Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference
NEW YORK, Dec. 5, 2019 -- 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 2019 financial guidance1
- Projected 2020 global sales of $4.5-5.0 billion; underlying2 growth 10-12%
- Estimated 2020 adjusted earnings per share3 $6.05-6.30
- Projected 2020 TAVR sales of $2.9-3.2 billion; underlying growth 12-15%
- Global transcatheter valve therapy opportunities projected to reach $10+ billion by 2024
- Focused long-term growth investments with 2020 R&D planned at 17-18% of sales
"In 2019, our therapies benefitted more patients than ever before, exceeding our expectations, and we believe 2020 will be another strong year for Edwards Lifesciences. Our global growth is being driven by innovative therapies that are intended to address the long-term structural heart opportunity, and continued advancement in each of our market-leading product lines," said Michael A. Mussallem, chairman and CEO. "In 2020, we are projecting another year of double-digit top-line and bottom-line growth while we continue to aggressively pursue breakthrough therapies for millions of patients suffering from structural heart diseases. During the year, we look forward to a number of significant milestones, including new product launches, and progress on multiple pivotal clinical trials and early feasibility studies."
Among the topics being discussed at today's conference are:
Transcatheter Aortic Valve Replacement (TAVR) – Edwards believes the global TAVR opportunity will reach $7+ billion by 2024 and continue to grow thereafter, fueled by broader indications, greater disease and therapy awareness and advances in the technology. 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 milestones include:
- TAVR growth driven by strong PARTNER 3 trial evidence that led to the recent FDA indication expansion for the company's SAPIEN 3 and SAPIEN 3 Ultra systems
- Edwards SAPIEN 3 valve or system recently received expanded low-risk approval in Europe
- SAPIEN 3 Ultra valve will account for most of the company's TAVR sales in the U.S. and Europe in 2020
- SAPIEN 3 pulmonic valve or system with Alterra system pivotal trial patient enrollment complete
- EARLY TAVR, studying treatment of severe aortic stenosis patients before they develop symptoms, expected to complete enrollment in 2021
Transcatheter Mitral and Tricuspid Therapies (TMTT) – With the global opportunity estimated to reach ~$3 billion by 2024 followed by a significantly larger longer-term opportunity, Edwards will discuss its portfolio strategy focused on transforming care for the many patients suffering from mitral and tricuspid valve diseases. Additional highlights and expected milestones include:
- Continuing the disciplined European launch of the PASCAL repair system for mitral patients
- Fully enrolling the PASCAL CLASP IID pivotal trial by year-end 2020
- Continue enrolling PASCAL CLASP IIF and CLASP IITR pivotal trials
- Enrolling SAPIEN M3, the first transseptal mitral valve replacement pivotal trial
- Initiate an early feasibility study for the EVOQUE tricuspid valve replacement system
Surgical Structural Heart – Edwards remains committed to advancing its leadership position as the partner of choice for surgeons in an effort to continually enhance patient outcomes. The company anticipates receiving regulatory approval in Europe for the HARPOON echo-guided beating-heart system by year-end 2019. Edwards also expects to launch the KONECT RESILIA system, featuring the first and only ready-to-implant tissue valve conduit, in 2020, and the SUTRAFIX automated fastening system in late 2020.
Critical Care – Edwards plans to continue to drive growth and leadership with innovations in critical care technologies, including its pioneering work in intelligent decision-support 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 our leadership in smart monitoring. Furthermore, Edwards anticipates the launch of the ClearSight system on HemoSphere in 2020.
During the conference, Edwards' management will reaffirm the company's financial guidance for 2019 and provide guidance for 2020.
Fiscal Year 2019 Outlook
December 2018 Guidance
Around the top of $4.0-4.3 billion
Below $40 million
Surgical Structural Heart
Adjusted Free Cash Flow4
Above the top end of $800-900 million
Fiscal Year 2020 Non-GAAP Guidance
Underlying Growth Rate
$4.5 – 5.0 billion
$2.9 – 3.2 billion
Surgical Structural Heart
FX Impact on Sales (at current rates)
~$40 million unfavorable
Gross Profit Margin
SG&A % of Sales
R&D % of Sales
Tax Rate (including ~5pp ETB benefit)
Free Cash Flow
In addition to Mr. Mussallem, other members of Edwards' management team presenting include:
Daveen Chopra, Corporate Vice President, Surgical Structural Heart;
Ted Feldman, VP Medical Affairs, Transcatheter Mitral and Tricuspid Therapies;
Katie M. Szyman, Corporate Vice President, Critical Care;
Scott B. Ullem, Chief Financial Officer;
Larry L. Wood, Corporate Vice President, Transcatheter Aortic Valve Replacement; and
Bernard J. Zovighian, Corporate Vice President, Transcatheter Mitral and Tricuspid Therapies.
Guest Speakers to Provide Clinical Perspective
Also speaking at the conference are: Geoff Strange, MD, University of Notre Dame Australia School of Medicine; Scott Lim, MD, Professor of Medicine & Pediatrics at the University of Virginia; and Robert Smith, MD, Baylor & White Cardiac Surgery Specialists.
The Edwards Lifesciences 2019 Investor Conference can be accessed via live webcast at http://ir.edwards.com/ beginning at 8:30 a.m. Eastern Time on Dec. 5, 2019. The presentations and 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, 2019 and 2020 financial guidance, expected investment, timing and results of milestones in R&D and expect timing and enrollment in clinical trials, and expected regulatory 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 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 filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2018. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Alterra, Cardioband, CLASP, ClearSight, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, EVOQUE, HARPOON, HemoSphere, KONECT, KONECT RESILIA, PARTNER, PARTNER 3, PASCAL, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, SAPIEN M3, SAPIEN X4, and SUTRAFIX 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 the United States or Germany. Cardioband is not available for commercial sale in the United States. HARPOON, KONECT, and SAPIEN M3 are not 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 exclude foreign exchange rate fluctuations, sales return reserves associated with product upgrades, the conversion to a consignment inventory system for surgical structural heart ("Surgical"), and includes the sales results of CASMED prior to its acquisition in the second quarter of 2019.
"Adjusted earnings per share" is a non-GAAP item computed on a diluted basis and in this press release excluding 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 positive impact of TAVR stocking sales in Germany and the negative impact of de-stocking, the conversion to a consignment inventory system for Surgical, sales return reserves and related costs associated with TAVR product upgrades, significant pension curtailment gains, gains and losses from significant investments, realignment expenses, charitable contributions to the Edwards Lifesciences Foundation, and the impact from implementation of tax law changes and settlements.
"Free cash flow" is defined as cash flows from operating activities less capital expenditures. During 2018, the Company excluded from its calculation payments related to tax audit settlements and the repatriation tax resulting from U.S. tax law changes. During 2017, the Company excluded from its calculation a receipt of a litigation payment and the amount of an escrow deposit related to the purchase of a building.
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