The speaker welcomes listeners to the Edwards Lifesciences Third Quarter 2023 Earnings Conference Call and introduces the CEO, CFO, and other executives who will be discussing the company's financial results. The call will also include forward-looking statements and address topics such as growth opportunities, regulatory approvals, and potential risks.

The paragraph discusses the information and safety precautions available on Edwards' website, as well as the company's strong third quarter results. It also mentions the progress made at the TCT conference and the presentation of data from clinical trials for the SAPIEN platform. The data demonstrates the benefits of SAPIEN technology and its high success rate in treating patients with aortic stenosis.

In the third quarter, the company saw an 11% increase in global sales, driven by their innovative therapies. They also achieved important milestones in their commitment to patient-focused innovation, including CE Mark approvals and completion of enrollment in a pivotal trial. Sales for their TAVR platform, SAPIEN, were up 10% year-over-year and their competitive positions and selling prices remained stable globally.

In the third quarter, Edwards saw strong sales growth in the U.S. driven by the successful launch of SAPIEN 3 Ultra RESILIA and a successful clinical trial for their next generation TAVR technology. In Europe, sales were driven by the adoption of their SAPIEN platform and they are looking forward to presenting additional data at a conference in November. Sales in Japan also grew, reflecting a recovery in market growth and strong adoption of their technology. In the mitral and tricuspid space, Edwards achieved significant milestones and saw a 65% increase in global sales driven by the adoption of their PASCAL precision platform and the activation of more centers. They are also expanding globally with an expected launch in Japan before the end of the year.

The company is looking forward to presenting results from their clinical trials at TCT, which will add to the evidence supporting TEER as an effective therapy for mitral valve disease. They have also received CE Mark approval for EVOQUE, a new therapy for tricuspid valve disease, and will be presenting data from the TRISCEND II pivotal trial at TCT. The company is committed to innovation and helping patients with unmet needs, and their surgical sales have increased by 11% due to global adoption of their premium technology.

The company has seen strong global momentum for its RESILIA portfolio, supported by recent clinical trial data and CE Mark approval for their MITRIS RESILIA mitral valve. In the Critical Care segment, sales increased by 6% in the third quarter, driven by the adoption of smart recovery technologies. The company remains confident in its pipeline of critical care innovation. The company achieved total sales of $1.48 billion in the third quarter, representing 11% year-over-year growth. Adjusted earnings per share were $0.59, with GAAP earnings per share of $0.63 due to a change in U.S. tax regulations. Double-digit global TAVR growth continued, driven by balanced hospital staffing and strong adoption of the SAPIEN family of valves.

Edwards saw strong sales growth in TAVR, TMTT, Surgical Structural Heart, and Critical Care in the third quarter, driven by the launch of new products and increased demand in various regions. They continue to expect steady growth in these areas and maintain their full year sales and earnings projections. Fourth quarter sales and earnings are also projected to be strong.

In the third quarter, the company's adjusted gross profit margin was 76.4%, lower than the previous year due to foreign exchange impacts. Selling, general and administrative expenses increased due to investments in personnel and therapy adoption initiatives, while research and development expenses grew due to investments in transcatheter valve innovations and clinical trials. The reported tax rate was 12.7%, benefiting from certain U.S. tax regulations and income mix, and the full year tax rate is expected to be between 13% and 17%. Foreign exchange rates also had a negative impact on reported sales growth.

The article discusses the current financial status of Edwards Lifesciences, including a $40 million negative impact on sales for 2023 due to FX rates, a 410 basis point decrease in gross profit margin compared to the previous year, and a $356 million free cash flow for the third quarter. The company also mentions maintaining a solid balance sheet and share repurchase activities. The CEO, Bernard Zovighian, expresses confidence in the company's growth potential, particularly in the areas of transcatheter mitral and tricuspid therapies.

The speaker, Mark Wilterding, introduces the next speaker, Bernard Zovighian, who talks about the potential for success in the future through patient-focused technologies and leadership. Mark then reminds listeners about an upcoming investor conference and opens the call for questions. The first question is about the 11% growth in the TAVR market and what is holding it back from being faster. Bernard and Larry respond, stating that they are pleased with the double-digit growth and that it is balanced between the U.S. and OUS.

Edwards is seeing success with their Ultra RESILIA adoption in the US and Japan, and they believe they are well-positioned for the future. They have had three quarters of double-digit growth and are working to get more patients off the sidelines. They also recently received CE Mark approval for EVOQUE in Europe and are looking to accelerate adoption in the tricuspid replacement market by focusing on patient outcomes, similar to their approach with TAVR.

The company is focused on training and equipping their team to support physicians in launching a new therapy in Europe. They believe that a comprehensive approach, including technology, innovation, and evidence, is necessary for success. They also plan to improve diagnosis, referral, and treatment for patients in the long term. The company is at the beginning of understanding tricuspid disease and expects to learn more with the adoption of their therapy. TAVR growth for the year is currently at 10% and the midpoint of guidance is 11.5%.

The company's guidance for TAVR for the full year is 10% to 13%, which reflects the stronger than expected results in the first and second quarters. The guidance for the full company in the fourth quarter is about $10 million higher than in the third quarter. The company is targeting double digit annual revenue growth for 2024 and will provide more details at their investor event in December. They are confident in their opportunity to help many patients.

The speaker discusses the company's solid global leadership position and expresses confidence for future growth. They also mention that the exchange rate may be a headwind to sales and EPS in 2024. The speaker then addresses a question about TAVR five year data and states that the data presented at an investor event was insightful. They highlight the 90% survival rate at five years and ask another speaker to provide more detail on the data.

The speaker discusses the results of a study comparing TAVR and surgical treatment for aortic valve stenosis. They mention that there was a higher rate of patient withdrawal on the surgical side, but overall, both groups had over 90% survival at five years. They also address concerns about TAVR causing cancer or COVID, and state that both groups performed well. The speaker defends the use of contemporary standards and feels confident about the data. They conclude by saying that it is not necessary for TAVR to be better than surgery, as long as the results are identical for patients.

The data presented at the meeting showed that the less invasive therapy for aortic valve replacement is just as effective as open heart surgery, with no durability issues at five years. This gives confidence to the referral community to recommend this procedure to patients who may have been hesitant before. There was also a question about GLP-1 exposure to TAVR, but there is no financial exposure in Europe and it is not expected to have any impact on TAVR patients.

The speaker discusses the lack of evidence showing a connection between weight loss and aortic stenosis disease. They also mention the potential impact on coronary disease, stating that genetics play a larger role. The next question is about patient reported outcomes and their role in gaining approvals and reimbursement decisions for tricuspid repair and replacement. The speaker mentions the positive results of the TRILUMINATE study and the upcoming EVOQUE study, but cannot go into detail until the investor conference tomorrow. They emphasize the importance of quality of life improvements and safety in these patients who have no other options.

The company is seeing positive outcomes from their PASCAL tricuspid technology in Europe, with patients experiencing improved quality of life. The recent randomized trial for TRILUMINATE has also shown significant reduction in tricuspid regurgitation and meaningful quality of life improvements. The company is excited about the potential of these therapies for tricuspid patients and continues to work with regulators to make them available. They are also expanding their toolbox of treatment options for physicians. Regarding their U.S. sales strategy, they have separate teams for TAVR and TMTT, but there may be concerns about missing cross-selling opportunities with TAVR sales reps who have strong relationships with interventional cardiologists.

The speaker, Larry Wood, discusses the decision to create a separate sales force for TAVR and how it has been successful in providing high-quality care for patients. He also mentions the importance of having a specialized team for each therapy, rather than having a generalist approach. The speaker emphasizes the importance of expertise and driving positive outcomes for patients.

In this paragraph, Daveen from TCT discusses the positive feedback they have received from physicians regarding their comprehensive high-touch model. She notes that physicians appreciate having a dedicated Edwards person who is knowledgeable in the mitral tricuspid space and can offer the best possible advice and collaboration for patient outcomes. The speaker also mentions that the Q4 guidance for the year is in line with the full year guidance and clarifies that the growth rates mentioned are for underlying constant currency. They also briefly touch on the topic of market share in 2024, stating that they cannot provide specific information but will continue to focus on maintaining stable share.

Scott Ullem and Travis Steed of a company are discussing the upcoming year and the impact of FX on gross margins. They are unable to provide specific details until their investor conference in December. Joanne Wuensch asks about the double-digit growth in surgical valve revenue and Bernard Zovighian responds that they are pleased with the growth and have been a pioneer in the field.

The company has been a successful innovator and this is reflected in their Q3 results, which show a balanced combination of adoption of their RESILIA platform, premium pricing, and procedural growth. The surgical business is not solely focused on aortic stenosis, but also treats other conditions such as mitral and aortic regurgitation. The idea of a zero sum game between the surgical and TAVR businesses is not accurate. When looking at different types of centers in the U.S., there was stable staffing and Larry Wood regularly analyzes this data.

The speaker discusses the growth rates of different segments during COVID and how larger centers saw less growth while smaller centers saw more. However, this trend is starting to become negligible as things return to normal. The speaker also mentions the valve-in-valve indication and how it is not a major factor in their growth currently, but they do offer TAVR in failed surgical valves. This has led to an increase in the usage of biological valves in younger patients because of the potential for TAVR in the future.

The company is optimistic about the future potential of their INSPIRIS valve for TAVR procedures. They believe that as patients live longer, there will be a need for a second procedure and having a TAB and TAB option will contribute to their growth. The company's surgical and TAVR platforms are both suitable for future valves. The five year data released yesterday does not provide any indication for the upcoming asymptomatic data readout.

The speaker believes that the data from the TAVR trial does not provide any significant insights and they have not analyzed the early TAVR data yet. They mention the importance of long-term data and durability for the success of the SVA asymptomatic trial and the progress trial. They also mention the progress made in getting more patients diagnosed and referred for TAVR.

The company sees their patient activation initiative as important and has been working on it for several years, with some success. They believe the future is even more exciting due to this initiative. The company has been doing a lot of digital and patient activation efforts, which have contributed to the growth of the market. They acknowledge that it is an ongoing process and will continue to work on it in order to reach more patients.

The speaker discusses the company's work streams and upcoming investor conference, mentioning various programs and pilots that are currently in progress. They also mention that the market share for their TAVR product has remained stable and that they are excited about the potential for their RESILIA product. There is a brief mention of positive pricing for RESILIA, but it was not the main driver of revenue growth. The speaker closes by expressing satisfaction with the company's performance in 2023.

The speaker is pleased with the progress the company has made in their TAVR leadership and expanding their reach in mitral and tricuspid patients. They are confident in their long-term strategy and thank everyone for their trust. The conference call is now concluded.

This summary was generated with AI and may contain some inaccuracies.