IRVINE, Calif., Dec. 10, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW) will discuss the company’s strategy for longer-term growth, provide an update on its technology pipeline and share its financial guidance today during its annual investor conference.
Highlights1 of today’s conference include:
- Presenting long-term strategic initiatives and growth outlook
- Projecting 2021 global sales of $4.9-5.3 billion; underlying growth in the mid-teens
- Projecting 2021 TAVR sales of $3.2-3.6 billion; underlying growth 15-20%
- Estimating 2021 adjusted earnings per share $2.00-2.20
“Putting patients first has never been more important than it is in 2020, and I am humbled by the agility, resourcefulness and passion of our partners and employees in maintaining their important work on behalf of patients during this particularly difficult time,” said Michael A. Mussallem, chairman and CEO. “Although we expect the pandemic to have a continuing impact on the global healthcare system, we are very optimistic about 2021 and we anticipate returning to strong, double-digit top-line growth. At the same time, we continue to aggressively pursue breakthrough therapies for the millions of patients with structural heart diseases and critical illnesses, which will help patients and result in success at Edwards in the years ahead.”
Among the topics being discussed at today’s conference are:
Transcatheter Aortic Valve Replacement (TAVR) – Edwards continues to believe the global TAVR opportunity will reach $7+ billion by 2024, with continuing growth thereafter, fueled by therapy expansion, technology advances and geographic expansion. Edwards will continue investing in groundbreaking trials, as well as research and development, to produce additional transformational TAVR technologies to help more patients and further strengthen its long-term leadership position. Additional highlights and expected 2021 milestones include:
- EARLY TAVR, a clinical trial studying the treatment of severe aortic stenosis patients before symptoms develop, expected to complete enrollment
- FDA approval to begin moderate aortic stenosis pivotal clinical trial
- Japan low risk approval expected in late 2021
- SAPIEN 3 pulmonic valve with Alterra pre-stent system expected to receive U.S. approval
- SAPIEN X4 clinical trial enrollment anticipated to begin
Transcatheter Mitral and Tricuspid Therapies (TMTT) – Edwards is guided by the vision to lead and transform treatment for patients with mitral and tricuspid valve disease, with the goal of changing the practice of medicine. The company strives to achieve this by focusing on three key value drivers: a portfolio of differentiated therapies, positive results from pivotal clinical trials and favorable real-world clinical outcomes. Progress across these areas will result in more patients diagnosed and treated and, in turn, a $3 billion mitral and tricuspid opportunity by 2025, with significant growth beyond 2025. Additional highlights and expected milestones include:
- Initial clinical experience with the next-generation PASCAL delivery system expected in 2021
- Initial clinical experience with the next-generation EVOQUE mitral system expected in 2021
- Continued enrollment in PASCAL CLASP IID, CLASP IIF and CLASP IITR pivotal trials
- Continued enrollment in the ENCIRCLE pivotal trial for SAPIEN M3
- TRISCEND study for EVOQUE tricuspid enrolling rapidly; initiating TRISCEND II pivotal trial
- U.S. approval for PASCAL DMR expected in late 2022
- EVOQUE tricuspid European approval expected in 2022
Surgical Structural Heart – The current $1.8 billion surgical structural heart opportunity is expected to grow mid-single digits through 2026 driven by global cardiac procedure growth. Edwards remains committed to advancing its leadership position as the partner of choice for surgeons by delivering new technologies that enhance patient outcomes. Adoption of Edwards’ flagship surgical heart valve, INSPIRIS RESILIA, remains robust in the U.S., Japan, and Europe and the company looks forward to its launch in China in 2021. In 2021, the company will also be enrolling patients in the RESTORE pivotal trial for U.S. approval of HARPOON, the echo-guided beating-heart mitral valve repair system. Also in 2021, Edwards expects to launch a new surgical mitral valve, MITRIS RESILIA, in the U.S. and Japan.
Critical Care – Edwards plans to drive growth and leadership with innovations in critical care technologies, including its pioneering work in Smart Recovery, by further advancing hemodynamic monitoring solutions. The company is currently integrating a full range of technologies on the HemoSphere monitoring platform that will create a unique offering of enhanced recovery tools to further strengthen the company’s leadership in smart monitoring. Furthermore, Edwards anticipates the launch of its Viewfinder connectivity solution in 2021.
During the conference, Edwards management will update the company’s financial guidance for 2020 and provide guidance for 2021. In the third quarter, underlying sales grew 3.7% and previously the company expected similar fourth quarter growth. Even with the recent resurgence of COVID, sequential growth is still trending positive compared to the third quarter, but underlying growth is trending flat year-over-year versus the fourth quarter of 2019, when sales grew nearly 20%.
The company is planning that COVID will continue to stress the global healthcare system at least through the winter and recover during the balance of 2021. As the pandemic persists, the company anticipates that hospitals will be better able to treat non-COVID patients who need care for structural heart conditions such as aortic stenosis compared to earlier this year.
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Fiscal Year 2021 Non-GAAP Guidance1 |
Amount |
|
Sales |
$4.9 – $5.3 billion (mid-teens underlying growth) |
|
TAVR |
$3.2 – $3.6 billion (15-20% underlying growth) |
|
Surgical Structural Heart |
$800 – $900 million |
|
Critical Care |
$725 – $800 million |
|
TMTT |
~$80 million |
|
FX Impact on Sales (at current rates) |
~$35 million favorable |
|
Gross Profit Margin |
76-77% |
|
SG&A and R&D as a % of Sales |
Similar to pre-COVID |
|
Operating Margin |
29% – 30% |
|
Tax Rate (including ~5pp ETB benefit) |
11% – 15% |
|
Adjusted EPS |
$2.00 – $2.20 |
|
Capital Expenditures |
~$350 million |
|
Shares Outstanding |
~630 million |
In addition to Mr. Mussallem, other members of Edwards’ management team presenting include:
Todd Brinton, MD, Corporate Vice President, Chief Scientific Officer;
Daveen Chopra, Corporate Vice President, Surgical Structural Heart;
Jean-Luc Lemercier, Corporate Vice President, EMEA, Canada and Latin America;
Katie Szyman, Corporate Vice President, Critical Care;
Scott Ullem, Corporate Vice President, Chief Financial Officer;
Huimin Wang, MD, Corporate Vice President, Japan, Asia and Pacific;
Larry Wood, Corporate Vice President, Transcatheter Aortic Valve Replacement; and
Bernard Zovighian, Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies.
We will also have a number of guest speakers to provide clinical perspective, including:
TAVR
Bassem Chehab, MD, FACC, Interventional Cardiology, Ascension Via Christi – Kansas City, Kan.
Suzanne Baron, MD, MSc, Interventional Cardiology, Lahey Hospital – Burlington, Mass.
Martin Leon, MD, FACC, Interventional Cardiology, Columbia University Medical Center – New York
Surgical Structural Heart
Joseph Bavaria, MD, Cardiac Surgery, Penn Medicine – Philadelphia, Pa.
TMTT
Neil Fam, MD, MSc, FRCPC, Interventional Cardiology, St. Michael’s Hospital – Toronto, Canada
Raj Makkar, MD, Interventional Cardiology, Cedars-Sinai Medical Center – Los Angeles, Calif.
Stephan Von Bardeleben, MD, Interventional Cardiology, Univ. Medical Center – Mainz, Germany
Critical Care
Simon Davies, MD, MBChB FRCA, Consultant Anesthetist, York Teaching Hospital – York, England
Michael Sander, MD, PhD, Chair, Dept. of Anesthesiology, University Hospital – Geissen, Germany
Thomas Scheeren, MD, PhD, Professor of Anesthesiology, University Medical Center – Netherlands
Gumersindo Solares, MD, Anesthesiologist, Marques de Valdecilla – Santander, Spain
Webcast Information
The Edwards Lifesciences 2020 virtual investor conference can be accessed via live webcast at http://ir.edwards.com/ beginning at 9:00 a.m. Pacific Time today. The presentations are available on the Edwards website. The webcast will also be available for replay after the conference concludes.
About Edwards Lifesciences
Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter and YouTube.
This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements can sometimes be identified by the use of words such as “may,” “will,” “should,” “anticipate,” “believe,” “plan,” “project,” “estimate,” “expect,” “intend,” “guidance,” “outlook,” “optimistic,” “aspire,” “unstoppable,” “confident” or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Mussallem, the potential opportunity sizes for TAVR and for transcatheter mitral and tricuspid therapies, 2020 and 2021 financial guidance, expected impact of COVID-19, expected benefits of technological developments, expected growth of opportunities in the long-term, expected investment, expected expansion in geographies, timing and results of milestones in R&D and expect timing and enrollment in clinical trials, and expected regulatory approvals, clinical milestones, product introductions and product launches. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. The company’s forward-looking statements speak only as of the date on which they are made and the company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the company does update or correct one or more of these statements, investors and others should not conclude that the company will make additional updates or corrections.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include risks and uncertainties associated with the COVID-19 pandemic, the timing and pace of therapy adoption, particularly in TAVR and transcatheter mitral and tricuspid therapies; unpredictability of the effectiveness and timing of new product launches; competitive dynamics; the timing and extent of regulatory approvals and reimbursement levels for the company’s products; the company’s success in developing new products and avoiding manufacturing and quality issues; the impact of currency exchange rates; the timing or results of R&D and clinical trials; unanticipated actions by the U.S. Food and Drug Administration and other regulatory agencies; unexpected litigation impacts or expenses, particularly in our TAVR patent litigation; unpredictability of changes in accounting standards and tax laws; and other risks detailed in the company’s periodic reports filed with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Alterra, CLASP, Edwards SAPIEN, Edwards SAPIEN 3, ENCIRCLE, EVOQUE, HARPOON, HemoSphere, INSPIRIS, MITRIS, PASCAL, SAPIEN, SAPIEN 3, SAPIEN M3, SAPIEN X4, TRISCEND, and Viewfinder are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. HARPOON and PASCAL are not available for commercial sale in the United States. EVOQUE, MITRIS, SAPIEN M3, SAPIEN X4, and Viewfinder are not available for commercial sale in any country.
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[1] |
Guidance for underlying sales growth and adjusted earnings per share are provided on a non-GAAP basis, adjusted for special items described below, due to the inherent difficulty in forecasting such items without unreasonable efforts. The Company is not able to provide a reconciliation of these non-GAAP guidance to comparable GAAP measures due to the unknown effect, timing and potential significance of special charges or gains, and management’s inability to forecast charges associated with future transactions and initiatives. |
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To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (“GAAP”), the Company uses non-GAAP financial measures. Management makes adjustments to the GAAP measures for items (both charges and gains) that (a) do not reflect the core operational activities of the Company, (b) are commonly adjusted within the Company’s industry to enhance comparability of the Company’s financial results with those of its peer group, or (c) are inconsistent in amount or frequency between periods (albeit such items are monitored and controlled with equal diligence relative to core operations). |
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The Company uses the term “underlying growth rate” when referring to non-GAAP sales information as adjusted for items referenced in (a) – (c) above, which in the future may exclude, as applicable, items such as foreign exchange rate fluctuations, the conversion to a consignment inventory system for surgical structural heart (“Surgical”), the positive impact of transcatheter aortic valve replacement stocking sales in Germany and the negative impact of de-stocking, sales return reserves associated with product upgrades, and proforma sales results of business acquisitions. The Company uses the term “adjusted earnings per share” which may in the future also exclude intellectual property litigation income and expenses, amortization of intangible assets, fair value adjustments to contingent consideration liabilities arising from acquisitions, impairments of long-lived assets, the purchase of intellectual property, significant pension curtailments, realignment expenses, charitable contributions to the Edwards Lifesciences Foundation and the impact from implementation of tax law changes and settlements. |
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“Free cash flow” is defined as cash flows from operating activities less capital expenditures. |
SOURCE Edwards Lifesciences Corporation
