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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(Exact name of registrant as specified in its charter) |
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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. ☐ |
Securities registered pursuant to Section 12(b) of the Act:
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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.
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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: March 9, 2023 |
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Exhibit 99.1
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
Full Year 2022 Highlights
“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
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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Twelve Months Ended |
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December 31, |
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January 1, |
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December 31, |
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January 1, |
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2022 |
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2022 |
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2022 |
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2022 |
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Total revenues |
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$ |
15,195 |
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$ |
15,254 |
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$ |
56,972 |
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$ |
53,903 |
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Cost of revenues |
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8,531 |
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9,252 |
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31,604 |
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31,072 |
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Gross profit |
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6,664 |
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6,002 |
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25,368 |
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22,831 |
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Operating expenses: |
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Research and development |
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1,450 |
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2,243 |
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7,175 |
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6,868 |
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Sales and marketing |
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4,826 |
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4,095 |
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18,178 |
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14,637 |
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General and administrative |
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1,798 |
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2,061 |
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7,557 |
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8,859 |
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Total operating expenses |
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8,074 |
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8,399 |
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32,910 |
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30,364 |
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Loss from operations |
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(1,410 |
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(2,397 |
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(7,542 |
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(7,533 |
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Other income (expense), net |
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276 |
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(30 |
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60 |
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2,348 |
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Loss from operations before provision for income taxes |
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(1,134 |
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(2,427 |
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(7,482 |
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(5,185 |
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Provision for income taxes |
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14 |
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16 |
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65 |
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40 |
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Net loss |
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$ |
(1,148 |
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$ |
(2,443 |
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$ |
(7,547 |
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$ |
(5,225 |
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Net loss per share: |
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Basic |
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$ |
(0.07 |
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$ |
(0.15 |
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$ |
(0.47 |
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$ |
(0.34 |
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Diluted |
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$ |
(0.07 |
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$ |
(0.15 |
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$ |
(0.47 |
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$ |
(0.34 |
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Weighted average shares used in computing net loss per share: |
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Basic |
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15,990 |
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15,867 |
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15,938 |
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15,421 |
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Diluted |
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15,990 |
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15,867 |
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15,938 |
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15,421 |
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IRIDEX Corporation
Condensed Consolidated Balance Sheets
(In thousands and unaudited)
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December 31, |
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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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$ |
13,922 |
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$ |
23,852 |
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Accounts receivable, net |
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9,768 |
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9,716 |
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Inventories |
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10,608 |
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7,614 |
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Prepaid expenses and other current assets |
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1,468 |
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1,071 |
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Total current assets |
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35,766 |
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42,253 |
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Property and equipment, net |
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462 |
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428 |
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Intangible assets, net |
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1,977 |
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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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1,665 |
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2,565 |
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Other long-term assets |
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1,455 |
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271 |
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Total assets |
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$ |
42,290 |
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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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$ |
3,873 |
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$ |
3,399 |
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Accrued compensation |
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2,448 |
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3,192 |
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Accrued expenses |
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1,548 |
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1,575 |
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Other current liabilities |
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968 |
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1,098 |
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Accrued warranty |
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168 |
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100 |
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Deferred revenue |
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2,411 |
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2,355 |
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Operating lease liabilities |
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1,037 |
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927 |
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Total current liabilities |
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12,453 |
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12,646 |
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Long-term liabilities: |
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Accrued warranty |
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106 |
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58 |
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Deferred revenue |
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11,742 |
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10,930 |
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Operating lease liabilities |
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732 |
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1,729 |
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Other long-term liabilities |
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26 |
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25 |
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Total liabilities |
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25,059 |
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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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86,802 |
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85,255 |
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Accumulated other comprehensive (loss) income |
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(24) |
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45 |
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Accumulated deficit |
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(69,716 |
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(62,169 |
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Total stockholders' equity |
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17,231 |
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23,299 |
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Total liabilities and stockholders' equity |
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$ |
42,290 |
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$ |
48,687 |
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