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 third quarter ended September 30, 2021 and provided business
updates.
Highlights
- Recorded record-high revenue of
$15.0 million for the third quarter of 2021, representing 21%
sequential growth from the previous quarter of 2021
- Reopened online sales of its OTC
LUCIRA CHECK IT COVID-19 Test Kit via the Company's website and on
Amazon
- Received Pandemic Special Access
Route ("PSAR") approval for its LUCIRA CHECK IT COVID-19 Test Kit
by Singapore's Health Sciences Authority
- Appointed two executive team
members, Ghazi Kashmolah, Chief Quality Officer and Executive Vice
President Regulatory Affairs, and Tony Allen, Chief Operations
Officer
- Completed manufacturing of first
commercial test kits from the Dominican Republic production
center
"During the third quarter, we made meaningful progress on
executing our business and strategic initiatives and achieved our
guidance of sequential growth," said Erik Engelson, President and
Chief Executive Officer of Lucira Health. "This quarter, we are
guiding to at least 100% sequential growth in revenues, and are
pleased with the initial production ramp-up in the Dominican
Republic. This initial increased production in the Dominican
Republic came late in the third quarter yet provided enough
incremental inventory to reactivate online ordering without
significantly impacting order fulfillment for existing
business-to-business and other customers. We have been selling into
business-to-business, healthcare systems, online, and international
markets, and are seeing early signs of demand continuing well into
2022. Total demand exceeded total shipments in the third quarter of
2021. We are extremely fortunate to have our current
deeply-experienced team that is delivering commercial results.
We remain on-track to bring the initial four production lines in
the Dominican Republic manufacturing facility to capacity
production in the first half of 2022. During the third quarter, we
began to see improved efficiencies in the Dominican Republic as the
first two production lines ramped. At the same time, we experienced
continued labor shortages in our Michigan plant. Ultimately, this
led us to the decision to consolidate all current manufacturing
into the Dominican Republic and to implement a fifth line that will
be operational and then at capacity in the first and second halves
of 2022, respectively”.
Third Quarter 2021 Financial Results
The third quarter of 2021 represented Lucira's third full
quarter of commercial activity.
Net Revenue was $15.0 million for the third
quarter of 2021. Net revenue was primarily driven by increased
volume of our test kit sales through increased contracted sales
with businesses, distributors, healthcare providers and
international customers.
GAAP Gross Loss was approximately $1.5 million
for the third quarter of 2021 or negative 10% of revenue. Non-GAAP
gross profit and non-GAAP gross margin were $2.4 million and 16%,
respectively. Increases in both gross loss and negative gross
margin from the second quarter of 2021 were primarily due to a $1.3
million obsolete inventory charge and a $1.6 million long-lived
asset impairment charge resulting from the Michigan production
facility that is managed by our manucturing partner, Jabil,
partially offset by increased manufacturing production.
GAAP Operating Expenses were $26.1 million in
the third quarter of 2021, compared to $10.5 million in the same
period in 2020. Non-GAAP operating expenses were $20.8 million in
the third quarter of 2021, compared to $10.3 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 $27.5 million in the third
quarter of 2021, compared to $11.8 million in the same period in
2020. Non-GAAP net loss was $18.3 million for the third quarter of
2021, compared to a non-GAAP net loss of $10.3 million for the same
period in 2020.
Cash Balance as of September 30, 2021 was
$117.3 million.
Q4 2021 Financial Guidance and 2022 Initial
Outlook
Lucira Health projects revenue for the fourth quarter of 2021 of
at least $30 million and 2022 revenues in excess of $150
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,
November 11, 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 8458678 . 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 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 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 the effect of 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 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, non-GAAP gross margin and non-GAAP net loss measures.
Obsolete inventory. The Company has excluded
the impact of certain obsolete inventory charges in calculating its
non-GAAP gross profit, non-GAAP gross margin and non-GAAP net loss
measures.
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 continue to expand internationally; our ability to enhance our
product offerings and market our products; our ability to hire and
retain key personnel; 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.
Investor Relations Greg
Chodaczekinvestorrelations@lucirahealth.com 347-620-7010
LUCIRA HEALTH, INC. |
CONDENSED BALANCE SHEETS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
September 30, |
|
December 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash |
|
$ |
117,286 |
|
|
$ |
58,212 |
|
Accounts receivable, net |
|
|
11,904 |
|
|
|
293 |
|
Inventory |
|
|
42,964 |
|
|
|
4,865 |
|
Grant income receivable |
|
|
125 |
|
|
|
183 |
|
Prepaid expenses |
|
|
8,165 |
|
|
|
3,496 |
|
Other current assets |
|
|
10,080 |
|
|
|
844 |
|
Restricted cash equivalents |
|
|
2,338 |
|
|
|
2,338 |
|
Total current assets |
|
|
192,862 |
|
|
|
70,231 |
|
Property and equipment,
net |
|
|
26,955 |
|
|
|
19,408 |
|
Operating lease right-of-use
assets |
|
|
2,726 |
|
|
|
748 |
|
Other assets |
|
|
245 |
|
|
|
2,316 |
|
Total assets |
|
$ |
222,788 |
|
|
$ |
92,703 |
|
Liabilities,
Redeemable Convertible Preferred Stock, and Stockholders’ Equity
(Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
10,453 |
|
|
$ |
3,981 |
|
Accrued liabilities |
|
|
15,194 |
|
|
|
4,445 |
|
Operating lease liabilities, current |
|
|
1,424 |
|
|
|
431 |
|
Customer deposits |
|
|
365 |
|
|
|
— |
|
Total current liabilities |
|
|
27,436 |
|
|
|
8,857 |
|
Convertible notes payable |
|
|
— |
|
|
|
24,694 |
|
Operating lease liabilities,
net of current portion |
|
|
1,364 |
|
|
|
380 |
|
Total liabilities |
|
|
28,800 |
|
|
|
33,931 |
|
Commitments and
contingencies |
|
|
|
|
Redeemable convertible preferred stock $0.001 par value; 0 and
103,355,827 shares authorized as of September 30, 2021 and December
31, 2020, respectively; 0 and 23,978,747 shares issued and
outstanding as of September 30, 2021 and December 31, 2020,
respectively; aggregate liquidation preference of $0 as of
September 30, 2021 |
|
|
— |
|
|
|
121,080 |
|
Stockholders’ equity
(deficit): |
|
|
|
|
Preferred stock $0.001 par value; 10,000,000 and 0 shares
authorized as of September 30, 2021 and December 31, 2020,
respectively; 0 shares issued and outstanding as of September 30,
2021 and December 31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares
authorized as of September 30, 2021 and December 31, 2020,
respectively; 39,003,504 and 2,712,694 shares issued and
outstanding as of September 30, 2021 and December 31, 2020,
respectively |
|
|
39 |
|
|
|
3 |
|
Additional paid-in capital |
|
|
314,675 |
|
|
|
1,403 |
|
Accumulated deficit |
|
|
(120,726 |
) |
|
|
(63,714 |
) |
Total stockholders’ equity
(deficit) |
|
|
193,988 |
|
|
|
(62,308 |
) |
Total liabilities, redeemable
convertible preferred stock, and stockholders’ equity
(deficit) |
|
$ |
222,788 |
|
|
$ |
92,703 |
|
|
|
|
|
|
LUCIRA HEALTH, INC. |
CONDENSED STATEMENTS OF OPERATIONS |
(Unaudited) |
(In thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Net sales |
|
$ |
14,976 |
|
|
$ |
— |
|
|
$ |
31,931 |
|
|
$ |
— |
|
Cost of products sold |
|
|
14,837 |
|
|
|
— |
|
|
|
32,710 |
|
|
|
— |
|
Impairment of long-lived
assets |
|
|
1,622 |
|
|
|
— |
|
|
|
1,622 |
|
|
|
— |
|
Gross profit/(loss) |
|
|
(1,483 |
) |
|
|
— |
|
|
|
(2,401 |
) |
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
14,342 |
|
|
|
8,793 |
|
|
|
30,741 |
|
|
|
16,108 |
|
Selling, general and administrative |
|
|
11,788 |
|
|
|
1,662 |
|
|
|
23,988 |
|
|
|
3,221 |
|
Total operating
expenses |
|
|
26,130 |
|
|
|
10,455 |
|
|
|
54,729 |
|
|
|
19,329 |
|
Loss from
operations |
|
|
(27,613 |
) |
|
|
(10,455 |
) |
|
|
(57,130 |
) |
|
|
(19,329 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
|
|
Grant income |
|
|
112 |
|
|
|
30 |
|
|
|
393 |
|
|
|
2,007 |
|
Interest income (expense) |
|
|
5 |
|
|
|
(34 |
) |
|
|
6 |
|
|
|
(44 |
) |
Remeasurement of derivative liabilities and convertible notes |
|
|
— |
|
|
|
(1,351 |
) |
|
|
(281 |
) |
|
|
(2,795 |
) |
Total other income (expense), net |
|
|
117 |
|
|
|
(1,355 |
) |
|
|
118 |
|
|
|
(832 |
) |
Net loss |
|
$ |
(27,496 |
) |
|
$ |
(11,810 |
) |
|
$ |
(57,012 |
) |
|
$ |
(20,161 |
) |
Net loss per share of common stock, basic and diluted |
|
$ |
(0.71 |
) |
|
$ |
(4.76 |
) |
|
$ |
(1.71 |
) |
|
$ |
(8.61 |
) |
Weighted-average number of shares used in net loss per share of
common stock, basic and diluted |
|
|
38,667,615 |
|
|
|
2,481,678 |
|
|
|
33,348,104 |
|
|
|
2,341,135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP
to non-GAAP Gross Profit (Loss): |
|
|
|
|
|
|
|
|
|
GAAP Gross Profit/Loss |
|
$ |
(1,483) |
|
|
$ |
— |
|
|
$ |
(2,401) |
|
|
$ |
— |
|
Stock-based compensation expense |
|
|
91 |
|
|
|
— |
|
|
|
351 |
|
|
|
— |
|
Depreciation and amortization |
|
|
842 |
|
|
|
— |
|
|
|
1,177 |
|
|
|
— |
|
Impairment of long-lived assets |
|
|
1,622 |
|
|
|
— |
|
|
|
1,622 |
|
|
|
— |
|
Inventory obsolescence charge |
|
|
1,284 |
|
|
|
— |
|
|
|
1,284 |
|
|
|
— |
|
Preappoval inventories |
|
|
— |
|
|
|
— |
|
|
|
(1,089) |
|
|
|
— |
|
Non-GAAP Gross profit
(loss) |
|
$ |
2,356 |
|
|
$ |
— |
|
|
$ |
944 |
|
|
$ |
— |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to non-GAAP Gross
margin |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Gross (negative)
margin |
|
|
-10% |
|
|
|
-% |
|
|
|
-8% |
|
|
|
-% |
|
Stock-based compensation expense |
|
|
1% |
|
|
|
- |
|
|
|
1% |
|
|
|
- |
|
Depreciation and amortization |
|
|
6% |
|
|
|
- |
|
|
|
4% |
|
|
|
- |
|
Impairment of long-lived assets |
|
|
11% |
|
|
|
- |
|
|
|
5% |
|
|
|
- |
|
Inventory obsolescence charge |
|
|
9% |
|
|
|
- |
|
|
|
4% |
|
|
|
- |
|
Preappoval inventories |
|
|
0% |
|
|
|
- |
|
|
|
-3% |
|
|
|
- |
|
Non-GAAP Gross (negative)
margin |
|
|
16% |
|
|
|
-% |
|
|
|
3% |
|
|
|
-% |
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP
to non-GAAP Operating expenses: |
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
$ |
26,130 |
|
|
$ |
10,455 |
|
|
$ |
54,729 |
|
|
$ |
19,329 |
|
Stock-based compensation expense |
|
|
(4,937 |
) |
|
|
(118 |
) |
|
|
(6,149 |
) |
|
|
(235 |
) |
Depreciation and amortization |
|
|
(433 |
) |
|
|
(35 |
) |
|
|
(981 |
) |
|
|
(153 |
) |
Preappoval inventories |
|
|
— |
|
|
|
— |
|
|
|
305 |
|
|
|
— |
|
Non-GAAP Operating
expenses |
|
$ |
20,760 |
|
|
$ |
10,302 |
|
|
$ |
47,904 |
|
|
$ |
18,941 |
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP
to non-GAAP Net loss: |
|
|
|
|
|
|
|
|
GAAP Net loss |
|
$ |
(27,496 |
) |
|
$ |
(11,810 |
) |
|
$ |
(57,012 |
) |
|
$ |
(20,161 |
) |
Stock-based compensation expense |
|
|
5,028 |
|
|
|
118 |
|
|
|
6,509 |
|
|
|
235 |
|
Depreciation and amortization |
|
|
1,275 |
|
|
|
35 |
|
|
|
2,158 |
|
|
|
153 |
|
Non-cash interest and other expense |
|
|
(5 |
) |
|
|
1,385 |
|
|
|
275 |
|
|
|
2,839 |
|
Impairment of long-lived assets |
|
|
1,622 |
|
|
|
— |
|
|
|
1,622 |
|
|
|
— |
|
Inventory obsolescence charge |
|
|
1,284 |
|
|
|
— |
|
|
|
1,284 |
|
|
|
— |
|
Preapproval inventories |
|
|
— |
|
|
|
— |
|
|
|
(1,394 |
) |
|
|
— |
|
Non-GAAP Net loss |
|
$ |
(18,292 |
) |
|
$ |
(10,272 |
) |
|
$ |
(46,567 |
) |
|
$ |
(16,934 |
) |
Lucira Health (NASDAQ:LHDX)
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Lucira Health (NASDAQ:LHDX)
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From Sep 2023 to Sep 2024