Cue Health Reports Strong Fourth Quarter and Full Year 2021 Financial Results
Key Highlights
-
Reported total revenue of
$192.5 million for the fourth quarter of 2021, compared to$13.3M in the fourth quarter of 2020 -
Full year revenue of
$618.1 million in 2021, compared to$23.0 million in 2020 -
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 to$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
Fourth Quarter 2021 Financial Results
Revenue was
Private Sector revenue grew to 54.0%, or
Public Sector revenue was
Disposable test cartridge revenue was
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
Net income was
Full Year 2021 Financial Results
Revenue was
Public Sector revenue was
Private Sector revenue was
Product gross margin was 55.1%, an increase from 2.9% for the prior year.
Operating expenses, excluding cost of revenues, were
Net income was
Adjusted net income was
Cash and cash equivalents were
Guidance
About
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
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 |
|
Year Ended |
|||||||||||||
|
|
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) |
||||||||
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|
|
|
|
|||||
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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, |
|
— |
|
|
|
— |
|
|
|
Common stock, |
|
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 |
|||||||||||||||
|
|
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
ir@cuehealth.com
(415) 202-5678
press@cuehealth.com
Source:
