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 tests, today reported financial results for the
second quarter ended June 30, 2022 and provided business updates.
Recent Highlights
- Achieved net
revenue of $26.1 million for the second quarter of 2022, an
increase of 110% over the second quarter of 2021
- Received regulatory
approval in Canada for the COVID-19 & Flu test with Self Test
at Home indication and a full exemption by the New Zealand Ministry
of Health for COVID-19 test
- Scaled
manufacturing to include capacity for the COVID-19 & Flu test
and put initial supply chain in place
- Submitted de novo
510(k) application to FDA for clearance of the COVID-19 test
- Submitted an EUA
application to FDA for commercial distribution of the COVID-19
& Flu test with over the counter (OTC) and Rx at Home
indication.
- Received FDA and
Health Canada approval to extend COVID-19 test shelf life to 18
months
"Second quarter results were an expected dip from our first
quarter performance as anticipated seasonality with our COVID-19
respiratory test product was experienced," said Erik Engelson,
President and Chief Executive Officer of Lucira Health. "COVID-19
test inventory increased in the second quarter. With the recent
18-month shelf life approvals, on-hand COVID-19 test inventory will
continue to enable Lucira to fulfill customer orders with a high
service level as fall and winter respiratory disease season
approaches. As this occurs, we anticipate a positive impact on
cash. We made progress on several significant initiatives, and are
delighted by the recent approval of the COVID-19 & Flu test in
Canada. This approval enables patients and healthcare providers to
accurately diagnose both COVID-19 & Flu on-the-spot in
30-minutes or less with a single swab, and we are eager to scale
commercially as Flu season ramps up in the northern hemisphere. In
addition, Lucira quickly built COVID-19 & Flu tests, and as a
result is immediately able to fulfill Canadian orders. The speed
with which Lucira was able to create the COVID-19 & Flu test
demonstrates the flexibility of the core Lucira technology as well
as the skill and agility of our team. Because Lucira has been
developing assays for nearly ten years, we benefited from past
work. Going forward, we anticipate being able to similarly leverage
work already accomplished on other assays such as Chlamydia and
Gonorrhea, for example. Longer term, we believe that the
flexibility of Lucira’s technology combined with our commercial
performance over the last several quarters demonstrates that strong
financial performance could be achieved with modest initial testing
volumes. In addition, substantial progress was made in the ongoing
development of Lucira’s digital reporting and integration platform,
and we look forward to sharing more about this in future
quarters."
Second Quarter 2022 Financial Results
Net Sales was $26.1 million for the second
quarter of 2022, an increase of $13.7 million or about two times
that of the second quarter of 2021. COVID-19 test sales drove
growth.
GAAP Gross Profit for the second quarter of
2022 was $8.0 million compared to a GAAP gross loss of $0.1 million
for the second quarter of 2021. GAAP gross margin for the second
quarter of 2022 was 31% compared to a negative gross margin of 1%
for the second quarter of 2021. Non-GAAP gross profit and non-GAAP
gross margin for the second quarter of 2022 were $8.9 million and
34%, respectively. Non-GAAP gross profit and non-GAAP gross margin
for the second quarter of 2021 were $0.3 million and 3%,
respectively. Increases in gross profit and gross margin were
primarily due to increased sales and operational efficiencies
gained through increased manufacturing output and scale.
GAAP Operating Expenses were $29.4 million
in the second quarter of 2022, compared to $16.2 million in the
same period in 2021. Non-GAAP operating expenses were $26.9 million
in the second quarter of 2022, compared to $15.1 million in the
same period of 2021. 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 $21.7 million in the
second quarter of 2022, compared to GAAP net loss of $16.2 million
in the same period in 2021. Non-GAAP net loss was $18.1 million for
the second quarter of 2022, compared to a non-GAAP net loss of
$14.7 million for the same period in 2021.
Cash and Cash Equivalents Balance as of
June 30, 2022 was $75.0 million.
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 Monday,
August 15, 2022, at 4:30 PM ET.
Investors interested in listening to the conference call should
register online. Participants are required to register a day in
advance or at minimum 15 minutes before the start of the call. A
replay of the webcast can be accessed via the Events page of the
investor section of Lucira's website.
About Lucira Health
Lucira is a medical technology company focused on the
development and commercialization of innovative infectious disease
tests to make lab-quality diagnostics more accessible. Lucira
designed its test platform to provide accurate, reliable,
PCR-quality test results anywhere and at any time. Beyond its
already commercialized COVID-19 and COVID-19 & Flu Tests,
Lucira is working on new diagnostic tests for respiratory
infections and other categories including women’s health and
sexually transmitted infections (STIs). 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 (loss), gross
(negative) margin, operating expenses, and net income (loss).
Non-GAAP adjustments include stock-based compensation, depreciation
and amortization, non-cash interest and other expense and
preapproval inventories. 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 income (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,
Employee Stock Purchase Plan, and restricted stock units. Depending
upon the size, timing and terms of the grants 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 income (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 income (loss) measure.
Preapproval inventories. The Company has
included the effect of preapproval inventories in calculating the
Company's non-GAAP gross profit (loss), gross (negative) margin,
operating expenses and net income (loss) measures. 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.
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," “could,” "believe," "will," "may," "anticipates," "goal,"
“forward,” and similar expressions are intended to identify
forward-looking statements. These forward-looking statements,
including but not limited to, statements regarding our future
financial performance and market positioning, including as it
relates to the upcoming winter respiratory disease season in the
Northern Hemisphere; our future financial performance coupled with
modest initial testing volumes; our ability to leverage our
previous work to develop new assays; and the expansion of our
digital reporting and integration platform; 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 and influenza test kits; our expected
future growth; our ability to obtain and maintain regulatory
approval for our test kits, including our existing Emergency Use
Authorization for our COVID-19 and influenza test kits and LUCI
Pass; the size and growth potential of the markets for our test
kits, including the COVID-19 and influenza diagnostic testing
market, and our ability to serve those markets; our ability to
accurately forecast demand for our test kits; the rate and degree
of physician and market acceptance of our test kits; the expected
future growth of our sales and marketing organization; coverage and
reimbursement for our test kits; the performance of, and our
reliance on, third parties in connection with the commercialization
of our test kits, including Jabil Inc. and our single-source
suppliers; our ability to accurately forecast, and Jabil’s ability
to manufacture, appropriate quantities of our COVID-19 and
influenza test kits to meet commercial demand; regulatory
developments in the United States and foreign countries; our
research and development for any future test kits; the development,
regulatory approval, and commercialization of competing products;
our ability to retain and hire senior management and key personnel;
our ability to develop and maintain our corporate infrastructure,
including our internal controls; our financial performance and
capital requirements; our expectations regarding our ability to
obtain and maintain intellectual property protection for our test
kits, as well as our ability to operate our business without
infringing the intellectual property rights of others; and our
ability to navigate unfavorable global economic conditions that may
result from recent geopolitical events, including the COVID-19
pandemic, Russia’s military intervention in Ukraine, and the global
sanctions imposed by countries against Russia that followed. 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.
Investor Relations Greg
Chodaczekinvestorrelations@lucirahealth.com 347-620-7010
LUCIRA HEALTH, INC. |
CONDENSED BALANCE SHEETS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
|
|
2021(1) |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
74,957 |
|
|
$ |
105,982 |
|
Accounts receivable, net |
|
8,723 |
|
|
|
27,245 |
|
Inventory |
|
119,576 |
|
|
|
50,776 |
|
Other receivable |
|
7,247 |
|
|
|
8,188 |
|
Prepaid expenses |
|
4,449 |
|
|
|
10,274 |
|
Other current assets |
|
5,573 |
|
|
|
3,817 |
|
Total current assets |
|
220,525 |
|
|
|
206,282 |
|
Property and equipment,
net |
|
46,782 |
|
|
|
30,974 |
|
Operating lease right-of-use
assets |
|
18,726 |
|
|
|
2,714 |
|
Restricted cash
equivalents |
|
1,943 |
|
|
|
— |
|
Other assets |
|
1,060 |
|
|
|
384 |
|
Total
assets |
$ |
289,036 |
|
|
$ |
240,354 |
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
24,584 |
|
|
$ |
19,371 |
|
Accrued liabilities |
|
31,160 |
|
|
|
29,162 |
|
Operating lease liabilities, current |
|
2,185 |
|
|
|
1,609 |
|
Customer deposits |
|
— |
|
|
|
189 |
|
Total current liabilities |
|
57,929 |
|
|
|
50,331 |
|
Term loan payable, net |
|
29,213 |
|
|
|
— |
|
Operating lease liabilities,
net of current portion |
|
16,827 |
|
|
|
1,220 |
|
Total liabilities |
|
103,969 |
|
|
|
51,551 |
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock $0.001 par value; 10,000,000 shares authorized asof
June 30, 2022 and December 31, 2021; 0 shares issuedand outstanding
as of June 30, 2022 and December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 shares authorized as
ofJune 30, 2022 and December 31, 2021; 40,081,464 and 39,663,645
sharesissued and outstanding as of June 30, 2022 and December 31,
2021, respectively |
|
40 |
|
|
|
40 |
|
Additional paid-in capital |
|
322,167 |
|
|
|
317,304 |
|
Accumulated deficit |
|
(137,140 |
) |
|
|
(128,541 |
) |
Total stockholders’
equity |
|
185,067 |
|
|
|
188,803 |
|
Total liabilities and
stockholders’ equity |
$ |
289,036 |
|
|
$ |
240,354 |
|
(1) The balance sheet as of December 31, 2021 is derived from
the audited financial statements as of that date
LUCIRA HEALTH, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Net sales |
$ |
26,146 |
|
|
$ |
12,439 |
|
|
$ |
116,620 |
|
|
$ |
16,955 |
|
Cost of products sold |
|
18,154 |
|
|
|
12,505 |
|
|
|
68,712 |
|
|
|
17,873 |
|
Gross profit (loss) |
|
7,992 |
|
|
|
(66 |
) |
|
|
47,908 |
|
|
|
(918 |
) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
10,753 |
|
|
$ |
10,117 |
|
|
$ |
22,948 |
|
|
$ |
16,399 |
|
Selling, general and administrative |
|
18,628 |
|
|
|
6,100 |
|
|
|
32,537 |
|
|
|
12,200 |
|
Total operating expenses |
|
29,381 |
|
|
|
16,217 |
|
|
|
55,485 |
|
|
|
28,599 |
|
Loss from operations |
|
(21,389 |
) |
|
|
(16,283 |
) |
|
|
(7,577 |
) |
|
|
(29,517 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
Interest income and other (expense), net |
|
281 |
|
|
|
83 |
|
|
|
343 |
|
|
|
1 |
|
Interest expense |
|
(826 |
) |
|
|
— |
|
|
|
(1,363 |
) |
|
|
— |
|
Total other income (expense), net |
|
(545 |
) |
|
|
83 |
|
|
|
(1,020 |
) |
|
|
1 |
|
Loss before provision for
income taxes |
|
(21,934 |
) |
|
|
(16,200 |
) |
|
|
(8,597 |
) |
|
|
(29,516 |
) |
(Benefit from) provision for income taxes |
|
(257 |
) |
|
|
— |
|
|
|
2 |
|
|
|
— |
|
Net loss |
$ |
(21,677 |
) |
|
$ |
(16,200 |
) |
|
$ |
(8,599 |
) |
|
$ |
(29,516 |
) |
Net loss per share of common
stock, |
|
|
|
|
|
|
|
Basic and diluted |
$ |
(0.54 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.96 |
) |
Weighted-average number of
shares used in net loss per share of common stock, |
|
|
|
|
|
|
|
Basic and diluted |
|
39,928,451 |
|
|
|
38,483,766 |
|
|
|
39,839,834 |
|
|
|
30,688,349 |
|
LUCIRA HEALTH, INC. |
The following tables represent the reconciliation of
non-GAAP financial measures to the mostdirectly
comparable GAAP financial measures: |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of GAAP to
non-GAAP Gross Profit (Loss): |
|
|
|
|
|
GAAP Gross Profit (Loss) |
$ |
7,992 |
|
|
$ |
(66 |
) |
|
$ |
47,908 |
|
|
$ |
(918 |
) |
Stock-based compensation |
|
134 |
|
|
|
208 |
|
|
|
390 |
|
|
|
260 |
|
Depreciation and amortization |
|
759 |
|
|
|
268 |
|
|
|
1,551 |
|
|
|
334 |
|
Preapproval inventories |
|
— |
|
|
|
(87 |
) |
|
|
— |
|
|
|
(1,089 |
) |
Non-GAAP Gross Profit
(Loss) |
$ |
8,885 |
|
|
$ |
323 |
|
|
$ |
49,849 |
|
|
$ |
(1,413 |
) |
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of GAAP to
non-GAAP Gross Margin: |
|
|
|
|
|
GAAP Gross Margin |
|
31 |
% |
|
|
(1 |
)% |
|
|
41 |
% |
|
|
(5 |
)% |
Stock-based compensation |
|
1 |
% |
|
|
2 |
% |
|
|
0 |
% |
|
|
2 |
% |
Depreciation and amortization |
|
3 |
% |
|
|
2 |
% |
|
|
1 |
% |
|
|
2 |
% |
Preapproval inventories |
|
0 |
% |
|
|
(1 |
)% |
|
|
0 |
% |
|
|
(6 |
)% |
Non-GAAP Gross (Negative)
Margin |
|
34 |
% |
|
|
3 |
% |
|
|
43 |
% |
|
|
(8 |
)% |
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of GAAP to
non-GAAP Operating Expenses: |
|
|
|
|
|
GAAP Operating Expenses |
$ |
29,381 |
|
|
$ |
16,217 |
|
|
$ |
55,485 |
|
|
$ |
28,599 |
|
Stock-based compensation |
|
(1,602 |
) |
|
|
(737 |
) |
|
|
(3,034 |
) |
|
|
(1,213 |
) |
Depreciation and amortization |
|
(917 |
) |
|
|
(408 |
) |
|
|
(1,724 |
) |
|
|
(547 |
) |
Preapproval inventories |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
305 |
|
Non-GAAP Operating
Expenses |
$ |
26,862 |
|
|
$ |
15,072 |
|
|
$ |
50,727 |
|
|
$ |
27,144 |
|
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months
EndedJune 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of GAAP to
non-GAAP Net Income (Loss): |
|
|
|
|
|
GAAP Net Loss |
$ |
(21,677 |
) |
|
$ |
(16,200 |
) |
|
$ |
(8,599 |
) |
|
$ |
(29,516 |
) |
Stock-based compensation |
|
1,736 |
|
|
|
945 |
|
|
|
3,424 |
|
|
|
1,473 |
|
Depreciation and amortization |
|
1,676 |
|
|
|
676 |
|
|
|
3,275 |
|
|
|
882 |
|
Non-cash interest and other expense |
|
207 |
|
|
|
(4 |
) |
|
|
333 |
|
|
|
280 |
|
Preapproval inventories |
|
— |
|
|
|
(87 |
) |
|
|
— |
|
|
|
(1,394 |
) |
Non-GAAP Net Income
(Loss) |
$ |
(18,058 |
) |
|
$ |
(14,670 |
) |
|
$ |
(1,567 |
) |
|
$ |
(28,275 |
) |
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