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 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2022.

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
(354) 640-0540

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      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 9, 2022, LumiraDx Limited (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022. A copy of this press release is furnished as Exhibit 99.1 herewith.

The unaudited consolidated financial information contained in the press release attached as Exhibit 99.1 to this report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (File No: 333-259874 and File No. 333-264611), and the registration statement on Form F 3 (File No: 333-264609), and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently furnished.

EXHIBIT INDEX 

Exhibit No. Description
99.1 Press release issued by LumiraDx Limited on November 9, 2022.


SIGNATURES

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

 

  LumiraDx Limited     
    
  
Date: November 9, 2022 By:  /s/ Dorian LeBlanc    
  Name:Dorian LeBlanc
  Title:Chief Financial Officer
  
EdgarFiling

EXHIBIT 99.1

LumiraDx Reports Third Quarter 2022 Results

Progress on Near-Term Growth Opportunities and Cost Savings

LONDON, Nov. 09, 2022 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care (POC) diagnostics company, today announced operational and financial results for the third quarter ended September 30, 2022.

“We are commercializing our portfolio of newly authorized products while reducing our cost base significantly,” said LumiraDx Chairman and CEO Ron Zwanziger. “Recently we began shipments of our HbA1c fingerstick assay for diabetes in Europe, a key market for our strategy to enable primary care physicians to consolidate multiple POC diagnostic instruments and tests onto our Platform. We are also on track to launch our NT-ProBNP assay for congestive heart failure by the end of this year in European and international markets. We strengthened our market position by more than doubling the number of customer sites in the U.S. this year and are excited about the diversification of our installed base across health systems, primary care, pharmacy and enterprise settings to support U.S. opportunities beyond COVID testing. Restructuring efforts have enabled us to right-size operations to meet customer needs efficiently and focus R&D and business priorities on near-term growth opportunities.”

2022 Third Quarter Financial Highlights

The global restructuring plan to resize operations to current market requirements was fully implemented in the third quarter, and we have already implemented additional cost reductions to bring the expected savings to approximately $18 million per quarter. At the same time, we are making strategic use of resources to advance our near-term R&D pipeline of assays for common health conditions and commercialize new products to drive revenue growth.

For the three months ended September 30, 2022, LumiraDx delivered revenue of $42.2 million compared to $109.1 million for the third quarter of 2021. Platform test strip revenues were $26.9 million, and sales of instruments, accessories and other items related to our point of care Platform were $1.7 million. Our Fast Labs revenues were $9.0 million in the third quarter of 2022. Substantially all of the revenues for test strips and Fast Labs were derived from our COVID-19 products.

LumiraDx’s COVID products are recognized for their significant performance and cost advantages over competing POC options. As the overall market for COVID testing has dropped, we have retained revenue through expansion of customer sites and use cases in key markets including the U.S., U.K., Italy and Japan.

Total gross margins for the third quarter of 2022 were 20% compared to 11% in the second quarter of 2022 and 36% in the third quarter of last year. Inventory reserves of $9 million related primarily to COVID testing materials negatively impacted gross margins in the quarter. The impact of our global restructuring program is expected to reduce fixed manufacturing costs in the fourth quarter of this year.

Research and development expenses were $31.3 million in the third quarter of 2022. Our non-IFRS R&D expenses in the third quarter of 2022 were $29.2 million, a decrease of 35% from the second quarter of this year. We have prioritized R&D spend to focus on our near-term pipeline and U.S. 510(k) submissions for the back half of 2022 and into next year.

Third quarter 2022 sales, marketing and administrative expenses were $35.3 million.  Adjusted non-IFRS sales, marketing and administrative expenses, excluding amortization and share-based payment expenses, were $27.9 million in the third quarter of 2022 as compared with $23.8 million for the same period last year. Third quarter 2022 non-IFRS SG&A represents a 10% decrease compared to the second quarter of 2022, due to currency translation effects of a strong U.S. dollar and the partial period impact of our global restructuring program.

Operating loss for the third quarter of 2022 was $57.9 million compared with a $55.5 million loss for the same period last year. Third quarter 2022 non-IFRS operating loss of $47.9 million improved $22.6 million from a second quarter of 2022 non-IFRS operating loss of $70.5 million. We expect our global restructuring efforts will continue to support this improving trend as we focus strongly on our cash position.

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 investors.lumiradx.com/news-and-events/investor-calendar. A replay of the webcast will be available on the Investors section of the company's website at investors.lumiradx.com shortly after the conclusion of the call. The webcast will be archived for one year.

About LumiraDx

LumiraDx Limited (Nasdaq: LMDX) is next-generation point of care diagnostics company that is transforming community-based healthcare. Its actively controlled microfluidic technology provides fast, high performance and accessible diagnostic solutions wherever the patient is for nearly any testing scenario, creating unique testing options at the point of need. The company offers a broad menu of lab comparable tests on a single portable Platform, with more than 30 assays on the market and in the pipeline, covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders. The company also supports high-complexity laboratory testing in an accessible high-throughput format to leverage current molecular laboratory operations.

Founded in 2014 and based in the UK, LumiraDx's diagnostic testing solutions are being deployed globally by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to help screen, diagnose, and monitor wellness as well as disease. More information on LumiraDx 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, the timing and results of our clinical trials, the timing of commercial launch of certain products, the benefits and performance of our tests, and the expected timing and results of our cost-saving initiatives and global restructuring activities. 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 our Annual Report on Form 20-F for the year ended December 31, 2021,which was filed with the Securities and Exchange Commission, or SEC on April 13, 2022, in our report on Form 6-K that was filed with the SEC on August 16, 2022, and in other filings that we make 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 define non-IFRS expenses as expenses excluding amortization and share-based payments. 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 
         
  SEPTEMBER 30, 2022  DECEMBER 31, 2021 
  (in thousands) 
ASSETS        
Non–Current Assets        
Other non-current assets $452  $569 
Intangibles and goodwill  30,560   37,048 
Right-of-use Assets  21,919   27,746 
Property, plant and equipment  153,792   173,397 
Total Non-Current Assets  206,723   238,760 
Current Assets        
Inventories  158,609   149,055 
Tax receivable  15,172   15,022 
Trade and other receivables  52,940   109,798 
Cash and cash equivalents  135,265   132,145 
Total Current Assets  361,986   406,020 
TOTAL ASSETS $568,709  $644,780 
LIABILITIES AND EQUITY        
Liabilities        
Non-Current Liabilities        
Debt due after more than one year $(358,397) $(301,129)
Other long term liabilities  (46,488)  - 
Lease liabilities  (20,476)  (25,514)
Stock warrants  (632)  (10,407)
Deferred tax liabilities  (408)  (779)
Total Non-Current Liabilities  (426,401)  (337,829)
Current Liabilities        
Debt due within one year  (109)  (191)
Government and other grants  (30,685)  (38,941)
Trade and other payables  (87,205)  (99,641)
Lease liabilities due within one year  (6,495)  (5,582)
Total Current Liabilities  (124,494)  (144,355)
Equity        
Share capital and share premium  (853,508)  (754,023)
Foreign currency translation reserve  (56,030)  19,706 
Other reserves  (104,957)  (104,957)
Accumulated deficit  996,416   676,223 
Total equity attributable to equity holders of the parent  (18,079)  (163,051)
Non-controlling interests  265   455 
Total Equity  (17,814)  (162,596)
TOTAL EQUITY AND LIABILITIES $(568,709) $(644,780)


  
  
LUMIRADX LIMITED 
Unaudited Consolidated Statement of Profit and Loss and Comprehensive Income 
                 
  THREE MONTHS ENDED SEPTEMBER 30,  NINE MONTHS ENDED SEPTEMBER 30, 
  2022  2021  2022  2021 
  (in thousands, except share and per share data) 
Revenue $42,218  $109,081  $213,356  $303,175 
Cost of sales  (33,585)  (70,241)  (149,860)  (206,155)
Gross Profit  8,633   38,840   63,496   97,020 
Research and development expenses  (31,255)  (35,396)  (120,024)  (96,399)
Selling, marketing and administrative expenses  (35,312)  (28,111)  (113,313)  (93,109)
Listing expenses  -   (30,809)  -   (30,809)
Operating Loss  (57,934)  (55,476)  (169,841)  (123,297)
Finance income  4,830   226,196   9,914   166,246 
Finance expense  (88,184)  (37,317)  (183,444)  (103,949)
Net finance expense  (83,354)  188,879   (173,530)  62,297 
Gain/(Loss) before Tax  (141,288)  133,403   (343,371)  (61,000)
Tax (provision)/credit for the period  (2,143)  (994)  (3,628)  (2,551)
Gain/(Loss) for the period $(143,431) $132,409  $(346,999) $(63,551)
Gain attributable to non-controlling interest  51   -   190   322 
Net gain/(loss) attributable to equity holders of parent—basic and diluted $(143,482) $132,409  $(347,189) $(63,873)
Net gain/(loss) per share attributable to equity holders of parent—basic $(0.47) $0.99  $(1.28) $(0.48)
Net gain/(loss) per share attributable to equity holders of parent—diluted $(0.47) $0.72  $(1.28) $(0.48)
Weighted-average number of Ordinary Shares used in loss per share—basic  304,414,189   133,546,183   270,844,070   132,649,878 
Weighted-average number of Ordinary Shares used in loss per share—diluted  304,414,189   183,227,228   270,844,070   132,649,878 


  
  
LUMIRADX LIMITED 
Unaudited Reconciliation of IFRS Financial Measures to Non-IFRS Financial Measures 
                                 
  THREE MONTHS ENDED SEPTEMBER 30,         
  Cost of Goods Sold  Research and Development  Selling, Marketing and Administrative         
  2022  2021  2022  2021  2022  2021         
  (in thousands)         
IFRS Financial Measure $(33,585) $(70,241) $(31,255) $(35,396) $(35,312) $(28,111)        
Amortization  -   -   37   43   432   673         
Share-based payments  553   -   2,028   422   6,998   3,674         
Non-IFRS Adjusted Financial Measure $(33,032) $(70,241) $(29,190) $(34,931) $(27,882) $(23,764)        
                                 
                                 
                                 
  THREE MONTHS ENDED SEPTEMBER 30, 
  Gross Margin  Operating Loss  Net Loss  Diluted EPS 
  2022  2021  2022  2021  2022  2021  2022  2021 
  (in thousands, except per share data) 
IFRS Financial Measure $8,633  $38,840  $(57,934) $(55,476) $(143,431) $132,409  $(0.47) $0.99 
Amortization  -   -   469   716   469   716   -   0.02 
Share-based payments  553   -   9,579   4,096   9,579   4,096   0.03   0.03 
Listing Charge1  -   -   -   30,809   -   30,809   -   0.23 
Change in fair value of financial instruments  -   -   -   -   (4,830)  (226,460)  (0.01)  (1.70)
Foreign exchange loss/(gain)2  -   -   -   -   71,284   18,095   0.23   0.13 
Dividends on preferred shares  -   -   -   -   -   5,445   -   0.04 
Non-cash interest  -   -   -   -   4,156   4,002   0.01   0.03 
Non-IFRS Adjusted Financial Measure $9,186  $38,840  $(47,886) $(19,855) $(62,773) $(30,888) $(0.21) $(0.23)
Adjusted Gross Profit Margin  22%  36%                        
                                 
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
2 - Net foreign currency exchange losses relate to transactions and asset and liability balances denominated in currencies other than the U.S. dollar, primarily related to the revaluation of long term balances between group subsidiaries of different functional currencies
         


            
            
  NINE MONTHS ENDED SEPTEMBER 30,         
  Cost of Goods Sold  Research and Development  Selling, Marketing and Administrative         
  2022  2021  2022  2021  2022  2021         
  (in thousands)         
IFRS Financial Measure $(149,860) $(206,155) $(120,024) $(96,399) $(113,313) $(93,109)        
Amortization  -   -   117   131   1,374   1,753         
Share-based payments  1,577   -   5,808   1,469   19,611   27,908         
Non-IFRS Adjusted Financial Measure $(148,283) $(206,155) $(114,099) $(94,799) $(92,328) $(63,448)        
                                 
                                 
  NINE MONTHS ENDED SEPTEMBER 30, 
  Gross Margin  Operating Loss  Net Loss  Diluted EPS 
  2022  2021  2022  2021  2022  2021  2022  2021 
  (in thousands, except per share data) 
IFRS Financial Measure $63,496  $97,020  $(169,841) $(123,297) $(346,999) $(63,551)  (1.28)  (0.48)
Amortization  -   -   1,491   1,884   1,491   1,884   0.01   0.01 
Share-based payments  1,577   -   26,996   29,377   26,996   29,377   0.10   0.22 
Listing Charge1  -   -   -   30,809   -   30,809   -   0.24 
Change in fair value of financial instruments  -   -   -   -   (9,775)  (166,208)  (0.05)  (1.25)
Foreign exchange loss/(gain)2  -   -   -   -   146,005   13,267   0.55   0.10 
Dividends on preferred shares  -   -   -   -   -   16,156   -   0.12 
Non-cash interest  -   -   -   -   7,825   46,654   0.03   0.35 
Non-IFRS Adjusted Financial Measure $65,073  $97,020  $(141,354) $(61,227) $(174,457) $(91,612) $(0.64) $(0.69)
Adjusted Gross Profit Margin  30%  32%                        
                                 
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
2 - Net foreign currency exchange losses relate to transactions and asset and liability balances denominated in currencies other than the U.S. dollar, primarily related to the revaluation of long term balances between group subsidiaries of different functional currencies
         


  
  
LUMIRADX LIMITED 
Unaudited Consolidated Statement of Cash Flows 
  THREE MONTHS ENDED  NINE MONTHS ENDED 
  SEPTEMBER 30,  SEPTEMBER 30, 
  2022  2021  2022  2021 
  (in thousands, except share and per share data) 
Cash Flows from Operating Activities                
Income/(Loss) for the period $(143,431) $132,409  $(346,999) $(63,551)
Adjustments to reconcile loss for the period to net cash used in operating activities:                
Depreciation  7,459   7,134   22,883   14,673 
Amortization  469   716   1,491   1,884 
Net finance (income)/expenses  83,022   (194,443)  172,659   (78,384)
Equity based share based payment transactions  9,579   4,096   26,996   29,377 
Increase in tax receivable  (742)  (1,466)  (2,777)  (2,839)
Accrued preferred shares dividends  -   5,445   -   16,156 
Listing charge      22,214   -   22,214 
Changes to working capital:                
Inventories  (2,267)  (4,188)  (34,558)  (92,995)
Trade and other receivables  5,694   (26,093)  48,865   27,526 
Trade payables and other liabilities  (9,899)  29,825   (23,116)  43,688 
Net Cash used in Operating Activities  (50,116)  (24,351)  (134,556)  (82,251)
Cash Flows from Investing Activities                
Purchases of property, plant, equipment  (5,879)  (19,678)  (22,606)  (81,419)
Cash paid for business acquisitions, net of cash received  -   38,244   -   36,276 
Net Cash generated from/(used in) Investing Activities  (5,879)  18,566   (22,606)  (45,143)
Cash Flows from Financing Activities                
Proceeds from issuance of convertible notes, net of issuance costs  -   -   54,009   - 
Proceeds from issuance of common stock, net of issuance costs  98,033   -   98,033   - 
Proceeds from instrument financing agreement  -   -   41,500   - 
Proceeds from debt issuance, net of issuance costs  -   -   -   361,729 
Shares issued on the exercise of share options  1,885   -   5,976   - 
Repayment of principal portion of lease liabilities  (1,357)  (2,572)  (4,333)  (4,830)
Cash interest paid, net of interest received  (8,173)  (9,035)  (20,424)  (23,662)
Early extinguishment of debt  -   (37)  -   (2,387)
Repayments of debt  28   (66)  (91)  (140,286)
Net Cash (used in)/generated from Financing Activities  90,416   (11,710)  174,670   190,564 
Net (Decrease)/Increase in Cash and Cash Equivalents $34,421  $(17,495) $17,508  $63,170 
Movement in Cash and Cash Equivalents                
Cash and cash equivalents at the beginning of the period  106,450   246,455   132,145   161,172 
Exchange gain/(loss) on cash and cash equivalents  (5,606)  (11,233)  (14,388)  (6,615)
Net increase/(decrease) in cash and cash equivalents  34,421   (17,495)  17,508   63,170 
Cash and Cash Equivalents at the end of the period $135,265  $217,727  $135,265  $217,727