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 second quarter ended June 30, 2021.
Recent Highlights
- Recorded record-high revenue of
$12.4 million for the second quarter of 2021, representing 175%
sequential growth from the previous quarter of 2021
- Commenced sale of LUCIRA CHECK IT
COVID-19 Test Kit through OTC channels, which does not require a
physician's prescription
- International demand fueled by OTC
indication
- New production center in the
Dominican Republic became operational, and steps are underway to
reach full manufacturing capacity
- LUCIRA CHECK IT COVID-19 Test Kit
detects all current variants highlighted by the Centers of Disease
Control and the World Health Organization, including the Delta
variant
"We are excited that we are continuing to generate strong growth
across all areas of the business," said Erik Engelson, President
and Chief Executive Officer of Lucira Health. "Our record-high
quarterly revenue is a testament to our product and the strategic
foundation that we have built. As the OTC EUA authorization for our
LUCIRA CHECK IT COVID-19 Test Kit propelled sales, we continued to
forge strategic partnerships, such as our relationship with Meenta
which customized a workflow for the LUCIRA All-IN-ONE Test Kit,
that was utilized by athletes and individuals traveling to Japan in
the summer of 2021 and more recently, AZOVA, which negotiated
authorization to sell the LUCIRA CHECK IT Test Kit with AZOVA’s
video observation services for travel to Hawaii. We have also
invested in establishing an infrastructure to support the
accelerating demand for our test kits. We look forward to
continuing to establish ourselves as market leaders in the at-home
testing space in the second half of 2021 and beyond."
Second Quarter 2021 Financial Results
The second quarter of 2021 represented Lucira’s second full
quarter of commercial activity.
Net Revenue was $12.4 million for the second
quarter of 2021. Net revenue was primarily driven by increased
volume of LUCIRA CHECK IT COVID-19 Test Kit sales through the OTC
indication, increased customer contracts, and international
demand.
GAAP Gross Loss was approximately $70 thousand
for the second quarter of 2021 or negative 1% of revenue. Non-GAAP
gross profit and non-GAAP gross margin were $0.3 million and 3%,
respectively. Gross loss and negative gross margin were primarily
due to increased manufacturing production.
GAAP Operating Expenses were $16.2 million in
the second quarter of 2021, compared to $5.5 million in the same
period in 2020. Non-GAAP operating expenses were $15.1 million in
the second quarter of 2021, compared to $5.4 million in the same
period of 2020. The increase is primarily related to increased
headcount and third-party services to facilitate commercial launch,
validation of manufacturing activities, new product development,
clinical studies, and public company compliance.
GAAP Net Loss was $16.2 million in the second
quarter of 2021, compared to $6.6 million in the same period in
2020. Non-GAAP net loss was $14.7 million for the second quarter of
2021, compared to a non-GAAP net loss of $5.1 million for the same
period in 2020.
Cash Balance as of June 30, 2021 was $161.7
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 Thursday,
August 12, 2021, at 4:30 PM ET.
To participate in the call, please dial (833) 562-0151
(domestic) or (661) 567-1232 (international) and provide conference
ID 4241018. A live and archived webcast of the event can be
accessed through the following link ir.lucirahealth.com.
About Lucira Health
Lucira Health is a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits. Lucira's testing platform produces
PCR 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
tests results anywhere and anytime. The LUCIRA CHECK IT COVID-19
Test Kits (OTC) and LUCIRA COVID-19 All-In-One Test Kits (Rx)
provide PCR quality clinically relevant COVID-19 result within 30
minutes from sample collection. Lucira’s CHECK IT (OTC) also
provides a SMS verified digital LUCI PASS test result back to a
user’s phone for work, travel and other places where negative test
verification may be required. 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 statement 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 loss, gross margin,
operating expenses and net 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 loss,
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 depreciation and amortization expense in calculating
its non-GAAP gross loss, 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 second quarter of 2021.
Caution Regarding Forward-Looking
Statements
This press release may contain forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Words such as "may," "will," "should," "believe," "expect,"
"continue," "forecast," "plan," or similar expressions, or
statements regarding intent, belief, or current expectations are
forward-looking statements and reflect the current beliefs of
Lucira's management. These statements are not guarantees of future
performance and are subject to certain risks, uncertainties and
other factors that could cause actual results and events to differ
materially and adversely from those indicated by such
forward-looking statements including, without limitation, our
expectations around production capacity and our plans to gain
market share and accelerate revenue growth. Important factors that
could cause actual results to differ materially include: the
evolution of the ongoing COVID-19 pandemic, including any impact on
the demand for our products due to an increased vaccinated
population or our manufacturing and 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 our product offerings; development and manufacturing
problems, including 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 updates
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.
Media Relations Kevin Knight
media@lucirahealth.com 206-451-4823
Investor Relations Greg
Chodaczekinvestorrelations@lucirahealth.com 347-620-7010
Lucira Health,
Inc.Condensed Balance Sheets(In
thousands, except share and per share
amounts)(Unaudited)
|
|
June 30, |
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash |
|
$ |
161,662 |
|
|
$ |
58,212 |
|
Accounts receivable, net |
|
|
3,392 |
|
|
|
293 |
|
Inventory |
|
|
36,182 |
|
|
|
4,865 |
|
Grant income receivable |
|
|
92 |
|
|
|
183 |
|
Prepaid expenses |
|
|
6,164 |
|
|
|
3,496 |
|
Other current assets |
|
|
6,099 |
|
|
|
844 |
|
Restricted cash equivalents |
|
|
2,338 |
|
|
|
2,338 |
|
Total current assets |
|
|
215,929 |
|
|
|
70,231 |
|
Property and equipment, net |
|
|
28,153 |
|
|
|
19,408 |
|
Operating lease right-of-use
assets |
|
|
576 |
|
|
|
748 |
|
Other assets |
|
|
31 |
|
|
|
2,316 |
|
Total assets |
|
$ |
244,689 |
|
|
$ |
92,703 |
|
Liabilities, Redeemable
Convertible Preferred Stock, and Stockholders’ Equity
(Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
6,673 |
|
|
$ |
3,981 |
|
Accrued liabilities |
|
|
18,672 |
|
|
|
4,445 |
|
Operating lease liabilities, current |
|
|
374 |
|
|
|
431 |
|
Customer deposits |
|
|
2,916 |
|
|
|
— |
|
Total current liabilities |
|
|
28,635 |
|
|
|
8,857 |
|
Convertible notes payable |
|
|
— |
|
|
|
24,694 |
|
Operating lease liabilities, net
of current portion |
|
|
254 |
|
|
|
380 |
|
Total liabilities |
|
|
28,889 |
|
|
|
33,931 |
|
Commitments and
contingencies |
|
|
|
|
Redeemable convertible preferred stock $0.001 par value; 0 and
103,355,827 shares authorized as of June 30, 2021 and December 31,
2020, respectively; 0 and 23,978,747 shares issued and outstanding
as of June 30, 2021 and December 31, 2020, respectively; aggregate
liquidation preference of $0 as of June 30, 2021 |
|
|
— |
|
|
|
121,080 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
Preferred stock $0.001 par value; 10,000,000 and 0 shares
authorized as of June 30, 2021 and December 31, 2020, respectively;
0 shares issued and outstanding as of June 30, 2021 and December
31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares
authorized as of June 30, 2021 and December 31, 2020, respectively;
38,684,546 and 2,712,694 shares issued and outstanding as of June
30, 2021 and December 31, 2020, respectively |
|
|
39 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
308,991 |
|
|
|
1,403 |
|
Accumulated deficit |
|
|
(93,230 |
) |
|
|
(63,714 |
) |
Total stockholders’ equity
(deficit) |
|
|
215,800 |
|
|
|
(62,308 |
) |
Total liabilities, redeemable
convertible preferred stock, and stockholders’ equity
(deficit) |
|
$ |
244,689 |
|
|
$ |
92,703 |
|
|
|
|
|
|
|
|
|
|
Lucira Health,
Inc.Condensed Statements of
Operations(In thousands, except share and per
share amounts)(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Net sales |
|
$ |
12,439 |
|
|
$ |
— |
|
|
$ |
16,955 |
|
|
$ |
— |
|
Cost of products sold |
|
|
12,505 |
|
|
|
— |
|
|
|
17,873 |
|
|
|
— |
|
Gross loss |
|
|
(66 |
) |
|
|
— |
|
|
|
(918 |
) |
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
10,117 |
|
|
|
4,574 |
|
|
|
16,399 |
|
|
|
7,315 |
|
Selling, general and administrative |
|
|
6,100 |
|
|
|
931 |
|
|
|
12,200 |
|
|
|
1,559 |
|
Total operating expenses |
|
|
16,217 |
|
|
|
5,505 |
|
|
|
28,599 |
|
|
|
8,874 |
|
Loss from operations |
|
|
(16,283 |
) |
|
|
(5,505 |
) |
|
|
(29,517 |
) |
|
|
(8,874 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
Grant income |
|
|
79 |
|
|
|
335 |
|
|
|
281 |
|
|
|
1,977 |
|
Interest income (expense) |
|
|
4 |
|
|
|
(10 |
) |
|
|
1 |
|
|
|
(10 |
) |
Remeasurement of derivative liabilities and convertible notes |
|
|
— |
|
|
|
(1,444 |
) |
|
|
(281 |
) |
|
|
(1,444 |
) |
Total other income (expense), net |
|
|
83 |
|
|
|
(1,119 |
) |
|
|
1 |
|
|
|
523 |
|
Net loss |
|
$ |
(16,200 |
) |
|
$ |
(6,624 |
) |
|
$ |
(29,516 |
) |
|
$ |
(8,351 |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(2.90 |
) |
|
$ |
(0.96 |
) |
|
$ |
(3.68 |
) |
Weighted-average number of shares used in net loss per share of
common stock, basic and diluted |
|
|
38,483,766 |
|
|
|
2,282,024 |
|
|
|
30,688,349 |
|
|
|
2,270,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP
Financial MeasuresThe following table represents the
reconciliation of non-GAAP financial measures to the most directly
comparable GAAP financial measures:(In thousands)(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Gross Profit (Loss): |
|
|
|
|
|
|
|
|
GAAP Gross Loss |
|
$ |
(66 |
) |
|
$ |
— |
|
|
$ |
(918 |
) |
|
$ |
— |
|
Less: Stock-based compensation expense |
|
|
208 |
|
|
|
— |
|
|
|
269 |
|
|
|
— |
|
Less: Depreciation and amortization |
|
|
268 |
|
|
|
— |
|
|
|
335 |
|
|
|
— |
|
Add: Preappoval inventories |
|
|
(87 |
) |
|
|
— |
|
|
|
(1,089 |
) |
|
|
— |
|
Non-GAAP Gross profit (loss) |
|
$ |
323 |
|
|
$ |
— |
|
|
$ |
(1,403 |
) |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Gross margin |
|
|
|
|
|
|
|
|
GAAP Negative Gross margin |
|
|
-1 |
% |
|
|
- |
% |
|
|
-5 |
% |
|
|
- |
% |
Less: Stock-based compensation expense |
|
|
2 |
% |
|
|
- |
|
|
|
2 |
% |
|
|
- |
|
Less: Depreciation and amortization |
|
|
2 |
% |
|
|
- |
|
|
|
2 |
% |
|
|
- |
|
Add: Preappoval Inventories |
|
|
-1 |
% |
|
|
- |
|
|
|
-6 |
% |
|
|
- |
|
Non-GAAP Gross (negative)
margin |
|
|
3 |
% |
|
|
- |
% |
|
|
-8 |
% |
|
|
- |
% |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Operating expenses: |
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
$ |
16,217 |
|
|
$ |
5,505 |
|
|
$ |
28,599 |
|
|
$ |
8,874 |
|
Less: Stock-based compensation expense |
|
|
(737 |
) |
|
|
(59 |
) |
|
|
(1,203 |
) |
|
|
(117 |
) |
Less: Depreciation and amortization |
|
|
(408 |
) |
|
|
(46 |
) |
|
|
(548 |
) |
|
|
(118 |
) |
Add: Preappoval inventories |
|
|
— |
|
|
|
— |
|
|
|
305 |
|
|
|
— |
|
Non-GAAP Operating expenses |
|
$ |
15,072 |
|
|
$ |
5,400 |
|
|
$ |
27,154 |
|
|
$ |
8,640 |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to
non-GAAP Net loss: |
|
|
|
|
|
|
|
|
GAAP Net loss |
|
$ |
(16,200 |
) |
|
$ |
(6,624 |
) |
|
$ |
(29,516 |
) |
|
$ |
(8,351 |
) |
Add: Stock-based compensation expense |
|
|
945 |
|
|
|
59 |
|
|
|
1,472 |
|
|
|
117 |
|
Add: Depreciation and amortization |
|
|
676 |
|
|
|
46 |
|
|
|
882 |
|
|
|
118 |
|
Add: Non-cash interest and other expense |
|
|
(4 |
) |
|
|
1,454 |
|
|
|
280 |
|
|
|
1,454 |
|
Less: Preapproval inventories |
|
|
(87 |
) |
|
|
— |
|
|
|
(1,394 |
) |
|
|
— |
|
Non-GAAP Net loss |
|
$ |
(14,670 |
) |
|
$ |
(5,065 |
) |
|
$ |
(28,276 |
) |
|
$ |
(6,663 |
) |
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