NEW YORK, Dec. 7, 2017 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, will discuss the company's strategy for longer-term growth, provide an update on its technology pipeline and share its financial guidance during its annual investor conference today in New York City.
Highlights of today's conference include:
Reaffirming October 2017 financial guidance1
Projected 2018 global sales of $3.5 to $3.9 billion, representing underlying2 growth of 9 to 10%
Projected 2018 THVT sales of $2.1 to $2.4 billion, representing underlying growth of 11 to 15%
Estimated 2018 adjusted earnings per share3 of $4.10 to $4.30
Aggressive R&D investments pursuing large opportunities in transcatheter valve therapies expected to drive continued organic growth
"As we come to the end of 2017, our performance and accomplishments this year significantly exceeded our expectations, and we expect 2018 to be another strong year for Edwards Lifesciences. Our global growth is being driven by our transcatheter aortic valve therapies, and continued advancement in each of our market-leading product lines," said Michael A. Mussallem, chairman and CEO. "In 2018, we are projecting strong financial results while we continue to invest aggressively to provide breakthrough therapies for patients in need. During the year, we expect to achieve a number of meaningful clinical milestones that will serve as indicators of our progress in advancing multiple transcatheter mitral and tricuspid programs."
Among the topics being discussed at today's conference are:
Transcatheter Heart Valve Therapy – Edwards continues to believe the global TAVR opportunity will exceed $5 billion by 2021 and continue to grow thereafter, fueled by broader indications for its TAVR therapy, greater therapy awareness and advances in the technology. Edwards is also investing in research and development to produce transformational TAVR technologies to further strengthen its leadership position. The company continues to anticipate launches of its Edwards SAPIEN 3 Ultra system and Edwards CENTERA valve system in 2018. In its clinical trial studying low-risk surgical patients, Edwards expects results to be presented in the first half of 2019 followed by commercial approval in late 2019.
Transcatheter Mitral and Tricuspid Therapies – Estimated to be a more than $3 billion opportunity by 2025, Edwards will discuss its multiple transcatheter programs aimed at transforming care for the many patients suffering from mitral and tricuspid regurgitation. The company has made significant progress in many of its programs and is expecting to achieve a number of meaningful clinical milestones in 2018. Edwards plans to launch at least one transformational therapy in Europe each year in 2018, 2019 and 2020 led by its Cardioband and PASCAL programs.
Surgical Heart Valve Therapy – Edwards expects growth in its market-leading surgical heart valve portfolio despite the continued strong adoption of TAVR therapy in more developed regions. The company is pursuing a robust pipeline of innovative new products including the Edwards INTUITY Elite valve system, and the Edwards INSPIRIS valve, which is expected to be introduced in the U.S. and Japan in 2018. As announced yesterday, Edwards acquired Harpoon Medical and plans to launch this mitral repair therapy in Europe next year.
Critical Care – Edwards plans to continue to distinguish its leadership position in Critical Care technologies with the ongoing rollout of its HemoSphere monitoring platform and further expansion of its Enhanced Surgical Recovery programs. The company is also pioneering a new predictive monitoring category with the planned U.S. launch of its Acumen Hypotension Prediction Indicator in 2018.
During the conference, Edwards' management will reaffirm the company's financial guidance for 2017 and provide guidance for 2018.
Fiscal Year 2017 Outlook
December 2016 Guidance
Sales (and underlying growth)
$3.0-$3.4 billion (10-14% underlying growth)
THVT underlying sales growth
Mid-point of 20-25%
SHVT underlying sales growth
CC underlying sales growth
Diluted Adjusted EPS
Free Cash Flow4
Exceed $675 million
Fiscal Year 2018 Guidance
Underlying Growth Rate
$2.1-$2.4 billion, including approximately $15 million of TMTT product sales
Diluted Adjusted EPS
Free Cash Flow4
Note: All guidance excludes special items and assumes repeal or suspension of Medical Device Excise Tax. Sales guidance assumes current FX rates.
In addition to Mr. Mussallem, other members of Edwards' management team presenting at the conference include:
Donald E. Bobo, Jr., Corporate Vice President, Strategy & Corporate Development;
Katie M. Szyman, Corporate Vice President, Critical Care;
Scott B. Ullem, Chief Financial Officer;
Larry L. Wood, Corporate Vice President, Transcatheter Heart Valves; and
Bernard J. Zovighian, Corporate Vice President, Surgical Heart Valve Therapy.
Guest Speakers to Provide Clinical Perspective
Also speaking at the conference are: Martin B. Leon, MD, Professor of Medicine and Director, Center for Interventional Vascular Therapy, Columbia University Medical Center in New York, and David A. Wood, MD, Structural & Interventional Cardiology, Vancouver General Hospital & St. Paul's Hospital in Vancouver, and Clinical Professor, University of British Columbia.
Other Financial Developments
During the fourth quarter, the company is contributing $25 million to the Edwards Lifesciences Foundation, whose mission is to support health- and community-focused charitable organizations. The contribution is being funded out of the successful litigation proceeds of $113 million the company recently received from Neovasc Inc. at the conclusion of the lawsuit for theft of trade secrets.
The Edwards Lifesciences 2017 Investor Conference can be accessed via live webcast at http://ir.edwards.com/ beginning at 9:00 a.m. Eastern Time on December 7, 2017. The webcast will also be live streamed via the Edwards conference app available for free download at the Apple App Store or Google Play. The webcast will also be archived on the Edwards Web site after the conference concludes.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.
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," "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, 2017 and 2018 financial guidance, expected advances in R&D, and expected new product approvals, clinical milestones and product introductions. 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 uncertainties associated with the timing and pace of therapy adoption, particularly in THVT and transcatheter mitral and tricuspid therapies; unpredictability of the effectiveness and timing of new product launches; changing 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 THVT patent litigation; unpredictability of changes in accounting standards and tax laws; and other risks detailed in the company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2016. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, EDWARDS INTUITY, EDWARDS INTUITY Elite, Edwards SAPIEN, Edwards SAPIEN 3, Enhanced Surgical Recovery program, SAPIEN, SAPIEN 3, and SAPIEN 3 Ultra are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. The Edwards SAPIEN 3 Ultra System is not currently available for commercial sale in any country.
Guidance for sales, underlying sales growth and adjusted earnings per share is provided on a non-GAAP basis, adjusted for special items discussed below, due to the inherent difficulty in forecasting such items. The Company is not able to provide a reconciliation of the 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.
"Underlying" growth rates are non-GAAP items and in this press release exclude foreign exchange fluctuations, sales return reserves associated with THVT product upgrades, the positive impact of 2017 THVT stocking sales in Germany, the negative impact of de-stocking, and other special items.
"Adjusted earnings per share" is a non-GAAP item computed on a diluted basis and in this press release excludes impairment of long-lived assets, intellectual property litigation expenses, amortization of intellectual property, fair value adjustments to contingent consideration liabilities arising from acquisitions, realignment expenses, the positive impact of 2017 THVT stocking sales in Germany, and the negative impact of de-stocking, and other special items.
"Free cash flow" is defined as cash flow from operating activities less capital expenditures. For 2017, this figure excludes the impact of the Neovasc litigation payment, net of the Edwards Foundation contribution.