Cue Health Reports Fourth Quarter 2023 Financial Results
Cue Health Inc. reports $18.8 million in Q4 revenue and $70.9 million in full-year 2023 revenue. The company submitted clinical data for RSV and Flu A/B tests to the FDA. Cue is in late-stage development of Herpes + Mpox Multiplex Molecular Test. They executed cost reduction plans saving $200 million annually. Fourth quarter revenue breakdown shows private sector revenue at $17.0 million and public sector revenue at $1.8 million. Cue reported a GAAP net loss of $148.4 million in Q4 2023.
Negative
- Cue Health Inc. reported a GAAP net loss of $148.4 million in the fourth quarter of 2023, indicating significant financial challenges despite revenue growth.
- Cue's adjusted net loss for the full year 2023 was $267.2 million, reflecting continued financial struggles.
- The company's GAAP product gross profit showed a loss of $62.9 million for the full year 2023, highlighting profitability concerns.
- Cue's adjusted EBITDA was a loss of $24.4 million in the fourth quarter of 2023, indicating operational inefficiencies.
- Despite revenue growth, Cue Health Inc. faces substantial financial losses, with a GAAP net loss of $373.5 million for the full year 2023.
The financial results reported by Cue Health Inc. for the fourth quarter and full year 2023 reflect a challenging period for the company, with significant net losses and operating costs . The reported net loss of $148.4 million for the fourth quarter and $373.5 million for the full year indicate substantial financial pressure, exacerbated by one-time inventory charges and impairment of long-lived assets. The adjusted EBITDA loss of $24.4 million for the quarter and $163.8 million for the year further underscores the need for stringent cost management and operational efficiency.
From an investment perspective, the company's cost reduction plans, which are projected to save approximately $200 million annually, could be a strategic move to improve financial health. However, investors should closely monitor the company's ability to generate revenue from its pipeline of diagnostic tests and the expansion of its Integrated Care Platform. The anticipated launch of new products, such as the Herpes + Mpox Multiplex Molecular Test, could provide additional revenue streams, but the success of these launches is not guaranteed.
The guidance for the first quarter of 2024, with revenues projected between $9 million to $11 million, suggests a continued downward trend in revenue, which could be a point of concern for stakeholders. The company's current cash reserves of $80.9 million, with no debt obligations, provide some buffer, but the burn rate will be a critical factor to watch in the coming quarters.
Examining Cue Health Inc.'s performance within the broader healthcare technology market, the company's focus on developing multiplex molecular tests for various diseases positions it within a competitive and high-growth potential segment. The demand for accurate, rapid diagnostic solutions, especially for conditions like Flu, RSV and COVID-19, is likely to remain high in the post-pandemic era.
However, the company's significant gross profit losses , both GAAP and adjusted, indicate pricing pressures or inefficiencies in the cost of goods sold. The private sector revenue , constituting 91% of total revenue, suggests a strong reliance on this segment, which could be both an opportunity and a risk, depending on the market dynamics and competition.
Given the anticipated product launches and the expansion of the Integrated Care Platform, the company's ability to capture market share and establish a strong customer base will be crucial. The 49% decrease in adjusted operating costs year-over-year is a positive sign of cost control, but it is essential to balance this with investments in marketing and sales to drive revenue growth.
From a medical research and regulatory standpoint, Cue Health's progress in submitting additional clinical samples and stability data for RSV and Flu A/B to the FDA is a critical step towards expanding its product portfolio. The de novo submission process is a rigorous FDA pathway for novel devices that can be lengthy and uncertain, but successful authorization can significantly enhance the company's market presence.
The development of a Herpes + Mpox Multiplex Molecular Test is particularly noteworthy, as it addresses emerging healthcare needs. The planned submission for Emergency Use Authorization (EUA) in the second quarter of 2024 could expedite the test's availability, which is essential during public health emergencies.
It is important to note that the company has already secured two FDA authorizations for its COVID-19 and Mpox Molecular Tests, which demonstrates a track record of regulatory success. However, the financial investment required for research and development, as well as the regulatory approval process, must be weighed against the potential market demand and revenue generation capabilities of these new products.
03/13/2024 - 04:01 PM
SAN DIEGO --(BUSINESS WIRE)--
Cue Health Inc. ("Cue" or the “Company”) (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the fourth quarter and full-year 2023.
Recent Highlights
Reported fourth quarter total revenue of $18.8 million $70.9 million
Submitted additional clinical samples and stability data for RSV to the FDA in support of de novo submission
Submitted additional clinical samples and gathering additional stability data for Flu A/B to the FDA in support of de novo submission
In late stage development of Herpes + Mpox Multiplex Molecular Test with plan to submit for EUA in 2Q24
Executed cost reduction plans, resulting in cash savings of approximately $200 million
Reported cash and cash equivalents of $80.9 million
“We made progress executing on our strategic priorities in 2023. We obtained two FDA authorizations including a de novo approval for our COVID-19 Molecular Test and an EUA for our Mpox Molecular Test, and made two de novo submissions for our RSV and Flu standalone molecular tests. We also drove significant development progress on our all-in-one Flu + COVID-19 + RSV test, our Herpes + Mpox multiplex test, and we expanded our Integrated Care Platform with a new suite of at-home diagnostics tests and treatments, all while streamlining our cost structure,” said Ayub Khattak, Chairman and CEO of Cue. “We believe that these successes have positioned us well for 2024.”
Fourth Quarter 2023 Financial Results
Revenue was $18.8 million $17.0 million 91% of total revenue with strong ordering from existing customers. Public sector revenue was $1.8 million $15.5 million
GAAP product gross profit was a loss of $18.4 million $2.7 million $15.7 million
GAAP operating costs and expenses in the fourth quarter of 2023 were $132.0 million $83.6 million $48.3 million 49% decrease from $94.6 million
GAAP net loss in the fourth quarter of 2023 was $148.4 million $0.96 $49.1 million $0.32 $24.4 million
Full-Year 2023 Financial Results
Revenue was $70.9 million $63.0 million 89% of total revenue. Public sector revenue was 11% of total revenue or $7.9 million $58.5 million
GAAP product gross profit was a loss of $62.9 million $35.2 million $12.0 million $15.7 million
GAAP operating costs and expenses for the full year 2023 were $338.7 million $83.6 million $14.5 million $240.6 million
GAAP net loss for the full year 2023 was $373.5 million $2.44 $267.2 million $1.75 $163.8 million
Cash and cash equivalents were $80.9 million
Guidance
Cue expects first quarter 2024 revenues in the range of $9 million $11 million
Webcast and Conference Call Information
Cue will host a conference call to discuss the fourth quarter and full year 2023 financial results, after market close on Wednesday, March 13, 2024, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
To access the live call via telephone, please register in advance using the link here . Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call.
The live webinar may be accessed by visiting the “Events” section of the Company’s website at investors.cuehealth.com . A replay of the webinar will be available on the Company’s website shortly after the conclusion of the call.
About Cue
Cue Health Inc. (Nasdaq: HLTH) is a healthcare technology company that uses diagnostic-enabled care to empower people to live their healthiest lives. Cue’s platform offers individuals and healthcare providers convenient and personalized access to lab-quality diagnostic tests at home and at the point-of-care, as well as on-demand telehealth consultations and treatment options for a wide range of health and wellness needs. Cue’s customers include federal and state public sector agencies and the private sector, which includes healthcare providers, enterprises, and individual consumers. Cue received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 test, which became the first home use respiratory test to receive this FDA approval. Cue also received Emergency Use Authorization from the FDA for its molecular Mpox test at the point-of-care and, to expand its test menu, Cue has a number of other submissions under review by the FDA. Cue, founded in 2010, owns over 100 patents and is headquartered in San Diego . For more information, please visit www.cuehealth.com .
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 and authorization and timing of such clearance, authorization and submissions, growth in our customer base, expectations regarding production capacity and product launches, potential technology enhancements, expectations related to availability of our programs and testing volumes, the ability to achieve growth in the future, and future results of operations and performance and our guidance, including first quarter 2024 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”, “look forward”, “believe,” “design” 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 expectations around FDA submissions, applications, authorizations and timing, 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 December 31, 2023, to be filed with the SEC. Any forward-looking statements contained in this press release are based on the current expectations of Cue’s management team and speak only as of the date hereof, and Cue specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
The Cue Mpox (Monkeypox) Molecular Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA. This product has been authorized only for the detection of nucleic acid from monkeypox virus, 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 infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, 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 (Loss) Margin, Adjusted Operating Expenses, Adjusted Net Loss, 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 loss before interest income, interest expense, income tax expense (benefit), depreciation and amortization, stock-based compensation, impairment of long-lived assets, restructuring expense, tax credits, disputed vendor payment, inventory charges, U.S. Department of Defense (the “DoD”) deferred revenue release.
Adjusted product gross profit (loss) is defined as product gross profit (loss), before DoD deferred revenue release, disputed vendor payment, inventory charges.
Adjusted operating costs and expenses is defined as operating costs and expenses before cost of product revenue, impairment of long-lived assets, restructuring expense.
Adjusted net loss is defined as Net loss, before impairment of long-lived assets, restructuring expense, tax credits, disputed vendor payment, inventory charges and tax effects.
Adjusted diluted EPS is defined as Diluted EPS before impairment of long-lived assets, restructuring expense, tax credits, disputed vendor payment, inventory charges and tax effects.
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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share data)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Revenue
Product revenue
$
17,381
$
145,701
$
64,223
$
474,166
Grant and other revenue
1,417
1,076
6,713
9,310
Total revenue
18,798
146,777
70,936
483,476
Operating costs and expenses:
Cost of product revenue
35,742
90,783
127,091
329,973
Sales and marketing
6,226
19,312
32,584
88,580
Research and development
32,248
56,149
150,620
171,452
General and administrative
9,866
19,157
57,355
97,103
Impairment of long-lived assets
83,639
—
83,639
—
Restructuring expense
(18
)
—
14,500
2,020
Total operating costs and expenses
167,703
185,401
465,789
689,128
Loss from operations
(148,905
)
(38,624
)
(394,853
)
(205,652
)
Interest income
1,084
1,988
6,240
3,328
Interest expense
(344
)
(232
)
(1,159
)
(645
)
Tax credits
—
—
20,939
—
Other income (expense), net
(207
)
46
162
(835
)
Net loss before income taxes
(148,372
)
(36,821
)
(368,671
)
(203,804
)
Income tax expense (benefit)
60
(5,315
)
4,793
(9,748
)
Net loss
$
(148,432
)
$
(31,506
)
$
(373,464
)
$
(194,056
)
Net loss per share – basic & diluted
$
(0.96
)
$
(0.21
)
$
(2.44
)
$
(1.31
)
Weighted-average number of shares used in computation of net loss per share – basic & diluted
154,807,021
149,711,419
152,877,306
148,024,749
CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts and share data)
December 31,
2023
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$
80,889
$
241,530
Restricted cash
800
800
Accounts receivable, net
1,352
18,751
Inventories, net - current
14,039
82,210
Prepaid expenses
8,479
15,728
Other current assets
4,803
12,134
Total current assets
110,362
371,153
Non-current inventories, net
56,273
25,436
Property and equipment, net
72,096
189,275
Operating lease right-of-use assets
78,519
85,321
Intangible assets, net
19,644
16,867
Other non-current assets
2,893
6,528
Total assets
$
339,787
$
694,580
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
7,705
$
7,150
Accrued liabilities and other current liabilities
29,300
52,378
Deferred revenue, current
162
1,566
Operating lease liabilities, current
5,142
7,739
Finance lease liabilities, current
1,157
2,362
Total current liabilities
43,466
71,195
Operating leases liabilities, net of current portion
41,640
44,045
Finance lease liabilities, net of current portion
—
849
Other non-current liabilities
4,429
1,997
Total liabilities
89,535
118,086
Stockholders’ Equity
Common stock
2
1
Additional paid-in-capital
841,788
794,567
Accumulated deficit
(591,538
)
(218,074
)
Total stockholders’ equity
250,252
576,494
Total liabilities and stockholders’ equity
$
339,787
$
694,580
Non-GAAP Measures
(In thousands, except share data)
The following table presents the reconciliation of Net loss to Adjusted EBITDA, for the periods presented:
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Net loss
$
(148,432
)
$
(31,506
)
$
(373,464
)
$
(194,056
)
Interest income
(1,084
)
(1,988
)
(6,240
)
(3,328
)
Interest expense
344
232
1,159
645
Income tax expense (benefit)
60
(5,315
)
4,793
(9,748
)
Depreciation and amortization
15,219
14,337
56,278
48,972
Stock-based compensation
10,138
15,776
48,735
64,291
Impairment of long-lived assets
83,639
—
83,639
—
Restructuring expense
(18
)
—
14,500
2,020
Tax credits
—
—
(20,939
)
—
Disputed vendor payment
—
—
12,000
—
Inventory charges
15,705
47,352
15,705
92,806
DoD deferred revenue release
—
(92,448
)
—
(92,448
)
Adjusted EBITDA
$
(24,429
)
$
(53,560
)
$
(163,834
)
$
(90,846
)
The following table presents the reconciliation of Product gross profit (loss) margin to Adjusted product gross profit (loss) margin, for the periods presented:
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Product revenue
$
17,381
$
145,701
$
64,223
$
474,166
Cost of product revenue
35,742
90,783
127,091
329,973
Product gross profit (loss)
$
(18,361
)
$
54,918
$
(62,868
)
$
144,193
Product gross profit (loss) margin
(106
)%
38
%
(98
)%
30
%
DoD deferred revenue release
—
(92,448
)
—
(92,448
)
Adjusted product revenue
17,381
53,253
64,223
381,718
Disputed vendor payment
—
—
12,000
—
Inventory charges
15,705
47,352
15,705
92,806
Adjusted product gross profit (loss)
$
(2,656
)
$
9,822
$
(35,163
)
$
144,551
Adjusted product gross profit (loss) margin
(15
)%
18
%
(55
)%
38
%
The following table presents the reconciliation of Operating costs and expenses to Adjusted operating costs and expenses, for the periods presented:
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Operating costs and expenses
$
167,703
$
185,401
$
465,789
$
689,128
Cost of product revenue
35,742
90,783
127,091
329,973
Operating costs and expenses excluding cost of product revenue
131,961
94,618
338,698
359,155
Impairment of long-lived assets
83,639
—
83,639
—
Restructuring expense
(18
)
—
14,500
2,020
Adjusted operating costs and expenses
$
48,340
$
94,618
$
240,559
$
357,135
The following table presents the reconciliation of Net loss / diluted EPS to Adjusted net loss / diluted EPS, for the periods presented:
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2023
Dollar
Amount
Per Diluted
Share
Dollar
Amount
Per Diluted
Share
Net loss / diluted EPS
$
(148,432
)
$
(0.96
)
$
(373,464
)
$
(2.44
)
Impairment of long-lived assets
83,639
0.54
83,639
0.55
Restructuring expense
(18
)
—
14,500
0.09
Tax credits
—
—
(20,939
)
(0.14
)
Disputed vendor payment
—
—
12,000
0.08
Inventory charges
15,705
0.10
15,705
0.10
Tax effects
40
—
1,364
0.01
Adjusted net loss / diluted EPS
$
(49,066
)
$
(0.32
)
$
(267,195
)
$
(1.75
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20240313695867/en/
Press
press@cuehealth.com
Investors
caroline.corner@westwicke.com
Source: Cue Health Inc.
What was Cue Health Inc.'s total revenue for the fourth quarter of 2023?
Cue Health Inc. reported total revenue of $18.8 million for the fourth quarter of 2023.
What was Cue Health Inc.'s total revenue for full-year 2023?
Cue Health Inc. reported total revenue of $70.9 million for full-year 2023.
What clinical data did Cue Health Inc. submit to the FDA?
Cue Health Inc. submitted additional clinical samples and stability data for RSV and Flu A/B tests to the FDA.
What is Cue Health Inc. in late-stage development of?
Cue Health Inc. is in late-stage development of Herpes + Mpox Multiplex Molecular Test.
What cost reduction plans did Cue Health Inc. execute?
Cue Health Inc. executed cost reduction plans resulting in cash savings of approximately $200 million on an annualized basis.
What was Cue Health Inc.'s GAAP net loss in the fourth quarter of 2023?
Cue Health Inc.'s GAAP net loss in the fourth quarter of 2023 was $148.4 million.
