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Stereotaxis Receives CE Mark Recertification Under EU’s MDR Regulatory Framework

ST. LOUIS, May 24, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. The recertification under MDR covers all Stereotaxis devices currently available in Europe. MDR (Regulation (EU) 2017/745) replaces the former European Medical Device Directive, which had governed the approval and marketing of medical devices in the EU. The new regulation includes more stringent standards and requirements across quality, clinical and post-market surveillance areas. It is intended to create a robust regulatory framework for improved clinical safety and market access for medical devices. Stereotaxis has now received its updated EU Quality Management System Certificate. This certificate shows that the Stereotaxis Quality System is in accordance with MDR and that Stereotaxis’ products now have a valid CE Mark under MDR. This MDR certification will support regulatory clearances of upcoming innovations. “This final step in the certification of our products and quality systems under MDR is the culmination of several years of diligent work by the Stereotaxis team,” said Matthew Stepanek, Sr. Director of Regulatory Affairs, Quality & Technical Writing. “We appreciate the collaboration with our Notified Body in this entire process.” “This is a reflection of Stereotaxis’ commitment to high-quality devices, systems, and processes to ensure the best possible experience for the patients and physicians that rely on our technology,” said David Fischel, Chairman and CEO. “Congratulations to all those at Stereotaxis who made this possible.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Company Contacts:                                                        David L. FischelChairman and Chief Executive Officer Kimberly R. Peery                                                        Chief Financial Officer 314-678-6100Investors@Stereotaxis.com

BridgeBio Pharma to Present Additional Analyses from the Phase 3 ATTRibute-CM Study of Acoramidis in Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) at the 2024 ISA Meeting

– BridgeBio to host investor call on Wednesday, May 29, 2024 at 5:30 pm ET, with presentations from Mathew Maurer, M.D. of Columbia University Irving Medical Center, U.S. and Ahmad Masri, M.D., M.S. of Oregon Health & Science University, U.S. PALO ALTO, Calif., May 24, 2024 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, announced today that 12 oral and moderated poster presentations will be shared at the 2024 International Symposium on Amyloidosis (ISA), taking place in Rochester, Minnesota on May 26 – 30, 2024. BridgeBio will also host an investor call on May 29, 2024, at 5:30 pm ET to discuss the recent analyses and positive data from the ATTRibute-CM Phase 3 trial and emerging real-world evidence in ATTR-CM. The investor call will include presentations from Mathew Maurer, M.D. of Columbia University Irving Medical Center and Ahmad Masri, M.D., M.S. of Oregon Health & Science University. To access the oral presentations and moderated poster presentations following the Company’s participation at the 2024 ISA, please visit investor.bridgebio.com/presentations. Oral presentation and moderated poster presentation details: Acoramidis impact on clinical outcomes: Early increase in serum transthyretin level is an independent predictor of improved survival in ATTR cardiomyopathy: Insights from the acoramidis phase 3 study ATTRibute-CM Presenter: Mathew Maurer, M.D., Columbia University Irving Medical Center, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis treatment-related increase in serum TTR is associated with lower cardiovascular mortality in ATTR-CM: Insights from ATTRibute-CMPresenter: Nitasha Sarswat, M.D., University of Chicago Medicine, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis treatment-related increase in serum TTR is associated with a lower risk of cardiovascular hospitalization in ATTR-CM patients: Insights from the ATTRibute-CM trial  Presenter: Margot Davis, M.D., Vancouver General Hospital, CAOral presentation date & time: Wednesday, May 29 at 10:30 am CT Acoramidis achieves early reduction in cardiovascular death or hospitalization in transthyretin amyloid cardiomyopathy (ATTR-CM): Results from the ATTRibute-CM clinical trialPresenter: Kevin M. Alexander, M.D., Stanford University School of Medicine, U.S.Oral presentation date & time: Wednesday, May 29 at 10:30 am CT Higher risk of mortality in previously hospitalized patients: Insights from ATTRibute-CMPresenter: John Whang, M.D., Chief Medical Affairs Officer of BridgeBio Cardiorenal, presenting on behalf of authorsModerated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis improves clinical outcomes in transthyretin amyloid cardiomyopathy [Encore]Presenter: Daniel Judge, M.D., Medical University of South Carolina, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT ATTRibute-CM: ITT sensitivity analysis and sub-analysis comparing acoramidis and placebo in stage 4 CKD [Encore]Presenter: Julian D. Gillmore, M.D., Ph.D., University College London’s Centre for Amyloidosis, UKModerated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis impact on quality of life: Health-related quality of life in patients with symptomatic transthyretin amyloid cardiomyopathy treated with acoramidis: an EQ-5D analysis from the ATTRibute-CM study [Encore] Presenter: Mazen Hanna, M.D., Cleveland Clinic, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Improved health-related quality of life in acoramidis-treated patients with ATTR-CM, demonstrated by improvements in KCCQ scores [Encore]Presenter: Brett W. Sperry, M.D., Saint Luke’s Health System, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis impact on biomarkers of clinical relevance in ATTR-CM: Acoramidis significantly improves NT-proBNP indices that indicate ATTR-CM disease progression and predict subsequent mortality: Insights from the ATTRibute-CM study [Encore] Presenter: Michel Khouri, M.D., Duke University Medical Center, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis treatment effects reflected in structural and functional measures by cardiac magnetic resonance imaging: Acoramidis may improve cardiac function and promote regression in ATTR-CM: Data from the ATTRibute-CM cardiac magnetic resonance (CMR) substudy [Encore] Presenter: Jean-Francois Tamby, M.D., M.B.A., VP of Clinical Development at BridgeBio, U.S.Moderated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Acoramidis and transthyretin amyloidosis prevention:   Rationale & design of ACT-EARLY, the acoramidis transthyretin amyloidosis prevention trial Poster presenter: Pablo Garcia-Pavia, M.D., Ph.D., Iron Gate Majadahonda University Hospital, ESModerated poster presentation date & time: Wednesday, May 29 at 10:00 am CT Webcast informationBridgeBio will host an investor call and simultaneous webcast to discuss the recent analyses and positive data from the ATTRibute-CM Phase 3 trial and emerging real-world evidence in ATTR-CM presented at the 2024 ISA, ESC Heart Failure 2024 and the 2024 ACC Annual Scientific Sessions & Expo on Wednesday, May 29 at 5:30 pm ET. A link to the webcast may be accessed from the event calendar page of BridgeBio’s website at https://investor.bridgebio.com/. A replay of the conference call and webcast will be archived on the Company’s website and will be available for at least 30 days following the event. About BridgeBio Pharma, Inc.BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter. BridgeBio Media Contact:Vikram Balicontact@bridgebio.com (650)-789-8220

HoneyNaps secures a $11.6 million Series B investment, becoming the No. 1 ranked A.I Sleep Technology Company

HoneyNaps secures $11.6 million in series B funding, propelling its entry into the American medical market.BOSTON, May 24, 2024 /PRNewswire/ — HoneyNaps, an industry-leading South Korean company in artificial intelligence (AI) sleep data analysis, announced on the 7th that it has closed its series B round of funding, securing $11.6 million.The series B funding is a successful achievement, nearly three times the $3.9 million raised through series A funding back in 2021. With the listing contract signed with Korea Investment & Securities Co., Ltd. in March 2024, the company is poised to become the no. 1 listed company in Sleep Technology (Sleep-Tech) that features an AI bio signal model.

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HoneyNaps Solutions

In this round, many institutions participated as new investors such as Korea Industrial Bank, Hi investment Partners and QUAD Investment Management. Despite a freeze-up in venture investment, this series B round achieved an early close due to overbooking, driven by overwhelming participation from prestigious domestic and foreign investors.
Founded in July 2015, HoneyNaps has amassed about $16.2 million to date, starting with seed funding for about $0.7 million, secured through success-share-funding from the Ministry of SMEs and Startups in 2019. This funding marks the largest scale among recent financings secured by domestic Sleep-Tech companies.HoneyNaps obtained FDA approval for its AI sleep diagnosis software SOMNUM in 2023, establishing partnerships with major university hospitals across the U.S. through its Boston-based American branch. The domestic sales growth coupled with the perceived potential for export to the American medical market are cited as key drivers to the company’s success in funding.SOMNUM is an algorithm that analyzes bio signal data during sleep and provides disease diagnoses under five minutes using its self-developed AI model. This AI diagnosis software is integrable into any medical and healthcare market using real-time large-scale bio signal.In particular, the company invested nine years to develop X.AI (eXplainable AI), a crucial component for the medical field. They have also registered 16 original patents and published SCIE-Level thesis, enhancing the technical value provided to its clients.HoneyNaps’ CFO states, “This successful funding amidst a challenging investment climate has validated our position as Korea’s leading Sleep-Tech company”, adding, “These resources will enable us to achieve results in the domestic and American medical market and earn recognition. Beyond the SOMNUM’s current use in sleep disease diagnosis, we plan to further advance the AI to expand its application to other critical areas such as cardiovascular disease, dementia, and Parkinson’s disease”.For additional information, please contact:HoneyNaps USA, Inc.Christine Kwon / Managing DirectorEmail: [email protected]Address: 6 Liberty SQ PMB 6202, Boston, MA 02109Website: www.honeynaps.comSOURCE HoneyNaps

Karoo Health and Heartbeat Health Team Up to Create First National, Scalable, End-to-end Cardiac Value-based Care Solution

With cardiac care becoming increasingly cursory and difficult to access, the integration of Heartbeat’s decentralized cardiovascular care with Karoo’s value-based model of care and proprietary technology creates a one-of-a-kind solution enabling unprecedented access, speed, information and scope.NEW YORK and ALBUQUERQUE, N.M., May 23, 2024 /PRNewswire/ — Heartbeat Health, the nation’s largest decentralized cardiology provider, and Karoo Health, the only operational provider of cardiac value-based care enablement with published value-based results, today announced the formation of a unique value-based enterprise (VBE), creating the first national, scalable, end-to-end cardiac value-based care (VBC) solution for payers, at-risk entities, and provider networks.
The first-of-its-kind VBE combines Karoo’s VBC-enabling AI-powered technology and wraparound model of care with Heartbeat’s leading virtual cardiac clinical services to expand access, improve outcomes, and lower cost of care for cardiovascular disease (CVD) patients, and the entities responsible for their care, in any given geography throughout the country.
Heartbeat Health leverages its clinicians (licensed and credentialed in all 50 states), diagnostic testing, and telehealth capabilities to deliver 24/7, on-demand cardiovascular care. Karoo Health empowers the transition to, and success within, cardiac VBC arrangements through use of its dedicated wraparound care teams and Kohere.ai, its proprietary technology platform enabling real-time patient communication, clinical information sharing, data amalgamation and analysis, and the provision of actionable insights to partners.
“We’re ‘pumped’ to announce the creation of this value-based enterprise with Karoo, launching the first truly nationwide, end-to-end cardiac VBC solution,” said Dr. Jeffrey Wessler, CEO and Founder of Heartbeat Health. “This partnership will positively impact patient outcomes by merging our advanced, decentralized cardiovascular care with effective VBC technologies and practices, ultimately reducing healthcare costs and vastly improving care outcomes and accessibility for patients in need.””Karoo’s model of care and proprietary enabling technologies, combined with Heartbeat’s virtual-clinical capabilities, support timely interventions and improved access to care, allowing our value-based enterprise to manage cardiac risk for populations throughout the nation,” said Karoo Health CEO and Cofounder Ian Koons. “The unique synergies between our two companies allow us to secure, and succeed in, cardiac VBC contracts across the full range of CVD patients, at-risk provider networks, and payers.”A recent proof of concept conducted by Karoo with participating providers revealed that 86% of eligible patients are converted to Karoo Health’s model of care, with 98% digital engagement among enrolled patients and 29% of patients diverted from at least one unnecessary ED visit. ED visits for high-acuity cardiac patients can cost $8,000 or more and are frequently either completely unnecessary and/or preventable.About Karoo HealthEmploying an exclusive mix of specialized care teams and proprietary technology, both grounded in value-based principles, Karoo Health enables cardiology networks, payers, and at-risk entities to seamlessly transition to, and succeed in, value-based care, and excel in outcomes-driven initiatives critically required today in the cardiac vertical. For more information, visit the company at www.karoohealth.com or connect with them on LinkedIn.About Heartbeat HealthHeartbeat Health is a decentralized cardiovascular care company pioneering a new approach to heart care. Powered by experienced clinicians, our virtual-first model uses real-time clinical data and device connectivity to deliver a range of clinical services, including same-day diagnostic reads, televisits, and virtual care programs. By improving the access, quality, and outcomes of cardiovascular disease, Heartbeat helps provider groups and at-risk organizations identify, monitor, and close gaps in care for their member populations with rising CVD risk. Heartbeat’s decentralized services are available in every state in the U.S., across every cardiac condition, and at every level of severity.Virtual-First Cardiology has arrived. Learn more at heartbeathealth.com.SOURCE Karoo Health

Inari Medical Files Patent Infringement Lawsuit Against Imperative Care and Truvic Medical

IRVINE, Calif., May 23, 2024 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced today that it had filed a patent infringement lawsuit against Imperative Care, Inc. and Truvic Medical, Inc. (collectively, “Truvic”). The suit was filed in the United States District Court for the Northern District of California. Inari is seeking injunctive relief and damages for infringement. Inari believes Truvic is infringing eight of Inari Medical’s patents for the use of aspiration-based thrombectomy devices to treat pulmonary emboli and deep vein thrombosis. Truvic products named in the suit include the Symphony Thrombectomy System. “Inari was founded to improve patients’ lives using purpose-built innovation. Our mission depends on these innovations, and we are deeply committed to protecting our intellectual property rights,” said Drew Hykes, CEO of Inari Medical. About Inari Medical, Inc.Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous and other diseases. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram. Investor Contact:John Hsu, CFAVP, Investor Relations949-658-3889IR@inarimedical.com

Medtronic reports full year and fourth quarter fiscal 2024 financial results; announces dividend increase

Broad-based, durable growth across the company, including Cranial & Spinal Technologies, Diabetes, Cardiac Pacing, Surgical, and Structural Heart; gaining momentum as company enters new product cycles across many high-growth marketsDUBLIN, May 23, 2024 /PRNewswire/ — Medtronic plc (NYSE:MDT) today announced financial results for its fourth quarter (Q4) and fiscal year 2024 (FY24), which ended April 26, 2024.Key Highlights

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Q4 revenue of $8.6 billion increased 0.5% as reported and 5.4% organic
Q4 GAAP diluted earnings per share (EPS) of $0.49; non-GAAP diluted EPS of $1.46
FY24 revenue of $32.4 billion increased 3.6% as reported and 5.2% organic
FY24 GAAP diluted EPS of $2.76; non-GAAP diluted EPS of $5.20
FY24 cash from operations of $6.8 billion increased 12%; FY24 free cash flow of $5.2 billion increased 14%
Company returned $5.5 billion to shareholders in FY24, including $1.6 billion through net share repurchases in Q4
Company issues FY25 guidance
Dividend increased to $0.70 per share quarterly, annual $2.80 per share; 47th consecutive year of dividend increases
Received U.S. FDA approval for Evolut™ FX+ TAVR system and Inceptiv™ closed-loop spinal cord stimulator; received China National Medical Products Administration (NMPA) approval for Symplicity Spyral™ renal denervation system; submitted Affera Sphere-9™ ablation catheter and Simplera Sync™ CGM to U.S. FDA seeking approval

Q4 Financial ResultsMedtronic reported Q4 worldwide revenue of $8.589 billion, an increase of 0.5% as reported and 5.4% on an organic basis. The company’s organic revenue results reflect broad-based growth across the company, with mid-single digit or higher organic revenue growth in all four segments. The organic revenue growth comparison excludes:
$57 million of current year revenue and $114 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$72 million of unfavorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time intellectual property (IP) agreement, which was reported in the Structural Heart & Aortic division in the Cardiovascular Portfolio
As reported, Q4 GAAP net income and diluted EPS were $654 million and $0.49, respectively, decreases of 45% and 44%, respectively. As detailed in the financial schedules included at the end of this release, Q4 non-GAAP net income and non-GAAP diluted EPS were $1.929 billion and $1.46, respectively, decreases of 8% and 7%, respectively. Included in Q4 non-GAAP diluted EPS was a 7 cent, or 4%, unfavorable impact from foreign currency translation.FY24 Financial ResultsMedtronic reported FY24 worldwide revenue of $32.364 billion, an increase of 3.6% as reported and 5.2% on an organic basis. The FY24 organic revenue growth comparison excludes:
$111 million of current year revenue and $358 million of prior year revenue reported as Other, stemming from business separations and product line exits;
$43 million of favorable impact from foreign currency translation on the remaining segments; and
$265 million of prior year revenue from a one-time IP agreement.
FY24 GAAP net income and diluted earnings per share (EPS) were $3.676 billion and $2.76, respectively, both representing decreases of 2%. As detailed in the financial schedules included at the end of this release, fiscal year 2024 non-GAAP net income and non-GAAP diluted EPS were $6.918 billion and $5.20, respectively, both representing decreases of 2%. Included in FY24 non-GAAP diluted EPS was a 33 cent unfavorable impact from foreign currency translation. FY24 non-GAAP diluted EPS on a constant currency basis increased 5%.FY24 cash from operations of $6.787 billion increased 12%. FY24 free cash flow of $5.200 billion increased 14%, representing free cash flow conversion from non-GAAP net earnings of 75%. Growth was driven by improvements in working capital.”We delivered a strong finish to the fiscal year, with broad strength across our businesses and each of our four segments posting mid-single digit or higher organic revenue growth,” said Geoff Martha, Medtronic chairman and chief executive officer. “Our momentum is building into the new fiscal year. We’re beginning new product cycles in some of MedTech’s most attractive markets, which is further enhanced as we apply AI across our portfolio. We are very optimistic about what we can achieve in fiscal ’25 and beyond.”Cardiovascular PortfolioThe Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. FY24 revenue of $11.831 billion increased 2.7% as reported and 5.0% organic, with a high-single digit increase in SHA, mid-single digit increase in CPV, and a low-single digit increase in CRHF, all on an organic basis. Q4 revenue of $3.130 billion decreased 5.2% as reported and increased 4.0% organic, with mid-single digit organic increases in SHA and CPV, and a low-single digit organic increase in CRHF.
CRHF Q4 results included low-single digit growth in Cardiac Rhythm Management, driven by high-single digit growth in Cardiac Pacing Therapies, including low-20s growth in Micra™ transcatheter pacing systems; Cardiac Ablation Solutions grew mid-single digits, with declines in cryoablation more than offset by strong growth in pulsed field ablation (PFA)
SHA Q4 results driven by high-single digit growth in Structural Heart and Cardiac Surgery; Structural Heart had double digit growth in Western Europe and Japan on the continued adoption of the Evolut™ FX transcatheter aortic valve replacement (TAVR) system
CPV in Q4 delivered mid-single digit Coronary growth with strength in guide catheters and balloons; Peripheral Vascular Health also grew mid-single digits, with mid-teens growth in drug-coated balloons and vascular embolization products
Received U.S. FDA approval for Evolut™ FX+ TAVR system in March, with early commercial experience this spring 2024 and full product launch in summer 2024; Launched Avalus Ultra™ surgical aortic tissue value in the U.S.; Symplicity Spyral™ renal denervation system received National Medical Products Administration (NMPA) approval in China and license from Health Canada
One-year results from SMART trial simultaneously presented at American College of Cardiology and published in The New England Journal of Medicine in April, demonstrating Medtronic Evolut™ TAVR platform as optimal treatment for severe aortic stenosis in patients with small annuli, which is primarily women
First-in-human data studying the Sphere-360™ PFA catheter presented at European Heart Rhythm Association annual meeting in April; one-year results from SPHERE-PER AF pivotal study of the Sphere-9™ pulsed field (PF) and radiofrequency (RF) ablation, and high density (HD) mapping catheter with the Affera cardiac mapping and navigation platform presented at Heart Rhythm last week, system has been submitted to U.S. FDA seeking approval
Neuroscience PortfolioThe Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. FY24 revenue of $9.406 billion increased 5.0% as reported and 5.2% organic, with a high-single digit increase in CST, mid-single digit increase in Specialty Therapies, and a low-single digit increase in Neuromodulation, all on an organic basis. Q4 revenue of $2.545 billion increased 5.6% as reported and 6.5% organic, with a high-single digit increase in CST, a mid-single digit increase in Neuromodulation, and low-single digit increase in Specialty Therapies, all on an organic basis.
CST Q4 performance driven by continued adoption of the AiBLE™ ecosystem, with mid-teens growth in Neurosurgery on strong capital equipment sales, high-single digit growth in Biologics, and mid-single digit growth in Core Spine
Specialty Therapies Q4 results driven by high-single digit growth in ENT, with strength in power capital and disposables and localized drug delivery sinus implants; Neurovascular declined low-single digits, as declines in China due to volume-based procurement tenders offset strength in flow diversion products; Pelvic Health increased mid-single digits on continued adoption of the InterStim X™ system
Neuromodulation in Q4 delivered low-double digit growth in Brain Modulation on the launch of the Percept™ RC neurostimulator with BrainSense™ technology; Pain Therapies grew mid-single digits, including low-double digit growth in Targeted Drug Delivery and low-single digit growth in Pain Stim
Received U.S. FDA approval for Inceptiv™ closed-loop spinal cord stimulator on last day of Q4; received U.S. FDA clearance for OsteoCool™ 2.0 bone tumor ablation system in Q4, with broad market launch planned later this calendar year
Medical Surgical PortfolioThe Medical Surgical Portfolio includes the Surgical & Endoscopy (SE) and the Acute Care & Monitoring (ACM) divisions. FY24 revenue of $8.417 billion increased 5.4% as reported and 4.7% organic, with a mid-single digit increase in SE and low-single digit increase in ACM, both on an organic basis. Q4 revenue of $2.198 billion increased 3.5% as reported and 4.5% organic, with mid-single digit organic growth in SE and low-single digit organic growth in ACM.
SE Q4 results included high-single digit growth in General Surgical Technologies, with strength in wound management and hernia products, low-single digit growth in Advanced Surgical Technologies, and high-single digit growth in Endoscopy on strength of capital sales
ACM Q4 performance driven by mid-single digit growth in Blood Oxygen Management on strong sales of Nellcor™ pulse oximetry products, and mid-single digit growth in Airways, driven by strong McGRATH™ MAC video laryngoscope demand
Launched Touch Surgery™ Live Stream and 14 new AI-driven algorithms on the Touch Surgery™ Performance Insights platform for laparoscopic and robotic-assisted procedures; received U.S. FDA clearance for the BIS™ Advance anesthesia monitor; started enrollment in two new U.S. indication studies for the Hugo™ robotic-assisted surgery system:  Hernia and Gynecology
DiabetesDiabetes FY24 revenue of $2.488 billion increased 10.0% as reported and 8.6% organic. Q4 revenue of $660 million increased 10.9% as reported and 11.1% organic.
U.S. Q4 revenue grew low-double digits on the continued launch of the MiniMed™ 780G system; high-forties growth in U.S. insulin pump sales with strong growth in sales to new patients
Non-U.S. Developed Markets grew high-single digits on continued MiniMed™ 780G system adoption and increased CGM attachment rates
Submitted Simplera Sync™ CGM to U.S. FDA in Q4 seeking approval for use with the MiniMed™ 780G system
GuidanceThe company today issued its fiscal year 2025 (FY25) revenue growth and EPS guidance.The company is guiding to FY25 organic revenue growth in the range of 4% to 5%. The organic revenue growth guidance excludes the impact of foreign currency exchange and revenue reported as Other. Including Other revenue and the impact of foreign currency exchange, if recent foreign currency exchange rates hold, FY25 revenue growth on a reported basis would be in the range of 2.4% to 3.7%.The company is guiding to FY25 diluted non-GAAP EPS in the range of $5.40 to $5.50, including an estimated 5% unfavorable impact from foreign currency exchange based on recent rates. This would represent FY25 diluted non-GAAP EPS growth in the range of 4 to 6%.Dividend IncreaseThe company today announced that effective May 22, 2024, the Medtronic board of directors approved an increase in Medtronic’s cash dividend for the first quarter of fiscal year 2025, raising the quarterly amount to $0.70 per ordinary share. This would translate into an annual amount of $2.80 per ordinary share. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. Today’s announcement marks the 47th consecutive year of an increase in the dividend payment. Including today’s increase, Medtronic’s dividend per share has grown by 30% over the past 5 years, 130% over the past 10 years, and has grown at a 16% compounded annual growth rate over the past 47 years.Medtronic has a strong track record of returning capital to its shareholders, including $5.5 billion in fiscal year 2024. The company remains committed to returning a minimum of 50% of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 12, 2024, to shareholders of record at the close of business on June 28, 2024.”We delivered on our commitments in the fourth quarter and the fiscal year, driving durable revenue growth, improved earnings power, and strong free cash flow,” said Karen Parkhill, Medtronic EVP & chief financial officer. “Our fiscal 2025 guidance, along with our dividend increase and recent share repurchase, reflects our confidence in our continued trajectory.”Video Webcast InformationMedtronic will host a video webcast today, May 23, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com, and this earnings release will be archived at news.medtronic.com. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com.Medtronic plans to report its FY25 first, second, third, and fourth quarter results on Tuesday, August 20, 2024, November 19, 2024, February 18, 2025, and Thursday, May 22, 2025, respectively. Confirmation and additional details will be provided closer to the specific event.Financial Schedules and Earnings PresentationThe fourth quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter earnings presentation, click here.

MEDTRONIC PLC WORLD WIDE REVENUE(1) (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

Growth

Currency Impact(3)

Adjusted FY24(4)

Adjusted FY23(5)

AdjustedGrowth

FY24

FY23

Growth

CurrencyImpact(3)

Adjusted FY24(4)

Adjusted FY23(5)

Adjusted Growth

Cardiovascular
$    3,130

$    3,302

(5.2) %

$       (28)

$    3,158

$    3,037

4.0 %

$   11,831

$   11,522

2.7 %

$         12

$   11,819

$   11,257

5.0 %

Cardiac Rhythm & Heart Failure
1,587

1,567

1.3

(15)

1,602

1,567

2.2

5,995

5,783

3.7

11

5,984

5,783

3.5

Structural Heart & Aortic
883

1,105

(20.1)

(6)

889

840

5.8

3,358

3,363

(0.1)

11

3,347

3,098

8.0

Coronary & Peripheral Vascular
660

631

4.6

(7)

667

631

5.7

2,478

2,375

4.3

(10)

2,488

2,375

4.8

Neuroscience
2,545

2,410

5.6

(21)

2,566

2,410

6.5

9,406

8,959

5.0

(16)

9,422

8,959

5.2

Cranial & Spinal Technologies
1,291

1,198

7.8

(11)

1,302

1,198

8.7

4,756

4,451

6.9

(11)

4,767

4,451

7.1

Specialty Therapies
778

763

2.0

(9)

787

763

3.1

2,905

2,815

3.2

(12)

2,917

2,815

3.6

Neuromodulation
475

449

5.8

(1)

476

449

6.0

1,746

1,693

3.1

7

1,739

1,693

2.7

Medical Surgical
2,198

2,124

3.5

(22)

2,220

2,124

4.5

8,417

7,989

5.4

16

8,512

8,127

4.7

Surgical & Endoscopy
1,705

1,638

4.1

(15)

1,720

1,638

5.0

6,508

6,152

5.8

20

6,488

6,152

5.5

Acute Care & Monitoring
492

486

1.2

(6)

498

486

2.5

1,908

1,837

3.9

(4)

2,024

1,975

2.5

Diabetes
660

595

10.9

(1)

661

595

11.1

2,488

2,262

10.0

31

2,457

2,262

8.6

Other (2)
57

114

(50.0)

(3)

221

495

(55.4)

(12)

TOTAL
$    8,589

$    8,544

0.5 %

$       (75)

$    8,604

$    8,165

5.4 %

$   32,364

$   31,227

3.6 %

$         31

$   32,210

$   30,604

5.2 %

(1)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(2)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(3)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(4)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (2) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(5)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (2). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC U.S.(1)(2) REVENUE (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

  Growth

Adjusted FY24(4)

AdjustedFY23(5)

Growth

FY24

FY23

Growth

Adjusted FY24(4)

Adjusted FY23(5)

Growth

Cardiovascular
$    1,448

$    1,737

(16.6) %

$    1,448

$    1,472

(1.6) %

$    5,597

$    5,796

(3.4) %

$    5,597

$    5,531

1.2 %

Cardiac Rhythm & Heart Failure
791

819

(3.4)

791

819

(3.4)

3,037

3,052

(0.5)

3,037

3,052

(0.5)

Structural Heart & Aortic
366

625

(41.4)

366

360

1.7

1,453

1,622

(10.4)

1,453

1,357

7.1

Coronary & Peripheral Vascular
291

293

(0.7)

291

293

(0.7)

1,107

1,122

(1.3)

1,107

1,122

(1.3)

Neuroscience
1,692

1,581

7.0

1,692

1,581

7.0

6,305

6,018

4.8

6,305

6,018

4.8

Cranial & Spinal Technologies
936

855

9.5

936

855

9.5

3,495

3,259

7.2

3,495

3,259

7.2

Specialty Therapies
439

422

4.0

439

422

4.0

1,641

1,608

2.1

1,641

1,608

2.1

Neuromodulation
317

304

4.3

317

304

4.3

1,169

1,151

1.6

1,169

1,151

1.6

Medical Surgical
954

919

3.8

954

919

3.8

3,717

3,549

4.7

3,759

3,604

4.3

Surgical & Endoscopy
679

653

4.0

679

653

4.0

2,650

2,541

4.3

2,650

2,541

4.3

Acute Care & Monitoring
275

266

3.4

275

266

3.4

1,067

1,008

5.9

1,109

1,063

4.3

Diabetes
223

199

12.1

223

199

12.1

852

849

0.4

852

849

0.4

Other (3)
26

39

(33.3)

91

160

(43.1)

TOTAL
$    4,343

$    4,476

(3.0) %

$    4,317

$    4,171

3.5 %

$   16,562

$   16,373

1.2 %

$   16,514

$   16,003

3.2 %

(1)
U.S. includes the United States and U.S. territories.

(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(4)
The three and twelve months ended April 26, 2024 excludes $26 million and $48 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $42 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(5)
The three and twelve months ended April 28, 2023 excludes $304 million and $370 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $39 million and $105 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $55 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC WORLD WIDE REVENUE: GEOGRAPHIC (1)(2) (Unaudited)

FOURTH QUARTER

FISCAL YEAR

REPORTED

ORGANIC

REPORTED

ORGANIC

(in millions)
FY24

FY23

Growth

CurrencyImpact(4)

Adjusted FY24(5)

Adjusted FY23(6)

Growth

FY24

FY23

Growth

CurrencyImpact(4)

Adjusted FY24(5)

AdjustedFY23(6)

Growth

U.S.
$    1,448

$    1,737

(16.6) %

$         —

$    1,448

$    1,472

(1.6) %

$    5,597

$    5,796

(3.4) %

$         —

$    5,597

$     5,531

1.2 %

Non-U.S. Developed
1,039

1,011

2.8

(13)

1,052

1,011

4.1

3,857

3,564

8.2

62

3,795

3,564

6.5

Emerging Markets
643

554

16.1

(15)

658

554

18.8

2,377

2,161

10.0

(49)

2,426

2,161

12.3

Cardiovascular
3,130

3,302

(5.2)

(28)

3,158

3,037

4.0

11,831

11,522

2.7

12

11,819

11,257

5.0

U.S.
1,692

1,581

7.0

1,692

1,581

7.0

6,305

6,018

4.8

6,305

6,018

4.8

Non-U.S. Developed
482

469

2.8

(11)

493

469

5.1

1,739

1,658

4.9

9

1,730

1,658

4.3

Emerging Markets
371

360

3.1

(10)

381

360

5.8

1,362

1,283

6.2

(25)

1,387

1,283

8.1

Neuroscience
2,545

2,410

5.6

(21)

2,566

2,410

6.5

9,406

8,959

5.0

(16)

9,422

8,959

5.2

U.S.
954

919

3.8

954

919

3.8

3,717

3,549

4.7

3,759

3,604

4.3

Non-U.S. Developed
805

799

0.8

(17)

822

799

2.9

3,049

2,917

4.5

20

3,055

2,944

3.8

Emerging Markets
439

405

8.4

(5)

444

405

9.6

1,650

1,522

8.4

(4)

1,697

1,579

7.5

Medical Surgical
2,198

2,124

3.5

(22)

2,220

2,124

4.5

8,417

7,989

5.4

16

8,512

8,127

4.7

U.S.
223

199

12.1

223

199

12.1

852

849

0.4

852

849

0.4

Non-U.S. Developed
337

314

7.3

1

336

314

7.0

1,284

1,106

16.1

37

1,247

1,106

12.7

Emerging Markets
99

82

20.7

(2)

101

82

23.2

352

307

14.7

(6)

358

307

16.6

Diabetes
660

595

10.9

(1)

661

595

11.1

2,488

2,262

10.0

31

2,457

2,262

8.6

U.S.
26

39

(33.3)

91

160

(43.1)

Non-U.S. Developed
11

35

(68.6)

(2)

50

163

(69.3)

(6)

Emerging Markets
21

39

(46.2)

(1)

81

172

(52.9)

(5)

Other (3)
57

114

(50.0)

(3)

221

495

(55.4)

(12)

U.S.
4,343

4,476

(3.0)

4,317

4,171

3.5

16,562

16,373

1.2

16,514

16,003

3.2

Non-U.S. Developed
2,674

2,629

1.7

(42)

2,702

2,593

4.2

9,979

9,408

6.1

121

9,828

9,272

6.0

Emerging Markets
1,572

1,440

9.2

(33)

1,584

1,401

13.1

5,823

5,446

6.9

(89)

5,869

5,330

10.1

TOTAL
$    8,589

$    8,544

0.5 %

$       (75)

$    8,604

$    8,165

5.4 %

$   32,364

$   31,227

3.6 %

$         31

$   32,210

$   30,604

5.2 %

(1)
U.S. includes the United States and U.S. territories. Non-U.S. developed markets include Japan, Australia, New Zealand, Korea, Canada, and the countries of Western Europe. Emerging Markets include the countries of the Middle East, Africa, Latin America, Eastern Europe, and the countries of Asia that are not included in the non-U.S. developed markets, as previously defined.

(2)
The data in this schedule has been intentionally rounded to the nearest million and, therefore, may not sum.

(3)
Includes historical operations and ongoing transition agreements from businesses the Company has exited or divested, which primarily includes the Company’s ventilator product line and the Renal Care Solutions (RCS) business.

(4)
The currency impact to revenue measures the change in revenue between current and prior year periods using constant exchange rates.

(5)
The three and twelve months ended April 26, 2024 excludes $57 million and $111 million, respectively, of inorganic revenue related to the activity noted in (3) and $72 million of unfavorable currency impact and $43 million of favorable currency impact on the remaining segments, respectively. The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $110 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

(6)
The three and twelve months ended April 28, 2023 excludes $379 million and $623 million, respectively, of inorganic revenue related to the following:

•  $265 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023, which is included in the reported results of the Structural Heart & Aortic division of the Cardiovascular portfolio, and

•  $114 million and $358 million, respectively, of inorganic revenue related to the activity noted in (3). The fiscal year organic revenue calculation reclassifies the first nine months of ventilator product line revenue of $138 million from the Other line to the Acute Care and Monitoring division of the Medical Surgical Portfolio.

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF INCOME (Unaudited) 

Three months ended

Fiscal year ended

(in millions, except per share data)
April 26, 2024

April 28, 2023

April 26, 2024

April 28, 2023

Net sales
$              8,589

$              8,544

$            32,364

$            31,227

Costs and expenses:

Cost of products sold, excluding amortization of intangible assets
3,044

2,980

11,216

10,719

Research and development expense
675

640

2,735

2,696

Selling, general, and administrative expense
2,765

2,616

10,736

10,415

Amortization of intangible assets
419

423

1,693

1,698

Restructuring charges, net
112

294

226

375

Certain litigation charges, net
44

(30)

149

(30)

Other operating expense (income), net
477

56

464

(131)

Operating profit
1,053

1,565

5,144

5,485

Other non-operating income, net
(4)

(173)

(412)

(515)

Interest expense, net
202

187

719

636

Income before income taxes
856

1,551

4,837

5,364

Income tax provision
196

362

1,133

1,580

Net income
659

1,188

3,705

3,784

Net income attributable to noncontrolling interests
(5)

(9)

(28)

(26)

Net income attributable to Medtronic
$                  654

$              1,179

$              3,676

$              3,758

Basic earnings per share
$                 0.49

$                 0.89

$                 2.77

$                 2.83

Diluted earnings per share
$                 0.49

$                 0.88

$                 2.76

$                 2.82

Basic weighted average shares outstanding
1,322.3

1,330.4

1,327.7

1,329.8

Diluted weighted average shares outstanding
1,325.4

1,332.8

1,330.2

1,332.8

The data in the schedule above has been intentionally rounded to the nearest million, and therefore, the quarterly amounts may not sum to the fiscal year-to-date amounts.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Three months ended April 26, 2024

(in millions, except per share data)
Net Sales

Cost of ProductsSold

Gross Margin Percent

Operating Profit

Operating Profit Percent

Income Before IncomeTaxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  8,589

$   3,044

64.6 %

$     1,053

12.3 %

$      856

$          654

$     0.49

22.9 %

Non-GAAP Adjustments:

Amortization of intangible assets

419

4.9

419

357

0.27

15.0

Restructuring and associated costs (2)

(13)

0.2

152

1.8

152

125

0.09

17.8

Acquisition and divestiture-related items (3)

(76)

0.9

611

7.1

611

515

0.39

15.9

Certain litigation charges, net

44

0.5

44

37

0.03

15.9

(Gain)/loss on minority investments (4)

195

197

0.15

(1.0)

Medical device regulations (5)

(21)

0.2

31

0.4

31

27

0.02

12.9

Certain tax adjustments, net

17

0.01

Non-GAAP
$  8,589

$   2,934

65.8 %

$     2,311

26.9 %

$    2,309

$       1,929

$     1.46

16.2 %

Currency impact
75

18

0.1

101

0.9

0.07

Currency Adjusted
$  8,664

$   2,952

65.9 %

$     2,412

27.8 %

$     1.53

Three months ended April 28, 2023

(in millions, except per share data)
Net Sales

Cost of Products Sold

GrossMarginPercent

Operating Profit

Operating Profit Percent

IncomeBefore Income Taxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  8,544

$   2,980

65.1 %

$     1,565

18.3 %

$    1,551

$       1,179

$     0.88

23.3 %

Non-GAAP Adjustments:

Amortization of intangible assets

423

5.0

423

361

0.27

14.7

Restructuring and associated costs (2)

(30)

0.4

372

4.4

372

288

0.22

22.6

Acquisition and divestiture-related items (6)

(7)

0.1

139

1.6

139

131

0.10

5.8

Certain litigation charges, net (7)

(30)

(0.4)

(30)

(22)

(0.02)

26.7

(Gain)/loss on minority investments (4)

(10)

(7)

(0.01)

(20.0)

Medical device regulations (5)

(25)

0.3

44

0.5

44

34

0.03

22.7

Certain tax adjustments, net (8)

127

0.10

Non-GAAP
$  8,544

$   2,917

65.9 %

$     2,512

29.4 %

$    2,488

$       2,091

$     1.57

15.8 %

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration.

(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific period.

(6)
The charges primarily include changes in the carrying value of the disposal group and other associated costs as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business, changes in fair value of contingent consideration, business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.

(7)
Certain litigation includes $35 million related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.

(8)
The charge primarily relates to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the impact from the sale of half of the Company’s RCS business.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Fiscal year ended April 26, 2024

(in millions, except per share data)
Net Sales

Cost of Products Sold

GrossMarginPercent

OperatingProfit

Operating Profit Percent

IncomeBeforeIncome Taxes

Net Income attributable toMedtronic

DilutedEPS

Effective Tax Rate

GAAP
$  32,364

$  11,216

65.3 %

$     5,144

15.9 %

$    4,837

$         3,676

$     2.76

23.4 %

Non-GAAP Adjustments:

Amortization of intangible assets

1,693

5.2

1,693

1,435

1.08

15.2

Restructuring and associated costs (2)

(55)

0.2

389

1.2

389

323

0.24

17.0

Acquisition and divestiture-related items (3)

(100)

0.3

777

2.4

777

664

0.50

14.5

Certain litigation charges

149

0.5

149

118

0.09

20.8

(Gain)/loss on minority investments (4)

308

305

0.23

0.6

Medical device regulations (5)

(81)

0.3

119

0.4

119

97

0.07

18.5

Certain tax adjustments, net (6)

299

0.22

Non-GAAP
$  32,364

$  10,980

66.1 %

$     8,272

25.6 %

$    8,273

$         6,918

$     5.20

16.0 %

Currency impact
(31)

(114)

0.3

507

1.6

0.33

Currency Adjusted
$  32,333

$  10,866

66.4 %

$     8,779

27.2 %

$     5.53

Fiscal year ended April 28, 2023

(in millions, except per share data)
Net Sales

Cost of Products Sold

Gross Margin Percent

OperatingProfit

OperatingProfit Percent

Income BeforeIncomeTaxes

Net Income attributable to Medtronic

Diluted EPS

Effective Tax Rate

GAAP
$  31,227

$  10,719

65.7 %

$     5,485

17.6 %

$    5,364

$         3,758

$     2.82

29.5 %

Non-GAAP Adjustments:

Amortization of intangible assets

1,698

5.4

1,698

1,443

1.08

15.0

Restructuring and associated costs (2)

(97)

0.3

647

2.1

647

507

0.38

21.5

Acquisition and divestiture-related items (7)

(66)

0.2

345

1.1

345

316

0.24

8.4

Certain litigation charges, net (8)

(30)

(0.1)

(30)

(23)

(0.02)

26.7

(Gain)/loss on minority investments (4)

(33)

(29)

(0.02)

(6.1)

Medical device regulations (5)

(88)

0.3

150

0.5

150

120

0.09

20.0

Debt redemption premium and other charges (9)

53

42

0.03

20.8

Certain tax adjustments, net (10)

910

0.68

Non-GAAP
$  31,227

$  10,469

66.5 %

$     8,295

26.6 %

$    8,194

$         7,045

$     5.29

13.8 %

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million or $0.01 for EPS figures, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program, consulting expenses, and asset write-offs.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments and inventory write-downs. In addition, other charges primarily consist of changes in fair value of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.

(4)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

(5)
The charges represent incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(6)
The net charge primarily relates to an income tax reserve adjustment associated with the June 2023, Israeli Central-Lod District Court decision and the establishment of a valuation allowance against certain net operating losses which were partially offset by a benefit from the change in a Swiss Cantonal tax rate associated with previously established deferred tax assets from intercompany intellectual property transactions and the step up in tax basis for Swiss Cantonal purposes.

(7)
The charges predominantly include non-cash pre-tax impairments, primarily related to goodwill, changes in the carrying value of the disposal group, and other associated costs, as a result of the April 2023 sale of half of the Company’s Renal Care Solutions (RCS) business; business combination costs, and associated costs related to the previously contemplated separation of the PMRI businesses.

(8)
Certain litigation includes $35 million income related to the one-time payment received as a result of the Intellectual Property Agreement entered into with Edwards Lifesciences in April 2023.

(9)
The charges relate to the early redemption of approximately $2.3 billion of debt and were recorded within interest expense, net within the consolidated statements of income.

(10)
The charge primarily relates to a $764 million reserve adjustment that was a direct result of the U.S. Tax Court opinion, issued in August 2022, on the previously disclosed litigation regarding the allocation of income between Medtronic, Inc. and its wholly owned subsidiary operating in Puerto Rico. Additional charges relate to the reduction of deferred tax assets due to the disallowance of certain interest deductions and the change in the reporting currency for certain carryover attributes, and the amortization on previously established deferred tax assets from intercompany intellectual property transactions.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited) 

Three months ended April 26, 2024

(in millions)
Net Sales

SG&A Expense

SG&A Expense as a % of Net Sales

R&DExpense

R&D Expense as a % of Net Sales

Other Operating(Income) Expense, net

Other Operating(Inc.)/Exp., net as a %of Net Sales

Other Non-OperatingIncome, net

GAAP
$      8,589

$     2,765

32.2 %

$       675

7.9 %

$         477

5.6 %

$             (4)

Non-GAAP Adjustments:

Restructuring and associated costs (2)

(28)

(0.3)

Acquisition and divestiture-related items (3)

(6)

(0.1)

(530)

(6.2)

Medical device regulations (4)

(1)

(9)

(0.1)

(Gain)/loss on minority investments (5)

(195)

Non-GAAP
$      8,589

$     2,731

31.8 %

$       666

7.8 %

$         (52)

(0.6) %

$          (200)

Fiscal year ended April 26, 2024

(in millions)
Net Sales

SG&AExpense

SG&A Expenseas a % of Net Sales

R&DExpense

R&D Expenseas a % of Net Sales

Other Operating(Income) Expense, net

Other Operating(Inc.)/Exp., net as a % of Net Sales

Other Non-Operating Income, net

GAAP
$    32,364

$   10,736

33.2 %

$    2,735

8.5 %

$         464

1.4 %

$          (412)

Non-GAAP Adjustments:

Restructuring and associated costs (2)

(108)

(0.3)

Acquisition and divestiture-related items (3)

(71)

(0.2)

(606)

(1.9)

Medical device regulations (4)

(2)

(36)

(0.1)

(Gain)/loss on minority investments (5)

(308)

Non-GAAP
$    32,364

$   10,555

32.6 %

$    2,698

8.3 %

$       (141)

(0.4) %

$          (720)

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

(2)
Associated costs include costs incurred as a direct result of the restructuring program, such as salaries for employees supporting the program and consulting expenses.

(3)
The charges predominantly include $439 million of charges related to the February 20, 2024 decision to exit the Company’s ventilator product line, which primarily includes long-lived intangible asset impairments. In addition, other charges primarily related to changes in fair of contingent consideration and associated costs related to the previously contemplated separation of the PMRI businesses.

(4)
The charges represent estimated incremental costs of complying with the new European Union medical device regulations for previously registered products and primarily include charges for contractors supporting the project and other direct third-party expenses. We consider these costs to be duplicative of previously incurred costs and/or one-time costs, which are limited to a specific time period.

(5)
We exclude unrealized and realized gains and losses on our minority investments as we do not believe that these components of income or expense have a direct correlation to our ongoing or future business operations.

MEDTRONIC PLC GAAP TO NON-GAAP RECONCILIATIONS(1) (Unaudited)

Fiscal Year

(in millions)
2024

2023

2022

Net cash provided by operating activities
$                      6,787

$                      6,039

$                      7,346

Additions to property, plant, and equipment
(1,587)

(1,459)

(1,368)

Free Cash Flow (2)
$                      5,200

$                      4,580

$                      5,978

See description of non-GAAP financial measures contained in the press release dated May 23, 2024.

(1)
The data in this schedule has been intentionally rounded to the nearest million, and therefore, may not sum.

(2)
Free cash flow represents operating cash flows less property, plant, and equipment additions.

MEDTRONIC PLC CONSOLIDATED BALANCE SHEETS (Unaudited)

(in millions)

April 26, 2024

April 28, 2023

ASSETS

Current assets:

Cash and cash equivalents

$               1,284

$               1,543

Investments

6,721

6,416

Accounts receivable, less allowances and credit losses of $173 and $176, respectively

6,128

5,998

Inventories, net

5,217

5,293

Other current assets

2,584

2,425

Total current assets

21,935

21,675

Property, plant, and equipment, net

6,131

5,569

Goodwill

40,986

41,425

Other intangible assets, net

13,225

14,844

Tax assets

3,657

3,477

Other assets

4,047

3,959

Total assets

$             89,981

$             90,948

LIABILITIES AND EQUITY

Current liabilities:

Current debt obligations

$               1,092

$                     20

Accounts payable

2,410

2,662

Accrued compensation

2,375

1,949

Accrued income taxes

1,330

840

Other accrued expenses

3,582

3,581

Total current liabilities

10,789

9,051

Long-term debt

23,932

24,344

Accrued compensation and retirement benefits

1,101

1,093

Accrued income taxes

1,859

2,360

Deferred tax liabilities

515

708

Other liabilities

1,365

1,727

Total liabilities

39,561

39,283

Commitments and contingencies

Shareholders’ equity:

Ordinary shares— par value $0.0001, 2.6 billion shares authorized, 1,311,337,531 and 1,330,809,036 shares issued and outstanding, respectively

Additional paid-in capital

23,129

24,590

Retained earnings

30,403

30,392

Accumulated other comprehensive loss

(3,318)

(3,499)

Total shareholders’ equity

50,214

51,483

Noncontrolling interests

206

182

Total equity

50,420

51,665

Total liabilities and equity

$             89,981

$             90,948

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

MEDTRONIC PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

Fiscal Year

(in millions)
2024

2023

2022

Operating Activities:

Net income
$           3,705

$           3,784

$           5,062

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization
2,647

2,697

2,707

Provision for credit losses
90

73

58

Deferred income taxes
(508)

(226)

(604)

Stock-based compensation
393

355

359

Loss on debt extinguishment

53

Asset impairments and inventory write-downs
371

515

Other, net
573

270

138

Change in operating assets and liabilities, net of acquisitions and divestitures:

Accounts receivable, net
(391)

(576)

(477)

Inventories, net
(139)

(939)

(560)

Accounts payable and accrued liabilities
391

696

213

Other operating assets and liabilities
(345)

(148)

(65)

Net cash provided by operating activities
6,787

6,039

7,346

Investing Activities:

Acquisitions, net of cash acquired
(211)

(1,867)

(91)

Additions to property, plant, and equipment
(1,587)

(1,459)

(1,368)

Purchases of investments
(7,748)

(7,514)

(9,882)

Sales and maturities of investments
7,441

7,343

9,692

Other investing activities, net
(261)

4

(10)

Net cash used in investing activities
(2,366)

(3,493)

(1,659)

Financing Activities:

Change in current debt obligations, net
1,073

Proceeds from short-term borrowings (maturities greater than 90 days)

2,284

Repayments from short-term borrowings (maturities greater than 90 days)

(2,279)

Issuance of long-term debt

5,409

Payments on long-term debt

(6,012)

(1)

Dividends to shareholders
(3,666)

(3,616)

(3,383)

Issuance of ordinary shares
284

308

429

Repurchase of ordinary shares
(2,138)

(645)

(2,544)

Other financing activities
(3)

(409)

163

Net cash used in financing activities
(4,450)

(4,960)

(5,336)

Effect of exchange rate changes on cash and cash equivalents
(230)

243

(231)

Net change in cash and cash equivalents
(259)

(2,171)

121

Cash and cash equivalents at beginning of period
1,543

3,714

3,593

Cash and cash equivalents at end of period
$           1,284

$           1,543

$           3,714

Supplemental Cash Flow Information

Cash paid for:

Income taxes
$           1,622

$           1,548

$               996

Interest
826

606

540

The data in this schedule has been intentionally rounded to the nearest million, and, therefore, may not sum.

About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow on X and LinkedIn.FORWARD LOOKING STATEMENTSThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. In some cases, you can identify these statements by forward-looking words or expressions, such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “looking ahead,” “may,” “plan,” “possible,” “potential,” “project,” “should,” “going to,” “will,” and similar words or expressions, the negative or plural of such words or expressions and other comparable terminology. Actual results may differ materially from anticipated results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release, including to reflect future events or circumstances.NON-GAAP FINANCIAL MEASURESThis press release contains financial measures, including adjusted net income, adjusted diluted EPS, and organic revenue, which are considered “non-GAAP” financial measures under applicable SEC rules and regulations. References to quarterly or annual figures increasing, decreasing or remaining flat are in comparison to fiscal year 2023.Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company’s underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking organic revenue growth guidance excludes the impact of foreign currency fluctuations, as well as significant acquisitions or divestitures. Forward-looking diluted non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, the company believes such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.

Contacts:

Erika Winkels           
Ryan Weispfenning

Public Relations       
Investor Relations

+1-763-526-8478     
+1-763-505-4626

SOURCE Medtronic plc

Cytokinetics and Royalty Pharma Announce Expanded Strategic Funding Collaboration Totaling Up to $575 Million to Support Commercial Launch of Aficamten and to Advance R&D Pipeline

SOUTH SAN FRANCISCO, Calif. and NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) and Royalty Pharma plc (Nasdaq: RPRX) today announced they have entered into a strategic funding collaboration providing capital to support the commercialization of aficamten and advance the company’s expanding cardiovascular pipeline while diversifying access to capital as the company advances its muscle biology-directed specialty cardiology business. “We have enjoyed a longstanding relationship with Royalty Pharma and this expanded strategic collaboration reinforces our shared conviction in the value of our cardiac myosin focused pipeline of drug candidates,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “This diversified access to capital from a trusted partner supports our launch of aficamten while also fortifying our capital structure and lowering our cost of capital as we become a sustainable company. We believe this deal delivers on stated objectives of advancing our later-stage portfolio of potential medicines alongside our goal of increasing shareholder value.” “We are excited to support Cytokinetics as the company advances towards commercialization of aficamten,” said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. “This is our third transaction with Cytokinetics and highlights our ability to structure creative, win-win funding solutions and underscores the breadth of our funding capabilities. Aficamten has demonstrated an impressive clinical profile in its pivotal Phase 3 study, and we believe it has the potential to significantly improve the lives of patients with HCM, if approved by the FDA.” “Both omecamtiv mecarbil and CK-586 represent strategic opportunities to expand our specialty cardiology pipeline in adjacent cardiovascular indications and help underserved patients,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Building on feedback from the FDA and EMA, we have designed a confirmatory Phase 3 clinical trial intended to replicate treatment effects previously observed with omecamtiv mecarbil among higher risk patients with heart failure with reduced ejection fraction. In addition, we look forward to advancing CK-586 to Phase 2 to further assess the pharmacology of cardiac myosin inhibition in sicker patients with heart failure with preserved ejection fraction.” The transaction includes funding for planned commercialization, development funding, royalty restructuring and revenue sharing and the purchase of Cytokinetics equity, together, affording Cytokinetics $250 million on closing and up to a total of $575 million to support the company’s further maturation and corporate development. The key components of this strategic funding collaboration include: Commercial launch funding: Cytokinetics to receive $50 million and is eligible to draw an additional $175 million within 12 months of approval of aficamten in oHCM; the capital will be repayable over 10 years in quarterly installments (totaling 1.9x). Royalty restructuring: Royalty Pharma’s royalty on aficamten was restructured so that Royalty Pharma will now receive 4.5% up to $5.0 billion of annual net sales of aficamten and 1% above $5.0 billion of annual net sales compared to the prior 4.5% up to $1.0 billion of annual net sales and 3.5% above $1.0 billion of annual net sales.Development funding: Cytokinetics will receive $100 million in upfront capital to fund a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure and reduced ejection fraction. If the Phase 3 clinical trial is positive and FDA approval is received within specified time frames, Royalty Pharma will receive fixed payments totaling $100 million following approval, as well as an incremental 2.0% royalty on annual net sales and/or fixed quarterly payments. If the Phase 3 trial is not successful or does not lead to FDA approval, Cytokinetics will repay Royalty Pharma up to $237.5 million over eighteen or twenty-two quarters, in fixed quarterly payments.Development funding: Cytokinetics to receive $50 million in upfront capital to fund a proof-of-concept Phase 2 clinical trial for CK-586 in patients with heart failure and preserved ejection fraction and Royalty Pharma will have an option to invest up to an additional $150 million to fund Phase 3 development of CK-586, for which it would be eligible to receive a $150 million milestone payment upon FDA approval and a 4.5% royalty on annual net sales of CK-586.If Royalty Pharma does not opt-in to fund Phase 3 development, Royalty Pharma will receive a 1.0% royalty on annual net sales of CK-586.Equity Purchase: Royalty Pharma will purchase $50 million of Cytokinetics’ common stock in a private placement that will be concurrent with the underwritten public offering that Cytokinetics plans to launch today. From these transactions, Cytokinetics anticipates receipt of up to $250 million in nearer-term funding. Together with its proforma cash at the end of the first quarter of 2024, this funding from Royalty Pharma enables Cytokinetics extended cash runway based on expected 2024 expenditures, inclusive of planned commercialization activities and expanded pipeline development programs. Advisors Cooley LLP and Morrison & Foerster LLP acted as legal advisors to Cytokinetics on the transactions. Goodwin Procter LLP, Fenwick & West LLP, Maiwald GmbH, and Wolf, Greenfield & Sacks, P.C., acted as legal advisors to Royalty Pharma. Evercore served as a financial advisor to Cytokinetics on the transactions. About Aficamten Aficamten is an investigational selective, small molecule cardiac myosin inhibitor discovered following an extensive chemical optimization program that was conducted with careful attention to therapeutic index and pharmacokinetic properties and as may translate into next-in-class potential in clinical development. Aficamten was designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, aficamten reduced myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. The development program for aficamten is assessing its potential as a treatment that improves exercise capacity and relieves symptoms in patients with HCM as well as its potential long-term effects on cardiac structure and function. Aficamten was evaluated in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), a positive pivotal Phase 3 clinical trial in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Aficamten received Breakthrough Therapy Designation for the treatment of symptomatic obstructive HCM from the U.S. Food & Drug Administration (FDA) as well as the National Medical Products Administration (NMPA) in China. Cytokinetics expects to submit a New Drug Application (NDA) to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024. About Omecamtiv Mecarbil Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Omecamtiv mecarbil is designed to increase the number of active actin-myosin cross bridges during each cardiac cycle and consequently augment the impaired contractility that is associated with heart failure with reduced ejection fraction (HFrEF). Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4 The development program for omecamtiv mecarbil assessed its potential for the treatment of HFrEF. Positive results from GALACTIC-HF demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care Adverse events and treatment discontinuation of study drug were balanced between the treatment arms. In February 2023, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for omecamtiv mecarbil, stating that GALACTIC-HF was not sufficiently persuasive to establish substantial evidence of effectiveness for reducing the risk of heart failure events and cardiovascular death in adults with chronic heart failure with reduced ejection fraction, in lieu of evidence from at least two adequate and well-controlled clinical investigations. In May 2024, Cytokinetics withdrew the Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) for omecamtiv mecarbil based on feedback from the Committee for Medicinal Products for Human Use (CHMP) indicating that the Committee would not be able to conclude that the benefits outweigh the risks on the basis of the results from GALACTIC-HF alone. Cytokinetics is planning to start an additional Phase 3 trial of omecamtiv mecarbil in Q4 2024 in advanced HFrEF patients with objective to confirm and elaborate on positive results previously observed in GALACTIC-HF. About CK-4021586 (CK-586) CK-4021586 (CK-586) is a novel, selective, oral, small molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction (HFpEF). In preclinical models, CK-586 reduced cardiac hypercontractility by decreasing the number of active myosin cross-bridges during cardiac contraction thereby reducing the contractile force, without effect on calcium transients. In some patients, HFpEF is a condition that resembles non-obstructive hypertrophic cardiomyopathy (HCM) in that the patients have higher ejection fractions, thickened walls of their heart, elevated biomarkers, and symptoms of heart failure. In a Phase 2 clinical trial in patients with non-obstructive HCM, aficamten, a cardiac myosin inhibitor also developed by the Company, was well tolerated, improved patient reported outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class) and biomarkers, measures that are also relevant to HFpEF, lending support for this mechanism of action in HFpEF. The Phase 1 study of CK-586 met its primary endpoint and secondary objectives, demonstrating that CK-586 was safe and well-tolerated in healthy participants with linear pharmacokinetics. These data are supportive of advancing CK-586 to a Phase 2 clinical trial in patients with HFpEF which is expected to begin in Q4 2024. About Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF, and CK-136, a cardiac troponin activator for the potential treatment HFrEF and other types of heart failure, such as right ventricular failure resulting from impaired cardiac contractility. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. About Royalty Pharma Founded in 1996, Royalty Pharma is the largest buyer of biopharmaceutical royalties and a leading funder of innovation across the biopharmaceutical industry, collaborating with innovators from academic institutions, research hospitals and non-profits through small and mid-cap biotechnology companies to leading global pharmaceutical companies. Royalty Pharma has assembled a portfolio of royalties which entitles it to payments based directly on the top-line sales of many of the industry’s leading therapies. Royalty Pharma funds innovation in the biopharmaceutical industry both directly and indirectly – directly when it partners with companies to co-fund late-stage clinical trials and new product launches in exchange for future royalties, and indirectly when it acquires existing royalties from the original innovators. Royalty Pharma’s current portfolio includes royalties on more than 35 commercial products, including Vertex’s Trikafta, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s Tremfya, Biogen’s Tysabri and Spinraza, AbbVie and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Novartis’ Promacta, Pfizer’s Nurtec ODT and Gilead’s Trodelvy, and 17 development-stage product candidates. Cytokinetics Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to: statements relating to the timing or availability of additional sale proceeds or loan disbursements from Royalty Pharma; Cytokinetics’ research and development and commercialization activities; anticipated cash runway, and the properties and potential benefits of Cytokinetics’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ latest Quarterly Report on Form 10-Q. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Royalty Pharma Forward Looking Statements The information set forth herein does not purport to be complete or to contain all of the information you may desire. Statements contained herein are made as of the date of this document unless stated otherwise, and neither the delivery of this document at any time, nor any sale of securities, shall under any circumstances create an implication that the information contained herein is correct as of any time after such date or that information will be updated or revised to reflect information that subsequently becomes available or changes occurring after the date hereof. This document contains statements that constitute “forward-looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of Royalty Pharma’s strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of Royalty Pharma’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, and other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this document are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. Certain information contained in this document relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the company’s own internal estimates and research. While the company believes these third-party sources to be reliable as of the date of this document, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this document involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while the company believes its own internal research is reliable, such research has not been verified by any independent source. For further information, please reference Royalty Pharma’s reports and documents filed with the U.S. Securities and Exchange Commission (“SEC”) by visiting EDGAR on the SEC’s website at www.sec.gov. Contacts: CytokineticsDiane WeiserSenior Vice President, Corporate Affairs 415-290-7757 Royalty Pharma Investor Relations and Communications+1 (212) 883-6772ir@royaltypharma.com References: Psotka MA, Gottlieb SS, Francis GS et al. Cardiac Calcitropes, Myotropes, and Mitotropes. JACC. 2019; 73:2345-53.Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al. Mechanistic and structural basis for activation of cardiac myosin force production by omecamtiv mecarbil. Nat Commun. 2017;8:190.Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011 Mar 18;331(6023):1439-43.

Brainomix Showcases Growing Evidence for its Novel AI-Based Imaging Biomarkers in Lung Fibrosis

The company unveiled a series of new studies highlighting the prognostic value of its imaging biomarkers in patients with fibrotic lung disease
The studies reflect the company’s expanding Life Science partnerships and academic collaborations with luminary research centers in the lung space

OXFORD, England and CHICAGO, May 22, 2024 /PRNewswire/ — Brainomix, a pioneer in artificial intelligence (AI) imaging solutions to enable precision medicine, announced a series of new studies that were presented this week at the American Thoracic Society (ATS) Conference in San Diego.
“The studies presented this week at ATS are a reflection of our continual focus on scientific excellence and academic collaboration with both world-class institutions as well as with Life Science partners,” noted Dr Michalis Papadakis, CEO and Co-Founder of Brainomix. “The results highlight the prognostic value of our novel Brainomix lung imaging biomarkers to accurately predict disease progression in Idiopathic Pulmonary Fibrosis (IPF) and non-IPF patients.”
Key abstracts accepted and presented at ATS included:

“Diagnosis and the role of imaging biomarkers in predicting outcomes for patients with Non-IPF Fibrotic ILD,” was a research collaboration with Heidelberg University in which a cohort of 347 patients with non-IPF over a 10-year period was analyzed with Brainomix’s novel lung imaging biomarker, the weighted reticulovascular score (WRVS). The results indicated WRVS was a strong predictor for death and independent risk factor for 10% Forced Vital Capacity (FVC) decline. “This study has demonstrated the prognostic value of the Brainomix WRVS imaging biomarker, which can be a valuable predictor of progressive disease in this cohort of patients with fibrotic non-IPF ILD,” noted Prof Dr Michael Kreuter, Director for the Lung Center Mainz.
“Differences in lung biomarker scores between treatment groups in post-hoc analysis of the ATLAS inhaled pirfenidone solution (AP01) for IPF clinical trials” was a research collaboration with Avalyn Pharma, a Seattle-based clinical-stage biopharmaceutical company. Brainomix lung imaging biomarkers (including WRVS) were studied in a post-hoc analysis of Avalyn’s phase 1b clinical trial of inhaled pirfenidone (ATLAS study) in patients with IPF, with results showing that WRVS was associated with risk of future IPF progression in the low-dose pirfenidone group. “This research can assist in the optimisation of AI imaging tools to enrich clinical trials for progressive patients, to facilitate matching treatment arms and further explore novel trial end points,” Dr Peter George, Senior Medical Director at Brainomix and Clinical Lead for ILD at Royal Brompton Hospital in London.
“Lung CT biomarkers can stratify patients at risk of Idiopathic Pulmonary Fibrosis progression at 52 weeks: post-hoc analysis from a randomised control trial” was a research collaboration with AstraZeneca using the Phase 2 IPF tralokinumab clinical trial. WRVS was shown to accurately predict patients at baseline at risk of 52-week FVC decline. “These data suggests that our WRVS biomarker may enable more sophisticated design of future clinical trials,” said Ross Stewart, Senior Business Development Manager, Pharma Partnerships, at Brainomix.

About Brainomix
Brainomix specializes in the creation of AI-powered software solutions to enable precision medicine for better treatment decisions in stroke and lung fibrosis. With origins as a spin-out from the University of Oxford, Brainomix is an expanding commercial-stage company with offices in the UK, Ireland and the USA, and operations in more than 30 countries. A private company, backed by leading healthtech investors, Brainomix has innovated award-winning imaging biomarkers and software solutions that have been clinically adopted in hundreds of hospitals worldwide. Its first product, the Brainomix 360 stroke platform, provides clinicians with the most comprehensive stroke imaging solution, driving increased treatment rates and improving functional independence for patients.
To learn more about Brainomix and its technology visit www.brainomix.com, and follow us on Twitter, LinkedIn and Facebook.
Contacts
Jeff Wyrtzen, Chief Marketing & Business Development Officer[email protected]M +44 (0)7927 164210T +44 (0)1865 582730
Media enquiries
Charles ConsultantsSue Charles[email protected]M +44 (0)7968 726585
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SOURCE Brainomix

Orchestra BioMed to Participate in Jefferies Global Healthcare Conference

NEW HOPE, Pa., May 22, 2024 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced that company management will present and be available for one-on-one meetings at the Jefferies Global Healthcare Conference being held in New York, NY, June 4-6, 2024. Details of the presentation are below. Format: Fireside Chat Date: Wednesday, June 5, 2024 Time: 4:00 PM ET (Track 1) Webcast: https://wsw.com/webcast/jeff302/obio/1835536 A replay of the webcast will be available on the Events section of the Orchestra BioMed website for 90 days following the presentation. About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is atrioventricular interval modulation (AVIM) therapy (also known as BackBeat Cardiac Neuromodulation Therapy (CNT™)) for the treatment of hypertension, a significant risk factor for death worldwide. Orchestra BioMed is also developing Virtue® Sirolimus AngioInfusion™ Balloon (SAB) for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Bob YedidLifeSci Advisors516-428-8577Bob@lifesciadvisors.com   Media Contact:Kelsey Kirk-EllisOrchestra BioMed484-682-4892Kkirkellis@orchestrabiomed.com

First Heart Rhythm Patients in Southern Italy Treated with Advanced Robotic Technology

ST. LOUIS, May 22, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announced that Hospital Santa Maria della Pietà, in Nola in the Metropolitan City of Naples, has established the first robotic cardiac heart program in Southern Italy. Patients suffering from heart rhythm disorders are now being successfully treated with robotic ablation procedures using this advanced technology, and Hospital Santa Maria della Pietà is the first hospital in Italy to adopt the cutting-edge Genesis Robotic Magnetic Navigation (RMN) system. “As electrophysiologists, our primary goal is to improve the lives of our patients,” said Dr. Mario Volpicelli, Head of the Electrophysiology Unit of the hospital. “With the Genesis RMN system, we now have an unprecedented level of precision and control during cardiac ablation procedures, allowing us to target arrhythmias with unmatched accuracy while minimizing risk to our patients.” Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “The adoption of the Genesis Robotic Magnetic Navigation system marks a significant milestone in our commitment to providing the highest standard of care to our patients.” added Giuseppe Russo, General Manager of the Hospital Santa Maria della Pietà. “We are proud to lead the way in Italy, revolutionizing cardiac treatment through innovative robotic technology.” added Luigi Caliendo, Chief of the Cardiology Department of the Hospital. “We are honored to partner with Hospital Santa Maria della Pietà in bringing the benefits of robotics to patients in Italy,” said David Fischel, Stereotaxis Chairman and CEO. “The adoption of the Genesis system reflects our shared commitment to advancing standard of care, innovation, and patient-focused solutions in electrophysiology.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com