8-K
false 0001652724 0001652724 2021-08-12 2021-08-12

 

 

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 12, 2021

 

 

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

(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 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 12, 2021, Lucira Health, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this report.

The information in this Item 2.02 and in 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 in 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

  

Exhibit Description

99.1    Press Release dated August 12, 2021.
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 hereunto duly authorized.

 

    Lucira Health, Inc.
Date: August 12, 2021     By:  

    /s/ Daniel George

     

    Daniel George

    Chief Financial Officer

EX-99.1

Exhibit 99.1

 

LOGO

Lucira Health Announces Second Quarter 2021 Financial Results

EMERYVILLE, Calif. – August 12, 2021 – 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 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 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 Chodaczek

investorrelations@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 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
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