Cue Health Reports Fourth Quarter and Full-Year 2022 Financial Results
Cue Health Inc. (Nasdaq: HLTH) reported a fourth quarter revenue of $146.8 million in 2022, boosted by $92.4 million in deferred revenue from a U.S. Department of Defense agreement. Full-year revenue reached $483.5 million. The company launched multiple diagnostic tests and a new at-home testing kit while aiming to save $100 million annually through a cost reduction plan. However, GAAP net income showed a loss of $31.5 million for Q4 and $194.1 million for the entire year. Cash reserves were strong at $241.5 million with no debt obligations. The company projects Q1 2023 revenues between $20 million and $25 million.
- Fourth quarter revenue increased to $146.8 million, including $92.4 million in deferred revenue.
- Full-year revenue reached $483.5 million, demonstrating strong demand in the private sector.
- Achieved all test menu expansion milestones, including multiple submissions to the FDA.
- Launched Cue CareTM, a diagnostic-to-treatment solution enhancing accessibility.
- Implemented a cost reduction plan expected to generate annual savings of $100 million.
- Maintained strong cash reserves of $241.5 million with no debt.
- GAAP net income loss of $31.5 million in Q4 and $194.1 million for the full year.
- Adjusted net income loss of $74.4 million in Q4 and $191.8 million for the year.
- Operating expenses rose to $94.6 million in Q4 and $359.2 million for the full year.
Recent and Full-Year 2022 Highlights
-
Reported fourth quarter revenue of
, including$146.8 million in deferred revenue related to our agreement with the$92.4 million U.S. Department of Defense . Full-year 2022 revenue was .$483.5 million -
Achieved all test menu expansion milestones for 2022 including four molecular diagnostic tests submissions to the
U.S. Food and Drug Administration (FDA):- COVID-19 de novo submission for full clearance in the second quarter of 2022
- Flu A/B de novo submission in the third quarter of 2022
- Flu A/B + COVID multiplex submission for emergency use authorization (EUA) in the third quarter of 2022
- Mpox, formerly known as monkeypox, submission for EUA for point-of-care use in the first quarter of 2023
- RSV molecular test clinical studies completed in the first quarter of 2023
- Chlamydia + Gonorrhea molecular clinical studies began in the fourth quarter of 2022
- Strep Throat molecular clinical studies began in the fourth quarter of 2022
- Launched Cue CareTM our foundational diagnostic-to-treatment solution, enabling individuals to consult with a healthcare professional and get treatment delivered to their home within hours, if medically indicated.
- Introduced a new collection of at-home diagnostic test kits for a variety of health conditions, including sexually transmitted infections, heart health, and food sensitivities, providing personalized care from the convenience and privacy of home. Individuals order tests online, collect samples, mail to a CLIA-certified laboratory partner, and get results delivered to their Cue Health App, with the option to access Cue Care for clinical consultation and prescriptions, if medically indicated.
-
Executed a cost reduction plan, which is expected to result in cash savings of approximately
on an annualized basis, while prioritizing near-term revenue generating opportunities.$100 million -
Cash and cash equivalents of
as of$241.5 million December 31, 2022 , while the secured revolving credit facility remains undrawn and company continues to operate with no debt obligations.$100 million
“Our full year 2022 results reflect the success we’ve seen with our first product and the investments we’ve made to execute on all of our strategic priorities, which position us well to become the category leader in diagnostic testing both in the home and at the point of care,” said
Fourth Quarter 2022 Financial Results
Revenue was
Excluding deferred revenue, fourth quarter of 2022 revenue was
Private sector revenue was
GAAP product gross profit margin was
Operating expenses in the fourth quarter of 2022 were
GAAP net income in the fourth quarter of 2022 was a loss of
Full-Year 2022 Financial Results
Revenue was
Private sector revenue was
GAAP product gross profit margin was
Operating expenses for the full year 2022 were
GAAP net income for the full year 2022 was a loss of
Cash and cash equivalents were
Guidance
About
Cue is a healthcare technology company that makes it easy for individuals to access health information and places diagnostic information at the center of care. Cue enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision. Outside
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, including statements related to the submission of any FDA applications and expectations around receiving clearance, growth in our customer base, expectations regarding production capacity, potential technology enhancements and future performance and our guidance, including first quarter 2023 guidance, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements”. The words, without limitation, “continue,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “would,” “develop,” “pave,” “seek,” “offer,” “grow”, “expand” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including those related to the expected capabilities of the flu A/B standalone, flu A/B + Covid multiplex, RSV test, Strep Throat test, mpox test and Chlamydia + Gonorrhea multiplex test, the expansion of Cue Care, our ability to maintain customer growth rates, our ability to increase private sector revenue, our ability maintain or replace the revenue historically generated from our government contracts, our ability to effectively scale our manufacturing capacity to meet contractual obligations with our customers and market demand, our ability to realize operating expense annualized savings as a result of the previously announced cost reduction program, and the factors discussed in the "Risk Factors" section of Cue’s Annual Report on Form 10-K for the year ended
This product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization, or EUA. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Use of Non-GAAP Financial Measures
To supplement our financial information presented in accordance with GAAP, we consider certain financial measures that are not prepared in accordance with GAAP, including Adjusted Product Gross Profit Margin, Adjusted Net (loss) Income, Adjusted Diluted EPS and Adjusted EBITDA (loss). We use these financial measures in conjunction with GAAP measures as part of our overall assessment of our performance, including the preparation of our annual operating budget and quarterly forecasts, to evaluate the effectiveness of our business strategies and to communicate with our board of directors concerning our business and financial performance. We believe that these non-GAAP financial measures provide useful information to investors about our business and financial performance, enhance their overall understanding of our past performance and future prospects, and allow for greater transparency with respect to metrics used by our management in their financial and operational decision making. We are presenting these non-GAAP financial measures to assist investors in seeing our business and financial performance through the eyes of management, and because we believe that these non-GAAP financial measures provide an additional tool for investors to use in comparing results of operations of our business over multiple periods with other companies in our industry.
Adjusted EBITDA is defined as net income before interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation, restructuring expense, inventory charges – inventory reserves/warranty reserves,
Adjusted product gross profit is defined as product gross profit, before
Adjusted net (loss) income is defined as Net (loss) income, before Inventory charges – inventory reserves / warranty reserves,
Adjusted diluted EPS is defined as Diluted EPS before Inventory charges – inventory reserves / warranty reserves,
Our definitions may differ from the definitions used by other companies and therefore comparability may be limited. In addition, other companies may not publish these or similar metrics. Further, these metrics have certain limitations in that they do not include the impact of certain expenses that are reflected in our consolidated statements of operations. Thus, these non-GAAP metrics should be considered in addition to, not as substitutes for, or in isolation from, measures prepared in accordance with GAAP. For reconciliations of these non-GAAP financial measures to their most directly comparable GAAP financial measures see the financial tables below.
CONDENSED STATEMENTS OF OPERATIONS |
|||||||||||||||
(In thousands, except share data) |
|||||||||||||||
|
Three Months Ended
|
|
Year Ended |
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue |
|
|
|
|
|
|
|
||||||||
Product revenue |
$ |
145,701 |
|
|
$ |
191,280 |
|
|
$ |
474,166 |
|
|
$ |
615,796 |
|
Grant and other revenue |
|
1,076 |
|
|
|
1,226 |
|
|
|
9,310 |
|
|
|
2,311 |
|
Total revenue |
|
146,777 |
|
|
|
192,506 |
|
|
|
483,476 |
|
|
|
618,107 |
|
|
|
|
|
|
|
|
|
||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of product revenue |
|
90,783 |
|
|
|
102,796 |
|
|
|
329,973 |
|
|
|
276,542 |
|
Sales and marketing |
|
19,312 |
|
|
|
21,198 |
|
|
|
88,580 |
|
|
|
28,729 |
|
Research and development |
|
56,149 |
|
|
|
21,679 |
|
|
|
171,452 |
|
|
|
42,829 |
|
General and administrative |
|
19,157 |
|
|
|
23,452 |
|
|
|
97,103 |
|
|
|
79,788 |
|
Restructuring Expense |
|
— |
|
|
|
— |
|
|
|
2,020 |
|
|
|
— |
|
Total operating costs and expenses |
|
185,401 |
|
|
|
169,125 |
|
|
|
689,128 |
|
|
|
427,888 |
|
Income (loss) from operations |
|
(38,624 |
) |
|
|
23,381 |
|
|
|
(205,652 |
) |
|
|
190,219 |
|
|
|
|
|
|
|
|
|
||||||||
Interest expense |
|
(232 |
) |
|
|
(57 |
) |
|
|
(645 |
) |
|
|
(9,809 |
) |
Change in fair value of redeemable convertible preferred stock warrants |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
53 |
|
Change in fair value of convertible notes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(59,560 |
) |
Loss on extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,998 |
) |
Other income (expense), net |
|
2,035 |
|
|
|
291 |
|
|
|
2,493 |
|
|
|
272 |
|
Net income (loss) before income taxes |
|
(36,821 |
) |
|
|
23,615 |
|
|
|
(203,804 |
) |
|
|
119,177 |
|
|
|
|
|
|
|
|
|
||||||||
Income tax expense (benefit) |
|
(5,315 |
) |
|
|
(10,615 |
) |
|
|
(9,748 |
) |
|
|
32,759 |
|
Net income (loss) |
$ |
(31,506 |
) |
|
$ |
34,230 |
|
|
$ |
(194,056 |
) |
|
$ |
86,418 |
|
Net income (loss) per share attributable to common stockholders – basic |
$ |
(0.21 |
) |
|
$ |
0.23 |
|
|
$ |
(1.31 |
) |
|
$ |
0.63 |
|
Weighted-average number of shares used in computation of net income (loss) per share attributable to common stockholders – basic |
|
149,711,419 |
|
|
|
146,367,756 |
|
|
|
148,024,749 |
|
|
|
52,815,449 |
|
Net income (loss) per share attributable to common stockholders – diluted |
$ |
(0.21 |
) |
|
$ |
0.22 |
|
|
$ |
(1.31 |
) |
|
$ |
0.59 |
|
Weighted-average number of shares used in computation of net income (loss) per share attributable to common stockholders – diluted |
|
149,711,419 |
|
|
|
152,531,173 |
|
|
|
148,024,749 |
|
|
|
59,635,384 |
|
CONDENSED BALANCE SHEETS |
|||||||
(In thousands, except share amounts and share data) |
|||||||
|
|
|
|
||||
Assets |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
241,530 |
|
|
$ |
409,873 |
|
Restricted cash |
|
800 |
|
|
|
13,837 |
|
Accounts receivable |
|
18,751 |
|
|
|
104,589 |
|
Inventories |
|
82,210 |
|
|
|
88,388 |
|
Prepaid expenses |
|
15,728 |
|
|
|
45,889 |
|
Other current assets |
|
12,134 |
|
|
|
7,446 |
|
Total current assets |
|
371,153 |
|
|
|
670,022 |
|
|
|
|
|
||||
Non-current inventories |
|
25,436 |
|
|
|
— |
|
Property and equipment, net |
|
189,275 |
|
|
|
177,456 |
|
Operating lease right-of-use assets |
|
85,321 |
|
|
|
79,474 |
|
Intangible assets, net |
|
16,867 |
|
|
|
7,673 |
|
Other non-current assets |
|
6,528 |
|
|
|
5,435 |
|
Total assets |
$ |
694,580 |
|
|
$ |
940,060 |
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity (Deficit) |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
7,150 |
|
|
$ |
37,208 |
|
Accrued liabilities and other current liabilities |
|
52,378 |
|
|
|
29,498 |
|
Income taxes payable |
|
— |
|
|
|
8,297 |
|
Deferred revenue, current |
|
1,566 |
|
|
|
82,165 |
|
Operating lease liabilities, current |
|
7,739 |
|
|
|
7,147 |
|
Finance lease liabilities, current |
|
2,362 |
|
|
|
2,621 |
|
Total current liabilities |
|
71,195 |
|
|
|
166,936 |
|
|
|
|
|
||||
Deferred revenue, net of current portion |
|
— |
|
|
|
10,283 |
|
Operating leases liabilities, net of current portion |
|
44,045 |
|
|
|
46,464 |
|
Finance lease liabilities, net of current portion |
|
849 |
|
|
|
3,271 |
|
Other non-current liabilities |
|
1,997 |
|
|
|
6,356 |
|
Total liabilities |
|
118,086 |
|
|
|
233,310 |
|
|
|
|
|
||||
Stockholders’ Equity (Deficit) |
|
|
|
||||
Common stock, |
|
1 |
|
|
|
1 |
|
Additional paid-in-capital |
|
794,567 |
|
|
|
730,767 |
|
Accumulated deficit |
|
(218,074 |
) |
|
|
(24,018 |
) |
Total stockholders’ equity (deficit) |
|
576,494 |
|
|
|
706,750 |
|
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
$ |
694,580 |
|
|
$ |
940,060 |
|
Non-GAAP Net Income (Loss)
(In thousands, except share data)
The following table presents the reconciliation of Net (loss) income to Adjusted EBITDA, for the periods presented:
|
Three Months Ended
|
|
Year Ended |
|||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
Net (loss) income |
$ |
(31,506 |
) |
|
$ |
34,230 |
|
|
$ |
(194,056 |
) |
|
$ |
86,418 |
Interest expense |
|
232 |
|
|
|
57 |
|
|
|
645 |
|
|
|
9,809 |
Income tax expense (benefit) |
|
(5,315 |
) |
|
|
(10,615 |
) |
|
|
(9,748 |
) |
|
|
32,759 |
Depreciation and amortization |
|
11,953 |
|
|
|
6,430 |
|
|
|
44,942 |
|
|
|
32,509 |
Stock-based compensation |
|
15,776 |
|
|
|
17,421 |
|
|
|
64,291 |
|
|
|
42,979 |
Restructuring expense |
|
— |
|
|
|
— |
|
|
|
2,020 |
|
|
|
— |
Inventory charges - inventory reserves / warranty reserves |
|
47,352 |
|
|
|
— |
|
|
|
92,806 |
|
|
|
— |
|
|
(92,448 |
) |
|
|
— |
|
|
|
(92,448 |
) |
|
|
— |
Fair value adjustment - convertible notes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
59,560 |
Forgiveness of promissory notes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12,880 |
Banking and finance-related items |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,998 |
Adjusted EBITDA |
$ |
(53,956 |
) |
|
$ |
47,523 |
|
|
$ |
(91,548 |
) |
|
$ |
284,912 |
The following table presents the reconciliation of Product gross profit margin to Adjusted product gross profit margin, for the periods presented:
|
Three Months Ended
|
|
Year Ended |
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Product revenue |
$ |
145,701 |
|
|
$ |
191,280 |
|
|
$ |
474,166 |
|
|
$ |
615,796 |
|
Cost of product revenue |
|
90,783 |
|
|
|
102,796 |
|
|
|
329,973 |
|
|
|
276,542 |
|
Product gross profit |
|
54,918 |
|
|
|
88,484 |
|
|
|
144,193 |
|
|
|
339,254 |
|
Product gross profit margin |
|
38 |
% |
|
|
46 |
% |
|
|
30 |
% |
|
|
55 |
% |
|
|
|
|
|
|
|
|
||||||||
|
|
(92,448 |
) |
|
|
— |
|
|
|
(92,448 |
) |
|
|
— |
|
Adjusted product revenue |
|
53,253 |
|
|
|
191,280 |
|
|
|
381,718 |
|
|
|
615,796 |
|
Inventory charges - inventory reserves / warranty reserves |
|
47,352 |
|
|
|
— |
|
|
|
92,806 |
|
|
|
— |
|
Adjusted product gross profit |
$ |
9,822 |
|
|
$ |
88,484 |
|
|
$ |
144,551 |
|
|
$ |
339,254 |
|
Adjusted product gross profit margin |
|
18 |
% |
|
|
46 |
% |
|
|
38 |
% |
|
|
55 |
% |
The following table presents the reconciliation of Net (loss) income / diluted EPS to Adjusted net (loss) income / diluted EPS, for the periods presented:
|
Three Months Ended
|
|
Year Ended |
||||||||||||
|
2022 |
|
|
2022 |
|
||||||||||
|
Dollar
|
|
Per Diluted
|
|
Dollar
|
|
Per Diluted
|
||||||||
Net (loss) income / diluted EPS |
$ |
(31,506 |
) |
|
$ |
(0.21 |
) |
|
$ |
(194,056 |
) |
|
$ |
(1.31 |
) |
Inventory charges - inventory reserves / warranty reserves |
|
47,352 |
|
|
|
0.32 |
|
|
|
92,806 |
|
|
|
0.63 |
|
|
|
(92,448 |
) |
|
|
(0.62 |
) |
|
|
(92,448 |
) |
|
|
(0.62 |
) |
Restructuring expense |
|
— |
|
|
|
— |
|
|
|
2,020 |
|
|
|
0.01 |
|
Tax effects |
|
2,165 |
|
|
|
0.01 |
|
|
|
(114 |
) |
|
|
— |
|
Adjusted net (loss) income / diluted EPS |
$ |
(74,437 |
) |
|
$ |
(0.50 |
) |
|
$ |
(191,792 |
) |
|
$ |
(1.29 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005833/en/
ir@cuehealth.com
press@cuehealth.com
Source:
FAQ
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