8-K
0001652724false00016527242022-08-152022-08-15

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 15, 2022

 

 

Lucira Health, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-39976

27-2491037

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

1412 62nd Street

 

Emeryville, California

 

94608

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (510) 350-8071

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

LHDX

 

NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 2.02 Results of Operations and Financial Condition.

On August 15, 2022, Lucira Health, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2022 and provided business updates. A copy of the press release is furnished as Exhibit 99.1 to this current report.

The information in this Item 2.02 and the press release furnished as Exhibit 99.1 to this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information contained in this Item 2.02 and the press release furnished as Exhibit 99.1 to this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

 

Description

99.1

 

Press Release dated August 15, 2022.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Lucira Health, Inc.

 

 

 

 

Date:

August 15, 2022

By:

/s/ Daniel George

 

 

 

Daniel George
Chief Financial Officer

 


EX-99.1

https://cdn.kscope.io/6899afbc71e0f7bd77b2df76c91fe904-img195784789_0.jpg 

Exhibit 99.1

Lucira Health Announces Second Quarter 2022 Results and Provides Business Updates

EMERYVILLE, Calif. – August 15, 2022 – 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 Measures

In 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 Chodaczek

investorrelations@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

 

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 as
of June 30, 2022 and December 31, 2021; 0 shares issued
and outstanding as of June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.001 par value; 200,000,000 shares authorized as of
June 30, 2022 and December 31, 2021; 40,081,464 and 39,663,645 shares
issued 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, net

 

 

(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 most directly comparable GAAP financial measures:

 

(Unaudited)

 

(In thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 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

 

 

 

335

 

Preapproval inventories

 

 

 

 

 

(87

)

 

 

 

 

 

(1,089

)

Non-GAAP Gross Profit (Loss)

 

$

8,885

 

 

$

323

 

 

$

49,849

 

 

$

(1,412

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 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 Margin

 

 

34

%

 

 

3

%

 

 

43

%

 

 

(8

)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 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 Ended June 30,

 

 

Six Months Ended June 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

)