Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) confirms the delivery of early milestones in its development program targeting the initial surgical triage test market for its simple and accurate blood test.
Highlights
Cleo has finalised the selection of biomarkers to be used in its ovarian cancer test-kit, along with completing the development for a prototype of the proprietary scoring algorithm. The performance metrics of the test were evaluated in a clinical study of 334 patients, the results of which are being prepared for publication in a peer-reviewed medical journal. The Company expects the publication outcome to be reported to the market by the end of CY2023. The data cannot be released prior to publication due to the nature of the peer-review process. Concurrently, Cleo is also preparing a further patent application based on the findings.
ANTIBODY DEVELOPMENT
A key objective for the Company is to develop its own antibodies and target proteins which will allow control of supply, quality, cost and high-performance of key reagents that will underpin the consistent and reliable manufacture of test-kits. Cleo can confirm that Surface Plasmon Resonance Analysis has shown that the core antibodies of the CXCL10 active ratio test are binding to their respective targets with high affinity and are suitable for commercial assay development and upscaling in commercial manufacturing. Hybridomas to produce the supporting biomarker antibodies are also well progressed, with expected completion of the full test-kit panel in Q2 CY2024.
Commenting on the early development progress, CLEO Chief Executive, Richard Allman, said:
“The commercial foundation for our ovarian cancer test-kit targeting the initial surgical triage market is coming together quickly. We are running a number of initiatives in parallel which are designed to place the Company in a strong position to achieve key milestones set this financial year.”
SELECTION PROCESS FOR ANTIBODY MANUFACTURING PARTNER
Cleo is in the late stages of evaluating four commercial antibody manufacturing partners as part of a robust tender process. The evaluation process considers a competitive review of the capabilities of each potential partner to ensure that the partner ultimately selected can deliver commercial product to the standard required by Cleo, which is largely set by regulatory bodies such as the Food and Drug Administration (FDA) and potential customer groups.
Figure 1: Indicative high-level timeline for the commercial development of Cleo’s ovarian cancer test-kit for the initial Surgical Triage Test market.
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This article includes content from CLEO Diagnostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
A medical technology company based in Australia, Cleo Diagnostics (ASX:COV) is revolutionising women's healthcare with its disruptive cancer detection platform technology, through a simple blood test that can accurately detect ovarian cancer early – the leading cause of cancer-related deaths among women.
Approximately 50 percent of women will die within five years of an ovarian cancer diagnosis. The chances of survival beyond five years, however, increase with early detection. According to the American Cancer Society, only about 20 percent of ovarian cancers are diagnosed at an early stage, and more than 90 percent of women live beyond five years when the cancer is detected early.
With early diagnosis being key to a higher survival rate, ovarian cancer has become a target for biomarker research. And one particular biomarker holds promise.
Cleo’s technology is underpinned by the CXCL10 novel and patented biomarker, which was first identified as a small inflammatory molecule in ovarian cancer tissue sections. Subsequent research demonstrated that CXCL10 was overexpressed in ovarian cancers, but importantly not expressed in benign disease, and remains throughout the lifetime of the cancer. The biomarker effectively provides a robust indicator at all stages of cancer. Recognizing that early detection is a significantly unmet need in the clinical diagnostics market, Cleo Diagnostics is focused on bringing to market a simple blood test to accurately detect ovarian cancer early.
The addressable market for a technology like this is compelling, and with a management team that brings to the table decades of leadership experience in the medical technology space, Cleo is well-positioned to leverage this market opportunity.
Cleo chief executive and executive director Dr. Richard Allman has over 30 years of experience in commercially focused scientific research and innovation. Over the course of his career, Allman has overseen and expedited a product development pipeline covering no less than six major cancers, cardiovascular disease, type-2 diabetes and a commercially available COVID-19 test.
Chief scientific officer Dr. Andrew Stephens boasts an equally impressive resume. A career research scientist with two decades of experience in molecular and cellular biology, Stephens is named in over 60 academic publications and holds numerous patents in the cancer therapy and diagnostic space. Cleo’s blood test looks for a novel and patented biomarker in the blood called CXCL10, which was discovered by Stephens, the product of over ten years of scientific work at Monash Medical Centre's Hudson Institute of Medical Research.
There's also Professor Tom Jobling, Cleo's non-executive director and medical advisor. As the head of gynaecological oncology at Monash Health and visiting medical officer at the Peter MacCallum Cancer Centre, Jobling has been treating ovarian cancer for over thirty years. He was also the founding Chairman of the Ovarian Cancer Research Foundation (OCRF)
Non-executive director Lucinda Nolan, meanwhile, brings significant business and strategic expertise to the table. Most recently, she served as the CEO of the Ovarian Cancer Research Foundation.
These experienced professionals, together with the other members of Cleo’s management and board, have developed a staged execution strategy focused on de-risking the pathway to the international screening market — ensuring that, although Cleo is still in its advanced R&D stage, its prospects for commercialisation remain incredibly promising.
Developed over the course of a decade by Dr. Andrew Stephens, Cleo’s blood test is underpinned by the CXCL10 novel and patented protein biomarker known to be present in all stages of ovarian cancer. By combining CXCL10 with several other biomarkers in a custom algorithm, Cleo can not only be used in triage, but also for the purposes of screening and recurrence testing. The project is currently in the advanced R&D stage and has so far conducted two clinical studies, analysing more than 700 patient samples in the process.
Dr. Richard Allman has over 30 years of scientific research leadership and innovation with a clear focus on commercialisation. He has wide experience in research leadership, innovation management, and intellectual property strategy, covering oncology, diagnostics, and product development.
Previously, Allman was chief scientific officer at Genetic Technologies (ASX:GTG). Recent successes include the strategic design and management of a second-generation breast cancer risk assessment test from concept to commercial launch and a similar test for colorectal cancer. These tests have now been NATA-accredited and comprise the first commercially available polygenic risk tests in Australia.
More recently, Allman supervised the underlying R&D, translation, regulatory approval, patent filing and commercial launch of a COVID-19 disease severity test within a 12-month period. This strategy has been utilised to expedite a product development pipeline covering six major cancers, cardiovascular disease and type-2 diabetes which were commercially launched in March 2022.
Dr. Andrew Stephens is a career research scientist with 20 years of experience in molecular and cellular biology research. He has broad experience in academic and pre-clinical research and a strong focus on translation and the commercialisation of research findings. He established and leads an independent academic research group at the Hudson Institute of Medical Research, investigating mechanisms that contribute to the formation, progression and dissemination of high grade, serous epithelial ovarian cancers. Since 2010, his research has focused on biomarker identification and development in ovarian cancer and the development of therapeutic strategies to improve patient outcomes. He is also actively involved across the biotech sector, with appointments to the scientific advisory for Invion and AMTBio.
Stephens has more than 60 academic publications and numerous patents (pending and provisional) in the cancer therapeutic and diagnostic space.
Professor Thomas Jobling is director of gynaecologic oncology at Monash Medical Centre. He graduated from Monash University in 1980 and did his postgraduate sub-specialist training in gynaecologic oncology in London at the Royal Marsden and St Bartholomew's hospitals. Jobling has subsequently been elected as a member of the Society of Pelvic Surgeons and is also founder of the Ovarian Cancer Research Foundation (1999). He was the chairman of the Ovarian Cancer Research Foundation Board. His major interests are in radical surgery for ovarian cancer and the application of robotic surgery for gynaecological malignancy.
Jobling is an active member of a research team in biomarker detection and proteomics in ovarian cancer. He is involved as a collaborative investigator on a number of international clinical trials and is a member of the Australia and New Zealand Gynaecologic Oncology Group, the Australian Society of Gynaecologic Oncology, the Victorian Cooperative Oncology Group and the International Society of Gynaecological Cancer.
Lucinda Nolan is a non-executive director and was most recently the CEO of the Ovarian Cancer Research Foundation. She has a wealth of knowledge and experience across the public sector and not-for-profit environments. Prior to joining the Ovarian Cancer Research Foundation, she was selected as the first female CEO of the Country Fire Authority, one of the world’s largest volunteer-based emergency services organisations. She also spent 32 years with Victoria Police, reaching the rank of deputy commissioner. She was awarded the Australian Police Medal in 2009.
Nolan is also the chair of BankVic and a director on the boards of Alkira Box Hill and the Melbourne Archdiocese of Catholic Schools. She has a Master of Arts and a Bachelor of Arts (Honours) from Melbourne University and is an alum of the Advanced Management Programme at Harvard University.
Adrien Wing began his professional career practising in the audit and corporate advisory divisions of a chartered accounting firm. He has over 25 years of experience in the corporate sector with a large portion of this experience in ASX small caps, lead in IPO transactions and post listing reverse takeovers and acquisitions across a range of industry sectors and jurisdictions. He also has a strong pedigree in the life sciences industry being the founder of Rhythm Biosciences and bringing that entity to the ASX in 2017.
Wing currently serves as an officer/director on the following company boards: New Age Exploration (ASX: NAE), director and joint company secretary; Red Sky Energy (ASX:ROG), director and joint company secretary; Sparc Technologies (ASX:SPN), company secretary; and Osmond Resources (ASX:OSM), company secretary.Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced that Marc N. Casper, chairman, president and chief executive officer, will present at the BofA Securities Health Care Conference on Tuesday, May 14, 2024 at 11:00 a.m. (ET).
The live webcast of the presentation can be accessed via the Investors section of our website, www.thermofisher.com .
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com .
View source version on businesswire.com: https://www.businesswire.com/news/home/20240507157515/en/
Media Contact Information:
Sandy Pound
Thermo Fisher Scientific
Phone: 781-622-1223
E-mail: sandy.pound@thermofisher.com
Investor Contact Information:
Rafael Tejada
Thermo Fisher Scientific
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.com
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Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, announced today that Samira Sakhia, President and Chief Executive Officer, is scheduled to participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024 at 3:05 pm ET at the InterContinental New York Barclay hotel in New York City.
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.
CONTACT INFORMATION:
| Investor Contact: | ||
| Knight Therapeutics Inc. | ||
| Samira Sakhia | Arvind Utchanah | |
| President & Chief Executive Officer | Chief Financial Officer | |
| T: 514.484.4483 | T. +598.2626.2344 | |
| F: 514.481.4116 | ||
| Email: IR@knighttx.com | Email: IR@knighttx.com | |
| Website: www.knighttx.com | Website: www.knighttx.com |
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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 |
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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
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