Cardiex Limited (ASX:CDX) is an ASX-listed medical technology company leveraging its proprietary SphygmoCor® technology to develop and market vascular biomarker technologies and digital solutions focused on the world’s largest health disorders. The company’s groundbreaking technology – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and related arterial health characteristics, collectively referred to as vascular biomarkers.
While measuring arterial health parameters had always been considered clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Founded on 40 years of hemodynamics studies and backed by 20+ years of research, Cardiex’s SphygmoCor technology employs non-invasive techniques to assess "central aortic waveforms," offering valuable insights into various clinically significant arterial health parameters including arterial stiffness, central blood pressure (the pressure at the heart), pulse pressure, and crucial indicators of vascular health for major organs such as the heart, brain and kidneys.
Assessing central blood pressure directly at the heart is deemed superior to conventional blood pressure measurements taken at the arm, primarily owing to the heart's proximity to vital organs. Cardiex’s FDA-cleared devices replace traditional blood pressure technology for first-line screening and monitoring of arterial health status. The unique physiologic insights from the company’s devices provide clinically relevant information that helps guide treatment decisions and offer profound benefits for all members of the healthcare community:
For Healthcare Providers: Enable physicians to make more informed treatment decisions based on clinically relevant vascular health data.
For Patients: Give patients the tools to make better decisions about their own health.
For Pharmaceutical Companies: Generate reliable, real-world, clinically relevant data to accelerate drug development and commercialization.
For more than two decades, the company’s SphygmoCor technology has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen technology for measuring central blood pressure in all of the "top 20 hospitals" in the US and has played a crucial role in the clinical trials of leading firms including Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.
Between 2002 and 2023, CDX received five FDA clearances, the latest for the CONNEQT Pulse, a first-of-its-kind connected vascular biometrics monitor.
Cardiex devices have previously been sold and used exclusively in clinical settings – principally by specialist clinicians, for research, and by pharmaceutical companies for drug assessment. The introduction of CONNEQT Pulse represents a significant shift for Cardiex, allowing the company to enter the connected care market and transition from niche segments to the mass healthcare market. Priced comparably to a home health monitor, the CONNEQT Pulse is positioned for widespread adoption and can be deployed at scale in general healthcare practices, homes, or any location where patients are present.
The CONNEQT Pulse will also bolster Cardiex's portfolio in clinical trial solutions with the introduction of a decentralized clinical trial (DCT) platform. The Cardiex DCT platform empowers clinical trial managers to remotely monitor thousands of patients in their homes, enabling pharmaceutical companies to more effectively evaluate potential vascular outcomes across various trial phases. This leads to increased efficiency and cost-effectiveness in trial outcomes.
Furthermore, in response to the growing demand for proactive health monitoring, Cardiex will be launching an innovative wrist-worn device that leverages the SphygmoCor technology to deliver a medical grade wearable with capabilities far beyond conventional health trackers. The CONNEQT Band will be a wearable “cuffless” device designed to monitor vascular health in patients as well as to provide general health insights to consumers.
Cardiex’s goal is to establish a holistic ecosystem that promotes cardiovascular well-being and empowers users to proactively manage their health as an integral part of individuals' health routines, contributing to a paradigm shift in preventive cardiovascular care.
The company’s first-mover advantage and exclusive technology FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers across all adult demographics grant it a distinctive market position. CDX recently secured AU$14 million in funding, which is enough to steer the company towards profitability.
With the entry into the connected care home market with the CONNEQT Pulse, CDX is transitioning towards a recurring revenue model based on monthly subscription fees. This should excite investors, given that the recurring revenue model will receive a higher multiple by the market, thereby boosting the company's valuation.
The company’s solution is organised under two brands: ATCOR and CONNEQT.
ATCOR offers solutions for hospitals, research and pharma, and specialist clinician markets. ATCOR's solutions have been utilized in 46 pharmaceutical clinical trials thus far, across more than 1,700 study sites worldwide, and have been highlighted in over 2,400 peer-reviewed studies showcased in top-tier medical journals. It offers two devices – the company’s flagship device, the SphygmoCor XCEL, and the SunTech Oscar 2 with “SphygmoCor Inside”.
SphygmoCor XCEL: The SphygmoCor XCEL measures central and brachial blood pressures, providing insights into cardiovascular function. Additionally, it assesses numerous other clinically relevant vascular biomarkers, offering a comprehensive understanding of arterial stiffness and health. These advanced physiological measurements enable early detection of potential cardiovascular issues, guiding targeted interventions for maintaining or improving overall cardiovascular health.
SunTech Oscar 2 with “SphygmoCor Inside”: Jointly developed and marketed by SunTech Medical and Cardiex, the Oscar 2™ ABPM with “SphygmoCor Inside” produces a suite of unique vascular health features and health insights captured by the SphygmoCor technology over a continuous period. It provides valuable diagnostic information that traditional ambulatory blood pressure monitors are incapable of measuring.
CONNEQT is focused on devices and solutions for home health, remote patient monitoring, and decentralized clinical trials. Cardiex offers two devices under the CONNEQT brand – the recently FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The company estimates CONNEQT’s total addressable market opportunity to be nearly $283 billion across three markets – remote patient monitoring ($175 billion), health wearables ($104 billion), and decentralized clinical trials ($14 billion).
CONNEQT Pulse: The CONNEQT Pulse provides measurements of both central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and overall vascular health—metrics once exclusively only available to specialist clinics, research, and pharmaceutical companies. As a Bluetooth-enabled device, it empowers patients and health enthusiasts to track their arterial health from home, employing the same advanced tools used by top cardiologists in research centers and clinics.
Physicians can prescribe the CONNEQT Pulse to patients requiring heart health monitoring. Patient data seamlessly integrates with the CONNEQT Patient Management Portal (CPMP), a HIPAA-compliant cloud-based tool that enables healthcare providers to remotely track patients' arterial health by way of a tablet. Furthermore, consumers and patients can access comprehensive arterial health insights, coaching, lifestyle programs, and additional health resources via the CONNEQT app.
CONNEQT Band: CONNEQT Band is a world's-first dual sensor arterial health wearable device featuring an innovative design with dual (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor continuously captures physiological data such as heart rate, respiration, stress, activity, sleep, and pulse oximetry, while our patented on-demand finger-based side sensor uniquely derives clinically meaningful vascular biomarkers representing arterial stiffness and cardiovascular health.
By combining data from both sensors, the CONNEQT Band offers users a comprehensive view of their overall cardiovascular health which has never been available outside of a physician’s office. The CONNEQT Band is also supported by the CONNEQT app, available for both iOS and Android devices, which serves as a hub where users can easily access detailed reports, track their progress over time, explore content, and receive personalized health insights and recommendations.
The CONNEQT Band is currently in the process of FDA submission preparation. This innovative device is poised to extend the company's portfolio in connected health technology, offering users a new, user-friendly tool for monitoring their health metrics. With its cutting-edge features, the CONNEQT Band is expected to make a significant impact in the way individuals manage their wellness, bridging the gap between advanced health monitoring and everyday convenience.
A significant global market opportunity in wearable health devices is driven by nearly 1.3 billion hypertensive and other vascular disease patients. Some of the other wearable device firms have attracted significant funding at high valuations in recent times. For instance, Oura Health, a Finnish company that makes smart rings for tracking sleep and physical activity, was valued at $2.55 billion in April 2022.
Craig Cooper has established numerous prosperous health, digital media, technology and wellness ventures. Notably, he co-founded Boost Mobile, a prominent telecommunications company recognized as one of the leading mobile phone businesses in the USA. He is acknowledged as a distinguished authority and influential figure on a global scale in mobile and wireless technology, as well as businesses related to digital health and medical technology. His venture capital endeavors have secured over AU$3 billion, financing some of the most impactful global digital media technology companies. Cooper is also a principal of C2 Ventures, Cardiex’s largest shareholder.
Niall Cairns boasts a successful 25-year record of investing in both private and public companies. He has played a pivotal role in advancing the global expansion of more than 50 enterprises spanning various sectors, including digital media, agtech, medtech, consumer internet, and SaaS-based businesses. Cairns is also a principal of C2 Ventures, Cardiex’s largest shareholder.
King Nelson brings over 30 years of extensive experience in medical devices. He was previously the president and CEO at Uptake Medical Corporation, concentrating on treatments for emphysema and lung cancer. Before Uptake, he served as president and CEO of Kerberos Proximal Solutions, a company later acquired by FoxHollow Technologies. He was also president and CEO of VenPro, a heart valve business acquired by Medtronic. King also accumulated 19 years of experience with Baxter International and American Hospital Supply Corporation, progressing through various roles with increasing responsibilities. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Services. Nelson is currently the CEO at Q’Apel Medical, a medical device company specializing in neurovascular disease.
Charlie Taylor has over three decades of international advisory experience and recently concluded his tenure as senior partner at McKinsey, where he oversaw the health and public sector practice. Taylor has counseled numerous private and public sector healthcare organizations in Australia and globally, covering areas such as strategy, digitalization, operational enhancements, growth transformations, international expansion, supply chain management, mergers and acquisitions, and board governance. He is a non-executive director of Healius, a leading Australian health diagnostics company, and a part-time senior board advisor at McKinsey for the health and public sector practice.
Dr. Sanjeev Bhavnani has served as a senior medical officer at the Digital Health Center of Excellence within the FDA's Center for Devices and Radiological Health (CDRH), overseeing clinical and scientific initiatives concerning digital health and medical devices incorporating artificial intelligence.
Bhavnani is also currently a senior cardiologist and principal investigator of digital health and machine learning at Scripps Clinic in San Diego, California, where he leads programs to develop and validate new technologies and to evaluate the safety and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging technologies, AI/ML algorithms and software as a medical device. For over a decade, Bhavnani was the principal investigator of 90 clinical trials and patient care programs. These programs have enrolled over 30,000 patients in the US and in resource-limited areas. His team developed the SMART-FHIR integration interface for DHT data into EMRs for remote patient monitoring, remote therapeutic monitoring, and chronic care management, creating a real-world data platform to monitor the healthcare quality of DHT and ML devices in traditional and new consumer models of care delivery.
Catherine Liao has served as our chief strategy officer since September 2022. Previously, Liao served as chief executive officer of Blumio, a pioneering medical device startup, from February 2016 to September 2022, where she led efforts in raising capital, formed a leadership and advisory board rich in knowledge spanning healthcare innovations, enterprise technology, and sensor technology. Her notable achievements include leading the commercialization of a groundbreaking medical radar sensor development platform, which garnered significant industry attention and was eventually acquired by Cardiex. Liao holds an MBA from Imperial College London and a Master of Science in Health Economics from the London School of Economics. These credentials underscore her deep and comprehensive insight into the intricacies of both the business world and the healthcare sector, demonstrating a balanced expertise critical for navigating and innovating within today’s complex healthcare economies.
Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of experience from various leadership roles in the health and wellness technology sector. With an impressive tenure beginning in 2007, he has been at the helm as managing director of XPhys Technologies, a company at the forefront of developing innovative fitness, health, and wellness products. His strategic vision was further demonstrated through his role as vice-president of Digital Health, from 2018 to 2019, at Performance Lab Technologies, acclaimed for its software development prowess in the health sector. Further cementing his reputation in health technology, Gorelick served as the chief science officer at PAI Health (originally Mio Global) from 2015 to 2018, where he was instrumental in advancing health technology software solutions. Holding a BSc and MSc in kinesiology from Dalhousie University and a Ph.D. in biomedical science from University of Wollongong, Gorelick’s educational background underscores his deep-rooted understanding and innovative approach to biomedical science and kinesiology, reinforcing his invaluable contribution to our company and the broader health technology landscape.
This profile was written in collaboration with Couloir Capital.
Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its first quarter 2024 financial results on Thursday, May 9, 2024 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.
Date : Thursday, May 9, 2024
Time : 8:30 a.m. ET
Telephone : Toll Free: 1-800-836-8184 or International 1-289-819-1350
Webcast : www.knighttx.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.
Replay : An archived replay will be available for 30 days at www.knighttx.com .
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.knighttx.com or www.sedarplus.ca .
Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2023, as filed on www.sedarplus.ca . Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law.
| Investor Contact: | |
| Knight Therapeutics Inc. | |
| Samira Sakhia | Arvind Utchanah |
| President & Chief Executive Officer | Chief Financial Officer |
| T: 514.484.4483 | T. +598.2626.2344 |
| F: 514.481.4116 | |
| Email: IR@knighttx.com | Email: IR@knighttx.com |
| Website: www.knighttx.com | Website: www.knighttx.com |
News Provided by GlobeNewswire via QuoteMedia
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its first quarter 2024 financial results and other key updates from the quarter
"We are pleased with our strong start to the year, delivering solid first-quarter performance, and our fourth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA. Furthermore, all our business segments posted year-over-year revenue growth on both a reported and organic basis. I'm very proud of what our team has accomplished and we remain focused on continuing our momentum by advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health.
"We are also pleased with other key developments for our business during the quarter, including the appeal decision in the Norwich matter in respect of Xifaxan®, which represents a significant milestone as it relates to achieving the full separation of Bausch + Lomb.
"We will continue to focus on the foundation we set across the enterprise to deliver results and improve the health of patients worldwide," continued Mr. Appio.
1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures to the most directly comparable GAAP measure.
Bausch Health (excl. B+L) R&D Update
Xifaxan® Appeal Decision Reinforces the Company's Salix Growth Strategy
On April 11, 2024, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. District Court for the District of Delaware in the Norwich matter. In its ruling, the Court denied Norwich Pharmaceuticals, Inc.'s motion for modification of the court's final order. As a result, the FDA cannot approve Norwich's abbreviated new drug application for Xifaxan® (rifaximin) 550 mg until October 2029.
The Company will continue to vigorously defend its intellectual property.
First Quarter 2024 Revenue Performance
Total reported revenues were $2.15 billion for the first quarter of 2024, compared with $1.94 billion in the first quarter of 2023, an increase of $209 million, or 11%. Excluding the impact of foreign exchange of $8 million, acquisitions of $88 million, and divestitures and discontinuations of $18 million, revenue increased by 8% organically1 compared with the first quarter of 2023.
Reported revenues by segment were as follows:
| Three Months Ended March 31, | Reported Change | |||||||||||||||||||||||
(in millions) | 2024 | 2023 | Amount | Pct. | Change at Constant Currency1 (Non-GAAP) | Change in Organic Revenue1 (Non-GAAP) | ||||||||||||||||||
Total Bausch Health Revenues | $ | 2,153 | $ | 1,944 | $ | 209 | 11 | % | 11 | % | 8 | % | ||||||||||||
Bausch Health (excl. B+L) | $ | 1,054 | $ | 1,013 | $ | 41 | 4 | % | 3 | % | 5 | % | ||||||||||||
Salix segment | $ | 499 | $ | 496 | $ | 3 | 1 | % | 1 | % | 2 | % | ||||||||||||
International segment | $ | 265 | $ | 247 | $ | 18 | 7 | % | 2 | % | 2 | % | ||||||||||||
Solta Medical segment | $ | 88 | $ | 73 | $ | 15 | 21 | % | 23 | % | 23 | % | ||||||||||||
Diversified segment | $ | 202 | $ | 197 | $ | 5 | 3 | % | 3 | % | 6 | % | ||||||||||||
Bausch + Lomb segment | $ | 1,099 | $ | 931 | $ | 168 | 18 | % | 20 | % | 11 | % | ||||||||||||
Salix Segment
Salix segment reported revenues were $499 million for the first quarter of 2024, compared with $496 million for the first quarter of 2023, an increase of $3 million, or 1%. Excluding the impact of divestitures and discontinuations of $9 million, segment revenues increased 2% on an organic1 basis. Sales growth was driven by Xifaxan® and Relistor®, partially offset by net pricing pressures for Trulance® and certain non-promoted products.
International Segment
International segment reported revenues were $265 million for the first quarter of 2024, compared with $247 million for the first quarter of 2023, an increase of $18 million, or 7%. Excluding the impact of foreign exchange of $14 million and divestitures and discontinuations of $1 million, segment revenues increased organically1 by 2% compared with the first quarter of 2023, led by growth in Canada.
Solta Medical Segment
Solta Medical segment reported revenues were $88 million for the first quarter of 2024, compared with $73 million in the first quarter of 2023, an increase of $15 million, or 21%, which was driven by growth in the Asia Pacific region and, to a lesser degree, the U.S. Excluding the impact of foreign exchange of $2 million, segment revenues increased organically1 by 23% compared with the first quarter of 2023.
Diversified Segment
Diversified segment reported revenues were $202 million for the first quarter of 2024, compared with $197 million for the first quarter of 2023, an increase of $5 million, or 3%. Excluding the impact of divestitures and discontinuations of $6 million, segment revenues increased 6% on an organic 1 basis, primarily attributable to increases in sales in Dermatology and Neurology.
Bausch + Lomb Segment
Bausch + Lomb segment reported revenues were $1,099 million for the first quarter of 2024, compared with $931 million for the first quarter of 2023, an increase of $168 million, or 18%. Excluding the impact of foreign exchange of $20 million, acquisitions of $88 million and divestitures and discontinuations of $2 million, the Bausch + Lomb segment revenue increased organically1 by 11% compared with the first quarter of 2023, driven by increases across all business units.
Consolidated Operating Income
Consolidated operating income was $281 million for the first quarter of 2024, compared with operating income of $175 million for the first quarter of 2023, an increase of $106 million. The change was primarily due to the effect of higher revenues and associated gross profit, which was partially offset by higher selling and advertising and promotion expenses, as well as investments in research and development.
Net Loss Attributable to Bausch Health
Net loss attributable to Bausch Health for the first quarter of 2024 was $64 million, compared with $201 million for the first quarter of 2023, a decrease of $137 million, primarily due to the increase in Operating Income and a gain on extinguishment of debt of $11 million recorded in the first quarter of 2024, partially offset by higher interest expense.
Adjusted net income attributable to Bausch Health (non-GAAP)1 for the first quarter of 2024 was $221 million, compared with $191 million for the first quarter of 2023, an increase of $30 million, primarily due to higher revenues and gross profit, partially offset by higher selling and advertising and promotion expenses, investments in research and development and higher interest expense.
Net Loss Per Share Attributable to Bausch Health
GAAP net loss per share attributable to Bausch Health for the first quarter of 2024 was ($0.17), compared with ($0.55) for the first quarter of 2023.
Adjusted EBITDA Attributable to Bausch Health (non-GAAP)1
Adjusted EBITDA attributable to Bausch Health (non-GAAP)1 was $665 million for the first quarter of 2024, as compared to $588 million for the first quarter of 2023, an increase of $77 million.
Cash Provided by Operating Activities
The Company generated $211 million of cash from operating activities in the first quarter of 2024 compared with cash generated of $154 million in the first quarter of 2023. The increase in cash flow reflected improved operating results as discussed above.
Balance Sheet Highlights as of March 31, 2024:
2024 Financial Outlook
The Company reaffirmed its full-year revenue and Adjusted EBITDA (non-GAAP)1 guidance:
Current Guidance (as of May 2, 2024) | |||
BHC | BHC (excl. B+L) | B+L | |
| Revenues (in Billions) | $9.300 - $9.550 | $4.700 - $4.850 | $4.600 - $4.700 |
Organic1 growth vs. Prior Year | 2%-5% | ||
Adjusted EBITDA1 (in Billions) | $3.20 - $3.35 | $2.36 - $2.46 | $0.84 - $0.89 |
Other than with respect to GAAP revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. Because deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. These statements represent forward-looking information and may represent a financial outlook, and actual results may vary. Please see the risks and assumptions referred to in the "Forward-looking Statements" section of this news release. The guidance in this news release is only effective as of the date it is given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.
Conference Call Details
Date: | Thursday, May 2, 2024 |
Time: | 8:00 a.m. ET |
Webcast: | http://ir.bauschhealth.com/events-and-presentations |
A replay of the conference call will be available on the investor relations website.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX:BHC) is a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.
Forward-looking Statements
This news release contains forward-looking information and statements, within the meaning of applicable securities laws (collectively, "forward-looking statements"), including, but not limited to, statements relating to the Company's: future prospects and performance, financial guidance, research and development efforts and anticipated timing or results thereof, proposed plan to separate its eye health business, including the timing thereof, management of its balance sheet, generation of cash, ability to launch and commercialize new products, including the timing of regulatory processes with respect to the Company's product pipeline, ability to enforce and defend its Xifaxan® intellectual property rights, ability to execute its growth strategies generally, and other corporate and strategic transactions. Forward-looking statements may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and positive and negative variations or similar expressions, and phrases or statements that certain actions, events or results may, could, should or will be achieved, received or taken, or will occur or result, and similar such expressions also identify forward-looking information. These forward-looking statements are based upon the current expectations and beliefs of management. The Company's 2024 financial outlook and full-year guidance are included to provide further information about management's expectations about the Company's future business operations, activities and results and may not be appropriate for other purposes.
These forward-looking statements are subject to certain factors, risks and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. These factors, risks and uncertainties include, but are not limited to the following: the impact of current market and economic conditions in one or more of the Company's markets; the impact of inflation and other macroeconomic factors on the Company's business and operations; the ability to complete the separation of Bausch + Lomb, including the timing and structure thereof, and to achieve the expected benefits thereof, and other risks and uncertainties relating to such separation, including actual and potential litigation related thereto; uncertainty of commercial success for new and existing products; challenges to patents; challenges to the Company's ability to enforce and defend against challenges to its patents; the impact of patent expirations and the ability of the company to successfully execute strategic plans; compliance with legal and regulatory requirements; our substantial debt and current and future debt service obligations; and other factors, risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors, risks and uncertainties are incorporated herein by reference.
Additional information regarding certain of these material factors and assumptions may be found in the Company's filings described above. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable in the circumstances, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
Non-GAAP Information
To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures and non-GAAP ratios to provide supplemental information to readers. Management uses these non-GAAP measures and ratios as key metrics in the evaluation of the Company's performance and the consolidated financial results and, in part, in the determination of cash bonuses for its executive officers. The Company believes these non-GAAP measures and ratios are useful to investors in their assessment of our operating performance and the valuation of the Company. In addition, these non-GAAP measures and ratios address questions the Company routinely receives from analysts and investors, and in order to assure that all investors have access to similar data, the Company has determined that it is appropriate to make this data available to all investors.
However, these measures and ratios are not prepared in accordance with GAAP nor do they have any standardized meaning under GAAP. In addition, other companies may use similarly titled non-GAAP financial measures and ratios that are calculated differently from the way we calculate such measures and ratios. Accordingly, our non-GAAP financial measures and ratios may not be comparable to such similarly titled non-GAAP financial measures and ratios used by other companies. We caution investors not to place undue reliance on such non-GAAP measures and ratios, but instead to consider them with the most directly comparable GAAP measures and ratios. Non-GAAP financial measures and ratios have limitations as analytical tools and should not be considered in isolation. They should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.
The reconciliations of these historic non-GAAP financial measures and ratios to the most directly comparable financial measures and ratios calculated and presented in accordance with GAAP are shown in the tables below. However, as indicated above, for guidance purposes, the Company does not provide reconciliations of projected Adjusted EBITDA (non-GAAP) to projected GAAP Net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations.
Specific Non-GAAP Measures
Adjusted EBITDA (non-GAAP) and Adjusted EBITDA attributable to Bausch Health (non-GAAP)
Adjusted EBITDA (non-GAAP) is Net income (loss) (its most directly comparable GAAP financial measure) adjusted for interest expense, net, (Benefit from) provision for income taxes, depreciation and amortization and certain other items described below. Adjusted EBITDA attributable to Bausch Health (non-GAAP) is Adjusted EBITDA (non-GAAP) further adjusted to exclude the Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) as defined below.
Management believes that Adjusted EBITDA (non-GAAP) and Adjusted EBITDA attributable to Bausch Health (non-GAAP), along with the GAAP measures used by management, most appropriately reflect how the Company measures the business internally and sets operational goals and incentives. In particular, the Company believes that these metrics focus management of the Company's underlying operational results and business performance. As a result, the Company uses these metrics to assess the financial performance of the Company and to forecast future results as part of its guidance. Management believes these metrics are a useful measure to evaluate current performance. These metrics are intended to show our unleveraged, pre-tax operating results and therefore reflects our financial performance based on operational factors. In addition, cash bonuses for the Company's executive officers and other key employees are based, in part, on the achievement of certain Adjusted EBITDA (non-GAAP) targets.
Adjusted EBITDA (non-GAAP) is Net income (loss) (its most directly comparable GAAP financial measure) adjusted for interest expense, net, (Benefit from) provision for income taxes, depreciation and amortization and the following items:
Adjusted EBITDA attributable to Bausch Health (non-GAAP) is Adjusted EBITDA (non-GAAP) further adjusted to exclude the Adjusted EBITDA attributable to noncontrolling interest (non-GAAP). Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) is Net income (loss) attributable to noncontrolling interest (its most directly comparable GAAP financial measure) adjusted for the portion of the adjustments described above attributable to noncontrolling interest.
Adjusted Net Income (non-GAAP) and Adjusted Net Income attributable to Bausch Health (non-GAAP)
Adjusted net income (non-GAAP) is Net income (its most directly comparable GAAP financial measure), adjusted for asset impairments, goodwill impairments, restructuring, integration and transformation costs, acquisition-related costs and adjustments (excluding amortization of intangible assets), gain (loss) on extinguishment of debt, separation costs and separation-related costs and other non-GAAP adjustments as these adjustments are described above, and amortization of intangible assets and acquisition-related costs and adjustments excluding amortization of intangible assets, as described below:
Adjusted net income attributable to Bausch Health (non-GAAP) is Adjusted net income (non-GAAP) further adjusted to exclude the Adjusted net income attributable to noncontrolling interest (non-GAAP). Adjusted net income attributable to noncontrolling interest (non-GAAP) is Net income attributable to noncontrolling interest (its most directly comparable GAAP financial measure) adjusted for the portion of the adjustments described above attributable to noncontrolling interest.
Historically, management has used Adjusted net income (loss) (non-GAAP) for strategic decision making, forecasting future results and evaluating current performance. This non-GAAP measure excludes the impact of certain items (as described above) that may obscure trends in the Company's underlying performance. By disclosing this non-GAAP measure, it is management's intention to provide investors with a meaningful, supplemental comparison of the Company's operating results and trends for the periods presented. Management believes that this measure is also useful to investors as such measure allows investors to evaluate the Company's performance using the same tools that management uses to evaluate past performance and prospects for future performance. Accordingly, the Company believes that Adjusted net income (non-GAAP) is useful to investors in their assessment of the Company's operating performance. It is also noted that, in recent periods, our GAAP Net income (loss) was significantly lower than our Adjusted net income (non-GAAP).
Organic Revenue (non-GAAP) and Change in Organic Revenue (non-GAAP)
Organic revenue (non-GAAP) and Change in organic revenue (non-GAAP), are defined as GAAP Revenue and change in GAAP Revenue (the most directly comparable GAAP financial measures), adjusted for changes in foreign currency exchange rates (if applicable) and excluding the impact of recent acquisitions, divestitures and discontinuations, as defined below. Organic revenue (non-GAAP) is impacted by changes in product volumes and price. The price component is made up of two key drivers: (i) changes in product gross selling price and (ii) changes in sales deductions. The Company uses organic revenue (non-GAAP) and change in organic revenue (non-GAAP) to assess performance of its reportable segments, and the Company in total. The Company believes that providing these non-GAAP measures is useful to investors as they provide a supplemental period-to-period comparison.
The adjustments to GAAP Revenue to determine Organic Revenue (non-GAAP) and Change in Organic Revenue (non-GAAP) are as follows:
Constant Currency
Changes in the relative values of non-U.S. currencies to the U.S. dollar may affect the Company's financial results and financial position. To assist investors in evaluating the Company's performance, we have adjusted for the effects of changes in foreign currencies. The impact of changes in foreign currency exchange rates is determined by comparing the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period.
Please also see the reconciliation tables below for further information as to how these non-GAAP measures and ratios are calculated for the periods presented.
Investor Contact: | Media Contact: |
Garen Sarafian | Kevin Wiggins |
(877) 281-6642 (toll free) | (908) 541-3785 |
FINANCIAL TABLES FOLLOW
Bausch Health Companies Inc.
Condensed Consolidated Statements of Operations
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 1 |
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Revenues | ||||||||
Product sales | $ | 2,129 | $ | 1,922 | ||||
Other revenues | 24 | 22 | ||||||
| 2,153 | 1,944 | |||||||
Expenses | ||||||||
Cost of goods sold (excluding amortization and impairments of intangible assets) | 628 | 572 | ||||||
Cost of other revenues | 12 | 10 | ||||||
Selling, general and administrative | 794 | 725 | ||||||
Research and development | 151 | 143 | ||||||
Amortization of intangible assets | 274 | 273 | ||||||
Asset impairments | 1 | 13 | ||||||
Restructuring, integration and separation costs | 12 | 10 | ||||||
Other expense, net | - | 23 | ||||||
| 1,872 | 1,769 | |||||||
Operating income | 281 | 175 | ||||||
Interest income | 9 | 6 | ||||||
Interest expense | (355 | ) | (307 | ) | ||||
Gain on extinguishment of debt | 11 | - | ||||||
Foreign exchange and other | (15 | ) | (10 | ) | ||||
Loss before income taxes | (69 | ) | (136 | ) | ||||
Provision for income taxes | (8 | ) | (73 | ) | ||||
Net loss | (77 | ) | (209 | ) | ||||
Net loss attributable to noncontrolling interest | 13 | 8 | ||||||
Net loss attributable to Bausch Health Companies Inc. | $ | (64 | ) | $ | (201 | ) | ||
Bausch Health Companies Inc.
Reconciliation of GAAP Net Loss to Adjusted Net Income (non-GAAP)
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 2 |
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Net loss | $ | (77 | ) | $ | (209 | ) | ||
Non-GAAP adjustments:(a) | ||||||||
Amortization of intangible assets | 274 | 273 | ||||||
Asset impairments | 1 | 13 | ||||||
Restructuring, integration and transformation costs | 19 | 27 | ||||||
Acquisition-related costs and adjustments (excluding amortization of intangible assets) | 18 | 31 | ||||||
Gain on extinguishment of debt | (11 | ) | - | |||||
IT infrastructure investment | 10 | 7 | ||||||
Separation costs and separation-related costs | 6 | 7 | ||||||
Legal and other professional fees | 6 | 3 | ||||||
Gain on sale of assets, net | (4 | ) | - | |||||
Litigation and other matters, net of insurance recoveries | 6 | (8 | ) | |||||
Other | 7 | - | ||||||
Tax effect of non-GAAP adjustments | (31 | ) | 49 | |||||
Total non-GAAP adjustments | 301 | 402 | ||||||
Adjusted net income (non-GAAP) | 224 | 193 | ||||||
Adjusted net income attributable to noncontrolling interest (non-GAAP) | (3 | ) | (2 | ) | ||||
Adjusted net income attributable to Bausch Health Companies Inc. (non-GAAP) | $ | 221 | $ | 191 | ||||
(a) The components of and further details respecting each of these non-GAAP adjustments and the financial statement line item to which each component relates can be found on Table 2a.
Bausch Health Companies Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 2a |
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Cost of goods sold reconciliation: | ||||||||
GAAP Cost of goods sold (excluding of amortization and impairments of intangible assets) | $ | 628 | $ | 572 | ||||
Fair value inventory step-up resulting from acquisitions(a) | (20 | ) | - | |||||
Adjusted cost of goods sold (excluding of amortization and impairments of intangible assets) (non-GAAP) | $ | 608 | $ | 572 | ||||
Selling, general and administrative reconciliation: | ||||||||
GAAP Selling, general and administrative | $ | 794 | $ | 725 | ||||
IT infrastructure investment(b) | (10 | ) | (7 | ) | ||||
Legal and other professional fees(c) | (6 | ) | (3 | ) | ||||
Separation-related costs(d) | (5 | ) | (6 | ) | ||||
Transformation costs(e) | (7 | ) | (18 | ) | ||||
Adjusted selling, general and administrative (non-GAAP) | $ | 766 | $ | 691 | ||||
Research and development reconciliation: | ||||||||
GAAP Research and development | $ | 151 | $ | 143 | ||||
Separation-related costs(d) | (1 | ) | - | |||||
Adjusted research and development (non-GAAP) | $ | 150 | $ | 143 | ||||
Amortization of intangible assets reconciliation: | ||||||||
GAAP Amortization of intangible assets | $ | 274 | $ | 273 | ||||
Amortization of intangible assets(f) | (274 | ) | (273 | ) | ||||
Adjusted amortization of intangible assets (non-GAAP) | $ | - | $ | - | ||||
Asset impairments: | ||||||||
GAAP Asset impairments | $ | 1 | $ | 13 | ||||
Asset impairments(g) | (1 | ) | (13 | ) | ||||
Adjusted asset impairments (non-GAAP) | $ | - | $ | - | ||||
Restructuring, integration and separation costs reconciliation: | ||||||||
GAAP Restructuring, integration and separation costs | $ | 12 | $ | 10 | ||||
Restructuring and integration costs(e) | (12 | ) | (9 | ) | ||||
Separation costs(d) | - | (1 | ) | |||||
Adjusted restructuring, integration and separation costs (non-GAAP) | $ | - | $ | - | ||||
Bausch Health Companies Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 2a (continued) |
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Other expense, netreconciliation: | ||||||||
GAAP Other expense, net | $ | - | $ | 23 | ||||
Litigation and other matters, net of insurance recoveries(h) | (6 | ) | 8 | |||||
Acquisition-related contingent consideration(a) | 2 | (31 | ) | |||||
Gain on sale of assets, net(i) | 4 | - | ||||||
Adjusted other expense, net (non-GAAP) | $ | - | $ | - | ||||
Gain on extinguishment of debt reconciliation: | ||||||||
GAAP Gain on extinguishment of debt | $ | 11 | $ | - | ||||
Gain on extinguishment of debt(j) | (11 | ) | - | |||||
Adjusted gain on extinguishment of debt (non-GAAP) | $ | - | $ | - | ||||
Foreign exchange and other reconciliation: | ||||||||
GAAP Foreign exchange and other | $ | (15 | ) | $ | (10 | ) | ||
Other professional fees(k) | (7 | ) | - | |||||
Adjusted foreign exchange and other (non-GAAP) | $ | (22 | ) | $ | (10 | ) | ||
Provision for income taxes reconciliation: | ||||||||
GAAP Provision for income taxes | $ | (8 | ) | $ | (73 | ) | ||
Tax effect of non-GAAP adjustments(l) | (31 | ) | 49 | |||||
Adjusted provision for income taxes (non-GAAP) | $ | (39 | ) | $ | (24 | ) | ||
Net loss (income) attributable to noncontrolling interest reconciliation: | ||||||||
GAAP Net loss attributable to noncontrolling interest | $ | 13 | $ | 8 | ||||
Noncontrolling interest portion of amortization of intangible asset (m) | (8 | ) | (6 | ) | ||||
Noncontrolling interest portion of all other adjustments(m) | (8 | ) | (4 | ) | ||||
Adjusted net income attributable to noncontrolling interest (non-GAAP) | $ | (3 | ) | $ | (2 | ) | ||
(a) Represents the two components of the non-GAAP adjustment of "Acquisition-related costs and adjustments (excluding amortization of intangible assets)" (see Table 2).
(b) Represents the sole component of the non-GAAP adjustment of "IT infrastructure investment" (see Table 2).
(c) Represents the sole component of the non-GAAP adjustment of "Legal and other professional fees" (see Table 2).
(d) Represents the two components of the non-GAAP adjustment of "Separation costs and separation-related costs" (see Table 2).
(e) Represents the two components of the non-GAAP adjustment of "Restructuring, integration and transformation costs" (see table 2).
(f) Represents the sole component of the non-GAAP adjustment of "Amortization of intangible assets" (see Table 2).
(g) Represents the sole component of the non-GAAP adjustment of "Asset impairments" (see Table 2).
(h) Represents the sole component of the non-GAAP adjustment of "Litigation and other matters, net of insurance recoveries" (see Table 2).
(i) Represents the sole component of the non-GAAP adjustment of "Gain on sale of assets, net" (see Table 2).
(j) Represents the sole component of the non-GAAP adjustment of "Gain on extinguishment of debt" (see Table 2).
(k) Represents the sole component of the non-GAAP adjustment of "Foreign exchange and other" (see Table 2).
(l) Represents the sole component of the non-GAAP adjustment of "Tax effect of non-GAAP adjustments" (see Table 2).
(m) Represents the portion of the non-GAAP adjustments above attributable to noncontrolling interest (see Table 2).
Bausch Health Companies Inc.
Reconciliation of GAAP Net Loss to Adjusted EBITDA (non-GAAP)
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 2b |
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Net loss | $ | (77 | ) | $ | (209 | ) | ||
Interest expense, net | 346 | 301 | ||||||
Provision for income taxes | 8 | 73 | ||||||
Depreciation and amortization | 320 | 319 | ||||||
EBITDA | 597 | 484 | ||||||
Adjustments: | ||||||||
Asset impairments | 1 | 13 | ||||||
Restructuring, integration and transformation costs | 19 | 27 | ||||||
Acquisition-related costs and adjustments (excluding amortization of intangible assets) | 18 | 31 | ||||||
Gain on extinguishment of debt | (11 | ) | - | |||||
Share-based compensation | 33 | 41 | ||||||
Separation costs and separation-related costs | 6 | 7 | ||||||
Other adjustments: | ||||||||
Litigation and other matters, net of insurance recoveries | 6 | (8 | ) | |||||
IT infrastructure investment | 10 | 7 | ||||||
Legal and other professional fees(a) | 6 | 3 | ||||||
Gain on sale of assets, net | (4 | ) | - | |||||
Other | 7 | - | ||||||
Adjusted EBITDA (non-GAAP) | 688 | 605 | ||||||
Adjusted EBITDA attributable to noncontrolling interest (non-GAAP)(b) | (23 | ) | (17 | ) | ||||
Adjusted EBITDA attributable to Bausch Health Companies Inc. (non-GAAP) | $ | 665 | $ | 588 | ||||
(a) Legal and other professional fees incurred during the three months ended March 31, 2024 and 2023 in connection with recent legal and governmental proceedings, investigations and information requests related to, among other matters, our distribution, marketing, pricing, disclosure and accounting practices.
(b) Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) is Net loss attributable to noncontrolling interest adjusted for the noncontrolling interest portion of the adjustments above as follows:
| Three Months Ended | ||||||||
| March 31, | ||||||||
(in millions) | 2024 | 2023 | ||||||
Net loss attributable to noncontrolling interest | $ | 13 | $ | 8 | ||||
Noncontrolling interest portion of adjustments for: | ||||||||
Interest expense, net | (11 | ) | (6 | ) | ||||
Depreciation and amortization | (12 | ) | (10 | ) | ||||
All other adjustments | (13 | ) | (9 | ) | ||||
Adjusted EBITDA attributable to noncontrolling interest (non-GAAP) | $ | (23 | ) | $ | (17 | ) | ||
Bausch Health Companies Inc.
Organic Growth (non-GAAP) - by Segment
For the Three Months Ended March 31, 2024 and 2023
(unaudited)
Table 3 |
| Calculation of Organic Revenue for the Three Months Ended | ||||||||||||||||||||||||||||||||||||||||||||
| March 31, 2024 | March 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||
Change in GAAP Revenues | Change in Organic Revenue | |||||||||||||||||||||||||||||||||||||||||||
(in millions) | Revenue as Reported | Changes in Exchange Rates(a) | Acquisitions | Organic Revenue (Non-GAAP)(b) | Revenue as Reported | Divestitures and Dis-continuations | Organic Revenue (Non-GAAP)(b) | Amount | Pct. | Amount | Pct. | |||||||||||||||||||||||||||||||||
Bausch Health (excl. B+L) | ||||||||||||||||||||||||||||||||||||||||||||
Salix | $ | 499 | $ | - | $ | - | $ | 499 | $ | 496 | $ | (9 | ) | $ | 487 | $ | 3 | 1% | $ | 12 | 2% | |||||||||||||||||||||||
International | 265 | (14 | ) | - | 251 | 247 | (1 | ) | 246 | 18 | 7% | 5 | 2% | |||||||||||||||||||||||||||||||
Solta Medical | 88 | 2 | - | 90 | 73 | - | 73 | 15 | 21% | 17 | 23% | |||||||||||||||||||||||||||||||||
Diversified | ||||||||||||||||||||||||||||||||||||||||||||
Neuro | 103 | - | - | 103 | 102 | - | 102 | 1 | 1% | 1 | 1% | |||||||||||||||||||||||||||||||||
Dermatology | 50 | - | - | 50 | 43 | (3 | ) | 40 | 7 | 16% | 10 | 25% | ||||||||||||||||||||||||||||||||
Generics | 25 | - | - | 25 | 27 | (3 | ) | 24 | (2 | ) | (7)% | 1 | 4% | |||||||||||||||||||||||||||||||
Dentistry | 24 | - | - | 24 | 25 | - | 25 | (1 | ) | (4)% | (1 | ) | (4)% | |||||||||||||||||||||||||||||||
Total Diversified | 202 | - | - | 202 | 197 | (6 | ) | 191 | 5 | 3% | 11 | 6% | ||||||||||||||||||||||||||||||||
Bausch Health (excl. B+L) revenues | 1,054 | (12 | ) | - | 1,042 | 1,013 | (16 | ) | 997 | 41 | 4% | 45 | 5% | |||||||||||||||||||||||||||||||
Bausch + Lomb | ||||||||||||||||||||||||||||||||||||||||||||
Vision Care | 635 | 18 | (9 | ) | 644 | 587 | (1 | ) | 586 | 48 | 8% | 58 | 10% | |||||||||||||||||||||||||||||||
Surgical | 197 | 1 | - | 198 | 183 | - | 183 | 14 | 8% | 15 | 8% | |||||||||||||||||||||||||||||||||
Pharmaceuticals | 267 | 1 | (79 | ) | 189 | 161 | (1 | ) | 160 | 106 | 66% | 29 | 18% | |||||||||||||||||||||||||||||||
Total Bausch + Lomb revenues | 1,099 | 20 | (88 | ) | 1,031 | 931 | (2 | ) | 929 | 168 | 18% | 102 | 11% | |||||||||||||||||||||||||||||||
Total Bausch Health Companies Inc. revenues | $ | 2,153 | $ | 8 | $ | (88 | ) | $ | 2,073 | $ | 1,944 | $ | (18 | ) | $ | 1,926 | $ | 209 | 11% | $ | 147 | 8% | ||||||||||||||||||||||
(a) The impact for changes in foreign currency exchange rates is determined as the difference in the current period reported revenues at their current period currency exchange rates and the current period reported revenues revalued using the monthly average currency exchange rates during the comparable prior period.
(b) To supplement the financial measures prepared in accordance with GAAP, the Company uses certain non-GAAP financial measures. For additional information about the Company's use of such non-GAAP financial measures, refer to the body of the news release to which these tables are attached. Organic revenue (non-GAAP) for the three months ended March 31, 2024 is calculated as revenue as reported adjusted for the impact for changes in exchange rates (previously defined in this news release) and acquisitions. Organic revenue (non-GAAP) for the three months ended March 31, 2023 is calculated as revenue as reported less revenues attributable to divestitures and discontinuances during the twelve months prior to the day of divestiture or discontinuance, as there are no revenues from those businesses and assets included in the comparable current period.
Bausch Health Companies Inc.
Other Financial Information
(unaudited)
(in millions) | March 31, 2024 | December 31, 2023 | ||||||
Cash, Cash Equivalents and Restricted Cash | ||||||||
Cash and cash equivalents | $ | 733 | $ | 947 | ||||
Restricted cash | 22 | 15 | ||||||
Cash, cash equivalents and restricted cash | $ | 755 | $ | 962 | ||||
Debt Obligations | ||||||||
Senior Secured Credit Facilities: | ||||||||
Revolving Credit Facilities | $ | 300 | $ | 275 | ||||
AR Credit Facility | 325 | 350 | ||||||
Term Loan Facilities | 5,235 | 5,273 | ||||||
Senior Secured Notes | 9,305 | 9,305 | ||||||
Senior Unsecured Notes | 5,540 | 5,791 | ||||||
Other | 12 | 12 | ||||||
Total long-term debt and other, net of premiums, discounts and issuance costs | 20,717 | 21,006 | ||||||
Plus: Unamortized premiums, discounts and issuance costs | 1,357 | 1,382 | ||||||
Total long-term debt and other | $ | 22,074 | $ | 22,388 | ||||
Maturities of Debt Obligations (at principal amount) | ||||||||
Remainder of 2024 | 116 | 155 | ||||||
2025 | 2,675 | 2,790 | ||||||
2026 | 757 | 892 | ||||||
2027 | 6,773 | 6,748 | ||||||
2028 | 7,194 | 7,219 | ||||||
2029 | 1,609 | 1,609 | ||||||
2030 - 2031 | 1,593 | 1,593 | ||||||
Total debt obligations | $ | 20,717 | $ | 21,006 | ||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
Cash provided by operating activities | $ | 211 | $ | 154 | ||||
SOURCE: Bausch Health Companies Inc.
News Provided by ACCESSWIRE via QuoteMedia
Female-specific results from first-of-its-kind clinical trial
Teaching first graders takes a lot of energy. So when Julia Garcia started feeling worn out, teaching became extremely difficult
"I got very tired and couldn't lift heavy things," she remembers. "I had dizzy spells and could barely walk. I thought 'my life is wreaking havoc on me.'"
Doctors struggled to pinpoint the problem, frustrating Julia and her husband Jose, both desperate for answers.
"Someone would diagnose one thing, then someone else would diagnose something else," Jose said. "I felt helpless. We didn't know which path to take."
Julia's case isn't unusual. Because when it comes to detecting and treating heart disease, the healthcare system often tilts in favor of men.1
"Heart disease is regularly undetected, misdiagnosed and undertreated in women. Part of the reason is that historically, clinical heart research mainly studied men. So detection, treatment and standards of care often favor men over women," said Dr. Roxana Mehran, MD, Director of Cardiovascular Research at the Icahn School of Medicine at Mount Sinai in New York.
In 2021, Dr. Mehran led an international commission studying gender inequities in heart health care. And in 2020, she became one of two principal investigators in the Medtronic SMART study.
"The SMART study finally gives us female-specific data that allows us to more effectively treat women with aortic stenosis (AS). It's a critical step forward in treating women with heart disease," said Dr. Mehran.
"Pivotal Moment"
The groundbreaking SMART clinical trial focused on women with AS, a potentially deadly heart condition. In patients with AS, the aortic heart valve thickens and narrows to the point that blood flow is severely restricted. Left untreated the condition can be fatal;2 treatment often requires replacement of the patient's aortic heart valve.3 While the study looked at both men and women with small annulus (heart valves), women typically have smaller heart valves than men, so nearly 90% of the patients in the study were women.
"It's a pivotal moment in women's health," said Nina Goodheart, senior vice president of the Structural Heart and Aortic Operating Unit at Medtronic. "For the first time, this trial gives physicians data from a head-to-head trial that tells them which transcatheter heart valve performs better, specifically in women with aortic stenosis. They've never had access to such female-specific data before."
The trial studied 716 patients at 83 sites in Canada, Europe, the Middle East and Asia (EMEA), and the United States. It compared the performance of the Medtronic Evolut™ transcatheter aortic heart valve replacement (TAVR) system against the Edwards Sapien™ TAVR system, in patients with severe aortic stenosis and smaller heart valves. The groundbreaking findings, released on April 7, concluded that the Medtronic Evolut TAVR system performed better, particularly in terms of post-procedure hemodynamics (blood flow).
"We have to stop thinking that men and women are the same because they're not," added Goodheart. "A woman's physiology is different, so she may also present different symptoms. We urgently need to start addressing this underrepresentation of women in clinical trials. That's why the SMART study results are so important in the history of women's health."
In the case of Julia Garcia, who was not involved in the SMART study, cardiologists eventually determined that she too suffered from AS - her aortic valve was almost completely closed. Doctors recommended replacing her diseased valve with the Medtronic Evolut TAVR system. Cardiologist Dr. Jorge A. Alvarez of the Cardiology Clinic of San Antonio, TX, says they got to Julia in the nick of time. "Had her case gone undiagnosed much longer we may not be talking about the positive impact we had on her," he said.
"I wasn't afraid at all," Garcia said. "I was more afraid of what I had been going through. I knew I was in good hands. I felt better almost immediately after the surgery. I have a new life."
More needs to be done
Garcia's experience demonstrates not only the promise of heart valve replacement treatment, but also how much farther the healthcare system has yet to go in detecting and treating heart disease equally in men and women.
Even though heart disease is the number one killer of both sexes, many people don't know the symptoms of heart problems can be significantly different for women than men.4 Even doctors aren't always aware of the differences, and the reasons lie in the data. Research has found that female patients are included in less than 40 percent of clinical studies.5
"The SMART trial is an exciting starting point, but we have a lot more work to do to close the gender gap in medicine," Goodheart said. "This trial shows we can change the trajectory of medical care. Now we're going to need everyone - physicians, hospitals, governments, medical societies, insurers and companies - to work together and focus on re-shaping the future of medical treatment for women."
Learn more about Medtronic here.
Important Safety Information
TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and the need for a permanent pacemaker.
See important safety information: https://bit.ly/43FqGf3
1 The Heart Disease Gender Gap: https://www.health.harvard.edu/heart-health/the-heart-disease-gender-gap
2 Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67.)
3https://www.mayoclinic.org/diseases-conditions/aortic-stenosis/diagnosis-treatment/drc-20353145
4https://give.brighamandwomens.org/7-differences-between-men-and-women/#:~:text=Men%20typically%20develop%20this%20plaque,to%20the%20accumulation%20of%20cholesterol.
5https://newsroom.heart.org/news/women-still-underrepresented-in-clinical-research-science-and-medicine-that-could-save-them-from-their-no-1-killer
View additional multimedia and more ESG storytelling from Medtronic on 3blmedia.com.
Contact Info:
Spokesperson: Medtronic
Website: https://www.3blmedia.com/profiles/medtronic
Email: info@3blmedia.com
SOURCE: Medtronic
News Provided by ACCESSWIRE via QuoteMedia
Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain
Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.
"Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment," said Dr. Krishnan Chakravarthy , M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation. "Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain."
Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience.
By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician's prescribed stimulation that is tailored to a patient's needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body's response to stimulation † 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.
The Inceptiv system delivers additional advantages beyond its closed-loop capability. Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI access with no power or impedance restrictions. ‡ It is the only FDA-approved closed-loop spinal cord stimulator that offers full-body 3T MRI access. Up to 84% of SCS-implanted patients are expected to need at least one MRI within five years of implant. 1 It is the world's smallest and thinnest fully implantable SCS device, designed for patient comfort. In addition, Inceptiv SCS allows the option of multiple types of waveforms, including Medtronic's proprietary DTM™ SCS therapy, which demonstrated an 84% responder rate at 12 months in a large, multicenter randomized controlled trial (RCT). 2,3 Patients with Inceptiv SCS can also access CareGuidePro™, a mobile application and web portal that serves as a virtual guide throughout their Medtronic spinal cord stimulation therapy journey.
"A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront," said David Carr , vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS."
Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system previously earned approvals for sale in Europe and in Japan . For more information, visit Medtronic.com/Inceptiv .
† Sensing signals may not be measurable in all cases |
‡ Under certain conditions. Refer to product labeling for full list of conditions. |
About Medtronic
Bold 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 Medtronic on LinkedIn .
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Desai, Mehul J., et al. "The rate of magnetic resonance imaging in patients with spinal cord stimulation." Spine, vol. 40, no. 9, 2015, https://doi.org/10.1097/brs.0000000000000805. |
2 Fishman, M, Cordner, H, Justiz, R, Provenzano, D, Merrell, C, Shah, B, et al. Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021; 21: 912– 923 |
3 DTM™ SCS outcomes demonstrated using open-loop SCS |
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