Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health,” “Lucira” or
the “Company”), a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits, today reported financial results for
the fourth quarter and full year ended December 31, 2021.
Recent Highlights
- Achieved net
revenue of $61.1 million for the fourth quarter of 2021,
representing approximately 300% sequential growth over the
preceding quarter
- Recorded full year
revenue of $93.1 million for 2021, the Company’s first full year of
commercialization
- Increased
manufacturing output through the Dominican Republic-based plant
resulted in positive gross profit and margin for both the fourth
quarter and the full year 2021
- Secured contract
with Canadian healthcare company, Switch Health, to provide more
than 2 million at-home COVID-19 test kits in 2022
“Lucira’s strong fourth quarter is indicative of the inflection
point the Company is experiencing in its growth,” said Erik
Engelson, President and Chief Executive Officer of Lucira Health.
“The strong financial performance was a result of a rise in
manufacturing output against consistently high demand in the
quarter. We offer consumers an easy-to-use, rapid, PCR-quality test
that’s untethered from instruments or readers. It’s a revolutionary
way to accurately and conveniently test for infectious disease, and
we look forward to capitalizing on the market’s continued
acceptance of decentralized testing in the future.”
Fourth Quarter 2021 Financial Results
The fourth quarter of 2021 represented Lucira's first full
fourth quarter of commercial activity.
Net Revenue was $61.1 million for the fourth
quarter of 2021, close to doubling the combined three prior
quarters in 2021 of $31.9 million. Net revenue growth was driven
primarily by increased manufacturing output as demand continued to
be strong in all four of our sales channels.
GAAP Gross Profit was approximately $12.6
million for the fourth quarter of 2021 or 21% of revenue. Non-GAAP
gross profit and non-GAAP gross margin were $19.1 million and 31%,
respectively. Increases in both gross profit and gross margin from
the third quarter of 2021 were primarily due to efficiencies
resulting from increased manufacturing output.
GAAP Operating Expenses were $20.6 million
in the fourth quarter of 2021, compared to $10.9 million in the
same period in 2020. Non-GAAP operating expenses were $19.0 million
in the fourth quarter of 2021, compared to $11.6 million in the
same period of 2020. The increase is primarily related to increased
headcount and third-party services to facilitate commercial
activities, validation of manufacturing activities, new product
development, clinical studies, and public company compliance.
GAAP Net Loss was $7.8 million in the
fourth quarter of 2021, compared to $17.2 million in the same
period in 2020. Non-GAAP net income was $0.3 million for the fourth
quarter of 2021, compared to a non-GAAP net loss of $13.1 million
for the same period in 2020.
Cash Balance as of December 31, 2021 was
$106.0 million.
First Quarter and Full Year 2022 Financial
Guidance
The Company anticipates first quarter revenue between $80.0 and
$85.0 million and 2022 full year revenue in excess of $450.0
million, in keeping with an announcement the Company previously
made on January 10, 2022.
Conference Call and Webcast Details
The Company will host a live conference call and webcast to
discuss these results and provide a corporate update on Thursday,
March 10, 2022, at 4:30 PM ET.
To participate in the call, please dial (833) 562-0151
(US/Canada) or (661) 567-1232 (International) and provide
conference ID 9897752. A live and archived webcast of the event can
be accessed through the following link ir.lucirahealth.com.
About Lucira Health
Lucira is a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits. Lucira's testing platform produces
lab quality molecular testing in a single-use, consumer-friendly,
palm-size test kit powered by two AA batteries. Lucira designed its
test kits to provide accurate, reliable, and on-the-spot molecular
test results anywhere and at any time. The Lucira™ Check-It
COVID-19 Test Kit (OTC) and Lucira™ COVID-19 All-In-One Test Kit
(Rx) are designed to provide a clinically relevant COVID-19 result
within 30 minutes from sample collection. For more information,
visit www.lucirahealth.com.
Non-GAAP Financial MeasuresIn this press
release, in order to supplement the Company's condensed financial
statements presented in accordance with U.S. Generally Accepted
Accounting Principles ("GAAP"), management has disclosed certain
non-GAAP financial measures for the Company's statements of
operations. The Company believes that an evaluation of its ongoing
operations (and comparisons of its current operations with
historical and future operations) would be difficult if the
disclosure of its financial results were limited to financial
measures prepared in accordance with GAAP. As a result, the Company
is disclosing certain non-GAAP results in order to supplement
investors' and other readers' understanding and assessment of the
Company's financial performance because Company management uses
these measurements as aids in monitoring the Company's ongoing
financial performance from quarter to quarter, and year to year, on
a regular basis and for financial and operational decision-making.
Non-GAAP financial measures include gross profit, gross margin,
operating expenses, and net loss. Non-GAAP adjustments include
stock-based compensation, depreciation and amortization, non-cash
interest and other expense, preapproval inventories, a long-lived
asset impairment charge and certain charges related to obsolete
inventory. From time to time in the future, there may be other
items that the Company may include or exclude if the Company
believes that doing so is consistent with the goal of providing
useful information to investors and management. The Company has
provided a reconciliation of each non-GAAP financial measure used
in this earnings release to the most directly comparable GAAP
financial measure.
Non-GAAP financial measures used by the Company may be
calculated differently from, and therefore may not be comparable
to, similarly titled measures used by other companies, which could
reduce the usefulness of the Company's non-GAAP financial measures
as tools for comparison. Investors are cautioned that there are a
number of limitations associated with the use of non-GAAP financial
measures as analytical tools. The Company has provided at the end
of this press release, following the accompanying financial data,
reconciliations of its non-GAAP measures to their most directly
comparable GAAP measures. Investors are encouraged to review these
reconciliations, and not to rely on any single financial measure to
evaluate the Company's business. Investors and other readers are
encouraged to review the related GAAP financial measures and the
reconciliation of non-GAAP measures to their most directly
comparable GAAP measures set forth below and should consider
non-GAAP measures only as a supplement to, not as a substitute for
or as a superior measure to, measures of financial performance
prepared in accordance with GAAP. Non-GAAP financial measures in
this earnings release exclude the following:
Stock-based compensation expense. The
Company has excluded the effect of stock-based compensation
expenses in calculating the Company's non-GAAP gross profit (loss),
gross (negative) margin, operating expenses and net loss measures.
Although stock-based compensation is a key incentive offered to
employees, consultants and board members the Company continues to
evaluate its business performance excluding stock-based
compensation expenses. The Company records stock-based compensation
expense related to grants of time-based options and restricted
stock units. Depending upon the size, timing and terms of the
grants, as well as the probability of achievement of
performance-based awards, this expense may vary significantly but
will recur in future periods. The Company believes that excluding
stock-based compensation expense better allows for comparisons from
period to period.
Depreciation and amortization. The Company
has excluded the effect of depreciation and amortization expense in
calculating its non-GAAP gross profit (loss), gross (negative)
margin, operating expenses and net loss measures. Depreciation and
amortization are non-cash charges to current operations.
Non-cash interest and other expense. The
Company has excluded the effect of non-cash interest and
remeasurement of derivative liabilities and convertible notes in
calculating its non-GAAP net loss measure.
Preapproval inventories. The Company has
included the effect of preapproval inventories. Preapproval
inventories were previously recorded as research and development
expense during the third quarter of 2020 and subsequently sold at
zero cost of product and internally consumed in research and
development and sales and marketing from the fourth quarter of 2020
through the third quarter of 2021.
Long-lived asset impairment charge. The Company
has excluded the impact of an impairment charge resulting from an
asset with reduced fair value in calculating its non-GAAP gross
profit (loss), gross (negative) margin and net loss measures.
Obsolete inventory. The Company has excluded
the impact of certain obsolete inventory charges in calculating its
non-GAAP gross profit (loss) gross (negative) margin and net loss
measures.
Forward Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as "can," "aim," "will," "may," "anticipates," "expects," and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
Lucira's current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results
could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, including our ability to increase production,
streamline operations and increase product availability; the
success of our test platform with COVID-19 including its variants,
the extent and duration of the COVID-19 pandemic and our
expectations regarding customer and user demand for our COVID-19
test kit; our ability to obtain and maintain regulatory approval
for our test kits, including our existing Emergency Use
Authorization for our COVID-19 test kit and LUCI Pass; the
performance of, and our reliance on, third parties in connection
with the commercialization of our test kits, including Jabil Inc.
Switch Health and our single-source suppliers; our ability to
successfully continue to expand internationally; any impact on our
ability to market our products; demand for our products due to
deferral of procedures using our products or disruption in our
supply chain; our ability to achieve or sustain profitability; our
ability to gain market acceptance for our products and to
accurately forecast and meet customer demand; our ability to
compete successfully; our ability to enhance and expand our product
offerings, broaden commercial activities and take advantage of
growth opportunities; our ability to accurately predict continued
expansion; our ability to accurately forecast revenue; our ability
to bolster capital reserves and reinforce our financial health;
development and manufacturing problems; capacity constraints or
delays in production of our products; maintenance of coverage and
adequate reimbursement for procedures using our products; and
product defects or failures. These and other risks and
uncertainties are described more fully in the "Risk Factors"
section and elsewhere in our filings with the Securities and
Exchange Commission and available at www.sec.gov, including in our
most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q. Any forward-looking statements that we make in this
announcement speak only as of the date of this press release, and
Lucira assumes no obligation to update forward-looking statements
whether as a result of new information, future events or otherwise
after the date of this press release, except as required under
applicable law.
LUCIRA HEALTH, INC. |
CONDENSED BALANCE SHEETS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash |
|
$ |
105,982 |
|
|
$ |
58,212 |
|
Accounts receivable, net |
|
|
27,245 |
|
|
|
293 |
|
Inventory |
|
|
50,776 |
|
|
|
4,865 |
|
Other Receivable |
|
|
8,188 |
|
|
|
798 |
|
Prepaid expenses |
|
|
10,274 |
|
|
|
3,496 |
|
Other current assets |
|
|
3,817 |
|
|
|
229 |
|
Restricted cash equivalents |
|
|
— |
|
|
|
2,338 |
|
Total current assets |
|
|
206,282 |
|
|
|
70,231 |
|
Property and equipment, net |
|
|
30,974 |
|
|
|
19,408 |
|
Operating lease right-of-use
assets |
|
|
2,714 |
|
|
|
748 |
|
Other assets |
|
|
384 |
|
|
|
2,316 |
|
Total assets |
|
$ |
240,354 |
|
|
$ |
92,703 |
|
Liabilities, Redeemable
Convertible Preferred Stock, and Stockholders’ Equity
(Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
19,371 |
|
|
$ |
3,981 |
|
Accrued liabilities |
|
|
29,162 |
|
|
|
4,445 |
|
Operating lease liabilities, current |
|
|
1,609 |
|
|
|
431 |
|
Customer deposits |
|
|
189 |
|
|
|
— |
|
Total current liabilities |
|
|
50,331 |
|
|
|
8,857 |
|
Convertible notes payable |
|
|
— |
|
|
|
24,694 |
|
Operating lease liabilities, net
of current portion |
|
|
1,220 |
|
|
|
380 |
|
Total liabilities |
|
|
51,551 |
|
|
|
33,931 |
|
Commitments and
contingencies |
|
|
|
|
Redeemable convertible preferred
stock $0.001 par value; 0 and 103,355,827shares authorized as of
December 31, 2021 and 2020, respectively;0 and 23,978,747 shares
issued and outstanding as of December 31, 2021 and
2020,respectively; aggregate liquidation preference of $0 as of
December 31, 2021 |
|
|
— |
|
|
|
121,080 |
|
Stockholders’ equity: |
|
|
|
|
Preferred stock $0.001 par value; 10,000,000 and 0 shares
authorized asof December 31, 2021 and 2020, respectively; 0 shares
issuedand outstanding as of December 31, 2021 and 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares
authorized as ofDecember 31, 2021 and 2020, respectively;
39,663,645 and 2,712,694 shares issued and outstanding as of
December 31, 2021 and 2020, respectively |
|
|
40 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
317,304 |
|
|
|
1,403 |
|
Accumulated deficit |
|
|
(128,541 |
) |
|
|
(63,714 |
) |
Total stockholders’ equity
(deficit) |
|
|
188,803 |
|
|
|
(62,308 |
) |
Total liabilities, redeemable
convertible preferred stock, and stockholders’ equity |
|
$ |
240,354 |
|
|
$ |
92,703 |
|
LUCIRA HEALTH, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Net sales |
|
$ |
61,124 |
|
|
$ |
269 |
|
|
$ |
93,055 |
|
|
$ |
269 |
|
Cost of products sold |
|
|
48,682 |
|
|
|
1,941 |
|
|
|
81,392 |
|
|
|
1,941 |
|
Impairment of long-lived
assets |
|
|
(183 |
) |
|
|
— |
|
|
|
1,439 |
|
|
|
— |
|
Gross profit (loss) |
|
|
12,625 |
|
|
|
(1,672 |
) |
|
|
10,224 |
|
|
|
(1,672 |
) |
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
9,099 |
|
|
|
8,512 |
|
|
|
39,840 |
|
|
|
24,620 |
|
Selling, general and administrative |
|
|
11,550 |
|
|
|
2,412 |
|
|
|
35,538 |
|
|
|
5,633 |
|
Total operating expenses |
|
|
20,649 |
|
|
|
10,924 |
|
|
|
75,378 |
|
|
|
30,253 |
|
Loss from operations |
|
|
(8,024 |
) |
|
|
(12,596 |
) |
|
|
(65,154 |
) |
|
|
(31,925 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
Grant income |
|
|
204 |
|
|
|
138 |
|
|
|
597 |
|
|
|
2,145 |
|
Interest income (expense), net |
|
|
5 |
|
|
|
(9 |
) |
|
|
11 |
|
|
|
(53 |
) |
Remeasurement of derivative liabilities and convertible notes |
|
|
— |
|
|
|
(4,720 |
) |
|
|
(281 |
) |
|
|
(7,515 |
) |
Total other income (expense), net |
|
|
209 |
|
|
|
(4,591 |
) |
|
|
327 |
|
|
|
(5,423 |
) |
Net loss |
|
$ |
(7,815 |
) |
|
$ |
(17,187 |
) |
|
$ |
(64,827 |
) |
|
$ |
(37,348 |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(6.70 |
) |
|
$ |
(1.86 |
) |
|
$ |
(15.58 |
) |
Weighted-average number of shares used in net loss per share of
common stock, basic and diluted |
|
|
39,029,856 |
|
|
|
2,565,252 |
|
|
|
34,768,542 |
|
|
|
2,396,798 |
|
Reconciliation of GAAP to Non-GAAP Financial
Measures |
The following table represents the reconciliation of
non-GAAP financial measures to the most directly comparable GAAP
financial measures: |
(In thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Gross Profit (Loss): |
|
|
|
|
|
|
|
|
GAAP Gross Profit (Loss) |
|
$ |
12,625 |
|
|
$ |
(1,672 |
) |
|
$ |
10,224 |
|
|
$ |
(1,672 |
) |
Stock-based compensation expense |
|
|
385 |
|
|
|
17 |
|
|
|
736 |
|
|
|
17 |
|
Depreciation and amortization |
|
|
1,082 |
|
|
|
87 |
|
|
|
2,259 |
|
|
|
87 |
|
Impairment of long-lived assets |
|
|
(183 |
) |
|
|
— |
|
|
|
1,439 |
|
|
|
— |
|
Inventory obsolescence charge |
|
|
5,223 |
|
|
|
— |
|
|
|
6,507 |
|
|
|
— |
|
Preapproval inventories |
|
|
— |
|
|
|
(60 |
) |
|
|
(1,089 |
) |
|
|
(60 |
) |
Non-GAAP Gross profit (loss) |
|
$ |
19,132 |
|
|
$ |
(1,628 |
) |
|
$ |
20,076 |
|
|
$ |
(1,628 |
) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Gross margin |
|
|
|
|
|
|
|
|
GAAP Gross (negative) margin |
|
|
21 |
% |
|
|
(622 |
%) |
|
|
11 |
% |
|
|
(622 |
%) |
Stock-based compensation expense |
|
|
1 |
% |
|
|
6 |
% |
|
|
1 |
% |
|
|
6 |
% |
Depreciation and amortization |
|
|
2 |
% |
|
|
32 |
% |
|
|
2 |
% |
|
|
32 |
% |
Impairment of long-lived assets |
|
|
0 |
% |
|
|
0 |
% |
|
|
2 |
% |
|
|
0 |
% |
Inventory obsolescence charge |
|
|
9 |
% |
|
|
0 |
% |
|
|
7 |
% |
|
|
0 |
% |
Preapproval inventories |
|
|
0 |
% |
|
|
(22 |
%) |
|
|
(1 |
%) |
|
|
(22 |
%) |
Non-GAAP Gross (negative)
margin |
|
|
31 |
% |
|
|
(605 |
%) |
|
|
22 |
% |
|
|
(605 |
%) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Operating expenses: |
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
$ |
20,649 |
|
|
$ |
10,924 |
|
|
$ |
75,378 |
|
|
$ |
30,253 |
|
Stock-based compensation expense |
|
|
(1,220 |
) |
|
|
(185 |
) |
|
|
(7,369 |
) |
|
|
(420 |
) |
Depreciation and amortization |
|
|
(431 |
) |
|
|
(40 |
) |
|
|
(1,412 |
) |
|
|
(193 |
) |
Preapproval inventories |
|
|
- |
|
|
|
893 |
|
|
|
305 |
|
|
|
893 |
|
Non-GAAP Operating expenses |
|
$ |
18,998 |
|
|
$ |
11,592 |
|
|
$ |
66,902 |
|
|
$ |
30,533 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Net loss: |
|
|
|
|
|
|
|
|
GAAP Net loss |
|
$ |
(7,815 |
) |
|
$ |
(17,187 |
) |
|
$ |
(64,827 |
) |
|
$ |
(37,348 |
) |
Stock-based compensation expense |
|
|
1,605 |
|
|
|
202 |
|
|
|
8,105 |
|
|
|
437 |
|
Depreciation and amortization |
|
|
1,513 |
|
|
|
127 |
|
|
|
3,671 |
|
|
|
280 |
|
Non-cash interest and other expense |
|
|
5 |
|
|
|
4,729 |
|
|
|
270 |
|
|
|
7,568 |
|
Impairment of long-lived assets |
|
|
(183 |
) |
|
|
— |
|
|
|
1,439 |
|
|
|
— |
|
Inventory obsolescence charge |
|
|
5,223 |
|
|
|
— |
|
|
|
6,507 |
|
|
|
— |
|
Preapproval inventories |
|
|
— |
|
|
|
(953 |
) |
|
|
(1,394 |
) |
|
|
(953 |
) |
Non-GAAP Net Income (loss) |
|
$ |
348 |
|
|
$ |
(13,082 |
) |
|
$ |
(46,229 |
) |
|
$ |
(30,016 |
) |
Investor Relations
Greg Chodaczek
investorrelations@lucirahealth.com
347-620-7010
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