Lucira Health, Inc. ("Lucira Health," "Lucira" or the "Company")
(NASDAQ: LHDX), a medical technology company focused on the
development and commercialization of transformative and innovative
infectious disease test kits, today reported financial results for
the first quarter ended March 31, 2021.
Recent Highlights
- Received second FDA EUA
Authorization for over-the-counter ("OTC") use of the LUCIRA CHECK
IT COVID-19 Test Kit, which does not require a physician's
prescription
- Formed strategic partnership with
the Golden State Warriors to launch a testing program that
supported safe reopening of the Chase Center
- Commenced relationship with Amazon
for online sale of the OTC LUCIRA CHECK IT Test Kit
- Established international presence
with Health Canada's authorization with conditions for the LUCIRA
CHECK IT Test Kit
- Opened Dominican Republic
manufacturing facility at Jabil, allowing for increased production
capacity
- Completed initial public offering of
approximately 10.35 million shares, raising approximately $176.0
million in gross proceeds, before deducting underwriting discounts
and commissions and estimated offering expenses
"We are excited about the momentum that we have generated during
the first quarter of 2021," said Erik Engelson, President and Chief
Executive Officer of Lucira Health. "Not only did we complete a
successful IPO, but the developments made with our COVID-19 test
kit this quarter are testaments to the quality technology platform
we have created. Our platform was adapted into a COVID-19 test kit
that has received OTC authorization in the U.S. and Canada and has
started aiding in testing programs that enable safe reopening. We
plan to build off our quarter of strong development to gain market
share and accelerate revenue growth."
First Quarter 2021 Financial Results
The first quarter of 2021 represented our first full quarter of
commercial activity.
Net Revenue was $4.5 million for the first
quarter of 2021. Net revenue was primarily driven by sales to
healthcare networks and physicians through our point of care and
prescription at home EUA authorization from the FDA.
GAAP Gross Loss was $0.9 million for the first
quarter of 2021 or negative 19% of revenue. Non-GAAP gross loss and
negative margin were $0.7 million and 16%, respectively. Our gross
loss and negative margin were primarily due to manufacturing
capacity that has been established for anticipated commercial
growth.
GAAP Operating Expenses were $12.4 million in
the first quarter of 2021, compared to $3.4 million in the same
period in 2020. Non-GAAP operating expenses were $11.8 million in
the first quarter of 2021, compared to $3.2 million in the same
period of 2020. The increase is primarily related to increased
headcount and third-party services to facilitate commercial launch,
new product development, clinical studies, and public company
compliance.
GAAP Net Loss was $13.3 million in the first
quarter of 2021, compared to $1.7 million in the same period in
2020. Non-GAAP net loss was $12.3 million for the first quarter of
2021, compared to a non-GAAP net loss of $1.6 million for the same
period in 2020.
Cash Balance as of March 31, 2021 was $189.8
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,
May 13, 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 3562914. The live webcast will be available on the Investor
Relations section of Lucira's website.
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
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
tests results anywhere and anytime. The LUCIRA CHECK IT COVID-19
Test Kits (OTC) and LUCIRA COVID-19 All-In-One Test Kits (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 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, operating expenses
and net loss. Non-GAAP adjustments include stock-based
compensation, depreciation and amortization and non-cash interest
and other expense. From time to time in the future, there may be
other items that the Company may 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. We have provided at the end of this
press release, following the accompanying financial data,
reconciliations of our 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.
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," "might," "will," "should," "believe,"
"expect," "anticipate," "estimate," "continue," "predict,"
"forecast," "project," "plan," "intend" 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 impact
to our business of the ongoing COVID-19 pandemic, including 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 our product
offerings; 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 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(Unaudited)(In thousands,
except share and per share data)
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
(See Note
1) |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash |
|
$ |
189,813 |
|
|
$ |
58,212 |
|
|
Accounts receivable, net |
|
|
531 |
|
|
|
293 |
|
|
Inventory |
|
|
17,469 |
|
|
|
4,865 |
|
|
Grant income receivable |
|
|
202 |
|
|
|
183 |
|
|
Prepaid expenses |
|
|
8,902 |
|
|
|
3,496 |
|
|
Other current assets |
|
|
2,632 |
|
|
|
844 |
|
|
Restricted cash equivalents |
|
|
2,338 |
|
|
|
2,338 |
|
|
Total
current assets |
|
|
221,887 |
|
|
|
70,231 |
|
|
Property and
equipment, net |
|
|
26,358 |
|
|
|
19,408 |
|
|
Operating
lease right-of-use assets |
|
|
664 |
|
|
|
748 |
|
|
Other
assets |
|
|
47 |
|
|
|
2,316 |
|
|
Total
assets |
|
$ |
248,956 |
|
|
$ |
92,703 |
|
|
Liabilities, Redeemable Convertible Preferred Stock, and
Stockholders’ Equity (Deficit) |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
$ |
10,028 |
|
|
$ |
3,981 |
|
|
Accrued liabilities |
|
|
7,295 |
|
|
|
4,445 |
|
|
Operating lease liabilities, current |
|
|
434 |
|
|
|
431 |
|
|
Total
current liabilities |
|
|
17,757 |
|
|
|
8,857 |
|
|
Convertible
notes payable |
|
|
— |
|
|
|
24,694 |
|
|
Operating
lease liabilities, net of current portion |
|
|
287 |
|
|
|
380 |
|
|
Total
liabilities |
|
|
18,044 |
|
|
|
33,931 |
|
|
Commitments
and contingencies (Note 5) |
|
|
|
|
|
Redeemable convertible preferred stock $0.001 par value; 0 and
103,355,827 shares authorized as of March 31, 2021 and December 31,
2020, respectively; 0 and 23,978,747 shares issued and outstanding
as of March 31, 2021 and December 31, 2020, respectively; aggregate
liquidation preference of $0 as of March 31, 2021 |
|
|
— |
|
|
|
121,080 |
|
|
Stockholders’ equity (deficit): |
|
|
|
|
|
Preferred stock $0.001 par value; 10,000,000 and 0 shares
authorized as of March 31, 2021 and December 31, 2020,
respectively; 0 shares issued and outstanding as of March 31, 2021
and December 31, 2020 |
|
|
— |
|
|
|
— |
|
|
Common stock, $0.001 par value; 200,000,000 and 150,000,000 shares
authorized as of March 31, 2021 and December 31, 2020,
respectively; 38,550,148 and 2,712,694 shares issued and
outstanding as of March 31, 2021 and December 31, 2020,
respectively |
|
|
39 |
|
|
|
3 |
|
|
Additional paid-in capital |
|
|
307,903 |
|
|
|
1,403 |
|
|
Accumulated deficit |
|
|
(77,030 |
) |
|
|
(63,714 |
) |
|
Total
stockholders’ equity (deficit) |
|
|
230,912 |
|
|
|
(62,308 |
) |
|
Total
liabilities, redeemable convertible preferred stock, and
stockholders’ equity (deficit) |
|
$ |
248,956 |
|
|
$ |
92,703 |
|
|
|
|
|
|
|
|
(1) The balance sheet as of December 31, 2020 is derived from the
audited financial statements as of that date |
|
LUCIRA HEALTH,
INC.CONDENSED STATEMENT OF
OPERATIONS(Unaudited)(In
thousands, except share and per share data)
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Net
sales |
|
$ |
4,516 |
|
|
$ |
— |
|
|
Cost of
products sold |
|
|
5,368 |
|
|
|
— |
|
|
Gross loss |
|
|
(852 |
) |
|
|
— |
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
6,283 |
|
|
|
2,741 |
|
|
Selling, general and administrative |
|
|
6,099 |
|
|
|
628 |
|
|
Total operating expenses |
|
|
12,382 |
|
|
|
3,369 |
|
|
Loss from operations |
|
|
(13,234 |
) |
|
|
(3,369 |
) |
|
Other income
(expense), net: |
|
|
|
|
|
Grant income |
|
|
202 |
|
|
|
1,642 |
|
|
Interest expense |
|
|
(3 |
) |
|
|
— |
|
|
Remeasurement of derivative liabilities and convertible notes |
|
|
(281 |
) |
|
|
— |
|
|
Total other income (expense), net |
|
|
(82 |
) |
|
|
1,642 |
|
|
Net loss |
|
$ |
(13,316 |
) |
|
$ |
(1,727 |
) |
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.76 |
) |
|
Weighted-average number of shares used in net loss per share of
common stock, basic and diluted |
|
|
22,892,932 |
|
|
|
2,258,236 |
|
|
|
|
|
|
|
|
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 EndedMarch 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to non-GAAP Gross
Loss: |
|
|
|
|
GAAP Gross
Loss |
|
$ |
(852 |
) |
|
$ |
— |
|
Add: Stock-based compensation expense |
|
|
61 |
|
|
|
— |
|
Add: Depreciation and amortization |
|
|
66 |
|
|
|
— |
|
Non-GAAP
Gross loss |
|
$ |
(725 |
) |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to non-GAAP Operating
expenses: |
|
|
|
|
GAAP
Operating expenses |
|
$ |
12,382 |
|
|
$ |
3,369 |
|
Less: Stock-based compensation expense |
|
|
(466 |
) |
|
|
(58 |
) |
Less: Depreciation and amortization |
|
|
(139 |
) |
|
|
(71 |
) |
Non-GAAP
Operating expenses |
|
$ |
11,777 |
|
|
$ |
3,240 |
|
|
|
|
|
|
|
|
Three Months EndedMarch 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Reconciliation of GAAP to non-GAAP Net loss: |
|
|
|
|
GAAP Net
loss |
|
$ |
(13,316 |
) |
|
$ |
(1,727 |
) |
Add: Stock-based compensation expense |
|
|
527 |
|
|
|
58 |
|
Add: Depreciation and amortization |
|
|
205 |
|
|
|
71 |
|
Add: Non-cash interest and other expense |
|
|
284 |
|
|
|
— |
|
Non-GAAP Net
loss |
|
$ |
(12,300 |
) |
|
$ |
(1,598 |
) |
|
|
|
|
|
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