ALR Technologies Inc. ("ALRT") (OTCQB: ALRT), the diabetes management company, is pleased to announce an update with respect to its migration to Singapore. Further to its Form 8-K filed May 20, 2022, and press release issued May 20, 2022, the Registration Statement on Form F-4 filed by its affiliate, ALR Technologies SG Ltd. ("ALRT Singapore"), has been declared effective by the Securities and Exchange Commission (the "SEC"). ALRT anticipates mailing the corresponding prospectus and information statement to its stockholders on or around October 4, 2022. ALRT expects to consummate the previously announced reincorporation merger in which ALRT will become a wholly owned subsidiary of ALRT Singapore as soon as practicable following the required 20-day waiting period subsequent to mailing of the prospectus and information statement, subject to the satisfaction of customary closing conditions, including certain regulatory approvals from FINRA, the OTC Markets Group, ACRA (Singapore), and the Secretaries of State of Nevada and Delaware.
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ALR Technologies Announces Reincorporation Merger
ALR Technologies Inc. ("ALRT USA") (OTCQB: ALRT), the diabetes management company, today announces that further to its release on June 1, 2021, ALRT USA has entered into an Agreement and Plan of Merger and Reorganization (the "Reincorporation Merger Agreement") with ALR Technologies SG Pte. Ltd., a Singapore company limited by shares ("ALRT Singapore"), and its wholly-owned subsidiary, ALRT Delaware, Inc., a Delaware corporation ("ALRT Delaware"), relating to a proposed merger transaction (the "Reincorporation Merger") for the purpose of changing the jurisdiction of incorporation of ALRT USA from Nevada to Singapore.
The Reincorporation Merger will consist of a one-for-one share exchange, where at closing of the transaction, ALRT Delaware will merge with and into ALRT USA, and ALRT USA will be the surviving entity and a wholly-owned subsidiary of ALRT Singapore. ALR Delaware will then cease to exist. At closing, the stockholders of ALRT USA will exchange their shares of common stock, and any options or warrants to purchase shares of common stock which they might hold, on a one-for-one basis, for ordinary shares ("ALRT Singapore Ordinary Shares") and options or warrants to subscribe for ALRT Singapore Ordinary Shares, as applicable. The shareholders of ALRT USA prior to the transaction will have the same number of shares and same proportionate ownership of ALRT Singapore as held in ALRT USA. The parties to the Reincorporation Merger expect that the ALRT Singapore Ordinary Shares will trade on the OTCQB subsequent to the close of the transaction.
The Reincorporation Merger Agreement has been approved by the board of directors of ALRT USA. The transaction has also been approved by the majority shareholders of ALRT USA, subject to dissemination to all shareholders of the Company, and a 20-day waiting period after dissemination, of an Information Statement explaining in detail the terms of the transaction to all shareholders of ALRT USA (the "Information Statement"). The Information Statement will also include a prospectus relating to the ALRT Singapore Ordinary Shares to be received by shareholders of ALRT USA (the "Prospectus"). The proposed forms of the Information Statement and Prospectus are included in a registration statement on Form F-4 to be filed by ALRT Singapore with the US Securities and Exchange Commission (the "SEC"), and completion of the transaction is subject to the effectiveness of the registration statement, and other customary closing conditions. To effect the Reincorporation Merger, the following related events have been approved by the Board of Directors and majority shareholders of ALRT USA:
- Solely for the purpose of facilitating the merger, and to meet requirements of Singapore Law, ALRT USA has transferred its ownership of its existing subsidiary, ALRT Singapore, to an entity controlled by Sidney Chan.
- ALRT Singapore has incorporated ALRT Delaware as a new subsidiary, also for the express purpose of facilitating the Reincorporation Merger.
- ALRT USA, ALRT Singapore, and ALRT Delaware have entered into the Reincorporation Merger Agreement.
"The Reincorporation Merger Agreement is necessary to complete our corporate migration to Singapore," said Sidney Chan, Chairman and CEO of ALR Technologies. "Singapore has established itself as a business epicenter and redomiciling ALRT to Singapore will better position the Company to achieve a stronger global presence. Over the last 7 years, the Company has increased its presence in Singapore and Southeast Asia in response to their publicized commitments to battle the plague of diabetes. We are working with Diabetes Singapore and Singapore General Hospital with respect to human health initiatives. Furthermore, better access to businesses and skilled personnel in Singapore and neighboring countries are key drivers for the migration, and we believe we will be better positioned to receive government support as a Singapore domiciled enterprise."
To effect the Reincorporation Merger Agreement and to close the transaction, the parties to the transaction will require clearance from the SEC, regulatory approvals from FINRA, the OTC Markets Group, ACRA (Singapore), Secretary of State of Nevada, and Secretary of State of Delaware. Upon effectiveness of the registration statement from the SEC, ALRT USA intends to disseminate the final form of Information Statement and Prospectus to all of its shareholders, and to close the Reincorporation Merger after completing the required 20 day waiting period after dissemination.
As previously announced, ALRT USA and ALRT Singapore continue to evaluate listing possibilities on additional or alternative share trading exchanges, including the NYSE American Exchange, and intends to apply for listing when and if qualified.
About ALR Technologies Inc.
ALRT USA is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT USA has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
On June 1, 2021, ALRT USA announced its intention to migrate to Singapore. More information about the company can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com.
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT USA with the SEC. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The forward-looking statements included in this news release are made as of the date hereof. ALRT USA disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
ALR Technologies Announces Update to Singapore Migration Merger and GluCurve Pet CGM Commercialization
ALRT further announces the proposed distribution agreement between ALRT Singapore and a leading animal health company for the commercialization of the GluCurve Pet CGM previously anticipated in September is now expected to be completed in the fourth quarter of 2022.
"We have a very strong relationship with both our hardware manufacturer and the leading animal health company we're working with on a distribution agreement for the GluCurve. After much discussion and consideration, we have decided to push back the commercialization date to later in Q4," explained Joe Stern, Head of Animal Health at ALRT and ALR Singapore. "The GluCurve production line is up and running, but our manufacturer has experienced delays before final testing can occur and our completed distribution agreement can be signed. During this time, we will continue to work closely with our planned partner on marketing content, strategy, and execution of the launch."
Mr. Stern concludes, "We believe this extra time will contribute to a stronger and more successful launch in the coming months. We have universally received fantastic feedback on both the product and its need in the marketplace, and we look forward to providing more updates in the near future."
About the GluCurve Pet CGM
The GluCurve Pet CGM is a Continuous Glucose Monitoring System for diabetic cats and dogs, consisting of an Applicator, Sensor, Transmitter, GluCurve App, and Veterinary Web Portal.
The Sensor is located inside the Applicator and once applied to a pet, the Sensor Electrode chemically reacts with glucose in the hypodermic interstitial fluid to generate an electrical signal. The electrical signal is analyzed to generates blood glucose values, which are sent to the GluCurve App where it is displayed for the pet owner and uploaded to the Veterinary Web Portal.
The GluCurve Pet CGM measures glucose levels every 3 minutes for a total of 480 readings each day, for up to 14 days. The monitor is equipped with built in memory that can store all 14 days of data to prevent the loss of readings when the pet owner is away from their pet. In addition, insulin injections and feeding times can be input into the GluCurve App which uploads the data to the Veterinary Web Portal. Inside the Veterinary Web Portal, glucose readings are organized into time saving graphs and tables with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more.
About ALR Technologies Inc.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes.
In addition, the animal health division of ALRT has developed the GluCurve Pet CGM, a solution to assist veterinarians better determine the efficacy of insulin treatments and to help to identify the appropriate dose and frequency of administration for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
More information about ALRT can be found at www.alrt.com .
About ALR Technologies SG Ltd.
ALRT Singapore is an affiliate of ALRT and is seeking to commercialize the GluCurve Pet CGM. More Information regarding ALRT Singapore can be found at https://sg.alrt.com .
Cautionary Statement Regarding Forward-Looking Statements
Regarding ALRT Singapore
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the Registration Statement on Form F-4 filed by ALRT Singapore with the SEC on September 15, 2022, other risks and uncertainties listed from time to time in documents filed with the SEC, and the following factors: ALRT Singapore's operation as a development-stage company with limited operating history and a history of operating losses; the need for substantial additional funding to continue the development of ALRT Singapore's product candidates before it can expect to become profitable from sales of its products and the possibility that it may be unable to raise additional capital when needed; the outcome of ALRT Singapore's review of strategic options and of any action that it may pursue as a result of such review; the chance that ALRT Singapore may become exposed to costly and damaging liability claims resulting from the testing of its product candidates in the clinic or in the commercial stage; the chance that ALRT Singapore's clinical trials may not be completed on schedule, or at all, as a result of factors such as delayed enrollment or the identification of adverse effects; uncertainty surrounding whether any of ALRT Singapore's product candidates will receive the regulatory approval necessary for commercialization; if ALRT Singapore's product candidates obtain regulatory approval, its product candidates being subject to expensive, ongoing obligations and continued regulatory overview; enacted and future legislation may increase the difficulty and cost for ALRT Singapore to obtain marketing approval and commercialization; dependence on governmental authorities and health insurers establishing adequate reimbursement levels and pricing policies; ALRT Singapore's products may not gain market acceptance, in which case ALRT Singapore may not be able to generate product revenues; ALRT Singapore's reliance on its current strategic relationships and the potential success or failure of strategic relationships, joint ventures or mergers and acquisitions transactions; ALRT Singapore's reliance on third parties to conduct its non-clinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; ALRT Singapore's ability to obtain, maintain and protect its intellectual property rights and operate its business without infringing or otherwise violating the intellectual property rights of others; ALRT Singapore's ability to comply with the requirements under applicable loan facilities, including repayment of amounts currently outstanding and overdue, and amounts outstanding when due; ALRT Singapore's ability to qualify for quotation and remain on the OTCQB as a trading market for its common stock; the chance that certain intangible assets related to ALRT Singapore's product candidates will be impaired; the occurrence of any event, change or other circumstances that could give rise to the right of ALRT Singapore or ALRT to terminate the merger agreement; the outcome of any legal proceedings that may be instituted against ALRT Singapore or ALRT; the failure to satisfy any of the remaining conditions to the closing of or otherwise consummate the reincorporation merger on a timely basis or at all; the possibility that the anticipated benefits of the reincorporation merger are not realized when expected or at all, including as a result of the impact of, or problems arising as a result of the strength of the economy and competitive factors in the areas where ALRT Singapore and ALRT do business; the possibility that the reincorporation merger may be more expensive to complete than anticipated, including as a result of unexpected factors or events; diversion of management's attention from ongoing business operations and opportunities; potential adverse reactions or changes to business or employee relationships, including those resulting from the announcement or completion of the reincorporation merger. ALRT Singapore can give no assurance that any goal or plan or expectation set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements. The forward-looking statements are made as of the date of this communication, and ALRT Singapore does not intend, and assumes no obligation, to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events or circumstances, except as required by applicable law.
Regarding ALRT
With respect to ALRT, stockholders are cautioned that any forward-looking statements that relate to time periods before the closing of the reincorporation merger, as identified through the use of words or phrases as noted above, including statements regarding the expected timing of the closing of the reincorporation merger, are subject to risks, assumptions and uncertainties that are difficult to predict. Although ALRT believes that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements. Such factors include, without limitation, the "Risk Factors" referenced in ALRT's definitive information statement related to the reincorporation merger and filed with the SEC on September 29, 2022, and its other SEC filings, including its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and the following factors: the occurrence of any event, change or other circumstances that could give rise to the right of ALRT Singapore or ALRT to terminate the merger agreement; the outcome of any legal proceedings that may be instituted against ALRT Singapore or ALRT; and the failure to satisfy any of the remaining conditions to the closing of the reincorporation merger on a timely basis or at all. The forward-looking statements are made as of the date of this communication, and ALRT does not intend, and assumes no obligation, to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events or circumstances, except as required by applicable law.
Important Additional Information
This news release is being made in respect of the pending reincorporation merger involving ALRT and ALRT Singapore. As described above, in connection with the pending reincorporation merger ALRT Singapore filed with the SEC a Registration Statement on Form F-4, which has been declared effective by the SEC (the "Registration Statement"), which included a preliminary information statement of ALRT and a prospectus of ALRT Singapore (the "Information Statement/Prospectus"). It is anticipated that the definitive Information Statement/Prospectus will be mailed or otherwise delivered to the stockholders of ALRT on or about October 4, 2022. Stockholders are urged to read the Registration Statement and Information Statement/Prospectus and any other relevant documents filed with the SEC, as well as any amendments or supplements to those documents, because they will contain important information.
This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Stockholders are able to obtain a free copy of the Registration Statement and Information Statement/Prospectus, as well as other filings containing information about ALRT and ALRT Singapore, without charge, at the SEC's website (https://www.sec.gov). Copies of the Registration Statement and Information Statement/Prospectus and the filings with the SEC incorporated by reference therein can also be obtained, without charge, by directing a request to ALR Technologies Inc., 7400 Beaufont Springs Drive, Suite 300, Richmond, Virginia 23225, Attention: Corporate Secretary.
Contact Information
ALR Technologies Inc.
Investor Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone US: +1 804 554 3500
Phone Singapore: +65 3129 2924
ALR Technologies SG Ltd.
Investor Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone US: +1 804 554 3500
Phone Singapore: +65 3129 2924
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Announces Update on the GluCurve Pet CGM Distribution and Commercialization
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces a distribution agreement with a global leader in animal health is now anticipated to be complete in September. The delay from the previous target of late August is not expected to affect commencement of commercialization. Furthermore, the Company has placed its first Purchase Order ("PO") for the GluCurve Pet CGM hardware with delivery scheduled for October.
"Finalizing a distribution partnership is taking longer than initially projected, but we believe we'll have it completed soon. Consequently, we have placed our first PO to ensure we begin selling in October," commented Joe Stern, Head of Animal Health at ALRT. "We are very happy with how things are progressing, we are in the process of securing booths at the Consumer Electronics Show which is the most influential tech event in the world, and the Veterinary Meeting & Expo (VMX) which is the largest veterinary conference in the world. We have also been identifying KOLs to work with on publications, case studies, testimonials, etc. to lay the foundation for our marketing plan. We want to thank our shareholders for their patience, and we look forward to sharing more details in the near future."
About the GluCurve Pet CGM
The GluCurve Pet CGM is a Continuous Glucose Monitoring Systems for diabetic cats and dogs, consisting of an Applicator, Sensor, Transmitter, GluCurve App, and Veterinary Web Portal.
The Sensor is located inside the Applicator and once applied to a pet, the Sensor Electrode chemically reacts with glucose in the hypodermic interstitial fluid to generate an electrical signal. The electrical signal is analyzed to generates blood glucose values, which are sent to the GluCurve App where it is displayed for the pet owner and uploaded to the Veterinary Web Portal.
The GluCurve Pet CGM measures glucose levels every 3 minutes for a total of 480 readings each day, for up to 14 days. The monitor is equipped with built in memory that can store all 14 days of data to prevent the loss of readings when the pet owner is away from their pet. In addition, insulin injections and feeding times can be inputted into the GluCurve App which uploads the data to the Veterinary Web Portal. Inside the Veterinary Web portal, glucose readings are organized into time saving graphs and tables with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more.
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTCQB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed early in the fourth quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about the ALR Technologies Inc. can be found at www.alrt.com . Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone (US): +1 804 554 3500
Phone (Singapore): +65 3129 2924
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. Forward-looking statements include, but are not limited to, representations to the effect that the Company will finalize the distribution agreement, if finalized that the delay will not impact the commercialization schedule, the Company will have supply of the CGM hardware from its supplier and the Redomicile Merger will close early in the fourth quarter of 2022.There can be no assurance that such statements included within this news release will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Announces First Shipment of GluCurve Pet CGMs Expected in October and Update on the Manufacturing Agreement
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces the Company has received manufacturing approval from Infinovo Medical Co., Ltd. ("Infinovo") to place the first purchase order ("PO") for the GluCurve Pet CGM with an expected delivery date of October 2022. Furthermore, the manufacturing and supply agreement with Infinovo was subject to certain closing conditions, including entering into a binding sales and distribution agreement for the GluCurve Pet CGM by July 31, 2022. Both parties agreed to let that agreement terminate and are now working on completing a new agreement under the same terms, extending the closing condition for ALRT to enter into a binding sales and distribution agreement for GluCurve to August 31, 2022.
"We have agreed in principle on the key terms for a global sales and distribution agreement with a leading animal health company," commented Joe Stern, Head of Animal Health at ALRT. "The last step in their due diligence process is to evaluate the GluCurve Pet CGM internally by using it on their own sample of customers and their respective pets. This step is taking longer than we initially projected due to scheduling delays. After discussing the delays with Infinovo we agreed it would be in both parties' best interest to complete a new contract extending the date of the closing condition for a sales and distribution agreement date to August 31, 2022. Based on our non-inferiority study results earlier this year, we do not expect this delay to alter our commercialization schedule and will provide further updates on timing and details of the initial launch upon the execution of the global sales and distribution agreement."
The GluCurve Pet CGM is the first and only continuous glucose monitoring system for diabetic cats and dogs. Veterinarians can quickly apply the monitor onto pets before sending them home where glucose levels are remotely recorded every 3 minutes and securely uploaded to the ALRT cloud. In the cloud, the data is analyzed and organized into time saving graphs and tables that are displayed in the veterinarian's patient management portal along with additional features such as glucose curve comparisons and overlays, insulin dose calculators, best practice guidelines, and more. The pet owner will also have access to live time glucose readings and graphs through the GluCurve app for iOS and Android.
ALRT is pleased to announce an updated investors presentation has been uploaded to the investor relations section of their website and can be viewed at https://www.alrt.com/investors .
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about ALR Technologies Inc. can be found at www.alrt.com . Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Email Investor Relations: ir@alrt.com
Email Animal Health Inquiries: animalhealth@alrt.com
Phone (US): +1 804 554 3500
Phone (Singapore): +65 3129 2924
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. There can be no assurance that such statements included within this news release will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Specifically, there is no assurance the Company will enter into a new manufacturing agreement with Infinovo, enter into a global sales and distribution agreement with a leading animal health company, or that such sales and distribution agreement will be executed in time to meet the closing conditions for the Manufacturing and Supply Agreement with Infinovo The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
News Provided by GlobeNewswire via QuoteMedia
ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware
ALR Technologies SG Pte. Ltd ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, announces the completion of a definitive manufacturing agreement with Infinovo Medical Co. Ltd ("Infinovo") to manufacture and supply the Continuous Glucose Monitor ("CGM") hardware that will be utilized as part of the ALRT GluCurve Pet CGM (the "Manufacturing Agreement"). The Manufacturing Agreement gives ALRT the exclusive global rights to distribute the Infinovo CGM hardware for the animal health market, providing long-term production and supply. Subject to the satisfaction of all closing conditions it is expected that initial deliveries of product by Infinovo will be made during Q4 of 2022
"Executing the Manufacturing Agreement with Infinovo marks another major milestone in our path to commercialization and profitability," comments Sidney Chan, Chairman and CEO of ALRT. "Our next targeted milestone is securing distribution for the ALRT GluCurve Pet CGM. We have been working with many of the largest global distributors and pharmaceutical companies in animal health, evaluating different distribution opportunities ranging from joint venture partnerships to sales and distribution agreements. We believe we have narrowed in on the right company and right deal structure to best bring value to our shareholders and to those who care for diabetic pets. We hope to announce the details of this pivotal next step in the near future."
The Manufacturing Agreement is subject to certain closing conditions including the completion of a distribution agreement with a third party by July 31, 2022.
About Infinovo Medical Co. Ltd
Founded in 2016, Infinovo is an innovative medical technology company, focusing on developing an accurate and affordable CGM for patients which will be available for both Type 1 and Type 2 Diabetics. https://www.infinovo.com/
ALR Technologies SG Pte. Ltd.
ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans.
ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol "ALRT". On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company's jurisdiction of incorporation from Nevada to Singapore (the "Redomicile Merger Agreement"). The Redomicile Merger Agreement is subject to the required approval of the Company's stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.
More information about the ALR Technologies Inc. can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking statements and information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events, or the negative of these terms, are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks include all risks and uncertainties expressed in the cautionary statements and risk factors in the annual report on Form 10-K and other filings of ALRT with the SEC. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Forward-looking statements include representations to the effect that the Company will receive initial deliveries of product from Infinovo in Q4 2022 and that the Redomicile Merger will close in Q3 2022. The forward-looking statements included in this news release are made as of the date hereof. ALRT disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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ALR Technologies Announces Completion of Pivotal Non-Inferiority Study on the GluCurve Pet CGM
ALR Technologies Inc. ("ALRT" or the "Company") (OTCQB: ALRT), the diabetes management company, today announced successful results from the conclusion of the non-inferiority study conducted on the GluCurve Pet CGM which was previously announced on February 10, 2022 and February 28, 2022. GluCurve is the first of its kind Continuous Glucose Monitor (CGM) specifically for diabetic cats and dogs.
Notable findings from the study:
- Utilizing a chemistry analyzer as the baseline, the GluCurve Pet CGM was more accurate than the leading Blood Glucose Meter (BGM) for animals 47.8% of the time.
- 100% of the GluCurve Pet CGM readings paired to the chemistry analyzer reference values were within ±20%, compared to 86.9% from the animal BGM
- The GluCurve Pet CGM's average deviation from the baseline was 9.7% compared to 8.2% from the animal BGM.
- No clinically significant differences were found when comparing the GluCurve Pet CGM to the chemistry analyzer or leading animal BGM.
- GluCurve displayed otherwise unavailable data on insulin injection times, eating habits, activity, and stress seen through changes in glucose on a day-to-day basis.
Dr. Imperato, lead veterinarian in the study commented, "The GluCurve Pet CGM plugs a long-standing gap in managing veterinary diabetic patients; not only will veterinarians finally receive effortlessly accurate data, the patients will live longer too."
"The non-inferiority study further demonstrates the significant need for GluCurve in veterinary medicine. The in-home data collected is invaluable to veterinarians and by analyzing and organizing it into effective patient management it greatly reduces the effort and time needed by clinicians to treat diabetic pets," said Sidney Chan, Chairman and CEO of ALR Technologies. "Now that we have the successful results of the non-inferiority study, a MOU for manufacturing with a definitive agreement in the works, and conducted preliminary discussions with the leading animal health pharmaceutical companies, we are well positioned to start realizing the full potentials of ALRT. We will now focus our attention on completing a partnership agreement in the near future to commercially launch GluCurve Pet CGM in a meaningful way in Q3 2022."
About ALR Technologies
ALR Technologies is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes: an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices; a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and will expand its services to cover other chronic diseases anchored on verifiable data.
In addition, the animal health division has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals. Thus, delivering the same optimization of diabetic drug therapies to pets as to humans.
On June 1, 2021, ALR Technologies Inc. announced its intention to migrate to Singapore. More information about ALR Technologies Inc. can be found at www.alrt.com. Information regarding ALR Technologies SG Pte. Ltd. can be found at https://sg.alrt.com .
Contact
Ken Robulak (US)
Phone: +1 (727) 736-3838
Anthony Ngai (Singapore)
Phone: +65 3129 2924
Email: ir@alrt.com
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
This news release includes certain "forward-looking statements" as defined under applicable securities legislation. All information and statements contained herein that are not clearly historical in nature constitute forward-looking information, and the words "anticipate", "estimate", "believe", "continue", "could", "expect", "intend", "plan", "postulates", "predict", "will", "may" or similar expressions suggesting future conditions or events or the negative of these terms are generally intended to identify forward-looking information. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Specifically, that the Company will enter into partnership to launch GluCurve Pet CGM, that GluCurve Pet CGM will launch in Q3 2022 or thereafter. The forward-looking statements included in this news release are made as of the date hereof. ALR Technologies disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Thermo Fisher Scientific to Present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, chairman, president and chief executive officer, will present at the Morgan Stanley 22 nd Annual Global Healthcare Conference on Thursday, September 5, 2024 at 8:30 a.m. (EDT).
You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com .
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240828108284/en/
Media Contact Information:
Sandy Pound
Thermo Fisher Scientific
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
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Medtronic chairman and CEO Geoff Martha to speak at the Wells Fargo Healthcare Conference
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it will participate in the 2024 Wells Fargo Healthcare Conference on Wednesday, September 4, 2024 .
Geoff Martha , Medtronic chairman and chief executive officer, will answer questions on the medtech industry and on the company beginning at approximately 11:55 a.m. EDT ( 12:55 p.m. CDT ).
A live webcast of the Q&A session will be available on September 4, 2024 , by clicking on the Events link at http://investorrelations.medtronic.com . An archive of the session will be available on the same webpage later in the day.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , 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 more than 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, visit www.Medtronic.com and follow on LinkedIn .
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
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SOURCE Medtronic plc
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Appendix 4E and 2024 Annual Report
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This article includes content from Cleo Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Artrya on Track for FDA Application Submission Following Second Q-Submission Meeting
Artrya Limited (ASX:AYA), (‘Artrya’ or the ‘Company’), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has received feedback its application for regulatory approval for the Salix product with the US Food and Drug Administration (FDA) is on track following a Q-Submission meeting.
Highlights
- Feedback and guidance were received during a second Q-Submission meeting held on the evening of 19 August 2024
- Artrya received feedback its application for regulatory approval for Salix product with the US FDA is on track
- Artrya plans to submit the 510(k) application to the FDA in the coming weeks.
A Q-sub is a formal written request from a company for feedback from the FDA to help guide application preparation. Artrya had requested this second meeting to validate and confirm the approach taken since the first Q-Sub meeting in June 2023.
Artrya CEO Mathew Regan said: "I am pleased to report the outcome of our second Q-sub meeting with the FDA was positive. The FDA provided valuable feedback and guidance on our upcoming application, confirming our approach is on track. This has validated the cautious approach we have taken to ensure we meet all requirements for the 510(k) application. We now have a clear path to submission, and I look forward to lodging our 510(k) application once the formal Q-Sub process is completed.”
Click here for the full ASX Release
This article includes content from Artrya Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Medtronic: Technology Bias Is Real. Here's What We're Doing To Fix It
MedtronicMedtronic has taken measurable steps to drive change
Doctors have used pulse oximeters for more than 40 years, but the pandemic put the devices in the spotlight after studies found they may not be accurate across all skin tones.
"What we saw during the pandemic was health disparities," said Bradley, who works in sales in the Acute Care & Monitoring (ACM) business at Medtronic. "We recognize that patients of color were not faring as well as their lighter skin counterparts."
In her presentations, Bradley, the mother of a multiracial daughter, elaborates on why the devices can sometimes fall short. She calls it "technology bias."
There's a lot we still don't understand about what drives that bias, but we know low perfusion, or the flow of blood to cells and tissues, along with skin pigmentation, and user error, are at the core.1
While our pulse oximeter, Nellcor™, has delivered monitoring solutions for decades, Medtronic can do better, ACM President Frank Chan said. It's why the company has taken measurable steps to drive change, such as participating in a U.S. Food and Drug Administration panel on the accuracy of pulse oximeters and opening a physiology lab in a racially diverse neighborhood to ensure inclusive clinical trial enrollment and participation.
"We saw all the studies coming out of the pandemic around equity and pulse oximetry and delivering safe care," said Chief Medical Officer for ACM Dr. Sam Ajizian. "We accelerated our work. In doing so, we aim to do the right thing for the patient."
What is a pulse oximeter?
Dr. Ajizian was a young physician when pulse oximeters were first introduced to the marketplace. They were a "transformative" tool that removed the guesswork in measuring the amount of oxygen in a patient's blood - and alerting doctors when more may be needed.
If you've had surgery, ridden in an ambulance, or even visited a clinic, chances are a pulse oximeter has been clipped to the end of your finger.
"It's kind of magical to be able to take something on the outside of the body and use it to measure how much oxygen is going to the tissue that's contained in the blood on the inside of the body," Dr. Ajizian said.
While pulse oximeters are essential to patient safety, not all are created equal. In a recent study enrolling healthy volunteers to measure the effects of skin pigmentation and perfusion index on pulse oximeter accuracy, one of the company's competitor's devices, for example, missed 30% of hypoxemic events, or when there's an abnormally low amount of oxygen in the blood. Nellcor™ pulse oximeters, on the other hand, missed 7.9%, said Vice President of Research & Development for ACM Jason Case.1
"The goal isn't to be better than everyone else," Case said. "The goal is to provide a solution that works for everybody. How do we get that 7.9% to zero, independent of if you have thick skin, dark skin, or low perfusion?"
Walking the walk
The commitment to getting it right - every time - is why the company opened a clinical physiology lab near the Five Points neighborhood of Denver, Colorado. It's a racially diverse area where community members can easily access the unassuming lab, which is embedded within a larger medical complex. Many trial participants walk to the lab from their homes.
"We decided to locate this lab in Denver, away from the central offices of Medtronic, and it has proven to be the right choice," said Lab Manager Roger Martin-Pressman. "To make it convenient for people from diverse backgrounds to access these research opportunities was really important to me."
The lab empowers the company to conduct its own clinical trials, meaning it can test devices with more speed and frequency and, in turn, innovate quickly. "We really want devices to get better based on the data we collect here," Martin-Pressman said. "And not just better so clinicians understand how to use them, but also better so that people who wear them have better outcomes."
The larger, more diverse data set being collected at the lab is critical to research and development work at Medtronic, Case said. It ensures we're approaching our work with equity before it leaves the innovation lab.
Building trust
Obioma Nwankwo is a clinical studies coordinator for the clinical physiology lab in Denver. She recruits trial participants and often leads engagement events in the community, such as hosting booths at the city's Juneteenth festival, to build trust within the community and educate about the trials and our commitment to health equity.
"Sometimes the end goal is not always getting someone in the chair and having them come and do the study," Obioma said. "Sometimes the end goal is just spreading awareness, or having a conversation."
But the community is responding; trial enrollment continues to tick upward. The lab has already enrolled more than 130 participants and will continuously recruit. The opportunity to be part of a clinical trial that could improve device accuracy across all skin pigmentations was a driving factor for Zahra Abdullahi to enroll.
"As a minority in the healthcare system, a lot of things are overlooked," said Abdullahi, a college student studying engineering. "I'm doing this not only for my safety, but for others' as well. I have siblings and friends who are also minorities and making sure they have accurate representation in healthcare is very important."
Lasting change
When Bradley first began her career in 1991, working as a respiratory therapist for neonatal and pediatric patients, she would have argued there weren't health disparities in her work.
"When I look retrospectively on it, I recognize that's not true, there probably always were some biases," she said, adding anyone who wants to be "intellectually honest" would agree there are disparities in the access and provision of healthcare.
Even though the Medtronic pulse oximetry device meets all current FDA standards, those questions about health equity are spurring broader change, and Medtronic is making meaningful contributions.
"I'm proud that Medtronic has taken a stance to say that's not good enough," Bradley said.
Not to mention, it's just the right thing to do, said Martin-Pressman, the lab manager.
"Equality is giving everybody the same opportunity, but equity is ensuring the outcome is the same," he said.
Ronda Bradley, left, with her family.
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Contact Info:
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Email: info@3blmedia.com
SOURCE: Medtronic
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Medtronic reports first quarter fiscal 2025 financial results
Product innovation driving growth across diversified health tech portfolio, including Automated Insulin Delivery, Transcatheter Aortic Valve Replacement, Pulsed Field Cardiac Ablation, Pain Stimulation, and Deep Brain Stimulation
- Medtronic plc (NYSE: MDT) today announced financial results for its first quarter (Q1) of fiscal year 2025 (FY25), which ended July 26, 2024 .
Key Highlights
- Revenue of $7.9 billion , adjusted revenue of $8.0 billion , increased 2.8% as reported and 5.3% organic
- GAAP diluted earnings per share (EPS) of $0.80 ; non-GAAP diluted EPS of $1.23
- Company increases FY25 organic revenue growth and EPS guidance
- Multiple franchises delivering, with growth acceleration in Cardiac Ablation Solutions and Neuromodulation and continued strength in Spine, Structural Heart, and Diabetes
Financial Results
Medtronic reported Q1 worldwide revenue of $7.915 billion and adjusted revenue of $8.004 billion , an increase of 2.8% as reported and 5.3% on an organic basis. Organic revenue growth comparison excludes:
- Other revenue of - $52 million in the current year and $50 million in the prior year; and
- Foreign currency translation of - $90 million on the remaining segments.
As reported, Q1 GAAP net income and diluted earnings per share (EPS) were $1.042 billion and $0.80 , respectively, representing increases of 32% and 36%, respectively. As detailed in the financial schedules included at the end of this release, Q1 non-GAAP net income and non-GAAP diluted EPS were $1.592 billion and $1.23 , respectively, representing flat results and an increase of 3%, respectively. Included in Q1 non-GAAP diluted EPS was a -6 cent impact from foreign currency translation. Non-GAAP diluted EPS grew 8% on a constant currency basis.
"We executed, exceeded our commitments, and delivered another good quarter. Our underlying markets are healthy, we're driving operating rigor, and new product innovation is fueling diversified growth across key health tech markets," said Geoff Martha , Medtronic chairman and chief executive officer. "As we deliver innovation and execute on our transformation, we expect this to translate into strong returns for our shareholders."
Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.007 billion increased 5.5% as reported and 6.9% organic, with high-single digit increases in CRHF and SHA, and a mid-single digit increase in CPV, all on an organic basis.
- CRHF results included high-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Defibrillation Solutions and low-double digit growth in Cardiac Pacing Therapies, including low-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions grew mid-single digits on strong growth of the PulseSelect™ pulsed field ablation (PFA) system
- SHA results driven by low-double digit Cardiac Surgery and high-single digit Structural Heart growth, excluding Congenital
- CPV delivered high-single digit Coronary growth with strength in guide catheters and balloons; Peripheral Vascular Health grew low-single digits, with high-single digit growth in drug-coated balloons and low-single digit growth in endoVenous products
- Evolut™ FX+ TAVR system limited U.S. commercial release initiated during the quarter; full market release now underway
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.317 billion increased 4.4% as reported and 5.3% organic, with a low-double digits increase in Neuromodulation, a mid-single digit increase in CST, and a low-single digit increase in Specialty Therapies, all on an organic basis.
- CST performance driven by continued adoption of the AiBLE™ ecosystem of spine implants and enabling technology, with high-single digit growth in both Core Spine and Biologics
- Specialty Therapies results driven by mid-single digit growth in Neurovascular with continued strength in hemorrhagic stroke products; Pelvic Health increased low-single digits on continued adoption of the InterStim X™ system; ENT grew low-single digits on strength in capital and localized drug delivery sinus implants
- Neuromodulation drove above market performance, with mid-teens growth in Brain Modulation on the continued launch of the Percept™ RC deep brain stimulator (DBS) with BrainSense™ technology; Pain Therapies grew high-single digits, including low-double digit growth in Pain Stim on the U.S. launch of the Inceptiv™ spinal cord stimulator
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $1.996 billion decreased 0.4% as reported and increased 1.0% organic, with a low-single digit increase in SE and flat result in ACM, both on an organic basis.
- SE results included low-single digit growth in both Advanced Surgical Technologies and General Surgical Technologies, and low-single digit growth in Endoscopy, driven by strength in Endoflip™ and GI Genius™ sales
- ACM performance included low-single digit growth in Blood Oxygen Management
Diabetes
Revenue of $647 million increased 11.8% as reported and 12.6% organic.
- U.S. revenue grew mid-teens on the continued adoption of the MiniMed™ 780G automated insulin delivery (AID) system, including low-thirties CGM growth driven by very high CGM attachment, high-single digit pump growth, and a return to growth in consumables
- International revenue grew low-double digits on increasing CGM attachment rates and the continued roll-out of Simplera Sync™
- Received FDA approval of Simplera™ CGM and announced global partnership with Abbott to complement future Medtronic integrated CGM offerings
Guidance
The company today raised its FY25 revenue growth and EPS guidance.
The company raised its FY25 organic revenue growth guidance to 4.5% to 5% versus the prior range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency 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 an adjusted basis would be in the range of 3.4% to 4.3%.
The company raised its FY25 diluted non-GAAP EPS guidance to the new range of $5.42 to $5.50 versus the prior $5.40 to $5.50 . This includes an estimated -5% impact from foreign currency exchange based on recent rates, unchanged from the prior guidance. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.
"Overall revenue outperformance flowed through to the bottom line, with adjusted EPS ahead of expectations," said Gary Corona , Medtronic interim chief financial officer. "We're raising our guidance today as we expect to sustain growth from new product introductions, continue to make the investments to support those launches, and deliver on our commitment to restore earnings power."
Video Webcast Information
Medtronic will host a video webcast today, August 20 , 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 second, third, and fourth quarter results on November 19, 2024 , February 18, 2025 , and Wednesday, May 21, 2025 , respectively. Confirmation and additional details will be provided closer to the specific event.
Financial Schedules and Earnings Presentation
The first 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 first quarter earnings presentation, click here .
MEDTRONIC PLC WORLD WIDE REVENUE (1) (Unaudited) | |||||||||||||
FIRST QUARTER | |||||||||||||
REPORTED | ORGANIC | ||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||
Cardiovascular | $ 3,007 | $ 2,850 | 5.5 % | $ (39) | $ 3,046 | $ 2,850 | 6.9 % | ||||||
Cardiac Rhythm & Heart Failure | 1,535 | 1,446 | 6.2 | (19) | 1,555 | 1,446 | 7.5 | ||||||
Structural Heart & Aortic | 856 | 814 | 5.1 | (12) | 868 | 814 | 6.6 | ||||||
Coronary & Peripheral Vascular | 616 | 589 | 4.5 | (8) | 624 | 589 | 5.8 | ||||||
Neuroscience | 2,317 | 2,219 | 4.4 | (18) | 2,336 | 2,219 | 5.3 | ||||||
Cranial & Spinal Technologies | 1,147 | 1,103 | 4.0 | (9) | 1,156 | 1,103 | 4.8 | ||||||
Specialty Therapies | 713 | 695 | 2.5 | (7) | 719 | 695 | 3.4 | ||||||
Neuromodulation | 457 | 420 | 8.9 | (3) | 460 | 420 | 9.6 | ||||||
Medical Surgical | 1,996 | 2,005 | (0.4) | (29) | 2,024 | 2,005 | 1.0 | ||||||
Surgical & Endoscopy | 1,544 | 1,546 | (0.1) | (22) | 1,566 | 1,546 | 1.3 | ||||||
Acute Care & Monitoring | 452 | 459 | (1.5) | (6) | 458 | 459 | (0.1) | ||||||
Diabetes | 647 | 578 | 11.8 | (4) | 651 | 578 | 12.6 | ||||||
Total Reportable Segments | 7,967 | 7,652 | 4.1 | (90) | 8,057 | 7,652 | 5.3 | ||||||
Other (2) | (52) | 50 | (203.7) | (2) | — | — | — | ||||||
TOTAL | $ 7,915 | $ 7,702 | 2.8 % | $ (93) | $ 8,057 | $ 7,652 | 5.3 % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended July 26, 2024 excludes $142 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $38 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $50 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC U.S. (1)(2) REVENUE (Unaudited) | |||||||||||
FIRST QUARTER | |||||||||||
REPORTED | ORGANIC | ||||||||||
(in millions) | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | |||||
Cardiovascular | $ 1,403 | $ 1,350 | 3.9 % | $ 1,403 | $ 1,350 | 3.9 % | |||||
Cardiac Rhythm & Heart Failure | 766 | 720 | 6.4 | 766 | 720 | 6.4 | |||||
Structural Heart & Aortic | 368 | 357 | 3.3 | 368 | 357 | 3.3 | |||||
Coronary & Peripheral Vascular | 268 | 273 | (1.6) | 268 | 273 | (1.6) | |||||
Neuroscience | 1,565 | 1,497 | 4.5 | 1,565 | 1,497 | 4.5 | |||||
Cranial & Spinal Technologies | 855 | 821 | 4.2 | 855 | 821 | 4.2 | |||||
Specialty Therapies | 398 | 392 | 1.5 | 398 | 392 | 1.5 | |||||
Neuromodulation | 312 | 284 | 9.8 | 312 | 284 | 9.8 | |||||
Medical Surgical | 881 | 867 | 1.6 | 881 | 867 | 1.6 | |||||
Surgical & Endoscopy | 630 | 619 | 1.6 | 630 | 619 | 1.6 | |||||
Acute Care & Monitoring | 251 | 248 | 1.4 | 251 | 248 | 1.4 | |||||
Diabetes | 215 | 188 | 14.3 | 215 | 188 | 14.3 | |||||
Total Reportable Segments | 4,064 | 3,903 | 4.1 | 4,064 | 3,903 | 4.1 | |||||
Other (3) | 18 | 22 | (15.6) | — | — | — | |||||
TOTAL | $ 4,082 | $ 3,924 | 4.0 % | $ 4,064 | $ 3,903 | 4.1 % |
(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. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(3) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested. |
MEDTRONIC PLC INTERNATIONAL REVENUE (1) (Unaudited) | |||||||||||||
FIRST QUARTER | |||||||||||||
REPORTED | ORGANIC | ||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||
Cardiovascular | $ 1,604 | $ 1,500 | 6.9 % | $ (39) | $ 1,643 | $ 1,500 | 9.5 % | ||||||
Cardiac Rhythm & Heart Failure | 769 | 726 | 5.9 | (19) | 789 | 726 | 8.6 | ||||||
Structural Heart & Aortic | 487 | 457 | 6.5 | (12) | 499 | 457 | 9.2 | ||||||
Coronary & Peripheral Vascular | 347 | 317 | 9.7 | (8) | 355 | 317 | 12.2 | ||||||
Neuroscience | 752 | 721 | 4.3 | (18) | 770 | 721 | 6.8 | ||||||
Cranial & Spinal Technologies | 292 | 282 | 3.4 | (9) | 301 | 282 | 6.6 | ||||||
Specialty Therapies | 314 | 303 | 3.8 | (7) | 321 | 303 | 5.9 | ||||||
Neuromodulation | 146 | 136 | 7.2 | (3) | 149 | 136 | 9.4 | ||||||
Medical Surgical | 1,115 | 1,137 | (2.0) | (29) | 1,143 | 1,137 | 0.5 | ||||||
Surgical & Endoscopy | 915 | 926 | (1.3) | (22) | 937 | 926 | 1.1 | ||||||
Acute Care & Monitoring | 200 | 211 | (5.0) | (6) | 207 | 211 | (2.0) | ||||||
Diabetes | 432 | 390 | 10.7 | (4) | 436 | 390 | 11.7 | ||||||
Total Reportable Segments | 3,903 | 3,749 | 4.1 | (90) | 3,993 | 3,749 | 6.5 | ||||||
Other (2) | (70) | 28 | (347.5) | (2) | — | — | — | ||||||
TOTAL | $ 3,832 | $ 3,777 | 1.5 % | $ (93) | $ 3,993 | $ 3,749 | 6.5 % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended July 26, 2024 excludes $161 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $19 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $28 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) | |||
Three months ended | |||
(in millions, except per share data) | July 26, 2024 | July 28, 2023 | |
Net sales | $ 7,915 | $ 7,702 | |
Costs and expenses: | |||
Cost of products sold, excluding amortization of intangible assets | 2,761 | 2,628 | |
Research and development expense | 676 | 668 | |
Selling, general, and administrative expense | 2,655 | 2,613 | |
Amortization of intangible assets | 414 | 429 | |
Restructuring charges, net | 47 | 54 | |
Certain litigation charges, net | 81 | 40 | |
Other operating expense, net | 1 | 1 | |
Operating profit | 1,278 | 1,268 | |
Other non-operating income, net | (157) | (76) | |
Interest expense, net | 167 | 148 | |
Income before income taxes | 1,268 | 1,196 | |
Income tax provision | 220 | 400 | |
Net income | 1,049 | 797 | |
Net income attributable to noncontrolling interests | (6) | (6) | |
Net income attributable to Medtronic | $ 1,042 | $ 791 | |
Basic earnings per share | $ 0.81 | $ 0.59 | |
Diluted earnings per share | $ 0.80 | $ 0.59 | |
Basic weighted average shares outstanding | 1,293.3 | 1,330.5 | |
Diluted weighted average shares outstanding | 1,296.5 | 1,333.8 |
The data in the schedule above has been intentionally rounded to the nearest million. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Three months ended July 26, 2024 | |||||||||||||||||
(in millions, except per share data) | Net Sales | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted EPS | Effective | ||||||||
GAAP | $ 7,915 | $ 2,761 | 65.1 % | $ 1,278 | 16.1 % | $ 1,268 | $ 1,042 | $ 0.80 | 17.4 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 414 | 5.1 | 414 | 340 | 0.26 | 18.1 | ||||||||
Restructuring and associated costs (2) | — | (9) | 0.1 | 62 | 0.8 | 62 | 51 | 0.04 | 19.4 | ||||||||
Acquisition and divestiture-related items (3) | — | (10) | 0.1 | 12 | 0.1 | 12 | 11 | 0.01 | 8.3 | ||||||||
Certain litigation charges, net | — | — | — | 81 | 1.0 | 81 | 68 | 0.05 | 16.0 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (17) | (17) | (0.01) | — | ||||||||
Medical device regulations (5) | — | (11) | 0.1 | 14 | 0.2 | 14 | 11 | 0.01 | 21.4 | ||||||||
Other (6) | 90 | — | 0.6 | 90 | 1.1 | 90 | 70 | 0.05 | 22.2 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 17 | 0.01 | — | ||||||||
Non-GAAP | $ 8,004 | $ 2,730 | 65.9 % | $ 1,953 | 24.4 % | $ 1,925 | $ 1,592 | $ 1.23 | 17.0 % | ||||||||
Currency impact | 91 | (31) | 0.8 | 100 | 1.0 | 0.06 | |||||||||||
Currency Adjusted | $ 8,095 | $ 2,699 | 66.7 % | $ 2,053 | 25.4 % | $ 1.29 | |||||||||||
Three months ended July 28, 2023 | |||||||||||||||||
(in millions, except per share data) | Net Sales | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted EPS | Effective | ||||||||
GAAP | $ 7,702 | $ 2,628 | 65.9 % | $ 1,268 | 16.5 % | $ 1,196 | $ 791 | $ 0.59 | 33.4 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 429 | 5.6 | 429 | 364 | 0.27 | 15.2 | ||||||||
Restructuring and associated costs (2) | — | (16) | 0.2 | 91 | 1.2 | 91 | 76 | 0.06 | 16.5 | ||||||||
Acquisition and divestiture-related items (3) | — | (6) | 0.1 | 50 | 0.6 | 50 | 46 | 0.03 | 6.0 | ||||||||
Certain litigation charges, net | — | — | — | 40 | 0.5 | 40 | 31 | 0.02 | 22.5 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 64 | 64 | 0.05 | — | ||||||||
Medical device regulations (5) | — | (21) | 0.3 | 31 | 0.4 | 31 | 25 | 0.02 | 22.6 | ||||||||
Certain tax adjustments, net (7) | — | — | — | — | — | — | 198 | 0.15 | — | ||||||||
Non-GAAP | $ 7,702 | $ 2,586 | 66.4 % | $ 1,909 | 24.8 % | $ 1,902 | $ 1,596 | $ 1.20 | 15.8 % |
See description of non-GAAP financial measures contained in the press release dated August 20, 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 and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges. |
(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 (E.U.) 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) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(7) | The charge relates to an income tax reserve adjustment associated with the June 2023 Israeli Central-Lod District Court decision in Medtronic Ventor Technologies Ltd v. Kfar Saba Assessing Office and amortization of previously established deferred tax assets from intercompany intellectual property transactions. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||
Three months ended July 26, 2024 | |||||||||||||||
(in millions) | Net Sales | SG&A | SG&A Expense | R&D | R&D Expense | Other Operating | Other Operating | Other | |||||||
GAAP | $ 7,915 | $ 2,655 | 33.5 % | $ 676 | 8.5 % | $ 1 | — % | $ (157) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (5) | (0.2) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (7) | (0.3) | — | — | 6 | 0.1 | — | |||||||
Medical device regulations (4) | — | — | — | (3) | — | — | — | — | |||||||
Other (5) | 90 | — | — | — | — | — | — | — | |||||||
(Gain)/loss on minority investments (6) | — | — | — | — | — | — | — | 17 | |||||||
Non-GAAP | $ 8,004 | $ 2,642 | 33.0 % | $ 673 | 8.4 % | $ 7 | 0.1 % | $ (140) |
See description of non-GAAP financial measures contained in the press release dated August 20, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Associated and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges. |
(4) | 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. |
(5) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(6) | 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) | |||
Three months ended | |||
(in millions) | July 26, 2024 | July 28, 2023 | |
Net cash provided by operating activities | $ 986 | $ 875 | |
Additions to property, plant, and equipment | (520) | (354) | |
Free Cash Flow (2) | $ 466 | $ 521 |
See description of non-GAAP financial measures contained in the press release dated August 20, 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) | July 26, 2024 | April 26, 2024 | ||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 1,311 | $ 1,284 | ||
Investments | 6,532 | 6,721 | ||
Accounts receivable, less allowances and credit losses of $170 and $173, respectively | 6,011 | 6,128 | ||
Inventories | 5,414 | 5,217 | ||
Other current assets | 2,679 | 2,584 | ||
Total current assets | 21,947 | 21,935 | ||
Property, plant, and equipment, net | 6,282 | 6,131 | ||
Goodwill | 41,084 | 40,986 | ||
Other intangible assets, net | 12,819 | 13,225 | ||
Tax assets | 3,554 | 3,657 | ||
Other assets | 4,062 | 4,047 | ||
Total assets | $ 89,749 | $ 89,981 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Current debt obligations | $ 1,553 | $ 1,092 | ||
Accounts payable | 2,291 | 2,410 | ||
Accrued compensation | 1,776 | 2,375 | ||
Accrued income taxes | 1,063 | 1,330 | ||
Other accrued expenses | 3,604 | 3,582 | ||
Total current liabilities | 10,287 | 10,789 | ||
Long-term debt | 26,312 | 23,932 | ||
Accrued compensation and retirement benefits | 1,107 | 1,101 | ||
Accrued income taxes | 1,917 | 1,859 | ||
Deferred tax liabilities | 496 | 515 | ||
Other liabilities | 1,470 | 1,365 | ||
Total liabilities | 41,589 | 39,561 | ||
Commitments and contingencies | ||||
Shareholders' equity: | ||||
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,494,588 and | — | — | ||
Additional paid-in capital | 20,810 | 23,129 | ||
Retained earnings | 30,547 | 30,403 | ||
Accumulated other comprehensive loss | (3,410) | (3,318) | ||
Total shareholders' equity | 47,947 | 50,214 | ||
Noncontrolling interests | 213 | 206 | ||
Total equity | 48,160 | 50,420 | ||
Total liabilities and equity | $ 89,749 | $ 89,981 |
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) | |||
Three months ended | |||
(in millions) | July 26, 2024 | July 28, 2023 | |
Operating Activities: | |||
Net income | $ 1,049 | $ 797 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 662 | 672 | |
Provision for credit losses | 18 | 21 | |
Deferred income taxes | 88 | — | |
Stock-based compensation | 83 | 73 | |
Other, net | (9) | 135 | |
Change in operating assets and liabilities, net of acquisitions and divestitures: | |||
Accounts receivable, net | 110 | 164 | |
Inventories | (217) | (410) | |
Accounts payable and accrued liabilities | (604) | (673) | |
Other operating assets and liabilities | (194) | 96 | |
Net cash provided by operating activities | 986 | 875 | |
Investing Activities: | |||
Additions to property, plant, and equipment | (520) | (354) | |
Purchases of investments | (1,879) | (1,916) | |
Sales and maturities of investments | 2,157 | 1,748 | |
Other investing activities, net | (17) | (17) | |
Net cash used in investing activities | (259) | (539) | |
Financing Activities: | |||
Change in current debt obligations, net | (624) | 500 | |
Issuance of long-term debt | 3,209 | — | |
Dividends to shareholders | (898) | (918) | |
Issuance of ordinary shares | 89 | 77 | |
Repurchase of ordinary shares | (2,492) | (152) | |
Other financing activities | (15) | (8) | |
Net cash used in financing activities | (731) | (501) | |
Effect of exchange rate changes on cash and cash equivalents | 31 | (39) | |
Net change in cash and cash equivalents | 27 | (204) | |
Cash and cash equivalents at beginning of period | 1,284 | 1,543 | |
Cash and cash equivalents at end of period | $ 1,311 | $ 1,339 | |
Supplemental Cash Flow Information | |||
Cash paid for: | |||
Income taxes | $ 394 | $ 117 | |
Interest | 119 | 84 |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, 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 more than 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 LinkedIn .
FORWARD LOOKING STATEMENTS
This 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 MEASURES
This 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 2024.
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 |
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SOURCE Medtronic plc
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