IRIX 8-K
Iridex Corp (IRIX)
UNITED STATES Washington, D.C. 20549 |
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FORM CURRENT REPORT |
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PURSUANT TO SECTION 13 OR 15(d) OF THE |
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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): |
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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). |
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Emerging growth company |
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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. ☐ |
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Securities registered pursuant to Section 12(b) of the Act:
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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.
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(d) |
Exhibits |
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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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.
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IRIDEX CORPORATION |
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By: |
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/s/David I. Bruce |
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David I. Bruce |
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President and Chief Executive Officer |
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Date: November 10, 2022 |
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Exhibit 99.1
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
“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
IRIDEX Corporation
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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October 1, |
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October 2, |
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October 1, |
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October 2, |
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2022 |
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2021 |
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2022 |
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2021 |
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Total revenues |
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$ |
14,635 |
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$ |
13,264 |
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$ |
41,777 |
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$ |
38,649 |
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Cost of revenues |
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8,175 |
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7,482 |
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23,073 |
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21,820 |
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Gross profit |
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6,460 |
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5,782 |
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18,704 |
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16,829 |
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Operating expenses: |
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Research and development |
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1,687 |
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1,788 |
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5,725 |
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4,625 |
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Sales and marketing |
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4,445 |
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3,914 |
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13,352 |
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10,542 |
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General and administrative |
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2,023 |
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2,237 |
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5,759 |
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6,798 |
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Total operating expenses |
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8,155 |
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7,939 |
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24,836 |
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21,965 |
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Loss from operations |
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(1,695 |
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(2,157 |
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(6,132 |
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(5,136 |
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Other (expense) income, net |
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(58 |
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- |
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(216 |
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2,378 |
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Loss from operations before provision for income taxes |
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(1,753 |
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(2,157 |
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(6,348 |
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(2,758 |
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Provision for income taxes |
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14 |
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8 |
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51 |
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24 |
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Net loss |
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$ |
(1,767 |
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$ |
(2,165 |
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$ |
(6,399 |
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$ |
(2,782 |
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Net loss per share: |
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Basic |
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$ |
(0.11 |
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$ |
(0.14 |
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$ |
(0.40 |
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$ |
(0.18 |
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Diluted |
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$ |
(0.11 |
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$ |
(0.14 |
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$ |
(0.40 |
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$ |
(0.18 |
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Weighted average shares used in computing net loss per share: |
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Basic |
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15,986 |
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15,824 |
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15,921 |
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15,272 |
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Diluted |
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15,986 |
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15,824 |
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15,921 |
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15,272 |
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IRIDEX Corporation
Condensed Consolidated Balance Sheets
(In thousands and unaudited)
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October 1, |
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January 1, |
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2022 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
15,856 |
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$ |
23,852 |
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Accounts receivable, net |
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9,744 |
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9,716 |
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Inventories |
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10,765 |
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7,614 |
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Prepaid expenses and other current assets |
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1,984 |
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1,071 |
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Total current assets |
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38,349 |
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42,253 |
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Property and equipment, net |
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435 |
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428 |
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Intangible assets, net |
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2,061 |
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2,205 |
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Goodwill |
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965 |
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965 |
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Operating lease right-of-use assets, net |
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1,862 |
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2,565 |
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Other long-term assets |
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1,287 |
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271 |
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Total assets |
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$ |
44,959 |
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$ |
48,687 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
4,640 |
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$ |
3,399 |
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Accrued compensation |
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2,862 |
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3,192 |
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Accrued expenses |
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1,705 |
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1,575 |
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Other current liabilities |
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841 |
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1,098 |
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Accrued warranty |
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142 |
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100 |
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Deferred revenue |
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2,431 |
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2,355 |
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Operating lease liabilities |
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1,012 |
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927 |
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Total current liabilities |
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13,633 |
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12,646 |
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Long-term liabilities: |
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Accrued warranty |
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91 |
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58 |
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Deferred revenue |
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12,172 |
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10,930 |
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Operating lease liabilities |
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961 |
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1,729 |
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Other long-term liabilities |
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27 |
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25 |
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Total liabilities |
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26,884 |
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25,388 |
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Stockholders' equity: |
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Common stock |
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169 |
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168 |
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Additional paid-in capital |
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86,286 |
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85,255 |
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Accumulated other comprehensive income |
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188 |
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45 |
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Accumulated deficit |
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(68,568 |
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(62,169 |
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Total stockholders' equity |
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18,075 |
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23,299 |
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Total liabilities and stockholders' equity |
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$ |
44,959 |
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$ |
48,687 |
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