Cayman Islands | 2834 | Not Applicable | ||
(State or other jurisdiction of incorporation or organization) | (Primary Standard Industrial Classification Code Number) | (I.R.S. Employer Identification Number) |
John J. Satory Ian Lopez Fried, Frank, Harris, Shriver & Jacobson (London) LLP 100 Bishopsgate London EC2N 4AG United Kingdom Telephone: +44 20 7972-9600 | Simon Raftopoulos Appleby (Cayman) Ltd 71 Fort Street, PO Box 190 Grand Cayman, KY1-1104 Telephone: +1 345 949-4900 | Denny Won Kristin VanderPas Charles S. Kim Dave Peinsipp Cooley LLP 3 Embarcadero Center, 20th Floor San Francisco, California 94111 (415) 693-2000 |
Per Common Share | Total | |||||||
Public offering price | $ | $ | ||||||
Underwriting discounts and commissions (1) | $ | $ | ||||||
Proceeds, before expenses, to LumiraDx Limited | $ | $ | ||||||
| (1) | See the section titled “Underwriting” for a description of the compensation payable to the underwriters. |
Goldman Sachs & Co. LLC | Evercore ISI | SVB Securities | Raymond James |
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F-1 |
| • | Offer a comprehensive menu of high-performance diagnostic tests for community-based healthcare settings. |
community-based healthcare on a single Platform is critical to transform the POC market. We are executing a global market-driven menu strategy designed to drive the conversion of our customers’ testing needs onto our Platform. Our tests, both cleared and in development, are initially focused on the most common medical conditions for certain respiratory disease, cardiovascular disease, diabetes, and coagulation disorders. Our portfolio includes high-volume tests currently available at the POC (e.g., INR, HbA1c, CRP), tests that currently do not have a viable POC solution (e.g., FDA-defined high-sensitivity Troponin I), and innovative diagnostic test panels, such as Flu A/B +SARS-CoV-2. |
| • | Grow our installed base by executing an institutional sales and channel partnership model. |
| • | Expand into additional healthcare settings and underserved markets. home-use settings. We plan further enhancements to our Platform, such as making the Instrument more robust to enable use in more challenging settings such as in areas of extreme heat and dust. |
| • | Continue to innovate to expand into specialty areas. in-patient hospital, that could benefit from fast, accurate diagnostic test results from our Platform. |
| • | Continue to innovate across our Platform. |
| • | Continue to expand use of our technology and apply it to non-healthcare settings and applications such as mass population screening and home-testing, initially through the potential commercial launch of our Amira System.SARS-CoV-2 COVID-19. We plan to distribute the AmiraSARS-CoV-2 COVID-19 pandemic in high burden countries as well as to support a continued safere-opening of economies, subject to regulatory approval, authorization, certification or clearance. |
| • | We are at a pivotal point in the commercialization of our Platform, and we may not succeed for a variety of reasons. |
| • | Our short-term revenue prospects will vary with the amount of demand for COVID-19 tests generally and our tests in particular, including as a result of the presence of variants, which may be further adversely impacted by wide-spread implementation of authorized vaccines or other vaccines or boosters that are subsequently approved or authorized. |
| • | Our SARS-CoV-2 SARS-CoV-2 |
| • | Our strategy to globally launch a broad menu of tests may not be as successful as currently envisioned. |
| • | We may not be able to generate sufficient revenue from our Platform to achieve and maintain profitability. |
| • | Our borrowing arrangements contain restrictions that limit our flexibility in operating our business, and failure to comply with any of these restrictions could result in acceleration of our debt. |
| • | As a result of our debt covenants, our consolidated financial statements contain a statement regarding a material uncertainty that may cast significant doubt about our ability to continue as a going concern. |
| • | Business or economic disruptions or global health concerns, such as the ongoing COVID-19 pandemic, have harmed and may continue to seriously harm our business and increase our costs and expenses. |
| • | We rely on a limited number of suppliers or, in some cases, sole source suppliers, for the components of our Platform and our Amira System and for other materials and may not be able to find replacements or immediately transition to alternative suppliers. |
| • | As we continue to expand our business, we may experience problems in scaling our manufacturing and commercial operations, and if we are unable to support demand for our Platform, our Amira System or our test strips, including ensuring that we have adequate capacity to meet increased demand, if any, or we are unable to successfully manage the evolution of our Platform or our Amira System, our business could suffer. |
| • | Our business and reputation will suffer if our products do not perform as expected. |
| • | We currently derive a significant portion of our revenue from a small number of tests and key customers, and loss of any of these customers could cause a material reduction in revenues. |
A significant portion of our revenue remains COVID-19 related, and we may not be able to scale other assays sufficiently fast. |
| • | The loss of any member of our senior management team or our inability to attract and retain highly skilled scientists, engineers, software developers, technicians and salespeople could adversely affect our business. |
| • | Our business and the sale of our products are subject to extensive regulatory requirements and there is a new regulatory framework which entered into application in the European Union on May 26, 2022, which could delay or otherwise impact our ability to obtain certification of new products and, after a transitionary period, of existing products and consequently our ability to continue to commercialize such products could be affected, impacting revenues. |
| • | If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue or achieve profitability. |
| • | The dual class structure of our ordinary shares and our common shares has the effect of concentrating voting control with those holders of our share capital prior to the merger of our wholly owned subsidiary, then known as LumiraDx Merger Sub, Inc., with and into CA Healthcare Acquisition Corp. (“CAH”), a Delaware corporation (the “Merger”). |
| • | If we are unable to obtain and maintain patent and other intellectual property protection for our products and technology, our ability to successfully commercialize any products we develop may be adversely affected. |
| • | If we experience a significant disruption in the expansion of our operations for any reason, our ability to continue to operate our business and meet increased demand could be materially harmed. |
| • | We have identified material weaknesses in our internal control over financial reporting and if our remediation of such material weaknesses is not effective, or if we fail to develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired. |
| • | Investors should not rely on prior financial projections used by CAH in connection with the Merger. |
| • | to the extent that we no longer qualify as a foreign private issuer, (i) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (ii) exemptions from the requirement to hold a non-binding advisory vote on executive compensation, including golden parachute compensation; |
| • | an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”); and |
| • | an exemption from compliance with the requirement that the Public Company Accounting Oversight Board has adopted regarding a supplement to the auditor’s report providing additional information about the audit and the financial statements. |
| • | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act; |
| • | the requirement to comply with Regulation FD, which requires selective disclosure of material information; |
| • | the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and |
| • | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form8-K upon the occurrence of specified significant events. |
Common shares offered by us | 40,000,000 common shares. | |
Option to purchase additional common shares | We have granted the underwriters an option for a period of 30 days after the date of this prospectus to purchase up to an additional 6,000,000 common shares from us. | |
Common shares to be outstanding after this offering and the concurrent private placement | 118,979,342 common shares (or 124,979,342 common shares if the underwriters exercise their option to purchase additional shares in full). | |
Concurrent private placement | BMGF has agreed to purchase from us, concurrently with this offering in a private placement, $25.0 million of our common shares at the public offering price. The sale of common shares in the concurrent private placement will not be registered under the Securities Act. The closing of this offering is not conditioned upon the closing of such private placement. See the section titled “Concurrent Private Placement”. | |
Use of proceeds | We expect the net proceeds from this offering to be approximately $85.9 million (or $99.0 million if the underwriters exercise in full their option to purchase additional common shares), assuming a public offering price of $2.35 per common share, which was the last reported sale price of our common shares on the Nasdaq Global Market (“Nasdaq”) on July 15, 2022, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. We currently expect to use the net proceeds from this offering, together with our cash and cash equivalents, principally for general corporate purposes, including working capital in respect of our R&D, business development, and sales and marketing activities as well as ordinary course capital expenditures. We may also use a portion of the net proceeds to acquire or invest in complementary businesses, technologies or other assets, although we currently have no agreements or understandings with respect to any such acquisitions or investments. See the section titled “Use of Proceeds.” | |
Listing | Our common shares are listed on the Nasdaq Global Market under the symbol “LMDX”. On July 15, 2022, the last reported sale price of our common shares as reported on Nasdaq was $2.35 per common share. | |
Dividend policy | We have never declared or paid any cash dividend on the ordinary shares or the common shares, and do not anticipate declaring or paying any cash dividends on the ordinary shares or common shares in the foreseeable future. We intend to retain all available funds and any future earnings to fund the commercialization of our products and expansion of our business. See the section titled “Dividend Policy.” | |
Voting rights | Common shares are entitled to one vote per share on a proposed shareholder resolution. By contrast, ordinary shares are entitled to ten votes per share on a proposed shareholder resolution. See the sections titled “Risk Factors” and “Description of Capital Stock” for further information on our dual class share structure and the rights attaching to our common shares and ordinary shares. | |
Risk factors | Investing in our securities involves substantial risks. See the section titled “Risk Factors” for a description of certain of the risks you should consider before investing in our securities. | |
Indications of Interest | We are aware of certain related parties who have indicated an interest in purchasing common shares in this offering, in each case at the public offering price. Morningside (as defined below) has indicated that they intend to purchase such number of common shares as necessary to maintain their current pro rata ownership of the Company’s common shares. In addition, Ron Zwanziger, who is our Chairman and Chief Executive Officer, and William Umphrey, who is a shareholder, either directly or through their affiliated vehicles, have indicated an interest in purchasing, in aggregate, up to $15 million of common shares in this offering. Because this indication of interest is not a binding agreement or commitment to purchase, we could determine to sell more, less, or no shares to such related parties. See the section titled “Underwriting - Indications of Interest.” Ron Zwanziger and any other officer or director who may purchase shares in this offering has entered into a lock-up agreement such that they will be subject to the lockup period with respect to such shares. Other related persons who may purchase shares in this offering would not be locked-up for such shares. | |
| • | 11,163,930 common shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $9.45 per common share; |
| • | 3,101,000 common shares issuable upon the exercise of outstanding stock options that were granted after March 31, 2022, with a weighted-average exercise price of $4.74 per common share; |
| • | 80,667,058 ordinary shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $6.55 per ordinary share; |
| • | 13,578,241 common shares issuable upon the exercise of outstanding warrants (comprising the public warrants, the 2020 Warrants, the Jefferies Warrants, the Pharmakon Warrants and the SVB Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted-average exercise price of $8.63 per common share (such weighted-average exercise price has been calculated, in respect of the Pharmakon Warrants only, using the exercise price of $10.00 per common share which applied to the Pharmakon Warrants on March 31, 2022 and until the amendment of the underlying warrant instrument is effective as described in the section titled “Description of Capital Stock – Warrants – Pharmakon Warrants”); |
| • | 5,403,892 ordinary shares issuable upon the exercise of warrants (comprising the 2016 Warrants and the 2019 Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted average exercise price of $2.10 per ordinary share; |
| • | 6,126,554 common shares reserved for issuance upon conversion of the Convertible Notes (as defined herein), assuming the initial conversion rate of 108.4346 common shares per $1,000 principal amount of Convertible Notes, as provided for in the indenture governing the Convertible Notes; |
| • | 19,301,591 common shares available for issuance under the 2021 Stock Option and Incentive Plan; and |
| • | 15,229,865 common shares available for issuance under the 2021 Employee Stock Purchase Plan (the “ESPP”). |
Year Ended December 31, | Three Months Ended March 31, | |||||||||||||||
2020 | 2021 | 2021 | 2022 | |||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Statement of Profit and Loss and Comprehensive Income: | ||||||||||||||||
Revenue | ||||||||||||||||
Products | $ | 135,656 | $ | 415,654 | $ | 105,786 | $ | 125,626 | ||||||||
Services | 3,497 | 5,774 | 1,086 | 786 | ||||||||||||
Total Revenue | 139,153 | 421,428 | 106,872 | 126,412 | ||||||||||||
Cost of sales | ||||||||||||||||
Products | (84,456 | ) | (268,835 | ) | (63,072 | ) | (76,363 | ) | ||||||||
Services | (1,750 | ) | (1,053 | ) | (483 | ) | (23 | ) | ||||||||
Total Cost of Sales | (86,206 | ) | (269,888 | ) | (63,555 | ) | (76,386 | ) | ||||||||
Gross Profit | 52,947 | 151,540 | 43,317 | 50,026 | ||||||||||||
Operating Expenses | ||||||||||||||||
Research and development expenses | (107,539 | ) | (130,221 | ) | (26,741 | ) | (41,319 | ) | ||||||||
Selling, marketing and administrative expenses | (46,129 | ) | (130,520 | ) | (38,051 | ) | (40,156 | ) | ||||||||
Listing expenses | — | (36,202 | ) | — | — | |||||||||||
Operating Loss | (100,721 | ) | (145,403 | ) | (21,475 | ) | (31,449 | ) | ||||||||
Finance income | 22,500 | 165,426 | 6,583 | 5,420 | ||||||||||||
Finance expense | (172,722 | ) | (117,943 | ) | (165,984 | ) | (27,926 | ) | ||||||||
Net finance (expense)/income | (150,222 | ) | 47,492 | (159,401 | ) | (22,506 | ) | |||||||||
Loss before Tax | (250,943 | ) | (97,911 | ) | (180,876 | ) | (53,955 | ) | ||||||||
Tax (expense)/credit for the period | 9,946 | (2,844 | ) | 87 | (2,217 | ) | ||||||||||
Loss for the period | $ | (240,997 | ) | $ | (100,755 | ) | $ | (180,789 | ) | $ | (56,172 | ) | ||||
Loss/(gain) attributable to non-controlling interest | (17 | ) | 174 | 44 | 78 | |||||||||||
Net loss attributable to equity holders of parent—basic and diluted | $ | (240,980 | ) | $ | (100,929 | ) | $ | (180,833 | ) | $ | (56,250 | ) | ||||
Net loss per share attributable to equity holders of parent—basic and diluted | $ | (1.82 | ) | $ | (0.62 | ) | $ | (1.37 | ) | $ | (0.22 | ) | ||||
Weighted-average number of ordinary and common shares used in loss per share—basic and diluted | 132,192,880 | 163,255,784 | 132,204,201 | 253,074,575 | ||||||||||||
As of December 31, | As of March 31, | |||||||||||
2020 | 2021 | 2022 | ||||||||||
(in thousands) | ||||||||||||
Consolidated Statement of Financial Position: | ||||||||||||
Cash and cash equivalents | $ | 158,717 | $ | 132,145 | $ | 166,046 | ||||||
Working capital (1) | 88,028 | 261,665 | 276,726 | |||||||||
Total assets | 515,095 | 644,780 | 659,227 | |||||||||
Preferred shares | (451,721 | ) | — | — | ||||||||
Total equity attributable to equity holders of the parent | 375,009 | (163,051 | ) | (125,235 | ) | |||||||
Non-controlling interests | 207 | 455 | 377 | |||||||||
Total Equity | $ | 375,216 | $ | (162,596 | ) | $ | (124,858 | ) | ||||
| (1) | We define working capital as current assets less current liabilities. |
Year Ended December 31, | Three Months Ended March 31, | |||||||||||||||
2020 | 2021 | 2021 | 2022 | |||||||||||||
Consolidated Statement of Cash Flows: | ||||||||||||||||
Net cash used in operating activities | $ | (149,327 | ) | $ | (134,583 | ) | $ | (9,271 | ) | $ | (1,696 | ) | ||||
Net cash used in investing activities | (64,381 | ) | (106,346 | ) | (35,427 | ) | (10,262 | ) | ||||||||
Net cash provided by financing activities | 236,586 | 219,022 | 215,163 | 47,677 | ||||||||||||
Net increase (decrease) in cash and cash equivalents | $ | 22,878 | $ | (21,907 | ) | $ | 170,465 | $ | 35,719 | |||||||
| • | Our tests, produced at large scale, might not perform to standards that we have experienced to date. We therefore may not obtain or maintain regulatory approval, authorization, certification or clearance for some of our diagnostic tests in research and development, which may have a significant impact on the commercialization of our Platform. |
| • | We have a number of diagnostic tests in our near-term pipeline. We may not receive relevant regulatory approval, authorization, certification or clearance for some or all of these diagnostic tests in a timely fashion, or at all, and this may impact significantly the commercialization of our Platform. |
| • | Unexpected or inconsistent clinical data from existing and future clinical trials, or a regulator’s or the market’s perception of these clinical data when compared to our internal comparative data, may adversely impact our ability to obtain regulatory approval, authorization, certification or clearance for, or market acceptance of, our diagnostic tests. |
| • | Our Instrument, the Amira Analyzer and our test strips are made on sophisticated manufacturing systems, and these may not operate at large scale as anticipated. |
| • | We may have difficulty sourcing raw materials and components, including micro processing or semiconductor chips or capacitors, to make our Instrument, Amira Analyzer and test strips in a timely fashion in necessary quantities, or these materials and components might not comply with our specifications, which are exacting. |
| • | We may not be able to supply our products through sales channels that are effective and efficient. |
| • | Potential users of our Platform might not accept our Platform as being better than those POC systems that are already available, at the prices we charge or at all. |
| • | Governmental and third-party payors might decline to cover our products or reimburse our users for the cost of our products at favorable rates or at all. |
| • | We may not be able to scale-up and sustain operations to a level that allows our investments in technology, equipment, personnel and other resources to achieve sustainable and profitable commercial activities. |
| • | Our management, manufacturing, sales and marketing, logistics, research and development, regulatory and other personnel might not be able to sustain the high level of operations that we anticipate we will require to generate revenue and to operate profitably. |
| • | External factors, such as the ongoing COVID-19 pandemic, or political or social instability or unrest in our principal markets, such as the recent conflict between Russia and Ukraine, and their potential impact might adversely affect us in ways that we have not planned for. |
| • | conduct substantial research and development, including validation studies and potentially clinical trials; |
| • | further develop and scale our research and development efforts to accommodate different test strip designs or adjustments; and |
| • | further develop and scale our infrastructure to be able to analyze increasingly large amounts of data. |
| • | failure of the products to perform as expected at the research or development stage; |
| • | lack of validation data; or |
| • | failure to demonstrate the clinical utility of the products or pass clinical trials or obtain relevant regulatory approval, authorization, certification or clearance. |
| • | improvements to our COVID-19 product line and Flu A/B tests are dependent on access to clinical trials and the prevalence of the flu, and we have experienced and may continue to experience delays in our clinical trials as a result of the lack of sample availability, particularly with respect to flu type B; |
| • | a delay in regulatory approval, authorization, certification or clearance by FDA, and other applicable foreign regulatory authorities to some of our diagnostic assays in development, if such foreign regulatory authorities focus their resources on and give priority to COVID-19 testing and treatments or to a specific form ofCOVID-19 testing that is different than our tests; |
| • | a disproportionate impact on the healthcare groups and other healthcare professionals with whom we contract; |
| • | supply shortages for materials used to manufacture our COVID-19 products, including swabs and extraction buffers necessary for use with ourSARS-CoV-2 |
| • | disruptions to our supply chains and sales and marketing efforts due to restrictions on courier delivery services and other transportation systems; |
| • | disruptions to operations at our current and future manufacturing systems and facilities and those of our third-party vendors, collaborators, and suppliers; |
| • | difficulty accessing the capital and credit markets on favorable terms, or at all, a severe disruption and instability in the global financial markets, and deteriorations in credit and financing conditions which could affect our access to capital necessary to fund our existing and scaled business operations or address maturing liabilities on a timely basis; |
| • | the potential negative impact on the health or productivity of employees, especially if a significant number of them are impacted by the COVID-19 pandemic; |
| • | a deterioration in our ability to ensure business continuity during a disruption; and |
| • | social, economic, and labor instability in the countries in which we or the third parties with whom we engage operate, including any impact of the current conflict between Russia and Ukraine. |
| • | our ability to demonstrate the clinical utility and cost effectiveness of our Platform and its potential advantages over existing POC systems, or for certain tests, over central lab counterparts, to the medical community; |
| • | our ability, and that of our collaborators, to secure and maintain FDA and other applicable regulatory approval, authorization, certification or clearance for certain components of our Platform; |
| • | our ability to expand our test menu and provide a broad range of tests on our Platform while maintaining consistency and precision; |
| • | our ability to obtain relevant regulatory approval, authorization, certification or clearance for our diagnostic assays in development, particularly those in our near-term pipeline; |
| • | the agreement by commercial third-party payors and government payors to cover and to reimburse our Instrument and test strips, the scope and extent of which will affect healthcare providers’ willingness to pay for our Instrument and test strips and likely heavily influence their decisions to recommend use of our Platform; |
| • | the willingness of healthcare providers to use a POC system over central lab counterparts and the rate of adoption of our Platform by healthcare providers and other users; and |
| • | the impact of our investments in our Platform innovation and commercial growth. |
| • | For our SARS-CoV-2 SARS-CoV-2 COVID-19 Ag Card, general lateral flow tests and others. |
| • | For our SARS CoV-2 antibody testAnti-SARS-CoV-2, SARS-CoV-2 COVID-19 IgM/IgG Rapid Test and others. |
| • | For our SARS-CoV-2 & Flu A/B tests SARS-CoV-2 |
| • | For our INR test |
| • | For our D-Dimer test |
| • | For our CRP test |
| • | greater name and brand recognition; |
| • | substantially greater financial and human resources and expertise; |
| • | broader or superior product lines; |
| • | larger sales forces and more established distributor networks; |
| • | substantial intellectual property portfolios; |
| • | larger and more established customer bases, relationships with healthcare professionals and third-party payors; and |
| • | better established, larger scale, and lower cost manufacturing capabilities. |
| • | cost of instruments and consumables; |
| • | flexibility and ease of use; |
| • | time to result; |
| • | accuracy, including sensitivity and specificity, and reproducibility of results; |
| • | reputation among customers; |
| • | innovation in product offerings; and |
| • | compatibility with existing processes. |
| • | multiple, conflicting and changing laws and regulations such as privacy regulations, tax laws, economic sanctions, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses; |
| • | potential competition from existing or future local and regional product offerings; |
| • | difficulties in complying with a multitude of product regulations in various jurisdictions, including evolving regulatory pathways in response to the ongoing COVID-19 pandemic; |
| • | failure by us or our distributors to obtain regulatory approvals, authorizations, certifications or clearances for the use of our products in various countries; |
| • | additional potentially relevant third-party patent rights; |
| • | complexities and difficulties in obtaining protection and enforcing our intellectual property; |
| • | difficulties in staffing and managing foreign operations; |
| • | complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay systems; |
| • | our dependence on cooperation and donor funding of local aid sources and private foundations, particularly in developing regions such as Africa, as well as cooperation from national healthcare programs and governments; |
| • | logistics and regulations associated with shipping samples, including infrastructure conditions and transportation delays; |
| • | limits in our ability to penetrate international markets if we are not able to conduct our tests locally; |
| • | financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products, and exposure to foreign currency exchange rate fluctuations; |
| • | additional exposure to foreign economic factors, including inflation, recession, and fluctuations in interest rates; |
| • | the risk that regional or local distributors may not commit the necessary resources to market and sell our products to the level of our expectations or may choose to favor marketing the products of our regional or local competitors; |
| • | natural disasters, political and economic instability, including wars, terrorism, and political and civil unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions (such as the military conflict involving Russia and Ukraine, and subsequent economic sanctions imposed on Russia and Belarus); and |
| • | regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act of 1977, as amended (“FCPA”), or its books and records or anti-bribery provisions, or similar anti-bribery or anti-corruption laws or regulations in other jurisdictions, such as the United Kingdom’s Bribery Act 2010. |
| • | making certain restricted payments, including paying dividends on, or repurchasing or making distributions with respect to, our equity securities subject to certain exceptions; |
| • | selling, transferring, leasing or disposing of certain assets; |
| • | encumbering or permitting liens on certain assets; |
| • | incurring certain indebtedness; and |
| • | entering into certain transactions with affiliates. |
| • | minimum net sales thresholds; and |
| • | minimum liquidity levels. |
Quarter End | Net Sales | |
| June 30, 2022 | $375,000,000 | |
| September 30, 2022 | $300,000,000 | |
| December 31, 2022 | $240,000,000 | |
| March 31, 2023 | $275,000,000 | |
| June 30, 2023 | $325,000,000 | |
| September 30, 2023 | $375,000,000 | |
| December 31, 2023 | $500,000,000 |
| • | prior to a Qualifying Financing occurring on or prior to December 31, 2022 (or if such Qualifying Financing does not occur), a minimum liquidity level of at least $40.0 million, tested on a monthly basis at the end of each calendar month; and |
| • | following a Qualifying Financing occurring on or prior to December 31, 2022, a minimum liquidity level of at least $75.0 million, tested on both the 15th day and last day of each such calendar month. |
| • | we could be forced to rely on private insurance coverage, which would greatly decrease our intended market opportunity for our Platform; |
| • | a negative coverage determination could adversely affect our ability to enter into partnerships with leading healthcare systems; and |
| • | we may need to conduct additional clinical validation, utility and other studies as part of an appeal of a negative Medicare coverage decision, and even if we expended the substantial time and resources to conduct such studies, they may not be successful and they may not result in a positive Medicare coverage determination. |
| • | not experimental or investigational and are otherwise authorized for marketing in the jurisdiction; |
| • | medically necessary; |
| • | appropriate for the specific patient; |
| • | cost-effective; |
| • | supported by peer-reviewed publications; |
| • | included in clinical practice guidelines; and |
| • | supported by clinical utility studies. |
| • | design, development and manufacturing; |
| • | testing and labeling, including directions for use, processes, controls, quality assurance and packaging; |
| • | storage, distribution, installation and servicing; |
| • | preclinical studies and clinical trials; |
| • | establishment registration and listing; |
| • | product safety and effectiveness; |
| • | marketing, sales and distribution; |
| • | premarket approval, certification, de novo classification, 510(k) clearance and EUA; |
| • | recordkeeping procedures; |
| • | advertising and promotion; |
| • | complaint handling, corrections and removals, and recalls; |
| • | post-market surveillance, including reporting of deaths or serious injuries, and malfunctions that, if they were to recur, would be likely to cause or contribute to a death or serious injury; and |
| • | product import and export. |
| • | we may not be able to demonstrate to the FDA’s satisfaction that our products are safe and effective for their intended uses; |
| • | the data from our preclinical studies and clinical trials may be insufficient to support clearance, classification, approval or authorization, where required; and |
| • | the manufacturing process or facilities we use may not meet applicable requirements. |
| • | the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual, or the purchase, lease, order, arrangement, or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The ACA amended the intent element of the federal Anti-Kickback Statute to clarify that a person or entity can be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. The term remuneration has been interpreted broadly to include anything of value. Further, courts have found that if “one purpose” of the remuneration is to induce referrals, the federal Anti-Kickback Statute is violated. Violations are subject to significant civil and criminal fines and penalties for each violation, imprisonment, and exclusion from government healthcare programs. In addition, a claim submitted for payment to any federal healthcare program that includes items or services that were made as a result of a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act (“FCA”). There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, though the exceptions and safe harbors are drawn narrowly and practices that involve remuneration intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor; |
| • | the federal civil and criminal false claims laws, including the FCA, and civil monetary penalty laws which prohibit, among other things, individuals or entities from knowingly presenting, or |
causing to be presented, false, fictitious or fraudulent claims for payment to, or approval by Medicare, Medicaid, or other federal healthcare programs; knowingly making, using, or causing to be made or used, a false record or statement material to a false, fictitious or fraudulent claim or an obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement. When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs; |
| • | HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materially false fictitious or fraudulent statement or entry in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity can be found guilty of violating HIPAA fraud provisions without actual knowledge of the statute or specific intent to violate it; |
| • | HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH Act”), and their respective implementing regulations, which impose, among other things, certain requirements relating to the privacy, security and transmission of individually identifiable health information on certain covered healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their respective “business associates,” or third parties that create, receive, maintain, transmit or obtain protected health information in connection with providing a service on behalf of a covered entity. The HITECH Act also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, there may be additional federal, state and non-U.S. laws which govern the privacy and security of health and other personal information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts; |
| • | the federal Physician Payments Sunshine Act, created under the ACA, as amended by the Health Care and Education Reconciliation Act of 2010, and its implementing regulations, which require manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to U.S.-licensed physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician providers (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by the physicians and their immediate family members; |
| • | federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; and |
| • | analogous U.S. state, local and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers and may be broader in scope than their federal equivalents; state and foreign laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources, state and foreign laws that require device manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers, marketing expenditures or product pricing; state, local and foreign laws that require the registration of medical device sales representatives; state laws that prohibit other specified practices, such as (i) billing physicians for testing that they order or waiving coinsurance, copayments, deductibles, and other amounts owed by patients, and (ii) billing a state Medicaid program at a price that is higher than what is charged to one or more other payors; and state and foreign laws governing the privacy and security of health information, some of which may be more stringent than those in the United States (such as the European Union, which adopted the GDPR (as defined below)) in certain circumstances, and may differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
| • | the General Data Protection Regulation (Regulation (EU) 2016/679) (“GDPR”), which sets out the data protection laws across the EEA and is particularly important for the collection, storage and use of patient data; |
| • | the U.K. General Data Protection Regulation (the “U.K. GDPR”), read alongside the Data Protection Act 2018 (the “U.K. DPA”) set out data protection laws for the United Kingdom; and |
| • | relevant anti-bribery and corruption laws enacted by EEA countries and the U.K. Bribery Act 2010. |
| • | high individual risk and high public health risk products (Class D): May 26, 2025; |
| • | high individual risk and/or moderate public health risk products (Class C): May 26, 2026; |
| • | moderate individual risk and/or low public health risk (Class B): May 26, 2027; and |
| • | low individual risk and low public health risk products placed on the market in a sterile condition (Class A sterile): May 26, 2027. |
| • | increase our sales and marketing efforts to drive market adoption of our Platform and address competitive developments; |
| • | seek approvals, authorizations, certifications or clearances from regulatory authorities for our existing and new products; |
| • | fund development and marketing efforts of any future products; |
| • | rapidly expand our manufacturing, sales and marketing efforts, including for our Platform and Amira System; |
| • | expand our technologies to cover additional tests; |
| • | acquire, license or invest in technologies; |
| • | acquire or invest in complementary businesses or assets; and |
| • | finance capital expenditures and general and administrative expenses. |
| • | our ability to achieve revenue growth; |
| • | the cost of rapidly expanding our operations and offerings, including our manufacturing, sales and marketing efforts; |
| • | our rate of progress in, and cost of the sales and marketing activities associated with, establishing adoption of and reimbursement for our Platform; |
| • | our rate of progress in, and cost of research and development activities associated with, products in research and early development; |
| • | the effect of competing technological and market developments; |
| • | costs related to rapid international expansion; |
| • | our rate of progress in establishing reimbursement arrangements with domestic and international commercial third-party payors and government payors; and |
| • | the potential cost of and delays in product development as a result of any regulatory oversight applicable to our products. |
| • | provisions that permit our board of directors by resolution to issue undesignated classes of shares with such preferred, deferred or other special rights or restrictions as the board of directors may determine in their discretion, without any further vote or action by our shareholders. If issued, the rights, preferences, designations and limitations of any class of undesignated shares could operate to the disadvantage of the outstanding ordinary shares or common shares, the holders of which would not have any pre-emption rights in respect of such an issue of undesignated shares. Such terms could include, among others, preferences as to dividends and distributions on liquidation, or could be used to prevent possible corporate takeovers; |
| • | our shareholders may not take action by written consent, but may only take action at annual or extraordinary meetings of our shareholders. As a result, a holder controlling a majority of our share capital would not be able to amend our Amended and Restated Articles or remove directors without holding a meeting of our shareholders called in accordance with our Amended and Restated Articles. Our Amended and Restated Articles further provide that special meetings of our shareholders may be called only by shareholders holding not less than one-third of the voting rights who are entitled to vote at general meetings. However, shareholders may propose only ordinary resolutions to be put to a vote at such a meeting and shall have no right to propose resolutions with respect to the election, appointment or removal of any person as a director or to amend our Amended and Restated Articles. Our Amended and Restated Articles provide no other right to put any proposals before an annual general |
meeting or an extraordinary general meeting. These provisions might delay the ability of our shareholders to force consideration of a proposal or for shareholders controlling a majority of our share capital to take any action, including the removal of directors; |
| • | our board of directors is classified into three classes of directors (being the Founder Directors, the Class I directors and the Class II directors). A third party may be discouraged from making a tender offer or otherwise attempting to obtain control of us as it is more difficult and time consuming for shareholders to replace a majority of the directors on a classified board of directors. Shareholders may only remove the Class I directors and Class II directors for cause by way of passing a special resolution; and |
| • | each of the Founder Directors cannot be removed from the board of directors absent the voting approval of the ordinary shares held by Ron Zwanziger, our Chief Executive Officer and co-founder, and his affiliates. This provision would prevent shareholders from removing any of the Founder Directors from their respective positions on the board of directors. |
| • | our ability to compete in the highly competitive markets in which we operate, and potential adverse effects of this competition; |
| • | our ability to maintain revenues if our products and services do not achieve and maintain broad market acceptance, or if we are unable to keep pace with or adapt to rapidly changing technology, evolving industry standards and changing regulatory requirements; |
| • | uncertainty, downturns and changes in the markets we serve; |
| • | our expectations regarding the size of the POC market for the Platform, the size of the various addressable markets for certain tests and our ability to penetrate such markets by driving the conversion of healthcare providers’ testing needs onto the Platform; |
| • | our commercialization strategy, including our plans to initially focus our sales efforts on large healthcare systems, government organizations and national pharmacy chains that want to deploy comprehensive POC testing across their networks, our strategy on the commercialization of our current and future assays and our ability to launch and obtain regulatory approval for new tests; |
| • | our ability to increase the installed base of our Instruments; |
| • | our ability to repay or service our debt obligations and meet the financial covenants related to such debt obligations; |
| • | our belief that we will be able to drive commercialization of the Platform through the launch of our SARS-CoV-2 SARS-CoV-2 |
| • | the willingness of healthcare providers to use a POC system over central lab systems and the rate of adoption of the Platform by healthcare providers and other users; |
| • | the scalability and commercial viability of our manufacturing methods and processes, especially in light of the anticipated demand for the Platform and our minimum commitments to supply the Platform to customers; |
| • | our ability to source suitable raw materials and components for the manufacture of the Instrument and test strips in a timely fashion; |
| • | our ability to maintain our current relationships, or enter into new relationships, with diagnostics or research and development companies, third party manufacturers and commercial distribution collaborators; |
| • | our ability to effectively manage our anticipated growth; |
| • | our ability to rapidly develop and commercialize diagnostics tests that are accurate and cost-effective; |
| • | the timing, progress and results of our diagnostics tests, including statements regarding launch plans and commercialization plans for such tests, all which may be delayed by or halted due to a number of factors, including the impact of the COVID-19 pandemic and the end of theCOVID-19 pandemic; |
| • | the timing, scope or likelihood of regulatory submissions, filings, approvals, authorizations, certifications, clinical trials or clearances; |
| • | the pricing, coverage and reimbursement of the Instrument and tests, if approved; |
| • | our ability to enforce our intellectual property rights and to operate our business without infringing, misappropriating, or otherwise violating the intellectual property rights and proprietary technology of third parties; |
| • | developments and projections relating to our competitors and our industry; |
| • | our ability to develop effective internal controls over financial reporting; |
| • | our ability to attract, motivate and retain qualified employees, including members of our senior management team; |
| • | the effects of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business or operations; |
| • | social, economic, and labor instability in the countries in which we or the third parties with whom we engage operate, including any impact of the current conflict between Russia and Ukraine; |
| • | our expectations regarding the time during which we will be an emerging growth company under the “JOBS Act and a foreign private issuer; |
| • | the future trading price of our common shares and impact of securities analysts’ reports on these prices; |
| • | our ability to fully derive anticipated benefits from existing or future acquisitions, joint ventures, investments or dispositions; |
| • | exchange rate fluctuations and volatility in global currency markets; |
| • | potential adverse tax consequences resulting from the international scope of our operations, corporate structure and financing structure; |
| • | U.S. tax legislation enacted in 2017, which could materially adversely affect our financial condition, results of operations and cash flows; |
| • | increased risks resulting from our international operations and expectations of future expansion of such operations; |
| • | our ability to comply with various trade restrictions, such as sanctions and export controls, resulting from our international operations; |
| • | government and agency demand for our products and services and our ability to comply with government contracting regulations; and |
| • | our ability to operate in a litigious environment. |
| • | on an actual basis; and |
| • | as adjusted to give effect to (i) the issuance and sale of 40,000,000 common shares in this offering at an assumed public offering price of $2.35 per common share, which was the last reported sale price of our common shares on Nasdaq on July 15, 2022, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and (ii) the issuance and sale by us in the concurrent private placement of $25.0 million of our common shares to BMGF. |
As of March 31, 2022 | ||||||||
Actual (1) | As Adjusted (2) | |||||||
(in thousands) | ||||||||
Cash and cash equivalents | $ | 166,046 | $ | 276,894 | ||||
Debt | (356,887 | ) | (356,887 | ) | ||||
Equity: | ||||||||
Share capital and share premium | (755,097 | ) | (644,249 | ) | ||||
Foreign currency translation reserve | 10,322 | 10,322 | ||||||
Other reserves | (104,957 | ) | (104,957 | ) | ||||
Accumulated deficit | 724,497 | 724,497 | ||||||
Total equity attributable to equity holders of the parent | (125,235 | ) | (14,387 | ) | ||||
Non-controlling interests | 377 | 377 | ||||||
Total equity | (124,858 | ) | (14,010 | ) | ||||
Total capitalization | $ | (315,699 | ) | $ | (94,002 | ) | ||
| (1) | This table does not reflect the investments of $26.1 million in April 2022 and $15.4 million in June 2022 pursuant to the Royalty Agreement. See the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Royalty Agreement.” |
| (2) | A $1.00 increase (decrease) in the assumed public offering price of $2.35 per share, the last reported sale price of our common shares on Nasdaq on July 15, 2022, would increase (decrease) the net proceeds to us from this offering by $37.4 million, assuming that the number of common shares offered by us, as set forth on the cover page of this prospectus, remains the same. An increase (decrease) of 1,000,000 in the number of common shares we are offering would increase (decrease) the net proceeds to us from this offering by $2.2 million, assuming the assumed public offering price remains the same, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. |
| • | 11,163,930 common shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $9.45 per common share; |
| • | 3,101,000 common shares issuable upon the exercise of outstanding stock options that were granted after March 31, 2022, with a weighted-average exercise price of $4.74 per common share; |
| • | 80,667,058 ordinary shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $6.55 per ordinary share; |
| • | 13,578,241 common shares issuable upon the exercise of outstanding warrants (comprising the public warrants, the 2020 Warrants, the Jefferies Warrants, the Pharmakon Warrants and the SVB Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted-average exercise price of $8.63 per common share (such weighted-average exercise price has been calculated, in respect of the Pharmakon Warrants only, using the exercise price of $10.00 per common share which applied to the Pharmakon Warrants on March 31, 2022 and until the amendment of the underlying warrant instrument is effective as described in the section titled “Description of Capital Stock – Warrants – Pharmakon Warrants”); |
| • | 5,403,892 ordinary shares issuable upon the exercise of warrants (comprising the 2016 Warrants and the 2019 Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted average exercise price of $2.10 per ordinary share; |
| • | 6,126,554 common shares reserved for issuance upon conversion of the Convertible Notes, assuming the initial conversion rate of 108.4346 common shares per $1,000 principal amount of Convertible Notes as provided for in the indenture governing the Convertible Notes; |
| • | 19,301,591 common shares available for issuance under the 2021 Stock Option and Incentive Plan; and |
| • | 15,229,865 common shares available for issuance under the ESPP. |
Assumed public offering price per common share | $ | 2.35 | ||||||
Net tangible book value per share (including our outstanding common shares and ordinary shares) as of March 31, 2022 | $ | 1.77 | ||||||
Increase in net tangible book value per share (including our outstanding common shares and ordinary shares) attributable to this offering and the concurrent private placement | $ | 0.07 | ||||||
As adjusted net tangible book value per share (including our outstanding common shares and ordinary shares) after giving effect to this offering and the concurrent private placement | $ | 1.84 | ||||||
Dilution per common share to new investors participating in this offering | $ | 0.51 | ||||||
| • | 11,163,930 common shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $9.45 per common share; |
| • | 3,101,000 common shares issuable upon the exercise of outstanding stock options that were granted after March 31, 2022, with a weighted-average exercise price of $4.74 per common share; |
| • | 80,667,058 ordinary shares issuable upon the exercise of outstanding stock options as of March 31, 2022, with a weighted-average exercise price of $6.55 per ordinary share; |
| • | 13,578,241 common shares issuable upon the exercise of outstanding warrants (comprising the public warrants, the 2020 Warrants, the Jefferies Warrants, the Pharmakon Warrants and the SVB Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted-average exercise price of $8.63 per common share (such weighted-average exercise price has been calculated, in respect of the Pharmakon Warrants only, using the exercise price of $10.00 per common share which applied to the Pharmakon Warrants on March 31, 2022 and until the amendment of the underlying warrant instrument is effective as described in the section titled “Description of Capital Stock – Warrants – Pharmakon Warrants”); |
| • | 5,403,892 ordinary shares issuable upon the exercise of outstanding warrants (comprising the 2016 Warrants and the 2019 Warrants, each as defined below) outstanding as of March 31, 2022, with a weighted average exercise price of $2.10 per ordinary share; |
| • | 6,126,554 common shares reserved for issuance upon conversion of the Convertible Notes, assuming the initial conversion rate of 108.4346 common shares per $1,000 principal amount of Convertible Notes as provided for in the indenture governing the Convertible Notes; |
| • | 19,301,591 common shares available for issuance under the 2021 Stock Option and Incentive Plan; and |
| • | 15,229,865 common shares available for issuance under the ESPP. |
Year Ended December 31, | Three Months Ended March 31, | |||||||||||||||
2020 | 2021 | 2021 | 2022 | |||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Statement of Profit and Loss and Comprehensive Income: | ||||||||||||||||
Revenue | ||||||||||||||||
Products | $ | 135,656 | $ | 415,654 | $ | 105,786 | $ | 125,626 | ||||||||
Services | 3,497 | 5,774 | 1,086 | 786 | ||||||||||||
Total Revenue | 139,153 | 421,428 | 106,872 | 126,412 | ||||||||||||
Cost of sales | ||||||||||||||||
Products | (84,456 | ) | (268,835 | ) | (63,072 | ) | (76,363 | ) | ||||||||
Services | (1,750 | ) | (1,053 | ) | (483 | ) | (23 | ) | ||||||||
Total cost of sales | (86,206 | ) | (269,888 | ) | (63,555 | ) | (76,386 | ) | ||||||||
Gross profit | 52,947 | 151,540 | 43,317 | 50,026 | ||||||||||||
Operating expenses | ||||||||||||||||
Research and development expenses | (107,539 | ) | (130,221 | ) | (26,741 | ) | (41,319 | ) | ||||||||
Selling, marketing and administrative expenses | (46,129 | ) | (130,520 | ) | (38,051 | ) | (40,156 | ) | ||||||||
Listing expenses | — | (36,202 | ) | — | — | |||||||||||
Operating loss | (100,721 | ) | (145,403 | ) | (21,475 | ) | (31,449 | ) | ||||||||
Finance income | 22,500 | 165,426 | 6,583 | 5,420 | ||||||||||||
Finance expense | (172,722 | ) | (117,943 | ) | (165,984 | ) | (27,926 | ) | ||||||||
Net finance (expense)/income | (150,222 | ) | 47,492 | (159,401 | ) | (22,506 | ) | |||||||||
Loss before tax | (250,943 | ) | (97,911 | ) | (180,876 | ) | (53,955 | ) | ||||||||
Tax (expense)/credit for the period | 9,946 | (2,844 | ) | 87 | (2,217 | ) | ||||||||||
Loss for the period | $ | (240,997 | ) | $ | (100,755 | ) | $ | (180,789 | ) | $ | (56,172 | ) | ||||
Loss/(gain) attributable to non-controlling interest | (17 | ) | 174 | 44 | 78 | |||||||||||
Net loss attributable to equity holders of parent—basic and diluted | $ | (240,980 | ) | $ | (100,929 | ) | $ | (180,833 | ) | $ | (56,250 | ) | ||||
Net loss per share attributable to equity holders of parent—basic and diluted | $ | (1.82 | ) | $ | (0.62 | ) | $ | (1.37 | ) | $ | (0.22 | ) | ||||
Weighted-average number of ordinary and common shares used in loss per share—basic and diluted | 132,192,880 | 163,255,784 | 132,204,201 | 253,074,575 | ||||||||||||
As of December 31, | As of March 31, | |||||||||||
2020 | 2021 | 2022 | ||||||||||
(in thousands) | ||||||||||||
Consolidated Statement of Financial Position: | ||||||||||||
Assets | ||||||||||||
Non–Current Assets | ||||||||||||
Other non-current assets | $ | 241 | $ | 569 | $ | 592 | ||||||
Intangibles and goodwill | 40,723 | 37,048 | 35,723 | |||||||||
Right-of-use | 10,386 | 27,746 | 25,823 | |||||||||
Property, plant and equipment | 87,082 | 173,397 | 172,691 | |||||||||
Total Non-Current Assets | 138,432 | 238,760 | 234,829 | |||||||||
Current Assets | ||||||||||||
Inventories | 85,516 | 149,055 | 164,729 | |||||||||
Tax receivable | 20,680 | 15,022 | 16,061 | |||||||||
Trade and other receivables | 109,295 | 109,798 | 77,562 | |||||||||
Restricted cash | 2,455 | — | — | |||||||||
Cash and cash equivalents | 158,717 | 132,145 | 166,046 | |||||||||
Total Current Assets | 376,663 | 406,020 | 424,398 | |||||||||
Total Assets | $ | 515,095 | $ | 644,780 | $ | 659,227 | ||||||
Liabilities and Equity | ||||||||||||
Liabilities | ||||||||||||
Non-Current Liabilities | ||||||||||||
Debt due after more than one year | $ | (139,734 | ) | $ | (301,129 | ) | $ | (356,887 | ) | |||
Preferred shares | (451,721 | ) | — | — | ||||||||
Lease liabilities | (8,991 | ) | (25,514 | ) | (24,132 | ) | ||||||
Stock warrants | — | (10,407 | ) | (5,002 | ) | |||||||
Deferred tax liabilities | (1,230 | ) | (779 | ) | (676 | ) | ||||||
Total Non-Current Liabilities | (601,676 | ) | (337,829 | ) | (386,697 | ) | ||||||
Current Liabilities | ||||||||||||
Debt due within one year | (147,238 | ) | (191 | ) | (133 | ) | ||||||
Government and other grants | (44,037 | ) | (38,941 | ) | (35,663 | ) | ||||||
Trade and other payables | (95,246 | ) | (99,641 | ) | (106,129 | ) | ||||||
Lease liabilities due within one year | (2,114 | ) | (5,582 | ) | (5,747 | ) | ||||||
Total Current Liabilities | (288,635 | ) | (144,355 | ) | (147,672 | ) | ||||||
Equity | ||||||||||||
Share capital and share premium | (152,732 | ) | (754,023 | ) | (755,097 | ) | ||||||
Foreign currency translation reserve | 19,905 | 19,706 | 10,322 | |||||||||
Other reserves | (99,821 | ) | (104,957 | ) | (104,957 | ) | ||||||
Accumulated deficit | 607,657 | (676,223 | ) | 724,497 | ||||||||
Total equity attributable to equity holders of the parent | 375,009 | (163,051 | ) | (125,235 | ) | |||||||
Non-controlling interests | 207 | 455 | 377 | |||||||||
Total Equity | 375,216 | (162,596 | ) | (124,858 | ) | |||||||
Total Equity and Liabilities | $ | (515,095 | ) | $ | (644,780 | ) | $ | (659,227 | ) | |||
Year Ended December 31 | Three Months Ended March 31, | |||||||||||||||
2020 | 2021 | 2021 | 2022 | |||||||||||||
(in thousands) | ||||||||||||||||
Consolidated Statement of Cash Flows: | ||||||||||||||||
Cash Flows from Operating Activities | ||||||||||||||||
Loss for the period | $ | (240,997 | ) | $ | (100,755 | ) | $ | (180,789 | ) | $ | (56,172 | ) | ||||
Adjustments to reconcile loss for the period to net cash used in operating activities: | ||||||||||||||||
Depreciation | 8,527 | 22,868 | 3,490 | 7,880 | ||||||||||||
Amortization | 2,387 | 2,827 | 582 | 525 | ||||||||||||
Net finance expenses | 126,774 | (63,625 | ) | 153,862 | 22,535 | |||||||||||
Equity based share based payment transactions | 3,191 | 33,909 | 21,002 | 7,976 | ||||||||||||
Increase in tax receivable | (11,269 | ) | (4,663 | ) | (688 | ) | (1,470 | ) | ||||||||
Accrued preferred shares dividends | 23,578 | 16,156 | 5,327 | — | ||||||||||||
Listing charge | — | 27,607 | — | — | ||||||||||||
Changes to working capital: | ||||||||||||||||
Inventories | (73,302 | ) | (66,874 | ) | (57,659 | ) | (18,608 | ) | ||||||||
Trade and other receivables | (89,213 | ) | 7,511 | 48,491 | 31,840 | |||||||||||
Trade payables and other liabilities | 100,997 | (9,544 | ) | (2,889 | ) | 3,798 | ||||||||||
Net Cash used in Operating Activities | (149,327 | ) | (134,583 | ) | (9,271 | ) | (1,696 | ) | ||||||||
Cash Flows from Investing Activities | ||||||||||||||||
Purchases of property, plant, equipment | (64,381 | ) | (106,346 | ) | (35,427 | ) | (10,262 | ) | ||||||||
Net Cash generated used in Investing Activities | (64,381 | ) | (106,346 | ) | (35,427 | ) | (10,262 | ) | ||||||||
Cash Flows from Financing Activities | ||||||||||||||||
Proceeds from issuance of preferred shares | 162,401 | — | — | — | ||||||||||||
Proceeds from debt issuance, net of issuance costs | 62,391 | 361,830 | 364,310 | — | ||||||||||||
Proceeds from issuance of convertible notes, net of issuance costs | 70,917 | — | — | 54,325 | ||||||||||||
Proceeds from issuance of share capital | — | 38,568 | — | — | ||||||||||||
Shares issued on the exercise of share options | 41 | 104 | — | 1,074 | ||||||||||||
Repayment of principal portion of lease liabilities | (3,054 | ) | (5,429 | ) | (1,172 | ) | (1,539 | ) | ||||||||
Cash interest paid, net of interest received | (12,114 | ) | (29,894 | ) | (5,522 | ) | (6,100 | ) | ||||||||
Early extinguishment of debt | (3,600 | ) | (3,637 | ) | (2,350 | ) | — | |||||||||
Cash issued for non-controlling interest | — | (1,968 | ) | — | — | |||||||||||
Repayments of debt | (40,396 | ) | (140,552 | ) | (140,103 | ) | (83 | ) | ||||||||
Net Cash generated from Financing Activities | 236,586 | 219,022 | 215,163 | 47,677 | ||||||||||||
Net (Decrease) / Increase in Cash and Cash Equivalents | $ | 22,878 | $ | (21,907 | ) | $ | 170,465 | $ | 35,719 | |||||||
Movement in Cash and Cash Equivalents | ||||||||||||||||
Cash and cash equivalents at the beginning of the period | 139,387 | 161,172 | 161,172 | 132,145 | ||||||||||||
Exchange (loss) / gain on cash and cash equivalents | (1,093 | ) | (7,120 | ) | 2,881 | (1,818 | ) | |||||||||
Net Increase / (decrease) in cash and cash equivalents | 22,878 | (21,907 | ) | 170,465 | 35,719 | |||||||||||
Cash and Cash Equivalents at the end of the period | $ | 161,172 | $ | 132,145 | $ | 334,518 | $ | 166,046 | ||||||||
| • | COVID-19 test utilization.COVID-19 tests during theCOVID-19 pandemic has established strong brand awareness and acceptance of our technology and built an installed base of Instruments with potential long-term POC customers. The ongoing test utilization of our current installed base will likely be strongly linked to the overall prevalence ofCOVID-19 infections and the overall need for testing in those settings where Instruments have been installed. Reduced test utilization at these settings would lead to reduced revenue for ourCOVID-19 test strips. |
| • | Increase the installed base of our Instruments. |
| • | Commercialization of our current and future assays. lab-comparable performance. We believe that successful execution of this global market-driven menu strategy will lead to wide adoption of our Platform and high utilization of our diagnostic tests. Any delays in commercialization of our assays or decreases in the expected market demand for our assays could adversely impact our operations and financial results. |
| • | Highly automated, cost efficient manufacturing process |
| • | Investment in regulatory approvals, authorizations, certifications and clinical trials |
authorizations, certifications or clearances as we commercialize our products across global markets. Clinical trials demonstrating the acceptable performance of our products may be required in order to obtain regulatory approvals or clearances. Additional regulatory approvals, authorizations, certifications or clearances will impact our ability to sell both our Instruments and test strips in various geographies. Any delays in regulatory approvals, authorizations, certifications or clearances of our tests or a lack of strong clinical trial evidence for the performance of our tests could adversely impact our operations and financial results. |
| • | Investment in global expansion |
Year Ended December 31, | ||||||||
2020 | 2021 | |||||||
(in thousands) | ||||||||
Consolidated Statement of Profit and Loss and Comprehensive Income | ||||||||
Revenue: | ||||||||
Products | $ | 135,656 | $ | 415,654 | ||||
Services | 3,497 | 5,774 | ||||||
Total revenue | 139,153 | 421,428 | ||||||
Cost of sales: | ||||||||
Products | (84,456 | ) | (268,835 | ) | ||||
Services | (1,750 | ) | (1,053 | ) | ||||
Total cost of sales | (86,206 | ) | (269,888 | ) | ||||
Gross profit | 52,947 | 151,540 | ||||||
Operating expenses: | ||||||||
Research and development expenses | (107,539 | ) | (130,221 | ) | ||||
Selling, marketing and administrative expenses | (46,129 | ) | (130,520 | ) | ||||
Listing expenses | — | (36,202 | ) | |||||
Total operating expense | (153,668 | ) | (296,943 | ) | ||||
Loss from operations | (100,721 | ) | (145,403 | ) | ||||
Finance income (expense): | ||||||||
Finance income | 22,500 | 165,426 | ||||||
Finance expense | (172,722 | ) | (117,934 | ) | ||||
Total finance expense, net | (150,222 | ) | (47,492 | ) | ||||
Loss before provision for income taxes | (250,943 | ) | (97,911 | ) | ||||
Benefit (provision) from income taxes | 9,946 | (2,844 | ) | |||||
Net loss | $ | (240,997 | ) | $ | (100,755 | ) | ||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Products | $ | 135,656 | $ | 415,654 | $ | 279,998 | 206.4 | % | ||||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Services | $ | 3,497 | $ | 5,774 | $ | 2,277 | 65.1 | % | ||||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Products | $ | (84,456 | ) | $ | (268,835 | ) | $ | (184,379 | ) | 218.3 | % | |||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Services | $ | (1,750 | ) | $ | (1,053 | ) | $ | 697 | (39.8 | )% | ||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
R&D expenses | $ | (107,539 | ) | $ | (130,221 | ) | $ | (22,682 | ) | 21.1 | % | |||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Selling, marketing and administrative expenses | $ | (46,129 | ) | $ | (130,520 | ) | $ | (84,391 | ) | 182.9 | % | |||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Listing expenses | $ | — | $ | (36,202 | ) | $ | (36,202 | ) | 100.0 | % | ||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Finance income | $ | 22,500 | $ | 165,426 | $ | 142,926 | 635.2 | % | ||||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Finance expense | $ | (172,722 | ) | $ | (117,934 | ) | $ | 54,788 | (31.7 | )% | ||||||
Year Ended December 31, | Change | |||||||||||||||
2020 | 2021 | $ | % | |||||||||||||
(in thousands) | ||||||||||||||||
Benefit (provision) for income taxes | $ | 9,946 | $ | (2,844 | ) | $ | (12,790 | ) | (128.6 | )% | ||||||
| • | the cost of purchasing materials to manufacture our products and to maintain sufficient inventory to meet demand; |
| • | the cost of maintaining and expanding our manufacturing capacity; |
| • | the cost of expanding sales, marketing and distribution capabilities in new and existing sales regions in which we may receive marketing approval, authorization, certification or clearance; |
| • | the scope and results of our current and planned research and development activities; |
| • | the outcome, timing and cost of meeting regulatory requirements to commercialize our products in global markets; |
| • | the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights covering our product candidates, including any such patent claims and intellectual property rights that we have licensed under our existing license agreements; |
| • | our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our Platform and its components; |
| • | the terms of our existing research and development and commercialization arrangements with third parties, including any minimum commitments in our contractual arrangements with such parties; |
| • | our ability to establish and maintain additional such arrangements on favorable terms and whether and to what extent we retain development or commercialization responsibilities under any new licensing, collaboration, partnership or similar arrangement; |
| • | our need and ability to hire additional management, scientific, medical, accounting and financial reporting and other personnel to scale the Company; |
| • | the costs to operate as a public company, including the need to implement additional financial and reporting systems and other internal systems and infrastructure for our business; |
| • | market acceptance of our product; and |
| • | the effect of competing technological and market developments, including other products that may compete with our Platform and other products and services. |
| • | issuance of $75.3 million of the 10% Notes in July and November 2020, from which we received $74.3 million from investors (the 10% Notes converted to common shares in connection with the Merger); |
| • | issuance of 33,008 series B preferred shares in November 2020, from which we raised $164.5 million from investors (such series B preferred shares converted to common shares in connection with the Merger); |
| • | entering into the 2021 Senior Secured Loan in March 2021, with borrowings of $300.0 million, which was used, in part, to prepay amounts outstanding under the 2020 Senior Secured Loan entered into in March 2021 with incremental additional facility in January 2021; |
| • | merger with CAH, a special purpose acquisition company, in September 2021, from which we received gross proceeds of $38.0 million; |
| • | partnering with BMGF to help them achieve certain key objectives, we have received approximately $119.0 million in support from them through a combination of equity, grants and loans, which includes grant funding in the aggregate amount of approximately $36.0 million from Gates Philanthropy Partners. Our $8.0 million grant agreement with BMGF required us to return any funds not utilized on qualifying expenses by December 31, 2020. COVID-19 pandemic, we reached an agreement with BMGF for an extension of the grant period to June 30, 2022. As of December 31, 2021, we had available $8.9 million in grant funds that had not been utilized related to multiple grants; |
| • | issuance of $56.5 million of the Convertible Notes in March 2022, from which we received approximately $54.0 million in net proceeds; and |
| • | entering into the Royalty Agreement, from which we have raised gross proceeds of $41.5 million as of the date of this prospectus. |
Year Ended December 31, | ||||||||
2020 | 2021 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (149,327 | ) | $ | (134,583 | ) | ||
Net cash used in investing activities | (64,381 | ) | (106,346 | ) | ||||
Net cash provided by financing activities | 236,586 | 219,022 | ||||||
Net increase (decrease) in cash and cash equivalents | $ | (22,878 | ) | $ | (21,907 | ) | ||
| • | making certain restricted payments, including paying dividends on, or repurchasing or making distributions with respect to, our equity securities subject to certain exceptions; |
| • | selling, transferring, leasing or disposing of certain assets; |
| • | encumbering or permitting liens on certain assets; |
| • | incurring certain indebtedness; and |
| • | entering into certain transactions with affiliates. |
| • | minimum net sales thresholds; and |
| • | minimum liquidity levels. |
Quarter End | Net Sales (with a Qualifying Financing on or prior to September 30, 2022) | Net Sales (no Qualifying Financing on or prior to December 31, 2022) | ||
| June 30, 2022 | $375,000,000 | $375,000,000 | ||
| September 30, 2022 | $300,000,000 | $400,000,000 | ||
| December 31, 2022 | $240,000,000 | $500,000,000 | ||
| March 31, 2023 | $275,000,000 | $500,000,000 | ||
| June 30, 2023 | $325,000,000 | $500,000,000 | ||
| September 30, 2023 | $375,000,000 | $500,000,000 | ||
| December 31, 2023 | $500,000,000 | $500,000,000 |
| • | prior to a Qualifying Financing that occurs on or prior to December 31, 2022 (or if such Qualifying Financing does not occur), at least $40.0 million, tested on a monthly basis at the end of each calendar month; and |
| • | following a Qualifying Financing that occurs on or prior to December 31, 2022, at least $75.0 million, tested on both the 15th day and last day of each such calendar month. |
Payments Due by Period | ||||||||||||||||||||
Total | Less than 1 Year | 1-3 Years | 3-5 Years | More than 5 Years | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Debt obligations (1)(2) | $ | 369,437 | $ | 24,809 | $ | 24,690 | $ | 319,937 | $ | — | ||||||||||
Lease commitments (3) | $ | 46,998 | $ | 5,546 | $ | 14,646 | $ | 10,505 | $ | 16,301 | ||||||||||
Capital commitments (4) | $ | 15,641 | $ | 15,641 | $ | — | $ | — | $ | — | ||||||||||
Total | $ | 432,076 | $ | 45,996 | $ | 39,336 | $ | 330,442 | $ | 16,301 | ||||||||||
| (1) | Amounts in the table reflect the contractually required principal and interest payable as of December 31, 2021 pursuant to outstanding borrowings under BMGF Unsecured Loan with an interest rate of 2.0%, and the 2021 Senior Secured Loan with an interest rate of 8.0%. |
| (2) | Not included are obligations entered into after December 31, 2021 including the Convertible Notes for $56.5 million due in more than 5 years from December 31, 2022 and the Royalty Agreement investments of $41.5 million due in 3-5 years from December 31, 2021. |
| (3) | Amounts in the table reflect minimum payments due for our leases of office and manufacturing space under operating leases that expire between January 2022 and October 2031. |
| (4) | Amounts in the table reflect amounts due on manufacturing equipment purchases. |
2020* | 2021 | |||||||||||
Employees | Founders | |||||||||||
Grant date fair value ($) | 1,634 to 3,861 | 1.37 to 4.02 | 1.26 to 2.85 | |||||||||
Exercise price ($) | 1,793 to 3,861 | 9.89 to 16.39 | 16.96 to 17.05 | |||||||||
Volatility | 35-40 | % | 40 | % | 40 | % | ||||||
Dividend yield | — | — | — | |||||||||
Expected life of option (years) | 2-2.5 | 4-6.25 | 4-6.25 | |||||||||
Annual risk free interest rate | 0.2-1.6 | % | 0.78-1.22 | % | 0.78-1.22 | % | ||||||
Total fair value of options granted | $ | 6,716 | $ | 8,567 | $ | 43,887 | ||||||
| * | Amounts not adjusted for 2021 share splits. |
| • | the prices at which we issued our ordinary shares and series A preferred shares and the superior rights and preferences of our series A preferred shares relative to our ordinary shares at the time of each grant; |
| • | the progress of our research and development programs; |
| • | our stage of development and our business strategy; |
| • | external market conditions affecting our industry and trends within the industry; |
| • | our financial position, including cash on hand, and our historical and forecasted performance and operating results; |
| • | the lack of an active public market for our ordinary shares, our series A preferred shares and series B preferred shares; |
| • | the likelihood of achieving a liquidity event, such as an IPO, in light of prevailing market conditions; and |
| • | the analysis of IPOs and the market performance of similar companies in our industry. |
| • | to the extent that we no longer qualify as a foreign private issuer, (i) reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and (ii) exemptions from the requirement to hold a non-binding advisory vote on executive compensation, including golden parachute compensation; |
| • | an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act; and |
| • | an exemption from compliance with the requirement that the PCAOB has adopted regarding a supplement to the auditor’s report providing additional information about the audit and the financial statements. |
| • | the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act; |
| • | the requirement to comply with Regulation FD, which requires selective disclosure of material information; |
| • | the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and |
| • | the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form8-K upon the occurrence of specified significant events. |
| • | Shift towards community-based healthcare. |
outcomes. POC testing is one of the innovations that is enabling such a shift in care into community-based healthcare settings. These settings provide direct patient access and are more convenient and cost-effective alternatives to hospital emergency departments for nonemergency conditions. Uptake of POC testing in these settings is driven by healthcare providers’ need for real-time diagnostic information that can be applied to improve patient outcomes and compliance, while lowering costs relative to hospital-based care. With reimbursement increasingly based on effectiveness of care, POC testing has been an effective tool for objectively measuring improvements in outcomes particularly for chronic conditions such as diabetes and cardiovascular disease. For example, POC HbA1c testing for diabetes patients at primary care settings enables healthcare providers to guide patient treatment decisions in real time. Similarly, POC flu testing at retail pharmacies allows for actionable results, including immediate access to adequate OTC medicines. |
| • | Improving health outcomes for patients. COVID-19 testing has been a key tool for employers to safely and effectivelyre-open their workplaces and keep them open. |
| • | Improvements in POC testing technology. |
| • | Poor clinical performance in areas of high clinical need. |
| • | Limited test menu. |
| • | High cost of total ownership. |
 |  | |
The LumiraDx Instrument | Image of the Test Strip (in this example, SARS-CoV-2 | |
 |  | |
Test Strip Inserted into Instrument | Seamless Connectivity: transferring test results to electronic health record, laboratory information system or patient health record | |
| • | Lab-comparable performance at the POC in minutes.lab-comparable results, where lab references are available, at the POC in minutes, rather than days or weeks. Each test is developed and validated against its respective lab reference standard. We believe that with our Platform, healthcare providers have the benefit of both central lab performance and real-time results. |
| • | Broad menu of tests on a single instrument. |
with further tests, with 12 tests currently having achieved regulatory approval, authorization, certification or clearance, which include tests currently run at the POC, such as CRP and HbA1c – both CE Marked-, tests not currently, available at the POC, such as high sensitivity Troponin I, and diagnostic test panels, such as Flu A/B + SARS-CoV-2 |
| • | Low cost of ownership. low-cost test strips as opposed to multiple instruments currently required for POC testing in community-based healthcare settings. We also believe our Platform will provide incremental cost savings, including reduced cost of training, maintenance and test supplies. All of this enables a lower cost per reportable result. |
| • | Simple workflow and intuitive user interface. step-by-step over-the-cloud |
| • | Seamless connectivity. out-of-the-box |
| • | Data reporting, analytics and decision support. |
| • | System portability and flexibility. |
| • | Offer a comprehensive menu of high-performance diagnostic tests for community-based healthcare settings. |
initially focused on the most common medical conditions for certain respiratory disease, cardiovascular disease, diabetes, and coagulation disorders. Our portfolio includes high-volume tests currently available at the POC (e.g., INR, HbA1c, CRP), tests that currently do not have a viable POC solution (e.g., FDA-defined high-sensitivity Troponin I), and innovative diagnostic test panels, such as Flu A/B +SARS-CoV-2. |
| • | Grow our installed base by executing an institutional sales and channel partnership model. |
| • | INR testing programs with regional governments in Italy and the United Kingdom; |
| • | BMGF collaboration aimed at implementing POC testing in low and middle income countries, primarily in Africa for the establishment of a primary healthcare model; |
| • | COVID rapid testing program with CVS MinuteClinic nationwide; and |
| • | D-Dimer testing program just starting in Southern region of Sweden. |
| • | Expand into additional healthcare settings and underserved markets home-use settings. We plan further enhancements to our Platform, such as making the Instrument more robust to enable use in more challenging settings such as in areas of extreme heat and dust. |
| • | Continue to innovate to expand into specialty areas. in-patient hospital, that could benefit from fast, accurate diagnostic test results from our Platform. |
| • | Continue to innovate across our Platform. |
| • | Continue to expand use of our technology and apply it to non-healthcare settings and applications such as mass population screening and home-testing, initially through the potential commercial launch of our Amira System.SARS-CoV-2 COVID-19. We plan to distribute the AmiraSARS-CoV-2 re-opening of economies, subject to regulatory approval, authorization, certification or clearance. |
Test | IVD Category | TAM (1) | Current Commercial Markets | |||||||
SARS-CoV-2 | Immunoassay | $12 billion (2) | U.S. (pursuant to EUA), EEA (CE Mark), Japan, Latin America | |||||||
SARS-CoV-2 | Immunoassay | $4-6 billion (2) | EEA (CE Mark) | |||||||
SARS-CoV-2 | Immunoassay | U.S. (pursuant to EUA), EEA (CE Mark) | ||||||||
SARS-CoV-2 | Immunoassay | $200-400 million (2) | EEA (CE Mark) | |||||||
SARS-CoV-2 | Immunoassay | $12 billion (2) | EEA (CE Mark) | |||||||
SARS-CoV-2 | Immunoassay | $4-6 billion(2) | EEA (CE Mark) | |||||||
SARS-CoV-2 | Immunoassay | $1.5-3 billion(2) | EEA (CE Mark), Japan (PDMA) | |||||||
INR | Coagulation | $500 million | EEA (CE Mark) | |||||||
D-Dimer | Immunoassay | $700 million | EEA (CE Mark) | |||||||
CRP | Immunoassay | $300 million | EEA (CE Mark) | |||||||
HbA1c | Immunoassay | $1.3 billion | EEA (CE Mark) | |||||||
NT-proBNP | Immunoassay | $350 million | EEA (CE Mark) | |||||||
| (1) | Global Total Addressable Market: We estimated for each test based on our current assumptions, including the (a) existing market sizes, (b) central lab market that could move to the POC, and (c) expansion of diagnostic testing. |
| (2) | SARS-CoV-2 SARS-CoV-2 SARS-CoV-2 SARS-CoV-2, SARS-CoV-2, SARS-CoV-2 SARS-CoV-2 |
| * | Items marked in bold are the 12 diagnostic tests for which we have obtained regulatory approval, authorization, certification or clearance for use on our Platform. |
| * | Regulatory times refer to submission dates and launch dates will be subject to review by corresponding regulatory authorities. |
Test | IVD Category | Phase | TAM | Expected Regulatory Submissions or Certifications in the Next 18 Months | ||||
SARS-CoV-2 | Immunoassay | EEA (CE Mark) for POC use in professional settings | $9 billion | U.S. (EUA) in H1 2022, Africa |
Phase | Milestones | Estimated Timelines | ||
Product concept | • Business case | 2 months | ||
• Establishment of target product profile | ||||
• Design control module and core team definition | ||||
Feasibility | • Demonstrate test strip and assay processing | 12 months (may decrease over time as Platform becomes more stable and uniform) | ||
• Define performance and design targets | ||||
• Establish proof-of-concept | ||||
• Reagent and chemistry developments | ||||
Development | • Risk mitigation plans | 2-6 months | ||
• System integration (hardware, software, test strip, assay script, calibration) | ||||
• Demonstrate performance and manufacturability | ||||
• Pre-clinical studies | ||||
• Establish design freeze and verify readiness for verification and validation | ||||
Verification and validation | • Establish process performance qualification (PPQ) – transfer to manufacturing | 2-4 months | ||
• Complete clinical studies | ||||
• Risk Summary Reports / Residual Risk Assessment reports | ||||
| Regulatory file preparation and submission, followed by launch | • Launch product in EEA market (CE Mark) | |||
• Regulatory file submission, such as EUA, and response to regulatory bodies and premarket review by regulatory bodies | ||||
| • | Tests that aid in diagnosis of active viral infection SARS-CoV-2 COVID-19 infection from the onset of symptoms, but are not able to detect previous infections. |
| • | Tests that aid in diagnosis of an immune response to COVID-19 SARS-CoV-2 COVID-19 antibody tests are used to directly detect the presence ofSARS-CoV-2 |
Positive | Negative | Total | ||||||||||||
SARS-CoV-2 | Positive | 81 | 6 | 87 | ||||||||||
Ag Test | Negative | 2 | 168 | 170 | ||||||||||
| Total | 83 | 174 | 257 | |||||||||||
Value | 95% CI | |||||||||||
SARS-CoV-2 | PPA | 97.60 | % | 91.6% -99.3 | % | |||||||
Ag Test | NPA | 96.60 | 92.7 -98.4 | |||||||||
Days of Symptom Onset | RT-PCR Comparator | LumiraDx | PPA | |||||||||
0 | 6 | 6 | 100.00 | % | ||||||||
1 | 12 | 12 | 100.00 | |||||||||
2 | 28 | 28 | 100.00 | |||||||||
3 | 37 | 37 | 100.00 | |||||||||
4 | 55 | 54 | 98.20 | |||||||||
5 | 61 | 60 | 98.40 | |||||||||
6 | 67 | 66 | 98.50 | |||||||||
7 | 73 | 72 | 98.60 | |||||||||
8 | 75 | 74 | 98.70 | |||||||||
9 | 75 | 74 | 98.70 | |||||||||
10 | 77 | 76 | 98.70 | |||||||||
11 | 80 | 79 | 98.80 | |||||||||
12 | 83 | 81 | 97.60 | |||||||||
| • | Alpha Variant, Beta Variant and Gamma Variant—Detection was demonstrated in patient samples by the U.K. Department of Health and Social Care, COVID-19 Technologies Validation Group. |
| • | Beta Variant—Detection was demonstrated by the South African National Health Laboratory Service. |
| • | Delta Variant—Detection was demonstrated in patient samples as discussed by the U.K. Department of Health and Social Care, COVID-19 Technologies Validation Group. |
| • | Omicron Variant—Testing with patient live samples was completed by LumiraDx. In addition, a prospective clinical study was carried out by Medical Research Network Diagnostics. Both studies showed that Omicron is detected by the LumiraDx SARS-CoV-2 |
WHO Label | Pango Lineage | Country in Which First Detected | Nucleocapsid Mutation | LumiraDx SARS-CoV-2 Antigen Test Result (Positive/Negative) | ||||||
Alpha | B.1.1.7 | UK, Sept 2020 | D3L, R203K, G204R, S235F | Positive | ||||||
Beta | B.1351 | South Africa, May 2020 | T2051 | Positive | ||||||
Gamma | P.1 | Brazil, Nov 2020 | P80R, R203K, G204R | Positive | ||||||
Delta | B.1.617.2 | India, Oct 2020 | D63G, R203M,G215C, D377Y | Positive | ||||||
Omicron* | B.1.1.529 | Multiple Countries | R203K, G2049, P13L, E31-R32-and | Positive | ||||||
| * | Descendent Pango Lineages of Omicron, BA.2 and BA.3 have the additional Nucleocapsid mutation S413R, which was tested in-house using recombinant protein and tested positive at 50 pg/ml on the LumiraDxSARS-CoV-2 |
Sample | Positive Agreement | Negative Agreement | ||||||
Direct Fingerstick | 100%(62/62) | 100%(54/54) | ||||||
Fingerstick via Transfer Tube | 100%(62/62) | 100%(56/56) | ||||||
Days from RT-PCR to Blood Collection | Number of Samples | Sensitivity RT-PCR Comparator | ||||
6 days | 13 | 84.60% | ||||
7-13 days | 7 | 100% | ||||
14-20 days | 6 | 100% | ||||
21 days | 46 | 100% | ||||
Total | 72 | 97.2% (90.4% – 99.2%) | ||||
Positive Pooled Specimens | Single Swab | |||||||||||||||
POS | NEG | Total | ||||||||||||||
Pool Test | POS | 30 | 0 | 30 | ||||||||||||
NEG | 0 | 0 | 0 | |||||||||||||
Total | 30 | 0 | 30 | |||||||||||||
Negative Pooled Specimens | Single Swab | |||||||||||||||
POS | NEG | Total | ||||||||||||||
Pool Test | POS | 0 | 1 | 1 | ||||||||||||
NEG | 0 | 28 | 28 | |||||||||||||
Total | 0 | 29 | 29 | |||||||||||||
Measure | Estimate | 95% Wilson Score CI | ||||||||||
PPA | 100.0 | % | 88.6 | % | 100.0 | % | ||||||
NPA | N/A | N/A | N/A | |||||||||
PPV | 100.0 | 88.6 | 100.0 | |||||||||
NPV | N/A | N/A | N/A | |||||||||
Prevalence | 100.0 | 88.6 | 100.0 | |||||||||
OPA | 100.0 | 88.6 | 100.0 | |||||||||
Measure | Estimate | 95% Wilson Score CI | ||||||||||
PPA | N/A | N/A | N/A | |||||||||
NPA | 96.6 | % | 82.8 | % | 99.4 | % | ||||||
PPV | 0.0 | 0.0 | 79.3 | |||||||||
NPV | 100.0 | 87.9 | 100.0 | |||||||||
Prevalence | 0.0 | 0.0 | 11.7 | |||||||||
OPA | 96.6 | 82.8 | 99.4 | |||||||||
SARS-CoV-2 | Flu A | Flu B | ||||||||||
PPA | up to 95.5 | %* | 83.3 | % | 80.0 | % | ||||||
NPA | up to 99.2 | * | 97.5 | 95.3 | ||||||||
| * | Based on 0-12 days since symptom onset data set. |
Grouping | N | PPA | 95% CI | |||||||||
Ct < 35 (all) | 149 | 96.0 | % | 91.5% - 98.1% | ||||||||
Ct < 33 (all) | 141 | �� | 98.6 | % | 95.0% - 99.6% | |||||||
Ct < 30 (all) | 128 | 98.4 | % | 94.5% - 99.6% | ||||||||
Ct < 25 (all) | 91 | 98.9 | % | 94.0% - 99.8% | ||||||||
D-Dimer Concentration (µg/L FEU) | Within Run Precision (% CV) | Within Day Precision (% CV) | Between Day Precision (% CV) | Total Precision (% CV) | n | |||||||||||||||
291 | 9.8 | 11.1 | 0 | 11.1 | 80 | |||||||||||||||
552 | 9.4 | 9.4 | 2.5 | 9.7 | 80 | |||||||||||||||
1790 | 10.1 | 10.1 | 0.7 | 10.2 | 80 | |||||||||||||||
CRP concentration (mg/L) | Within Day Precision (% CV) | Between Day Precision (% CV) | Between Site Precision (% CV) | Total precision (% CV) | n | |||||||||||||||
11.6 | 4.8 | 0.5 | 5.6 | 7.4 | 75 | |||||||||||||||
20.2 | 4.8 | 0.0 | 3.7 | 6.0 | 75 | |||||||||||||||
148.3 | 4.5 | 1.4 | 3.2 | 5.6 | 75 | |||||||||||||||
| 1. | LumiraDx SARS-CoV-2 SARS-CoV-2 |
| 2. | LumiraDx SARS-CoV-2 SARS-CoV-2 SARS-CoV-2 two- to four-fold increase of testing throughput over common open molecular systems, allowing laboratories to improve turnaround time of patient results and expand their testing capacity with existing instrumentation. In December 2021, we achieved several FDA EUA updates for RNA STAR Complete molecular reagents including asymptomatic testing, pooling of up to five individuals, and access to 384 well configuration on validated openRT-PCR systems. In addition, through expanded authorization with HealthPulse@Home, we are now able to offer sample collection at home and elsewhere, increasing access to molecular testing. In February 2022, we also achieved MHRA authorization for RNA STAR Complete, enabling us to fulfill customer demand in the United Kingdom for high throughput, high sensitivity and high efficiency testing at events, schools, airports, and other public venues. |
| • | Connect Manager is our cloud-based service that provides all capabilities to remotely manage and configure Instruments as well as user access. It has provisions to manage quality control policy, simplify workgroups, produce reports and run data analyses. The ability to manage a large-scale implementation of POC instruments through Connect Manager enables a health care system or large procurer to enforce quality controls policy and effectively manage diagnostic results wherever they are generated in a centralized controlled manner. |
| • | EHR Connect allows for direct integration with existing hospital systems either via cloud or local connectivity. Local connections can be made directly via integration protocols such as HL7, FHIR, GDT/LDT/XDT or through middleware. |
| • | management of operators and role-based access, Instrument, quality control policy and training information to meet regulatory and compliance requirements; |
| • | reporting of patient demographics, test results, Instrument function and errors; and |
| • | analytics, including surveillance and hotspot detection. |
Physician Office / Retail / Pharmacy | Acute / Emergency Care | Global Health | ||||
Install base | ~8,500 | ~5,400 | ~5,100 | |||
Regulatory approved or authorized | INR, D-Dimer, COVID-19 Antigen,COVID-19 Antibody, CRP,COVID-19 + Flu A/B ,RSV + COVID-19, HbA1c,NT-proBNP | D-Dimer, COVID-19 Antigen,COVID-19 Antibody,COVID-19 + Flu A/B , RSV +COVID-19, NT-proBNP | COVID-19 Antigen, CRP,COVID-19 +Flu A/B, HbA1c | |||
Expected 2022-2023 regulatory submissions | Na/K, Strep A, Lipids | HS Troponin Na/K, PCT | TB, HIV Viral Load | |||
3-year road map | Sexual Health Diabetes Cardiovascular disease Respiratory | Cardiac Respiratory Hospital Acquired Infection | Virology Vector Borne Disease | |||
| • | For our SARS-CoV-2 SARS-CoV-2 COVID-19 Ag Card and others, as well as molecular tests such as Cepheid GeneXpert, Abbott ID NOW andlab-based PCR tests. |
| • | For our SARS CoV-2 antibody test: |
| • | For our INR test: |
| • | For our D-Dimer test: |
| • | For our SARS-CoV-2 |
| • | For our CRP test: |
| • | developing assays with significant potential to improve global health, including a test for HIV viral load; |
| • | accelerating development of LumiraDx’s next-generation instrument that is low-cost, robust and appropriate for all clinical settings, globally; and |
| • | supporting local healthcare delivery partners in foundation-priority markets to incorporate the potential of LumiraDx technology into high-impact, low-cost disruptive diagnostic treatment models. |
Family No. | Exemplary Jurisdictions | Patent/Application and Status | Exemplary Subject Matter and Scope (1) | Expiration (2) | ||||
| 1 | Canada, China, Europe, Japan and U.S. | Granted European patents validated in France, Germany, Italy, Ireland, & U.K. and others; granted patents in Argentina, China, Russia, South Africa and Hong Kong Pending patent applications: Australia, Brazil, Canada, Japan, Korea, Mexico, Taiwan, U.S., and others | Assay system containing improved microfluidic cartridge and reader, and associated assay method – machine and method of use | 2037 | ||||
| 2 | Canada, China, Europe, Japan and U.S. | Pending patent applications: Canada, China, Europe, Japan, U.S. | Improved magnetic capture assembly for use in reader, associated reader and assay method – machine and method of use | 2039 | ||||
| 3 | PCT, U.K. and Taiwan | Pending patent applications | Improved assay methods and related cartridges (e.g., assays and cartridges for performing SARS-CoV-2 | 2041 | ||||
| 4 | Canada, China, Europe, Japan and U.S. | Granted European patent (3) validated in France, Germany, U.K., Ireland, Italy, Spain, Switzerland, and the Netherlands; granted patents in Hong Kong, Japan, Korea, Russia, and TaiwanPending patent applications: Argentina, Australia, Brazil, Canada, China, Mexico, Singapore, U.S., South Africa, and others | STAR amplification – method of use | 2037 | ||||
| 5 | Canada, China, Europe, Japan and U.S. | Granted European patent validated in France, Germany, U.K., Ireland, | qSTAR amplification – method of use | 2039 |
Family No. | Exemplary Jurisdictions | Patent/Application and Status | Exemplary Subject Matter and Scope (1) | Expiration (2) | ||||
Italy, Spain, and Switzerland; granted patents in Hong Kong and South Africa Pending patent applications: Argentina, Brazil, Canada, China, Japan, Taiwan, and U.S. | ||||||||
| 6 | Canada, China, Europe, Japan and U.S. | Pending patent applications: Canada, China, Europe, Japan, and U.S. | Kinetic assay for detecting an analyte such as an enzyme (e.g., PT/INR kinetic assay) and related cartridge – method of use and article of manufacture | 2039 | ||||
| 7 | Europe and U.S. | Pending patent applications: Europe, U.S., | HbA1c Assays | 2039 | ||||
| 8 | PCT | Pending patent applications: PCT application | Amira System – method of use and article of manufacture | 2041 |
| (1) | The general types of subject matter for which patent protection is being pursued includes machines (e.g., a reader), articles of manufacture (e.g., assay strips), and methods of use (e.g., assay methods). |
| (2) | The expiration dates assume that non-provisional patent applications will be filed approximately one year after the earliest priority date and that national stage applications will be filed, as appropriate, and pursued until grant, and that all renewal and annuity fees will be paid. |
| (3) | An Opposition has been filed against our granted European patent covering STAR amplification. |
| • | high individual risk and high public health risk products (Class D): 26 May 2025; |
| • | high individual risk and/or moderate public health risk products (Class C): 26 May 2026; |
| • | moderate individual risk and/or low public health risk (Class B): 26 May 2027; |
| • | low individual risk and low public health risk products placed on the market in a sterile condition (Class A sterile): 26 May 2027. |
| • | General IVDs; |
| • | IVDs for self-testing; |
| • | IVDs falling within the scope of Annex II, List A: |
| • | reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e), or anti-Kell; and |
| • | reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of human immunodeficiency virus, or HIV, infection (HIV 1 and 2), human T-lymphotropic virus I and II, and hepatitis B, C and D. |
| • | IVDs falling within the scope of Annex II, List B: |
| • | reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd; |
| • | reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocyte antibodies; |
| • | reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis; |
| • | reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria; |
| • | reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia; |
| • | reagents and reagent products, including related calibrators and control materials, for determining the following human leukocyte antigen tissue groups: DR, A, B; |
| • | reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: prostate-specific antigen; |
| • | reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21; and |
| • | the following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar. |
Facility Location | Approx. Size (sq. ft.) | Lease Expiration | ||
| Motherwell, Scotland | 41,568 | September 1, 2040 | ||
| San Diego, California | 24,200 | June 3, 2026 | ||
| San Diego, California | 15,565 | August 31, 2024 |
Name | Country of incorporation and Residence | Nature of Business | Proportion of Equity Shares Held by Lumiradx | |||
| LumiraDx Brazil Holdings Limited | United Kingdom | Holding Company | 100% | |||
| LumiraDx Healthcare Ltda | Brazil | Distributor of medical diagnostics | 98% | |||
| LumiraDx Colombia Holdings Limited | United Kingdom | Holding Company | 81% | |||
| LumiraDx SAS | Colombia | Distributor of medical diagnostics | 100%* | |||
| LumiraDx SAS | France | Distributor of medical diagnostics | 100% | |||
| LumiraDx GmbH | Germany | Distributor of medical diagnostics | 100% |
Name | Country of incorporation and Residence | Nature of Business | Proportion of Equity Shares Held by Lumiradx | |||
| LumiraDx AB | Sweden | Distributor of medical diagnostics | 100% | |||
| LumiraDx UK Limited | United Kingdom | Manufacture and distribution of medical diagnostics | 100% | |||
| LumiraDx Technology Limited | United Kingdom | Research and development | 100% | |||
| LumiraDx Ltd. | United Kingdom | Distributor of medical diagnostics | 100% | |||
| LumiraDx Group Limited | United Kingdom | Holding Company | 100% | |||
| LumiraDx International Limited | United Kingdom | Holding Company | 100% | |||
| LumiraDx Investment Limited | United Kingdom | Holding Company | 100% | |||
| LumiraDx Care Solutions UK Limited | United Kingdom | Healthcare IT and services | 100% | |||
| LumiraDx, Inc. | United States | Healthcare IT and services | 100% | |||
| ACS Acquisition LLC | United States | Healthcare IT and services | 100% | |||
| LumiraDx Healthcare LLC | United States | Healthcare IT and services | 100% | |||
| Biomedical Service S.r.l. | Italy | Distributor of medical diagnostics | 100% | |||
| LumiraDx AS | Norway | Distributor of medical diagnostics | 100% | |||
| LumiraDx GmbH | Austria | Distributor of medical diagnostics | 100% | |||
| LumiraDx GmbH | Switzerland | Distributor of medical diagnostics | 100% | |||
| LumiraDx Japan Co Ltd | Japan | Distributor of medical diagnostics | 100% | |||
| LumiraDx Oy | Finland | Distributor of medical diagnostics | 100% | |||
| LumiraDx A/S | Denmark | Distributor of medical diagnostics | 100% | |||
| LumiraDx Healthcare S.L. | Spain | Distributor of medical diagnostics | 100% | |||
| SureSensors Limited | United Kingdom | Developer and manufacturer of medical diagnostics | 100% | |||
| LumiraDx (Pty) Limited | South Africa | Distributor of medical diagnostics | 100% | |||
| LumiraDx B.V. | Netherlands | Distributor of medical diagnostics | 100% | |||
| LumiraDx Benelux B.V | Netherlands | Distributor of medical diagnostics | 100% | |||
| LumiraDx Limited | Ireland | Distributor of medical diagnostics | 100% |
Name | Country of incorporation and Residence | Nature of Business | Proportion of Equity Shares Held by Lumiradx | |||
| LumiraDx Healthcare Private Limited | India | Distributor of medical diagnostics | 100% | |||
| CA Healthcare Acquisition Corp. | United States | Holding Company | 100% |
| *—LumiraDx | Colombia Holdings Limited holds 100% of the equity shares of LumiraDx SAS |
Name | Age | Position(s) | ||||
Executive Officers: | ||||||
Ron Zwanziger | 68 | Chief Executive Officer, Co-Founder, Chairman and Director | ||||
Dorian LeBlanc, C.P.A. | 47 | Chief Financial Officer and Vice President, Global Operations | ||||
Dave Scott, Ph.D. | 65 | Chief Technology Officer, Co-Founder and Director | ||||
Jerry McAleer, Ph.D. | 67 | Chief Scientist, Co-Founder and Director | ||||
Nigel Lindner, Ph.D. | 65 | Chief Innovation Officer | ||||
David Walton, D.M.S. | 69 | Chief Commercial Officer | ||||
Peter Scheu | 57 | President, North American Commercial Operations | ||||
Veronique Ameye | 46 | Executive Vice President and General Counsel | ||||
Pooja Pathak | 45 | Chief Product Officer | ||||
Tom Quinlan | 60 | Senior Vice President, Instrumentation & Health IT | ||||
Non-Employee Directors: | ||||||
Donald Berwick, M.D., M.P.P. (1) | 75 | Director | ||||
Troyen Brennan, M.D., M.P.H. | 67 | Director | ||||
Gerald Chan | 71 | Director | ||||
Lu Huang, M.D. (2) | 48 | Director | ||||
Lurene Joseph (1)(2) | 62 | Director | ||||
Bruce Keogh, K.B.E., F.R.C.S., F.R.C.P. (2) | 67 | Director | ||||
George Neble (1) | 66 | Director | ||||
| (1) | Member of the audit committee. |
| (2) | Member of the compensation committee. |
Board Diversity Matrix for LumiraDx Limited (As of March 31, 2022) | ||||||||||||||||
Total Number of Directors: | 10 | |||||||||||||||
Female | Male | Non-Binary | Did Not Disclose Gender | |||||||||||||
Part I: Gender Identity | ||||||||||||||||
Directors | 2 | 8 | — | — | ||||||||||||
Part II: Demographic Background | ||||||||||||||||
Underrepresented race, ethnicity, nationality, culture or religious identity | 2 | — | — | — | ||||||||||||
LGBTQ+ | — | — | — | — | ||||||||||||
None of the above | — | 5 | — | — | ||||||||||||
Did not disclose | — | 3 | — | — | ||||||||||||
| • | The Class I directors are Donald Berwick, George Neble and Lu Huang, and their terms will expire at LumiraDx’s annual general meeting of shareholders to be held in 2022; and |
| • | The Class II directors will be Bruce Keogh, Lurene Joseph, Gerald Chan and Troyen Brennan, and their terms will expire at LumiraDx’s annual general meeting of shareholders to be held in 2023. |
| • | recommending the appointment of the independent auditor to the annual general meeting of shareholders; |
| • | the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or performing other audit services; |
| • | pre-approving the audit services andnon-audit services to be provided by the Company’s independent auditor before the auditor is engaged to render such services; |
| • | evaluating the independent auditor’s qualifications, performance and independence, and presenting its conclusions to the full board of directors on at least an annual basis; |
| • | reviewing and discussing with management and the Company’s independent registered public accounting firm the Company’s financial statements and financial reporting process; and |
| • | reviewing, approving or ratifying any related party transactions. |
| • | review of the charter of the compensation committee; |
| • | reviewing and reassessing processes and procedures for considering and determining non-employee director and executive Officer compensation; |
| • | preparing any report on compensation required under the rules and regulations of the SEC, Nasdaq, and any other rules and regulations applicable to the Company; |
| • | reviewing and approving incentive-compensation and equity-based plans; |
| • | reviewing and approving matters related to compensation of the Company’s Chief Executive Officer; |
| • | reviewing and approving matters covered under the charter related to compensation of the officers other than the Chief Executive Officer; and |
| • | reviewing and approving matters covered under the charter related to compensation of the Company’s non-employee directors or consulting firms or other outside advisers. |
| • | Executive Sessions . IM5605-2 of the Nasdaq Rules requires independent directors of a Nasdaq listed company to meet regularly in executive session (without members of management present), and such executive sessions should occur at least twice a year. In this regard we have elected to adopt the practices of our home country, the Cayman Islands, which practices which do not require independent directors to meet regularly in executive sessions separate from the full board of directors. |
| • | Nomination of Directors |
| • | Composition of Board |
| • | Compensation Committee |
| • | Shareholder Meeting Quorum |
| • | Shareholder Approval |
| • | Director Compensation |
| • | Types of Awards |
| • | Plan Administration |
| • | Award Agreement |
| • | Eligibility non-employees who provide services to us or our affiliates, or any prospective employee nominated by us. Under the Employee Plan, we may grant awards to any executive director or any employee of us or our affiliates. Awards are made by the board of directors in its discretion, in consultation with our Founder Directors and managers, to further our interests by retaining and incentivizing our management team and board members and, further, by aligning such persons’ interests with our shareholders’ interests. Individual board members do not participate in the decision regarding their own awards. |
| • | Vesting Schedule 12-month anniversary of the date of grant, 25% on the24-month anniversary of the date of grant, 25% on the36-month anniversary of the date of grant, and 25% on the48-month anniversary of the date of grant. Our board of directors may also specify a different vesting schedule in the relevant option certificate. Accelerated vesting is generally provided upon a sale of the Company and certain reconstructions. There is no accelerated vesting on an initial public offering of our shares. No options accelerated solely as a result of the Merger. |
| • | Exercise of Options |
| • | Leavers |
| • | each person, or group of affiliated persons, known by us to beneficially own more than 5% of outstanding common shares and ordinary shares; |
| • | each of our directors and executive officers; and |
| • | all of our directors and executive officers as a group. |
Ordinary Shares | Common Shares | |||||||||||||||||||
Name of Beneficial Owner | Number of Shares | Percentage of Outstanding (1) | Number of Shares | Percentage of Outstanding (2) | Total Voting Power | |||||||||||||||
Directors and Executive Officers of LumiraDx: | ||||||||||||||||||||
Ron Zwanziger and affiliated entities (3) | 42,909,216 | 22.5 | % | 2,552,025 | 3.7 | % | 22.5 | % | ||||||||||||
Dorian LeBlanc and affiliated entities (4) | 2,103,183 | 1.1 | % | 19,726 | * | 1.1 | % | |||||||||||||
Dave Scott (5) | 15,906,373 | 8.3 | % | — | — | 8.3 | % | |||||||||||||
Jerry McAleer (6) | 12,972,528 | 6.8 | % | — | — | 6.8 | % | |||||||||||||
Nigel Lindner (7) | 2,670,990 | 1.4 | % | — | — | 1.4 | % | |||||||||||||
David Walton (8) | 2,582,546 | 1.4 | % | — | — | 1.3 | % | |||||||||||||
Peter Scheu (9) | 1,293,396 | * | — | — | 0.7 | % | ||||||||||||||
Veronique Ameye and affiliated entities (10) | 2,712,381 | 1.4 | % | 19,726 | * | 1.4 | % | |||||||||||||
Pooja Pathak (11) | 300,707 | * | — | — | * | |||||||||||||||
Tom Quinlan (12) | 1,872,875 | 1.0 | % | — | — | * | ||||||||||||||
Donald Berwick (13) | 353,773 | * | 106,000 | * | * | |||||||||||||||
Bruce Keogh (14) | 353,773 | * | 106,000 | * | * | |||||||||||||||
Lurene Joseph (15) | 353,773 | * | 106,000 | * | * | |||||||||||||||
Troyen Brennan (16) | 353,773 | * | — | — | * | |||||||||||||||
George Neble (17) | 221,107 | * | 135,589 | * | * | |||||||||||||||
Lu Huang | — | — | — | — | — | |||||||||||||||
Gerald Chan | — | — | — | — | — | |||||||||||||||
All directors and executive officers as a group (17 individuals) | 86,960,394 | 44.2 | % | 3,045,066 | 4.5 | % | 45.4 | % | ||||||||||||
5% and Greater Shareholders: | ||||||||||||||||||||
William Umphrey and Affiliates (18) | 20,176,420 | 10.8 | % | 5,397,505 | 7.7 | % | 10.8 | % | ||||||||||||
Morningside entities (19) | 24,296,120 | 13.1 | % | 19,495,155 | 27.0 | % | 13.6 | % | ||||||||||||
Petrichor Healthcare Capital Management LP (20) | 3,204,836 | 1.7 | % | 3,592,622 | 5.0 | % | 1.9 | % | ||||||||||||
Senvest Management, LLC (21) | 5,575,474 | 3.0 | % | 5,160,943 | 7.4 | % | 3.2 | % | ||||||||||||
Bill & Melinda Gates Foundation (22) | 5,574,059 | 3.0 | % | — | — | 2.9 | % | |||||||||||||
Thermo Fisher Scientific Inc. (23) | 4,711,912 | 2.5 | % | — | — | 2.5 | % | |||||||||||||
| * | Less than one percent. |
| (1) | The percentage of beneficial ownership is based on 185,343,353 ordinary shares outstanding. Under Rule 13d-3 of the Exchange Act, beneficial ownership includes any ordinary shares as to which the holder has sole or shared voting power or investment power and also any ordinary shares which the holder has the right to acquire within 60 days of March 31, 2022 through the exercise of any option, warrant, conversion or any other right, although these shares are not considered outstanding for purposes of computing the percentage ownership of any other person. |
| (2) | The percentage of beneficial ownership is based on 68,341,044 common shares outstanding and assumes that no ordinary shares are converted into common shares within 60 days of March 31, 2022. Under Rule 13d-3 of the Exchange Act, beneficial ownership includes any common shares as to which the holder has sole or shared voting power or investment power and also any common shares which the holder has the right to acquire within 60 days of March 31, 2022 through the exercise of any option, warrant, conversion or any other right, although these shares are not considered outstanding for purposes of computing the percentage ownership of any other person. |
| (3) | Consists of (A) 42,909,216 ordinary shares beneficially owned, which includes (i) 37,184,803 ordinary shares outstanding; (ii) 488,562 ordinary shares issuable upon the exercise of the 2016 Warrants; and (iii) 5,235,851 ordinary shares issuable upon exercise of options; and (B) 2,552,025 common shares beneficially owned, which includes (i) 2,138,104 common shares; (ii) 197,052 common shares issuable upon the exercise of the 2020 Warrants; and (iii) 216,869 common shares issuable upon conversion of Convertible Notes. In addition, Mr. Zwanziger has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. These securities are owned by Mr. Zwanziger, by Zwanziger Family Ventures LLC and Zwanziger Ventures, entities controlled by Mr. Zwanziger. |
| (4) | Consists of (A) 2,103,183 ordinary shares beneficially owned, which includes (i) 215,800 ordinary shares outstanding; and (ii) 1,887,833 ordinary shares issuable upon exercise of options; and (B) 19,726 common shares beneficially owned. In addition, Mr. LeBlanc has unvested options over common shares that are not exercisable within 60 days of March 31, 2022. These securities are owned by Mr. LeBlanc and by members of his family and by Mohawk Investment Partners and Salem Rentals LLC, entities controlled by Mr. LeBlanc. |
| (5) | Consists of 15,906,373 ordinary shares beneficially owned, which includes (i) 10,670,522 ordinary shares outstanding; and (ii) 5,235,851 ordinary shares issuable upon exercise of options. In addition, Mr. Scott has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. |
| (6) | Consists of 12,972,528 ordinary shares beneficially owned, which includes (i) 7,736,677 ordinary shares outstanding; and (ii) 5,235,851 ordinary shares issuable upon exercise of options. In addition, Mr. McAleer has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. |
| (7) | Consists of 2,670,990 ordinary shares beneficially owned, which includes (i) 902,123 ordinary shares outstanding; and (ii) 1,768,867 ordinary shares issuable upon exercise of options. These securities are owned by Dr. Lindner and Dr. Jayne Ellis, Dr. Lindner’s spouse. In addition, Dr. Lindner has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. |
| (8) | Consists of 2,582,546 ordinary shares beneficially owned, which includes (i) 902,123 ordinary shares outstanding; and (ii) 1,680,424 ordinary shares issuable upon exercise of options. These securities are owned by Mr. Walton and Marianne Walton, Mr. Walton’s spouse. |
| (9) | Consists of 1,293,396 ordinary shares beneficially owned, which includes (i) 55,188 ordinary shares outstanding; and (ii) 1,238,208 ordinary shares issuable upon exercise of options. |
| (10) | Consists of (A) 2,712,381 ordinary shares beneficially owned, which includes (i) 91,272 ordinary shares outstanding; and (ii) 2,621,109 ordinary shares issuable upon exercise of options; and (B) 19,726 common shares outstanding. These securities are owed by Ms. Ameye and by Suneet Bakhshi, Ms. Ameye’s spouse and by Jaiventures Limited, an entity controlled by Ms. Ameye. |
| (11) | Consists of 300,707 ordinary shares issuable upon exercise of options. In addition, Ms. Pathak has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. |
| (12) | Consists of 1,872,875 ordinary shares issuable upon exercise of options. |
| (13) | Consists of (A) 353,773 ordinary shares issuable upon exercise of options and (B) 106,000 common shares issuable upon exercise of options. |
| (14) | Consists of (A) 353,773 ordinary shares issuable upon exercise of options and (B) 106,000 common shares issuable upon exercise of options. |
| (15) | Consists of (A) 353,773 ordinary shares issuable upon exercise of options and (B) 106,000 common shares issuable upon exercise of options. |
| (16) | Consists of 353,773 ordinary shares beneficially owned, which includes 353,773 ordinary shares issuable upon exercise of options. |
| (17) | Consists of (A) 221,107 ordinary shares issuable upon exercise of options; and (B) 135,589 common shares, which includes 106,000 shares issuable upon exercise of options. In addition, Mr. Neble has unvested options over ordinary shares that are not exercisable within 60 days of March 31, 2022. |
| (18) | Consists of (A) 20,176,420 ordinary shares beneficially owned, which includes (i) 19,239,981 ordinary shares outstanding; and (ii) 936,439 ordinary shares issuable upon the exercise of the 2016 Warrants; and (B) 5,397,505 common shares beneficially owned, which includes (i) 4,997,954 common shares outstanding; and (ii) 399,551 common shares issuable upon the exercise of the 2020 Warrants. These securities are owned by (i) Willard L. Umphrey, (ii) Anne M. Umphrey, Mr. Umphrey’s spouse and (iii) Pensco Trust Company, a retirement account of Mr. Umphrey. |
| (19) | Consists of (A) 24,296,120 ordinary shares outstanding; and (B) 19,495,155 common shares, which includes (i) 17,128,408 common shares outstanding; and (ii) 2,366,747 common shares issuable upon the exercise of the 2020 Warrants. These securities are owed directly by MVIL LLC and Morningside Ventures Investments Limited. The address of MVIL LLC and Morningside Ventures Investments Limited is c/o THC Management Services S.A.M., 2nd Floor, Le Prince De Galles, 3-5 Avenue Des Citronniers, MC 98000, Monaco. |
| (20) | Consists of (A) 3,204,836 ordinary shares beneficially owned, which includes (i) 2,892,100 ordinary shares outstanding and (ii) 312,736 ordinary shares issuable upon exercise of warrants; and (B) 3,592,622 common shares beneficially owned, which includes (i) 2,803,706 common shares outstanding and (ii) 788,916 common shares issuable upon the exercise of warrants. These securities are owed directly by Petrichor Opportunities Fund I Intermediate LP and Petrichor Opportunities Fund LP. The address of Petrichor Healthcare Capital Management LP is 220 East 42nd Street, New York, NY 10017. |
| (21) | Consists of (A) 5,575,474 ordinary shares outstanding; and (B) 5,160,943 common shares beneficially owned, which includes (i) 2,783,925 common shares outstanding, (ii) 1,928,171 common shares issuable upon the exercise of warrants |
| that are subject to a 9.99% beneficial ownership blocker and (iii) 448,847 common shares issuable upon conversion of Convertible Notes. These securities are owed directly by Senvest Global (KY) LP, Senvest Master Fund LP and Senvest Technology Partners Master Fund LP. The address of the reporting persons is c/o Senvest Management, LLC, 540 Madison Avenue, 32nd Floor, New York, New York 10022. |
| (22) | Consists of 5,574,059 outstanding ordinary shares, as reflected in the records of our transfer agent as of March 31, 2022. The address of the Bill & Melinda Gates Foundation is 500 Fifth Avenue North, Seattle, Washington 98109. Such beneficial ownership has been included on the basis that upon conversion of such ordinary shares, the Bill & Melinda Gates Foundation would beneficially hold more than 5% of the outstanding common shares (assuming no conversion of ordinary shares held by any other ordinary shareholder). |
| (23) | Consists of 4,711,912 outstanding ordinary shares, as reflected in the records of our transfer agent as of March 31, 2022. The address of Thermo Fisher Scientific Inc. is 168 Third Avenue, Waltham, Massachusetts 02451. Such beneficial ownership has been included on the basis that upon conversion of such ordinary shares, Thermo Fisher Scientific Inc. would beneficially hold more than 5% of the outstanding common shares (assuming no conversion of ordinary shares held by any other ordinary shareholder). |
| • | all resolutions to be voted on by shareholders at an extraordinary general meeting or at an annual general meeting will be held by way of a poll; |
| • | each holder of ordinary shares is entitled to ten votes per ordinary share on matters to be voted on by shareholders; |
| • | each holder of common shares is entitled to one vote per common share on matters to be voted on by shareholders; |
| • | the holders of ordinary shares and common shares shall be entitled to receive notice of, attend, speak and vote by way of a poll at an extraordinary general meeting or at an annual general meeting; |
| • | the holders of ordinary shares and common shares shall be entitled to receive such dividends as may be declared by the board of directors, which shall be distributed pro rata (as if they were one class of shares) according to the number of ordinary shares and common shares held by the relevant holder and as recommended by the directors and declared by the shareholders of LumiraDx; |
| • | all of the issued and outstanding ordinary shares and common shares are fully paid and non-assessable; |
| • | the ordinary shares and common shares are issued in registered form, and are issued when registered in the register of members of LumiraDx; |
| • | LumiraDx’s board of directors may issue undesignated shares in one or more series and designate the price, rights, preferences, privileges and restrictions of such shares without any further vote or action by LumiraDx’s shareholders; |
| • | LumiraDx’s shareholders who are non-residents of the Cayman Islands may freely hold and vote their ordinary shares and common shares; and |
| • | LumiraDx may not issue shares to bearer. |
| • | at any general meeting (being extraordinary general meetings and annual general meetings) all resolutions put to the vote of the meeting shall be decided by way of a poll; |
| • | every holder of an ordinary share who is present in person or by proxy shall have ten votes for each ordinary share of which he/she/it is the holder; and |
| • | every holder of a common share who is present in person or by proxy shall have one vote for each common share of which he/she/it is the holder. |
| • | the following transfers of ordinary shares are “Permitted Transfers”: |
| • | transfers by one holder of ordinary shares to another holder of ordinary shares; |
| • | transfers to and from employee trusts; |
| • | transfers to Privileged Relations (which, in general, includes shareholders and certain of their family members) (if being transferred by an employee) or to trusts established for the benefit of Privileged Relations or charities and/or their nominees (“Family Trust”); and |
| • | transfers by a corporate shareholder to another member of its wholly owned group; and |
| • | the following transfers of ordinary shares are “Mandatory Transfers”: |
| • | if any trust ceases to be a Family Trust or there ceases to be any beneficiaries of the Family Trust, a transfer back to the settlor of that Family Trust or to a Privileged Relation of the settlor or to another Family Trust of the settlor; |
| • | if any Privileged Relation ceases to be a Privileged Relation of the original shareholder, a transfer back to the original shareholder or to another Privileged Relation of the original shareholder or to another Family Trust of the original shareholder; and |
| • | if a corporate shareholder ceases to be member of the same wholly owned group as the original corporate shareholder, a transfer back to the original corporate shareholder or to another member of the original corporate shareholder’s wholly owned group. |
| • | increase the share capital by such sum, to be divided into shares of such classes and amount, as the resolution shall prescribe; |
| • | consolidate and divide all or any of the share capital into shares of a larger amount than the existing shares of LumiraDx; |
| • | sub-divide LumiraDx’s existing shares, or any of them into shares of a smaller amount, provided that in the subdivision the proportion between the amount paid and the amount, if any, unpaid on each reduced share shall be the same as it was in case of the share from which the reduced share is derived; or |
| • | cancel any shares which, at the date of the passing of the resolution, have not been taken or agreed to be taken by any person and diminish the amount of LumiraDx’s share capital by the amount of the shares so cancelled. |
| • | the names and addresses of the shareholders of LumiraDx, a statement of the shares held by each member (such statement will distinguish each share by its number (where applicable), confirm the amount paid or agreed to be considered as paid on the shares of each member, confirm the number and category of the shares held by each member and confirm whether each relevant category of shares held by a member carries voting rights under the articles of association of LumiraDx, and if so, whether such voting rights are conditional); |
| • | the date on which the name of any person was entered on the register as a member; and |
| • | the date on which any person ceased to be a member. |
| • | the statutory provisions as to the required majority vote have been met; |
| • | the shareholders have been fairly represented at the meeting in question and the statutory majority are acting bona fide without coercion of the minority to promote interests adverse to those of the class; |
| • | the arrangement is such that may be reasonably approved by an intelligent and honest man of that class acting in respect of his or her interest; and |
| • | the arrangement is not one that would more properly be sanctioned under some other provision of the Cayman Companies Act. |
| • | an act that is illegal or ultra vires with respect to LumiraDx and is therefore incapable of ratification by the shareholders; |
| • | an act that, although not ultra vires, requires authorization by a qualified (or special) majority (that is, more than a simple majority) that has not been obtained; and |
| • | an act that constitutes a “fraud on the minority” where the wrongdoers are themselves in control of LumiraDx. |
| • | Dual Class Stock |
| • | Board of Directors Vacancies |
| • | Classified Board |
| • | Shareholder Action; Special Meeting of Shareholders one-third of the voting rights who are entitled to vote at general meetings. However, shareholders may propose only ordinary resolutions to be put to a vote at such meetings and shall have no right to propose resolutions with respect to the election, appointment or removal of directors or to amend the Amended and Restated Articles. The Amended and Restated Articles provide no other right to put any proposals before annual general meetings or extraordinary general meeting. These provisions might delay the ability of the shareholders to force consideration of a proposal or for shareholders controlling a majority of LumiraDx’s share capital to take any action, including the removal of directors. |
| • | Founder Directors co-founder, and his affiliates. This provision would |
prevent shareholders from removing any of the Founder Directors from their respective positions on the board of directors who LumiraDx considers as being fundamental to the running and continued development LumiraDx’s business. |
| • | Class I and Class II Directors Removed Only for Cause |
| • | Issuance of Undesignated Shares |
| • | 1% of the total number of the Company’s common shares then outstanding; or |
| • | the average weekly reported trading volume of the common shares during the four calendar weeks preceding the filing of a notice on Form 144 with respect to the sale. |
| • | U.S. expatriates and former citizens or long-term residents of the United States; |
| • | persons subject to the alternative minimum tax; |
| • | persons that hold common shares, as part of a hedge, straddle or other risk reduction strategy or as part of a conversion transaction, constructive sale, wash sale or other integrated transaction; |
| • | banks, insurance companies and other financial institutions; |
| • | brokers, dealers or traders in securities; |
| • | “controlled foreign corporations,” “passive foreign investment companies” and corporations that accumulate earnings to avoid U.S. federal income tax; |
| • | S corporations, partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors therein); |
| • | tax-exempt organizations or governmental organizations; |
| • | persons subject to special tax accounting rules as a result of any item of gross income with respect to their common shares being taken into account in an applicable financial statement; |
| • | U.S. holders (as defined below) whose functional currency is not the U.S. dollar; |
| • | persons who own 5% or more of the total outstanding common shares, or the total outstanding equity of LumiraDx, in each case, directly, indirectly or constructively, by vote or value; |
| • | persons that acquired or will hold common shares pursuant to an exercise of employee options, in connection with employee incentive plans or otherwise as compensation; |
| • | regulated investment companies or real estate investment trusts; and |
| • | tax-qualified retirement plans. |
| • | an individual who is a citizen or resident of the United States; |
| • | a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) organized in or under the laws of the United States, any state thereof or the District of Columbia; |
| • | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
| • | an entity treated as a trust that (i) is subject to the primary supervision of a court within the United States and the control of one or more “United States persons” (within the meaning of Section 7701(a)(30) of the Code) or (ii) was in existence on August 20, 1996 and has a valid election in effect to be treated as a United States person for U.S. federal income tax purposes. |
| • | the excess distribution or the gain will be allocated ratably over the U.S. holder’s holding period for its common shares; |
| • | the amount of such excess distribution or the gain allocated to the taxable year of disposition, and any taxable year prior to the first taxable year in which LumiraDx became a PFIC, will be treated as ordinary income; and |
| • | the amount of such excess distribution or the gain allocated to each other year will be subject to the highest U.S. federal income tax rate in effect for that year for individuals or corporations, as appropriate, and the interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
Underwriters | Number of Common Shares | |||
Goldman Sachs & Co. LLC | ||||
Evercore Group L.L.C. | ||||
SVB Securities LLC | ||||
Raymond James & Associates, Inc. | ||||
Total | 40,000,000 | |||
No Exercise | Full Exercise | |||||||
Per common share | $ | $ | ||||||
Total | $ | $ | ||||||
| (a) | to any legal entity which is a qualified investor as defined under Article 2 of the Prospectus Regulation; |
| (b) | to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or |
| (c) | in any other circumstances falling within Article 1(4) of the Prospectus Regulation, |
| (a) | to any legal entity which is a qualified investor as defined under Article 2 of the U.K. Prospectus Regulation; |
| (b) | to fewer than 150 natural or legal persons (other than qualified investors as defined under Article 2 of the U.K. Prospectus Regulation), subject to obtaining the prior consent of the representatives for any such offer; or |
| (c) | in any other circumstances falling within Section 86 of the FSMA. |
Paid or to be Paid | ||||
SEC registration fee | $ | 10,021 | ||
FINRA filing fee | 16,715 | |||
Legal fees and expenses | 1,200,000 | |||
Accounting fees and expenses | 240,000 | |||
Printing expenses | 200,000 | |||
Miscellaneous expenses | 100,000 | |||
Total | $ | 1,766,736 | ||
Page | ||||
Consolidated Financial Statements of LumiraDx Limited | ||||
| F-2 | ||||
| F-3 | ||||
| F-4 | ||||
| F-5 | ||||
| F-6 | ||||
| F-7 | ||||
Year Ended December 31, 2019 | Year Ended December 31, 2020 | Year Ended December 31, 2021 | ||||||||||||||
Note | (in thousands, except share data and EPS) | |||||||||||||||
Revenue | ||||||||||||||||
Products | 4 | $ | 19,802 | $ | 135,656 | $ | 415,654 | |||||||||
Services | 4 | 3,340 | 3,497 | 5,774 | ||||||||||||
Total Revenue | 23,142 | 139,153 | 421,428 | |||||||||||||
Cost of sales | ||||||||||||||||
Products | (12,469 | ) | (84,456 | ) | (268,835 | ) | ||||||||||
Services | (1,853 | ) | (1,750 | ) | (1,053 | ) | ||||||||||
Total Cost of Sales | (14,322 | ) | (86,206 | ) | (269,888 | ) | ||||||||||
Gross Profit | 8,820 | 52,947 | 151,540 | |||||||||||||
Research and development expenses | (86,546 | ) | (107,539 | ) | (130,221 | ) | ||||||||||
| Selling, marketing and administrative expenses | (37,294 | ) | (46,129 | ) | (130,520 | ) | ||||||||||
Listing expenses | 27 | — | — | (36,202 | ) | |||||||||||
Operating Loss | (115,020 | ) | (100,721 | ) | (145,403 | ) | ||||||||||
Finance income | 6 | 11,705 | 22,500 | 165,426 | ||||||||||||
Finance expense | 6 | (39,335 | ) | (172,722 | ) | (117,934 | ) | |||||||||
Net finance income/(expense) | (27,630 | ) | (150,222 | ) | 47,492 | |||||||||||
Loss before Tax | (142,650 | ) | (250,943 | ) | (97,911 | ) | ||||||||||
Tax credit/(expense) for the period | 7 | 9,541 | 9,946 | (2,844 | ) | |||||||||||
Loss for the period | $ | (133,109 | ) | $ | (240,997 | ) | $ | (100,755 | ) | |||||||
Loss/(gain) attributable to non-controlling interest | 9 | (302 | ) | (17 | ) | 174 | ||||||||||
Net loss attributable to equity holders of parent—basic and diluted | $ | (132,807 | ) | $ | (240,980 | ) | $ | (100,929 | ) | |||||||
Net loss per share attributable to equity holders of parent—basic and diluted | 8 | $ | (1.01 | ) | $ | (1.82 | ) | $ | (0.62 | ) | ||||||
Weighted-average number of Ordinary Shares used in loss per share—basic and diluted | 8 | 131,757,738 | 132,192,880 | 163,255,784 | ||||||||||||
Other Comprehensive Loss: | ||||||||||||||||
Items that may be reclassified subsequently to profit or loss | ||||||||||||||||
Foreign currency translation differences—foreign operations | (7,580 | ) | (17,560 | ) | 199 | |||||||||||
Total Comprehensive loss for the year | (140,689 | ) | (258,557 | ) | (100,556 | ) | ||||||||||
Total comprehensive loss attributable to: | ||||||||||||||||
Equity holders of the parent | (140,389 | ) | (258,544 | ) | (100,730 | ) | ||||||||||
Non-controlling interest | 9 | (300 | ) | (13 | ) | 174 | ||||||||||
Total | $ | (140,689 | ) | $ | (258,557 | ) | $ | (100,556 | ) | |||||||
As of December 31, 2020 | As of December 31, 2021 | |||||||||||
Note | (in thousands, except share data) | |||||||||||
ASSETS | ||||||||||||
Non–Current Assets | ||||||||||||
Other non-current assets | $ | 241 | $ | 569 | ||||||||
Intangibles and goodwill | 10 | 40,723 | 37,048 | |||||||||
Right-of-use | 24 | 10,386 | 27,746 | |||||||||
Property, plant and equipment | 11 | 87,082 | 173,397 | |||||||||
Total Non-Current Assets | 138,432 | 238,760 | ||||||||||
Current Assets | ||||||||||||
Inventories | 12 | 85,516 | 149,055 | |||||||||
Tax receivable | 7 | 20,680 | 15,022 | |||||||||
Trade and other receivables | 13 | 109,295 | 109,798 | |||||||||
Restricted cash | 2 | 2,455 | — | |||||||||
Cash and cash equivalents | 158,717 | 132,145 | ||||||||||
Total Current Assets | 376,663 | 406,020 | ||||||||||
TOTAL ASSETS | $ | 515,095 | $ | 644,780 | ||||||||
LIABILITIES AND EQUITY | ||||||||||||
Liabilities | ||||||||||||
Non-Current Liabilities | ||||||||||||
Debt due after more than one year | 17 | $ | (139,734 | ) | $ | (301,129 | ) | |||||
Preferred shares | 16 | (451,721 | ) | — | ||||||||
Lease liabilities | (8,991 | ) | (25,514 | ) | ||||||||
Stock warrants | 27 | — | (10,407 | ) | ||||||||
Deferred tax liabilities | 19 | (1,230 | ) | (779 | ) | |||||||
Total Non-Current Liabilities | (601,676 | ) | (337,829 | ) | ||||||||
Current Liabilities | ||||||||||||
Debt due within one year | 17 | (147,238 | ) | (191 | ) | |||||||
Government and other grants | 21 | (44,037 | ) | (38,941 | ) | |||||||
Trade and other payables | 20 | (95,246 | ) | (99,641 | ) | |||||||
Lease liabilities due within one year | (2,114 | ) | (5,582 | ) | ||||||||
Total Current Liabilities | (288,635 | ) | (144,355 | ) | ||||||||
Equity | ||||||||||||
Share capital and share premium | 14 | (152,732 | ) | (754,023 | ) | |||||||
Foreign currency translation reserve | 19,905 | 19,706 | ||||||||||
Other reserves | 14 | (99,821 | ) | (104,957 | ) | |||||||
Accumulated deficit | 607,657 | 676,223 | ||||||||||
Total equity attributable to equity holders of the parent | 375,009 | (163,051 | ) | |||||||||
Non-controlling interests | 9 | 207 | 455 | |||||||||
Total Equity | 375,216 | (162,596 | ) | |||||||||
TOTAL EQUITY AND LIABILITIES | $ | (515,095 | ) | $ | (644,780 | ) | ||||||
Share Capital | Share Premium | Translation Reserves | Other Reserves | Accumulated Deficit | Total | Non- Controlling Interest | Total Equity | |||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||
Balance at January 1, 2019 | $ | — | $ | 152,125 | $ | 5,241 | $ | 49,582 | $ | (241,031 | ) | $ | (34,083 | ) | $ | 106 | $ | (33,977 | ) | |||||||||||||
Loss for the period | — | — | — | — | (132,807 | ) | (132,807 | ) | (302 | ) | (133,109 | ) | ||||||||||||||||||||
Other comprehensive loss | ||||||||||||||||||||||||||||||||
Currency translation differences | — | — | (7,582 | ) | — | — | (7,582 | ) | 2 | (7,580 | ) | |||||||||||||||||||||
Total comprehensive loss for the period | — | — | (7,582 | ) | — | (132,807 | ) | (140,389 | ) | (300 | ) | (140,689 | ) | |||||||||||||||||||
Shares issued | — | 2,601 | (255 | ) | — | 2,346 | — | 2,346 | ||||||||||||||||||||||||
Equity compensation plans | — | — | — | — | 3,970 | 3,970 | — | 3,970 | ||||||||||||||||||||||||
Equity conversion feature of convertible notes | — | — | — | 17,065 | — | 17,065 | — | 17,065 | ||||||||||||||||||||||||
Issue of other equity instruments | — | — | — | 491 | — | 491 | — | 491 | ||||||||||||||||||||||||
Shares repurchased | — | (2,035 | ) | — | — | — | (2,035 | ) | — | (2,035 | ) | |||||||||||||||||||||
Transaction with owners, recognized directly in equity | — | 566 | — | 17,301 | 3,970 | 21,837 | — | 21,837 | ||||||||||||||||||||||||
Changes in non-controlling interests | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Balance at December 31, 2019 | $ | — | $ | 152,691 | $ | (2,341 | ) | $ | 66,883 | $ | (369,868 | ) | $ | (152,635 | ) | $ | (194 | ) | $ | (152,829 | ) | |||||||||||
Balance at January 1, 2020 | $ | — | $ | 152,691 | $ | (2,341 | ) | $ | 66,883 | $ | (369,868 | ) | $ | (152,635 | ) | $ | (194 | ) | $ | (152,829 | ) | |||||||||||
Loss for the period | — | — | — | — | (240,980 | ) | (240,980 | ) | (17 | ) | (240,997 | ) | ||||||||||||||||||||
Other comprehensive loss | ||||||||||||||||||||||||||||||||
Currency translation differences | — | — | (17,564 | ) | — | — | (17,564 | ) | 4 | (17,560 | ) | |||||||||||||||||||||
Total comprehensive loss for the period | — | — | (17,564 | ) | — | (240,980 | ) | (258,544 | ) | (13 | ) | (258,557 | ) | |||||||||||||||||||
Equity compensation plans | — | — | — | — | 3,191 | 3,191 | — | 3,191 | ||||||||||||||||||||||||
Issue of other equity instruments | — | — | — | 32,938 | — | 32,938 | — | 32,938 | ||||||||||||||||||||||||
Shares issued on exercise of share options | — | 41 | — | — | — | 41 | — | 41 | ||||||||||||||||||||||||
Transaction with owners, recognized directly in equity | — | 41 | — | 32,938 | 3,191 | 36,170 | — | 36,170 | ||||||||||||||||||||||||
Changes in non-controlling interests | — | — | — | — | — | — | — | — | ||||||||||||||||||||||||
Balance at December 31, 2020 | $ | — | $ | 152,732 | $ | (19,905 | ) | $ | 99,821 | $ | (607,657 | ) | $ | (375,009 | ) | $ | (207 | ) | $ | (375,216 | ) | |||||||||||
Balance at January 1, 2021 | $ | — | $ | 152,732 | $ | (19,905 | ) | $ | 99,821 | $ | (607,657 | ) | $ | (375,009 | ) | $ | (207 | ) | $ | (375,216 | ) | |||||||||||
Loss for the period | — | — | — | — | (100,929 | ) | (100,929 | ) | 174 | (100,755 | ) | |||||||||||||||||||||
Other comprehensive loss | ||||||||||||||||||||||||||||||||
Currency translation differences | — | — | 199 | — | — | 199 | — | 199 | ||||||||||||||||||||||||
Total comprehensive loss for the period | — | — | 199 | — | (100,929 | ) | (100,730 | ) | 174 | (100,556 | ) | |||||||||||||||||||||
Equity compensation plans | — | — | — | — | 33,909 | 33,909 | — | 33,909 | ||||||||||||||||||||||||
Issue of other equity instruments | — | — | — | 5,136 | — | 5,136 | — | 5,136 | ||||||||||||||||||||||||
Shares issued on exercise of share options | — | 104 | — | — | — | 104 | — | 104 | ||||||||||||||||||||||||
Conversion of debt and preferred shares in merger | — | 576,210 | — | — | — | 576,210 | — | 576,210 | ||||||||||||||||||||||||
Shares issued in merger | — | 24,977 | — | — | 24,977 | — | 24,977 | |||||||||||||||||||||||||
Transaction with owners, recognized directly in equity | — | 601,291 | — | 5,136 | 33,909 | 640,336 | — | 640,336 | ||||||||||||||||||||||||
Changes in non-controlling interests | — | — | — | — | (1,546 | ) | (1,546 | ) | (422 | ) | (1,968 | ) | ||||||||||||||||||||
Balance at December 31, 2021 | $ | — | $ | 754,023 | $ | (19,706 | ) | $ | 104,957 | $ | (676,223 | ) | $ | 163,051 | $ | (455 | ) | $ | 162,596 | |||||||||||||
Year Ended December 31, 2019 | Year Ended December 31, 2020 | Year Ended December 31, 2021 | ||||||||||
(in thousands, except share data) | ||||||||||||
Cash Flows from Operating Activities | ||||||||||||
Loss for the period | $ | (133,109 | ) | $ | (240,997 | ) | $ | (100,755 | ) | |||
Adjustments to reconcile loss for the year to net cash used in operating activities: | ||||||||||||
Depreciation | 5,502 | 8,527 | 22,868 | |||||||||
Amortization | 2,494 | 2,387 | 2,827 | |||||||||
Net finance expenses | 6,001 | 126,774 | (63,625 | ) | ||||||||
Equity based share based payment transactions | 3,970 | 3,191 | 33,909 | |||||||||
Increase in tax receivable | (9,549 | ) | (11,269 | ) | (4,663 | ) | ||||||
Accrued preferred shares dividends | 21,600 | 23,578 | 16,156 | |||||||||
Listing charge | — | — | 27,607 | |||||||||
Changes to working capital: | ||||||||||||
Inventories | (8,389 | ) | (73,302 | ) | (66,874 | ) | ||||||
Trade and other receivables | 6,388 | (89,213 | ) | 7,511 | ||||||||
Trade payables and other liabilities | 13,337 | 100,997 | (9,544 | ) | ||||||||
Net Cash used in Operating Activities | (91,755 | ) | (149,327 | ) | (134,583 | ) | ||||||
Cash Flows from Investing Activities | ||||||||||||
Purchases of property, plant, equipment | (10,625 | ) | (64,381 | ) | (106,346 | ) | ||||||
Purchases of intangible assets | (102 | ) | — | — | ||||||||
Cash paid for business acquisitions, net of cash received | (581 | ) | — | — | ||||||||
Net Cash used in Investing Activities | (11,308 | ) | (64,381 | ) | (106,346 | ) | ||||||
Cash Flows from Financing Activities | ||||||||||||
Proceeds from issuance of preferred shares | — | 162,401 | — | |||||||||
Proceeds from debt issuance, net of issuance costs | 55,769 | 62,391 | 361,830 | |||||||||
Proceeds from issuance of convertible notes, net of issuance costs | 71,932 | 70,917 | — | |||||||||
Proceeds from issuance of share capital | — | — | 38,568 | |||||||||
Shares issued on the exercise of share options | — | 41 | 104 | |||||||||
Repayment of principal portion of lease liabilities | (1,866 | ) | (3,054 | ) | (5,429 | ) | ||||||
Cash interest paid, net of interest received | (3,771 | ) | (12,114 | ) | (29,894 | ) | ||||||
Early extinguishment of debt | — | (3,600 | ) | (3,637 | ) | |||||||
Repurchase of shares | (2,035 | ) | ||||||||||
Cash issued for non-controlling interest | — | (1,968 | ) | |||||||||
Repayments of debt | (49,328 | ) | (40,396 | ) | (140,552 | ) | ||||||
Net Cash generated from Financing Activities | 70,701 | 236,586 | 219,022 | |||||||||
Net (Decrease) / Increase in Cash and Cash Equivalents | $ | (32,362 | ) | $ | 22,878 | $ | (21,907 | ) | ||||
Movement in Cash and Cash Equivalents | ||||||||||||
Cash and cash equivalents at the beginning of the year | $ | 171,273 | $ | 139,387 | $ | 161,172 | ||||||
Exchange loss on cash and cash equivalents | 476 | (1,093 | ) | (7,120 | ) | |||||||
Net Increase / (decrease) in cash and cash equivalents | (32,362 | ) | 22,878 | (21,907 | ) | |||||||
Cash and Cash Equivalents at the end of the year | $ | 139,387 | $ | 161,172 | $ | 132,145 | ||||||
| • | assets and liabilities for each Statement of Financial Position presented are translated at the closing rate at the date of that Statement of Financial Position; |
| • | income and expenses for each statement of comprehensive income are translated at average exchange rates (unless this average is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions); and |
| • | all resulting exchange differences are recognized in other comprehensive income. |
| • | Land and buildings—length of the lease up to 15 years |
| • | Plant and equipment—3-15 years |
| • | Fixtures and fittings—3-7 years |
| • | fixed lease payments (including in-substance fixed payments), less any lease incentives; |
| • | variable lease payments that depend on an index or rate, initially measured using the index or rate at the commencement date; |
| • | the amount expected to be payable by the lessee under residual value guarantees; |
| • | the exercise price of purchase options, if the lessee is reasonably certain to exercise the options; and |
| • | payments of penalties for terminating the lease, if the lease term reflects the exercise of an option to terminate the lease. |
| • | the lease term has changed or there is a change in the assessment of exercise of a purchase option, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate. |
| • | the lease payments change due to changes in an index or rate or a change in expected payment under a guaranteed residual value, in which cases the lease liability is measured by discounting the revised lease payments using the initial discount rate (unless the lease payments change is due to a change in a floating interest rate, in which case a revised discount rate is used). |
| • | a lease contract is modified and the lease modification is not accounted for as a separate lease, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate. |
2020* | 2021 | |||||||||||
Employees | Founders | |||||||||||
Grant date fair value ($) | 1,634 to 3,861 | 1.37 to 4.02 | 1.26 to 2.85 | |||||||||
Exercise price ($) | 1,793 to 3,861 | 9.89 to 16.39 | 16.96 to 17.05 | |||||||||
Volatility | 35-40 | % | 40.0 | % | 40.0 | % | ||||||
Dividend yield | — | — | — | |||||||||
Expected life of option (years) | 2-2.5 | 4-6.25 | 4-6.25 | |||||||||
Annual risk free interest rate | 0.2-1.6 | % | 0.78-1.22 | % | 0.78-1.22 | % | ||||||
Total fair value of options granted | $ | 6,716 | $ | 8,567 | $ | 43,887 | ||||||
| * | Amounts not adjusted for 2021 share splits |
| • | the prices at which the Group issued ordinary and preferred shares and the superior rights and preferences of the preferred shares relative to the ordinary shares at the time of each grant; |
| • | the progress of the Group’s research and development programs; |
| • | the stage of development and the Group’s business strategy; |
| • | external market conditions affecting the Group’s industry and trends within the industry; |
| • | the Group’s financial position, including cash on hand, and historical and forecasted performance and operating results; |
| • | the lack of an active public market for the Group’s ordinary shares and preferred shares; |
| • | the likelihood of achieving a liquidity event, such as an IPO, in light of prevailing market conditions; and |
| • | the analysis of IPOs and the market performance of similar companies in the Group’s industry. |
2019 | 2020 | 2021 | ||||||||||||||||||||||||||||||||||
Revenue Stream | Revenue From Contracts With Customers | Revenue From Other Sources | Total | Revenue From Contracts With Customers | Revenue From Other Sources | Total | Revenue From Contracts With Customers | Revenue From Other Sources | Total | |||||||||||||||||||||||||||
Products | $ | 18,817 | $ | 985 | $ | 19,802 | $ | 133,794 | $ | 862 | $ | 135,656 | $ | 414,114 | $ | 1,540 | $ | 415,654 | ||||||||||||||||||
Services | 3,340 | — | 3,340 | 3,497 | — | 3,497 | 5,774 | — | 5,774 | |||||||||||||||||||||||||||
Total Revenue | $ | 22,157 | $ | 985 | $ | 23,142 | $ | 137,291 | $ | 862 | $ | 139,153 | $ | 419,888 | $ | 1,540 | $ | 421,428 | ||||||||||||||||||
Deferred Revenue | ||||||||
2020 | 2021 | |||||||
Balance at start of the period | 2,639 | 1,760 | ||||||
Recognized revenue from prior years’ invoicing | (2,348 | ) | (1,760 | ) | ||||
Amounts invoiced to be recognized over time | 2,509 | 4,149 | ||||||
Recognized revenue from current year invoicing | (1,131 | ) | (2,703 | ) | ||||
Foreign exchange impact | 91 | 71 | ||||||
Balance at end of the period | 1,760 | 1,517 | ||||||
Analysis of Revenue By Country: | 2019 | 2020 | 2021 | |||||||||
United States | $ | 20 | $ | 54,655 | $ | 250,755 | ||||||
Italy | 5,993 | 24,098 | 65,659 | |||||||||
United Kingdom | 5,373 | 39,936 | 56,282 | |||||||||
Germany | 282 | 1,462 | 16,261 | |||||||||
Colombia | 8,177 | 8,789 | 12,101 | |||||||||
Sweden | 1,097 | 3,128 | 6,954 | |||||||||
Netherlands | — | 101 | 2,610 | |||||||||
Switzerland | 63 | 581 | 2,491 | |||||||||
Brazil | 1,758 | 3,209 | 2,320 | |||||||||
Japan | — | — | 2,251 | |||||||||
Austria | 104 | 1,622 | 2,002 | |||||||||
Spain | — | — | 1,014 | |||||||||
Denmark | — | 1,354 | 98 | |||||||||
Other | 275 | 218 | 630 | |||||||||
Total revenue | $ | 23,142 | $ | 139,153 | $ | 421,428 | ||||||
Analysis of Non-Current Assets By Country: | 2020 | 2021 | ||||||
United Kingdom | $ | 115,135 | $ | 199,312 | ||||
United States | 7,985 | 22,537 | ||||||
Italy | 9,280 | 10,600 | ||||||
Colombia | 4,306 | 3,780 | ||||||
Sweden | 593 | 630 | ||||||
Other | 1,133 | 1,901 | ||||||
Total | $ | 138,432 | $ | 238,760 | ||||
2019 | 2020 | 2021 | ||||||||||
Net gain on conversion of convertible financial instruments | $ | — | $ | — | $ | 64,143 | ||||||
Change in fair value of 2020 convertible notes (Note 17) | — | — | 52,267 | |||||||||
Change in fair value of Series B preferred shares (Note 16) | — | — | 48,956 | |||||||||
Interest Income | 1,978 | 581 | 60 | |||||||||
Foreign exchange gain | 9,727 | 21,908 | — | |||||||||
Other | 11 | — | ||||||||||
Finance income | $ | 11,705 | $ | 22,500 | $ | 165,426 | ||||||
Interest expense (cash) | $ | (5,749 | ) | $ | (12,695 | ) | $ | (29,954 | ) | |||
Interest expense (non-cash) | (11,044 | ) | (18,152 | ) | (43,939 | ) | ||||||
Lease liability interest expense (Note 24) | (396 | ) | (751 | ) | (2,501 | ) | ||||||
Foreign exchange loss | — | — | (14,594 | ) | ||||||||
Dividend on preferred shares (Note 16) | (21,600 | ) | (23,578 | ) | (16,156 | ) | ||||||
Debt extinguishment fee (cash) | — | — | (3,636 | ) | ||||||||
Debt extinguishment fee (non-cash) | (520 | ) | (5,647 | ) | (4,170 | ) | ||||||
Change in fair value of 2020 convertible notes (Note 17) | — | (102,548 | ) | — | ||||||||
Change in fair value of Series B preferred shares (Note 16) | — | (9,351 | ) | — | ||||||||
Change in fair value of Stock Warrants (Note 27) | — | — | (2,875 | ) | ||||||||
Other | (26 | ) | — | (109 | ) | |||||||
Finance expense | $ | (39,335 | ) | $ | (172,722 | ) | $ | (117,934 | ) | |||
Tax Credit for the Period | 2019 | 2020 | 2021 | |||||||||
Current income credit / (tax) | ||||||||||||
- Current year | $ | 8,228 | $ | 10,320 | $ | (4,087 | ) | |||||
- Prior years | 1,030 | (767 | ) | — | ||||||||
Total current income credit / (tax) | 9,258 | 9,553 | (4,087 | ) | ||||||||
Deferred income tax credit | ||||||||||||
- Current year | 283 | 393 | 1,243 | |||||||||
- Prior years | — | — | — | |||||||||
Total deferred income credit | 283 | 393 | 1,243 | |||||||||
Total income tax credit/(expense) | $ | 9,541 | $ | 9,946 | $ | (2,844 | ) | |||||
2019 | 2020 | 2021 | ||||||||||
Loss for the period before taxation | $ | 142,650 | $ | 250,943 | $ | 97,911 | ||||||
Tax benefit at standard U.K. rate at 19% | 27,104 | 47,679 | 18,603 | |||||||||
Difference in overseas tax rates | 409 | 145 | (700 | ) | ||||||||
Expenses not deductible for tax purposes | (5,345 | ) | (5,389 | ) | 7,359 | |||||||
Tax losses for which no deferred tax asset was recognized | (14,683 | ) | (37,694 | ) | (21,887 | ) | ||||||
Share-based payment (not deductible for tax purposes) | (693 | ) | (572 | ) | (6,443 | ) | ||||||
Research and development credit | 3,943 | 4,804 | — | |||||||||
Adjustments for prior year | (1,030 | ) | 767 | — | ||||||||
Other timing differences and adjustments | (164 | ) | 206 | 224 | ||||||||
Income tax credit/(expense) | $ | 9,541 | $ | 9,946 | $ | (2,844 | ) | |||||
Effective tax rate | 7 | % | 4 | % | -3 | % | ||||||
Loss attributable to ordinary shareholders: | 2019 | 2020 | 2021 | |||||||||||||||||||||
Basic | Diluted | Basic | Diluted | Basic | Diluted | |||||||||||||||||||
Loss for the year, attributable to equity holders of the parent | $ | (132,807 | ) | $ | (132,807 | ) | $ | (240,980 | ) | $ | (240,980 | ) | $ | (100,929 | ) | $ | (100,929 | ) | ||||||
Loss attributable to ordinary shareholders | (132,807 | ) | (132,807 | ) | (240,980 | ) | (240,980 | ) | (100,929 | ) | (100,929 | ) | ||||||||||||
Weighted-average number of ordinary shares: | ||||||||||||||||||||||||
Basic | Diluted | Basic | Diluted | Basic | Diluted | |||||||||||||||||||
Issued ordinary shares at January 1 | 133,597,362 | 133,597,362 | 132,188,281 | 132,188,281 | 132,204,201 | 132,204,201 | ||||||||||||||||||
Effect of shares issued | (1,839,624 | ) | (1,839,624 | ) | 4,599 | 4,599 | 31,051,583 | 31,051,583 | ||||||||||||||||
Weighted-average number of ordinary shares | 131,757,738 | 131,757,738 | 132,192,880 | 132,192,880 | 163,255,784 | 163,255,784 | ||||||||||||||||||
Loss per share: | ||||||||||||||||||||||||
Basic | Diluted | Basic | Diluted | Basic | Diluted | |||||||||||||||||||
Loss per share | $ | (1.01 | ) | $ | (1.01 | ) | $ | (1.82 | ) | $ | (1.82 | ) | $ | (0.62 | ) | $ | (0.62 | ) | ||||||
Year Ended December 31, | ||||||||
2020 | 2021 | |||||||
Convertible preferred shares (as converted to A Ordinary shares) | 87,711,133 | — | ||||||
Options to purchase A Ordinary shares | 57,212,650 | 83,573,631 | ||||||
Convertible Debt (as converted to common shares) | 25,944,000 | — | ||||||
Warrants to purchase A Ordinary shares | 5,430,781 | 5,430,781 | ||||||
Warrants to purchase common shares | 6,200,947 | 13,578,294 | ||||||
| 182,499,511 | 102,582,706 | |||||||
2020 | 2021 | |||||||||||||||
LumiraDx Colombia Holdings Limited* | LumiraDx Healthcare Ltda. | LumiraDx Colombia Holdings Limited* | LumiraDx Healthcare Ltda. | |||||||||||||
Non-current assets | $ | 430 | $ | 93 | $ | 189 | $ | 237 | ||||||||
Current assets | 6,986 | 2,001 | 8,627 | 1,517 | ||||||||||||
Non-current liabilities | (6,119 | ) | (3,016 | ) | (5,643 | ) | (3,594 | ) | ||||||||
Current liabilities | (1,730 | ) | (504 | ) | (3,213 | ) | (543 | ) | ||||||||
Net assets/(liabilities) (100%) | (433 | ) | (1,426 | ) | (40 | ) | (2,383 | ) | ||||||||
Carrying amount of Non-controlling interest | 921 | (1,128 | ) | 805 | (1,260 | ) | ||||||||||
Revenue | 8,789 | 3,208 | 12,101 | 2,320 | ||||||||||||
Profit/(loss) | 817 | (2,023 | ) | 1,609 | (879 | ) | ||||||||||
Other comprehensive gain | (5 | ) | 40 | — | — | |||||||||||
Total comprehensive profit/(loss) (100%) | 812 | (1,983 | ) | 1,609 | (879 | ) | ||||||||||
Profit/(loss) allocated to non-controlling interest | 286 | (303 | ) | 306 | (132 | ) | ||||||||||
Other comprehensive loss allocated to non- controlling interest | (2 | ) | 6 | — | — | |||||||||||
Cash flows from operating activities | 731 | (352 | ) | 1,810 | (701 | ) | ||||||||||
Cash flows from investment activities | (184 | ) | (18 | ) | (98 | ) | (38 | ) | ||||||||
Cash flows from financing activities | 0— | 700 | 0— | 500 | ||||||||||||
Net increase/(decrease) in cash and cash equivalents | $ | 547 | $ | 330 | $ | 1,712 | $ | (239 | ) | |||||||
| * | —Represents the consolidation of LumiraDx Colombia Holdings Limited and LumiraDx SAS, a wholly owned subsidiary of LumiraDx Colombia Holdings Limited |
Principal Subsidiaries | ||||||||||||
Country of Incorporation and Residence | Proportion of Equity Shares Held By Company | |||||||||||
Name | Nature of Business | 2020 | 2021 | |||||||||
| LumiraDx Brazil Holdings Limited | United Kingdom | Holding Company | 100 | % | 100 | % | ||||||
| LumiraDx Healthcare Ltda | Brazil | Distributor of medical diagnostics | 98 | % | 98 | % | ||||||
| LumiraDx Colombia Holdings Limited | United Kingdom | Holding Company | 65 | % | 81 | % | ||||||
| Lumira SAS | Colombia | Distributor of medical diagnostics | 100 | %* | 100 | %* | ||||||
| Lumira SAS | France | Distributor of medical diagnostics | n/a | 100 | % | |||||||
| LumiraDx GmbH | Germany | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx AB | Sweden | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx UK Limited | United Kingdom | Manufacture and distribution of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Technology Limited | United Kingdom | Research and development | 100 | % | 100 | % | ||||||
| LumiraDx Ltd. | United Kingdom | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Group Limited | United Kingdom | Holding Company | 100 | % | 100 | % | ||||||
| LumiraDx International Limited | United Kingdom | Holding Company | 100 | % | 100 | % | ||||||
| LumiraDx Investment Limited | United Kingdom | Holding Company | 100 | % | 100 | % | ||||||
| LumiraDx Care Solutions UK Limited | United Kingdom | Healthcare IT and services | 100 | % | 100 | % | ||||||
| LumiraDx, Inc | United States | Healthcare IT and services | 100 | % | 100 | % | ||||||
| ACS Acquisition LLC | United States | Healthcare IT and services | 100 | % | 100 | % | ||||||
| LumiraDx Healthcare LLC | United States | Healthcare IT and services | 100 | % | 100 | % | ||||||
| Biomedical Service S.r.l. | Italy | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx AS | Norway | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx GmbH | Austria | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx GmbH | Switzerland | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Japan KK | Japan | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Oy | Finland | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx A/S | Denmark | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Healthcare S.L. | Spain | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| SureSensors Ltd. | United Kingdom | Developer and manufacturer of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx (Pty) Limited | South Africa | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx B.V. | Netherlands | Distributor of medical diagnostics | 100 | % | 100 | % | ||||||
| LumiraDx Benelux B.V. | Netherlands | Distributor of medical diagnostics | n/a | 100 | % | |||||||
| LumiraDx Limited | Ireland | Distributor of medical diagnostics | n/a | 100 | % | |||||||
| LumiraDx Healthcare Private Limited | India | Distributor of medical diagnostics | n/a | 100 | % | |||||||
| CA Healthcare Acquisition Corp. | United States | Holding Company | 0 | % | 100 | % | ||||||
| * | —LumiraDx Colombia Holdings Limited holds 100% of the equity shares of LumiraDx SAS |
Goodwill | Patents | Customer Intangibles | Supplier Relationships | Technology and Software | Total | |||||||||||||||||||
Cost | ||||||||||||||||||||||||
At 1 January 2019 | $ | 13,635 | $ | 18,020 | $ | 8,731 | $ | 2,856 | $ | 11,177 | $ | 54,419 | ||||||||||||
Additions | — | 102 | — | — | — | 102 | ||||||||||||||||||
Acquisition of subsidiaries | 1,506 | — | — | — | — | 1,506 | ||||||||||||||||||
Exchange differences | 250 | — | — | — | — | 250 | ||||||||||||||||||
At 31 December 2019 | 15,391 | 18,122 | 8,731 | 2,856 | 11,177 | 56,277 | ||||||||||||||||||
Amortisation | ||||||||||||||||||||||||
At 1 January 2019 | — | 2,312 | 2,977 | 757 | 6,711 | 12,757 | ||||||||||||||||||
Charge for the period | — | 930 | 890 | 286 | 388 | 2,494 | ||||||||||||||||||
Impairments | — | — | — | — | — | — | ||||||||||||||||||
Exchange differences | — | (532 | ) | 167 | — | (142 | ) | (507 | ) | |||||||||||||||
At 31 December 2019 | — | 2,710 | 4,034 | 1,043 | 6,957 | 14,744 | ||||||||||||||||||
Net Book Value | ||||||||||||||||||||||||
At 31 December 2019 | $ | 15,391 | $ | 15,412 | $ | 4,697 | $ | 1,813 | $ | 4,220 | $ | 41,533 | ||||||||||||
Cost | ||||||||||||||||||||||||
At January 1, 2020 | $ | 15,391 | $ | 18,122 | $ | 8,731 | $ | 2,856 | $ | 11,177 | $ | 56,277 | ||||||||||||
Additions | — | — | — | — | — | — | ||||||||||||||||||
Acquisition of subsidiaries | — | — | — | — | — | — | ||||||||||||||||||
Exchange differences | 600 | 549 | 408 | — | 156 | 1,713 | ||||||||||||||||||
At December 31, 2020 | 15,991 | 18,671 | 9,139 | 2,856 | 11,333 | 57,990 | ||||||||||||||||||
Amortization | ||||||||||||||||||||||||
At January 1, 2020 | — | 2,710 | 4,034 | 1,043 | 6,957 | 14,744 | ||||||||||||||||||
Charge for the period | — | 831 | 951 | 286 | 319 | 2,387 | ||||||||||||||||||
Impairments | — | — | — | — | — | — | ||||||||||||||||||
Exchange differences | — | 54 | 62 | — | 20 | 136 | ||||||||||||||||||
At December 31, 2020 | — | 3,595 | 5,047 | 1,329 | 7,296 | 17,267 | ||||||||||||||||||
Net Book Value | ||||||||||||||||||||||||
At December 31, 2020 | $ | 15,991 | $ | 15,076 | $ | 4,092 | $ | 1,527 | $ | 4,037 | $ | 40,723 | ||||||||||||
Cost | ||||||||||||||||||||||||
At January 1, 2021 | $ | 15,991 | $ | 18,671 | $ | 9,139 | $ | 2,856 | $ | 11,333 | $ | 57,990 | ||||||||||||
Additions | — | — | — | — | — | — | ||||||||||||||||||
Exchange differences | (385 | ) | (178 | ) | (278 | ) | — | (48 | ) | (889 | ) | |||||||||||||
At December 31, 2021 | 15,606 | 18,493 | 8,861 | 2,856 | 11,285 | 57,101 | ||||||||||||||||||
Amortization | ||||||||||||||||||||||||
At January 1, 2021 | — | 3,595 | 5,047 | 1,329 | 7,296 | 17,267 | ||||||||||||||||||
Charge for the period | — | 890 | 1,317 | 286 | 334 | 2,827 | ||||||||||||||||||
Exchange differences | — | (16 | ) | (21 | ) | — | (4 | ) | (41 | ) | ||||||||||||||
At December 31, 2021 | — | 4,469 | 6,343 | 1,615 | 7,626 | 20,053 | ||||||||||||||||||
Net Book Value | ||||||||||||||||||||||||
At December 31, 2021 | $ | 15,606 | $ | 14,024 | $ | 2,518 | $ | 1,241 | $ | 3,659 | $ | 37,048 | ||||||||||||
Intangible assets in use | Type of intangible asset | Net book value | Remaining amortization period | |||||||||
Acquired Patents | Patents | 8,033 | 9 years | |||||||||
Acquired Technology | Technology | 356 | 2 years | |||||||||
Acquired Supplier relationships | Supplier relationships | 1,243 | 4 years | |||||||||
Acquired Customer-related intangible | Customer-related | 2,517 | 5-6 years | |||||||||
Acquired Technology | Technology | 1,180 | 7 years | |||||||||
Intangible assets under development | Type of intangible asset | Net book value | Remaining amortization period | |||||||||
Technology License | Technology | 2,120 | n/a | |||||||||
Patent License | Patents | 5,301 | n/a | |||||||||
Patents | Patents | 692 | n/a | |||||||||
| • | Five years of cash flow projections are based on the Group’s long term financial projections, including the launch and commercialization of its new diagnostic products and services. These projects are based on the Group’s existing commercial experience and its overall understanding of new product launches. |
| • | A terminal value based on a perpetual growth rate of 5% (2020 3%) for free cash flow |
| • | A discount rate of 25% (2020: 25%) calculated using a risk-free interest rate of 1.5% (2020: 1.5%) and appropriate market risk and small company specific risk premiums |
| • | Five years of cash flow projections are based on the Group’s long term financial projections, including the launch and commercialization of products and services related to the underlying technology. These projects are based on the Group’s existing commercial experience and its overall understanding of new product launches. |
| • | A discount rate of 25% (2020: 25%) calculated using a risk-free interest rate of 1.5% (2020: 1.5%) and appropriate market risk and small company specific risk premiums |
Land and Buildings | Fixtures and Fittings | Plant and Equipment | Under Construction | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
At 1 January 2019 | $ | 2,180 | $ | 2,314 | $ | 14,140 | $ | 3,312 | $ | 21,946 | ||||||||||
Additions | 188 | 581 | 2,409 | 7,542 | 10,720 | |||||||||||||||
Transfers | 602 | 216 | (88 | ) | (730 | ) | — | |||||||||||||
Acquisition of subsidiaries | — | — | 633 | — | 633 | |||||||||||||||
Disposals | — | (29 | ) | (209 | ) | — | (238 | ) | ||||||||||||
Exchange differences | 84 | 33 | 402 | 308 | 827 | |||||||||||||||
At 31 December 2019 | 3,054 | 3,115 | 17,287 | 10,432 | 33,888 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
At 1 January 2019 | 442 | 1,266 | 3,178 | �� | — | 4,886 | ||||||||||||||
Charge for the period | 478 | 622 | 2,681 | — | 3,781 | |||||||||||||||
Transfers | 110 | 108 | (218 | ) | — | — | ||||||||||||||
Disposals | — | (17 | ) | (126 | ) | — | (143 | ) | ||||||||||||
Exchange differences | 37 | 35 | 151 | — | 223 | |||||||||||||||
At 31 December 2019 | 1,067 | 2,014 | 5,666 | — | 8,747 | |||||||||||||||
Carrying Amount | ||||||||||||||||||||
At 31 December 2019 | $ | 1,987 | $ | 1,101 | $ | 11,621 | $ | 10,432 | $ | 25,141 | ||||||||||
Cost | ||||||||||||||||||||
At January 1, 2020 | $ | 3,054 | $ | 3,115 | $ | 17,287 | $ | 10,432 | $ | 33,888 | ||||||||||
Additions | 3,686 | 1,115 | 25,831 | 33,749 | 64,381 | |||||||||||||||
Transfers | — | (22 | ) | 22 | — | — | ||||||||||||||
Disposals | — | (126 | ) | (137 | ) | (406 | ) | (669 | ) | |||||||||||
Exchange differences | 366 | 64 | 1,799 | 2,090 | 4,319 | |||||||||||||||
At December 31, 2020 | 7,106 | 4,146 | 44,802 | 45,865 | 101,919 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
At January 1, 2020 | 1,067 | 2,014 | 5,666 | — | 8,747 | |||||||||||||||
Charge for the period | 841 | 618 | 4,258 | — | 5,717 | |||||||||||||||
Transfers | — | (1 | ) | 1 | — | — | ||||||||||||||
Disposals | — | (47 | ) | (135 | ) | — | (182 | ) | ||||||||||||
Exchange differences | 151 | 52 | 352 | — | 555 | |||||||||||||||
At December 31, 2020 | 2,059 | 2,636 | 10,142 | — | 14,837 | |||||||||||||||
Carrying Amount | ||||||||||||||||||||
At December 31, 2020 | $ | 5,047 | $ | 1,510 | $ | 34,660 | $ | 45,865 | $ | 87,082 | ||||||||||
Land and Buildings | Fixtures and Fittings | Plant and Equipment | Under Construction | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
At January 1, 2021 | $ | 7,106 | $ | 4,146 | $ | 44,802 | $ | 45,865 | $ | 101,919 | ||||||||||
Additions | 28,047 | 4,144 | 72,186 | 1,969 | 106,346 | |||||||||||||||
Transfers | — | 2,137 | (2,137 | ) | — | — | ||||||||||||||
Disposals | (67 | ) | (452 | ) | (91 | ) | — | (610 | ) | |||||||||||
Exchange differences | (562 | ) | (322 | ) | (2,084 | ) | (574 | ) | (3,542 | ) | ||||||||||
At December 31, 2021 | 34,524 | 9,653 | 112,676 | 47,260 | 204,113 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
At January 1, 2021 | 2,059 | 2,636 | 10,142 | — | 14,837 | |||||||||||||||
Charge for the period | 2,773 | 2,204 | 12,298 | — | 17,275 | |||||||||||||||
Transfers | — | 1,686 | (1,686 | ) | — | — | ||||||||||||||
Disposals | (21 | ) | (366 | ) | (91 | ) | — | (478 | ) | |||||||||||
Exchange differences | (106 | ) | (223 | ) | (589 | ) | — | (918 | ) | |||||||||||
At December 31, 2021 | 4,705 | 5,937 | 20,074 | — | 30,716 | |||||||||||||||
Carrying Amount | ||||||||||||||||||||
At December 31, 2021 | $ | 29,819 | $ | 3,716 | $ | 92,602 | $ | 47,260 | $ | 173,397 | ||||||||||
2020 | 2021 | |||||||
Finished goods | $ | 50,054 | $ | 78,245 | ||||
Raw Materials | 37,789 | 86,613 | ||||||
WIP | 10,859 | 7,026 | ||||||
Total Inventory | $ | 85,516 | $ | 149,055 | ||||
2020 | 2021 | |||||||
Trade receivables | $ | 83,941 | $ | 75,207 | ||||
Reserves on trade receivables | (661 | ) | (1,681 | ) | ||||
Prepaids | 10,970 | 20,349 | ||||||
Other receivables | 4,011 | 9,408 | ||||||
VAT receivable | 11,034 | 6,515 | ||||||
Total trade and other receivables | $ | 109,295 | $ | 109,798 | ||||
Shares Authorized, Fully Paid and Allocated | A Ordinary Shares | A Ordinary Shares | Common Shares | Common Shares | ||||||||||||
2020 | 2021 | 2020 | 2021 | |||||||||||||
In issue at start of period | 373,652 | 373,697 | — | — | ||||||||||||
February Subdivision (220:1) | — | 81,839,643 | — | — | ||||||||||||
Issued for cash | 45 | 104,200 | — | — | ||||||||||||
Issued in other transactions | — | — | — | 5,307,607 | ||||||||||||
Merger Subdivision at the LMDX Conversion Factor (1.60806264:1) | — | 78,446,580 | — | 4,796,852 | ||||||||||||
Shares issued upon conversion of financial instruments | — | 46,797,960 | — | 35,137,307 | ||||||||||||
In issue at December—fully paid and allocated | 373,697 | 207,562,080 | — | 45,241,766 | ||||||||||||
Number of Options | Weighted Average Exercise Price | |||||||
Outstanding at January 1, 2020 | 54,198,851 | $ | 1.67 | |||||
Granted | 3,073,940 | 9.39 | ||||||
Exercised | (15,920 | ) | (2.56 | ) | ||||
Forfeited | (44,221 | ) | (3.81 | ) | ||||
Outstanding at December 31, 2020 | 57,212,650 | 2.09 | ||||||
Granted | 26,557,293 | 16.45 | ||||||
Exercised | (104,200 | ) | (1.00 | ) | ||||
Forfeited | (92,112 | ) | (9.72 | ) | ||||
Outstanding at December 31, 2021 | 83,573,631 | 6.72 | ||||||
Exercisable at December 31, 2020 | 45,770,544 | 1.44 | ||||||
Exercisable at December 31, 2021 | 66,322,324 | $ | 5.28 | |||||
Preferred Shares | Dividends | Total | ||||||||||
Balance at January 1, 2020 | $ | 221,927 | $ | 26,713 | $ | 248,640 | ||||||
Issuance, net of related costs | 162,401 | — | 162,401 | |||||||||
Accretion of issuance costs | 7,751 | — | 7,751 | |||||||||
Dividends accrued | — | 23,578 | 23,578 | |||||||||
Fair value adjustment of convertible feature | 9,351 | — | 9,351 | |||||||||
Balance at December 31, 2020 | 401,430 | 50,291 | 451,721 | |||||||||
Accretion of issuance costs | 8,498 | — | 8,498 | |||||||||
Dividends accrued | — | 16,156 | 16,156 | |||||||||
Converted to Share Premium from Merger | (409,928 | ) | (66,447 | ) | (476,375 | ) | ||||||
Balance at December 31, 2021 | $ | — | $ | — | $ | — | ||||||
Currency | Nominal Interest Rate | Year of Maturity | 2020 Face Value | 2020 Carrying Amount | 2020 Fair Value | 2021 Face Value | 2021 Carrying Amount | 2021 Fair Value | ||||||||||||||||||||||||||||
Unsecured Loan | USD | 2.00 | % | 2024 | $ | 18,000 | $ | 18,000 | $ | 18,849 | $ | 14,242 | $ | 14,242 | $ | 14,557 | ||||||||||||||||||||
Convertible Notes | USD | 5.00 | % | 2024 | 75,156 | 59,113 | 62,530 | — | — | — | ||||||||||||||||||||||||||
2020 Convertible Notes | USD | 10.00 | % | 2021 | 75,370 | 146,844 | 146,844 | — | — | — | ||||||||||||||||||||||||||
2020 Senior Secured Loans | USD | 8.00 | % | 2022 | 65,000 | 62,339 | 62,351 | — | — | — | ||||||||||||||||||||||||||
2021 Senior Secured Loans | USD | 8.00 | % | 2024 | — | — | — | 300,000 | 286,815 | 283,893 | ||||||||||||||||||||||||||
Instrument Financing Loans | EUR | 1.70-2.60 | % | 2022-2023 | 676 | 676 | 676 | 263 | 263 | 263 | ||||||||||||||||||||||||||
Balance at January 1, 2020 | $ | 111,923 | ||
Changes from financing cash flows | ||||
Proceeds from borrowings, net of issuance costs | ||||
2020 Convertible Notes | 70,917 | |||
2020 Senior Secured Loan | 62,391 | |||
Repayments of borrowings | ||||
Senior Secured Loans | (40,000 | ) | ||
Instrument Financing Loans | (396 | ) | ||
Total changes from financing cash flows | 92,912 | |||
Other changes | ||||
Warrants | ||||
2020 Convertible Notes | (32,531 | ) | ||
2020 Senior Secured Loan | (407 | ) | ||
Loss on extinguishment of debt | ||||
Senior Secured Loans | 2,047 | |||
Change in fair value | ||||
2020 Convertible Notes | 102,548 | |||
Amortization of debt issuance costs | ||||
Convertible Notes | 3,636 | |||
Senior Secured Loans | 500 | |||
2020 Convertible Notes | 5,909 | |||
2020 Senior Secured Loan | 355 | |||
Foreign exchange impact | ||||
Instrument Financing Loans | 80 | |||
Total other changes | 82,137 | |||
Balance at December 31, 2020 | 286,972 | |||
Less: Debt due within one year | (147,238 | ) | ||
$ | 139,734 | |||
Changes from financing cash flows | ||||
Proceeds from borrowings, net of issuance costs | ||||
2020 Senior Secured Loan | $ | 34,125 | ||
Incremental term loan | 39,000 | |||
2021 Senior Secured Loan | 288,513 | |||
Instrument Financing Loans | 192 | |||
Repayments of borrowings | ||||
2020 Senior Secured Loan | (100,000 | ) | ||
Incremental term loan | (40,000 | ) | ||
Instrument Financing Loans | (552 | ) | ||
Total changes from financing cash flows | 221,278 |
Other changes | ||||
Reclassification of Unsecured Loan amounts to grant liability in accordance with IAS 20 | $ | (3,758 | ) | |
Warrants | ||||
2021 Senior Secured Loan | (5,136 | ) | ||
Conversion to equity | ||||
Convertible Notes | (61,980 | ) | ||
2021 Convertible Notes | (125,652 | ) | ||
Loss on extinguishment of debt | ||||
2020 Senior Secured Loan | 3,170 | |||
Incremental term loan | 1,000 | |||
Change in fair value | ||||
2021 Convertible Notes | (52,267 | ) | ||
Amortization of debt issuance costs | ||||
2020 Senior Secured Loan | 366 | |||
Convertible Notes | 2,866 | |||
2021 Convertible Notes | 31,075 | |||
2021 Senior Secured Loan | 3,438 | |||
Foreign exchange impact | ||||
Instrument Financing Loans | (52 | ) | ||
Total other changes | (206,930 | ) | ||
Balance at December 31, 2021 | 301,320 | |||
Less: Debt due within one year | (191 | ) | ||
$ | 301,129 | |||
2020 | 2021 | |||||||
Due in less than one year | $ | 3,149 | $ | 5,546 | ||||
Due between one and five years | 9,018 | 25,151 | ||||||
Due in more than five years | 2,269 | 16,301 | ||||||
Total | $ | 14,436 | $ | 46,998 | ||||
2020 | 2021 | |||||||
Deferred taxes: | ||||||||
- Liabilities | $ | 1,230 | $ | 779 | ||||
Total net deferred tax liabilities | $ | 1,230 | $ | 779 | ||||
January 1, 2021 | Recognized in Income | Recognized in equity | December 31, 2021 | |||||||||||||
Deferred tax liabilities | ||||||||||||||||
Intangible assets | $ | 1,727 | $ | (383 | ) | $ | (106 | ) | $ | 1,238 | ||||||
Deferred tax assets | ||||||||||||||||
Net operating losses and other timing differences | (497 | ) | 197 | (159 | ) | (459 | ) | |||||||||
Net deferred tax liability | $ | 1,230 | $ | (186 | ) | $ | (265 | ) | $ | 779 | ||||||
January 1, 2020 | Recognized in Income | Recognized in Equity | December 31, 2020 | |||||||||||||
Deferred tax liabilities | ||||||||||||||||
Intangible assets | $ | 2,036 | $ | (393 | ) | $ | 84 | $ | 1,727 | |||||||
Deferred tax assets | ||||||||||||||||
Net operating losses and other timing differences | (477 | ) | — | (20 | ) | (497 | ) | |||||||||
Net deferred tax liability | $ | 1,559 | $ | (393 | ) | $ | 64 | $ | 1,230 | |||||||
2020 | 2021 | |||||||
Trade payables | $ | 57,898 | $ | 59,718 | ||||
Accrued expenses and other liabilities | 23,301 | 26,366 | ||||||
Accrued interest | 5,730 | 6,239 | ||||||
Warranty provision | 6,557 | 5,801 | ||||||
Deferred revenue | 1,760 | 1,517 | ||||||
Total trade and other payables | $ | 95,246 | $ | 99,641 | ||||
2020 | 2021 | |||||||
US Dollars | 45,863 | 51,568 | ||||||
U.K. Pounds | 46,093 | 27,089 | ||||||
Euros | 10,825 | 24,057 | ||||||
Colombian Pesos | 3,473 | 3,398 | ||||||
Swiss Francs | 8 | 992 | ||||||
Swedish Krona | 1,903 | 954 | ||||||
Brazilian Reals | 900 | 783 | ||||||
Other | 230 | 957 | ||||||
109,295 | 109,798 | |||||||
Loss allowance as of January 1, 2020: | $ | 674 | ||
Loss allowance recognized during the year | 119 | |||
Balances written off during the year | (132 | ) | ||
Balances recovered during the year | — | |||
Loss allowance at December 31, 2020: | 661 | |||
Loss allowance recognized during the year | 1,253 | |||
Balances written off during the year | (222 | ) | ||
Balances recovered during the year | (12 | ) | ||
Loss allowance at December 31, 2021: | $ | 1,680 | ||
Non-Derivative Financial Liability | Effective Interest Rate* | Year of Maturity | Carrying Amount | Contractual Cash Flows | Less Than 1 YeaR | 1—2 Years | 2—5 Years | |||||||||||||||||||||
Unsecured Loan | 10.55 | % | 2024 | 14,242 | 15,040 | 285 | 285 | 14,471 | ||||||||||||||||||||
2021 Senior Secured Loan | 10.02 | % | 2024 | 286,815 | 354,133 | 24,333 | 24,333 | 305,467 | ||||||||||||||||||||
Instrument Financing Loans | 1.7-2.6 | % | 2022 -2023 | 263 | 263 | 191 | 72 | — | ||||||||||||||||||||
Trade and other payables | 99,641 | 99,641 | 99,641 | — | — | |||||||||||||||||||||||
Total | 400,961 | 469,078 | 124,450 | 24,690 | 319,937 | |||||||||||||||||||||||
| * | —the effective interest rate for both the Convertible Notes and Preferred Shares include the accretion of the portion of proceeds allocated to equity ( Notes 16 17 |
Non-Derivative Financial Liability | Effective Interest Rate* | Year of Maturity | Carrying Amount | Contractual Cash Flows | Less Than 1 Year | 1—2 Years | 2—5 Years | |||||||||||||||||||||
Unsecured Loan | 10.55 | % | 2024 | 18,000 | 19,369 | 360 | 360 | 18,649 | ||||||||||||||||||||
Convertible Notes | 11.38 | % | 2024 | 59,113 | 71,616 | 3,758 | 3,758 | 64,100 | ||||||||||||||||||||
2020 Convertible Notes | 21.67 | % | 2021 | 146,844 | 79,025 | 79,025 | — | — | ||||||||||||||||||||
2020 Senior Secured Loans | 10.32 | % | 2022 | 62,401 | 74,161 | 5,200 | 68,961 | — | ||||||||||||||||||||
Instrument Financing Loans | 1.7-2.6 | % | | 2021- 2023 | 676 | 705 | 409 | 212 | 84 | |||||||||||||||||||
Series A Preferred Shares | 11.45 | % | 2025 | 277,995 | 421,199 | — | — | 421,199 | ||||||||||||||||||||
Series B Preferred Shares | 8.23 | % | 2027 | 173,726 | 257,462 | — | — | 257,462 | ||||||||||||||||||||
Trade and other payables | 139,283 | 139,283 | 139,283 | — | — | |||||||||||||||||||||||
Total | 878,038 | 1,062,820 | 228,035 | 73,291 | 761,494 | |||||||||||||||||||||||
As of December 31, 2020 | As of December 31, 2021 | |||||||
Capital | $ | 51,264 | $ | 15,641 | ||||
Inventory | 35,631 | 43,573 | ||||||
Total | $ | 86,895 | $ | 59,214 | ||||
Right-of-use | ||||
Net Carrying Amount | ||||
December 31, 2020 | $ | 10,386 | ||
December 31, 2021 | 27,746 | |||
Depreciation expense for the year ended | ||||
December 31, 2020 | $ | 2,810 | ||
December 31, 2021 | 5,593 |
Amounts Recognized in Profit and Loss | 2019 | 2020 | 2021 | |||||||||
Depreciation expense of right-of-use-assets | $ | 1,643 | $ | 2,810 | $ | 5,593 | ||||||
Interest expense on lease liabilities | 396 | 751 | 2,501 | |||||||||
$ | 2,039 | $ | 3,561 | $ | 8,094 | |||||||
2019 | 2020 | 2021 | ||||||||||
Salaries and wages | $ | 534 | $ | 537 | $ | 1,743 | ||||||
Stock compensation expense | 133 | 62 | $ | 28,376 | ||||||||
Pension and other post-employment benefits | 32 | 33 | $ | 60 | ||||||||
Other employee benefits | 84 | 29 | $ | 18 | ||||||||
Total | $ | 783 | $ | 661 | $ | 30,197 | ||||||
Amount | Number of Shares | |||||||
(a) Shares issued to CAH shareholders | 5,307,607 | |||||||
(b) Opening price of LMDX shares on NASDAQ as of September 29, 2021 | $ | 9.89 | ||||||
(c) Fair value of LMDX shares issued to CAH shareholders (a * b) | 52,492 | |||||||
(d) CAH cash in trust | 38,244 | |||||||
(e) CAH other assets | 325 | |||||||
(f) CAH liabilities | (13,683 | ) | ||||||
(g) Net assets of CAH (d + e + f) | 24,886 | |||||||
IFRS 2 listing expense (c - g) | $ | 27,606 | ||||||
Goldman Sachs & Co. LLC | Evercore ISI | SVB Securities | Raymond James |
ITEM 8. | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES |
| # | Indicates a management contract or compensatory plan. |
| † | Portions of this exhibit (indicated by brackets and asterisks) have been omitted in accordance with the rules of the SEC. LumiraDx Limited agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request. |
| (a) | The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser. |
| (b) | Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, (the “Securities Act”) may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission, such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities, other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding, is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue. |
| (c) | The undersigned registrant hereby undertakes that: |
| i. | For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b) (1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective. |
| ii. | For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
LumiraDx Limited | ||||
| By: | /s/ Ron Zwanziger | |||
| Name: | Ron Zwanziger | |||
| Title: | Chief Executive Officer, Chairman, and Director | |||
SIGNATURE | CAPACITY | DATE | ||
/s/ Ron Zwanziger Ron Zwanziger | Chief Executive Officer, Chairman and Director ( Principal Executive Officer | July 19, 2022 | ||
/s/ Dorian LeBlanc Dorian LeBlanc | Chief Financial Officer and Vice President, Global Operations ( Principal Financial Officer and Principal Accounting Officer | July 19, 2022 | ||
/s/ Donald Berwick Donald Berwick | Director | July 19, 2022 | ||
/s/ Troyen A. Brennan Troyen A. Brennan | Director | July 19, 2022 | ||
/s/ Lu Huang Lu Huang | Director | July 19, 2022 | ||
/s/ Lurene Joseph Lurene Joseph | Director | July 19, 2022 | ||
/s/ Jerry McAleer Jerry McAleer | Director | July 19, 2022 | ||
/s/ George Neble George Neble | Director | July 19, 2022 | ||
/s/ Dave Scott Dave Scott | Director | July 19, 2022 | ||
LumiraDx, Inc. | ||||
| By: | /s/ Ron Zwanziger | |||
| Name: | Ron Zwanziger | |||
| Title: | Chief Executive Officer, Chairman, and Director | |||
