Cue Health Reports Strong Fourth Quarter and Full Year 2021 Financial Results
03/29/2022 - 04:01 PM
SAN DIEGO --(BUSINESS WIRE)--
Cue Health Inc.
Key Highlights
Reported total revenue of $192.5 million $13.3M
Full year revenue of $618.1 million $23.0 million
Diluted EPS of $0.22 for the fourth quarter of 2021, compared to a loss of $1.16 in the fourth quarter of 2020
Full year diluted EPS of $0.59 in 2021, compared to a loss of $2.90 in 2020
Shipped more than 230,000 Cue Readers to date, almost doubling the number of readers shipped through Q3 2021
Today we have more than 220 directly contracted organizations as customers, up from more than 80 at the end of the third quarter 2021
Successfully launched virtual health platform to individual consumers across the US
Ended 2021 with cash and cash equivalents of $409.9 million
Q1 FY22 revenue guidance range of $170 million $180 million
“In the fourth quarter, we made great progress across our growth drivers: building and diversifying our customer base, progressing the expansion of our test menu, and introducing new digital enhancements to our platform,” said Ayub Khattak , Chief Executive Office and Co-Founder of Cue Health . “We’re driving this momentum into 2022 as we plan to launch a number of clinical studies and make multiple FDA submissions before year-end. With our growing install base of nearly a quarter million Cue Readers and the further integration of our diagnostics with virtual care capabilities, we are executing on our strategy and advancing Cue’s mission of making healthcare more timely and accessible for people around the world.”
Fourth Quarter 2021 Financial Results
Revenue was $192.5 million $13.3 million U.S. Department of Defense (“U.S. DoD”) contract, and expansion of our customer base across all customer categories.
Private Sector revenue grew to 54.0% , or $104.0M
Public Sector revenue was $88.5 million 46.0% of revenues for the fourth quarter of 2021. During the quarter we completed shipment of our contract with the U.S. DoD .
Disposable test cartridge revenue was $165.4 million
Product gross margin was 46.3% for the fourth quarter of 2021, up from 7.2% in the fourth quarter 2020 due to the scale up production and related efficiencies that resulted in more favorable absorption of fixed costs on a per unit basis in 2021.
Operating expenses for the fourth quarter of 2021 were $66.3 million $19.0 million
Net income was $34.2 million $19.5 million $0.22 for the fourth quarter of 2021 compared to a loss of $1.16 per diluted share in the fourth quarter 2020.
Full Year 2021 Financial Results
Revenue was $618.1 million $23.0 million
Public Sector revenue was $385.3 million $16.4 million
Private Sector revenue was $232.8 million $6.5 million
Product gross margin was 55.1% , an increase from 2.9% for the prior year.
Operating expenses, excluding cost of revenues, were $151.3 million $53.1 million
Net income was $86.4 million $47.4 million $0.59 , compared to a loss of $2.90 for the prior year.
Adjusted net income was $164.5 million $47.4 million
Cash and cash equivalents were $409.9 million December 31, 2021 .
Guidance
Cue Health expects first quarter 2022 revenues in the range of $170 million $180 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 commencement of any clinical studies, the submission of any FDA applications, 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, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” “develop,” “progress,” “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 Annual Report on Form 10-K for the year ended December 31, 2021 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 December 31 ,
Year Ended December 31 ,
2021
2020
2021
2020
Revenue
Product revenue
$
191,280
$
13,263
$
615,796
$
15,391
Grant and other revenue
1,226
—
2,311
7,562
Total revenue
192,506
13,263
618,107
22,953
Operating costs and expenses:
Cost of product revenue
102,796
12,310
276,542
14,951
Sales and marketing
21,198
650
28,729
714
Research and development
21,679
1,920
42,829
28,478
General and administrative
23,452
16,478
79,788
23,936
Total operating costs and expenses
169,125
31,358
427,888
68,079
Income (loss) from operations
23,381
(18,095
)
190,219
(45,126
)
Interest expense
(57
)
(100
)
(9,809
)
(374
)
Change in fair value of redeemable convertible preferred stock warrants
—
(1,289
)
53
(1,289
)
Change in fair value of convertible notes
—
—
(59,560
)
—
Loss on extinguishment of debt
—
—
(1,998
)
(610
)
Other income (expense), net
291
(52
)
272
47
Net income (loss) before income taxes
23,615
(19,536
)
119,177
(47,352
)
Income tax expense (benefit)
(10,615
)
—
32,759
—
Net income (loss)
$
34,230
$
(19,536
)
$
86,418
$
(47,352
)
Net income (loss) per share attributable to common stockholders – basic
$
0.23
$
(1.16
)
$
0.63
$
(2.90
)
Weighted-average number of shares used in computation of net income (loss) per share attributable to common stockholders – basic
146,367,756
16,878,866
52,815,449
16,315,730
Net income (loss) per share attributable to common stockholders – diluted
$
0.22
$
(1.16
)
$
0.59
$
(2.90
)
Weighted-average number of shares used in computation of net income (loss) per share attributable to common stockholders – diluted
152,531,173
16,878,866
59,635,384
16,315,730
CONDENSED BALANCE SHEETS
(In thousands, except share amounts and share data)
December 31 ,
December 31 ,
Assets
Current assets:
Cash and cash equivalents
$
409,873
$
121,578
Restricted cash
13,837
6,000
Accounts receivable, net
104,589
4,168
Inventory
88,388
36,842
Prepaid expenses
45,889
13,847
Other current assets
7,446
1,263
Total current assets
670,022
183,698
Restricted cash, non-current
—
1,677
Property and equipment, net
177,456
103,683
Prepaid rent
1,567
16,771
Operating lease right-of-use assets
79,474
8,281
Intangible assets, net
7,673
2,038
Other non-current assets
3,868
180
Total assets
$
940,060
$
316,328
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
37,208
$
23,847
Accrued liabilities and other current liabilities
29,498
8,822
Income taxes payable
8,297
—
Deferred revenue, current
82,165
115,747
Debt, current
—
5,434
Operating lease liabilities, current
7,147
797
Finance lease liabilities, current
2,621
1,249
Total current liabilities
166,936
155,896
Redeemable convertible preferred stock warrant liabilities
—
1,331
Deferred revenue, net of current portion
10,283
67,349
Operating leases liabilities, net of current portion
46,464
10,472
Finance lease liabilities, net of current portion
3,271
1,857
Other non-current liabilities
6,356
4,500
Total liabilities
233,310
241,405
Commitments and contingencies
Total redeemable convertible preferred stock
—
176,323
Stockholders’ Equity (Deficit)
Preferred stock, $0.00001 par value; 50,000,000 and no shares authorized, no shares issued and outstanding at December 31, 2021 and December 31, 2020 , respectively
—
—
Common stock, $0.00001 par value; 500,000,000 and 129,030,355 shares authorized, 146,402,991 and 27,995,780 issued and outstanding at December 31, 2021 and December 31, 2020 , respectively
1
—
Additional paid-in-capital
730,767
9,036
Accumulated deficit
(24,018
)
(110,436
)
Total stockholders’ equity (deficit)
706,750
(101,400
)
Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)
$
940,060
$
316,328
Non-GAAP Net Income (Loss)
(In thousands, except share data)
Year Ended December 31 ,
2021
2020
Dollar
Per
Dollar
Per
Net income (loss)/diluted EPS
$
86,418
0.59
$
(47,352
)
(2.90
)
Fair value adjustments of convertible notes
59,560
0.47
—
—
Banking and financing-related items
7,998
0.07
—
—
Forgiveness of promissory notes
12,880
0.10
—
—
Tax effects
(2,315
)
(0.02
)
—
—
Adjusted net income (loss)/adjusted diluted EPS
$
164,541
$
1.21
$
(47,352
)
$
(2.90
)
View source version on businesswire.com : https://www.businesswire.com/news/home/20220329005938/en/
ICR Westwicke
Caroline Corner
ir@cuehealth.com
Cue Health
press@cuehealth.com
Source: Cue Health Inc.
