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.
News Provided by GlobeNewswire via QuoteMedia
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.
News Provided by GlobeNewswire via QuoteMedia
Thermo Fisher Scientific Reports Third Quarter 2024 Results
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the third quarter ended September 28, 2024.
Third Quarter 2024 Highlights
- Third quarter revenue was $10.60 billion.
- Third quarter GAAP diluted earnings per share (EPS) was $4.25.
- Third quarter adjusted EPS was $5.28.
- Advanced our proven growth strategy, launching a range of high-impact, innovative new products during the quarter. To enable the development of advanced materials, we launched the groundbreaking Thermo Scientific Iliad scanning transmission electron microscope , which integrates a number of our advanced technologies into a user-friendly workflow to enable research of the most sophisticated modern materials down to the atomic level. To advance life sciences research, we launched the Applied Biosystems MagMAX Sequential DNA/RNA kit , which maximizes the isolation of DNA and RNA from blood cancer samples helping researchers identify unique insights into cancer-causing genetic alterations; and the Invitrogen Vivofectamine Delivery Solutions , a novel method for delivering nucleic acids into multiple targets with therapeutic effect, paving the way for groundbreaking new medicines.
- Continued to deepen our trusted partner status with customers to accelerate their innovation and enhance their productivity. In the quarter, we announced a partnership with the National Cancer Institute on the myeloMATCH precision medicine umbrella trial, which will leverage our next-generation sequencing technology to test patients for specific genetic biomarkers to match them more quickly with optimal treatments based on their unique cancer profile. In our pharma services business, we announced the expansion of our Cincinnati, Ohio, and Bend, Oregon, sites to further enhance our solid dose formulation capabilities for our pharma and biotech customers. In our clinical research business, we also announced the expansion of our global laboratory services network with a new bioanalytical lab in Gothenburg, Sweden , which will provide pharma and biotech customers with advanced laboratory services to support all phases of development.
"We are pleased to deliver strong financial results in the third quarter, reflecting another quarter of sequential improvement in growth," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We continue to deliver differentiated performance through our proven growth strategy and PPI Business System. Our trusted partner status is resonating strongly with customers, and this is translating into meaningful commercial wins."
Casper added, "Looking ahead, we're in a great position to deliver on our 2024 objectives, as we continue to create value for all of our stakeholders and build an even brighter future for our company."
Third Quarter 2024
Revenue for the quarter was $10.60 billion in 2024 versus $10.57 billion in 2023. Growth in revenue, organic revenue and Core organic revenue all improved sequentially from Q2 and were flat versus the prior-year quarter.
GAAP Earnings Results
GAAP diluted EPS in the third quarter of 2024 was $4.25, versus $4.42 in the same quarter last year. GAAP operating income for the third quarter of 2024 was $1.84 billion, compared with $1.86 billion in the year-ago quarter. GAAP operating margin was 17.3%, compared with 17.6% in the third quarter of 2023.
Non-GAAP Earnings Results
Adjusted EPS in the third quarter of 2024 was $5.28, versus $5.69 in the third quarter of 2023. Adjusted operating income for the third quarter of 2024 was $2.36 billion, compared with $2.56 billion in the year-ago quarter. Adjusted operating margin was 22.3%, compared with 24.2% in the third quarter of 2023.
Annual Guidance for 2024
Thermo Fisher is raising its full-year adjusted EPS guidance to a new range of $21.35 to $22.07 versus its previous guidance of $21.29 to $22.07. Revenue guidance continues to be in the range of $42.4 to $43.3 billion.
Use of Non-GAAP Financial Measures
Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.
Note on Presentation
Certain amounts and percentages reported within this press release are presented and calculated based on underlying unrounded amounts. As a result, the sum of components may not equal corresponding totals due to rounding.
Conference Call
Thermo Fisher Scientific will hold its earnings conference call today, October 23, at 8:30 a.m. Eastern Daylight Time. During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 296868. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com . The earnings press release and related information can also be found in that section of our website under the heading "Financials". A replay of the call will be available under "News, Events & Presentations" through November 6, 2024.
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 .
Safe Harbor Statement
The following constitutes a "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the COVID-19 pandemic; the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of economic and political conditions and exchange rate fluctuations on international operations; use and protection of intellectual property; the effect of changes in governmental regulations; any natural disaster, public health crisis or other catastrophic event; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to recent or pending acquisitions, may not materialize as expected. Additional important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in our most recent annual report on Form 10-K, and subsequent quarterly reports on Form 10-Q, which are on file with the SEC and available in the "Investors" section of our website under the heading "SEC Filings." While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.
Condensed Consolidated Statements of Income (unaudited) | ||||||||||||||
Three months ended | ||||||||||||||
September 28, | % of | September 30, | % of | |||||||||||
(Dollars in millions except per share amounts) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | $ | 10,598 | $ | 10,574 | ||||||||||
Costs and operating expenses: | ||||||||||||||
Cost of revenues (a) | 6,180 | 58.3 | % | 6,145 | 58.1 | % | ||||||||
Selling, general and administrative expenses (b) | 1,739 | 16.4 | % | 1,578 | 14.9 | % | ||||||||
Amortization of acquisition-related intangible assets | 450 | 4.2 | % | 584 | 5.6 | % | ||||||||
Research and development expenses | 346 | 3.3 | % | 319 | 3.0 | % | ||||||||
Restructuring and other costs (c) | 45 | 0.4 | % | 84 | 0.8 | % | ||||||||
Total costs and operating expenses | 8,759 | 82.7 | % | 8,710 | 82.4 | % | ||||||||
Operating income | 1,838 | 17.3 | % | 1,864 | 17.6 | % | ||||||||
Interest income | 277 | 246 | ||||||||||||
Interest expense | (356 | ) | (359 | ) | ||||||||||
Other income/(expense) (d) | (16 | ) | 14 | |||||||||||
Income before income taxes | 1,742 | 1,765 | ||||||||||||
Provision for income taxes (e) | (99 | ) | (53 | ) | ||||||||||
Equity in earnings/(losses) of unconsolidated entities | (14 | ) | (17 | ) | ||||||||||
Net income | 1,629 | 1,695 | ||||||||||||
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f) | — | (20 | ) | |||||||||||
Net income attributable to Thermo Fisher Scientific Inc. | $ | 1,630 | 15.4 | % | $ | 1,715 | 16.2 | % | ||||||
Earnings per share attributable to Thermo Fisher Scientific Inc.: | ||||||||||||||
Basic | $ | 4.26 | $ | 4.44 | ||||||||||
Diluted | $ | 4.25 | $ | 4.42 | ||||||||||
Weighted average shares: | ||||||||||||||
Basic | 382 | 386 | ||||||||||||
Diluted | 384 | 388 | ||||||||||||
Reconciliation of adjusted operating income and adjusted operating margin | ||||||||||||||
GAAP operating income | $ | 1,838 | 17.3 | % | $ | 1,864 | 17.6 | % | ||||||
Cost of revenues adjustments (a) | 9 | 0.1 | % | 14 | 0.1 | % | ||||||||
Selling, general and administrative expenses adjustments (b) | 21 | 0.2 | % | 14 | 0.1 | % | ||||||||
Restructuring and other costs (c) | 45 | 0.4 | % | 84 | 0.8 | % | ||||||||
Amortization of acquisition-related intangible assets | 450 | 4.2 | % | 584 | 5.6 | % | ||||||||
Adjusted operating income (non-GAAP measure) | $ | 2,362 | 22.3 | % | $ | 2,560 | 24.2 | % | ||||||
Reconciliation of adjusted net income | ||||||||||||||
GAAP net income attributable to Thermo Fisher Scientific Inc. | $ | 1,630 | $ | 1,715 | ||||||||||
Cost of revenues adjustments (a) | 9 | 14 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | 21 | 14 | ||||||||||||
Restructuring and other costs (c) | 45 | 84 | ||||||||||||
Amortization of acquisition-related intangible assets | 450 | 584 | ||||||||||||
Other income/expense adjustments (d) | 3 | (9 | ) | |||||||||||
Provision for income taxes adjustments (e) | (139 | ) | (192 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 14 | 17 | ||||||||||||
Noncontrolling interests adjustments (f) | (6 | ) | (19 | ) | ||||||||||
Adjusted net income (non-GAAP measure) | $ | 2,026 | $ | 2,208 | ||||||||||
Reconciliation of adjusted earnings per share | ||||||||||||||
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc. | $ | 4.25 | $ | 4.42 | ||||||||||
Cost of revenues adjustments (a) | 0.02 | 0.04 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | 0.05 | 0.03 | ||||||||||||
Restructuring and other costs (c) | 0.12 | 0.22 | ||||||||||||
Amortization of acquisition-related intangible assets | 1.17 | 1.50 | ||||||||||||
Other income/expense adjustments (d) | 0.01 | (0.02 | ) | |||||||||||
Provision for income taxes adjustments (e) | (0.36 | ) | (0.49 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 0.04 | 0.04 | ||||||||||||
Noncontrolling interests adjustments (f) | (0.02 | ) | (0.05 | ) | ||||||||||
Adjusted EPS (non-GAAP measure) | $ | 5.28 | $ | 5.69 | ||||||||||
Reconciliation of free cash flow | ||||||||||||||
GAAP net cash provided by operating activities | $ | 2,167 | $ | 2,414 | ||||||||||
Purchases of property, plant and equipment | (271 | ) | (332 | ) | ||||||||||
Proceeds from sale of property, plant and equipment | 20 | 66 | ||||||||||||
Free cash flow (non-GAAP measure) | $ | 1,915 | $ | 2,148 |
Business Segment Information | Three months ended | |||||||||||||
September 28, | % of | September 30, | % of | |||||||||||
(Dollars in millions) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | ||||||||||||||
Life Sciences Solutions | $ | 2,387 | 22.5 | % | $ | 2,433 | 23.0 | % | ||||||
Analytical Instruments | 1,808 | 17.1 | % | 1,754 | 16.6 | % | ||||||||
Specialty Diagnostics | 1,129 | 10.7 | % | 1,083 | 10.2 | % | ||||||||
Laboratory Products and Biopharma Services | 5,740 | 54.2 | % | 5,728 | 54.2 | % | ||||||||
Eliminations | (467 | ) | -4.4 | % | (424 | ) | -4.0 | % | ||||||
Consolidated revenues | $ | 10,598 | 100.0 | % | $ | 10,574 | 100.0 | % | ||||||
Segment income and segment income margin | ||||||||||||||
Life Sciences Solutions | $ | 845 | 35.4 | % | $ | 872 | 35.9 | % | ||||||
Analytical Instruments | 451 | 24.9 | % | 468 | 26.7 | % | ||||||||
Specialty Diagnostics | 293 | 25.9 | % | 283 | 26.1 | % | ||||||||
Laboratory Products and Biopharma Services | 773 | 13.5 | % | 937 | 16.4 | % | ||||||||
Subtotal reportable segments | 2,362 | 22.3 | % | 2,560 | 24.2 | % | ||||||||
Cost of revenues adjustments (a) | (9 | ) | -0.1 | % | (14 | ) | -0.1 | % | ||||||
Selling, general and administrative expenses adjustments (b) | (21 | ) | -0.2 | % | (14 | ) | -0.1 | % | ||||||
Restructuring and other costs (c) | (45 | ) | -0.4 | % | (84 | ) | -0.8 | % | ||||||
Amortization of acquisition-related intangible assets | (450 | ) | -4.2 | % | (584 | ) | -5.6 | % | ||||||
Consolidated GAAP operating income | $ | 1,838 | 17.3 | % | $ | 1,864 | 17.6 | % | ||||||
(a) Adjusted results in 2024 and 2023 exclude charges for the sale of inventory revalued at the date of acquisition and accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations. | ||||||||||||||
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $5 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations. | ||||||||||||||
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, net charges/credits for pre-acquisition litigation and other matters, net gains on the sale of real estate, and abandoned facility and other expenses of headcount reductions and real estate consolidations. | ||||||||||||||
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments. | ||||||||||||||
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes, and the tax impacts from audit settlements. | ||||||||||||||
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests. | ||||||||||||||
Note: | ||||||||||||||
Consolidated depreciation expense is $291 and $269 in 2024 and 2023, respectively. |
Organic and Core organic revenue growth | Three months ended | ||
September 28, 2024 | |||
Revenue growth | 0% | ||
Acquisitions | 1% | ||
Currency translation | 0% | ||
Organic revenue growth (non-GAAP measure) | 0% | ||
COVID-19 testing revenue | 0% | ||
Core organic revenue growth (non-GAAP measure) | 0% | ||
Note: | |||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. |
Condensed Consolidated Statements of Income (unaudited) | ||||||||||||||
Nine months ended | ||||||||||||||
September 28, | % of | September 30, | % of | |||||||||||
(Dollars in millions except per share amounts) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | $ | 31,484 | $ | 31,971 | ||||||||||
Costs and operating expenses: | ||||||||||||||
Cost of revenues (a) | 18,326 | 58.2 | % | 18,905 | 59.1 | % | ||||||||
Selling, general and administrative expenses (b) | 5,156 | 16.4 | % | 4,897 | 15.3 | % | ||||||||
Amortization of acquisition-related intangible assets | 1,514 | 4.8 | % | 1,775 | 5.5 | % | ||||||||
Research and development expenses | 1,016 | 3.2 | % | 1,010 | 3.2 | % | ||||||||
Restructuring and other costs (c) | 151 | 0.5 | % | 379 | 1.2 | % | ||||||||
Total costs and operating expenses | 26,163 | 83.1 | % | 26,966 | 84.3 | % | ||||||||
Operating income | 5,321 | 16.9 | % | 5,005 | 15.7 | % | ||||||||
Interest income | 851 | 570 | ||||||||||||
Interest expense | (1,073 | ) | (985 | ) | ||||||||||
Other income/(expense) (d) | (2 | ) | (32 | ) | ||||||||||
Income before income taxes | 5,096 | 4,558 | ||||||||||||
Provision for income taxes (e) | (507 | ) | (151 | ) | ||||||||||
Equity in earnings/(losses) of unconsolidated entities | (75 | ) | (58 | ) | ||||||||||
Net income | 4,514 | 4,349 | ||||||||||||
Less: net income/(losses) attributable to noncontrolling interests and redeemable noncontrolling interest (f) | 9 | (16 | ) | |||||||||||
Net income attributable to Thermo Fisher Scientific Inc. | $ | 4,505 | 14.3 | % | $ | 4,365 | 13.7 | % | ||||||
Earnings per share attributable to Thermo Fisher Scientific Inc.: | ||||||||||||||
Basic | $ | 11.79 | $ | 11.31 | ||||||||||
Diluted | $ | 11.75 | $ | 11.25 | ||||||||||
Weighted average shares: | ||||||||||||||
Basic | 382 | 386 | ||||||||||||
Diluted | 383 | 388 | ||||||||||||
Reconciliation of adjusted operating income and adjusted operating margin | ||||||||||||||
GAAP operating income | $ | 5,321 | 16.9 | % | $ | 5,005 | 15.7 | % | ||||||
Cost of revenues adjustments (a) | 25 | 0.1 | % | 73 | 0.2 | % | ||||||||
Selling, general and administrative expenses adjustments (b) | (24 | ) | -0.1 | % | 28 | 0.1 | % | |||||||
Restructuring and other costs (c) | 151 | 0.5 | % | 379 | 1.2 | % | ||||||||
Amortization of acquisition-related intangible assets | 1,514 | 4.8 | % | 1,775 | 5.5 | % | ||||||||
Adjusted operating income (non-GAAP measure) | $ | 6,987 | 22.2 | % | $ | 7,260 | 22.7 | % | ||||||
Reconciliation of adjusted net income | ||||||||||||||
GAAP net income attributable to Thermo Fisher Scientific Inc. | $ | 4,505 | $ | 4,365 | ||||||||||
Cost of revenues adjustments (a) | 25 | 73 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (24 | ) | 28 | |||||||||||
Restructuring and other costs (c) | 151 | 379 | ||||||||||||
Amortization of acquisition-related intangible assets | 1,514 | 1,775 | ||||||||||||
Other income/expense adjustments (d) | (8 | ) | 36 | |||||||||||
Provision for income taxes adjustments (e) | (190 | ) | (534 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 75 | 58 | ||||||||||||
Noncontrolling interests adjustments (f) | (6 | ) | (19 | ) | ||||||||||
Adjusted net income (non-GAAP measure) | $ | 6,042 | $ | 6,161 | ||||||||||
Reconciliation of adjusted earnings per share | ||||||||||||||
GAAP diluted EPS attributable to Thermo Fisher Scientific Inc. | $ | 11.75 | $ | 11.25 | ||||||||||
Cost of revenues adjustments (a) | 0.07 | 0.19 | ||||||||||||
Selling, general and administrative expenses adjustments (b) | (0.06 | ) | 0.07 | |||||||||||
Restructuring and other costs (c) | 0.39 | 0.98 | ||||||||||||
Amortization of acquisition-related intangible assets | 3.95 | 4.57 | ||||||||||||
Other income/expense adjustments (d) | (0.02 | ) | 0.09 | |||||||||||
Provision for income taxes adjustments (e) | (0.50 | ) | (1.38 | ) | ||||||||||
Equity in earnings/losses of unconsolidated entities | 0.20 | 0.15 | ||||||||||||
Noncontrolling interests adjustments (f) | (0.02 | ) | (0.05 | ) | ||||||||||
Adjusted EPS (non-GAAP measure) | $ | 15.76 | $ | 15.87 | ||||||||||
Reconciliation of free cash flow | ||||||||||||||
GAAP net cash provided by operating activities | $ | 5,377 | $ | 4,683 | ||||||||||
Purchases of property, plant and equipment | (920 | ) | (1,074 | ) | ||||||||||
Proceeds from sale of property, plant and equipment | 40 | 76 | ||||||||||||
Free cash flow (non-GAAP measure) | $ | 4,498 | $ | 3,685 |
Business Segment Information | Nine months ended | |||||||||||||
September 28, | % of | September 30, | % of | |||||||||||
(Dollars in millions) | 2024 | Revenues | 2023 | Revenues | ||||||||||
Revenues | ||||||||||||||
Life Sciences Solutions | $ | 7,027 | 22.3 | % | $ | 7,508 | 23.5 | % | ||||||
Analytical Instruments | 5,277 | 16.8 | % | 5,226 | 16.3 | % | ||||||||
Specialty Diagnostics | 3,355 | 10.7 | % | 3,300 | 10.3 | % | ||||||||
Laboratory Products and Biopharma Services | 17,221 | 54.7 | % | 17,322 | 54.2 | % | ||||||||
Eliminations | (1,397 | ) | -4.4 | % | (1,385 | ) | -4.3 | % | ||||||
Consolidated revenues | $ | 31,484 | 100.0 | % | $ | 31,971 | 100.0 | % | ||||||
Segment income and segment income margin | ||||||||||||||
Life Sciences Solutions | $ | 2,551 | 36.3 | % | $ | 2,525 | 33.6 | % | ||||||
Analytical Instruments | 1,289 | 24.4 | % | 1,321 | 25.3 | % | ||||||||
Specialty Diagnostics | 886 | 26.4 | % | 860 | 26.1 | % | ||||||||
Laboratory Products and Biopharma Services | 2,262 | 13.1 | % | 2,554 | 14.7 | % | ||||||||
Subtotal reportable segments | 6,987 | 22.2 | % | 7,260 | 22.7 | % | ||||||||
Cost of revenues adjustments (a) | (25 | ) | -0.1 | % | (73 | ) | -0.2 | % | ||||||
Selling, general and administrative expenses adjustments (b) | 24 | 0.1 | % | (28 | ) | -0.1 | % | |||||||
Restructuring and other costs (c) | (151 | ) | -0.5 | % | (379 | ) | -1.2 | % | ||||||
Amortization of acquisition-related intangible assets | (1,514 | ) | -4.8 | % | (1,775 | ) | -5.5 | % | ||||||
Consolidated GAAP operating income | $ | 5,321 | 16.9 | % | $ | 5,005 | 15.7 | % | ||||||
(a) Adjusted results in 2024 and 2023 exclude charges for inventory write-downs associated with large-scale abandonment of product lines, accelerated depreciation on manufacturing assets to be abandoned due to facility consolidations, and charges for the sale of inventory revalued at the date of acquisition. | ||||||||||||||
(b) Adjusted results in 2024 and 2023 exclude certain third-party expenses, principally transaction/integration costs related to recent acquisitions, charges/credits for changes in estimates of contingent acquisition consideration, and charges associated with product liability litigation. Adjusted results in 2024 also exclude $5 of accelerated depreciation on fixed assets to be abandoned due to facility consolidations. | ||||||||||||||
(c) Adjusted results in 2024 and 2023 exclude restructuring and other costs consisting principally of severance, impairments of long-lived assets, net charges for pre-acquisition litigation and other matters, net gains on the sale of real estate, and abandoned facility and other expenses of headcount reductions and real estate consolidations. Adjusted results in 2023 also exclude $26 of contract termination costs associated with facility closures. | ||||||||||||||
(d) Adjusted results in 2024 and 2023 exclude net gains/losses on investments. | ||||||||||||||
(e) Adjusted results in 2024 and 2023 exclude incremental tax impacts for the reconciling items between GAAP and adjusted net income, incremental tax impacts as a result of tax rate/law changes and the tax impacts from audit settlements. | ||||||||||||||
(f) Adjusted results exclude the incremental impacts for the reconciling items between GAAP and adjusted net income attributable to noncontrolling interests. | ||||||||||||||
Notes: | ||||||||||||||
Consolidated depreciation expense is $852 and $792 in 2024 and 2023, respectively. | ||||||||||||||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. | ||||||||||||||
Condensed Consolidated Balance Sheets (unaudited) | ||||||
September 28, | December 31, | |||||
(In millions) | 2024 | 2023 | ||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 4,645 | $ | 8,077 | ||
Short-term investments | 2,000 | 3 | ||||
Accounts receivable, net | 8,255 | 8,221 | ||||
Inventories | 5,430 | 5,088 | ||||
Other current assets | 3,453 | 3,200 | ||||
Total current assets | 23,783 | 24,589 | ||||
Property, plant and equipment, net | 9,412 | 9,448 | ||||
Acquisition-related intangible assets, net | 16,262 | 16,670 | ||||
Other assets | 4,180 | 3,999 | ||||
Goodwill | 46,726 | 44,020 | ||||
Total assets | $ | 100,364 | $ | 98,726 | ||
Liabilities, redeemable noncontrolling interest and equity | ||||||
Current liabilities: | ||||||
Short-term obligations and current maturities of long-term obligations | $ | 4,116 | $ | 3,609 | ||
Other current liabilities | 10,485 | 10,403 | ||||
Total current liabilities | 14,601 | 14,012 | ||||
Other long-term liabilities | 5,466 | 6,564 | ||||
Long-term obligations | 31,197 | 31,308 | ||||
Redeemable noncontrolling interest | 127 | 118 | ||||
Total equity | 48,972 | 46,724 | ||||
Total liabilities, redeemable noncontrolling interest and equity | $ | 100,364 | $ | 98,726 | ||
Condensed Consolidated Statements of Cash Flows (unaudited) | ||||||||
Nine months ended | ||||||||
September 28, | September 30, | |||||||
(In millions) | 2024 | 2023 | ||||||
Operating activities | ||||||||
Net income | $ | 4,514 | $ | 4,349 | ||||
Adjustments to reconcile net income to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 2,367 | 2,567 | ||||||
Change in deferred income taxes | (1,007 | ) | (631 | ) | ||||
Other non-cash expenses, net | 477 | 658 | ||||||
Changes in assets and liabilities, excluding the effects of acquisitions | (973 | ) | (2,260 | ) | ||||
Net cash provided by operating activities | 5,377 | 4,683 | ||||||
Investing activities | ||||||||
Purchases of property, plant and equipment | (920 | ) | (1,074 | ) | ||||
Proceeds from sale of property, plant and equipment | 40 | 76 | ||||||
Proceeds from cross-currency interest rate swap interest settlements | 203 | 36 | ||||||
Acquisitions, net of cash acquired | (3,132 | ) | (3,660 | ) | ||||
Purchases of investments | (2,065 | ) | (200 | ) | ||||
Other investing activities, net | 14 | 56 | ||||||
Net cash used in investing activities | (5,861 | ) | (4,766 | ) | ||||
Financing activities | ||||||||
Net proceeds from issuance of debt | 1,204 | 3,466 | ||||||
Repayment of debt | (1,107 | ) | (2,000 | ) | ||||
Net proceeds from issuance of commercial paper | — | 1,620 | ||||||
Repayment of commercial paper | — | (1,935 | ) | |||||
Purchases of company common stock | (3,000 | ) | (3,000 | ) | ||||
Dividends paid | (434 | ) | (387 | ) | ||||
Other financing activities, net | 212 | 42 | ||||||
Net cash used in financing activities | (3,126 | ) | (2,194 | ) | ||||
Exchange rate effect on cash | 182 | (92 | ) | |||||
Decrease in cash, cash equivalents and restricted cash | (3,427 | ) | (2,369 | ) | ||||
Cash, cash equivalents and restricted cash at beginning of period | 8,097 | 8,537 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 4,670 | $ | 6,168 | ||||
Free cash flow (non-GAAP measure) | $ | 4,498 | $ | 3,685 | ||||
Note: | ||||||||
For more information related to non-GAAP financial measures, refer to the section titled "Supplemental Information Regarding Non-GAAP Financial Measures" of this release. | ||||||||
Supplemental Information Regarding Non-GAAP Financial Measures
In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures such as organic revenue growth, which is reported revenue growth, excluding the impacts of acquisitions/divestitures and the effects of currency translation. We also report Core organic revenue growth, which is reported revenue growth, excluding the impacts of COVID-19 testing revenue, and excluding the impacts of acquisitions/divestitures and the effects of currency translation. We report these measures because Thermo Fisher management believes that in order to understand the company's short-term and long-term financial trends, investors may wish to consider the impact of acquisitions/divestitures, foreign currency translation and/or COVID-19 testing on revenues. Thermo Fisher management uses these measures to forecast and evaluate the operational performance of the company as well as to compare revenues of current periods to prior periods.
We report adjusted operating income, adjusted operating margin, adjusted net income, and adjusted EPS. We believe that the use of these non-GAAP financial measures, in addition to GAAP financial measures, helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company's core operating performance, especially when comparing such results to previous periods, forecasts, and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes. To calculate these measures we exclude, as applicable:
- Certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition, significant transaction/acquisition-related costs, including changes in estimates of contingent acquisition-related consideration, and other costs associated with obtaining short-term financing commitments for pending/recent acquisitions. We exclude these costs because we do not believe they are indicative of our normal operating costs.
- Costs/income associated with restructuring activities and large-scale abandonments of product lines, such as reducing overhead and consolidating facilities. We exclude these costs because we believe that the costs related to restructuring activities are not indicative of our normal operating costs.
- Equity in earnings/losses of unconsolidated entities; impairments of long-lived assets; and certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, including gains/losses on investments, the sale of businesses, product lines, and real estate, significant litigation-related matters, curtailments/settlements of pension plans, and the early retirement of debt. We exclude these items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods.
- The expense associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.
- The noncontrolling interest and tax impacts of the above items and the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate/law changes), the latter of which we exclude because they are outside of our normal operations and difficult to forecast accurately for future periods.
We report free cash flow, which is operating cash flow excluding net capital expenditures, to provide a view of the continuing operations' ability to generate cash for use in acquisitions and other investing and financing activities. The company also uses this measure as an indication of the strength of the company. Free cash flow is not a measure of cash available for discretionary expenditures since we have certain non-discretionary obligations such as debt service that are not deducted from the measure.
Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific's results computed in accordance with GAAP.
The non-GAAP financial measures of Thermo Fisher Scientific's results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific's results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the tables above.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241023525601/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 Bike Donation Brightens School Year
Medtronic employees surprised 200 students in Columbia Heights with new bikes. Hundreds of Medtronic volunteers built the bikes, which were later donated to the students along with bike locks, and helmets. This effort is one of many that continue the legacy of Medtronic's founder, Earl Bakken, who grew up in Columbia Heights and inspired employees to contribute to their communities and create lasting change
Learn more about how employees' commitment to giving back makes an impact across communities.
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
View the original press release on accesswire.com
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Knight Therapeutics Announces Approval of Minjuvi® in Mexico
Knight Therapeutics Inc., (TSX: GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced today that its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V. has obtained regulatory approval by COFEPRIS, the Mexican health regulatory agency, for Minjuvi ® (tafasitamab) in combination with lenalidomide followed by Minjuvi ® monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cell transplantation (ASCT).
DLBCL is the most common subtype of non-Hodgkin lymphoma, presenting an aggressive clinical profile. While a significant number of patients can be cured with standard front-line therapy, many will develop refractory disease or relapse following an initial response, and these individuals are often ineligible for ASCT. Such patients face a very poor prognosis, emphasizing the need for treatment options to improve their outcomes 1 .
The approval is based on the data from L-MIND trial, an open label, multicenter, single arm Phase 2 study, that evaluated Minjuvi ® in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL ineligible for ASCT. The study primary analysis results demonstrated an objective response rate (ORR, primary endpoint) of 60%, including a complete response rate (CR) of 43% and a disease control rate (DCR) of 74% 3 . According to the 2024 National Comprehensive Cancer Network (NCCN) Guidelines, Minjuvi ® is listed as one of the preferred second-line treatments for DLBCL patients who are ineligible for transplantation 2 .
"Minjuvi ® has a unique and innovative mechanism of action targeting CD19 and represents a significant advancement in the treatment of DLBCL. It is a chemo-free targeted immunotherapy which offers sustained remission for non-transplant eligible adult patients who have relapsed or are refractory to at least one previous line of treatment. I am enthusiastic about the transformative potential of Minjuvi ® in improving patient outcomes," said Dr. Adrian Alejandro Ceballos, internist and hematologist at CENIT Medical Center in Merida, Mexico.
"We are thrilled to announce the approval of Minjuvi ® , in Mexico, an innovative treatment for adult patients with relapsed or refractory DLBCL. With its novel mechanism of action, Minjuvi ® offers a new treatment alternative to non-transplant eligible patients who have limited treatment options. This approval, with launch expected in the first half of 2025, marks an important step in our mission to bring life-changing therapies to the Mexican market and improve the lives of patients facing this challenging condition," said Samira Sakhia, President and CEO of Knight.
In September 2021, Knight entered into a supply and distribution agreement with Incyte (NASDAQ: INCY), for the exclusive rights to distribute tafasitamab (sold as Monjuvi ® in the United States and Minjuvi ® in Europe) in Latin America.
About Minjuvi ® (tafasitamab)
Minjuvi ® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally.
In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi ® monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.
XmAb ® is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the "triangle" design are registered trademarks of Incyte.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statements for Knight
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
References:
- Duarte C, Kamdar M. Management Considerations for Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma. Am Soc Clin Oncol Educ Book. 2023 Jan;43:e390802
- National Comprehensive Cancer Network (NCCN) Guidelines. B-Cell Lymphomas dated January 18, 2024. Accessible at: Treatment by Cancer Type ( nccn.org )
- Duell, J et al. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958
CONTACT INFORMATION FOR KNIGHT:
Investor Contact: | ||
Knight Therapeutics Inc. | ||
Samira Sakhia | Arvind Utchanah | |
President & Chief Executive Officer | Chief Financial Officer | |
T: 514.484.4483 | T. +598.2626.2344 | |
F: 514.481.4116 | ||
Email: IR@knighttx.com | Email: IR@knighttx.com | |
Website: www.knighttx.com | Website: www.knighttx.com |
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Significant Increase in Revenue from Faster NDIS Approvals and Launch of New Leasing Programs
Control Bionics Limited (ASX: CBL) is pleased to report a significant improvement in NDIS approvals alongside the successful launch of our long-term leasing program for the Trilogy system.
Strong NDIS Approval Momentum
Following a challenging period marked by industry-wide delays in NDIS approvals since late 2023, we are pleased to report a significant and steady increase in approvals over the past eight weeks. During this time, we have received approvals totalling close to $400,000, reflecting growing momentum in the approval process. These approvals will be recognised as revenue as devices are shipped to our customers. This $400,000 in approvals totals more than CBL received from the NDIS over the previous 5 months. Our team has continued to grow the pipeline of opportunities, with nearly $1.0 million currently awaiting approval from the NDIS or expected to be submitted shortly. We have been really encouraged by the level of engagement we’ve had with the NDIS and are confident we will see continued approvals from the Agency in the coming months.
Launch of New Leasing Programs for Trilogy and NeuroNode in Australia
We recently launched in Australia a long-term leasing program for our Trilogy system, designed to help individuals with neurodegenerative conditions gain quicker access to vital communication technology. This flexible program allows our customers to lease the device for 12 months at a lower cost than purchasing outright. The equipment will remain owned by Control Bionics. This program has been well received, and the NDIS has already approved our first submitted application under this new offering. This marks a positive response from the NDIS and validates the effectiveness of our leasing initiative. Additionally, we are preparing to launch a similar leasing program for our NeuroNode product, further expanding the range of funding options for our customers.
Rights Issue Update
Control Bionics is currently conducting a pro rata non-renounceable rights issue to raise up to $2.1 million. The issue offers shareholders one new ordinary share for every seven held at an issue price of 7c per share, with one option for every two shares, exercisable at 10c within two years. The rights issue is underwritten for ~$890,000 and will support the commercialisation of the NeuroStrip, the launch of DROVE, and the expansion of the NeuroNode Only strategy.
In parallel to the Rights Issue, CBL successfully received subscriptions for $1.15m in new shares on the same terms as the rights issues. This placement will complete subject to shareholder approval at CBL’s AGM on 10 October 2024.
Research and Development Tax Incentive
Control Bionics is pleased to announce it recently received a Research and Development Tax Incentive of $736,794 for the financial year ended 30 June 2024. This amount is consistent with that disclosed in the Annual Report lodged with the ASX. The debt facility with Radium Capital has been repaid leaving a residual amount of $288,587.
This announcement is authorised by CBL CEO Jeremy Steele.
Click here for the full ASX Release
This article includes content from Control Bionics, 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.
Thermo Fisher Scientific to Hold Earnings Conference Call on Wednesday, October 23, 2024
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that it will release its financial results for the third quarter 2024 before the market opens on Wednesday, October 23, 2024, and will hold a conference call on the same day at 8:30 a.m. EDT.
During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 296868. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can also be found in that section of our website under the heading "Financials." A replay of the call will be available under "News, Events & Presentations" through Wednesday, November 6, 2024.
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/20241001490746/en/
Media Contact Information:
Sandy Pound
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Website: www.thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
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New clinical data demonstrate excellent lesion durability with PulseSelect Pulsed Field Ablation System in real-world setting as approvals and adoption expand globally
- APHRS: New data confirm robust long-term durability and highly efficient procedure performed without fluoroscopy
- Successful launch in Japan follows recent reimbursement approval
- Approvals across APAC including China and Australia broaden reach for patients
Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the presentation of clinical study results demonstrating a high rate of durable lesion formation for the PulseSelectâ„¢ Pulsed Field Ablation (PFA) System in treating atrial fibrillation (Afib). Invasive remapping conducted approximately two months post-ablation with the PulseSelect PFA System demonstrated durable isolation in 98% of pulmonary veins (PV) and 96% of patients had all veins isolated.
Results were presented as a late breaking clinical trial at the Asia Pacific Heart Rhythm Society (APHRS) meeting in Sydney, Australia .
"Real-world evidence on chronic lesion formation and durability is critical as use of PFA for the treatment of Afib rapidly increases, making these results impactful and timely for the electrophysiology community," said Devi Nair , M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernard's Medical Center & Arrhythmia Research Group, Jonesboro, Arkansas . "Our research shows that treatment with PulseSelect results in durable lesion formation, which is the cornerstone of successful pulmonary vein isolation and an important addition to previous evidence establishing the safety and effectiveness of this technology."
About the Study
A total of 25 AFib patients with persistent or paroxysmal AFib (56% paroxysmal, 52% male, 69±9 years) undergoing pulmonary vein isolation (PVI) with the PulseSelect PFA System were evaluated. Invasive remapping conducted in all patients (57±9 days post-ablation) demonstrated durable isolation in 98% of PVs (102/104), and 96% of patients (24/25) had all veins isolated.
All index ablation procedures were conducted using intracardiac echocardiography and electroanatomical mapping (EAM) without fluoroscopy. General anesthesia was used in 24 of 25 patients, and all patients were discharged on the same day. Average skin-to-skin procedure time was 36 minutes. Acute PV isolation was achieved in 100% of patients. There were no complications during an average follow-up of 74 days.
PulseSelect Global Expansion
Broad adoption of PulseSelect continues globally, with more than 10,000 cases performed worldwide. In the Asia Pacific (APAC) region, milestones include regulatory approvals in China and Australia and launch in Japan following reimbursement approval.
Prof. Hiroshi Tada , Professor of the Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Japan , and President of the Japanese Heart Rhythm Society, said "PulseSelect is the first PFA catheter to receive reimbursement approval in Japan based on clinical trial results that include Japanese patients. We believe that the future widespread availability of this breakthrough technology under insurance coverage will be of great significance in the history of arrhythmia treatment in Japan ."
"These important results clearly address the durability question and add to the real-world evidence for PulseSelect," said Rebecca Seidel , president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "With expansion in new markets across the Asia Pacific region, physicians around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency and now durability as well. We are thrilled to provide this important tool to physicians for the treatment of patients with AFib."
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases. 2-5
For more information on PulseSelect, visit Medtronic.com .
About Medtronic Â
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 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 Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
References
- Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
- Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
- Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
- Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126.
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SOURCE Medtronic plc
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