Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference
IRVINE, Calif., Dec. 5, 2018 -- 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 Irvine, California.
Highlights of today's conference include:
- Reaffirming October 2018 financial guidance1
- Projected 2019 global sales $3.9-4.3 billion; underlying2 growth 9-12%
- Estimated 2019 adjusted earnings per share3 $5.05-5.30
- Projected 2019 TAVR sales $2.4-2.7 billion; underlying growth 11-15%
- Favorable PARTNER 3 Trial results expected in March; commercial approval in late 2019
- Global transcatheter valve therapy opportunities projected to reach ~$10 billion by 2024
- Completed $250 million accelerated share repurchase during the fourth quarter
- Focused long-term growth investments with 2019 R&D planned at 17-18% of sales
"In 2018, we are delivering results and making significant progress on milestones to drive future growth and success," said Michael A. Mussallem, chairman and CEO. "In 2019, we are projecting strong sales growth and financial performance 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 the PARTNER 3 Trial results, new product launches, and progress on multiple clinical trials and early feasibility studies, advancing innovations to treat mitral and tricuspid valve diseases."
Among the topics being discussed at today's conference are:
Transcatheter Aortic Valve Replacement (TAVR; formerly THVT) – 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 plans to 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. Select milestones include:
- Recently received CE Mark for the Edwards SAPIEN 3 Ultra system in Europe and anticipate approval in the U.S. around the end of the year
- U.S. trial for the Edwards CENTERA valve system continues to enroll and controlled commercial rollout underway in Europe
- Results for the PARTNER 3 clinical trial, studying low-risk surgical patients, are expected to be presented in March; also expect receipt of a low risk indication in the U.S. in late 2019
- Initiation of a single-arm clinical trial in the U.S. in 2019 to study TAVR in underrepresented and minority populations
- Transcatheter system designed to treat pulmonic valves expected to move into pivotal clinical trial phase in the first quarter of 2019
- EARLY TAVR, studying treatment of severe aortic stenosis patients before they develop symptoms, expected to complete enrollment in 2020
Transcatheter Mitral and Tricuspid Therapies (TMTT) – With the opportunity estimated to reach ~$3 billion by 2024, Edwards will discuss its portfolio strategy aimed at transforming care for the many patients suffering from mitral and tricuspid valve diseases. The company expects a strong cadence of transformational therapies with three repair technologies commercially available in Europe in 2019: the PASCAL system for patients with mitral regurgitation and the Cardioband system for patients with both mitral and tricuspid regurgitation. Additional highlights and expected milestones include:
- Launch of the PASCAL repair system for mitral patients in Europe by mid-year 2019
- Continue enrolling the PASCAL CLASP DMR U.S. pivotal trial
- Initiate PASCAL CLASP FMR U.S. pivotal trial in late 2019
- Initiate SAPIEN M3 system U.S. pivotal trial in late 2019
- Cardioband ACTIVE MR U.S. pivotal trial enrollment has been paused to evaluate trial design
- Initiate Cardioband ACTIVE TR U.S. pivotal trial in late 2019
Surgical Structural Heart (formerly SHVT) – Edwards expects to extend its leadership position through additional surgical structural heart advancements, including the INSPIRIS valve and its new class of resilient valves. The company is committed to partnering with cardiac surgeons to continually enhance surgical outcomes for patients. Edwards expects to launch the KONECT system, featuring the first and only ready-to-implant tissue valve conduit, in 2019 in both the U.S. and Europe. And, after completing its review of the early experience with the HARPOON system, the company anticipates treating patients in Europe by mid-year 2019.
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 HemoSphere platform is the first and only platform to integrate a variety of hemodynamic monitoring solutions and predictive monitoring tools to address patient needs in a range of surgical settings. With the recently received FDA clearance of the Acumen Hypotension Prediction Index (HPI), the ongoing phased rollout of the HemoSphere platform will now include HPI, with plans to launch in early 2019 in the U.S. and Europe.
During the conference, Edwards' management will reaffirm the company's financial guidance for 2018 and provide guidance for 2019.
Fiscal Year 2018 Outlook
December 2017 Guidance
Higher end $3.5-3.9 billion
THVT underlying sales growth
SHVT underlying sales growth
CC underlying sales growth
Exceed top end of 6-8%
Adjusted Free Cash Flow4
Higher end $700-775 million
Fiscal Year 2019 Non-GAAP Guidance
Underlying Growth Rate
TAVR (formerly THVT)
Surgical Structural Heart (formerly SHVT)
FX Impact on Sales (at current rates)
Gross Profit Margin
SG&A % of Sales
R&D % of Sales
Tax Rate (including estimated ETB impact)
Free Cash Flow
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;
Daveen Chopra, Corporate Vice President, Surgical Structural Heart;
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: Randolph P. Martin, MD, Chief Medical Officer of Bay Labs and Chief of Valvular & Structural Heart Disease, Piedmont Heart Institute; and Jeffrey J. Popma, MD, Interventional Cardiologist, Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center.
Yesterday's Evening Symposium
The prior evening's showcase included a discussion of recent learnings on aortic stenosis patients in the U.S., as well as clinician guest speakers, product demonstrations and facility tours.
The Edwards Lifesciences 2018 Investor Conference can be accessed via live webcast at http://ir.edwards.com/ beginning at 8:00 a.m. Pacific Time on December 5, 2018. The webcast will be live streamed via the Edwards IR app available for free download at the Apple App Store or Google Play. 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, 2018 and 2019 financial guidance, expected timing and results of milestones in R&D and clinical trials, 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 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, 2017. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Acumen, Cardioband, CENTERA, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, HARPOON, HemoSphere, HPI , INSPIRIS, KONECT, PARTNER, PARTNER 3, PASCAL, SAPIEN, SAPIEN 3, SAPIEN M3, 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 the United States or Germany. Cardioband and CENTERA are not available for commercial sale in the United States. HARPOON, KONECT, PASCAL 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 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, the conversion to a consignment inventory system for surgical heart valves ("SHV"), and other special items.
"Adjusted earnings per share" is a non-GAAP item computed on a diluted basis and in this press release excludes intellectual property litigation income and 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 2018, this amount excludes tax audit settlements and repatriation taxes.
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