Bernard J. Zovighian
Chief Executive Officer at Edwards Lifesciences
Thank you, Mark, and thank you all for joining us. This afternoon we issued two press releases which the team and I will review in more detail with you now. The first, outlining our Q2 results. And the second, highlighting our acquisition of JenaValve, a pioneer in the transcatheter treatment of aortic rehabilitation or AR. And Endotronix, a leader in heart failure management solutions.
I will start with our second quarter performance. Total company sales of $1.6 billion increased 8% on a constant currency basis versus the year ago period. In addition, we made important advancements in our clinical research, new product in production and efforts by Edwards employees to address the unmet needs of many more patients around the world.
TAVR growth in the second quarter was lower than expected, yet we are pleased with the increasingly significant contribution from TMTT. Our vision for TMTT is becoming a reality and our strategic commitment has developed into a growth portfolio of differentiated technology. Overall, Edwards remain well-positioned to deliver strong, sustainable growth.
We also announced this afternoon two acquisitions, JenaValve and Endotronix. We have known this company for many years. Discussions with the companies have been ongoing for some time and the timing of these acquisitions coincided with earnings. We are pleased to expand into two new structural heart therapeutic areas, AR and heart failure, and we will leverage our innovation capabilities with worldclass science and clinical evidence to ensure accelerated access to life-saving technologies for patients around the world.
Now I will provide some additional detail on Q2 results by product group. In TAVR, second quarter global sales of $1.04 billion increased 6% year-over-year, lower than we planned. Edwards competitive position did not meaningfully change globally, although we experienced some regional pressure, and we maintain pricing. We are confident in our differentiated technology, high-quality evidence and the value we continue to demonstrate to patients, clinicians and the healthcare system.
We remain focused on continuing our deep commitment to advancing evidence for AS patients. At the New York Valves meeting in June, we presented additional analysis from the PARTNER trials, which demonstrated excellent clinical outcome up to 5 years in women and patient with small annuli. Adding to the global body of evidence on the platform, we also anticipate additional data from the RHEIA study to be presented at the upcoming ESC Meeting in London. RHEIA is a prospective randomized study in more than 400 patients across 35 sites in Europe comparing the safety and efficacy of TAVR versus surgery in women with severe symptomatic aortic stenosis.
We are actively pursuing significant opportunity to grow TAVR globally over the long-term and are proud to continue our deep commitment to advancing science for aortic stenosis patient through the progress and early TAVR trials, which could fundamentally change how AS patients are treated. Early TAVR trial results will be presented at TCT this year, and we believe if the data are compelling, it could have a meaningful impact on the timing for patient treatment, while also streamlining referral and patient care for all severe AS patients.
In the US, our year-over-year second quarter TAVR sales growth was slightly below our global constant currency growth rate. We believe our US competitive position was largely unchanged. Second quarter, US TAVR sales grew slower than expected. The continued growth and expansion of structural heart therapies, including newly approved tricuspid therapies and other fast-growing structural heart therapies put pressure on hospital workflows, which impacted TAVR. These pressures were also observed in the recent spike in emergent TAVR cases as reflected in claims data. As centers adopt these new therapies and they become part of extended processes, we expect this will stabilize. We know from experience that hospital have historically demonstrated the ability to scale to support transcatheter procedure growth over time. We believe significant undertreatment of severe AS persists, evidence demonstrates that a large number of in-system patients currently go untreated.
We are accelerating our efforts to improve referrals and treatment rates for patient already in the hospital system who are suffering from severe symptomatic aortic stenosis. We recently launched the Edwards ENACT patient activation program, which leverage a comprehensive cardiovascular AI platform and worldclass support to bring real-time insights to TAVR program and improve quality of care for patients. This first of its kind program is focused on streamlining the identification, evaluation and treatment of severe aortic stenosis patient within the hospital system.
Outside of the US, in the second quarter, our constant currency TAVR sales growth was slightly above our global TAVR growth. In Japan, we generated double-digit sales growth driven by SAPIEN 3 Ultra RESILIA. We continue to focus on expanding the ability of this therapy and believe AS remain a significant under threated disease among the substantial elderly population in Japan. In Europe, while share is down slightly on an annualized basis, we were pleased with the momentum driven by the launch of SAPIEN 3 Ultra RESILIA. We are pleased with high procedure success rate and exceptional patient outcome. We expect the momentum to continue to build as more centers have experienced with the first-choice valve for lifetime management.
In closing, we now anticipate second half TAVR sales growth similar to the first half year-over-year growth rate of 5% to 7% full year growth rate versus previously guidance of 8% to 10%. This equate to full year global TAVR sales of $4 billion to $4.2 billion. We believe hospitals are motivated to continue scaling to accommodate increase in volume of transcatheter procedures, which will bring tremendous value to patients and the healthcare system. We remain confident that Edwards is positioned for healthy and sustainable TAVR growth driven by our differentiated TAVR portfolio, our deep commitment to advancing patient care for high-quality clinical evidence and new indications and our investment in patient activation initiative.
Turning to TMTT. Our deep structural heart expertise has enabled us to significantly advance our portfolio of differentiated technologies, including the PASCAL repair system, the EVOQUE tricuspid replacement system and the SAPIEN M3 mitral replacement system. Our exciting pipeline of innovations is addressing the large unmet needs for patients with mitral and tricuspid disease. In Q2, we achieved positive results with sales of $83 million, representing a 75% increase versus the prior year. Q2 sales were led by PASCAL globally and early commercial introduction of EVOQUE in the US and Europe. PASCAL adoption is growing, reflecting its premium differentiation and the value it brings to physician and patients. We believe the mitral tier markets continues to grow double-digit in both the US and. Europe. We are excited to bring this therapy to more geographies, more physicians and more patients.
The EVOQUE commercial launch continue to progress well. Our disciplined strategy is focused on outstanding patient outcome in centers investing resources required to grow a successful tricuspid program. We are now opening new centers both in Europe and the US after having started with our clinical trial sites. We continue to see strong interest in the therapy, which reflects the significant unmet need in this population of patient who have few options for treatment. Our early real-world commercial experience has demonstrated excellent clinical results. Consistent with those from the TRISCEND II trial. We look forward to presenting the full cohort of TRISCEND II data at the TCT Conference in October. Last month, CMS announced the opening of a national coverage analysis for transcatheter tricuspid valve replacement. Since EVOQUE was granted FDA breakthrough status and is utilizing the CMS parallel review process, we believe CMS can move quickly to finalize national coverage.
SAPIEN M3 remains on-track to be our first transcatheter mitral valve replacement therapy to gain regulatory approval and launch around the world. We are also pleased to have received a breakthrough designation from the FDA, and we completed enrollment in the mitral annulus or MAC arm of our ENCIRCLE study. We now expect SAPIEN M3 to receive CE Mark earlier than previously expected by mid 2025, with FDA approval in the US to follow in 2026.
Earlier this month, we announced the acquisition of JenaValve. JenaValve early-stage technology will add to our growing pipeline of innovative therapy in TMTT, and we expect to close the acquisition later this year. We further expect that JenaValve technology combined with Edwards expertise in mitral disease will enhance the company TMVR technologies to address large unmet structural heart patient needs and support sustainable long-term growth. Based on the first half 2024 momentum and the ongoing global adoption of our differentiated technology PASCAL and EVOQUE we are increasing full year sales guidance for TMTT to the higher end of our previous $320 million to $340 million range. We remain confident that our unique portfolio strategy with repair and replacement therapies for both mitral and tricuspid disease will offer clinician the broader set of options needed to treat this complex and diverse patients. The advancement of our long-term TMTT strategy has positioned us for strong, sustainable growth over many years driven by a growing portfolio of innovative therapies.
In surgical structural heart second quarter sales of $264 million increased 5% over the prior year. Growth was driven by strong global adoption of Edwards premium surgical technologies INSPIRIS, MITRIS and KONECT. We continue to see positive procedure growth globally for the many patients best treated surgically, including those undergoing complex procedures. We continue to expand the overall body of RESILIA evidence and have completed enrollment in the US and Canada for our momentous critical trial studying RESILIA performance and the mitral position. MITRIS adoption in Europe is ramping up, and we are pleased to have been granted reimbursement for the device in France earlier than expected.
In summary, we remain confident that our full year 2024 surgical sales will be 6% to 8% driven by continued adoption of our RESILIA portfolio and growth in overall heart valve surgeries. In Critical Care, second quarter sales were $246 million, which increased 7% versus the prior year. Growth was led by a pressure monitoring devices using the ICU with strong contribution from our SMART Recovery technologies, including the Acumen IQ sensor. Demand was also strong for Swan-Ganz catheter. Critical Care remains focused on driving growth through SMART Recovery and SMART Expansion, which are designed to help clinicians make more informed decision and get patients home to their family faster. Since announcing the sales of Critical Care to Becton Dickinson in June, our team has made significant progress and we plan to close by late Q3. I want to thank all of them for their hard work and dedication.
Turning now to the strategic acquisition of JenaValve and Endotronix. These acquisitions provide an expanded opportunity in new therapeutic areas to address the unmet needs of AR and heart failure patients around the world. Furthermore, the acquisition reflects our deep commitment to advancing patient care through our unique strategy and reinforce our confidence in Edwards sustainable long-term growth. Starting with JenaValve, a pioneer in the transcatheter treatment of AR, a deadly disease that impacts more than 100,000 patients in the US alone and is largely untreated today. Edwards anticipate US FDA approval of the JenaValve Trilogy Heart Valve System in late 2025, which will represent the first approved therapy for patient suffering from AR. Edwards will invest to accelerate development of this novel technology to enable earlier patient access. As the pioneers in valve innovation, we believe we are best positioned to lead this next frontier of aortic valve disease treatment. We expect this to be the beginning of a long-term iterative strategy similar to TAVR.
Turning to Endotronix. Edwards made its first investment in the company in 2016. So we are very familiar with the technology, the opportunity and the employees. Many structural heart patients Edwards serves today also suffer from heart failure with limited options. This acquisition will expand Edwards structural heart portfolio into a new therapeutic area to address the large unmet needs of patients suffering from heart failure, which we believe has a significant long-term growth opportunity. Last month, Endotronix received FDA approval for Cordella, an implantable preliminary artillery pressure sensor that directly measure the leading indicator of congestion following the publication of a successful US pivotal trial. We are pleased to enter the structural heart therapeutic area with innovation, worldclass science, and clinical evidence to provide access to life-saving technologies for patients around the world. We anticipate this investment will strengthen its leadership in structural heart innovation and represent long-term growth opportunity. Minimal revenue contribution from JenaValve and Endotronix is expected to begin late in 2025. As you can tell, we have a lot of positive momentum and many catalysts across our core businesses, TAVR, TMTT and Surgical combined with opportunities to reach new patient population.
And now I will turn the call over to Scott.
