(62,169

)

Total stockholders' equity

 

 

17,231

 

 

 

23,299

 

Total liabilities and stockholders' equity

 

$

42,290

 

 

$

48,687