LumiraDx Reports Second Quarter 2023 Results
- Submitted First 510(k) Application to the U.S. FDA for 5-minute COVID Ultra test
- Submitted COVID/Flu combo test for FDA EUA
- More than 1,500 new instruments shipped in Q2
- Q2 revenues decreased from $44.7M to $21.0M
- IFRS gross profit was a loss of $9.9M
- Net loss for the quarter was $49.7M
- Cash balance at June 30, 2023, was $25.3M
LONDON, Aug. 24, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (NASDAQ: LMDX), a next-generation point of care (POC) diagnostics company, today announced financial results for its second quarter ended June 30, 2023.
- Second quarter 2023 revenues of
$21.0 million - Submitted First 510(k) Application to the U.S. Food and Drug Administration (FDA) for 5-minute COVID Ultra test
- Submitted COVID/Flu combo test for FDA Emergency Use Authorization (EUA) as part of the NIH's Independent Test Assessment (ITAP) program
- More than 1,500 new instruments shipped in Q2, primarily to U.S. pharmacy locations to expand testing capacity for the upcoming respiratory season
Ron Zwanziger, Chairman and CEO of LumiraDx, stated, "The submission of our first 510(k) application to the FDA for our COVID Ultra test represents a significant milestone in our ability to deliver on product expansion into the U.S. and could pave the way for additional submissions of other high performing assays on our Platform, many of which are already available in Europe and elsewhere and others which are in late stages of development. In addition, we are seeing revenues from our non-COVID products continue to grow, with the second quarter marking our highest quarter to date for non-COVID revenues. As we continue to innovate and expand our portfolio, we remain dedicated to transforming healthcare delivery worldwide.”
2023 Second Quarter Financial Highlights
For the three months ended June 30, 2023, LumiraDx delivered revenue of
IFRS gross profit was a loss of
Research and development expenses were
Sales, marketing and administrative expenses were
The continued reductions in operating expenses reflect the impact of the Company’s restructuring programs.
Net loss for the quarter was
At June 30, 2023, the company’s cash balance was
Recent Developments
On July 20, 2023, we entered into a ninth amendment and waiver to that certain Loan Agreement, dated March 23, 2021 (as amended from time to time, the “Loan Agreement”), with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, as lenders, and BioPharma Credit PLC, as collateral agent (the “Ninth Amendment”). The Ninth Amendment provides additional term loans in an aggregate amount of up to
We continue to work with various strategic advisors on the previously disclosed strategic review of our business and we are also engaged in discussions with our senior lender about the terms of the Loan Agreement, including the covenants in the Ninth Amendment which are scheduled to be measured on September 1, 2023.
In August 2023, we completed the divestiture of INRstar, a patient reporting and decision support tool, as part of our ongoing efforts to reduce costs and focus available resources on the launch of high value assays.
We are pleased to announce the appointment of Giffin Daughtridge as President, North America Commercial Operations, and Global Molecular Solutions, effective as of August 1, 2023. Peter Scheu, the previous President, North America Commercial Operations, resigned from his role effective August 1, 2023 but continues to support LumiraDx in an advisory capacity.
Conference Call
LumiraDx will host a conference call to discuss these results today at 8:30 a.m. Eastern Time / 1:30 p.m. United Kingdom Time. 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 a 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 various stages of development, 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.
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 outcome of the strategic review process, our ability to renegotiate the terms of the Loan Agreement with our senior lender, the timing of commercial launch of certain products, the benefits and performance of our tests, the expected timing and results of our cost-saving initiatives and global restructuring activities, and the timing, scope or likelihood of regulatory submissions, filings, approvals, authorizations, certifications, clinical trials or clearances, including our ability to successfully transition any test that has previously been authorized by the FDA under an EUA declaration related to COVID-19, to the required FDA marketing submission (e.g., 510(k), de novo or PMA) on a timely basis, or at all. 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; changes in interest rates, inflation rates and global and domestic market conditions; the effect of COVID-19 on our business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission, or SEC, on May 1, 2023, 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 loss as operating loss and net loss, respectively, excluding depreciation, amortization, share-based payments, change in fair value of financial instruments, foreign exchange (gain)/loss, restructuring and severance payments and non-cash interest. We define non-IFRS expenses as expenses excluding depreciation, amortization, restructuring and severance payments 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 | ||||||||
| JUNE 30, 2023 | DECEMBER 31, 2022 | |||||||
| (in thousands) | ||||||||
| ASSETS | ||||||||
| Non–Current Assets | ||||||||
| Other non-current assets | $ | 798 | $ | 497 | ||||
| Intangibles and goodwill | 32,331 | 32,170 | ||||||
| Right-of-Use Assets | 14,035 | 16,580 | ||||||
| Property, plant and equipment | 106,827 | 113,406 | ||||||
| Investment in sublease | 11,526 | 11,421 | ||||||
| Total Non-Current Assets | 165,517 | 174,074 | ||||||
| Current Assets | ||||||||
| Inventories | 85,191 | 89,965 | ||||||
| Tax receivable | 25,207 | 20,987 | ||||||
| Trade and other receivables | 39,569 | 55,977 | ||||||
| Cash and cash equivalents | 25,343 | 100,010 | ||||||
| Total Current Assets | 175,310 | 266,939 | ||||||
| TOTAL ASSETS | $ | 340,827 | $ | 441,013 | ||||
| LIABILITIES AND EQUITY | ||||||||
| Liabilities | ||||||||
| Non-Current Liabilities | ||||||||
| Debt due after more than one year | $ | (372,346 | ) | $ | (366,479 | ) | ||
| Long term grants | (14,446 | ) | (15,769 | ) | ||||
| Other long term liabilities | (57,763 | ) | (49,158 | ) | ||||
| Lease liabilities | (21,562 | ) | (22,303 | ) | ||||
| Stock warrants | (172 | ) | (339 | ) | ||||
| Deferred tax liabilities | (260 | ) | (542 | ) | ||||
| Total Non-Current Liabilities | (466,549 | ) | (454,590 | ) | ||||
| Current Liabilities | ||||||||
| Debt due within one year | (2 | ) | (76 | ) | ||||
| Government and other grants | (14,163 | ) | (16,296 | ) | ||||
| Trade and other payables | (65,993 | ) | (66,277 | ) | ||||
| Lease liabilities due within one year | (8,847 | ) | (9,149 | ) | ||||
| Total Current Liabilities | (89,005 | ) | (91,798 | ) | ||||
| Equity | ||||||||
| Share capital and share premium | (858,429 | ) | (858,085 | ) | ||||
| Foreign currency translation reserve | 5,835 | (20,026 | ) | |||||
| Other reserves | (105,585 | ) | (105,585 | ) | ||||
| Accumulated deficit | 1,172,788 | 1,088,804 | ||||||
| Total equity attributable to equity holders of the parent | 214,609 | 105,108 | ||||||
| Non-controlling interests | 118 | 267 | ||||||
| Total Equity | 214,727 | 105,375 | ||||||
| TOTAL EQUITY AND LIABILITIES | $ | (340,827 | ) | $ | (441,013 | ) | ||
| LUMIRADX LIMITED | ||||||||||||||||
| Unaudited Consolidated Statement of Profit and Loss and Comprehensive Income | ||||||||||||||||
| THREE MONTHS ENDED JUNE 30, | SIX MONTHS ENDED JUNE 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| Revenue | $ | 21,004 | $ | 44,726 | $ | 43,177 | $ | 171,138 | ||||||||
| Cost of sales | (30,905 | ) | (39,889 | ) | (54,836 | ) | (116,275 | ) | ||||||||
| Gross (Loss)/Profit | (9,901 | ) | 4,837 | (11,659 | ) | 54,863 | ||||||||||
| Gross Margin | -47 | % | 11 | % | -27 | % | 32 | % | ||||||||
| Research and development expenses | (15,834 | ) | (47,450 | ) | (35,315 | ) | (88,769 | ) | ||||||||
| Selling, marketing and administrative expenses | (22,695 | ) | (37,845 | ) | (48,671 | ) | (78,001 | ) | ||||||||
| Operating Loss | (48,430 | ) | (80,458 | ) | (95,645 | ) | (111,907 | ) | ||||||||
| Finance income | 18,105 | 188 | 36,787 | 5,139 | ||||||||||||
| Finance expense | (19,057 | ) | (67,858 | ) | (34,167 | ) | (95,315 | ) | ||||||||
| Net finance income / (expense) | (952 | ) | (67,670 | ) | 2,620 | (90,176 | ) | |||||||||
| Loss before Tax | (49,382 | ) | (148,128 | ) | (93,025 | ) | (202,083 | ) | ||||||||
| Tax (provision) / credit for the period | (294 | ) | 732 | (774 | ) | (1,485 | ) | |||||||||
| Loss for the period | $ | (49,676 | ) | $ | (147,396 | ) | $ | (93,799 | ) | $ | (203,568 | ) | ||||
| Gain attributable to non-controlling interest | 61 | 61 | 149 | 139 | ||||||||||||
| Net loss attributable to equity holders of parent—basic and diluted | $ | (49,737 | ) | $ | (147,457 | ) | $ | (93,948 | ) | $ | (203,707 | ) | ||||
| Net loss per share attributable to equity holders of parent—basic and diluted | $ | (0.16 | ) | $ | (0.58 | ) | $ | (0.29 | ) | $ | (0.80 | ) | ||||
| Weighted-average number of Ordinary and Common shares used in loss per share—basic and diluted | 318,881,049 | 254,686,967 | 318,843,574 | 253,945,274 | ||||||||||||
| LUMIRADX LIMITED | ||||||||||||||||||||||||||||||||
| Unaudited Reconciliation of IFRS Financial Measures to Non-IFRS Financial Measures | ||||||||||||||||||||||||||||||||
| THREE MONTHS ENDED JUNE 30, | ||||||||||||||||||||||||||||||||
| Cost of Goods Sold | Research and Development | Selling, Marketing and Administrative | ||||||||||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||||||||
| IFRS Financial Measure | $ | (30,905 | ) | $ | (39,889 | ) | $ | (15,834 | ) | $ | (47,450 | ) | $ | (22,695 | ) | $ | (37,845 | ) | ||||||||||||||
| Depreciation1 | 1,902 | 3,982 | 1,943 | 2,386 | 756 | 681 | ||||||||||||||||||||||||||
| Amortization | - | - | 40 | 39 | 480 | 459 | ||||||||||||||||||||||||||
| Restructuring & Severance | 863 | - | 892 | - | 1,105 | - | ||||||||||||||||||||||||||
| Share-based payments | 519 | 621 | (1,364 | ) | 2,266 | 2,792 | 6,554 | |||||||||||||||||||||||||
| Non-IFRS Adjusted Financial Measure | $ | (27,621 | ) | $ | (35,286 | ) | $ | (14,323 | ) | $ | (42,759 | ) | $ | (17,562 | ) | $ | (30,151 | ) | ||||||||||||||
| 1 - Net of grants for capital equipment | ||||||||||||||||||||||||||||||||
| THREE MONTHS ENDED JUNE 30, | ||||||||||||||||||||||||||||||||
| Gross Margin | Operating Loss | Net Loss | Diluted EPS | |||||||||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||||||||||||||||||
| IFRS Financial Measure | $ | (9,901 | ) | $ | 4,837 | $ | (48,430 | ) | $ | (80,458 | ) | $ | (49,676 | ) | $ | (147,396 | ) | $ | (0.16 | ) | $ | (0.58 | ) | |||||||||
| Depreciation1 | 1,902 | 3,982 | 4,601 | 7,049 | 4,601 | 7,049 | 0.02 | 0.03 | ||||||||||||||||||||||||
| Amortization | - | - | 520 | 498 | 520 | 498 | - | - | ||||||||||||||||||||||||
| Share-based payments | 519 | 621 | 1,947 | 9,441 | 1,947 | 9,441 | 0.01 | 0.04 | ||||||||||||||||||||||||
| Change in fair value of financial instruments | - | - | - | - | 7,068 | 2,083 | 0.02 | 0.01 | ||||||||||||||||||||||||
| Foreign exchange loss/(gain) | - | - | - | - | (17,573 | ) | 55,512 | (0.06 | ) | 0.22 | ||||||||||||||||||||||
| Restructuring & Severance | 863 | - | 2,860 | - | - | - | - | - | ||||||||||||||||||||||||
| Non-cash interest | - | - | - | - | 2,888 | 1,890 | 0.01 | - | ||||||||||||||||||||||||
| Non-IFRS Adjusted Financial Measure | $ | (6,617 | ) | $ | 9,440 | $ | (38,502 | ) | $ | (63,470 | ) | $ | (50,225 | ) | $ | (70,923 | ) | $ | (0.16 | ) | $ | (0.28 | ) | |||||||||
| Adjusted Gross Profit Margin | -32 | % | 21 | % | ||||||||||||||||||||||||||||
| 1 - Net of grants for capital equipment | ||||||||||||||||||||||||||||||||
| SIX MONTHS ENDED JUNE 30, | ||||||||||||||||||||||||||||||||
| Cost of Goods Sold | Research and Development | Selling, Marketing and Administrative | ||||||||||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||||||||
| IFRS Financial Measure | $ | (54,836 | ) | $ | (116,275 | ) | $ | (35,315 | ) | $ | (88,769 | ) | $ | (48,671 | ) | $ | (78,001 | ) | ||||||||||||||
| Depreciation1 | 3,708 | 4,430 | 4,640 | 4,812 | 1,475 | 1,392 | ||||||||||||||||||||||||||
| Amortization | - | - | 80 | 81 | 939 | 942 | ||||||||||||||||||||||||||
| Restructuring & Severance | 1,002 | - | 892 | - | 1,148 | - | ||||||||||||||||||||||||||
| Share-based payments | 839 | 1,024 | 535 | 3,780 | 8,591 | 12,613 | ||||||||||||||||||||||||||
| Non-IFRS Adjusted Financial Measure | $ | (49,287 | ) | $ | (110,821 | ) | $ | (29,168 | ) | $ | (80,096 | ) | $ | (36,518 | ) | $ | (63,054 | ) | ||||||||||||||
| 1 - Net of grants for capital equipment | ||||||||||||||||||||||||||||||||
| SIX MONTHS ENDED JUNE 30, | ||||||||||||||||||||||||||||||||
| Gross Margin | Operating Loss | Net Loss | Diluted EPS | |||||||||||||||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | 2023 | 2022 | |||||||||||||||||||||||||
| (in thousands, except per share data) | ||||||||||||||||||||||||||||||||
| IFRS Financial Measure | $ | (11,659 | ) | $ | 54,863 | $ | (95,645 | ) | $ | (111,907 | ) | $ | (93,799 | ) | $ | (203,568 | ) | (0.29 | ) | (0.80 | ) | |||||||||||
| Depreciation1 | 3,708 | 4,430 | 9,823 | 10,634 | 9,823 | 10,634 | 0.03 | 0.04 | ||||||||||||||||||||||||
| Amortization | - | - | 1,019 | 1,023 | 1,019 | 1,023 | - | - | ||||||||||||||||||||||||
| Share-based payments | 839 | 1,024 | 9,965 | 17,417 | 9,965 | 17,417 | 0.03 | 0.07 | ||||||||||||||||||||||||
| Change in fair value of financial instruments | - | - | - | - | 11,469 | (3,333 | ) | 0.03 | (0.01 | ) | ||||||||||||||||||||||
| Foreign exchange (gain)/loss | - | - | - | - | (35,636 | ) | 74,721 | (0.11 | ) | 0.29 | ||||||||||||||||||||||
| Restructuring & Severance | 787 | - | 3,419 | - | 3,419 | - | 0.01 | - | ||||||||||||||||||||||||
| Non-cash interest | - | - | - | - | 5,809 | 3,669 | 0.02 | 0.02 | ||||||||||||||||||||||||
| Non-IFRS Adjusted Financial Measure | $ | (6,325 | ) | $ | 60,317 | $ | (71,419 | ) | $ | (82,833 | ) | $ | (87,931 | ) | $ | (99,437 | ) | $ | (0.28 | ) | $ | (0.39 | ) | |||||||||
| Adjusted Gross Profit Margin | -15 | % | 35 | % | ||||||||||||||||||||||||||||
| 1 - Net of grants for capital equipment | ||||||||||||||||||||||||||||||||
| LUMIRADX LIMITED | ||||||||||||||||
| Unaudited Consolidated Statement of Cash Flows | ||||||||||||||||
| THREE MONTHS ENDED | SIX MONTHS ENDED | |||||||||||||||
| JUNE 30, | JUNE 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (in thousands) | ||||||||||||||||
| Cash Flows from Operating Activities | ||||||||||||||||
| Loss for the period | $ | (49,676 | ) | $ | (147,396 | ) | $ | (93,799 | ) | $ | (203,568 | ) | ||||
| Adjustments to reconcile loss for the period to net cash used in operating activities: | ||||||||||||||||
| Depreciation | 7,615 | 7,501 | 14,816 | 15,381 | ||||||||||||
| Amortization | 524 | 498 | 1,019 | 1,023 | ||||||||||||
| Net finance expenses | 7,437 | 67,102 | 4,423 | 89,637 | ||||||||||||
| Equity based share based payment transactions | 1,947 | 9,441 | 9,965 | 17,417 | ||||||||||||
| Increase in tax receivable | (424 | ) | (565 | ) | (3,238 | ) | (2,035 | ) | ||||||||
| Changes to working capital: | ||||||||||||||||
| Inventories | 5,487 | (13,684 | ) | 5,896 | (32,292 | ) | ||||||||||
| Trade and other receivables | 567 | 11,331 | 15,433 | 43,171 | ||||||||||||
| Trade payables and other liabilities | (527 | ) | (17,015 | ) | (6,553 | ) | (13,217 | ) | ||||||||
| Net Cash used in Operating Activities | (27,050 | ) | (82,787 | ) | (52,038 | ) | (84,483 | ) | ||||||||
| Cash Flows from Investing Activities | ||||||||||||||||
| Purchases of property, plant, equipment | (821 | ) | (6,465 | ) | (2,555 | ) | (16,727 | ) | ||||||||
| Net Cash used in Investing Activities | (821 | ) | (6,465 | ) | (2,555 | ) | (16,727 | ) | ||||||||
| Cash Flows from Financing Activities | ||||||||||||||||
| Proceeds from issuance of convertible notes, net of issuance costs | - | (316 | ) | - | 54,009 | |||||||||||
| Proceeds from royalty agreement | - | 41,500 | - | 41,500 | ||||||||||||
| Shares issued on the exercise of share options | - | 3,017 | - | 4,091 | ||||||||||||
| Shares issued on employee stock purchase plan | 174 | - | 344 | - | ||||||||||||
| Receipt of principal portion of lease receivable | 149 | - | 764 | - | ||||||||||||
| Cash interest paid, net of interest received | (13,428 | ) | (6,151 | ) | (20,062 | ) | (12,251 | ) | ||||||||
| Repayment of principal portion of lease liabilities | (1,604 | ) | (1,407 | ) | (3,872 | ) | (2,946 | ) | ||||||||
| Repayments of debt | (74 | ) | (35 | ) | (74 | ) | (118 | ) | ||||||||
| Net Cash (used in)/generated from Financing Activities | (14,783 | ) | 36,608 | (22,900 | ) | 84,285 | ||||||||||
| Net Decrease in Cash and Cash Equivalents | $ | (42,654 | ) | $ | (52,644 | ) | $ | (77,493 | ) | $ | (16,925 | ) | ||||
| Movement in Cash and Cash Equivalents | ||||||||||||||||
| Cash and cash equivalents at the beginning of the period | 68,051 | 166,046 | 100,010 | 132,145 | ||||||||||||
| Exchange gain/(loss) on cash and cash equivalents | (54 | ) | (6,952 | ) | 2,826 | (8,770 | ) | |||||||||
| Net decrease in cash and cash equivalents | (42,654 | ) | (52,644 | ) | (77,493 | ) | (16,925 | ) | ||||||||
| Cash and Cash Equivalents at the end of the period | $ | 25,343 | $ | 106,450 | $ | 25,343 | $ | 106,450 | ||||||||
