6-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16 of the

Securities Exchange Act of 1934

For the month of November 2021

Commission File Number: 001-40852

 

 

LUMIRADX LIMITED

(Translation of registrant’s name into English)

 

 

LumiraDx Limited

c/o Ocorian Trust (Cayman) Limited

PO Box 1350, Windward 3, Regatta Office Park

Grand Cayman KY1-1108

Cayman Islands

(345) 640-0540

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

 

 

 


EXPLANATORY NOTE

On November 10, 2021, LumiraDx Limited issued a press release announcing its financial results for the period ended September 30, 2021. A copy of this press release is furnished as Exhibit 99.1 herewith.

The information in this Form 6-K (including in Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.


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.

 

    LUMIRADX LIMITED
Date: November 10, 2021     By:  

/s/ Ron Zwanziger

      Ron Zwanziger
      Chief Executive Officer


EXHIBIT INDEX

 

Exhibit   

Description

99.1    Press release issued by LumiraDx Limited on November 10, 2021, furnished herewith.
EX-99.1

Exhibit 99.1

LumiraDx Reports Third Quarter 2021 Financial Results

Strong Revenue Growth and Strategic Progress on Platform, Products and Pipeline

London, UK (November 10, 2021), LumiraDx (Nasdaq:LMDX), a next-generation point of care (POC) diagnostics company, today announced financial results for the quarter ended September 30, 2021.

 

   

Revenue of $109.1M for the three months ended Sept. 30, 2021 and $303.2M for the nine months ended Sept. 30, 2021 rose significantly over revenue of $139.2M for the twelve months ended Dec. 31, 2020 on strong traction for our long-term strategy

 

   

Platform revenue driven by higher COVID testing rates in all markets, especially U.S.; uptick in Europe for COVID Ag Pool tests enabling high throughput screening

 

   

Fast Lab Solutions doubled its business enabling fast, accurate testing for laboratory customers

 

   

Positive market development for INR tests for monitoring patients on oral anticoagulation therapy and D-Dimer for diagnosing deep vein thrombosis and pulmonary embolism

 

   

Steady progress expanding geographies and testing menu for 30+ common health conditions in our planned pipeline

“LumiraDx’s disruptive next generation platform is just beginning to drive the transformation of community-based testing,” said Chairman and CEO Ron Zwanziger: “Our first financial results as a public company demonstrate LumiraDx’s tremendous growth potential driven by the need for fast, accurate and comprehensive diagnostic information to healthcare providers at the point of need. Our five platform tests in the market are delivering strong performance and we continue to make progress to expand our testing menu for diagnosing common conditions and improving health outcomes around the world.”

2021 Third Quarter and First Nine Months Financial Highlights

For the first nine months of 2021, LumiraDx delivered $303.2 million in revenue compared to $26.9 million for the same period last year and $139.2 million for full year 2020. The company currently expects full year revenue for 2021 to be substantially in line with the average consensus analyst estimate of $367 million.

The pandemic accelerated the company’s vision to transform point-of-care diagnostics, enabling more than 19,300 Platforms shipped to customers as of the end of September 2021.

For the third quarter of 2021, LumiraDx reported $109.1 million in revenue compared to $13.9 million for the same period last year. Covid Ag test strips accounted for $92.0 million of revenue in the third quarter of 2021 driven by higher testing rates in all markets, while Fast Lab Solutions delivered revenue of $10.3 million as adoption of our unique molecular chemistry has been accelerating.

Gross margin for the third quarter of 2021 was 36% and gross margin for the nine months ended September 30, 2021 was 32%. Margins were negatively impacted by non-recurring costs related to our rapid increase in production capacity and capabilities.


Research and development costs were $35.4 million in the third quarter of 2021. This represents an increase of 27% over the third quarter in 2020 as we continued to increase capabilities, opened our new R&D center in Glasgow and further resourced our development teams for continued pipeline delivery.

SG&A expenses for the third quarter of 2021 of $58.9 million includes an IFRS 2 charge of $22.2 million for the difference in the fair value of the shares deemed to have been issued by LumiraDx in the merger transaction to CA Healthcare shareholders and the net assets of CA Healthcare and $8.6 million of LumiraDx transaction costs as part of LumiraDx’s transaction to go public on Nasdaq. Excluding these items, SG&A expenses were $28.1 million, an increase of $15.9 million from the third quarter in 2020 as we expanded staffing globally to support the commercial growth of LumiraDx’s Platform and Fast Lab Solutions.

Net income for the third quarter of 2021 was $84.8 million, or $0.46 per fully diluted share. Net income arose from certain accounting gains on the conversion of our debt and equity securities as part of the merger transaction. Our non-IFRS adjusted net loss for the period, excluding merger expenses and excluding amortization, share-based payment expenses and unrealized foreign exchange gains was $29.8 million, or a loss of $0.16 per share.

At September 30, 2021, LumiraDx had $300 million in senior debt and $18 million in other term debt. The company’s cash balance at September 30, 2021 was $217.7 million.

Conference Call

LumiraDx’s senior management team will host a conference call today at 8:00 AM ET to discuss the company’s financial results and business updates. Call in details and a link to view the webcast may be found at https://investors.lumiradx.com/news-and-events/investor-calendar. A replay of the webcast will be available on the Investor’s section of the company’s website at investors.lumiradx.com shortly after the conclusion of the call. The webcast will be archived for 90 days.

About LumiraDx

LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need. LumiraDx is based in the UK with more than 1500 employees worldwide.

Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com

Contact:

Colleen McMillen

Colleen.McMillen@lumiradx.com

+1.917.344.9360


Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the effectiveness of our strategy, regulatory progress and the advancement of our pipeline of tests, and the benefits and performance of our tests. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business conditions; the effect of COVID-19 on LumiraDx’s business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header “Risk Factors” in the Proxy Statement and Prospectus filed pursuant to Rule 424B(3) with the Securities and Exchange Commission, or SEC on September 10, 2021 and other filings with the SEC. Although LumiraDx believes that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Non-IFRS Financial Measures

We present non-IFRS financial measures because we believe that they and other similar measures are widely used by certain investors, securities analysts and other interested parties as supplemental measures of performance and liquidity. We also use these measures internally to establish forecasts, budgets and operational goals to manage and monitor our business, as well as evaluate our underlying historical performance, as we believe that these non-IFRS financial measures depict the true performance of the business by encompassing only relevant and controllable events, enabling us to evaluate and plan more effectively for the future. The non-IFRS financial measures may not be comparable to other similarly titled measures of other companies and have limitations as analytical tools and should not be considered in isolation or as a substitute for analysis of our operating results as reported under IFRS as issued by the IASB. Non-IFRS financial measures and margins are not measurements of our performance, financial condition or liquidity under IFRS as issued by the IASB and should not be considered as alternatives to [operating loss, gross margin or net income (loss)] or any other performance measures, derived in accordance with IFRS as issued by the IASB or any other generally accepted accounting principles.

We define non-IFRS operating loss and non-IFRS net income (loss) as operating loss and net income (loss), respectively, excluding amortization, share-based payments, IFRS 2 listing expense, change in fair value of financial instruments, foreign exchange (gain)/loss, dividends on preferred shares and non-cash interest. We recommend that you review the reconciliation of the non-IFRS measure to the most directly comparable IFRS financial measure provided in the financial statement tables included below, and that you not rely on any single financial measure to evaluate our business.


LUMIRADX LIMITED

Unaudited Consolidated Statement of Financial Position

 

     DECEMBER 31, 2020     SEPTEMBER 30, 2021  
              
     (in thousands, except share data)  

ASSETS

    

Non-Current Assets

    

Other non-current assets

   $ 241     $ 545  

Intangibles and goodwill

     40,723       38,208  

Right-of-Use Assets

     10,386       15,258  

Property, plant and equipment

     87,082       155,084  
  

 

 

   

 

 

 

Total Non-Current Assets

     138,432       209,095  
  

 

 

   

 

 

 

Current Assets

    

Inventories

     85,516       178,163  

Tax receivable

     20,680       13,281  

Trade and other receivables

     109,295       93,133  

Restricted Cash

     2,455       2,442  

Cash and cash equivalents

     158,717       215,285  
  

 

 

   

 

 

 

Total Current Assets

     376,663       502,304  
  

 

 

   

 

 

 

TOTAL ASSETS

   $ 515,095     $ 711,399  
  

 

 

   

 

 

 

LIABILITIES AND EQUITY

    

Liabilities

    

Non-Current Liabilities

    

Debt due after more than one year

   $  (139,734   $  (308,399

Preferred shares

     (451,721      

Lease liabilities

     (8,991     (13,432

Warrant liability

           (6,690

Deferred tax liabilities

     (1,230     (910
  

 

 

   

 

 

 

Total Non-Current Liabilities

     (601,676     (329,431
  

 

 

   

 

 

 

Current Liabilities

    

Debt due within one year

     (147,238     (557

Trade and other payables

     (138,783     (191,143

Lease liabilities due within one year

     (2,114     (4,874
  

 

 

   

 

 

 

Total Current Liabilities

     (288,135     (196,574

Equity

    

Share capital and share premium

     (152,732     (769,217

Foreign currency translation reserve

     19,905       17,532  

Other reserves

     (99,821     (123,383

Accumulated deficit

     607,157       690,211  
  

 

 

   

 

 

 

Total equity attributable to equity holders of the parent

     374,509       (184,857
  

 

 

   

 

 

 

Non-controlling interests

     207       (537
  

 

 

   

 

 

 

Total Equity

     374,716       (185,394
  

 

 

   

 

 

 

TOTAL EQUITY AND LIABILITIES

   $  (515,095   $  (711,399
  

 

 

   

 

 

 


LUMIRADX LIMITED

Unaudited Consolidated Statement of Profit and Loss and Comprehensive Income

 

     THREE MONTHS ENDED
SEPTEMBER 30,
    NINE MONTHS ENDED
SEPTEMBER 30,
 
     2021     2020     2021     2020  
                          
    

(in thousands, except share

and per share data)

 

Revenue

        

Products

   $ 108,131     $ 12,688     $ 300,064     $ 23,318  

Services

     950       1,240       3,111       3,560  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Revenue

     109,081       13,928       303,175       26,878  

Cost of sales

        

Products

     70,066       12,397       205,326       18,915  

Services

     175       482       829       1,425  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total Cost of Sales

     70,241       12,879       206,155       20,340  

Gross Profit

     38,840       1,049       97,020       6,538  

Gross Profit Margin

     36     8     32     24

Research and development expenses

     35,396       27,919       96,399       79,843  

Selling, marketing and administrative expenses

     58,920       12,227       123,918       30,314  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Loss

     (55,476     (39,097     (123,297     (103,619

Finance income

     178,832       264       118,610       774  

Finance expense

     (37,589     (27,970     (103,949     (75,596
  

 

 

   

 

 

   

 

 

   

 

 

 

Net finance expense

     141,243       (27,706     14,661       (74,822

Gain/(Loss) before Tax

     85,767       (66,803     (108,636     (178,441

Tax (provision)/credit for the period

     (994     4,473       (2,551     9,143  
  

 

 

   

 

 

   

 

 

   

 

 

 

Gain/(Loss) for the period

   $ 84,773     $ (62,330   $ (111,187   $ (169,298
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss attributable to non-controlling interest

     34       36       322       (213
  

 

 

   

 

 

   

 

 

   

 

 

 

Net gain/(loss) attributable to equity holders of parent—basic and diluted

   $ 84,739     $ (62,366   $ (111,509   $ (169,085
  

 

 

   

 

 

   

 

 

   

 

 

 

Net gain/(loss) per share attributable to equity holders of parent—basic

   $ 0.63     $ (0.47   $ (0.84   $ (1.28

Net gain/(loss) per share attributable to equity holders of parent—diluted

   $ 0.46     $ (0.47   $ (0.84   $ (1.28

Weighted-average number of Ordinary Shares used in loss per share—basic

     135,546,183       132,191,196       132,649,878       132,192,865  

Weighted-average number of Ordinary Shares used in loss per share—diluted

     183,227,228       132,191,196       132,649,878       132,192,865  


LUMIRADX LIMITED

Unaudited Consolidated Statement of Cash Flows

 

     THREE MONTHS ENDED
SEPTEMBER 30,
    NINE MONTHS ENDED
SEPTEMBER 30,
 
     2021     2020     2021     2020  
                          
    

(in thousands, except share

and per share data)

 

Cash Flows from Operating Activities

        

Income/(Loss) for the period

   $ 84,773     $  (62,330   $  (111,187   $  (169,298

Adjustments to reconcile loss for the period to net cash used in operating activities:

        

Depreciation

     7,134       1,948       14,673       4,935  

Amortization

     587       589       1,755       1,750  

Net finance (income)/expenses

     (146,807     22,261       (30,748     58,607  

Share based payment expense

     4,096       696       29,377       2,265  

Increase in tax receivable

     (1,466     (4,666     (2,839     (9,208

Accrued preferred shares dividends

     5,445       5,445       16,156       16,215  

IFRS 2 charge for difference in fair value of shares deemed issued

     22,214       —         22,214       —    

Changes to working capital:

        

Inventories

     (4,188     (20,531     (92,995     (31,824

Trade and other receivables

     (26,093     (18,477     27,526       (12,534

Trade payables and other liabilities

     29,825       8,294       43,688       14,426  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Cash used in Operating Activities

     (24,480     (66,771     (82,380     (124,666
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Investing Activities

        

Purchases of property, plant, equipment

     (19,678     (9,120     (81,419     (35,655

Purchases of intangible assets

     —         (23     —         (45

Cash paid for business investments

     —         —         (1,968     —    

Cash received from merger

     38,244       —         38,244       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Cash generated from/(used in) Investing Activities

     18,566       (9,143     (45,143     (35,700
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash Flows from Financing Activities

        

Proceeds from issuance of convertible notes, net of issuance costs

     —         70,917       —         70,917  

Proceeds from debt issuance, net of issuance costs

     —         —         361,729       —    

Proceeds from shares issued on the exercise of share options

     —         15       —         15  

Repayment of principal portion of lease liabilities

     (2,572     (925     (4,830     (2,028

Cash interest paid, net of interest received

     (9,035     (4,026     (23,662     (7,894

Fee on early extinguishment of debt

     (37     —         (2,387     —    

Repayments of debt

     (66     (52     (140,286     (244
  

 

 

   

 

 

   

 

 

   

 

 

 

Net Cash (used in)/generated from Financing Activities

     (11,710     65,929       190,564       60,766  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (Decrease)/Increase in Cash and Cash Equivalents

     (17,624     (9,985     63,041       (99,600
  

 

 

   

 

 

   

 

 

   

 

 

 

Movement in Cash and Cash Equivalents

        

Cash and cash equivalents at the beginning of the period

     246,455       47,013       161,172       139,387  

Exchange gain/(loss) on cash and cash equivalents

     (11,104     521       (6,486     (2,238

Net increase/(decrease) in cash and cash equivalents

     (17,624     (9,985     63,041       (99,600
  

 

 

   

 

 

   

 

 

   

 

 

 

Cash and Cash Equivalents at the end of the period

   $ 217,727     $ 37,549     $ 217,727     $ 37,549  
  

 

 

   

 

 

   

 

 

   

 

 

 


LUMIRADX LIMITED

Reconciliation of IFRS Financial Measures to Non-IFRS Financial Measures

 

     THREE MONTHS ENDED SEPTEMBER 30,  
     Operating Loss     Net Income/(Loss)     Diluted EPS  
     2021     2020     2021     2020     2021     2020  
     (in thousands except share and per share data)  

IFRS Financial Measure

   $ (55,476   $ (39,097   $ 84,773     $ (62,330   $ 0.46     $ (0.47

Amortization

     717       609       717       609       —         —    

Share-based payments

     4,097       784       4,097       784       0.02       0.01  

SPAC merger transaction costs1

     30,809       —         30,809       —         0.17       —    

Change in fair value of financial instruments

     —         —         (162,317     29,740       (0.88     0.22  

Foreign exchange (gain)/loss

     —         —         18,095       (15,198     0.10       (0.11

Dividends on preferred shares

     —         —         (61,002     5,445       (0.33     0.04  

Non-cash interest

     —         —         55,009       3,877       0.30       0.03  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-IFRS Adjusted Financial Measure

   $ (19,853   $ (37,704   $ (29,819   $ (37,073   $ (0.16   $ (0.28
     NINE MONTHS ENDED SEPTEMBER 30,  
     Operating Loss     Net Income/(Loss)     Diluted EPS  
     2021     2020     2021     2020     2021     2020  
     (in thousands except share and per share data)  

IFRS Financial Measure

   $ (123,297   $ (103,619   $ (111,187   $ (169,298   $ (0.84   $ (1.28

Amortization

     1,885       1,769       1,885       1,769       0.02       0.01  

Share-based payments

     26,904       2,353       26,904       2,353       0.20       0.02  

SPAC merger transaction costs1

     30,809       —         30,809       —         0.23       —    

Change in fair value of financial instruments

     —         —         (102,065     29,740       (0.77     0.23  

Foreign exchange (gain)/loss

     —         —         13,267       11,058       0.10       0.08  

Dividends on preferred shares

     —         —         (50,291     16,215       (0.38     0.12  

Non-cash interest

     —         —         96,594       9,782       0.73       0.08  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Non-IFRS Adjusted Financial Measure

   $ (63,699   $ (99,497   $ (94,084   $ (98,381   $ (0.71   $ (0.74

 

1 - Includes an IFRS 2 charge of $22.2 million for the difference in the fair value of the shares deemed to have been issued by LumiraDx in the merger transaction to CA Healthcare shareholders and the net assets of CA Healthcare and $8.6 million of LumiraDx transaction costs.