Cue Health Inc. (Nasdaq: HLTH), a healthcare technology company,
(“Cue") today reported financial results for the first quarter of
2022.
Recent Highlights
- Revenue of $179.4 million in the first quarter of 2022,
compared to $64.5 million in the first quarter of 2021
- 235,000+ Cue Readers shipped through the end of the first
quarter of 2022, including 72,000+ in the quarter
- Cue Covid-19 Test de novo submission to the U.S. Food and Drug
Administration (FDA) for full clearance for at-home and
point-of-care use
- Flu clinical studies nearing completion, with full submission
to the FDA expected in the third quarter of 2022
- Flu + COVID multiplex starting clinical studies this quarter,
ahead of schedule
- RSV expected to begin clinical studies in the third quarter of
2022 and Chlamydia + Gonorrhea multiplex in the second half of
2022, as planned
- Generated cash of $16.6 million in the first quarter 2022,
ending with cash and cash equivalents of $426.5 million
“I am pleased with our first quarter 2022 financial results,
including $179 million in revenue, which reflects year-over-year
growth of 178%. We made excellent progress on our menu expansion
activities, with all of our programs on track or ahead of
schedule,” said Ayub Khattak, Co-Founder, Chairman and Chief
Executive Officer of Cue Health. “Our recent COVID-19 test de novo
submission to the FDA marked a major milestone for the company and
we believe it will be the first of many submissions as we seek to
address a range of diseases and conditions with our menu of
molecular diagnostic tests and future care offerings.”
First Quarter 2022 Financial Results
Revenue was $179.4 million in the first quarter 2022, an
increase from $64.5 million in the first quarter 2021. The growth
was primarily driven by the continued expansion of our customer
base and increases in production capacity.
Private Sector revenue grew to 98.0%, or $175.8 million, in the
first quarter 2022.
Public Sector revenue was 2.0%, or $3.6 million, in the first
quarter 2022, as we completed shipment of our contract with the
U.S. Department of Defense in the fourth quarter 2021.
Disposable test cartridge revenue was $163.2 million in the
first quarter 2022.
Product gross margin was 51.1% in the first quarter 2022,
compared to 53.4% in the first quarter 2021.
Operating expenses in the first quarter 2022 were $89.9 million,
excluding cost of revenues, compared to $19.7 million in the first
quarter 2021. The increase was driven by growth in our overall
organization, digital marketing spend, and spend related to product
development.
Net income was $2.8 million in the first quarter 2022, compared
to $13.0 million in the first quarter 2021. Earnings per diluted
share was $0.02 in the first quarter 2022, compared to $0.08 in the
first quarter 2021.
Cash and cash equivalents were $426.5 million as of March 31,
2022.
Guidance
Cue Health expects second quarter 2022 revenues in the range of
$50 million to $55 million.
About Cue Health
Cue Health (Nasdaq: HLTH) 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 Health
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 Health’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 the United States, Cue Health has received the
CE mark in the European Union, Interim Order authorization from
Health Canada, regulatory approval from India’s Central Drugs
Standard Control Organisation, and PSAR authorization from
Singapore’s Health Sciences Authority. Cue Health was founded in
2010 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, growth in our customer base, expectations regarding
production capacity, potential technology enhancements and future
performance and our guidance, including first quarter 2022
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 new Omicron-specific genotyping Cue test, 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, and the factors
discussed in the "Risk Factors" section of Cue’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2022 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.
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.
CONDENSED STATEMENTS OF
OPERATIONS
(In thousands, except share
data)
Three Months Ended
March 31,
2022
2021
Revenue
Product revenue
$
177,454
$
64,499
Grant and other revenue
1,956
—
Total revenue
179,410
64,499
Operating costs and expenses:
Cost of product revenue
86,697
30,035
Sales and marketing
34,168
430
Research and development
28,787
7,409
General and administrative
26,910
11,870
Total operating costs and expenses
176,562
49,744
Income (loss) from operations
2,848
14,755
Interest expense
(51
)
(535
)
Other income (expense), net
6
37
Net income (loss) before income taxes
2,803
14,257
Income tax expense (benefit)
—
1,226
Net income (loss)
$
2,803
$
13,031
Net income (loss) per share attributable
to common stockholders – basic
$
0.02
$
0.09
Weighted-average number of shares used in
computation of net income (loss) per share attributable to common
stockholders – basic
146,526,370
18,378,777
Net income (loss) per share attributable
to common stockholders – diluted
$
0.02
$
0.08
Weighted-average number of shares used in
computation of net income (loss) per share attributable to common
stockholders – diluted
153,036,804
25,904,338
CONDENSED BALANCE
SHEETS
(In thousands, except share
amounts and share data)
March 31, 2022
December 31,
2021
Assets
Current assets:
Cash and cash equivalents
$
426,465
$
409,873
Restricted cash
13,838
13,837
Accounts receivable
75,830
104,589
Inventory
132,567
88,388
Prepaid expenses
42,902
45,889
Other current assets
9,807
7,446
Total current assets
701,409
670,022
Property and Equipment, Net
182,750
177,456
Prepaid rent
480
1,567
Operating lease right-of-use assets
84,212
79,474
Intangible assets, net
9,240
7,673
Other non-current assets
5,679
3,868
Total assets
$
983,770
$
940,060
Liabilities, Redeemable Convertible
Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
48,842
$
37,208
Accrued liabilities and other current
liabilities
39,809
29,498
Income taxes payable
8,246
8,297
Deferred revenue, current
84,629
82,165
Operating lease liabilities, current
7,594
7,147
Finance lease liabilities, current
2,620
2,621
Total current liabilities
191,740
166,936
Deferred revenue, net of current
portion
10,283
10,283
Operating leases liabilities, net of
current portion
47,626
46,464
Finance lease liabilities, net of current
portion
2,627
3,271
Other non-current liabilities
6,356
6,356
Total liabilities
258,632
233,310
Commitments and contingencies (Note
16)
Stockholders’ Equity (Deficit)
Common stock, $0.00001 par value;
500,000,000 and 500,000,000 shares authorized, 146,958,296 and
146,402,991 issued and outstanding at March 31, 2022 and December
31, 2021, respectively
1
1
Additional paid-in-capital
746,352
730,767
Accumulated deficit
(21,215
)
(24,018
)
Total stockholders’ equity (deficit)
725,138
706,750
Total liabilities, redeemable convertible
preferred stock and stockholders’ equity (deficit)
$
983,770
$
940,060
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version on businesswire.com: https://www.businesswire.com/news/home/20220511006049/en/
ICR Westwicke Caroline Corner ir@cuehealth.com (415)
202-5678
Cue Health press@cuehealth.com
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