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 and
provided business updates for the first quarter ended March 31,
2022.
Recent Highlights
- Achieved net
revenue of $90.5 million for the first quarter of 2022, equivalent
to 97% of fiscal year 2021 net revenue
- Recorded first-time
net income of $13.1 million
- Entered into a debt
facility agreement up to $80 million with Silicon Valley Bank and
Hercules Capital; drew down first tranche of $30 million
- Submitted a request
for Emergency Use Authorization (EUA) application to the U.S. Food
and Drug Administration for our combination COVID-19 & Flu
molecular test. We are seeking to have FDA authorization by Q4
2022
- Received CE Marks
for professional use for both our COVID-19 & Flu and COVID-19
molecular tests, clearing both tests for sale and distribution
throughout the European Union
"Lucira's first quarter performance was very strong," said Erik
Engelson, President and Chief Executive Officer of Lucira Health.
"Our healthy financial results reflect our ability to leverage our
infrastructure and scale quickly, which we believe is impressive
given our five-quarter commercial history. Our strong financial
performance for the quarter was driven by demand for our accurate,
untethered molecular test that provides results similar to that of
PCR lab tests. Ultimately, while our long-term success is not
COVID-19 dependent, we believe the first quarter results
demonstrate our ability to achieve strong financial performance at
modest testing volumes.”
First Quarter 2022 Financial Results
Net Revenue was $90.5 million for the first
quarter of 2022, an increase of $86.0 million or 19 times that of
the first quarter of 2021. Growth was driven by COVID-19 test
sales.
GAAP Gross Profit for the first quarter of 2022
was $39.9 million compared to a GAAP gross loss of $0.9 million for
the first quarter of 2021. GAAP gross margin for the first quarter
of 2022 was 44% compared to a negative gross margin of 19% for the
first quarter of 2021. Non-GAAP gross profit and non-GAAP gross
margin for the first quarter of 2022 were $41.1 million and 45%,
respectively. Non-GAAP gross loss and non-GAAP negative gross
margin for the first quarter of 2021 were $1.7 million and 38%,
respectively. Increases in both 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 $26.1 million
in the first quarter of 2022, compared to $12.4 million in the same
period in 2021. Non-GAAP operating expenses were $23.9 million in
the first quarter of 2022, compared to $12.1 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 Income was $13.1 million in the
first quarter of 2022, compared to GAAP net loss of $13.3 million
in the same period in 2021. Non-GAAP net income was $16.7 million
for the first quarter of 2022, compared to a non-GAAP net loss of
$13.6 million for the same period in 2021.
Cash Balance as of March 31, 2022 was
$120.6 million.
Full Year 2022 Financial Guidance
Lucira is withdrawing its previously announced 2022 annual
revenue guidance of $450.0 million, due to the unpredictable nature
of future COVID-19 infection rates.
"Visibility into the severity and prevalence of COVID-19 for the
remainder of the year is limited," commented Mr. Engelson. "Our
results may be subject to many factors, including cycling COVID-19
peaks, new variants that challenge vaccine efficacy, anticipated
seasonality of COVID-19, varying prevalence associated with booster
cycles and timing of global regulatory approvals and testing
demand. Given this uncertainty, we are withdrawing our previously
announced full year revenue guidance."
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,
May 12, 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 1052178. 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 (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, 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 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 grantsthis 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. 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," “believe,” "will," "may," "anticipates," "expects,"
“goal,” 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, 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.
Investor Relations Greg
Chodaczekinvestorrelations@lucirahealth.com 347-620-7010
LUCIRA HEALTH, INC. |
CONDENSED BALANCE SHEETS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2022 |
|
|
2021 (1) |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash |
|
$ |
120,551 |
|
|
$ |
105,982 |
|
Accounts receivable, net |
|
|
38,860 |
|
|
|
27,245 |
|
Inventory |
|
|
72,905 |
|
|
|
50,776 |
|
Other receivable |
|
|
12,783 |
|
|
|
8,188 |
|
Prepaid expenses |
|
|
10,396 |
|
|
|
10,274 |
|
Other current assets |
|
|
4,597 |
|
|
|
3,817 |
|
Total current assets |
|
|
260,092 |
|
|
|
206,282 |
|
Property and equipment,
net |
|
|
39,952 |
|
|
|
30,974 |
|
Operating lease right-of-use
assets |
|
|
2,059 |
|
|
|
2,714 |
|
Restricted cash
equivalents |
|
|
1,200 |
|
|
|
— |
|
Other assets |
|
|
1,059 |
|
|
|
384 |
|
Total
assets |
|
$ |
304,362 |
|
|
$ |
240,354 |
|
Liabilities, and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
23,137 |
|
|
$ |
19,371 |
|
Accrued liabilities |
|
|
45,409 |
|
|
|
29,162 |
|
Operating lease liabilities, current |
|
|
1,450 |
|
|
|
1,609 |
|
Customer deposits |
|
|
— |
|
|
|
189 |
|
Total current liabilities |
|
|
69,996 |
|
|
|
50,331 |
|
Notes payable |
|
|
29,022 |
|
|
|
— |
|
Operating lease liabilities,
net of current portion |
|
|
712 |
|
|
|
1,220 |
|
Total liabilities |
|
|
99,730 |
|
|
|
51,551 |
|
|
|
|
|
|
Stockholders’ equity : |
|
|
|
|
Preferred stock $0.001 par value; 10,000,000 shares authorized as
of March 31, 2022 and December 31, 2021; 0 shares issued and
outstanding as of March 31, 2022 and December 31, 2021 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized as of
March 31, 2022 and December 31, 2021; 39,850,088 and 39,663,645
shares issued and outstanding as of March 31, 2022 and December 31,
2021, respectively |
|
|
40 |
|
|
|
40 |
|
Additional paid-in capital |
|
|
320,055 |
|
|
|
317,304 |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
(115,463 |
) |
|
|
(128,541 |
) |
Total stockholders’
equity |
|
|
204,632 |
|
|
|
188,803 |
|
Total
liabilities and stockholders’ equity |
$ |
304,362 |
|
|
$ |
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 March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Net sales |
|
$ |
90,474 |
|
|
$ |
4,516 |
|
Cost of products sold |
|
|
50,558 |
|
|
|
5,368 |
|
Gross profit (loss) |
|
|
39,916 |
|
|
|
(852 |
) |
Operating expenses: |
|
|
|
|
Research and development |
|
|
12,195 |
|
|
|
6,283 |
|
Selling, general and administrative |
|
|
13,909 |
|
|
|
6,099 |
|
Total operating expenses |
|
|
26,104 |
|
|
|
12,382 |
|
Income (loss) from operations |
|
|
13,812 |
|
|
|
(13,234 |
) |
Other income (expense),
net: |
|
|
|
|
Interest income and other (expense), net |
|
|
62 |
|
|
|
(79 |
) |
Interest expense |
|
|
(537 |
) |
|
|
(3 |
) |
Total other income (expense), net |
|
|
(475 |
) |
|
|
(82 |
) |
Income (loss) before provision
for income taxes |
|
|
13,337 |
|
|
|
(13,316 |
) |
Provision for income taxes |
|
|
259 |
|
|
|
— |
|
Net income (loss) |
|
$ |
13,078 |
|
|
$ |
(13,316 |
) |
|
|
|
|
|
Net income (loss) per share of
common stock |
|
|
|
|
Basic |
|
$ |
0.33 |
|
|
$ |
(0.58 |
) |
Diluted |
|
$ |
0.31 |
|
|
$ |
(0.58 |
) |
Weighted-average number of
shares used in net loss per share of common stock |
|
|
|
|
Basic |
|
|
39,739,610 |
|
|
|
22,892,932 |
|
Diluted |
|
|
41,832,643 |
|
|
|
22,892,932 |
|
LUCIRA HEALTH, INC. |
The following tables represent the reconciliation of
non-GAAP financial measures to the most directly comparable GAAP
financial measures: |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of
GAAP to non-GAAP Gross Profit (Loss): |
|
|
GAAP Gross profit (loss) |
|
$ |
39,916 |
|
|
$ |
(852 |
) |
Stock-based compensation |
|
|
432 |
|
|
|
61 |
|
Depreciation and amortization |
|
|
792 |
|
|
|
66 |
|
Preapproval inventories |
|
|
— |
|
|
|
(1,000 |
) |
Non-GAAP Gross profit
(loss) |
|
$ |
41,140 |
|
|
$ |
(1,725 |
) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of
GAAP to non-GAAP Gross Margin: |
|
|
GAAP Gross (negative)
margin |
|
|
44 |
% |
|
|
-19 |
% |
Stock-based compensation |
|
|
0 |
% |
|
|
1 |
% |
Depreciation and amortization |
|
|
1 |
% |
|
|
2 |
% |
Preapproval inventories |
|
|
0 |
% |
|
|
-22 |
% |
Non-GAAP Gross (negative)
margin |
|
|
45 |
% |
|
|
-38 |
% |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of
GAAP to non-GAAP Operating Expenses: |
|
|
GAAP Operating Expenses |
|
$ |
26,104 |
|
|
$ |
12,382 |
|
Stock-based compensation |
|
|
(1,433 |
) |
|
|
(466 |
) |
Depreciation and amortization |
|
|
(807 |
) |
|
|
(140 |
) |
Preapproval inventories |
|
|
— |
|
|
|
300 |
|
Non-GAAP Operating
Expenses |
|
$ |
23,864 |
|
|
$ |
12,076 |
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Reconciliation of
GAAP to non-GAAP Net Income (Loss): |
|
|
GAAP Net Income (Loss) |
|
$ |
13,078 |
|
|
$ |
(13,316 |
) |
Stock-based compensation |
|
|
1,865 |
|
|
|
527 |
|
Depreciation and amortization |
|
|
1,599 |
|
|
|
205 |
|
Preapproval inventories |
|
|
— |
|
|
|
(1,300 |
) |
Non-cash interest and other expense |
|
|
126 |
|
|
|
284 |
|
Non-GAAP Net Income
(Loss) |
|
$ |
16,668 |
|
|
$ |
(13,599 |
) |
|
|
|
|
|
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