Edwards Lifesciences (EW) Offers Financial Guidance

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

(**Street sees FY19 EPS of $5.21)

"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.

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.

Webcast Information 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.

You May Also Be Interested In

• Meta capex to surge in 2027, neocloud fears ’erroneous’ - SemiAnalysis
• Cloudastructure restructures preferred stock, issues $1.3M promissory note
• FDA accepts Organogenesis BLA for knee osteoarthritis treatment ReNu