MedtronicMedtronic has taken measurable steps to drive change
Doctors have used pulse oximeters for more than 40 years, but the pandemic put the devices in the spotlight after studies found they may not be accurate across all skin tones.
Click here for the full ASX Release
This article includes content from Cleo Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
Cleo’s first clinical validation study for its ovarian cancer triage test has been published in the peer-reviewed international journal Cancers. The article concluded that Cleo’s ovarian cancer test was highly accurate with 95 percent sensitivity and 95 percent specificity, correctly discriminated malignant from benign samples, and has outperformed and was superior to current clinical methods. The second peer-reviewed dataset has also been published in the medical journal Diagnostics, which concluded that CLEO’s test has correctly identified most cancer cases that were missed by the standard marker CA125. It also eliminated the majority of “false positive” results caused by CA125 use, and it correctly identified the majority of patients with early-stage ovarian cancers.CLEO has appointed New York-based healthcare industry consultancy, HcFocus, to support the commencement of its US market access program. HcFocus will provide specialised and strategic expertise to assist CLEO in navigating the complexities of the US health system and regulatory environment.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Throughout his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and lead medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Developed over a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Cleo is bringing to market three testsfor ovarian cancer diagnosis, monitoring and screening.
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within 12 months. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high-grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Before joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.
Artrya Limited (ASX:AYA), (‘Artrya’ or the ‘Company’), a medical technology company focused on commercialising its patented AI platform that detects key coronary artery disease imaging markers, has received feedback its application for regulatory approval for the Salix product with the US Food and Drug Administration (FDA) is on track following a Q-Submission meeting.
Highlights
A Q-sub is a formal written request from a company for feedback from the FDA to help guide application preparation. Artrya had requested this second meeting to validate and confirm the approach taken since the first Q-Sub meeting in June 2023.
Artrya CEO Mathew Regan said: "I am pleased to report the outcome of our second Q-sub meeting with the FDA was positive. The FDA provided valuable feedback and guidance on our upcoming application, confirming our approach is on track. This has validated the cautious approach we have taken to ensure we meet all requirements for the 510(k) application. We now have a clear path to submission, and I look forward to lodging our 510(k) application once the formal Q-Sub process is completed.”
Click here for the full ASX Release
This article includes content from Artrya Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
MedtronicMedtronic has taken measurable steps to drive change
Doctors have used pulse oximeters for more than 40 years, but the pandemic put the devices in the spotlight after studies found they may not be accurate across all skin tones.
"What we saw during the pandemic was health disparities," said Bradley, who works in sales in the Acute Care & Monitoring (ACM) business at Medtronic. "We recognize that patients of color were not faring as well as their lighter skin counterparts."
In her presentations, Bradley, the mother of a multiracial daughter, elaborates on why the devices can sometimes fall short. She calls it "technology bias."
There's a lot we still don't understand about what drives that bias, but we know low perfusion, or the flow of blood to cells and tissues, along with skin pigmentation, and user error, are at the core.1
While our pulse oximeter, Nellcor™, has delivered monitoring solutions for decades, Medtronic can do better, ACM President Frank Chan said. It's why the company has taken measurable steps to drive change, such as participating in a U.S. Food and Drug Administration panel on the accuracy of pulse oximeters and opening a physiology lab in a racially diverse neighborhood to ensure inclusive clinical trial enrollment and participation.
"We saw all the studies coming out of the pandemic around equity and pulse oximetry and delivering safe care," said Chief Medical Officer for ACM Dr. Sam Ajizian. "We accelerated our work. In doing so, we aim to do the right thing for the patient."
What is a pulse oximeter?
Dr. Ajizian was a young physician when pulse oximeters were first introduced to the marketplace. They were a "transformative" tool that removed the guesswork in measuring the amount of oxygen in a patient's blood - and alerting doctors when more may be needed.
If you've had surgery, ridden in an ambulance, or even visited a clinic, chances are a pulse oximeter has been clipped to the end of your finger.
"It's kind of magical to be able to take something on the outside of the body and use it to measure how much oxygen is going to the tissue that's contained in the blood on the inside of the body," Dr. Ajizian said.
While pulse oximeters are essential to patient safety, not all are created equal. In a recent study enrolling healthy volunteers to measure the effects of skin pigmentation and perfusion index on pulse oximeter accuracy, one of the company's competitor's devices, for example, missed 30% of hypoxemic events, or when there's an abnormally low amount of oxygen in the blood. Nellcor™ pulse oximeters, on the other hand, missed 7.9%, said Vice President of Research & Development for ACM Jason Case.1
"The goal isn't to be better than everyone else," Case said. "The goal is to provide a solution that works for everybody. How do we get that 7.9% to zero, independent of if you have thick skin, dark skin, or low perfusion?"
Walking the walk
The commitment to getting it right - every time - is why the company opened a clinical physiology lab near the Five Points neighborhood of Denver, Colorado. It's a racially diverse area where community members can easily access the unassuming lab, which is embedded within a larger medical complex. Many trial participants walk to the lab from their homes.
"We decided to locate this lab in Denver, away from the central offices of Medtronic, and it has proven to be the right choice," said Lab Manager Roger Martin-Pressman. "To make it convenient for people from diverse backgrounds to access these research opportunities was really important to me."
The lab empowers the company to conduct its own clinical trials, meaning it can test devices with more speed and frequency and, in turn, innovate quickly. "We really want devices to get better based on the data we collect here," Martin-Pressman said. "And not just better so clinicians understand how to use them, but also better so that people who wear them have better outcomes."
The larger, more diverse data set being collected at the lab is critical to research and development work at Medtronic, Case said. It ensures we're approaching our work with equity before it leaves the innovation lab.
Building trust
Obioma Nwankwo is a clinical studies coordinator for the clinical physiology lab in Denver. She recruits trial participants and often leads engagement events in the community, such as hosting booths at the city's Juneteenth festival, to build trust within the community and educate about the trials and our commitment to health equity.
"Sometimes the end goal is not always getting someone in the chair and having them come and do the study," Obioma said. "Sometimes the end goal is just spreading awareness, or having a conversation."
But the community is responding; trial enrollment continues to tick upward. The lab has already enrolled more than 130 participants and will continuously recruit. The opportunity to be part of a clinical trial that could improve device accuracy across all skin pigmentations was a driving factor for Zahra Abdullahi to enroll.
"As a minority in the healthcare system, a lot of things are overlooked," said Abdullahi, a college student studying engineering. "I'm doing this not only for my safety, but for others' as well. I have siblings and friends who are also minorities and making sure they have accurate representation in healthcare is very important."
Lasting change
When Bradley first began her career in 1991, working as a respiratory therapist for neonatal and pediatric patients, she would have argued there weren't health disparities in her work.
"When I look retrospectively on it, I recognize that's not true, there probably always were some biases," she said, adding anyone who wants to be "intellectually honest" would agree there are disparities in the access and provision of healthcare.
Even though the Medtronic pulse oximetry device meets all current FDA standards, those questions about health equity are spurring broader change, and Medtronic is making meaningful contributions.
"I'm proud that Medtronic has taken a stance to say that's not good enough," Bradley said.
Not to mention, it's just the right thing to do, said Martin-Pressman, the lab manager.
"Equality is giving everybody the same opportunity, but equity is ensuring the outcome is the same," he said.
Ronda Bradley, left, with her family.
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SOURCE: Medtronic
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Product innovation driving growth across diversified health tech portfolio, including Automated Insulin Delivery, Transcatheter Aortic Valve Replacement, Pulsed Field Cardiac Ablation, Pain Stimulation, and Deep Brain Stimulation
- Medtronic plc (NYSE: MDT) today announced financial results for its first quarter (Q1) of fiscal year 2025 (FY25), which ended July 26, 2024 .
Key Highlights
Financial Results
Medtronic reported Q1 worldwide revenue of $7.915 billion and adjusted revenue of $8.004 billion , an increase of 2.8% as reported and 5.3% on an organic basis. Organic revenue growth comparison excludes:
As reported, Q1 GAAP net income and diluted earnings per share (EPS) were $1.042 billion and $0.80 , respectively, representing increases of 32% and 36%, respectively. As detailed in the financial schedules included at the end of this release, Q1 non-GAAP net income and non-GAAP diluted EPS were $1.592 billion and $1.23 , respectively, representing flat results and an increase of 3%, respectively. Included in Q1 non-GAAP diluted EPS was a -6 cent impact from foreign currency translation. Non-GAAP diluted EPS grew 8% on a constant currency basis.
"We executed, exceeded our commitments, and delivered another good quarter. Our underlying markets are healthy, we're driving operating rigor, and new product innovation is fueling diversified growth across key health tech markets," said Geoff Martha , Medtronic chairman and chief executive officer. "As we deliver innovation and execute on our transformation, we expect this to translate into strong returns for our shareholders."
Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Revenue of $3.007 billion increased 5.5% as reported and 6.9% organic, with high-single digit increases in CRHF and SHA, and a mid-single digit increase in CPV, all on an organic basis.
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Revenue of $2.317 billion increased 4.4% as reported and 5.3% organic, with a low-double digits increase in Neuromodulation, a mid-single digit increase in CST, and a low-single digit increase in Specialty Therapies, all on an organic basis.
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. Revenue of $1.996 billion decreased 0.4% as reported and increased 1.0% organic, with a low-single digit increase in SE and flat result in ACM, both on an organic basis.
Diabetes
Revenue of $647 million increased 11.8% as reported and 12.6% organic.
Guidance
The company today raised its FY25 revenue growth and EPS guidance.
The company raised its FY25 organic revenue growth guidance to 4.5% to 5% versus the prior range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on an adjusted basis would be in the range of 3.4% to 4.3%.
The company raised its FY25 diluted non-GAAP EPS guidance to the new range of $5.42 to $5.50 versus the prior $5.40 to $5.50 . This includes an estimated -5% impact from foreign currency exchange based on recent rates, unchanged from the prior guidance. The company's guidance represents FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.
"Overall revenue outperformance flowed through to the bottom line, with adjusted EPS ahead of expectations," said Gary Corona , Medtronic interim chief financial officer. "We're raising our guidance today as we expect to sustain growth from new product introductions, continue to make the investments to support those launches, and deliver on our commitment to restore earnings power."
Video Webcast Information
Medtronic will host a video webcast today, August 20 , at 8:00 a.m. EDT ( 7:00 a.m. CDT ) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com , and this earnings release will be archived at news.medtronic.com . Within 24 hours of the webcast, a replay of the webcast and transcript of the company's prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com .
Medtronic plans to report its FY25 second, third, and fourth quarter results on November 19, 2024 , February 18, 2025 , and Wednesday, May 21, 2025 , respectively. Confirmation and additional details will be provided closer to the specific event.
Financial Schedules and Earnings Presentation
The first quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com . To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here . To view the first quarter earnings presentation, click here .
MEDTRONIC PLC WORLD WIDE REVENUE (1) (Unaudited) | |||||||||||||
FIRST QUARTER | |||||||||||||
REPORTED | ORGANIC | ||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||
Cardiovascular | $ 3,007 | $ 2,850 | 5.5 % | $ (39) | $ 3,046 | $ 2,850 | 6.9 % | ||||||
Cardiac Rhythm & Heart Failure | 1,535 | 1,446 | 6.2 | (19) | 1,555 | 1,446 | 7.5 | ||||||
Structural Heart & Aortic | 856 | 814 | 5.1 | (12) | 868 | 814 | 6.6 | ||||||
Coronary & Peripheral Vascular | 616 | 589 | 4.5 | (8) | 624 | 589 | 5.8 | ||||||
Neuroscience | 2,317 | 2,219 | 4.4 | (18) | 2,336 | 2,219 | 5.3 | ||||||
Cranial & Spinal Technologies | 1,147 | 1,103 | 4.0 | (9) | 1,156 | 1,103 | 4.8 | ||||||
Specialty Therapies | 713 | 695 | 2.5 | (7) | 719 | 695 | 3.4 | ||||||
Neuromodulation | 457 | 420 | 8.9 | (3) | 460 | 420 | 9.6 | ||||||
Medical Surgical | 1,996 | 2,005 | (0.4) | (29) | 2,024 | 2,005 | 1.0 | ||||||
Surgical & Endoscopy | 1,544 | 1,546 | (0.1) | (22) | 1,566 | 1,546 | 1.3 | ||||||
Acute Care & Monitoring | 452 | 459 | (1.5) | (6) | 458 | 459 | (0.1) | ||||||
Diabetes | 647 | 578 | 11.8 | (4) | 651 | 578 | 12.6 | ||||||
Total Reportable Segments | 7,967 | 7,652 | 4.1 | (90) | 8,057 | 7,652 | 5.3 | ||||||
Other (2) | (52) | 50 | (203.7) | (2) | — | — | — | ||||||
TOTAL | $ 7,915 | $ 7,702 | 2.8 % | $ (93) | $ 8,057 | $ 7,652 | 5.3 % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended July 26, 2024 excludes $142 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $38 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $50 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC U.S. (1)(2) REVENUE (Unaudited) | |||||||||||
FIRST QUARTER | |||||||||||
REPORTED | ORGANIC | ||||||||||
(in millions) | FY25 | FY24 | Growth | Adjusted | Adjusted | Growth | |||||
Cardiovascular | $ 1,403 | $ 1,350 | 3.9 % | $ 1,403 | $ 1,350 | 3.9 % | |||||
Cardiac Rhythm & Heart Failure | 766 | 720 | 6.4 | 766 | 720 | 6.4 | |||||
Structural Heart & Aortic | 368 | 357 | 3.3 | 368 | 357 | 3.3 | |||||
Coronary & Peripheral Vascular | 268 | 273 | (1.6) | 268 | 273 | (1.6) | |||||
Neuroscience | 1,565 | 1,497 | 4.5 | 1,565 | 1,497 | 4.5 | |||||
Cranial & Spinal Technologies | 855 | 821 | 4.2 | 855 | 821 | 4.2 | |||||
Specialty Therapies | 398 | 392 | 1.5 | 398 | 392 | 1.5 | |||||
Neuromodulation | 312 | 284 | 9.8 | 312 | 284 | 9.8 | |||||
Medical Surgical | 881 | 867 | 1.6 | 881 | 867 | 1.6 | |||||
Surgical & Endoscopy | 630 | 619 | 1.6 | 630 | 619 | 1.6 | |||||
Acute Care & Monitoring | 251 | 248 | 1.4 | 251 | 248 | 1.4 | |||||
Diabetes | 215 | 188 | 14.3 | 215 | 188 | 14.3 | |||||
Total Reportable Segments | 4,064 | 3,903 | 4.1 | 4,064 | 3,903 | 4.1 | |||||
Other (3) | 18 | 22 | (15.6) | — | — | — | |||||
TOTAL | $ 4,082 | $ 3,924 | 4.0 % | $ 4,064 | $ 3,903 | 4.1 % |
(1) | U.S. includes the United States and U.S. territories. |
(2) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(3) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested. |
MEDTRONIC PLC INTERNATIONAL REVENUE (1) (Unaudited) | |||||||||||||
FIRST QUARTER | |||||||||||||
REPORTED | ORGANIC | ||||||||||||
(in millions) | FY25 | FY24 | Growth | Currency | Adjusted | Adjusted | Growth | ||||||
Cardiovascular | $ 1,604 | $ 1,500 | 6.9 % | $ (39) | $ 1,643 | $ 1,500 | 9.5 % | ||||||
Cardiac Rhythm & Heart Failure | 769 | 726 | 5.9 | (19) | 789 | 726 | 8.6 | ||||||
Structural Heart & Aortic | 487 | 457 | 6.5 | (12) | 499 | 457 | 9.2 | ||||||
Coronary & Peripheral Vascular | 347 | 317 | 9.7 | (8) | 355 | 317 | 12.2 | ||||||
Neuroscience | 752 | 721 | 4.3 | (18) | 770 | 721 | 6.8 | ||||||
Cranial & Spinal Technologies | 292 | 282 | 3.4 | (9) | 301 | 282 | 6.6 | ||||||
Specialty Therapies | 314 | 303 | 3.8 | (7) | 321 | 303 | 5.9 | ||||||
Neuromodulation | 146 | 136 | 7.2 | (3) | 149 | 136 | 9.4 | ||||||
Medical Surgical | 1,115 | 1,137 | (2.0) | (29) | 1,143 | 1,137 | 0.5 | ||||||
Surgical & Endoscopy | 915 | 926 | (1.3) | (22) | 937 | 926 | 1.1 | ||||||
Acute Care & Monitoring | 200 | 211 | (5.0) | (6) | 207 | 211 | (2.0) | ||||||
Diabetes | 432 | 390 | 10.7 | (4) | 436 | 390 | 11.7 | ||||||
Total Reportable Segments | 3,903 | 3,749 | 4.1 | (90) | 3,993 | 3,749 | 6.5 | ||||||
Other (2) | (70) | 28 | (347.5) | (2) | — | — | — | ||||||
TOTAL | $ 3,832 | $ 3,777 | 1.5 % | $ (93) | $ 3,993 | $ 3,749 | 6.5 % |
(1) | The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum. Percentages have been calculated using actual, non-rounded figures and, therefore, may not recalculate precisely. |
(2) | Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, and specifically for the first quarter of fiscal year 2025, incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(3) | The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates. |
(4) | The three months ended July 26, 2024 excludes $161 million of revenue adjustments related to $90 million of incremental Italian payback accruals further described in note (2), $19 million of inorganic revenue related to the transition activity noted in (2), and $90 million of unfavorable currency impact on the remaining segments. The three months ended July 28, 2023 excludes $28 million of inorganic revenue related to the transition activity noted in (2). |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) | |||
Three months ended | |||
(in millions, except per share data) | July 26, 2024 | July 28, 2023 | |
Net sales | $ 7,915 | $ 7,702 | |
Costs and expenses: | |||
Cost of products sold, excluding amortization of intangible assets | 2,761 | 2,628 | |
Research and development expense | 676 | 668 | |
Selling, general, and administrative expense | 2,655 | 2,613 | |
Amortization of intangible assets | 414 | 429 | |
Restructuring charges, net | 47 | 54 | |
Certain litigation charges, net | 81 | 40 | |
Other operating expense, net | 1 | 1 | |
Operating profit | 1,278 | 1,268 | |
Other non-operating income, net | (157) | (76) | |
Interest expense, net | 167 | 148 | |
Income before income taxes | 1,268 | 1,196 | |
Income tax provision | 220 | 400 | |
Net income | 1,049 | 797 | |
Net income attributable to noncontrolling interests | (6) | (6) | |
Net income attributable to Medtronic | $ 1,042 | $ 791 | |
Basic earnings per share | $ 0.81 | $ 0.59 | |
Diluted earnings per share | $ 0.80 | $ 0.59 | |
Basic weighted average shares outstanding | 1,293.3 | 1,330.5 | |
Diluted weighted average shares outstanding | 1,296.5 | 1,333.8 |
The data in the schedule above has been intentionally rounded to the nearest million. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||||
Three months ended July 26, 2024 | |||||||||||||||||
(in millions, except per share data) | Net Sales | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted EPS | Effective | ||||||||
GAAP | $ 7,915 | $ 2,761 | 65.1 % | $ 1,278 | 16.1 % | $ 1,268 | $ 1,042 | $ 0.80 | 17.4 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 414 | 5.1 | 414 | 340 | 0.26 | 18.1 | ||||||||
Restructuring and associated costs (2) | — | (9) | 0.1 | 62 | 0.8 | 62 | 51 | 0.04 | 19.4 | ||||||||
Acquisition and divestiture-related items (3) | — | (10) | 0.1 | 12 | 0.1 | 12 | 11 | 0.01 | 8.3 | ||||||||
Certain litigation charges, net | — | — | — | 81 | 1.0 | 81 | 68 | 0.05 | 16.0 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | (17) | (17) | (0.01) | — | ||||||||
Medical device regulations (5) | — | (11) | 0.1 | 14 | 0.2 | 14 | 11 | 0.01 | 21.4 | ||||||||
Other (6) | 90 | — | 0.6 | 90 | 1.1 | 90 | 70 | 0.05 | 22.2 | ||||||||
Certain tax adjustments, net | — | — | — | — | — | — | 17 | 0.01 | — | ||||||||
Non-GAAP | $ 8,004 | $ 2,730 | 65.9 % | $ 1,953 | 24.4 % | $ 1,925 | $ 1,592 | $ 1.23 | 17.0 % | ||||||||
Currency impact | 91 | (31) | 0.8 | 100 | 1.0 | 0.06 | |||||||||||
Currency Adjusted | $ 8,095 | $ 2,699 | 66.7 % | $ 2,053 | 25.4 % | $ 1.29 | |||||||||||
Three months ended July 28, 2023 | |||||||||||||||||
(in millions, except per share data) | Net Sales | Cost of | Gross | Operating | Operating | Income | Net Income | Diluted EPS | Effective | ||||||||
GAAP | $ 7,702 | $ 2,628 | 65.9 % | $ 1,268 | 16.5 % | $ 1,196 | $ 791 | $ 0.59 | 33.4 % | ||||||||
Non-GAAP Adjustments: | |||||||||||||||||
Amortization of intangible assets | — | — | — | 429 | 5.6 | 429 | 364 | 0.27 | 15.2 | ||||||||
Restructuring and associated costs (2) | — | (16) | 0.2 | 91 | 1.2 | 91 | 76 | 0.06 | 16.5 | ||||||||
Acquisition and divestiture-related items (3) | — | (6) | 0.1 | 50 | 0.6 | 50 | 46 | 0.03 | 6.0 | ||||||||
Certain litigation charges, net | — | — | — | 40 | 0.5 | 40 | 31 | 0.02 | 22.5 | ||||||||
(Gain)/loss on minority investments (4) | — | — | — | — | — | 64 | 64 | 0.05 | — | ||||||||
Medical device regulations (5) | — | (21) | 0.3 | 31 | 0.4 | 31 | 25 | 0.02 | 22.6 | ||||||||
Certain tax adjustments, net (7) | — | — | — | — | — | — | 198 | 0.15 | — | ||||||||
Non-GAAP | $ 7,702 | $ 2,586 | 66.4 % | $ 1,909 | 24.8 % | $ 1,902 | $ 1,596 | $ 1.20 | 15.8 % |
See description of non-GAAP financial measures contained in the press release dated August 20, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum. |
(2) | Associated and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges. |
(4) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
(5) | The charges represent incremental costs of complying with the new European Union (E.U.) medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(6) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(7) | The charge relates to an income tax reserve adjustment associated with the June 2023 Israeli Central-Lod District Court decision in Medtronic Ventor Technologies Ltd v. Kfar Saba Assessing Office and amortization of previously established deferred tax assets from intercompany intellectual property transactions. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||||||||||||||
Three months ended July 26, 2024 | |||||||||||||||
(in millions) | Net Sales | SG&A | SG&A Expense | R&D | R&D Expense | Other Operating | Other Operating | Other | |||||||
GAAP | $ 7,915 | $ 2,655 | 33.5 % | $ 676 | 8.5 % | $ 1 | — % | $ (157) | |||||||
Non-GAAP Adjustments: | |||||||||||||||
Restructuring and associated costs (2) | — | (5) | (0.2) | — | — | — | — | — | |||||||
Acquisition and divestiture-related items (3) | — | (7) | (0.3) | — | — | 6 | 0.1 | — | |||||||
Medical device regulations (4) | — | — | — | (3) | — | — | — | — | |||||||
Other (5) | 90 | — | — | — | — | — | — | — | |||||||
(Gain)/loss on minority investments (6) | — | — | — | — | — | — | — | 17 | |||||||
Non-GAAP | $ 8,004 | $ 2,642 | 33.0 % | $ 673 | 8.4 % | $ 7 | 0.1 % | $ (140) |
See description of non-GAAP financial measures contained in the press release dated August 20, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Associated and other costs primarily include salaries and wages for employees supporting the restructuring activities, consulting expenses, and asset write-offs. |
(3) | The charges primarily include business combination costs, changes in fair value of contingent consideration, and exit of business related charges. |
(4) | The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period. |
(5) | Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015. |
(6) | We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations. |
MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS (1) (Unaudited) | |||
Three months ended | |||
(in millions) | July 26, 2024 | July 28, 2023 | |
Net cash provided by operating activities | $ 986 | $ 875 | |
Additions to property, plant, and equipment | (520) | (354) | |
Free Cash Flow (2) | $ 466 | $ 521 |
See description of non-GAAP financial measures contained in the press release dated August 20, 2024. | |
(1) | The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
(2) | Free cash flow represents operating cash flows less property, plant, and equipment additions. |
MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||
(in millions) | July 26, 2024 | April 26, 2024 | ||
ASSETS | ||||
Current assets: | ||||
Cash and cash equivalents | $ 1,311 | $ 1,284 | ||
Investments | 6,532 | 6,721 | ||
Accounts receivable, less allowances and credit losses of $170 and $173, respectively | 6,011 | 6,128 | ||
Inventories | 5,414 | 5,217 | ||
Other current assets | 2,679 | 2,584 | ||
Total current assets | 21,947 | 21,935 | ||
Property, plant, and equipment, net | 6,282 | 6,131 | ||
Goodwill | 41,084 | 40,986 | ||
Other intangible assets, net | 12,819 | 13,225 | ||
Tax assets | 3,554 | 3,657 | ||
Other assets | 4,062 | 4,047 | ||
Total assets | $ 89,749 | $ 89,981 | ||
LIABILITIES AND EQUITY | ||||
Current liabilities: | ||||
Current debt obligations | $ 1,553 | $ 1,092 | ||
Accounts payable | 2,291 | 2,410 | ||
Accrued compensation | 1,776 | 2,375 | ||
Accrued income taxes | 1,063 | 1,330 | ||
Other accrued expenses | 3,604 | 3,582 | ||
Total current liabilities | 10,287 | 10,789 | ||
Long-term debt | 26,312 | 23,932 | ||
Accrued compensation and retirement benefits | 1,107 | 1,101 | ||
Accrued income taxes | 1,917 | 1,859 | ||
Deferred tax liabilities | 496 | 515 | ||
Other liabilities | 1,470 | 1,365 | ||
Total liabilities | 41,589 | 39,561 | ||
Commitments and contingencies | ||||
Shareholders' equity: | ||||
Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,282,494,588 and | — | — | ||
Additional paid-in capital | 20,810 | 23,129 | ||
Retained earnings | 30,547 | 30,403 | ||
Accumulated other comprehensive loss | (3,410) | (3,318) | ||
Total shareholders' equity | 47,947 | 50,214 | ||
Noncontrolling interests | 213 | 206 | ||
Total equity | 48,160 | 50,420 | ||
Total liabilities and equity | $ 89,749 | $ 89,981 |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) | |||
Three months ended | |||
(in millions) | July 26, 2024 | July 28, 2023 | |
Operating Activities: | |||
Net income | $ 1,049 | $ 797 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 662 | 672 | |
Provision for credit losses | 18 | 21 | |
Deferred income taxes | 88 | — | |
Stock-based compensation | 83 | 73 | |
Other, net | (9) | 135 | |
Change in operating assets and liabilities, net of acquisitions and divestitures: | |||
Accounts receivable, net | 110 | 164 | |
Inventories | (217) | (410) | |
Accounts payable and accrued liabilities | (604) | (673) | |
Other operating assets and liabilities | (194) | 96 | |
Net cash provided by operating activities | 986 | 875 | |
Investing Activities: | |||
Additions to property, plant, and equipment | (520) | (354) | |
Purchases of investments | (1,879) | (1,916) | |
Sales and maturities of investments | 2,157 | 1,748 | |
Other investing activities, net | (17) | (17) | |
Net cash used in investing activities | (259) | (539) | |
Financing Activities: | |||
Change in current debt obligations, net | (624) | 500 | |
Issuance of long-term debt | 3,209 | — | |
Dividends to shareholders | (898) | (918) | |
Issuance of ordinary shares | 89 | 77 | |
Repurchase of ordinary shares | (2,492) | (152) | |
Other financing activities | (15) | (8) | |
Net cash used in financing activities | (731) | (501) | |
Effect of exchange rate changes on cash and cash equivalents | 31 | (39) | |
Net change in cash and cash equivalents | 27 | (204) | |
Cash and cash equivalents at beginning of period | 1,284 | 1,543 | |
Cash and cash equivalents at end of period | $ 1,311 | $ 1,339 | |
Supplemental Cash Flow Information | |||
Cash paid for: | |||
Income taxes | $ 394 | $ 117 | |
Interest | 119 | 84 |
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum. |
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow on LinkedIn .
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company's periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "looking ahead," "may," "plan," "possible," "potential," "project," "should," "going to," "will," and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.
NON-GAAP FINANCIAL MEASURES
This press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2024.
Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company's underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management's review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company's consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.
Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
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SOURCE Medtronic plc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/August2024/20/c5612.html
News Provided by Canada Newswire via QuoteMedia
The board of directors of Medtronic plc (NYSE:MDT) on Thursday, August 15, 2024 approved the company's cash dividend for the second quarter of fiscal year 2025 of $0.70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024 . Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on October 11, 2024 to shareholders of record at the close of business on September 27, 2024 .
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-announces-cash-dividend-for-second-quarter-of-fiscal-year-2025-302224139.html
SOURCE Medtronic plc
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News Provided by Canada Newswire via QuoteMedia
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its second quarter 2024 financial results and provided a business update.
"Our work in hypertension and coronary artery disease aligns with a renaissance occurring in cardiac pacing and balloon angioplasty, applying new innovations to enhance these foundational device-based interventions and create more potent therapeutic solutions. At our inaugural R&D day in June, we were excited to share our insights into this renaissance and the potential role we believe our lead programs – AVIM therapy and Virtue SAB – will play in improving outcomes for patients. We were delighted to host esteemed cardiology leaders Drs. David Kandzari and Vivek Reddy, who highlighted the critical unmet needs in high-risk hypertension and expressed their enthusiasm for the potential of AVIM therapy to transform care for these patient populations," stated David Hochman, founder, chief executive officer, and chairman of Orchestra BioMed. "As we look ahead to the second half of the year, we remain focused on driving patient enrollment in the BACKBEAT global pivotal study across the U.S. and EU, and look forward to providing key updates on our Virtue SAB program."
Second Quarter 2024 and Recent Business Update
During its June 11 th R&D Day, Orchestra BioMed provided an educational program on its lead asset, atrioventricular interval modulation ("AVIM") therapy for the treatment of hypertension in high-risk patient populations. Orchestra BioMed has a strategic collaboration with Medtronic (NYSE: MDT) for the development and commercialization of AVIM therapy for the treatment of hypertension in patients indicated for a cardiac pacemaker. The replay of the webcast is available on the Orchestra BioMed website: link to webcast .
The event featured presentations from key opinion leaders, David Kandzari, M.D., FACC, FSCAI and Vivek Reddy, M.D., focused on the unmet hypertension treatment need in older high-risk patients, the AVIM therapy mechanism of action, clinical data from the MODERATO I and II studies, and design of the BACKBEAT study.
R&D Day Takeaways:
Additional Recent Highlights:
Financial Results for the Second Quarter Ended June 30, 2024
About Orchestra BioMed
Orchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed's lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing the Virtue ® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com , and follow us on LinkedIn .
References to Websites and Social Media Platforms
References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release.
About AVIM Therapy
AVIM therapy, also known as BackBeat CNT™, is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized, pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will further evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in a similar target population of patients who have been indicated for, and recently implanted with, a dual-chamber cardiac pacemaker.
About Virtue SAB
Virtue SAB is a patented drug/device combination product candidate in development for the treatment of certain forms of artery disease that is designed to deliver a proprietary, investigational, extended-release formulation of sirolimus, SirolimusEFR™, to the vessel wall during balloon angioplasty without any coating on the balloon surface or the need to leave a stent or other permanent implant in the artery. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated clinical study conducted in Europe. Virtue SAB has been granted Breakthrough Device designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Orchestra BioMed has a strategic partnership with Terumo (Terumo, TSE: 4543), a global leader in medical technology headquartered in Tokyo, Japan, as well as Terumo Medical Corporation, its U.S. subsidiary, to collaborate on the global development and commercialization of Virtue SAB in coronary and peripheral vascular indications.
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the initiation, enrollment, timing, implementation and design of the Company's planned and ongoing pivotal trials and reporting of top-line results, realizing the clinical and commercial value of BackBeat CNT and Virtue SAB, the expected runway of the Company's current cash, cash equivalents, marketable securities and expected proceeds from a revised Terumo agreement, the Company's ability to conclude a favorable collaboration agreement with Terumo, the potential safety and efficacy of the Company's product candidates and the ability of the Company's partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company's management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company's commercial product candidates and ongoing regulation of the Company's product candidates, if approved; the timing of, and the Company's ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading "Item 1A. Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 27, 2024.
The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law.
ORCHESTRA BIOMED HOLDINGS, INC. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share data) | |||||||
(Unaudited) | |||||||
June 30, | December 31, | ||||||
2024 | 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 23,713 | $ | 30,559 | |||
Marketable securities | 41,468 | 56,968 | |||||
Strategic investments, current portion | — | 68 | |||||
Accounts receivable, net | 80 | 99 | |||||
Inventory | 70 | 146 | |||||
Prepaid expenses and other current assets | 1,150 | 1,274 | |||||
Total current assets | 66,481 | 89,114 | |||||
Property and equipment, net | 1,235 | 1,279 | |||||
Right-of-use assets | 1,331 | 1,555 | |||||
Strategic investments, less current portion | 2,495 | 2,495 | |||||
Deposits and other assets | 841 | 769 | |||||
TOTAL ASSETS | $ | 72,383 | $ | 95,212 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 6,273 | $ | 2,900 | |||
Accrued expenses and other liabilities | 4,225 | 5,149 | |||||
Operating lease liability, current portion | 350 | 649 | |||||
Deferred revenue, current portion | 3,656 | 2,510 | |||||
Total current liabilities | 14,504 | 11,208 | |||||
Deferred revenue, less current portion | 12,652 | 14,923 | |||||
Operating lease liability, less current portion | 1,102 | 1,038 | |||||
TOTAL LIABILITIES | 28,258 | 27,169 | |||||
STOCKHOLDERS' EQUITY | |||||||
Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023. | — | — | |||||
Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 35,824,571 and 35,777,412 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. | 4 | 4 | |||||
Additional paid-in capital | 322,441 | 316,903 | |||||
Accumulated other comprehensive loss | (23 | ) | (10 | ) | |||
Accumulated deficit | (278,297 | ) | (248,854 | ) | |||
TOTAL STOCKHOLDERS' EQUITY | 44,125 | 68,043 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 72,383 | $ | 95,212 | |||
ORCHESTRA BIOMED HOLDINGS, INC. | |||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(in thousands, except share and per share data) | |||||||
(Unaudited) | |||||||
Three Months Ended June 30, | |||||||
2024 | 2023 | ||||||
Revenue: | |||||||
Partnership revenue | $ | 628 | $ | 728 | |||
Product revenue | 150 | 187 | |||||
Total revenue | 778 | 915 | |||||
Expenses: | |||||||
Cost of product revenues | 44 | 54 | |||||
Research and development | 11,126 | 8,499 | |||||
Selling, general and administrative | 6,467 | 5,318 | |||||
Total expenses | 17,637 | 13,871 | |||||
Loss from operations | (16,859 | ) | (12,956 | ) | |||
Other income (expense): | |||||||
Interest income, net | 902 | 941 | |||||
Loss on fair value of strategic investments | (23 | ) | (31 | ) | |||
Total other income | 879 | 910 | |||||
Net loss | $ | (15,980 | ) | $ | (12,046 | ) | |
Net loss per share | |||||||
Basic and diluted | $ | (0.45 | ) | $ | (0.35 | ) | |
Weighted-average shares used in computing net loss per share, basic and diluted | 35,800,273 | 34,613,466 | |||||
Comprehensive loss | |||||||
Net loss | $ | (15,980 | ) | $ | (12,046 | ) | |
Unrealized loss on marketable securities | (15 | ) | (61 | ) | |||
Comprehensive loss | $ | (15,995 | ) | $ | (12,107 | ) | |
Investor Contact:
Bob Yedid
LifeSci Advisors
(516) 428-8577
Bob@lifesciadvisors.com
Media Contact:
Kelsey Kirk-Ellis
Orchestra BioMed
(484) 682-4892
Kkirkellis@orchestrabiomed.com
News Provided by GlobeNewswire via QuoteMedia
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its first quarter of fiscal year 2025 on Tuesday, August 20, 2024 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's first quarter of fiscal year 2025, which ended on Friday, July 26, 2024 .
Medtronic will host a video webcast at 7:00 a.m. CDT on Tuesday, August 20, 2024 , to discuss results for its first quarter of full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .
Within 24 hours of the broadcast, a replay and transcript of the prepared remarks will be available by clicking on the Events link at https://investorrelations.medtronic.com .
Looking ahead, Medtronic plans to report its second, third, and fourth quarter fiscal year 2025 results on Tuesday, November 19, 2024 , Tuesday, February 18, 2025 , and Wednesday, May 21, 2025 , respectively. For these events, confirmation and additional details will be provided closer to the specific event.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow 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.
Contacts: | |
Erika Winkels | Ryan Weispfenning |
Public Relations | Investor Relations |
+1-763-526-8478 | +1-763-505-4626 |
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SOURCE Medtronic plc
View original content to download multimedia: http://www.newswire.ca/en/releases/archive/August2024/12/c5385.html
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