0000950170-23-063762.txt : 20231114 0000950170-23-063762.hdr.sgml : 20231114 20231114162859 ACCESSION NUMBER: 0000950170-23-063762 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20231114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231114 DATE AS OF CHANGE: 20231114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IRIDEX CORP CENTRAL INDEX KEY: 0001006045 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 770210467 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27598 FILM NUMBER: 231406899 BUSINESS ADDRESS: STREET 1: 1212 TERRA BELLA AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 BUSINESS PHONE: 6509404700 MAIL ADDRESS: STREET 1: 1212 TERRA BELLA AVENUE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 8-K 1 irix-20231114.htm 8-K 8-K
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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 14, 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 November 14, 2023, IRIDEX Corporation issued a press release discussing its financial results for its third fiscal quarter of fiscal year 2023, which ended on September 30, 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 November 14, 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: November 14, 2023

 

 

 

 

-3-


EX-99.1 2 irix-ex99_1.htm EX-99.1 EX-99.1

img156381773_0.jpg 

 

Exhibit 99.1

 

Iridex Reports Third Quarter 2023 Financial Results and Business Update

MOUNTAIN VIEW, Calif., November 14, 2023 -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and procedure probes for the treatment of glaucoma and retinal diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Recent Business Updates

Generated total revenue of $12.9 million, representing flat sequential quarter revenue and a decrease of 12% year-over-year
Cyclo G6® product family revenue in the third quarter of $3.0 million, representing a decrease 12% year-over-year due to reduced systems sales
o
Sold 13,200 Cyclo G6 probes, representing a 3% revenue increase and 3% unit decrease year-over-year
o
Sold 27 Cyclo G6 Glaucoma Laser Systems, compared to 41 in the second quarter of 2023 and 54 in the prior year period
Retina product revenue was $7.9 million, representing sequential growth of 15% and a decrease of 10% year-over-year
Cash and cash equivalents totaled approximately $8.0 million as of September 30, 2023
Announced in late August that the Company is undertaking a review and evaluation of strategic alternatives to unlock shareholder value
Subsequent to the quarter end, five of seven U.S. Medicare Administrative Contractors (MACs) issued Local Coverage Determinations that impose additional clinical requirements for reimbursement of minimally invasive glaucoma surgery (MIGS) device procedures and for cyclophotocoagulation procedures performed by the Company’s G6 laser system and probes

“Our third quarter results reflected a seasonally strong rebound in retina revenue from softness in the first half, but came in below last year’s third quarter results, reflecting continued softer environment for capital equipment and the conclusion of a long-running royalty contract earlier this year,” said David Bruce, Iridex President and CEO. “While we remain confident in our market position and continuing opportunities based on our differentiated retina laser platforms and unique glaucoma products supported by strong clinical evidence and global user base of thousands of ophthalmologists, subsequent to the quarter end new restrictions to parts of US glaucoma Medicare reimbursement were announced, injecting new challenges in our U.S. glaucoma business. We strongly disagree with the method used by these MACs in determining these changes and in the specific coverage criteria that resulted. We are challenging these restrictions on multiple fronts.”

Third Quarter 2023 Financial Results

Revenue for the three months ended September 30, 2023 was $12.9 million compared to $14.6 million during the same period of the prior year and flat versus the second quarter. Retina product revenue


img156381773_0.jpg 

 

decreased 10% compared to the prior year period to $7.9 million, primarily driven by continued softness in capital equipment demand, and represents an increase of 15% sequentially compared to the second quarter of 2023. Total product revenue from the Cyclo G6 glaucoma product group was $3.0 million, a decrease of 12% compared to the third quarter of 2022 driven entirely by reduced laser systems, while Cyclo G6 probe revenue grew 3%. Other revenue decreased to $1.9 million in the third quarter of 2023 compared to the prior year period of $2.4 million, primarily driven by decreased royalties due to expiration of licensed patents and lower service revenue.

Gross profit for the third quarter of 2023 was $5.6 million or a 43.7% gross margin, a decrease compared to $6.5 million, or a 44.1% gross margin, in the same period of the prior year, and represents sequential growth of 200 basis points compared to the second quarter of 2023.

Operating expenses for the third quarter of 2023 decreased to $7.3 million for the third quarter of 2023 compared to $8.2 million in the same period of the prior year and $8.3 million in the second quarter of 2023. The decrease is the result of cost optimization efforts that began in the second quarter of 2023.

Net loss for the third quarter of 2023 was $1.8 million, or $0.11 per share, compared to a net loss of $1.8 million, or $0.11 per share, in the same period of the prior year and $2.8 million, or $0.17 per share in the second quarter of 2023.

Cash and cash equivalents totaled $8.0 million as of September 30, 2023. Cash use of $1.8 million in the third quarter increased compared to $1.2 million in the second quarter of 2023. Balance sheet shifts affected cash usage in the quarter as previously announced operating cost reductions and inventory reductions to reduce cash usage were offset by a $1.7 million reduction in accounts payable. We expect to continue making progress with inventory reductions and expect fourth quarter cash usage to be significantly less than the third quarter.

Glaucoma Reimbursement Developments

Between October 24th and November 9th, five of the seven Medicare Administrative Contractors (“MACs”) that manage part of US Medicare coverage in the U.S. published “Local Coverage Determination” (the “LCDs”), that become effective December 24, 2023. The new LCDs primarily targeted Minimally Invasive Glaucoma Surgery (MIGS) procedures and devices, however also significantly restricted the criteria for coverage of cyclophotocoagulation reimbursement, the procedures which utilize Iridex’s G6 laser system and probes, for glaucoma patients.

After consultation with expert external advisors, Iridex believes that the LCDs will likely be interpreted to materially limit the patient types for which the respective MACs will reimburse cyclophotocoagulation procedures.

Iridex has been in contact with a number of societies and individual physicians who communicated concern over the potential limitation in the range of their patients covered for transscleral cyclophotocoagulation laser treatment. Iridex intends to appeal the restrictive criteria of the LCDs and to engage with the MACs to distinguish the clinical justification between non-incisional transscleral cyclophotocoagulation procedures and the alternative incisional surgical MIGS procedures.

At this time, Iridex cannot accurately predict the impact these LCDs coverage changes will have on its glaucoma business. Approximately two-thirds of our total U.S. glaucoma procedure volume is performed in regions covered by the five MACs that issued LCDs. The American Glaucoma Society estimates 60% of


img156381773_0.jpg 

 

U.S. glaucoma patients are covered by Medicare, and among Medicare patients, approximately half are covered by MACs, with the other half enrolled in Medicare Advantage plans who have not restricted the coverage criteria for cyclophotocoagulation. This implies about 20% of U.S. procedures fall directly under the coverage restrictions, with our glaucoma procedures for the most severe patients least affected and those for more moderate stage most affected. At this time, it is uncertain how physicians will react to coverage reductions and their decisions to offer our treatments to patients. Iridex is working to educate physicians about specific patient coverage ratios in their practice area and to support continued use and further expand adoption of our procedures where coverage for the devices and related procedures is maintained. Outside the U.S., which accounts for approximately 50% of Iridex glaucoma revenue, no material impact to the business is expected.

“Our top priority is maintaining fair market access to the procedures performed by the G6 laser platform following the recently issued LCDs. We disagree with the restrictive criteria defined to deem the procedures medically necessary and are collaborating with industry stakeholders to have the coverage policies appealed to reflect the extensive clinical evidence in support of cyclophotocoagulation procedures. We have submitted an appeal for correction based on inconsistency between the conclusions of the referenced studies and the final coverage restrictions. Among other unintended consequences, we believe that by limiting coverage of our MicroPulse and continuous-wave procedures, the LCDs have the potential to direct more patients into higher risk surgical procedures that both increase the potential for complications in patients, increase the total cost of care and decrease overall patient welfare,” said David Bruce, Iridex President and CEO. “As we work to retain full coverage of CPC in the affected MAC regions, we remain focused on our initiatives to accelerate G6 probe adoption in the covered population, including advancing our large multicenter prospective trial to further validate the safety and effectiveness of MPTLT procedures. We have high confidence that the efficacy and safety of or procedures will prevail, and the increased clinician awareness generated through this process can provide increased exposure to position MPTLT solidly as a key non-incisional procedure in the glaucoma continuum of care.”

Guidance Withdrawn for Full Year 2023

Iridex cannot accurately predict the impact to our glaucoma probes and system sales that will result from the reimbursement changes of the five LCDs as our customers and prospects evaluate their usage of probes and system purchases. Given this uncertainty, guidance has been withdrawn as the impact to Cyclo G6 system and probe sales is evaluated further.

Strategic Review to Unlock Shareholder Value

In August 2023, the Iridex board of directors announced it is conducting, in consultation with its financial and legal advisors, a review and evaluation of strategic alternatives that may be available to the Company to unlock shareholder value. Iridex has engaged Piper Sandler to act as financial advisor in connection with the strategic review process.

Scott Shuda, Chairman of the board of directors, commented on the strategic review process, “As a public company, Iridex must always seek to maximize shareholder value. Iridex’s product offerings today are stronger than they have ever been, and the board believes this is an appropriate time to explore strategic options for the future of each of our product lines.”


img156381773_0.jpg 

 

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 expectations and commercial trends, market adoption and expansion, demand for and utilization of the Company's products 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 10, 2023. 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

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 expectations and commercial trends, market adoption and expansion, demand for and utilization of the Company's products and results and expected sales volumes. These statements are not guarantees of future performance and actual results may differ


img156381773_0.jpg 

 

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 10, 2023. 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

 

 

 


img156381773_0.jpg 

 

 

IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(unaudited)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

September 30, 2023

 

 

October 1, 2022

 

 

September 30, 2023

 

 

October 1, 2022

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

12,850

 

 

$

14,635

 

 

$

39,411

 

 

$

41,777

Cost of revenues

 

7,229

 

 

 

8,175

 

 

 

22,489

 

 

 

23,073

     Gross profit

 

5,621

 

 

 

6,460

 

 

 

16,922

 

 

 

18,704

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

1,541

 

 

 

1,687

 

 

 

5,135

 

 

 

5,725

Sales and marketing

 

3,823

 

 

 

4,445

 

 

 

12,370

 

 

 

13,352

General and administrative

 

1,945

 

 

 

2,023

 

 

 

6,343

 

 

 

5,759

Total operating expenses

 

7,309

 

 

 

8,155

 

 

 

23,848

 

 

 

24,836

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,688)

 

 

 

(1,695)

 

 

 

(6,926)

 

 

 

(6,132)

Other income (expense), net

 

(58)

 

 

 

(58)

 

 

 

346

 

 

 

(216)

Loss from operations before
   provision for income taxes

 

(1,746)

 

 

 

(1,753)

 

 

 

(6,580)

 

 

 

(6,348)

Provision for income taxes

 

8

 

 

 

14

 

 

 

30

 

 

 

51

Net loss

$

(1,754)

 

 

$

(1,767)

 

 

$

(6,610)

 

 

$

(6,399)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

$

(0.11)

 

 

$

(0.11)

 

 

$

(0.41)

 

 

$

(0.40)

     Diluted

$

(0.11)

 

 

$

(0.11)

 

 

$

(0.41)

 

 

$

(0.40)

Weighted average shares used in
   computing net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Basic

 

16,231

 

 

 

15,986

 

 

 

16,089

 

 

 

15,921

     Diluted

 

16,231

 

 

 

15,986

 

 

 

16,089

 

 

 

15,921

 

 

 

 


img156381773_0.jpg 

 

img156381773_1.jpg 

IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

 

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

 

7,981

 

 

$

 

13,922

 

Accounts receivable, net

 

 

 

8,114

 

 

 

 

9,768

 

Inventories

 

 

 

10,118

 

 

 

 

10,608

 

Prepaid expenses and other current assets

 

 

 

1,129

 

 

 

 

1,468

 

Total current assets

 

 

 

27,342

 

 

 

 

35,766

 

Property and equipment, net

 

 

 

524

 

 

 

 

462

 

Intangible assets, net

 

 

 

1,726

 

 

 

 

1,977

 

Goodwill

 

 

 

965

 

 

 

 

965

 

Operating lease right-of-use assets, net

 

 

 

2,789

 

 

 

 

1,665

 

Other long-term assets

 

 

 

1,603

 

 

 

 

1,455

 

Total assets

 

$

 

34,949

 

 

$

 

42,290

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

 

2,613

 

 

$

 

3,873

 

Accrued compensation

 

 

 

2,197

 

 

 

 

2,448

 

Accrued expenses

 

 

 

1,171

 

 

 

 

1,548

 

Other current liabilities

 

 

 

886

 

 

 

 

968

 

Accrued warranty

 

 

 

247

 

 

 

 

168

 

Deferred revenue

 

 

 

2,239

 

 

 

 

2,411

 

Operating lease liabilities

 

 

 

995

 

 

 

 

1,037

 

Total current liabilities

 

 

 

10,348

 

 

 

 

12,453

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Deferred revenue

 

 

 

10,472

 

 

 

 

11,742

 

Other long-term liabilities

 

 

 

2,065

 

 

 

 

864

 

Total liabilities

 

 

 

22,885

 

 

 

 

25,059

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock

 

 

 

172

 

 

 

 

169

 

Additional paid-in capital

 

 

 

87,993

 

 

 

 

86,802

 

Accumulated other comprehensive loss

 

 

 

(19

)

 

 

 

(24

)

Accumulated deficit

 

 

 

(76,082

)

 

 

 

(69,716

)

Total stockholders' equity

 

 

 

12,064

 

 

 

 

17,231

 

Total liabilities and stockholders' equity

 

$

 

34,949

 

 

$

 

42,290

 

 


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Document and Entity Information
Nov. 14, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 14, 2023
Entity Registrant Name IRIDEX CORPORATION
Entity Central Index Key 0001006045
Entity File Number 000-27598
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 77-0210467
Entity Address, Address Line One 1212 Terra Bella Avenue
Entity Address, City or Town Mountain View
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94043
City Area Code 650
Local Phone Number 940-4700
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.01 per share
Trading Symbol IRIX
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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