The paragraph is from a company's press release, where Mark Wilterding introduces the session, including disclosures about forward-looking statements and associated risks. It mentions that Edwards does not undertake to update these statements, and details about factors that can cause differing results are available in the press release and SEC filings on their website. The comments concern sales growth in constant currency, excluding certain operations like Critical Care, which was sold in Q3 2024. Bernard Zovighian then takes over, welcoming participants and outlining the agenda, which includes discussing Q4 and full-year 2024 results, as well as the company's 2025 vision. Edwards is focused on addressing unmet needs in structural heart through innovative strategies to sustain long-term growth.

In the past year, Edwards experienced strong growth and progress, with sales increasing by 9% to $5.4 billion, aligned with their original guidance. Despite lower-than-expected TAVR growth, TMTT surpassed expectations. Edwards remains focused on long-term TAVR prospects and anticipates significant contributions from TMTT as their technology portfolio expands. They made strategic moves, including the sale of Critical Care, investments in R&D, and acquisitions of JC Medical, JenaValve, and Endotronix, to enhance their capabilities in addressing heart conditions. In Q4, Edwards, now concentrating solely on structural heart, saw a 9% sales increase, boosting earnings per share and ending the year strongly with key growth drivers in TAVR, mitral, tricuspid, and emerging opportunities in structural heart failure and aortic regurgitation.

The paragraph highlights Edwards' strong foundation and strategic positioning for growth in 2025 and beyond, driven by innovations and global expansion. The successful early TAVR trial and anticipated FDA approval in 2025 are key catalysts for enhanced patient care and potential policy changes. The TMTT business is making significant contributions and is expected to generate over $500 million in sales by 2025. The surgical division is set for consistent global growth, supported by the adoption of Resilia-based technology. Edwards aims for 8% to 10% sales growth in 2025, with plans for 10% annual growth beyond, enhancing shareholder value. The paragraph concludes with an overview of Q4 and 2024 sales details, emphasizing a 6% increase in global TAVR sales for the year.

In the fourth quarter, global sales reached $1.04 billion, a 5.3% increase from the previous year, primarily driven by growth in the U.S. and Europe. Edwards maintained a strong competitive position with stable pricing, despite regional pressures. The company's commitment to advancing clinical evidence was demonstrated by the positive results of the early TAVR trial, which showed superior outcomes for asymptomatic severe AS patients using the SAPIEN platform. These findings suggest a need for changes in the standard of care to enhance patient outcomes and reduce system costs. The SAPIEN 3 Ultra RESILIA platform performed well in the U.S., with a focus on growing capacity for structural heart procedures. Sales growth outside the U.S. was bolstered by the launch of SAPIEN 3 Ultra RESILIA in Europe.

The paragraph highlights the strong growth and potential of the company's medical platforms, particularly for treating heart conditions like aortic stenosis, mitral, and tricuspid valve diseases. Despite slower sales growth in Japan, the company sees significant opportunities internationally, given the low adoption rates of TAVR therapy outside the U.S. Their portfolio, including the PASCAL repair, EVOQUE tricuspid replacement, and SAPIEN M3 mitral replacement systems, is driving strong sales growth, with Q4 reaching $105 million and full-year sales up 77% to $352 million. The PASCAL and EVOQUE systems are gaining traction in the U.S. and Europe, supported by positive clinical outcomes and increasing adoption rates.

The paragraph discusses the progress and future plans of Edwards' transcatheter Mitral and Tricuspid therapies (TMTT). The company is successfully launching the EVOQUE system in the U.S. and Europe, with strong pricing growth indicating unmet patient needs. They anticipate a final national coverage determination from CMS to facilitate Medicare access to EVOQUE by Q1 2025. European approval for the SAPIEN M3 is expected by mid-2025, with U.S. approval following in 2026, and pivotal trial results to be presented at the TCT Conference. The company expects 2025 TMTT sales of $500-$530 million, supported by PASCAL and EVOQUE technologies. Additionally, the surgical product group's sales for 2024 rose by 6% to $981 million, with continued global adoption of the RESILIA portfolio.

The paragraph focuses on the company's financial performance and expectations for growth. They expect global procedural growth, particularly in surgical treatments, driven by the adoption of their RESILIA portfolio. The company's full-year 2025 surgical sales growth is projected to be in the mid-single digits. Scott Ullem provides a summary of 2024, highlighting a successful Q4 with total sales of $1.39 billion, a 9% year-over-year increase. The adjusted earnings per share was $0.59, while GAAP earnings per share was $0.58. The adjusted gross profit margin for Q4 was 79%, down slightly from the previous year. SG&A expenses increased to $492 million, partly due to growth in field-based teams and strategic acquisitions. The company plans to maintain SG&A spending levels through 2025 and aims for a lower SG&A ratio over time.

In the fourth quarter, research and development expenses increased by 12% to $271 million, primarily due to acquisitions, and are expected to remain at this level in 2025. The adjusted operating profit margin was 25.6%, with a 2025 guidance of 27% to 28%. The reported tax rate was 11.6%, or 13.3% excluding special items, benefiting from onetime tax events, with a 2025 forecast of 15% to 18%. Tariffs are expected to have minimal impact, and foreign exchange rates boosted sales growth but slightly decreased the gross profit margin in Q4. In 2025, FX is expected to reduce sales by $130 million.

The paragraph details the company's strong financial position with $3 billion in cash and cash equivalents and a remaining $1.4 billion for share repurchases. It reaffirms the financial guidance for 2025, predicting total company sales of $5.6 billion to $6 billion, with specific sales figures for TAVR, TMTT, and Surgical segments. The company expects a sequential increase in first-quarter sales but notes that year-over-year growth rates for Q1 may be below the full-year guidance. They anticipate benefits from U.S. approval of asymptomatic TAVR and future policy changes. Projected Q1 sales are $1.35 billion to $1.43 billion, with adjusted EPS between $0.58 and $0.64. Bernard Zovighian concludes by expressing pride in the employees' achievements and optimism for growth in structural heart disease solutions.

In the article paragraph, during a question-and-answer session, David Roman from Goldman Sachs inquires about the performance dynamics of the TMTT segment for the year 2024, which exceeded expectations. He asks what operational changes need to occur to achieve further growth, referencing their progress from annualizing at $420 million in Q4 to over $500 million as per their guidance. Bernard Zovighian responds, highlighting the contribution of the PASCAL and EVOQUE products, particularly in Europe and the U.S., and emphasizes the company's successful realization of a long-held vision. Daveen Chopra is invited to add more details to the discussion.

The paragraph discusses the growth and outlook for two new therapies, EVOQUE and PASCAL, which began making strides in 2024 and are anticipated to continue expanding throughout 2025, particularly in the U.S. and Europe. Despite the challenges in Q4, such as a hurricane impact and competitive pressures from Boston Scientific in Europe, both therapies are seen as vital growth drivers for the company. David Roman seeks clarification on the discrepancy between the observed sequential deceleration from Q4 to Q1 and the projected full-year acceleration in revenue growth. Bernard Zovighian responds by expressing satisfaction with the company's strong performance in Q4 and anticipates further comments from colleagues Daveen and Larry.

In the paragraph, the company discusses its expectations for sales and growth rates. They anticipate a sequential increase in Q1 sales but suggest growth rates for TAVR and the company might be below their full-year targets. They highlight a few key points for 2025, including the scaling of TMTT products like PASCAL and EVOQUE, and an upcoming approval as potential catalysts for growth. Daveen Chopra and Larry Wood provide insights into the TMTT's growth trajectory and TAVR's performance, respectively. Despite a slowing down at the end of December affecting January's start, those aspects are considered in their guidance. The conversation then shifts to financial planning and operating expenses for 2025.

The paragraph discusses guidance on operating profit, with an emphasis on managing SG&A (Selling, General and Administrative) and R&D (Research and Development) expenses. Scott Ullem explains that the anticipated 200 basis point improvement in operating profit for 2025 is expected to be equally driven by reductions in R&D and SG&A as a percentage of sales. This is achieved by maintaining flat spending levels in 2025 compared to Q4, with a lower growth rate in spending relative to revenue growth. Bernard Zovighian adds that the company's primary goal is to invest in sustainable and profitable growth, expecting EPS (Earnings Per Share) to grow faster than revenue beyond 2025. Robbie Marcus then asks about regional pressures affecting the business, noting that the company's performance exceeded expectations despite these challenges.

Bernard Zovighian discusses the growth potential for their company in Japan, particularly in treating structural heart diseases in the aging population, despite being unsatisfied with Q4 growth there. The company is committed to improving its capabilities and innovation in the region. Larry Biegelsen from Wells Fargo asks Daveen Chopra about the impact of NTAP, effective from October 1, and the NCD, expected in March. Daveen shares positive stories from EVOQUE patients, illustrating the treatment's transformative impact, such as a 62-year-old CEO and a 79-year-old hospice patient who regained their quality of life.

The paragraph discusses the growing demand for the EVOQUE procedure among both physicians and patients, driven by positive clinical results similar to those seen in trials. The speaker notes that coverage decisions like NTAP and NCD are crucial for expanding patient access. They express optimism about growth and emphasize the importance of education and communication in promoting procedures like early TAVR. The speaker believes that a combination of factors, including data dissemination at key conferences, will positively impact procedure adoption.

The paragraph discusses the long-term strategy and potential growth opportunities for promoting a medical product, likely EVOQUE, in hospitals. Initially, focus was on hospitals involved in trials, about 50 in the U.S., but they've now expanded to other high-volume tricuspid centers. The company is conducting monthly training programs in Irvine and across the U.S. to train more centers and doctors. This expansion is expected to drive long-term growth and investment in hospitals' capacity improvement, supported by positive data and a steady stream of patients.

The paragraph discusses the growth expectations and market distribution for TMTT and TAVR. Initially, TMTT experienced growth primarily in Europe, which remains its largest market, though the U.S. is emerging as a significant contributor expected to grow by 2025. Travis Steed from Bank of America seeks clarification on the Q1 TAVR guidance. Scott Ullem confirms that the 5% to 7% growth forecast for TAVR is based on constant currency, with a one less selling day impacting growth by about 1 percentage point globally. This aligns the expectations with the Q4 results of around 5.3% growth.

The paragraph is a discussion from a conference call where Daveen Chopra provides updates on trials for two medical products: the CLASP IIF trial for mitral repair and the Class II TR trial for tricuspid repair using the PASCAL system. The CLASP IIF trial is expected to continue enrolling patients through 2025, with positive results shown in a related study for functional mitral repair. For the Class II TR trial, enrollment was completed in Q4 2024, with a 12-month follow-up required before preparing and submitting a PMA to the FDA, which itself takes at least six months for approval. Another question from Vijay Kumar addresses guidance for Q1, questioning why it shouldn't be better given that Q4 exceeded expectations despite unfavorable factors such as fewer business days, hurricane impacts, and issues in China.

In the discussion, Scott Ullem addresses the impact of an extra selling day, noting that apart from this, there isn't much else to report. He mentions that the early signals from China regarding hurricanes did not significantly affect Q4 results. He feels optimistic about the growth of TAVR in Q1. Larry Wood adds that a typical year-end slowdown affects patient funneling, causing a slow start to January, though higher growth rates are expected in future quarters. Vijay Kumar asks Bernard Zovighian about the NCD language concerning tricuspid procedures, noting that it seems more complex than TAVR guidelines. Bernard responds that they are satisfied with the progress made with CMS, and the proposed language aligns with their expectations.

The paragraph discusses a Medicare patient rework and its implications for future developments. Daveen Chopra comments on the involvement of multi-specialty heart teams in patient care, emphasizing the benefits of such an approach. He mentions the positive outlook on the National Coverage Determination (NCD) and the coverage with evidence determination (CED), which will not hinder their rollout plans. Vijay Kumar acknowledges the clarification. The conversation then shifts to Rick Wise from Stifel, who mentions an airport setting and seeks clarification on first-quarter TAVR guidance, aligned with thoughts from an Analyst Day concerning quarters of 2025.

In the discussion, Scott Ullem states that the company's guidance on TAVR expectations for 2025 remains unchanged, despite varying quarterly growth rates. Frederick Wise remarks on early TAVR trends, suggesting increasing referral volumes. Larry Wood responds, acknowledging anecdotal evidence of increased interest and discussions among some physicians about early TAVR. He emphasizes that while the implant community is familiar with early TAVR data, it will take time to reach the broader referral community, but anticipates that compelling data will eventually lead to more patients entering the system.

The paragraph discusses the efforts to address capacity challenges in hospitals to manage an increased inflow of patients, focusing on improving quality metrics like the time from diagnosis to treatment. It mentions the importance of measuring these metrics to improve patient flow. The discussion then shifts to a question by Matthew Miksic about the expansion of initial trial centers for EVOQUE, specifically regarding the potential number of centers similar to those for structural heart programs, which are currently around 850. Daveen Chopra responds that while it's challenging to predict an exact number, the expansion will likely be a portion of those existing centers, emphasizing the difficulty in determining how each center will adapt to new programs.

The discussion focuses on the challenges and progress in adopting a new therapy for tricuspid disease. The approach involves preparing medical centers individually to optimize treatment. Initial challenges, such as patient identification, procedure timing, and reimbursement, are typical for new therapies. Over time, as practitioners gain experience, procedures become more efficient and predictable. Early skepticism from referring physicians is addressed as successful outcomes lead to increased referrals. Overall, the process improves with practice and better integration into hospital systems.

The paragraph discusses the progress and efficiency of centers implementing the EVOQUE or other tricuspid programs, noting that established centers are becoming more efficient while new centers take longer to ramp up. There's emphasis on increasing awareness and proper diagnosis of tricuspid conditions, similar to previous efforts made for TAVR and Mitral. Matthew Taylor from Jefferies inquires about growth expectations in TMTT (Transcatheter Mitral and Tricuspid Therapies) for 2025, specifically seeking insight on growth sources and market share expectations. Bernard Zovighian responds that the focus is on creating a new category of treatments for patients who previously had few options, rather than concentrating on market share.

The paragraph discusses the strategic vision for the TMTT business, with expectations to grow from $300 million to $500 million this year and potentially $2 billion by 2030. Daveen Chopra emphasizes the significant opportunities to improve patient outcomes for those with tricuspid and mitral diseases, particularly through the PASCAL and EVOQUE products in Europe and the U.S. in 2025. Additionally, M3 is expected to start in Europe and contribute to revenue following its anticipated CE Mark approval by the end of the year, with data release planned for TCT 2025. Overall, the focus is on expanding the number of procedures to treat more patients rather than simply increasing market share.

In the paragraph, Daveen Chopra discusses the market opportunity for the M3 medical device, highlighting its expected CE Mark approval in Europe by mid-2025 and U.S. approval in 2026. The InCircle study, involving patients unsuitable for TR (transcatheter replacement), aims to demonstrate M3's role in treating this significant patient group. The company plans to focus on physician training and support to ensure successful outcomes and establish M3 as a key component of their transcatheter mitral and tricuspid therapies (TMTT) growth strategy. They aim for substantial revenue growth, targeting $2 billion by 2030.

The paragraph discusses the company's strong performance in 2024, with a 9% sales growth, and expresses confidence in continued financial success in 2025 and beyond. The growth is driven by diversified sources such as TAVR, Mitral, and Tricuspid markets. The company anticipates sustainable revenue, EPS growth, and shareholder value. The speakers, including Scott, Mark, and Larry, express their gratitude for continued interest in Edwards and invite further questions via telephone.

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