WESTLAKE, Ohio–(BUSINESS WIRE)–Nordson Corporation (Nasdaq: NDSN) today announced that it has entered into a definitive agreement to acquire Atrion Corporation (Nasdaq: ATRI), a leader in proprietary medical infusion fluid delivery and niche cardiovascular solutions, for $460.00 per share in cash. This reflects a valuation of 15X Atrion’s 2024 full-year estimated […]
Financial
Semler Scientific® Announces Bitcoin Treasury Strategy
SANTA CLARA, Calif., May 28, 2024 /PRNewswire/ — Semler Scientific, Inc. (Nasdaq: SMLR), a pioneer in developing and marketing technology products and services to healthcare providers to combat chronic diseases, announced today that its board of directors has adopted bitcoin as its primary treasury reserve asset. In addition, Semler Scientific announced that it has purchased 581 bitcoins for an aggregate amount of $40 million, inclusive of fees and expenses.
“Our bitcoin treasury strategy and purchase of bitcoin underscore our belief that bitcoin is a reliable store of value and a compelling investment,” said Eric Semler, Semler Scientific’s chairman. “Bitcoin is now a major asset class with more than $1 trillion of market value. We believe it has unique characteristics as a scarce and finite asset that can serve as a reasonable inflation hedge and safe haven amid global instability. We also believe its digital, architectural resilience makes it preferable to gold, which has a market value of approximately 10 times that of bitcoin. Given the gap in value between gold and bitcoin, we believe that bitcoin has the potential to generate outsize returns as it gains increasing acceptance as digital gold.
“Furthermore, we are energized by the growing global acceptance and ‘institutionalization’ of bitcoin — reflected most recently by the Securities and Exchange Commission’s January 2024 approval of 11 bitcoin exchange-traded funds. These funds have reported more than $13 billion of net inflows, with investments from nearly 1,000 institutions, including global banks, pensions, endowments and registered investment advisors. It is estimated that more than 10% of all bitcoins are now held by institutions,” added Mr. Semler.
Semler Scientific’s board and senior management have spent substantial time examining potential uses of cash, including acquisitions. “After studying various alternatives, we decided that holding bitcoin would be the best use of our excess cash,” said Mr. Semler.
In conjunction with its bitcoin treasury strategy, Semler Scientific will continue to focus on its core medical products and services. “We remain dedicated to our customers and our goal of operating a growing and profitable healthcare company,” said Doug Murphy-Chutorian, MD, Semler Scientific’s chief executive officer. “We are focused on maintaining sales of QuantaFlo® for peripheral arterial disease testing, while seeking a new 510(k) clearance from the FDA with expanded labeling for use as an aid in the diagnosis of other cardiovascular diseases.”
As Semler Scientific continues to generate revenue and free cash flow from sales of QuantaFlo, it will proactively evaluate its use of excess cash. Bitcoin will serve as Semler Scientific’s principal treasury holding on an ongoing basis, subject to market conditions and the anticipated cash needs of Semler Scientific.
More information regarding Semler Scientific’s bitcoin treasury strategy will be posted on its website at www.semlerscientific.com.
About Semler Scientific, Inc:
Semler Scientific, Inc. develops, manufactures and markets innovative products and services to combat chronic diseases. Its flagship product, QuantaFlo®, which is patented and cleared by the U.S. Food and Drug Administration (FDA), is a rapid point-of-care test that measures arterial blood flow in the extremities. The QuantaFlo test aids in the diagnosis of cardiovascular diseases, such as peripheral arterial disease (PAD), and Semler Scientific is seeking a new 510(k) clearance for expanded indications. QuantaFlo is used by healthcare providers to evaluate their patient’s risk of mortality and major adverse cardiovascular events (MACE). Semler Scientific also invests in bitcoin and has adopted bitcoin as its primary treasury reserve asset. Additional information about Semler Scientific can be found at www.semlerscientific.com.
Forward-Looking Statements
This press release contains “forward-looking” statements. Such statements can be identified by, among other things, the use of forward-looking language such as the words “believe,” “goal,” “may,” “will,” “intend,” “expect,” “anticipate,” “estimate,” “project,” “would,” “could” or words with similar meaning or the negatives of these terms or by the discussion of strategy or intentions. The forward-looking statements in this release include express or implied statements regarding the new bitcoin strategy and its ability to generate outsize returns, Website posting of information regarding the bitcoin strategy, as well as seeking a new 510(k) clearance for QuantaFlo with expanded indications for use, among others. Such forward-looking statements are subject to a number of risks and uncertainties that could cause Semler Scientific’s actual results to differ materially from those discussed here, such as risks inherent with investing in bitcoin, including bitcoin’s volatility; risk of implementing a new treasury strategy; risk that insurance plans and other customers will not continue to license its cardiovascular testing products; risk of changes in the reimbursement landscape for its customers including related to the CMS rate announcement; risk of obtaining a new 510(k) clearance for expanded indications; along with those other risk factors detailed in Semler Scientific’s filings with the Securities and Exchange Commission. These forward-looking statements involve assumptions, estimates, and uncertainties that reflect current internal projections, expectations or beliefs. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. All forward-looking statements contained in this press release are qualified in their entirety by these cautionary statements and the risk factors described above. Furthermore, all such statements are made as of the date of this release and Semler Scientific assumes no obligation to update or revise these statements unless otherwise required by law.
INVESTOR CONTACT:
Renae CormierChief Financial Officer[email protected]
SOURCE Semler Scientific, Inc.
Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.
— Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce cardiovascular risk in statin-treated adult patients with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and other high-risk characteristics as studied in REDUCE-IT1 — — Approval marks seventh national reimbursement of VAZKEPA® in Europe — — Vianex S.A., one of the leading pharmaceutical companies in Greece, will commercialize VAZKEPA® as Amarin’s exclusive distributor in the country — DUBLIN, Ireland and BRIDGEWATER, N.J., May 28, 2024 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announces that the Greek Ministry of Health has approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥ 150 mg/ml [≥ 1.7 mmol/l) and established cardiovascular disease, or diabetes and at least one other cardiovascular risk factor1. As in most European countries, cardiovascular diseases are the main cause of death in Greece2. Today’s approval – which marks the seventh national reimbursement of VAZKEPA® in Europe – provides eligible patients across Greece access to a new treatment option to reduce their cardiovascular risk and help improve their overall heart health. “We are very pleased with this seventh national reimbursement for VAZKEPA® supporting our continued growth opportunity in Europe which is a testament to the strength of our scientific data and the value of our product for patients at-risk for a cardiovascular event,” said Patrick Holt, President & CEO of Amarin. To support the commercialization of VAZKEPA® in Greece, Amarin has entered into an exclusive agreement with Vianex S.A., one of the leading pharmaceutical companies in Greece celebrating its 100-year anniversary this year. Under the terms of the agreement, Vianex S.A. will be the sole and exclusive distributor of VAZKEPA® in the territory to import, register, distribute and commercialize the product. Amarin will be responsible for supplying finished product to Vianex at a transfer price paid to Amarin. Vianex will start commercializing VAZKEPA® in the course of the next weeks. Christos Papadopoulos, Senior Vice President and Head of Commercial Europe at Amarin, commented: “We look forward to working with Vianex in bringing our VAZKEPA® treatment to healthcare providers and patients across Greece. As one of the country’s leading pharmaceutical companies, Vianex has strong commercial capabilities and deep expertise in cardiology and cardiovascular risk management. Their capabilities and experience align well with the opportunity to successfully commercialize VAZKEPA® and its proven ability to reduce cardiovascular risk and improve outcomes for patients.” About Amarin Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. About VIANEX S.A. VIANEX S.A. is a Greek pharmaceutical company, founded in 1971 by the Giannakopoulos’ family that has been involved with the pharmaceutical industry since 1924. Through its 100-year history, VIANEX produces, imports, markets, packages and distributes a large number of pharmaceuticals, covering various therapeutic classes. It has formed strategic partnerships and alliances with major pharmaceutical entities across the globe. VIANEX owns four state-of-the-art fully specialized Manufacturing Plants that guarantee outstanding production capabilities. It covers the entire spectrum of manufacturing activities while it continuously upgrades the range of services by investing in technological equipment. VIANEX has also been exporting registered products for over 20 years in 114 countries worldwide and is an approved supplier of the World Health Organization. Strategic planning, focus to quality, operational excellence and long-term experience have contributed to a leading position in the Greek Pharmaceutical market, based on a long-term effort, that passes from generation to generation and constantly focuses to the future. Forward-Looking Statements This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (https://amarincorp.com/investor-relations), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com 1 https://www.moh.gov.gr/articles/times-farmakwn/epitroph-aksiologhshs-kai-apozhmiwshs-farmakwn/12338-entaksh-farmakwn-ston-katalogo-apozhmioymenwn-farmakwn?fdl=270532 European Commission – Greece Country Health Profile 2023 – access May 2024
Nanox Announces First Quarter of 2024 Financial Results and Provides Business Update
Accelerates Deployment of Nanox.ARC in United States Signed two commercial agreements for Nanox.AI Management to host conference call and webcast Tuesday, May 28, 2024 at 8:30 AM ET PETAH TIKVA, Israel, May 28, 2024 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2024 and provided a business update. First Quarter 2024 Highlights and Recent Developments: Generated $2.6 million in revenue in the first quarter of 2024, compared to $2.4 million in the first quarter of 2023.In the first quarter of 2024, we have continued to make strides in our U.S operational performance.Secured agreements for Nanox.AI with Dandelion Health and Covera Health.Hosted a live demonstration of the Nanox.ARC, scanning a patient at Dynamic Medical Imaging in New Jersey in early April, which showcased the clinical utility of the Nanox.ARC in real time.Entered into an agreement with US-based Swissray, a leading provider of radiology services, to further strengthen Nanox’s customer support infrastructure.Continued to generate clinical data supporting the use of Nanox.ARC for chest and other musculoskeletal indications. “The entire Nanox team performed at a high level in the first quarter of 2024, marking positive strides commercializing the full Nanox technology suite worldwide, while also strengthening our customer support network and building the clinical data to support the use of the Nanox.ARC for an expanded array of musculoskeletal indications,” said Erez Meltzer, Nanox Chief Executive Officer. “We have also strengthened the crucial Nanox.AI product suite, receiving a new FDA clearance for Health FLD in February, and securing agreements with leading healthcare AI data platforms Dandelion Health and Covera. Alongside our commercial efforts in the US, we are also advancing in other geographies. The entire Nanox team is focused on acceleration into the rest of 2024.” Financial results for three months ended March 31, 2024 For the three months ended March 31, 2024 (the “reported period”), the Company reported a net loss of $12.2 million, compared to a net loss of $11.8 million for the three months ended March 31, 2023 (which is referred as the “comparable period”), representing an increase of $0.4 million. The increase was largely due to onetime income that was recorded in the comparable period due to a decrease in the Company’s earn-out liabilities in the amount of $4.7 million and an increase in gross loss in the amount of $0.5 million, which was offset by a decrease of $1.1 million in the research and development expenses, a decrease of $0.4 million in the sales and marketing expenses, a decrease of $2.8 million in the general and administrative expenses and increase of $0.4 in the Company’s financial income. The Company reported revenue of $2.6 million in the reported period, compared to $2.4 million in the comparable period. During the reported period, the Company generated revenue through teleradiology services, the sales and deployment of its imaging systems and the sale of its AI solutions. The Company’s gross loss during the reported period totaled $2.1 million (gross loss margin of (81%)) on a GAAP basis, as compared to $1.5 million (gross loss margin of (62%)) in the comparable period. Non-GAAP gross profit for the reported period was $0.6 million (gross profit margin of approximately 22%), as compared to $1.0 million (gross profit margin of approximately 43%) in the comparable period. The Company’s revenue from teleradiology services for the reported period was $2.4 million in the reported and comparable periods. The Company’s GAAP gross profit from teleradiology services for the reported period was $0.3 million (gross profit margin of approximately 14%), as compared to $0.5 million (gross profit margin of approximately 21%) in the comparable period. Non-GAAP gross profit of the Company’s teleradiology services for the reported period was $0.9 million (gross profit margin of approximately 37%) as compared to $1.1 million (gross profit margin of approximately 45%) in the comparable period. The decrease was attributable mainly to an increase in the cost of the engaged radiologists due to increases in reading rates. During the reported period the Company generated revenue through the sales and deployment of its imaging systems which amounted to $48 thousand for the reported period, with a gross loss of 0.4 million on a GAAP and non-GAAP basis. The revenue stems from the sale and deployment of our 2D systems in Africa and our ARC systems in the U.S. The Company’s revenue from its AI solutions for the reported period was $97 thousand with a gross loss of $2.0 million on a GAAP basis, as compared to revenue of $49 thousand with a gross loss of $2.0 million in the comparable period. Non-GAAP gross profit of the Company’s AI solutions for the reported period was $29 thousand, as compared to a loss of $20 thousand in the comparable period. During the reported period, Nanox AI continued to complete pilot programs with health organizations and other prospects in anticipation of full deployment of its products. Research and development expenses net for the reported period were $5.2 million, as compared to $6.3 million in the comparable period, reflecting a decrease of $1.1 million. The decrease was mainly due to a research grant of $0.9 million that was received as part of the NHSX project, decrease of $0.2 million in salaries and wages, decrease of $0.2 million in share-based compensation which was offset by an increase of $0.3 million in the expenses related to our research and development activities. Sales and marketing expenses for the reported period were $0.8 million, as compared to $1.2 million in the comparable period, reflecting a decrease of $0.4 million in the Company’s marketing expenses. General and administrative expenses for the reported period were $5.0 million, as compared to $7.8 million in the comparable period. The decrease of $2.8 million was mainly due to a decrease in our legal expenses in the amount of $2.2 million, largely as result of the finalization of the SEC investigation and the settlement of the class action and a decrease in the cost of the directors’ and officers’ liability insurance premium in the amount of $0.4 million. Non-GAAP net loss attributable to ordinary shares for the reported period was $8.1 million, as compared to $10.5 million in the comparable period. The decrease of $2.4 million was mainly due to a decrease in non-GAAP operating expenses of $2.4 million and an increase of $0.4 million in our non-GAAP interest income which was mitigated by a decrease of $0.6 million in our non-GAAP cost of goods sold. Non-GAAP gross profit for the reported period was $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP research and development expenses, net for the reported period, were $4.6 million, as compared to $5.5 million in the comparable period. Non-GAAP sales and marketing expenses for the reported period were $0.6 million, as compared to $1.0 million in the comparable period. Non-GAAP general and administrative expenses for the reported period were $4.3 million as compared to $5.4 million in the comparable period. The difference between the GAAP and non-GAAP financial measures above is mainly attributable to amortization of intangible assets, share-based compensation, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. A reconciliation between GAAP and non-GAAP financial measures for the three months periods ended March 31, 2024, and 2023 is provided in the financial results that are part of this press release. Liquidity and Capital Resources As of March 31, 2024, the Company had total cash, cash equivalents, restricted deposits and marketable securities of $73.3 million, compared to $82.8 million as of December 31, 2023. The decrease of $9.5 million during the reported period was primarily due to negative cash flow from operations of $9.4 million. Other Assets As of March 31, 2024 and December 31, 2023, the Company had property and equipment of $42.3 million. As of March 31, 2024, the Company had intangible assets of $78.0 million as compared to $80.6 million as of December 31, 2023. The decrease was attributable to the periodic amortization of intangible assets in the amount of $2.6 million. Shareholders’ Equity As of March 31, 2024, and December 31, 2023, the Company had approximately 57.8 million shares outstanding. Conference Call and Webcast Details Tuesday, May 28, 2024 @ 8:30am ET Individuals interested in listening to the conference call may do so by joining the live webcast on the Investors section of the Nanox website under Events and Presentations. Alternatively, individuals can register online to receive a dial-in number and personalized PIN to participate in the call. An archived webcast of the event will be available for replay following the event. About Nanox: Nanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Forward-Looking Statements: This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, those relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to continue to develop of the Nanox imaging system; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox imaging system and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; and (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces, including the continuation and escalation of the military conflicts in Israel and current war between Israel and Hamas; (x) the costs incurred with respect to and the outcome of litigation Nanox is currently subject to and any similar or other claims and potential litigation it may be subject to in the future; and (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the United States (“GAAP”), including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with class-action litigation and the SEC investigation. The Company’s management and board of directors utilize these non-GAAP financial measures to evaluate the Company’s performance. The Company provides these non-GAAP measures of the Company’s performance to investors because management believes that these non-GAAP financial measures, when viewed with the Company’s results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, these non-GAAP measures should not be considered measures of the Company’s liquidity. A reconciliation of certain GAAP to non-GAAP financial measures has been provided in the tables included in this press release. NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands except share and per share data) March 31,2024 December 31, 2023 U.S. Dollars in thousands Assets CURRENT ASSETS: Cash and cash equivalents 44,921 56,377 Restricted deposit 46 46 Marketable securities 28,043 26,006 Accounts receivables net of allowance for credit losses of $55 as of March 31, 2024 and December 31, 2023, respectively. 1,442 1,484 Inventories 2,952 2,356 Prepaid expenses 1,004 1,274 Other current assets 625 1,092 TOTAL CURRENT ASSETS 79,033 88,635 NON-CURRENT ASSETS: Restricted deposit 323 327 Property and equipment, net 42,328 42,343 Operating lease right-of-use asset 4,370 4,573 Intangible assets 77,954 80,607 Other non-current assets 1,869 2,163 TOTAL NON-CURRENT ASSETS 126,844 130,013 TOTAL ASSETS 205,877 218,648 Liabilities and Shareholders’ Equity CURRENT LIABILITIES: Current maturities of long term loan 3,341 3,490 Accounts payable 1,860 3,303 Accrued expenses 3,267 3,920 Deferred revenue 496 543 Current maturities of operating lease liabilities 883 861 Other current liabilities 3,762 3,407 TOTAL CURRENT LIABILITIES 13,609 15,524 NON-CURRENT LIABILITIES: Non-current operating lease liabilities 3,819 4,045 Deferred tax liability 2,859 2,953 Other long-term liabilities 629 612 TOTAL NON-CURRENT LIABILITIES 7,307 7,610 TOTAL LIABILITIES 20,916 23,134 COMMITMENTS AND CONTINGENCIES SHAREHOLDERS’ EQUITY: Ordinary Shares, par value NIS 0.01 per share 100,000,000 authorized at March 31, 2024 and December 31 2023, 57,779,033 and 57,778,628 issued and outstanding at March 31, 2024 and December 31, 2023, respectively 165 165 Additional paid-in capital 517,388 515,887 Accumulated other comprehensive loss (118) (305)Accumulated deficit (332,474) (320,233)TOTAL SHAREHOLDERS’ EQUITY 184,961 195,514 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 205,877 218,648 NANO-X IMAGING LTD.UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS ANDCOMPREHENSIVE LOSS(U.S. dollars in thousands except share and per share data) Three Months EndedMarch 31, 2024 2023 REVENUE 2,553 2,447 COST OF REVENUE 4,607 3,970 GROSS LOSS (2,054) (1,523) OPERATING EXPENSES: Research and development, net 5,220 6,286 Sales and marketing 800 1,153 General and administrative 5,042 7,808 Change in contingent earnout liability – (4,660)Other expense (income), net 9 (32)TOTAL OPERATING EXPENSES 11,071 10,555 OPERATING LOSS (13,125) (12,078) REALIZED LOSS FROM SALE OF MARKETABLE SECURITIES – (178)FINANCIAL INCOME, net 790 401 OPERATING LOSS BEFORE INCOME TAXES (12,335) (11,855) INCOME TAX BENEFIT 94 94 NET LOSS (12,241) (11,761) BASIC AND DILUTED LOSS PER SHARE (0.21) (0.21)Weighted average number of basic and diluted ordinary shares outstanding (in thousands) 57,901 55,157 Comprehensive Loss: Net loss (12,241) (11,761)Other comprehensive gain (loss): Reclassification of net losses realized in income statement – 178 Unrealized gain from available for-sale securities 187 414 Total comprehensive loss (12,054) (11,169) NANO-X IMAGING LTD.UNAUDITED CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY(U.S. dollars in thousands, except share and per share data) Ordinary shares Additional Accumulatedother Number ofshares Amount paid-incapital comprehensiveloss Accumulateddeficit Total BALANCE AT JANUARY 1, 2024 57,778,628 165 515,887 (305) (320,233) 195,514 Changes during the period: Issuance of ordinary shares upon exercise of options 405 * 24 – – 24 Share-based compensation – – 1,477 – – 1,477 Unrealized gain from marketable securities – – – 187 187 Net loss for the period – – – – (12,241) (12,241)BALANCE AT MARCH 31, 2024 57,779,033 165 517,388 (118) (332,474) 184,961 * Less than $1. Ordinary shares Additional Accumulatedother Number ofshares Amount paid-incapital comprehensivedeficit Accumulateddeficit Total U.S. Dollars in thousands BALANCE AT JANUARY 1, 2023 55,094,237 158 477,953 (1,974) (259,457) 216,680 Changes during the period: Issuance of ordinary shares upon exercise of options 56,108 – 176 – – 176 Unrealized gain from marketable securities, net – – – 592 592 Share-based compensation – – 1,043 – – 1,043 Net loss for the period – – – – (11,761) (11,761)BALANCE AT MARCH 31, 2023 55,150,345 158 479,172 (1,382) (271,218) 206,730 * Less than $1. NANO-X IMAGING LTD. UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S. dollars in thousands) Three Months EndedMarch 31, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss for the period (12,241) (11,761)Adjustments required to reconcile net loss to net cash used in operating activities: Share-based compensation 1,477 1,043 Amortization of intangible assets 2,653 2,653 Exchange rate differentials (174) (19)Change in contingent earnout liability – (4,660)Depreciation 286 255 Deferred tax liability, net (94) (94)Realized loss from sale of marketable securities – 178 Amortization of premium, discount and accrued interest on marketable securities 73 324 Impairment of property and equipment 25 145 Changes in Operating Assets and Liabilities: Inventories (676) – Accounts receivable 42 (331)Prepaid expenses and other current assets 737 1,404 Other non-current assets 219 142 Accounts payable (1,443) 706 Operating lease assets and liabilities (1) (7)Accrued expenses and other liabilities (298) (559)Deferred Revenue (47) (107)Other long-term liabilities 17 14 Net cash used in operating activities (9,445) (10,674) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment (141) (1,495)Proceeds from maturity of marketable securities 12,874 10,289 Purchase of marketable securities (14,797) – Proceeds from sale of marketable securities – 822 Net cash provided by (used in) investing activities (2,064) 9,616 CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from Issuance of ordinary shares upon exercise of options 24 176 Net cash provided by financing activities 24 176 EFFECT OF CHANGES IN EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS 29 (11)NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS (11,456) (893)CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT BEGINNING OF THE PERIOD 56,377 38,529 CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT END OF THE PERIOD 44,921 37,636 SUPPLEMENTARY INFORMATION ON ACTIVITIES INVOLVING CASH FLOWS Cash paid for interest 37 40 Cash paid for income taxes – – SUPPLEMENTARY INFORMATION ON ACTIVITIES NOT INVOLVING CASH FLOWS – Operating lease liabilities arising from obtaining operating right-of use assets – 572 UNAUDITED RECONCILIATION OF GAAP AND NON-GAAP RESULTS(U.S. dollars in thousands (except per share data)) Use of non-GAAP Financial Measures The unaudited condensed consolidated financial information is prepared in conformity with GAAP. The Company uses information about certain financial measures that are not prepared in accordance with GAAP, including non-GAAP net loss attributable to ordinary shares, non-GAAP cost of revenue, non-GAAP gross profit, non-GAAP gross profit margin, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses and non-GAAP basic and diluted loss per share. These non-GAAP measures are adjusted for (as applicable) amortization of intangible assets, share-based compensation expenses, change in contingent earnout liability and legal fees in connection with the class-action litigation and the SEC investigation. The Company believes that separate analysis and exclusion of the one-off or non-cash impact of the above reconciling items (as applicable) adds clarity to the constituent parts of its performance. The Company reviews these non-GAAP financial measures together with GAAP financial measures to obtain a better understanding of its operating performance. It uses the non-GAAP financial measures for planning, forecasting, and measuring results against the forecast. The Company believes that the non-GAAP financial measures are useful supplemental information for investors and analysts to assess its operating performance. However, these non-GAAP measures are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Reconciliation of GAAP net loss attributable to ordinary shares to Non-GAAP net loss attributable to ordinary shares and Non-GAAP basic and diluted loss per share (U.S. dollars in thousands) Three Months Ended March 31, 2024 2023 GAAP net loss attributable to ordinary shares 12,241 11,761 Non-GAAP adjustments: Less: Class-action litigation and SEC investigation 32 2,236 Less: Amortization of intangible assets 2,653 2,653 Less (Add): Change in contingent earnout liability – (4,660)Less: Share-based compensation 1,477 1,043 Non-GAAP net loss attributable to ordinary shares 8,079 10,489 Non-GAAP BASIC AND DILUTED LOSS PER SHARE 0.14 0.19 WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES (in thousands) 57,901 55,157 Reconciliation of GAAP cost of revenue to Non-GAAP cost of revenue (U.S. dollars in thousands) GAAP cost of revenue 4,607 3,970 Non-GAAP adjustments: Amortization of intangible assets 2,556 2,556 Share-based compensation 53 14 Non-GAAP cost of revenue 1,998 1,400 Reconciliation of GAAP gross loss to Non-GAAP gross profit (U.S. dollars in thousands) GAAP gross loss (2,054) (1,523)Non-GAAP adjustments: Amortization of intangible assets 2,556 2,556 Share-based compensation 53 14 Non-GAAP gross profit 555 1,047 Reconciliation of GAAP gross loss margin to Non-GAAP gross profit margin (in percentage of revenue) GAAP gross loss margin (80)% (62)%Non-GAAP adjustments: Amortization of intangible assets 100% 104%Share-based compensation 2% 1%Non-GAAP gross profit margin 22% 43% Reconciliation of GAAP research and development expenses to Non-GAAP research and development expenses (U.S. dollars in thousands) GAAP research and development expenses, net 5,220 6,286 Non-GAAP adjustments: Share-based compensation 589 788 Non-GAAP research and development expenses, net 4,631 5,498 Reconciliation of GAAP sales and marketing expenses to Non-GAAP sales and marketing expenses (U.S. dollars in thousands) GAAP sales and marketing expenses 800 1,153 Non-GAAP adjustments: Amortization of intangible assets 97 97 Share-based compensation 146 78 Non-GAAP sales and marketing expenses 557 978 Reconciliation of GAAP general and administrative expenses to Non-GAAP general and administrative expenses (U.S. dollars in thousands) GAAP general and administrative expenses 5,042 7,808 Non-GAAP adjustments: Class-action litigation and SEC investigation 32 2,236 Share-based compensation 689 163 Non-GAAP general and administrative expenses 4,321 5,409 Contacts Media Contact:Ben ShannonICR WestwickeNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Westwickemike.cavanaugh@westwicke.com
HoneyNaps secures a $11.6 million Series B investment, becoming the No. 1 ranked A.I Sleep Technology Company
HoneyNaps secures $11.6 million in series B funding, propelling its entry into the American medical market.BOSTON, May 24, 2024 /PRNewswire/ — HoneyNaps, an industry-leading South Korean company in artificial intelligence (AI) sleep data analysis, announced on the 7th that it has closed its series B round of funding, securing $11.6 million.The series B funding is a successful achievement, nearly three times the $3.9 million raised through series A funding back in 2021. With the listing contract signed with Korea Investment & Securities Co., Ltd. in March 2024, the company is poised to become the no. 1 listed company in Sleep Technology (Sleep-Tech) that features an AI bio signal model.
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HoneyNaps Solutions
In this round, many institutions participated as new investors such as Korea Industrial Bank, Hi investment Partners and QUAD Investment Management. Despite a freeze-up in venture investment, this series B round achieved an early close due to overbooking, driven by overwhelming participation from prestigious domestic and foreign investors.
Founded in July 2015, HoneyNaps has amassed about $16.2 million to date, starting with seed funding for about $0.7 million, secured through success-share-funding from the Ministry of SMEs and Startups in 2019. This funding marks the largest scale among recent financings secured by domestic Sleep-Tech companies.HoneyNaps obtained FDA approval for its AI sleep diagnosis software SOMNUM in 2023, establishing partnerships with major university hospitals across the U.S. through its Boston-based American branch. The domestic sales growth coupled with the perceived potential for export to the American medical market are cited as key drivers to the company’s success in funding.SOMNUM is an algorithm that analyzes bio signal data during sleep and provides disease diagnoses under five minutes using its self-developed AI model. This AI diagnosis software is integrable into any medical and healthcare market using real-time large-scale bio signal.In particular, the company invested nine years to develop X.AI (eXplainable AI), a crucial component for the medical field. They have also registered 16 original patents and published SCIE-Level thesis, enhancing the technical value provided to its clients.HoneyNaps’ CFO states, “This successful funding amidst a challenging investment climate has validated our position as Korea’s leading Sleep-Tech company”, adding, “These resources will enable us to achieve results in the domestic and American medical market and earn recognition. Beyond the SOMNUM’s current use in sleep disease diagnosis, we plan to further advance the AI to expand its application to other critical areas such as cardiovascular disease, dementia, and Parkinson’s disease”.For additional information, please contact:HoneyNaps USA, Inc.Christine Kwon / Managing DirectorEmail: [email protected]Address: 6 Liberty SQ PMB 6202, Boston, MA 02109Website: www.honeynaps.comSOURCE HoneyNaps
Inari Medical Files Patent Infringement Lawsuit Against Imperative Care and Truvic Medical
IRVINE, Calif., May 23, 2024 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced today that it had filed a patent infringement lawsuit against Imperative Care, Inc. and Truvic Medical, Inc. (collectively, “Truvic”). The suit was filed in the United States District Court for the Northern District of California. Inari is seeking injunctive relief and damages for infringement. Inari believes Truvic is infringing eight of Inari Medical’s patents for the use of aspiration-based thrombectomy devices to treat pulmonary emboli and deep vein thrombosis. Truvic products named in the suit include the Symphony Thrombectomy System. “Inari was founded to improve patients’ lives using purpose-built innovation. Our mission depends on these innovations, and we are deeply committed to protecting our intellectual property rights,” said Drew Hykes, CEO of Inari Medical. About Inari Medical, Inc.Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous and other diseases. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram. Investor Contact:John Hsu, CFAVP, Investor Relations949-658-3889IR@inarimedical.com
Medtronic reports full year and fourth quarter fiscal 2024 financial results; announces dividend increase
Broad-based, durable growth across the company, including Cranial & Spinal Technologies, Diabetes, Cardiac Pacing, Surgical, and Structural Heart; gaining momentum as company enters new product cycles across many high-growth marketsDUBLIN, May 23, 2024 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its fourth quarter (Q4) and fiscal year 2024 (FY24), which ended April 26, 2024.Key Highlights
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Q4 revenue of $8.6 billion increased 0.5% as reported and 5.4% organic
Q4 GAAP diluted earnings per share (EPS) of $0.49; non-GAAP diluted EPS of $1.46
FY24 revenue of $32.4 billion increased 3.6% as reported and 5.2% organic
FY24 GAAP diluted EPS of $2.76; non-GAAP diluted EPS of $5.20
FY24 cash from operations of $6.8 billion increased 12%; FY24 free cash flow of $5.2 billion increased 14%
Company returned $5.5 billion to shareholders in FY24, including $1.6 billion through net share repurchases in Q4
Company issues FY25 guidance
Dividend increased to $0.70 per share quarterly, annual $2.80 per share; 47th consecutive year of dividend increases
Received U.S. FDA approval for Evolut™ FX+ TAVR system and Inceptiv™ closed-loop spinal cord stimulator; received China National Medical Products Administration (NMPA) approval for Symplicity Spyral™ renal denervation system; submitted Affera Sphere-9™ ablation catheter and Simplera Sync™ CGM to U.S. FDA seeking approval
Q4 Financial ResultsMedtronic reported Q4 worldwide revenue of $8.589 billion, an increase of 0.5% as reported and 5.4% on an organic basis. The company’s organic revenue results reflect broad-based growth across the company, with mid-single digit or higher organic revenue growth in all four segments. The organic revenue growth comparison excludes:
$57 million of current year revenue and $114 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$72 million of unfavorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time intellectual property (IP) agreement, which was reported in the Structural Heart & Aortic division in the Cardiovascular Portfolio
As reported, Q4 GAAP net income and diluted EPS were $654 million and $0.49, respectively, decreases of 45% and 44%, respectively. As detailed in the financial schedules included at the end of this release, Q4 non-GAAP net income and non-GAAP diluted EPS were $1.929 billion and $1.46, respectively, decreases of 8% and 7%, respectively. Included in Q4 non-GAAP diluted EPS was a 7 cent, or 4%, unfavorable impact from foreign currency translation.FY24 Financial ResultsMedtronic reported FY24 worldwide revenue of $32.364 billion, an increase of 3.6% as reported and 5.2% on an organic basis. The FY24 organic revenue growth comparison excludes:
$111 million of current year revenue and $358 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$43 million of favorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time IP agreement.
FY24 GAAP net income and diluted earnings per share (EPS) were $3.676 billion and $2.76, respectively, both representing decreases of 2%. As detailed in the financial schedules included at the end of this release, fiscal year 2024 non-GAAP net income and non-GAAP diluted EPS were $6.918 billion and $5.20, respectively, both representing decreases of 2%. Included in FY24 non-GAAP diluted EPS was a 33 cent unfavorable impact from foreign currency translation. FY24 non-GAAP diluted EPS on a constant currency basis increased 5%.FY24 cash from operations of $6.787 billion increased 12%. FY24 free cash flow of $5.200 billion increased 14%, representing free cash flow conversion from non-GAAP net earnings of 75%. Growth was driven by improvements in working capital.”We delivered a strong finish to the fiscal year, with broad strength across our businesses and each of our four segments posting mid-single digit or higher organic revenue growth,” said Geoff Martha, Medtronic chairman and chief executive officer. “Our momentum is building into the new fiscal year. We’re beginning new product cycles in some of MedTech’s most attractive markets, which is further enhanced as we apply AI across our portfolio. We are very optimistic about what we can achieve in fiscal ’25 and beyond.”Cardiovascular PortfolioThe Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. FY24 revenue of $11.831 billion increased 2.7% as reported and 5.0% organic, with a high-single digit increase in SHA, mid-single digit increase in CPV, and a low-single digit increase in CRHF, all on an organic basis. Q4 revenue of $3.130 billion decreased 5.2% as reported and increased 4.0% organic, with mid-single digit organic increases in SHA and CPV, and a low-single digit organic increase in CRHF.
CRHF Q4 results included low-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Cardiac Pacing Therapies, including low-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions grew mid-single digits, with declines in cryoablation more than offset by strong growth in pulsed field ablation (PFA)
SHA Q4 results driven by high-single digit growth in Structural Heart and Cardiac Surgery; Structural Heart had double digit growth in Western Europe and Japan on the continued adoption of the Evolut™ FX transcatheter aortic valve replacement (TAVR) system
CPV in Q4 delivered mid-single digit Coronary growth with strength in guide catheters and balloons; Peripheral Vascular Health also grew mid-single digits, with mid-teens growth in drug-coated balloons and vascular embolization products
Received U.S. FDA approval for Evolut™ FX+ TAVR system in March, with early commercial experience this spring 2024 and full product launch in summer 2024; Launched Avalus Ultra™ surgical aortic tissue value in the U.S.; Symplicity Spyral™ renal denervation system received National Medical Products Administration (NMPA) approval in China and license from Health Canada
One-year results from SMART trial simultaneously presented at American College of Cardiology and published in The New England Journal of Medicine in April, demonstrating Medtronic Evolut™ TAVR platform as optimal treatment for severe aortic stenosis in patients with small annuli, which is primarily women
First-in-human data studying the Sphere-360™ PFA catheter presented at European Heart Rhythm Association annual meeting in April; one-year results from SPHERE-PER AF pivotal study of the Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform presented at Heart Rhythm last week, system has been submitted to U.S. FDA seeking approval
Neuroscience PortfolioThe Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. FY24 revenue of $9.406 billion increased 5.0% as reported and 5.2% organic, with a high-single digit increase in CST, mid-single digit increase in Specialty Therapies, and a low-single digit increase in Neuromodulation, all on an organic basis. Q4 revenue of $2.545 billion increased 5.6% as reported and 6.5% organic, with a high-single digit increase in CST, a mid-single digit increase in Neuromodulation, and low-single digit increase in Specialty Therapies, all on an organic basis.
CST Q4 performance driven by continued adoption of the AiBLE™ ecosystem, with mid-teens growth in Neurosurgery on strong capital equipment sales, high-single digit growth in Biologics, and mid-single digit growth in Core Spine
Specialty Therapies Q4 results driven by high-single digit growth in ENT, with strength in power capital and disposables and localized drug delivery sinus implants; Neurovascular declined low-single digits, as declines in China due to volume-based procurement tenders offset strength in flow diversion products; Pelvic Health increased mid-single digits on continued adoption of the InterStim X™ system
Neuromodulation in Q4 delivered low-double digit growth in Brain Modulation on the launch of the Percept™ RC neurostimulator with BrainSense™ technology; Pain Therapies grew mid-single digits, including low-double digit growth in Targeted Drug Delivery and low-single digit growth in Pain Stim
Received U.S. FDA approval for Inceptiv™ closed-loop spinal cord stimulator on last day of Q4; received U.S. FDA clearance for OsteoCool™ 2.0 bone tumor ablation system in Q4, with broad market launch planned later this calendar year
Medical Surgical PortfolioThe Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. FY24 revenue of $8.417 billion increased 5.4% as reported and 4.7% organic, with a mid-single digit increase in SE and low-single digit increase in ACM, both on an organic basis. Q4 revenue of $2.198 billion increased 3.5% as reported and 4.5% organic, with mid-single digit organic growth in SE and low-single digit organic growth in ACM.
SE Q4 results included high-single digit growth in General Surgical Technologies, with strength in wound management and hernia products, low-single digit growth in Advanced Surgical Technologies, and high-single digit growth in Endoscopy on strength of capital sales
ACM Q4 performance driven by mid-single digit growth in Blood Oxygen Management on strong sales of Nellcor™ pulse oximetry products, and mid-single digit growth in Airways, driven by strong McGRATH™ MAC video laryngoscope demand
Launched Touch Surgery™ Live Stream and 14 new AI-driven algorithms on the Touch Surgery™ Performance Insights platform for laparoscopic and robotic-assisted procedures; received U.S. FDA clearance for the BIS™ Advance anesthesia monitor; started enrollment in two new U.S. indication studies for the Hugo™ robotic-assisted surgery system: Hernia and Gynecology
DiabetesDiabetes FY24 revenue of $2.488 billion increased 10.0% as reported and 8.6% organic. Q4 revenue of $660 million increased 10.9% as reported and 11.1% organic.
U.S. Q4 revenue grew low-double digits on the continued launch of the MiniMed™ 780G system; high-forties growth in U.S. insulin pump sales with strong growth in sales to new patients
Non-U.S. Developed Markets grew high-single digits on continued MiniMed™ 780G system adoption and increased CGM attachment rates
Submitted Simplera Sync™ CGM to U.S. FDA in Q4 seeking approval for use with the MiniMed™ 780G system
GuidanceThe company today issued its fiscal year 2025 (FY25) revenue growth and EPS guidance.The company is guiding to FY25 organic revenue growth in the range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency exchange and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on a reported basis would be in the range of 2.4% to 3.7%.The company is guiding to FY25 diluted non-GAAP EPS in the range of $5.40 to $5.50, including an estimated 5% unfavorable impact from foreign currency exchange based on recent rates. This would represent FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.Dividend IncreaseThe company today announced that effective May 22, 2024, the Medtronic board of directors approved an increase in Medtronic’s cash dividend for the first quarter of fiscal year 2025, raising the quarterly amount to $0.70 per ordinary share. This would translate into an annual amount of $2.80 per ordinary share. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. Today’s announcement marks the 47th consecutive year of an increase in the dividend payment. Including today’s increase, Medtronic’s dividend per share has grown by 30% over the past 5 years, 130% over the past 10 years, and has grown at a 16% compounded annual growth rate over the past 47 years.Medtronic has a strong track record of returning capital to its shareholders, including $5.5 billion in fiscal year 2024. The company remains committed to returning a minimum of 50% of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 12, 2024, to shareholders of record at the close of business on June 28, 2024.”We delivered on our commitments in the fourth quarter and the fiscal year, driving durable revenue growth, improved earnings power, and strong free cash flow,” said Karen Parkhill, Medtronic EVP & chief financial officer. “Our fiscal 2025 guidance, along with our dividend increase and recent share repurchase, reflects our confidence in our continued trajectory.”Video Webcast InformationMedtronic will host a video webcast today, May 23, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com, and this earnings release will be archived at news.medtronic.com. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com.Medtronic plans to report its FY25 first, second, third, and fourth quarter results on Tuesday, August 20, 2024, November 19, 2024, February 18, 2025, and Thursday, May 22, 2025, respectively. Confirmation and additional details will be provided closer to the specific event.Financial Schedules and Earnings PresentationThe fourth quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter earnings presentation, click here.
MEDTRONIC PLC WORLD WIDE REVENUE(1) (Unaudited)
FOURTH QUARTER
FISCAL YEAR
REPORTED
ORGANIC
REPORTED
ORGANIC
(in millions)
FY24
FY23
Growth
Currency Impact(3)
Adjusted FY24(4)
Adjusted FY23(5)
AdjustedGrowth
FY24
FY23
Growth
CurrencyImpact(3)
Adjusted FY24(4)
Adjusted FY23(5)
Adjusted Growth
Cardiovascular
$ 3,130
$ 3,302
(5.2) %
$ (28)
$ 3,158
$ 3,037
4.0 %
$ 11,831
$ 11,522
2.7 %
$ 12
$ 11,819
$ 11,257
5.0 %
Cardiac Rhythm & Heart Failure
1,587
1,567
1.3
(15)
1,602
1,567
2.2
5,995
5,783
3.7
11
5,984
5,783
3.5
Structural Heart & Aortic
883
1,105
(20.1)
(6)
889
840
5.8
3,358
3,363
(0.1)
11
3,347
3,098
8.0
Coronary & Peripheral Vascular
660
631
4.6
(7)
667
631
5.7
2,478
2,375
4.3
(10)
2,488
2,375
4.8
Neuroscience
2,545
2,410
5.6
(21)
2,566
2,410
6.5
9,406
8,959
5.0
(16)
9,422
8,959
5.2
Cranial & Spinal Technologies
1,291
1,198
7.8
(11)
1,302
1,198
8.7
4,756
4,451
6.9
(11)
4,767
4,451
7.1
Specialty Therapies
778
763
2.0
(9)
787
763
3.1
2,905
2,815
3.2
(12)
2,917
2,815
3.6
Neuromodulation
475
449
5.8
(1)
476
449
6.0
1,746
1,693
3.1
7
1,739
1,693
2.7
Medical Surgical
2,198
2,124
3.5
(22)
2,220
2,124
4.5
8,417
7,989
5.4
16
8,512
8,127
4.7
Surgical & Endoscopy
1,705
1,638
4.1
(15)
1,720
1,638
5.0
6,508
6,152
5.8
20
6,488
6,152
5.5
Acute Care & Monitoring
492
486
1.2
(6)
498
486
2.5
1,908
1,837
3.9
(4)
2,024
1,975
2.5
Diabetes
660
595
10.9
(1)
661
595
11.1
2,488
2,262
10.0
31
2,457
2,262
8.6
Other (2)
57
114
(50.0)
(3)
—
—
—
221
495
(55.4)
(12)
—
—
—
TOTAL
$ 8,589
$ 8,544
0.5 %
$ (75)
$ 8,604
$ 8,165
5.4 %
$ 32,364
$ 31,227
3.6 %
$ 31
$ 32,210
$ 30,604
5.2 %
(1)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(2)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.
(3)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(4)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (2) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
(5)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:
• $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and
• $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (2). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
MEDTRONIC PLC U.S.(1)(2) REVENUE (Unaudited)
FOURTH QUARTER
FISCAL YEAR
REPORTED
ORGANIC
REPORTED
ORGANIC
(in millions)
FY24
FY23
Growth
Adjusted FY24(4)
AdjustedFY23(5)
Growth
FY24
FY23
Growth
Adjusted FY24(4)
Adjusted FY23(5)
Growth
Cardiovascular
$ 1,448
$ 1,737
(16.6) %
$ 1,448
$ 1,472
(1.6) %
$ 5,597
$ 5,796
(3.4) %
$ 5,597
$ 5,531
1.2 %
Cardiac Rhythm & Heart Failure
791
819
(3.4)
791
819
(3.4)
3,037
3,052
(0.5)
3,037
3,052
(0.5)
Structural Heart & Aortic
366
625
(41.4)
366
360
1.7
1,453
1,622
(10.4)
1,453
1,357
7.1
Coronary & Peripheral Vascular
291
293
(0.7)
291
293
(0.7)
1,107
1,122
(1.3)
1,107
1,122
(1.3)
Neuroscience
1,692
1,581
7.0
1,692
1,581
7.0
6,305
6,018
4.8
6,305
6,018
4.8
Cranial & Spinal Technologies
936
855
9.5
936
855
9.5
3,495
3,259
7.2
3,495
3,259
7.2
Specialty Therapies
439
422
4.0
439
422
4.0
1,641
1,608
2.1
1,641
1,608
2.1
Neuromodulation
317
304
4.3
317
304
4.3
1,169
1,151
1.6
1,169
1,151
1.6
Medical Surgical
954
919
3.8
954
919
3.8
3,717
3,549
4.7
3,759
3,604
4.3
Surgical & Endoscopy
679
653
4.0
679
653
4.0
2,650
2,541
4.3
2,650
2,541
4.3
Acute Care & Monitoring
275
266
3.4
275
266
3.4
1,067
1,008
5.9
1,109
1,063
4.3
Diabetes
223
199
12.1
223
199
12.1
852
849
0.4
852
849
0.4
Other (3)
26
39
(33.3)
—
—
—
91
160
(43.1)
—
—
—
TOTAL
$ 4,343
$ 4,476
(3.0) %
$ 4,317
$ 4,171
3.5 %
$ 16,562
$ 16,373
1.2 %
$ 16,514
$ 16,003
3.2 %
(1)
U.S. includes the United States and U.S. territories.
(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.
(4)
The three and twelve months ended April 26, 2024 excludes $26 million and $48 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $42 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
(5)
The three and twelve months ended April 28, 2023 excludes $304 million and $370 million, respectively, of inorganic revenue related to the following:
• $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and
• $39 million and $105 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $55 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
MEDTRONIC PLC WORLD WIDE REVENUE: GEOGRAPHIC (1)(2) (Unaudited)
FOURTH QUARTER
FISCAL YEAR
REPORTED
ORGANIC
REPORTED
ORGANIC
(in millions)
FY24
FY23
Growth
CurrencyImpact(4)
Adjusted FY24(5)
Adjusted FY23(6)
Growth
FY24
FY23
Growth
CurrencyImpact(4)
Adjusted FY24(5)
AdjustedFY23(6)
Growth
U.S.
$ 1,448
$ 1,737
(16.6) %
$ —
$ 1,448
$ 1,472
(1.6) %
$ 5,597
$ 5,796
(3.4) %
$ —
$ 5,597
$ 5,531
1.2 %
Non-U.S. Developed
1,039
1,011
2.8
(13)
1,052
1,011
4.1
3,857
3,564
8.2
62
3,795
3,564
6.5
Emerging Markets
643
554
16.1
(15)
658
554
18.8
2,377
2,161
10.0
(49)
2,426
2,161
12.3
Cardiovascular
3,130
3,302
(5.2)
(28)
3,158
3,037
4.0
11,831
11,522
2.7
12
11,819
11,257
5.0
U.S.
1,692
1,581
7.0
—
1,692
1,581
7.0
6,305
6,018
4.8
—
6,305
6,018
4.8
Non-U.S. Developed
482
469
2.8
(11)
493
469
5.1
1,739
1,658
4.9
9
1,730
1,658
4.3
Emerging Markets
371
360
3.1
(10)
381
360
5.8
1,362
1,283
6.2
(25)
1,387
1,283
8.1
Neuroscience
2,545
2,410
5.6
(21)
2,566
2,410
6.5
9,406
8,959
5.0
(16)
9,422
8,959
5.2
U.S.
954
919
3.8
—
954
919
3.8
3,717
3,549
4.7
—
3,759
3,604
4.3
Non-U.S. Developed
805
799
0.8
(17)
822
799
2.9
3,049
2,917
4.5
20
3,055
2,944
3.8
Emerging Markets
439
405
8.4
(5)
444
405
9.6
1,650
1,522
8.4
(4)
1,697
1,579
7.5
Medical Surgical
2,198
2,124
3.5
(22)
2,220
2,124
4.5
8,417
7,989
5.4
16
8,512
8,127
4.7
U.S.
223
199
12.1
—
223
199
12.1
852
849
0.4
—
852
849
0.4
Non-U.S. Developed
337
314
7.3
1
336
314
7.0
1,284
1,106
16.1
37
1,247
1,106
12.7
Emerging Markets
99
82
20.7
(2)
101
82
23.2
352
307
14.7
(6)
358
307
16.6
Diabetes
660
595
10.9
(1)
661
595
11.1
2,488
2,262
10.0
31
2,457
2,262
8.6
U.S.
26
39
(33.3)
—
—
—
—
91
160
(43.1)
—
—
—
—
Non-U.S. Developed
11
35
(68.6)
(2)
—
—
—
50
163
(69.3)
(6)
—
—
—
Emerging Markets
21
39
(46.2)
(1)
—
—
—
81
172
(52.9)
(5)
—
—
—
Other (3)
57
114
(50.0)
(3)
—
—
—
221
495
(55.4)
(12)
—
—
—
U.S.
4,343
4,476
(3.0)
—
4,317
4,171
3.5
16,562
16,373
1.2
—
16,514
16,003
3.2
Non-U.S. Developed
2,674
2,629
1.7
(42)
2,702
2,593
4.2
9,979
9,408
6.1
121
9,828
9,272
6.0
Emerging Markets
1,572
1,440
9.2
(33)
1,584
1,401
13.1
5,823
5,446
6.9
(89)
5,869
5,330
10.1
TOTAL
$ 8,589
$ 8,544
0.5 %
$ (75)
$ 8,604
$ 8,165
5.4 %
$ 32,364
$ 31,227
3.6 %
$ 31
$ 32,210
$ 30,604
5.2 %
(1)
U.S. includes the United States and U.S. territories. Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries of Western Europe. Emerging Markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in the non-U.S. developed markets, as previously defined.
(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.
(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.
(4)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.
(5)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (3) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
(6)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:
• $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and
• $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited)
Three months ended
Fiscal year ended
(in millions, except per share data)
April 26, 2024
April 28, 2023
April 26, 2024
April 28, 2023
Net sales
$ 8,589
$ 8,544
$ 32,364
$ 31,227
Costs and expenses:
Cost of products sold, excluding amortization of intangible assets
3,044
2,980
11,216
10,719
Research and development expense
675
640
2,735
2,696
Selling, general, and administrative expense
2,765
2,616
10,736
10,415
Amortization of intangible assets
419
423
1,693
1,698
Restructuring charges, net
112
294
226
375
Certain litigation charges, net
44
(30)
149
(30)
Other operating expense (income), net
477
56
464
(131)
Operating profit
1,053
1,565
5,144
5,485
Other non-operating income, net
(4)
(173)
(412)
(515)
Interest expense, net
202
187
719
636
Income before income taxes
856
1,551
4,837
5,364
Income tax provision
196
362
1,133
1,580
Net income
659
1,188
3,705
3,784
Net income attributable to noncontrolling interests
(5)
(9)
(28)
(26)
Net income attributable to Medtronic
$ 654
$ 1,179
$ 3,676
$ 3,758
Basic earnings per share
$ 0.49
$ 0.89
$ 2.77
$ 2.83
Diluted earnings per share
$ 0.49
$ 0.88
$ 2.76
$ 2.82
Basic weighted average shares outstanding
1,322.3
1,330.4
1,327.7
1,329.8
Diluted weighted average shares outstanding
1,325.4
1,332.8
1,330.2
1,332.8
The data in the schedule above has been intentionally rounded to the nearest million, and therefore, the quarterly amounts may not sum to the fiscal year-to-date amounts.
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)
Three months ended April 26, 2024
(in millions, except per share data)
Net Sales
Cost of ProductsSold
Gross Margin Percent
Operating Profit
Operating Profit Percent
Income Before IncomeTaxes
Net Income attributable to Medtronic
Diluted EPS
Effective Tax Rate
GAAP
$ 8,589
$ 3,044
64.6 %
$ 1,053
12.3 %
$ 856
$ 654
$ 0.49
22.9 %
Non-GAAP Adjustments:
Amortization of intangible assets
—
—
—
419
4.9
419
357
0.27
15.0
Restructuring and associated costs (2)
—
(13)
0.2
152
1.8
152
125
0.09
17.8
Acquisition and divestiture-related items (3)
—
(76)
0.9
611
7.1
611
515
0.39
15.9
Certain litigation charges, net
—
—
—
44
0.5
44
37
0.03
15.9
(Gain)/loss on minority investments (4)
—
—
—
—
—
195
197
0.15
(1.0)
Medical device regulations (5)
—
(21)
0.2
31
0.4
31
27
0.02
12.9
Certain tax adjustments, net
—
—
—
—
—
—
17
0.01
—
Non-GAAP
$ 8,589
$ 2,934
65.8 %
$ 2,311
26.9 %
$ 2,309
$ 1,929
$ 1.46
16.2 %
Currency impact
75
18
0.1
101
0.9
0.07
Currency Adjusted
$ 8,664
$ 2,952
65.9 %
$ 2,412
27.8 %
$ 1.53
Three months ended April 28, 2023
(in millions, except per share data)
Net Sales
Cost of Products Sold
GrossMarginPercent
Operating Profit
Operating Profit Percent
IncomeBefore Income Taxes
Net Income attributable to Medtronic
Diluted EPS
Effective Tax Rate
GAAP
$ 8,544
$ 2,980
65.1 %
$ 1,565
18.3 %
$ 1,551
$ 1,179
$ 0.88
23.3 %
Non-GAAP Adjustments:
Amortization of intangible assets
—
—
—
423
5.0
423
361
0.27
14.7
Restructuring and associated costs (2)
—
(30)
0.4
372
4.4
372
288
0.22
22.6
Acquisition and divestiture-related items (6)
—
(7)
0.1
139
1.6
139
131
0.10
5.8
Certain litigation charges, net (7)
—
—
—
(30)
(0.4)
(30)
(22)
(0.02)
26.7
(Gain)/loss on minority investments (4)
—
—
—
—
—
(10)
(7)
(0.01)
(20.0)
Medical device regulations (5)
—
(25)
0.3
44
0.5
44
34
0.03
22.7
Certain tax adjustments, net (8)
—
—
—
—
—
—
127
0.10
—
Non-GAAP
$ 8,544
$ 2,917
65.9 %
$ 2,512
29.4 %
$ 2,488
$ 2,091
$ 1.57
15.8 %
See description of non-GAAP financial measures contained in the press release dated May 23, 2024.
(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.
(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration.
(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific period.
(6)
The charges primarily include changes in the carrying value of the disposal group and other associated costs as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business, changes in fair value of contingent consideration, business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.
(7)
Certain litigation includes $35 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.
(8)
The charge primarily relates to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the impact from the sale of half of the Company’s RCS business.
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)
Fiscal year ended April 26, 2024
(in millions, except per share data)
Net Sales
Cost of Products Sold
GrossMarginPercent
OperatingProfit
Operating Profit Percent
IncomeBeforeIncome Taxes
Net Income attributable toMedtronic
DilutedEPS
Effective Tax Rate
GAAP
$ 32,364
$ 11,216
65.3 %
$ 5,144
15.9 %
$ 4,837
$ 3,676
$ 2.76
23.4 %
Non-GAAP Adjustments:
Amortization of intangible assets
—
—
—
1,693
5.2
1,693
1,435
1.08
15.2
Restructuring and associated costs (2)
—
(55)
0.2
389
1.2
389
323
0.24
17.0
Acquisition and divestiture-related items (3)
—
(100)
0.3
777
2.4
777
664
0.50
14.5
Certain litigation charges
—
—
—
149
0.5
149
118
0.09
20.8
(Gain)/loss on minority investments (4)
—
—
—
—
—
308
305
0.23
0.6
Medical device regulations (5)
—
(81)
0.3
119
0.4
119
97
0.07
18.5
Certain tax adjustments, net (6)
—
—
—
—
—
—
299
0.22
—
Non-GAAP
$ 32,364
$ 10,980
66.1 %
$ 8,272
25.6 %
$ 8,273
$ 6,918
$ 5.20
16.0 %
Currency impact
(31)
(114)
0.3
507
1.6
0.33
Currency Adjusted
$ 32,333
$ 10,866
66.4 %
$ 8,779
27.2 %
$ 5.53
Fiscal year ended April 28, 2023
(in millions, except per share data)
Net Sales
Cost of Products Sold
Gross Margin Percent
OperatingProfit
OperatingProfit Percent
Income BeforeIncomeTaxes
Net Income attributable to Medtronic
Diluted EPS
Effective Tax Rate
GAAP
$ 31,227
$ 10,719
65.7 %
$ 5,485
17.6 %
$ 5,364
$ 3,758
$ 2.82
29.5 %
Non-GAAP Adjustments:
Amortization of intangible assets
—
—
—
1,698
5.4
1,698
1,443
1.08
15.0
Restructuring and associated costs (2)
—
(97)
0.3
647
2.1
647
507
0.38
21.5
Acquisition and divestiture-related items (7)
—
(66)
0.2
345
1.1
345
316
0.24
8.4
Certain litigation charges, net (8)
—
—
—
(30)
(0.1)
(30)
(23)
(0.02)
26.7
(Gain)/loss on minority investments (4)
—
—
—
—
—
(33)
(29)
(0.02)
(6.1)
Medical device regulations (5)
—
(88)
0.3
150
0.5
150
120
0.09
20.0
Debt redemption premium and other charges (9)
—
—
—
—
—
53
42
0.03
20.8
Certain tax adjustments, net (10)
—
—
—
—
—
—
910
0.68
—
Non-GAAP
$ 31,227
$ 10,469
66.5 %
$ 8,295
26.6 %
$ 8,194
$ 7,045
$ 5.29
13.8 %
See description of non-GAAP financial measures contained in the press release dated May 23, 2024.
(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.
(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.
(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.
(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
(6)
The net charge primarily relates to an income tax reserve adjustment associated with the June 2023, Israeli Central-Lod District Court decision and the establishment of a valuation allowance against certain net operating losses which were partially offset by a benefit from the change in a Swiss Cantonal tax rate associated with previously established deferred tax assets from intercompany intellectual property transactions and the step up in tax basis for Swiss Cantonal purposes.
(7)
The charges predominantly include non-cash pre-tax impairments, primarily related to goodwill, changes in the carrying value of the disposal group, and other associated costs, as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business; business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.
(8)
Certain litigation includes $35 million income related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.
(9)
The charges relate to the early redemption of approximately $2.3 billion of debt and were recorded within interest expense, net within the consolidated statements of income.
(10)
The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued in August 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico. Additional charges relate to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the amortization on previously established deferred tax assets from intercompany intellectual property transactions.
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)
Three months ended April 26, 2024
(in millions)
Net Sales
SG&A Expense
SG&A Expense as a % of Net Sales
R&DExpense
R&D Expense as a % of Net Sales
Other Operating(Income) Expense, net
Other Operating(Inc.)/Exp., net as a %of Net Sales
Other Non-OperatingIncome, net
GAAP
$ 8,589
$ 2,765
32.2 %
$ 675
7.9 %
$ 477
5.6 %
$ (4)
Non-GAAP Adjustments:
Restructuring and associated costs (2)
—
(28)
(0.3)
—
—
—
—
—
Acquisition and divestiture-related items (3)
—
(6)
(0.1)
—
—
(530)
(6.2)
—
Medical device regulations (4)
—
(1)
—
(9)
(0.1)
—
—
—
(Gain)/loss on minority investments (5)
—
—
—
—
—
—
—
(195)
Non-GAAP
$ 8,589
$ 2,731
31.8 %
$ 666
7.8 %
$ (52)
(0.6) %
$ (200)
Fiscal year ended April 26, 2024
(in millions)
Net Sales
SG&AExpense
SG&A Expenseas a % of Net Sales
R&DExpense
R&D Expenseas a % of Net Sales
Other Operating(Income) Expense, net
Other Operating(Inc.)/Exp., net as a % of Net Sales
Other Non-Operating Income, net
GAAP
$ 32,364
$ 10,736
33.2 %
$ 2,735
8.5 %
$ 464
1.4 %
$ (412)
Non-GAAP Adjustments:
Restructuring and associated costs (2)
—
(108)
(0.3)
—
—
—
—
—
Acquisition and divestiture-related items (3)
—
(71)
(0.2)
—
—
(606)
(1.9)
—
Medical device regulations (4)
—
(2)
—
(36)
(0.1)
—
—
—
(Gain)/loss on minority investments (5)
—
—
—
—
—
—
—
(308)
Non-GAAP
$ 32,364
$ 10,555
32.6 %
$ 2,698
8.3 %
$ (141)
(0.4) %
$ (720)
See description of non-GAAP financial measures contained in the press release dated May 23, 2024.
(1)
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and consulting expenses.
(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments. In addition, other charges primarily related to changes in fair of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.
(4)
The charges represent estimated incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.
(5)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)
Fiscal Year
(in millions)
2024
2023
2022
Net cash provided by operating activities
$ 6,787
$ 6,039
$ 7,346
Additions to property, plant, and equipment
(1,587)
(1,459)
(1,368)
Free Cash Flow (2)
$ 5,200
$ 4,580
$ 5,978
See description of non-GAAP financial measures contained in the press release dated May 23, 2024.
(1)
The data in this schedule has been intentionally rounded to the nearest million, and therefore, may not sum.
(2)
Free cash flow represents operating cash flows less property, plant, and equipment additions.
MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited)
(in millions)
April 26, 2024
April 28, 2023
ASSETS
Current assets:
Cash and cash equivalents
$ 1,284
$ 1,543
Investments
6,721
6,416
Accounts receivable, less allowances and credit losses of $173 and $176, respectively
6,128
5,998
Inventories, net
5,217
5,293
Other current assets
2,584
2,425
Total current assets
21,935
21,675
Property, plant, and equipment, net
6,131
5,569
Goodwill
40,986
41,425
Other intangible assets, net
13,225
14,844
Tax assets
3,657
3,477
Other assets
4,047
3,959
Total assets
$ 89,981
$ 90,948
LIABILITIES AND EQUITY
Current liabilities:
Current debt obligations
$ 1,092
$ 20
Accounts payable
2,410
2,662
Accrued compensation
2,375
1,949
Accrued income taxes
1,330
840
Other accrued expenses
3,582
3,581
Total current liabilities
10,789
9,051
Long-term debt
23,932
24,344
Accrued compensation and retirement benefits
1,101
1,093
Accrued income taxes
1,859
2,360
Deferred tax liabilities
515
708
Other liabilities
1,365
1,727
Total liabilities
39,561
39,283
Commitments and contingencies
Shareholders’ equity:
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,311,337,531 and 1,330,809,036 shares issued and outstanding, respectively
—
—
Additional paid-in capital
23,129
24,590
Retained earnings
30,403
30,392
Accumulated other comprehensive loss
(3,318)
(3,499)
Total shareholders’ equity
50,214
51,483
Noncontrolling interests
206
182
Total equity
50,420
51,665
Total liabilities and equity
$ 89,981
$ 90,948
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
Fiscal Year
(in millions)
2024
2023
2022
Operating Activities:
Net income
$ 3,705
$ 3,784
$ 5,062
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization
2,647
2,697
2,707
Provision for credit losses
90
73
58
Deferred income taxes
(508)
(226)
(604)
Stock-based compensation
393
355
359
Loss on debt extinguishment
—
53
—
Asset impairments and inventory write-downs
371
—
515
Other, net
573
270
138
Change in operating assets and liabilities, net of acquisitions and divestitures:
Accounts receivable, net
(391)
(576)
(477)
Inventories, net
(139)
(939)
(560)
Accounts payable and accrued liabilities
391
696
213
Other operating assets and liabilities
(345)
(148)
(65)
Net cash provided by operating activities
6,787
6,039
7,346
Investing Activities:
Acquisitions, net of cash acquired
(211)
(1,867)
(91)
Additions to property, plant, and equipment
(1,587)
(1,459)
(1,368)
Purchases of investments
(7,748)
(7,514)
(9,882)
Sales and maturities of investments
7,441
7,343
9,692
Other investing activities, net
(261)
4
(10)
Net cash used in investing activities
(2,366)
(3,493)
(1,659)
Financing Activities:
Change in current debt obligations, net
1,073
—
—
Proceeds from short-term borrowings (maturities greater than 90 days)
—
2,284
—
Repayments from short-term borrowings (maturities greater than 90 days)
—
(2,279)
—
Issuance of long-term debt
—
5,409
—
Payments on long-term debt
—
(6,012)
(1)
Dividends to shareholders
(3,666)
(3,616)
(3,383)
Issuance of ordinary shares
284
308
429
Repurchase of ordinary shares
(2,138)
(645)
(2,544)
Other financing activities
(3)
(409)
163
Net cash used in financing activities
(4,450)
(4,960)
(5,336)
Effect of exchange rate changes on cash and cash equivalents
(230)
243
(231)
Net change in cash and cash equivalents
(259)
(2,171)
121
Cash and cash equivalents at beginning of period
1,543
3,714
3,593
Cash and cash equivalents at end of period
$ 1,284
$ 1,543
$ 3,714
Supplemental Cash Flow Information
Cash paid for:
Income taxes
$ 1,622
$ 1,548
$ 996
Interest
826
606
540
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.
About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow on X and LinkedIn.FORWARD LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “going to,” “will,” and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.NON-GAAP FINANCIAL MEASURESThis press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered “non-GAAP” financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2023.Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company’s underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.
Contacts:
Erika Winkels
Ryan Weispfenning
Public Relations
Investor Relations
+1-763-526-8478
+1-763-505-4626
SOURCE Medtronic plc
Orchestra BioMed to Participate in Jefferies Global Healthcare Conference
NEW HOPE, Pa., May 22, 2024 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will present and be available for one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York, NY, June 4-6, 2024. Details of the presentation are below. Format: Fireside Chat Date: Wednesday, June 5, 2024 Time: 4:00 PM ET (Track 1) Webcast: https://wsw.com/webcast/jeff302/obio/1835536 A replay of the webcast will be available on the Events section of the Orchestra BioMed website for 90 days following the presentation. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Bob YedidLifeSci Advisors516-428-8577Bob@lifesciadvisors.com Media Contact:Kelsey Kirk-EllisOrchestra BioMed484-682-4892Kkirkellis@orchestrabiomed.com
CVRx to Present at the William Blair 44th Annual Growth Stock Conference
MINNEAPOLIS, May 22, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced that the management team will present at the William Blair 44th Annual Growth Stock Conference on Wednesday, June 5, 2024. The Company is scheduled to present at 8:40am Central Time the same day via webcast. A live audio webcast of the conference presentation will be available online at the investor relations page of the Company’s website at ir.cvrx.com. About CVRx, Inc. CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact: Laura O’NeillFinn Partners402-499-8203laura.oneill@finnpartners.com
Novo Nordisk Foundation and Technical University of Denmark press release: Bacteria in our gut could play a role in cardiometabolic disease: A new initiative aims to find out
A new Denmark-based research initiative aims to establish a potential causal link between the gut microbiome – the combined genetic material of the communities of bacteria and other microbes in the human gut – and the development of cardiometabolic diseases (CMD) such as obesity, type 2 diabetes, and cardiovascular disease. The goal is to generate knowledge that can lead to new prevention or treatment options for people living with, or at risk of, CMD.
COPENHAGEN, Denmark, May 22, 2024 /PRNewswire/ — The Novo Nordisk Foundation has committed DKK 150 million (USD 22 million) for the first phase of the Microbiome Health Initiative, a virtual research centre anchored at the Technical University of Denmark (DTU), north of Copenhagen. Professor Fredrik Bäckhed from the University of Gothenburg will be employed part-time at DTU to lead the initiative, with Professor Tine Rask Licht from DTU National Food Institute as co-Director.
Research has already shown associations between several gut bacteria or metabolites – substances produced by microbes – and CMD. In Phase 1, the initiative will therefore focus on collaborative research projects that investigate the specific effects of these bacteria or metabolites and advance understanding on how microbiome interventions could reduce the risk of CMD or help manage it. This phase will run from 2024-2028.
“Our task is to verify a causal connection between the intestinal microbiome and diseases such as cardiovascular disease and diabetes,” says Professor Licht.
“These links have been partially elucidated in laboratory trials and animal experiments, but there is yet no solid evidence of causal relationships in humans. Once we have this knowledge, the next step in the project will be to find and develop new strategies to treat or prevent these major diseases. Such new strategies will rely on modification of our gut microbiome, for example by adding new microbes, or new dietary components.”
The initiative also involves leading scientists at the University of Copenhagen, Amsterdam University Medical Centre, and the Weizmann Institute of Science in Israel, and clinicians at Odense University Hospital and Steno Diabetes Centre Copenhagen. Together, they cover a broad range of disciplines, including microbial physiology, bioinformatics, aetiology of CMD, and human interventions.
While DTU’s strength in the project is research into the impact of diet on the structure and activity of the human microbiome, the other research centres in the initiative have extensive expertise in CMD research, microbiome research, and translation into clinical settings.
“The interdisciplinary approach of the project makes it possible to coordinate research between the strongest international environments,” says Professor Bäckhed. “It is unique that we can coordinate efforts between universities and hospitals to develop the most promising treatment concepts.”
‘A whole new set of tools’Despite major advances in research and treatment, the prevalence of CMD has doubled in the last 30 years. This group of conditions – including obesity and type 2 diabetes – and associated complications such as heart attack and stroke are now the leading cause of death worldwide.
Also in the last years, advances in microbiome research have led to new understanding regarding the impact of microbes and their metabolic output on human physiology, immunity, and disease processes. In the case of CMD, evidence strongly suggests that the gut microbiome – partly due to the metabolites the microbes produce – plays a critical role, and that by making small changes, individuals could reduce their risk of, for example, developing diabetes or suffering a heart attack. This initiative aims to generate significant new knowledge that, in the future, could lead to approved microbiome-based solutions such as supplements or improved dietary guidance to prevent or treat CMD.
“The Danish microbiome research field is strong but, in order to take the critical next steps, we need an ambitious, interdisciplinary approach that also includes leading international experts,” says Birgitte Holst, Scientific Director in Medical Science at the Novo Nordisk Foundation.
“If this initiative succeeds in establishing a causal link between the microbiome and CMD, it could lead to a whole new set of tools for managing these devastating diseases and help resolve a major global health challenge.”
Phase 2, which is subject to approval following a mid-term evaluation of Phase 1, would run from 2026-2030. In this phase, the initiative would support human intervention studies and invest in infrastructure to support the development of microbes, microbial compounds, or targeted supplements for therapeutic purposes.
Editor’s Notes
About DTU National Food Institute
DTU National Food Institute conducts research into and disseminates – through advice, innovation and teaching – sustainable and value-creating solutions in the area of food and health for the benefit of society. The DTU National Food institute’s vision is to make a difference by generating future prosperity through research into food and health. The institute prevents disease and promotes health, develops new and better food products for a growing population and creates sustainable technological solutions. The institute’s tasks are carried out in a unique interdisciplinary cooperation in e.g. nutrition, chemistry, toxicology, microbiology, epidemiology, modelling and technology.
About the Novo Nordisk Foundation
Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people’s health and the sustainability of society and the planet. The Foundation’s mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society.
www.novonordiskfonden.dk/en
SOURCE Novo Nordisk Foundation



