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. ☐ |
Securities registered pursuant to Section 12(b) of the Act:
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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.
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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: August 15, 2022 |
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Exhibit 99.1
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
“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
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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Six Months Ended |
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July 2, |
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July 3, |
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July 2, |
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July 3, |
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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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$ |
13,755 |
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$ |
13,426 |
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$ |
27,142 |
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$ |
25,385 |
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Cost of revenues |
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7,488 |
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7,318 |
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14,898 |
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14,338 |
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Gross profit |
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6,267 |
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6,108 |
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12,244 |
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11,047 |
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Operating expenses: |
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Research and development |
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1,922 |
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1,672 |
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4,038 |
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2,837 |
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Sales and marketing |
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4,607 |
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3,646 |
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8,907 |
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6,628 |
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General and administrative |
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1,898 |
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1,928 |
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3,736 |
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4,561 |
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Total operating expenses |
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8,427 |
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7,246 |
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16,681 |
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14,026 |
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Loss from operations |
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(2,160 |
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(1,138 |
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(4,437 |
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(2,979 |
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Other (expense) income, net |
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(64 |
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2,539 |
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(158 |
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2,378 |
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(Loss) income from operations before provision for income taxes |
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(2,224 |
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1,401 |
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(4,595 |
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(601 |
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Provision for income taxes |
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17 |
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8 |
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37 |
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16 |
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Net (loss) income |
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$ |
(2,241 |
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$ |
1,393 |
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$ |
(4,632 |
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$ |
(617 |
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Net (loss) income per share: |
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Basic |
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$ |
(0.14 |
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$ |
0.09 |
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$ |
(0.29 |
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$ |
(0.04 |
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Diluted |
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$ |
(0.14 |
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$ |
0.09 |
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$ |
(0.29 |
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$ |
(0.04 |
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Weighted average shares used in computing net (loss) income per share: |
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Basic |
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15,894 |
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15,647 |
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15,888 |
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14,996 |
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Diluted |
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15,894 |
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16,307 |
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15,888 |
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14,996 |
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IRIDEX Corporation
Condensed Consolidated Balance Sheets
(In thousands and unaudited)
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July 2, |
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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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$ |
17,966 |
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$ |
23,852 |
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Accounts receivable, net |
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9,237 |
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9,716 |
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Inventories |
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10,176 |
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7,614 |
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Prepaid expenses and other current assets |
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2,065 |
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1,071 |
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Total current assets |
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39,444 |
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42,253 |
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Property and equipment, net |
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431 |
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428 |
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Intangible assets, net |
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2,109 |
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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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2,098 |
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2,565 |
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Other long-term assets |
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599 |
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271 |
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Total assets |
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$ |
45,646 |
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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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$ |
3,992 |
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$ |
3,399 |
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Accrued compensation |
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2,303 |
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3,192 |
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Accrued expenses |
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1,697 |
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1,575 |
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Other current expenses |
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868 |
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1,098 |
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Accrued warranty |
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131 |
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100 |
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Deferred revenue |
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2,367 |
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2,355 |
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Operating lease liabilities |
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994 |
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927 |
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Total current liabilities |
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12,352 |
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12,646 |
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Long-term liabilities: |
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Accrued warranty |
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76 |
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58 |
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Deferred revenue |
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12,540 |
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10,930 |
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Operating lease liabilities |
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1,222 |
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1,729 |
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Other long-term liabilities |
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24 |
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25 |
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Total liabilities |
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26,214 |
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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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85,935 |
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85,255 |
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Accumulated other comprehensive income |
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129 |
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45 |
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Accumulated deficit |
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(66,801 |
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(62,169 |
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Total stockholders' equity |
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19,432 |
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23,299 |
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Total liabilities and stockholders' equity |
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$ |
45,646 |
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$ |
48,687 |
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