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Form 8-K IRIDEX CORP For: Aug 15

August 15, 2022 5:03 PM EDT

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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

 

August 15, 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 August 15, 2022, IRIDEX Corporation issued a press release discussing its financial results for its second fiscal quarter of fiscal year 2022, which ended on July 2, 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 August 15, 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: August 15, 2022

 

 

 

 

-3-


 

Exhibit 99.1

img156381773_0.jpg 

 

Iridex Announces Second Quarter 2022 Financial Results

 

MOUNTAIN VIEW, Calif., August 15, 2022 -- Iridex Corporation (Nasdaq: IRIX) today reported financial results for the second quarter ended July 2, 2022.

 

Second Quarter 2022 Highlights

Total revenue of $13.8 million, an increase of 2% over the prior year period
o
Gross Margin was 45.6% compared to 45.5% in the prior year period
Cyclo G6® product family revenue of $3.5 million, a decrease of 3% year-over-year
o
15,000 Cyclo G6 probes sold, a 6% decrease year-over-year and a 2% increase quarter-over-quarter
o
48 Cyclo G6 Glaucoma Laser Systems sold, compared to 47 in the prior year quarter
Retina product revenue was relatively flat year-over-year at $7.5 million
Net Cash use of $2.7 million resulting in cash balance on July 2, 2022 of $18.0 million
o
Cash reduction includes $1.1 million increase in inventories to mitigate against potential supply chain issues
Achieved regulatory clearance to market and sell the Cyclo G6 Platform in China
o
Sold initial systems and probes and conducted clinical launch meetings with 70 physicians
Hired new VP of Marketing and added five sales reps worldwide

 

“Softer growth in the second quarter of 2022 demonstrates the tougher business environment we faced after several quarters of strong results and record revenue. Macro headwinds impacted our international business and a COVID surge hampered procedure volumes during the second half of the quarter as capacity limitations and patient cancellations rose,” said David Bruce, President and CEO. “The continued traction we are achieving, however, with our strengthened U.S. and international commercial network leaves us confident we are tracking for a stronger second half of the year. We continue to make steady progress building physician adoption of our non-incisional approach to treating glaucoma and retinal disease worldwide.”

 

“In June we achieved regulatory clearance to market and sell our Cyclo G6 platform in China by its National Medical Products Administration (NMPA). This long-anticipated milestone is a significant catalyst for Iridex as it opens up a vast new population of glaucoma patients that can benefit from our MicroPulse Transcleral Laser Therapy (TLT),” continued Bruce. “We are also excitedly preparing for the launch of our new suite of retina laser systems at the upcoming AAO Conference starting September 30th.”

 

Second Quarter 2022 Financial Results

Revenue for the three months ended July 2, 2022, increased 2% to $13.8 million from $13.4 million during the same period of the prior year.

 

Total product revenue from the Cyclo G6 glaucoma product family was $3.5 million, 3% lower than second quarter of 2021. The year-over-year decline was driven by lower OUS probe sales relative to a record high in Q2 2021 but was still the second highest OUS volume on record. Retina product revenue in the second quarter was $7.5 million compared to $7.6 million in the prior year. Other revenue, which includes royalties, services, and other legacy products, increased 22% to $2.7 million in the second quarter of 2022 compared to the same period in 2021. The increase in other revenue resulted from higher amortized revenue recognition from the sale of distribution rights to Topcon plus higher service and other product revenue.

 


Gross profit for the second quarter of 2022 increased 3% to $6.3 million, or a 45.6% gross margin, compared to $6.1 million, a 45.5% gross margin in the same period of the prior year.

 

Operating expenses for the second quarter of 2022 increased 16% to $8.4 million compared to $7.2 million in the same period of the prior year. The increase is the result of the expansion of sales and marketing programs and in continued R&D investment in PASCAL, as well as other new product development initiatives.

 

Net loss for the second quarter of 2022 was $2.2 million, or $0.14 per share, compared to a net income of $1.4 million or $0.09 per share, in the same period of the prior year. The net income last year was due to one-time inclusion of $2.5 million non-operating gain from PPP loan forgiveness.

 

Updated Guidance for Full Year 2022

Iridex now expects total revenue for fiscal year 2022 to range from $56 million to $58 million, reflecting growth of 4% to 8% over fiscal year 2021. This compares to the previous range of $57 million to $59 million. Cyclo G6 probe sales are now expected to range from 61,000 to 63,000, representing 5% to 8% growth. This compares to the previous range of 67,000 to 70,000. The Company continues to expect Glaucoma Laser System installed base to expand by 225 to 250 in 2022.

 

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/BIf351956916684213814f57c91be423cf). 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 May 12, 2022.

 

Investor Relations Contact

Hunter Cabi

[email protected]

 

 


img156381773_1.jpg 

IRIDEX Corporation

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(unaudited)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

July 2,

 

 

July 3,

 

 

July 2,

 

 

July 3,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues

 

$

13,755

 

 

$

13,426

 

 

$

27,142

 

 

$

25,385

 

Cost of revenues

 

 

7,488

 

 

 

7,318

 

 

 

14,898

 

 

 

14,338

 

Gross profit

 

 

6,267

 

 

 

6,108

 

 

 

12,244

 

 

 

11,047

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,922

 

 

 

1,672

 

 

 

4,038

 

 

 

2,837

 

Sales and marketing

 

 

4,607

 

 

 

3,646

 

 

 

8,907

 

 

 

6,628

 

General and administrative

 

 

1,898

 

 

 

1,928

 

 

 

3,736

 

 

 

 4,561

 

   Total operating expenses

 

 

8,427

 

 

 

7,246

 

 

 

16,681

 

 

 

14,026

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(2,160

)

 

 

(1,138

)

 

 

(4,437

)

 

 

(2,979

)

Other (expense) income, net

 

 

(64

)

 

 

2,539

 

 

 

(158

)

 

 

2,378

 

(Loss) income from operations before provision for income taxes

 

 

(2,224

)

 

 

1,401

 

 

 

(4,595

)

 

 

(601

)

Provision for income taxes

 

 

17

 

 

 

8

 

 

 

37

 

 

 

16

 

Net (loss) income

 

$

(2,241

)

 

$

1,393

 

 

$

(4,632

)

 

$

(617

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net (loss) income per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

$

(0.14

)

 

$

0.09

 

 

$

(0.29

)

 

$

(0.04

)

    Diluted

 

$

(0.14

)

 

$

0.09

 

 

$

(0.29

)

 

$

(0.04

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares used in computing net (loss) income per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    Basic

 

 

15,894

 

 

 

15,647

 

 

 

15,888

 

 

 

14,996

 

    Diluted

 

 

15,894

 

 

 

16,307

 

 

 

15,888

 

 

 

14,996

 

 

 


img156381773_1.jpg 

IRIDEX Corporation

Condensed Consolidated Balance Sheets

(In thousands and unaudited)

 

 

 

July 2,

 

 

January 1,

 

 

 

2022

 

 

2022

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

17,966

 

 

$

23,852

 

Accounts receivable, net

 

 

9,237

 

 

 

9,716

 

Inventories

 

 

10,176

 

 

 

7,614

 

Prepaid expenses and other current assets

 

 

2,065

 

 

 

1,071

 

Total current assets

 

 

39,444

 

 

 

42,253

 

Property and equipment, net

 

 

431

 

 

 

428

 

Intangible assets, net

 

 

2,109

 

 

 

2,205

 

Goodwill

 

 

965

 

 

 

965

 

Operating lease right-of-use assets, net

 

 

2,098

 

 

 

2,565

 

Other long-term assets

 

 

599

 

 

 

271

 

Total assets

 

$

45,646

 

 

$

48,687

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,992

 

 

$

3,399

 

Accrued compensation

 

 

2,303

 

 

 

3,192

 

Accrued expenses

 

 

1,697

 

 

 

1,575

 

Other current expenses

 

 

868

 

 

 

1,098

 

Accrued warranty

 

 

131

 

 

 

100

 

Deferred revenue

 

 

2,367

 

 

 

2,355

 

Operating lease liabilities

 

 

994

 

 

 

927

 

Total current liabilities

 

 

12,352

 

 

 

12,646

 

 

 

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Accrued warranty

 

 

76

 

 

 

58

 

Deferred revenue

 

 

12,540

 

 

 

10,930

 

Operating lease liabilities

 

 

1,222

 

 

 

1,729

 

Other long-term liabilities

 

 

24

 

 

 

25

 

Total liabilities

 

 

26,214

 

 

 

25,388

 

 

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock

 

 

169

 

 

 

168

 

Additional paid-in capital

 

 

85,935

 

 

 

85,255

 

Accumulated other comprehensive income

 

 

129

 

 

 

45

 

Accumulated deficit

 

 

(66,801

)

 

 

(62,169

)

Total stockholders' equity

 

 

19,432

 

 

 

23,299

 

Total liabilities and stockholders' equity

 

$

45,646

 

 

$

48,687

 

 




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