Recent Quotes View Full List My Watchlist Create Watchlist Indicators DJI Nasdaq Composite SPX Gold Crude Oil Hydroworld Market Index Markets Stocks ETFs Tools Overview News Currencies International Treasuries Lucira Health Announces Third Quarter 2022 Results and Provides Business Updates By: Lucira Health Inc. via GlobeNewswire November 14, 2022 at 16:02 PM EST EMERYVILLE, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Nasdaq: LHDX) ("Lucira Health," "Lucira" or the "Company"), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, today reported financial results for the third quarter ended September 30, 2022 and provided business updates. Recent Highlights Achieved net revenue of $34.4 million for the third quarter of 2022, an increase of 130% over the third quarter of 2021.Executed a marketing agreement with Pfizer to increase awareness of the risks of COVID-19 and the availability of treatment. Partnered with telehealth marketplace, Sesame Care, to offer all Lucira test users an immediate and affordable option to speak to a doctor about their test result without leaving home.Launched the new combination COVID-19 and influenza test kit in Canada.Published interim results from Pilot Study for Chlamydia and Gonorrhea assays indicating 98% accuracy.Amended Emergency Use Authorization (EUA) for our combination COVID-19 and influenza test kit for a point-of-care (POC) indication; and plan to subsequently submit amended EUA to include over-the-counter (OTC) once additional prospective clinical data has been obtained. "The third quarter was one of continued year-over-year revenue growth in the COVID-19 test business and launch of the new combination COVID-19 Flu and influenza test kit in Canada," said Erik Engelson, President and Chief Executive Officer of Lucira Health. "We are excited about our agreement with Pfizer and Sesame. We endeavor to simplify and speed up the way people navigate COVID-19 infections. We also continue to eagerly await FDA EUA approval of the COVID-19 Flu and influenza test kit in the United States." Third Quarter 2022 Financial Results Net Sales was $34.4 million for the third quarter of 2022, an increase of $19.4 million over the third quarter of 2021. GAAP Gross Loss for the third quarter of 2022 was $99.6 million compared to a GAAP gross loss of $1.5 million for the third quarter of 2021. GAAP negative gross margin for the third quarter of 2022 was 289% compared to a negative gross margin of 10% for the third quarter of 2021. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2022 were $9.5 million and 28%, respectively. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2021 were $2.4 million and 16%, respectively. Increases in GAAP gross loss and negative gross margin were primarily due to a charge for excess inventory, non-cancellable purchase commitments and prepaid inventory based on management's assessment of current inventory levels as compared to current net sales forecasts of its COVID-19 test kit and combination COVID-19 and influenza test kit. GAAP Operating Expenses were $26.7 million in the third quarter of 2022 , compared to $26.1 million in the same period in 2021. Non-GAAP operating expenses were $24.6 million in the third quarter of 2022, compared to $20.8 million in the same period of 2021. The increase is primarily related to increased personnel-related costs and third-party services to facilitate commercial activities, validation of manufacturing activities, new product development, clinical studies, and public company compliance. GAAP Net Loss was $126.9 million in the third quarter of 2022, compared to GAAP net loss of $27.5 million in the same period in 2021. Non-GAAP net loss was $15.4 million for the third quarter of 2022, compared to a non-GAAP net loss of $18.4 million for the same period in 2021. Cash and Cash Equivalents as of September 30, 2022 was $39.8 million. Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Monday, November 14, 2022, at 4:30 PM ET. Investors interested in listening to the conference call should register online. Participants are required to register a day in advance or at minimum 15 minutes before the start of the call. A replay of the webcast can be accessed via the Events page of the investor section of Lucira's website. About Lucira Health Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Beyond its already commercialized COVID-19 and COVID-19 & Flu Tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com. Non-GAAP Financial Measures In this press release, in order to supplement the Company's condensed financial statements presented in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), management has disclosed certain non-GAAP financial measures for the Company's statements of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because Company management uses these measurements as aids in monitoring the Company's ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP financial measures include gross profit (loss), gross (negative) margin, operating expenses, and net loss. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, non-cash interest and other expense, preapproval inventories and charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. From time to time in the future, there may be other items that the Company may include or exclude if the Company believes that doing so is consistent with the goal of providing useful information to investors and management. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company's non-GAAP financial measures as tools for comparison. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. The Company has provided at the end of this press release, following the accompanying financial data, reconciliations of its non-GAAP measures to their most directly comparable GAAP measures. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company's business. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude the following: Stock-based compensation expense. The Company has excluded the effect of stock-based compensation expenses in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Although stock-based compensation is a key incentive offered to employees, consultants and board members the Company continues to evaluate its business performance excluding stock-based compensation expenses. The Company records stock-based compensation expense related to grants of time-based options, Employee Stock Purchase Plan, and restricted stock units. Depending upon the size, timing and terms of the grants this expense may vary significantly but will recur in future periods. The Company believes that excluding stock-based compensation expense better allows for comparisons from period to period. Depreciation and amortization. The Company has excluded the effect of depreciation and amortization expense in calculating its non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Depreciation and amortization are non-cash charges to current operations. Non-cash interest and other expense. The Company has excluded the effect of non-cash interest and remeasurement of derivative liabilities and convertible notes in calculating its non-GAAP net loss measure. Preapproval inventories. The Company has included the effect of preapproval inventories in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Preapproval inventories were previously recorded as research and development expense during the third quarter of 2021 and subsequently sold at zero cost of product and internally consumed in research and development and sales and marketing from the fourth quarter of 2021 through the third quarter of 2022. Charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. Includes charges for inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory. The Company has excluded the effect of excess inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory in calculating its non-GAAP gross profit (loss), gross (negative) margin and net loss measures. The Company believes that excluding charges for excess inventory, non-cancellable commitments and prepaid inventory better allows for comparisons from period to period. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believe," "will," "may,", “endeavor”, "goal," and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, statements regarding our future financial performance and market positioning; our collaboration with Pfizer and Sesame Care; our initiatives to re-balance our cost structure; and our plan to submit an Emergency Use Authorization amendment for OTC use to the FDA, are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to continue as a going concern, our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 and influenza test kits; our expected future growth; our ability to obtain and maintain regulatory approval for our test kits especially for OTC use, including our existing Emergency Use Authorization for our COVID-19 and influenza test kits and LUCI Pass; the size and growth potential of the markets for our test kits, including the COVID-19 and influenza diagnostic testing market, and our ability to serve those markets; our ability to accurately forecast demand for our test kits; the rate and degree of physician and market acceptance of our test kits; coverage and reimbursement for our test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; our ability to accurately forecast, and Jabil’s ability to manufacture, appropriate quantities of our COVID-19 and influenza test kits to meet commercial demand; regulatory developments in the United States and foreign countries; our research and development for any future test kits; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others; and our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russia’s military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Investor Relations Greg Chodaczek investorrelations@lucirahealth.com 347-620-7010 LUCIRA HEALTH, INC. CONDENSED BALANCE SHEETS (Unaudited) (In thousands, except share and per share data) September 30, December 31, 2022 2021 (1) Assets Current assets: Cash and cash equivalents $39,774 $105,982 Accounts receivable, net 14,392 27,245 Inventory 55,625 50,776 Other receivable 4,824 8,188 Prepaid expenses 2,506 10,274 Other current assets 3,350 3,817 Total current assets 120,471 206,282 Property and equipment, net 48,295 30,974 Operating lease right-of-use assets 17,704 2,714 Restricted cash equivalents 1,943 — Other assets 772 384 Total assets $189,185 $240,354 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $25,173 $19,371 Accrued liabilities 55,032 29,162 Operating lease liabilities, current 2,316 1,609 Customer deposits — 189 Total current liabilities 82,521 50,331 Term loan payable, net 29,408 — Operating lease liabilities, net of current portion 16,367 1,220 Total liabilities 128,296 51,551 Commitments and contingencies Stockholders’ equity: Preferred stock $0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 — — Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 40,448,703 and 39,663,645 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively 40 40 Additional paid-in capital 324,851 317,304 Accumulated deficit (264,002) (128,541)Total stockholders’ equity 60,889 188,803 Total liabilities and stockholders’ equity $189,185 $240,354 (1) The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date LUCIRA HEALTH, INC. CONDENSED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net sales $34,390 $14,976 $151,010 $31,931 Cost of products sold 133,945 14,837 202,657 32,710 Impairment of long-lived assets — 1,622 — 1,622 Gross loss (99,555) (1,483) (51,647) (2,401)Operating expenses: Research and development 9,141 14,342 32,089 30,741 Selling, general and administrative 17,596 11,788 50,133 23,988 Total operating expenses 26,737 26,130 82,222 54,729 Loss from operations (126,292) (27,613) (133,869) (57,130)Other income (expense), net: Interest income and other (expense), net 393 117 736 399 Interest expense, net (949) — (2,312) (281)Total other income (expense), net (556) 117 (1,576) 118 Loss before provision for income taxes (126,848) (27,496) (135,445) (57,012)Provision for income taxes 14 — 16 — Net loss $(126,862) $(27,496) $(135,461) $(57,012)Net loss per share of common stock, Basic and diluted $(3.15) $(0.71) $(3.39) $(1.71)Weighted-average number of shares used in net loss per share of common stock, Basic and diluted 40,216,244 38,667,615 39,974,997 33,348,104 LUCIRA HEALTH, INC. The following tables represent the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures: (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP Gross Loss to non-GAAP Gross Profit: GAAP Gross Loss $(99,555) $(1,483) $(51,647) $(2,401)Stock-based compensation 377 91 767 351 Depreciation and amortization 1,548 842 4,071 1,177 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — — — (1,089)Non-GAAP Gross Profit $9,529 $2,356 $60,350 $944 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Gross Margin: GAAP Gross Margin (289)% (10)% (34)% (8)%Stock-based compensation 1% 1% 1% 1%Depreciation and amortization 5% 6% 3% 4%Impairment of long-lived assets —% 11% —% 5%Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 312% 9% 71% 4%Preapproval inventories —% —% —% (3)%Non-GAAP Gross Margin 28% 16% 40% 3% Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Operating Expenses: GAAP Operating Expenses $26,737 $26,130 $82,222 $54,729 Stock-based compensation (1,995) (4,937) (5,029) (6,149)Depreciation and amortization (191) (433) (943) (980)Preapproval inventories — — — 305 Non-GAAP Operating Expenses $24,551 $20,760 $76,250 $47,905 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Net Loss: GAAP Net Loss $(126,862) $(27,496) $(135,461) $(57,012)Stock-based compensation 2,372 5,028 5,796 6,500 Depreciation and amortization 1,739 1,275 5,014 2,158 Non-cash interest and other expense 189 (5) 522 275 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — (87) — (1,394)Non-GAAP Net Loss $(15,403) $(18,379) $(16,970) $(46,567) Data & News supplied by www.cloudquote.io Stock quotes supplied by Barchart Quotes delayed at least 20 minutes. 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Lucira Health Announces Third Quarter 2022 Results and Provides Business Updates By: Lucira Health Inc. via GlobeNewswire November 14, 2022 at 16:02 PM EST EMERYVILLE, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Nasdaq: LHDX) ("Lucira Health," "Lucira" or the "Company"), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, today reported financial results for the third quarter ended September 30, 2022 and provided business updates. Recent Highlights Achieved net revenue of $34.4 million for the third quarter of 2022, an increase of 130% over the third quarter of 2021.Executed a marketing agreement with Pfizer to increase awareness of the risks of COVID-19 and the availability of treatment. Partnered with telehealth marketplace, Sesame Care, to offer all Lucira test users an immediate and affordable option to speak to a doctor about their test result without leaving home.Launched the new combination COVID-19 and influenza test kit in Canada.Published interim results from Pilot Study for Chlamydia and Gonorrhea assays indicating 98% accuracy.Amended Emergency Use Authorization (EUA) for our combination COVID-19 and influenza test kit for a point-of-care (POC) indication; and plan to subsequently submit amended EUA to include over-the-counter (OTC) once additional prospective clinical data has been obtained. "The third quarter was one of continued year-over-year revenue growth in the COVID-19 test business and launch of the new combination COVID-19 Flu and influenza test kit in Canada," said Erik Engelson, President and Chief Executive Officer of Lucira Health. "We are excited about our agreement with Pfizer and Sesame. We endeavor to simplify and speed up the way people navigate COVID-19 infections. We also continue to eagerly await FDA EUA approval of the COVID-19 Flu and influenza test kit in the United States." Third Quarter 2022 Financial Results Net Sales was $34.4 million for the third quarter of 2022, an increase of $19.4 million over the third quarter of 2021. GAAP Gross Loss for the third quarter of 2022 was $99.6 million compared to a GAAP gross loss of $1.5 million for the third quarter of 2021. GAAP negative gross margin for the third quarter of 2022 was 289% compared to a negative gross margin of 10% for the third quarter of 2021. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2022 were $9.5 million and 28%, respectively. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2021 were $2.4 million and 16%, respectively. Increases in GAAP gross loss and negative gross margin were primarily due to a charge for excess inventory, non-cancellable purchase commitments and prepaid inventory based on management's assessment of current inventory levels as compared to current net sales forecasts of its COVID-19 test kit and combination COVID-19 and influenza test kit. GAAP Operating Expenses were $26.7 million in the third quarter of 2022 , compared to $26.1 million in the same period in 2021. Non-GAAP operating expenses were $24.6 million in the third quarter of 2022, compared to $20.8 million in the same period of 2021. The increase is primarily related to increased personnel-related costs and third-party services to facilitate commercial activities, validation of manufacturing activities, new product development, clinical studies, and public company compliance. GAAP Net Loss was $126.9 million in the third quarter of 2022, compared to GAAP net loss of $27.5 million in the same period in 2021. Non-GAAP net loss was $15.4 million for the third quarter of 2022, compared to a non-GAAP net loss of $18.4 million for the same period in 2021. Cash and Cash Equivalents as of September 30, 2022 was $39.8 million. Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Monday, November 14, 2022, at 4:30 PM ET. Investors interested in listening to the conference call should register online. Participants are required to register a day in advance or at minimum 15 minutes before the start of the call. A replay of the webcast can be accessed via the Events page of the investor section of Lucira's website. About Lucira Health Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Beyond its already commercialized COVID-19 and COVID-19 & Flu Tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com. Non-GAAP Financial Measures In this press release, in order to supplement the Company's condensed financial statements presented in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), management has disclosed certain non-GAAP financial measures for the Company's statements of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because Company management uses these measurements as aids in monitoring the Company's ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP financial measures include gross profit (loss), gross (negative) margin, operating expenses, and net loss. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, non-cash interest and other expense, preapproval inventories and charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. From time to time in the future, there may be other items that the Company may include or exclude if the Company believes that doing so is consistent with the goal of providing useful information to investors and management. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company's non-GAAP financial measures as tools for comparison. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. The Company has provided at the end of this press release, following the accompanying financial data, reconciliations of its non-GAAP measures to their most directly comparable GAAP measures. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company's business. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude the following: Stock-based compensation expense. The Company has excluded the effect of stock-based compensation expenses in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Although stock-based compensation is a key incentive offered to employees, consultants and board members the Company continues to evaluate its business performance excluding stock-based compensation expenses. The Company records stock-based compensation expense related to grants of time-based options, Employee Stock Purchase Plan, and restricted stock units. Depending upon the size, timing and terms of the grants this expense may vary significantly but will recur in future periods. The Company believes that excluding stock-based compensation expense better allows for comparisons from period to period. Depreciation and amortization. The Company has excluded the effect of depreciation and amortization expense in calculating its non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Depreciation and amortization are non-cash charges to current operations. Non-cash interest and other expense. The Company has excluded the effect of non-cash interest and remeasurement of derivative liabilities and convertible notes in calculating its non-GAAP net loss measure. Preapproval inventories. The Company has included the effect of preapproval inventories in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Preapproval inventories were previously recorded as research and development expense during the third quarter of 2021 and subsequently sold at zero cost of product and internally consumed in research and development and sales and marketing from the fourth quarter of 2021 through the third quarter of 2022. Charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. Includes charges for inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory. The Company has excluded the effect of excess inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory in calculating its non-GAAP gross profit (loss), gross (negative) margin and net loss measures. The Company believes that excluding charges for excess inventory, non-cancellable commitments and prepaid inventory better allows for comparisons from period to period. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believe," "will," "may,", “endeavor”, "goal," and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, statements regarding our future financial performance and market positioning; our collaboration with Pfizer and Sesame Care; our initiatives to re-balance our cost structure; and our plan to submit an Emergency Use Authorization amendment for OTC use to the FDA, are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to continue as a going concern, our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 and influenza test kits; our expected future growth; our ability to obtain and maintain regulatory approval for our test kits especially for OTC use, including our existing Emergency Use Authorization for our COVID-19 and influenza test kits and LUCI Pass; the size and growth potential of the markets for our test kits, including the COVID-19 and influenza diagnostic testing market, and our ability to serve those markets; our ability to accurately forecast demand for our test kits; the rate and degree of physician and market acceptance of our test kits; coverage and reimbursement for our test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; our ability to accurately forecast, and Jabil’s ability to manufacture, appropriate quantities of our COVID-19 and influenza test kits to meet commercial demand; regulatory developments in the United States and foreign countries; our research and development for any future test kits; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others; and our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russia’s military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Investor Relations Greg Chodaczek investorrelations@lucirahealth.com 347-620-7010 LUCIRA HEALTH, INC. CONDENSED BALANCE SHEETS (Unaudited) (In thousands, except share and per share data) September 30, December 31, 2022 2021 (1) Assets Current assets: Cash and cash equivalents $39,774 $105,982 Accounts receivable, net 14,392 27,245 Inventory 55,625 50,776 Other receivable 4,824 8,188 Prepaid expenses 2,506 10,274 Other current assets 3,350 3,817 Total current assets 120,471 206,282 Property and equipment, net 48,295 30,974 Operating lease right-of-use assets 17,704 2,714 Restricted cash equivalents 1,943 — Other assets 772 384 Total assets $189,185 $240,354 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $25,173 $19,371 Accrued liabilities 55,032 29,162 Operating lease liabilities, current 2,316 1,609 Customer deposits — 189 Total current liabilities 82,521 50,331 Term loan payable, net 29,408 — Operating lease liabilities, net of current portion 16,367 1,220 Total liabilities 128,296 51,551 Commitments and contingencies Stockholders’ equity: Preferred stock $0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 — — Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 40,448,703 and 39,663,645 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively 40 40 Additional paid-in capital 324,851 317,304 Accumulated deficit (264,002) (128,541)Total stockholders’ equity 60,889 188,803 Total liabilities and stockholders’ equity $189,185 $240,354 (1) The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date LUCIRA HEALTH, INC. CONDENSED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net sales $34,390 $14,976 $151,010 $31,931 Cost of products sold 133,945 14,837 202,657 32,710 Impairment of long-lived assets — 1,622 — 1,622 Gross loss (99,555) (1,483) (51,647) (2,401)Operating expenses: Research and development 9,141 14,342 32,089 30,741 Selling, general and administrative 17,596 11,788 50,133 23,988 Total operating expenses 26,737 26,130 82,222 54,729 Loss from operations (126,292) (27,613) (133,869) (57,130)Other income (expense), net: Interest income and other (expense), net 393 117 736 399 Interest expense, net (949) — (2,312) (281)Total other income (expense), net (556) 117 (1,576) 118 Loss before provision for income taxes (126,848) (27,496) (135,445) (57,012)Provision for income taxes 14 — 16 — Net loss $(126,862) $(27,496) $(135,461) $(57,012)Net loss per share of common stock, Basic and diluted $(3.15) $(0.71) $(3.39) $(1.71)Weighted-average number of shares used in net loss per share of common stock, Basic and diluted 40,216,244 38,667,615 39,974,997 33,348,104 LUCIRA HEALTH, INC. The following tables represent the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures: (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP Gross Loss to non-GAAP Gross Profit: GAAP Gross Loss $(99,555) $(1,483) $(51,647) $(2,401)Stock-based compensation 377 91 767 351 Depreciation and amortization 1,548 842 4,071 1,177 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — — — (1,089)Non-GAAP Gross Profit $9,529 $2,356 $60,350 $944 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Gross Margin: GAAP Gross Margin (289)% (10)% (34)% (8)%Stock-based compensation 1% 1% 1% 1%Depreciation and amortization 5% 6% 3% 4%Impairment of long-lived assets —% 11% —% 5%Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 312% 9% 71% 4%Preapproval inventories —% —% —% (3)%Non-GAAP Gross Margin 28% 16% 40% 3% Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Operating Expenses: GAAP Operating Expenses $26,737 $26,130 $82,222 $54,729 Stock-based compensation (1,995) (4,937) (5,029) (6,149)Depreciation and amortization (191) (433) (943) (980)Preapproval inventories — — — 305 Non-GAAP Operating Expenses $24,551 $20,760 $76,250 $47,905 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Net Loss: GAAP Net Loss $(126,862) $(27,496) $(135,461) $(57,012)Stock-based compensation 2,372 5,028 5,796 6,500 Depreciation and amortization 1,739 1,275 5,014 2,158 Non-cash interest and other expense 189 (5) 522 275 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — (87) — (1,394)Non-GAAP Net Loss $(15,403) $(18,379) $(16,970) $(46,567)
EMERYVILLE, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Lucira Health, Inc. (Nasdaq: LHDX) ("Lucira Health," "Lucira" or the "Company"), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, today reported financial results for the third quarter ended September 30, 2022 and provided business updates. Recent Highlights Achieved net revenue of $34.4 million for the third quarter of 2022, an increase of 130% over the third quarter of 2021.Executed a marketing agreement with Pfizer to increase awareness of the risks of COVID-19 and the availability of treatment. Partnered with telehealth marketplace, Sesame Care, to offer all Lucira test users an immediate and affordable option to speak to a doctor about their test result without leaving home.Launched the new combination COVID-19 and influenza test kit in Canada.Published interim results from Pilot Study for Chlamydia and Gonorrhea assays indicating 98% accuracy.Amended Emergency Use Authorization (EUA) for our combination COVID-19 and influenza test kit for a point-of-care (POC) indication; and plan to subsequently submit amended EUA to include over-the-counter (OTC) once additional prospective clinical data has been obtained. "The third quarter was one of continued year-over-year revenue growth in the COVID-19 test business and launch of the new combination COVID-19 Flu and influenza test kit in Canada," said Erik Engelson, President and Chief Executive Officer of Lucira Health. "We are excited about our agreement with Pfizer and Sesame. We endeavor to simplify and speed up the way people navigate COVID-19 infections. We also continue to eagerly await FDA EUA approval of the COVID-19 Flu and influenza test kit in the United States." Third Quarter 2022 Financial Results Net Sales was $34.4 million for the third quarter of 2022, an increase of $19.4 million over the third quarter of 2021. GAAP Gross Loss for the third quarter of 2022 was $99.6 million compared to a GAAP gross loss of $1.5 million for the third quarter of 2021. GAAP negative gross margin for the third quarter of 2022 was 289% compared to a negative gross margin of 10% for the third quarter of 2021. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2022 were $9.5 million and 28%, respectively. Non-GAAP gross profit and non-GAAP gross margin for the third quarter of 2021 were $2.4 million and 16%, respectively. Increases in GAAP gross loss and negative gross margin were primarily due to a charge for excess inventory, non-cancellable purchase commitments and prepaid inventory based on management's assessment of current inventory levels as compared to current net sales forecasts of its COVID-19 test kit and combination COVID-19 and influenza test kit. GAAP Operating Expenses were $26.7 million in the third quarter of 2022 , compared to $26.1 million in the same period in 2021. Non-GAAP operating expenses were $24.6 million in the third quarter of 2022, compared to $20.8 million in the same period of 2021. The increase is primarily related to increased personnel-related costs and third-party services to facilitate commercial activities, validation of manufacturing activities, new product development, clinical studies, and public company compliance. GAAP Net Loss was $126.9 million in the third quarter of 2022, compared to GAAP net loss of $27.5 million in the same period in 2021. Non-GAAP net loss was $15.4 million for the third quarter of 2022, compared to a non-GAAP net loss of $18.4 million for the same period in 2021. Cash and Cash Equivalents as of September 30, 2022 was $39.8 million. Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Monday, November 14, 2022, at 4:30 PM ET. Investors interested in listening to the conference call should register online. Participants are required to register a day in advance or at minimum 15 minutes before the start of the call. A replay of the webcast can be accessed via the Events page of the investor section of Lucira's website. About Lucira Health Lucira is a medical technology company focused on the development and commercialization of innovative infectious disease tests to make lab-quality diagnostics more accessible. Lucira designed its test platform to provide accurate, reliable, PCR-quality test results anywhere and at any time. Beyond its already commercialized COVID-19 and COVID-19 & Flu Tests, Lucira is working on new diagnostic tests for respiratory infections and other categories including women’s health and sexually transmitted infections (STIs). For more information, visit www.lucirahealth.com. Non-GAAP Financial Measures In this press release, in order to supplement the Company's condensed financial statements presented in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), management has disclosed certain non-GAAP financial measures for the Company's statements of operations. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because Company management uses these measurements as aids in monitoring the Company's ongoing financial performance from quarter to quarter, and year to year, on a regular basis and for financial and operational decision-making. Non-GAAP financial measures include gross profit (loss), gross (negative) margin, operating expenses, and net loss. Non-GAAP adjustments include stock-based compensation, depreciation and amortization, non-cash interest and other expense, preapproval inventories and charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. From time to time in the future, there may be other items that the Company may include or exclude if the Company believes that doing so is consistent with the goal of providing useful information to investors and management. The Company has provided a reconciliation of each non-GAAP financial measure used in this earnings release to the most directly comparable GAAP financial measure. Non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies, which could reduce the usefulness of the Company's non-GAAP financial measures as tools for comparison. Investors are cautioned that there are a number of limitations associated with the use of non-GAAP financial measures as analytical tools. The Company has provided at the end of this press release, following the accompanying financial data, reconciliations of its non-GAAP measures to their most directly comparable GAAP measures. Investors are encouraged to review these reconciliations, and not to rely on any single financial measure to evaluate the Company's business. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Non-GAAP financial measures in this earnings release exclude the following: Stock-based compensation expense. The Company has excluded the effect of stock-based compensation expenses in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Although stock-based compensation is a key incentive offered to employees, consultants and board members the Company continues to evaluate its business performance excluding stock-based compensation expenses. The Company records stock-based compensation expense related to grants of time-based options, Employee Stock Purchase Plan, and restricted stock units. Depending upon the size, timing and terms of the grants this expense may vary significantly but will recur in future periods. The Company believes that excluding stock-based compensation expense better allows for comparisons from period to period. Depreciation and amortization. The Company has excluded the effect of depreciation and amortization expense in calculating its non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Depreciation and amortization are non-cash charges to current operations. Non-cash interest and other expense. The Company has excluded the effect of non-cash interest and remeasurement of derivative liabilities and convertible notes in calculating its non-GAAP net loss measure. Preapproval inventories. The Company has included the effect of preapproval inventories in calculating the Company's non-GAAP gross profit (loss), gross (negative) margin, operating expenses and net loss measures. Preapproval inventories were previously recorded as research and development expense during the third quarter of 2021 and subsequently sold at zero cost of product and internally consumed in research and development and sales and marketing from the fourth quarter of 2021 through the third quarter of 2022. Charge for excess inventory, non-cancellable purchase commitments, and prepaid inventory. Includes charges for inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory. The Company has excluded the effect of excess inventory on hand, non-cancellable commitments to purchase inventory and prepaid inventory in calculating its non-GAAP gross profit (loss), gross (negative) margin and net loss measures. The Company believes that excluding charges for excess inventory, non-cancellable commitments and prepaid inventory better allows for comparisons from period to period. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believe," "will," "may,", “endeavor”, "goal," and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including but not limited to, statements regarding our future financial performance and market positioning; our collaboration with Pfizer and Sesame Care; our initiatives to re-balance our cost structure; and our plan to submit an Emergency Use Authorization amendment for OTC use to the FDA, are based upon Lucira's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including our ability to continue as a going concern, our ability to increase production, streamline operations and increase product availability; the success of our test platform with COVID-19 including its variants, the extent and duration of the COVID-19 pandemic and our expectations regarding customer and user demand for our COVID-19 and influenza test kits; our expected future growth; our ability to obtain and maintain regulatory approval for our test kits especially for OTC use, including our existing Emergency Use Authorization for our COVID-19 and influenza test kits and LUCI Pass; the size and growth potential of the markets for our test kits, including the COVID-19 and influenza diagnostic testing market, and our ability to serve those markets; our ability to accurately forecast demand for our test kits; the rate and degree of physician and market acceptance of our test kits; coverage and reimbursement for our test kits; the performance of, and our reliance on, third parties in connection with the commercialization of our test kits, including Jabil Inc. and our single-source suppliers; our ability to accurately forecast, and Jabil’s ability to manufacture, appropriate quantities of our COVID-19 and influenza test kits to meet commercial demand; regulatory developments in the United States and foreign countries; our research and development for any future test kits; the development, regulatory approval, and commercialization of competing products; our ability to retain and hire senior management and key personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; our expectations regarding our ability to obtain and maintain intellectual property protection for our test kits, as well as our ability to operate our business without infringing the intellectual property rights of others; and our ability to navigate unfavorable global economic conditions that may result from recent geopolitical events, including the COVID-19 pandemic, Russia’s military intervention in Ukraine, and the global sanctions imposed by countries against Russia that followed. These and other risks and uncertainties are described more fully in the "Risk Factors" section and elsewhere in our filings with the Securities and Exchange Commission and available at www.sec.gov, including in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Lucira assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law. Investor Relations Greg Chodaczek investorrelations@lucirahealth.com 347-620-7010 LUCIRA HEALTH, INC. CONDENSED BALANCE SHEETS (Unaudited) (In thousands, except share and per share data) September 30, December 31, 2022 2021 (1) Assets Current assets: Cash and cash equivalents $39,774 $105,982 Accounts receivable, net 14,392 27,245 Inventory 55,625 50,776 Other receivable 4,824 8,188 Prepaid expenses 2,506 10,274 Other current assets 3,350 3,817 Total current assets 120,471 206,282 Property and equipment, net 48,295 30,974 Operating lease right-of-use assets 17,704 2,714 Restricted cash equivalents 1,943 — Other assets 772 384 Total assets $189,185 $240,354 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $25,173 $19,371 Accrued liabilities 55,032 29,162 Operating lease liabilities, current 2,316 1,609 Customer deposits — 189 Total current liabilities 82,521 50,331 Term loan payable, net 29,408 — Operating lease liabilities, net of current portion 16,367 1,220 Total liabilities 128,296 51,551 Commitments and contingencies Stockholders’ equity: Preferred stock $0.001 par value; 10,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 0 shares issued and outstanding as of September 30, 2022 and December 31, 2021 — — Common stock, $0.001 par value; 200,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 40,448,703 and 39,663,645 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively 40 40 Additional paid-in capital 324,851 317,304 Accumulated deficit (264,002) (128,541)Total stockholders’ equity 60,889 188,803 Total liabilities and stockholders’ equity $189,185 $240,354 (1) The balance sheet as of December 31, 2021 is derived from the audited financial statements as of that date LUCIRA HEALTH, INC. CONDENSED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share and per share data) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net sales $34,390 $14,976 $151,010 $31,931 Cost of products sold 133,945 14,837 202,657 32,710 Impairment of long-lived assets — 1,622 — 1,622 Gross loss (99,555) (1,483) (51,647) (2,401)Operating expenses: Research and development 9,141 14,342 32,089 30,741 Selling, general and administrative 17,596 11,788 50,133 23,988 Total operating expenses 26,737 26,130 82,222 54,729 Loss from operations (126,292) (27,613) (133,869) (57,130)Other income (expense), net: Interest income and other (expense), net 393 117 736 399 Interest expense, net (949) — (2,312) (281)Total other income (expense), net (556) 117 (1,576) 118 Loss before provision for income taxes (126,848) (27,496) (135,445) (57,012)Provision for income taxes 14 — 16 — Net loss $(126,862) $(27,496) $(135,461) $(57,012)Net loss per share of common stock, Basic and diluted $(3.15) $(0.71) $(3.39) $(1.71)Weighted-average number of shares used in net loss per share of common stock, Basic and diluted 40,216,244 38,667,615 39,974,997 33,348,104 LUCIRA HEALTH, INC. The following tables represent the reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures: (Unaudited) (In thousands) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP Gross Loss to non-GAAP Gross Profit: GAAP Gross Loss $(99,555) $(1,483) $(51,647) $(2,401)Stock-based compensation 377 91 767 351 Depreciation and amortization 1,548 842 4,071 1,177 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — — — (1,089)Non-GAAP Gross Profit $9,529 $2,356 $60,350 $944 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Gross Margin: GAAP Gross Margin (289)% (10)% (34)% (8)%Stock-based compensation 1% 1% 1% 1%Depreciation and amortization 5% 6% 3% 4%Impairment of long-lived assets —% 11% —% 5%Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 312% 9% 71% 4%Preapproval inventories —% —% —% (3)%Non-GAAP Gross Margin 28% 16% 40% 3% Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Operating Expenses: GAAP Operating Expenses $26,737 $26,130 $82,222 $54,729 Stock-based compensation (1,995) (4,937) (5,029) (6,149)Depreciation and amortization (191) (433) (943) (980)Preapproval inventories — — — 305 Non-GAAP Operating Expenses $24,551 $20,760 $76,250 $47,905 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Reconciliation of GAAP to non-GAAP Net Loss: GAAP Net Loss $(126,862) $(27,496) $(135,461) $(57,012)Stock-based compensation 2,372 5,028 5,796 6,500 Depreciation and amortization 1,739 1,275 5,014 2,158 Non-cash interest and other expense 189 (5) 522 275 Impairment of long-lived assets — 1,622 — 1,622 Charge for excess inventory, non-cancellable purchase commitments and prepaid inventory 107,159 1,284 107,159 1,284 Preapproval inventories — (87) — (1,394)Non-GAAP Net Loss $(15,403) $(18,379) $(16,970) $(46,567)
