Edwards Lifesciences: A Market Leader with a Bright Future.

Edwards Lifesciences is a medical device company that helps treat people with serious heart valve problems. Its products make it possible to repair or replace damaged heart valves without open-heart surgery, which is especially important for older patients or those who are too weak for major operations. The company is best known for its leading aortic valve replacement system, but it is also expanding into other areas like mitral and tricuspid valve repair. With a focus on innovation and treating more patients, Edwards is aiming for steady growth in the years ahead. The question is: Could this heart care specialist be a smart long-term investment?

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The Business

Edwards Lifesciences is a global leader in structural heart innovations, dedicated to advancing therapies for patients with valvular heart disease. Founded in 1958 and based in California, the company pioneered the development of artificial heart valves and has grown into a specialized medical technology firm focused on transcatheter and surgical solutions. Its main business segments include transcatheter aortic valve replacement, transcatheter mitral and tricuspid therapies, and surgical structural heart products. The transcatheter aortic valve replacement segment is the company’s largest. It treats patients with aortic stenosis, a condition where the main valve that lets blood leave the heart becomes too narrow. Instead of open-heart surgery, doctors can now insert a new valve using a thin tube, often through a blood vessel in the leg. Edwards’ SAPIEN valve system has become the standard for this kind of less invasive treatment and is used around the world. It allows patients to recover faster and with fewer risks compared to traditional surgery. The transcatheter mitral and tricuspid therapies segment focuses on two other heart valves that regulate blood flow inside the heart. Problems with these valves can lead to leakage, where blood flows the wrong way. Edwards is developing both repair and replacement options that, like the aortic procedure, can be done without surgery. One example is the PASCAL system, which clips the valve to reduce leakage. Another is the EVOQUE system, which replaces the valve entirely. These solutions help patients who might be too weak or too ill for open-heart surgery. The surgical structural heart segment covers Edwards’ more traditional products, which are used in operations where the chest is opened and the damaged valve is removed. The company’s surgical valves are made from tissue rather than metal and are designed to last a long time. Many of them use a material called RESILIA, which helps the valves stay in good condition by slowing down calcium build-up. Some products are also used in more complex surgeries where the valve and surrounding parts of the heart need to be replaced together. Edwards’ competitive moat comes from its deep experience built over more than sixty years in a highly specialized and tightly regulated field. Making heart valves requires advanced skills, strict quality standards, and a strong understanding of both engineering and medical needs. Many companies have tried to enter this market but have left again after a few years, underestimating how difficult it is to succeed. Edwards has remained a leader by continuing to improve its products and by consistently delivering reliable results. The company also benefits from high switching costs. Doctors and medical teams spend a lot of time learning how to use Edwards’ devices, and changing to a different brand would mean retraining, higher risk of complications, and added effort, all of which make hospitals less likely to switch.

Management

Bernard J. Zovighian serves as the CEO of Edwards Lifesciences, a role he assumed in 2023 after joining the company in 2015. He brings a strong background in global healthcare, having previously held roles of increasing responsibility at Johnson & Johnson, where he gained extensive leadership experience across multiple medical device segments. Bernard Zovighian holds dual master’s degrees in science and business from the Universities of Marseille, France. During his time at Edwards Lifesciences, Bernard Zovighian played a key role in the company’s growth, including leading its transcatheter heart valve business, which is the company’s largest and most important segment. Known for his strategic mindset and people-focused approach, he has emphasized the importance of preserving the company’s patient-centered culture, investing in employee development, and building trusted long-term partnerships with physicians and healthcare systems. Since becoming Chief Executive Officer, Bernard Zovighian has reinforced the company’s commitment to addressing unmet patient needs through innovation while executing on its long-term strategy. In a recent earnings call, he expressed confidence in the company’s pipeline of new therapies and its ability to deliver strong organic sales growth. He also underlined the importance of creating lasting value for both patients and shareholders through consistent execution and responsible leadership. While it is still early in his tenure as CEO, Bernard Zovighian brings deep experience, continuity, and a clear vision for the future. I believe he is the right person to lead the company moving forward.

The Numbers

The first number we will look into is the return on invested capital, also known as ROIC. We want to see a 10-year history, with all numbers exceeding 10% in each year. Edwards Lifesciences has managed to achieve a ROIC above 10% in all years for the past decade, and above 20% in seven of the past ten years. There are several reasons why the company has consistently delivered strong returns. First, Edwards Lifesciences focuses on a specialized portfolio of medical devices, particularly in the structural heart space, including both transcatheter and surgical heart valves. These products are highly complex, face limited competition, and allow for premium pricing, which supports high profitability. Second, the company maintains efficient operations and takes a disciplined approach to how it invests its capital. This focus helps ensure that money is directed toward projects with strong return potential. Third, Edwards holds a leading position in the global transcatheter heart valve market. Its scale, brand reputation, and long-standing relationships with hospitals and physicians give it pricing power and customer loyalty, both of which contribute to consistently high returns. That said, ROIC declined in 2024, marking its lowest level in a decade. One key factor was slower growth in the transcatheter aortic valve business, as hospitals faced scheduling constraints due to rising demand for a broader range of structural heart treatments. This led to fewer procedures than expected. At the same time, Edwards increased its spending on research and development to support new product development and ongoing clinical trials. These investments are expected to fuel future growth but had a short-term impact on profitability. The company also made two strategic acquisitions to strengthen its position in structural heart therapies. While these deals align with its long-term strategy, they contributed to higher capital costs in the near term. In addition, Edwards faced a number of one-time challenges, including weather disruptions in the United States, shortages of IV fluids, and a pricing adjustment in China. These factors affected operational efficiency and returns in the short run. Hence, I am not worried about the decline in 2024.

The next numbers are the book value + dividend. In my old format this was known as the equity growth rate. It was the most important of the four growth rates I used to use in my analyses, which is why I will continue to use it moving forward. As you are used to see the numbers in percentage, I have decided to share both the numbers and the percentage growth year over year. To put it simply, equity is the part of the company that belongs to its shareholders – like the portion of a house you truly own after paying off part of the mortgage. Growing equity over time means the company is becoming more valuable for its owners. So, when we track book value plus dividends, we’re essentially looking at how much value is being built for shareholders year after year. Edwards Lifesciences has managed to increase its equity year over year in nine out of the past ten years. There are several reasons why the company has been able to grow equity so consistently. First, it has maintained steady profitability by focusing on high-margin, specialized medical devices, particularly in the structural heart space. This consistent earnings stream has allowed Edwards to reinvest profits back into the business, directly boosting equity. Second, the company follows a long-term strategy of reinvesting in research and development and making acquisitions that align with its core focus. These investments help drive innovation, strengthen its product offering, and expand its asset base, all of which support equity growth. Edwards Lifesciences saw a particularly large increase in equity from 2023 to 2024. This was mainly driven by a sharp rise in net income during the year. The jump in earnings was largely the result of the sale of the company’s Critical Care division to Becton Dickinson.

Finally, we will analyze the free cash flow. Free cash flow, in short, refers to the cash that a company generates after covering its operating expenses and capital expenditures. I use levered free cash flow margin because I believe that margins provide a better understanding of the numbers. Free cash flow yield refers to the amount of free cash flow per share that a company is expected to generate in relation to its market value per share. It is not surprising that Edwards Lifesciences has delivered positive free cash flow every year for the past decade. However, what stands out is that free cash flow and the levered free cash flow margin declined in 2023 and fell even further in 2024, reaching their lowest levels in more than a decade. The decline in 2024 was driven by several factors. First, the company made unusually large tax payments related to the sale of its Critical Care division and to address ongoing tax matters. These one-time payments reduced the cash generated from operations. Second, Edwards Lifesciences completed two acquisitions to strengthen its structural heart business. While these moves are expected to support long-term growth, they required significant upfront investments that temporarily reduced free cash flow. Finally, the company also faced several one-off challenges, including severe weather in parts of the United States, shortages of IV fluids, and a pricing adjustment in China. These disruptions affected operations and placed further pressure on cash generation. Even so, the recent decline in free cash flow and margin is not necessarily a cause for concern. The largest impact came from one-time events that are unlikely to repeat. The strategic acquisitions made in 2024 may reduce cash in the short term, but they are expected to contribute to growth and margin expansion over time. Looking ahead, management remains confident in the company’s long-term prospects and has not signaled any fundamental issues with its ability to generate cash. As temporary costs fade and new acquisitions are integrated, free cash flow and margins are expected to recover. The free cash flow yield has historically been low, which reflects the fact that a high-quality company like Edwards Lifesciences rarely trades at a low valuation. While the free cash flow yield reached its lowest point in 2024, that does not necessarily mean the shares are expensive, given the one-time factors discussed above. We will revisit valuation later in the analysis.

Debt

Another important aspect to consider is the company's level of debt. It is essential to assess whether a business maintains a manageable debt level that can be repaid within three years, which is determined by dividing the total long-term debt by earnings. For Edwards Lifesciences, this calculation shows that the company has only 0,43 years of earnings in debt, which is well below the three-year threshold. Consequently, debt is not a concern in this case. Historically, Edwards Lifesciences has maintained a low level of debt, reflecting a conservative and disciplined approach to financial management. This track record suggests that debt is unlikely to become a significant issue for the company in the future. Combined with consistent profitability and strong cash generation, the company’s balance sheet remains a source of strength and flexibility.

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Risks

Competition is a risk for Edwards Lifesciences. The company operates in an intensely competitive medical technology market, where success depends not only on innovation but also on timing, pricing, and clinical outcomes. This risk has become even more visible following the 2024 launch of Abbott’s TriClip system for tricuspid valve repair, which quickly gained market share in the United States and pressured Edwards’ growth in related segments. Edwards competes with both large multinational companies such as Medtronic, Abbott, and Boston Scientific, as well as smaller, fast-moving firms and startups. In its largest business area, transcatheter aortic valve replacement, Medtronic’s Evolut system is a direct competitor, and new products from other players continue to emerge. In treatments for the heart’s mitral and tricuspid valves, Edwards faces strong competition from Abbott. Abbott is already well known for its MitraClip device, which is widely used to repair the mitral valve, and the company is now expanding into devices that treat the tricuspid valve as well. The structural heart market is driven by rapid innovation cycles, with frequent product launches and evolving clinical standards. This puts constant pressure on Edwards to stay ahead with new technologies. If the company cannot keep up in areas like valve durability, ease of use, or delivery systems, its current products may become less attractive or even obsolete. This is particularly important in a healthcare environment that increasingly prioritizes value, cost effectiveness, and patient outcomes. Finally, the medical device industry is seeing more consolidation, and purchasing decisions are often made by large hospital systems and healthcare networks that are focused on reducing costs and working with fewer suppliers. This means Edwards must not only continue to innovate but also build strong relationships and clearly show how its products deliver value to both healthcare providers and patients.

Laws and regulations are a significant risk for Edwards Lifesciences. As a global medical device company, Edwards operates in an industry where nearly every part of its business is closely controlled by governments around the world. This includes how products are developed, tested, manufactured, labeled, marketed, and sold. In the United States, the Food and Drug Administration plays a central role in reviewing and approving Edwards’ products. This process can be long, complex, and expensive, especially for high risk devices like heart valves. Any delays, unexpected requests for more data, or rejections from the FDA can postpone product launches and affect growth plans. Even after a product is approved, the FDA can require additional testing, conduct inspections, and issue penalties if it finds problems. Failing to comply could result in fines, recalls, or even a suspension of product sales. Outside the United States, the regulatory landscape is equally demanding. In the European Union, Edwards must comply with the Medical Device Regulation, which introduced stricter requirements for clinical evidence, documentation, post market monitoring, and product labeling. These rules have increased the time and cost needed to get products approved, and delays can disrupt supply or limit the company’s ability to compete. Countries such as Japan also have their own complex approval processes and quality standards, which add further requirements. Regulatory rules are also changing over time. New laws may be introduced, or existing ones may be revised, which can require expensive changes to how Edwards operates. As oversight continues to increase, so does the cost and effort required to stay in full compliance. All of this means that Edwards Lifesciences must invest heavily in compliance, legal, and quality systems. If the company falls short in any area, it could face serious consequences, including lost sales, reputational damage, or legal action.

Reliance on third party suppliers is a risk for Edwards Lifesciences. The company depends on outside vendors for many critical aspects of its operations, including the supply of raw materials, the manufacture of certain components, and the sterilization of medical devices. This makes Edwards vulnerable to any disruption in the supply chain, whether from financial issues at a supplier, changes in regulations, or broader economic pressures. In some cases, Edwards relies on single source suppliers. These relationships are often based on factors such as quality control, cost efficiency, or regulatory requirements that limit the number of qualified vendors. While this can help maintain consistency, it also creates a risk: if one of these suppliers is unable or unwilling to continue providing materials or services, it can be very difficult and time consuming to find and certify an alternative. The company must comply with strict regulatory standards, so switching suppliers is not a quick or simple process. There are many reasons supply issues can arise. Vendors may leave the medical device market due to rising regulatory burdens, cost pressures, or strategic shifts. In other cases, economic instability or financial distress may impact a supplier’s ability to deliver on time. Regulatory bans or restrictions on certain chemicals or materials used in manufacturing can also cause delays. In addition, trade restrictions, geopolitical tensions, or tariffs can further complicate sourcing and raise costs. Even when supplies are available, significant increases in the cost of raw materials can impact Edwards’ profitability. Because of the complexity of its products and the importance of quality control, the company cannot always pass these costs on to customers quickly or easily. If a key supplier fails to deliver, or if replacement sources cannot be approved in time, Edwards could face delays in product availability, increased costs, or even temporary disruptions to its operations. In an industry where timely access to life saving technologies is critical, even short interruptions can have serious consequences for the business.

Reasons to invest

The strength of Edwards Lifesciences’ TAVR segment is a major reason to consider the company as a long-term investment. TAVR stands for transcatheter aortic valve replacement, a procedure that allows doctors to replace a damaged heart valve without opening the chest. This approach is less invasive than traditional open-heart surgery and is especially important for older patients or those who may not be strong enough to go through major surgery. Edwards is a pioneer in this area, and its SAPIEN valve system is widely seen as the leading solution for this type of treatment. The company continues to improve its products, and newer versions of the valve are helping more patients and delivering strong results. One of the most important developments in recent years comes from a large clinical study called EARLY TAVR. This study showed that even patients who do not yet show symptoms but have serious valve disease benefit from early treatment. Traditionally, doctors would wait until symptoms appeared before recommending treatment, but the data now suggest it is safer and more effective to act sooner. This could lead to changes in medical guidelines and expand the number of people eligible for TAVR. Edwards expects approval in the United States for this broader use of TAVR in 2025. This would allow more patients to be treated earlier, which could drive several years of growth for the company. In addition to this, another ongoing study called PROGRESS is looking at whether TAVR should be used for patients with moderate disease - those whose condition is not yet advanced but may get worse over time. If this is successful, it could further expand the number of people who benefit from the procedure. Outside the United States, the company sees significant opportunity. In many parts of the world, the treatment is still not widely available, even though aging populations and heart valve disease are common. As more hospitals begin using TAVR and more doctors become trained in the procedure, international demand is likely to grow. Edwards is also working to spread awareness and education so that more patients are identified earlier and referred for treatment. As more data becomes available and as hospitals invest in expanding their ability to care for these patients, the number of procedures is expected to rise steadily.

The growing success of Edwards Lifesciences’ TMTT segment is another compelling reason to consider the company as a long-term investment. TMTT stands for Transcatheter Mitral and Tricuspid Therapies, which are focused on treating two important valves in the heart. Many patients around the world suffer from problems with these valves, and until recently, their treatment options were limited. Edwards is working to change that with new, less invasive procedures that allow doctors to repair or replace damaged heart valves without the need for open-heart surgery. The company has developed a broad range of devices to treat these conditions. Two of the most important are the PASCAL repair system and the EVOQUE replacement system. PASCAL is designed to repair faulty mitral or tricuspid valves, while EVOQUE can completely replace a damaged tricuspid valve. These technologies are already being used in hospitals across the United States and Europe and are gaining strong acceptance from both doctors and patients. The company is also preparing to introduce a new mitral valve replacement system called SAPIEN M3, which is expected to expand treatment options even further. What makes this segment exciting is the strong demand for these therapies. Many patients who were previously considered too risky for surgery can now be treated with these newer, less invasive options. Clinical trials and real-world results have shown that patients experience significant improvements in their quality of life, which is encouraging more hospitals to adopt these treatments. In recent years, TMTT has moved from being a long-term vision to a growing reality. Edwards is no longer just developing these products, it is actively building a new market.  As awareness grows and more hospitals begin offering these procedures, the number of treated patients is expected to increase steadily year after year. Several developments support this long-term growth. For example, Medicare in the United States is working on policies that would expand access to tricuspid therapies like EVOQUE. At the same time, new clinical studies are underway that could support approval of additional devices and broader use of existing ones. The combination of regulatory progress, growing adoption, and ongoing product innovation puts Edwards in a strong position to lead this segment.

The strategic focus on structural heart disease is a reason to invest in Edwards Lifesciences. By concentrating fully on its core area of strength, the company is reinforcing its commitment to long term innovation and growth. In 2024, Edwards sold its Critical Care business to Becton Dickinson. This divestiture allows Edwards to redirect its full attention and resources toward structural heart therapies, where it sees the greatest opportunity to improve patient outcomes and deliver shareholder value. The proceeds from the sale are being reinvested into targeted acquisitions that broaden the company’s capabilities in areas such as aortic regurgitation, mitral disease, and heart failure. These include JenaValve, JC Medical, and Endotronix. JenaValve brings technology designed to treat aortic regurgitation, a condition where the aortic valve does not close properly and allows blood to flow backward into the heart. This condition has historically lacked effective minimally invasive treatment options, so JenaValve’s technology enables Edwards to address a significant gap in care. JC Medical strengthens the company’s position in mitral valve disease, another area with large unmet needs and a growing patient population. Endotronix offers remote heart failure monitoring solutions, including implantable sensors that continuously track pressure in the pulmonary artery. These tools support earlier intervention and better disease management, which can reduce hospitalizations and improve quality of life for patients. Together, these acquisitions enhance Edwards’ structural heart portfolio by adding differentiated and clinically valuable solutions that target underserved conditions. They also expand the company’s innovation pipeline beyond valve replacement, helping Edwards diversify its revenue sources while maintaining its focus on high impact cardiovascular therapies. This broader platform positions Edwards to serve a wider range of patients and strengthens its long term growth potential in a market that is both expanding and evolving. Focusing solely on structural heart disease makes the company more agile and improves its ability to execute across research, development, and commercialization. It sharpens Edwards’ position as a leader in transcatheter therapies, building on its established track record in aortic valve replacement. This strategic clarity also helps the company better align its pipeline with patient needs and regulatory expectations.

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Valuation

Now it is time to calculate the share price. I perform three different calculations that I learned at a Phil Town seminar. If you want to make the calculations yourself for this or other stocks, you can do so through the tools page on my website, where you have access to all three calculators for free.

The first is called the Margin of Safety price, which is calculated based on earnings per share (EPS), estimated future EPS growth, and estimated future price-to-earnings ratio (P/E). The minimum acceptable rate of return is 15%. I chose to use an EPS of 2,34, which is from 2024. I have selected a projected future EPS growth rate of 11%. Finbox expects EPS to grow by 10,6% a year in the next five years. Additionally, I have selected a projected future P/E ratio of 22, which is twice the growth rate. This decision is based on the Edwards Lifesciences' historically higher price-to-earnings (P/E) ratio. Finally, our minimum acceptable rate of return has already been established at 15%. After performing the calculations, we determined the sticker price (also known as fair value or intrinsic value) to be $36,13. We want to have a margin of safety of 50%, so we will divide it by 2. This means that we want to buy Edwards Lifesciences at a price of $18,07 (or lower, obviously) if we use the Margin of Safety price.

The second calculation is known as the Ten Cap price. The rate of return that a company owner (or stockholder) receives on the purchase price of the company essentially represents its return on investment. The minimum annual return should be at least 10%, which I calculate as follows: The operating cash flow last year was 542, and capital expenditures were 252. I attempted to analyze their annual report to calculate the percentage of capital expenditures allocated to maintenance. I couldn't find it, but as a rule of thumb, you can expect that 70% of the capital expenditures will be allocated to maintenance purposes. This means that we will use 176 in our calculations. The tax provision was 152. We have 589,8 outstanding shares. Hence, the calculation will be as follows: (542 – 176 + 152) / 589,8 x 10 = $8,78 in Ten Cap price.

The final calculation is called the Payback Time price. It is a calculation based on the free cash flow per share. With Edwards Lifesciences' Free Cash Flow Per Share at $0,49 and a growth rate of 11%, if you want to recoup your investment in 8 years, the Payback Time price is $6,45. However, if it wasn't for the one-time tax payments mentioned earlier in the analysis, the Payback Time price would have been $37,91.

Conclusion

I believe that Edwards Lifesciences is an intriguing company with strong leadership. It has built a moat through over sixty years of experience in a highly specialized and tightly regulated field. The company has consistently delivered high returns on invested capital, and although ROIC fell to a record low in 2024, this was due to short-term headwinds and increased investments, not a decline in the underlying quality of the business. Free cash flow and levered free cash flow margins also declined in 2024, but this was mainly due to a one-time tax payment related to the sale of the Critical Care division. This payment is not expected to recur and does not reflect ongoing business performance. Competition is a risk because Edwards operates in a fast-moving medical technology market, where companies like Abbott and Medtronic are rapidly developing alternative valve therapies. To stay ahead, Edwards must continue to innovate and demonstrate the clinical and economic value of its solutions. Laws and regulations pose another risk. Edwards’ products are subject to complex approval processes and ongoing oversight in all major markets. Regulatory delays, unexpected requirements, or changes in standards can slow product launches, increase costs, and disrupt sales. Noncompliance can result in fines, recalls, or damage to the company’s reputation. The company also relies heavily on third-party suppliers for raw materials, manufacturing, and sterilization. Disruptions in the supply chain can cause production delays, increase costs, and impact product availability. Despite these risks, Edwards Lifesciences’ TAVR segment remains a core reason to invest. Edwards is a leader in less invasive heart valve therapy, and its SAPIEN system continues to benefit from strong clinical data, including evidence that supports earlier intervention. With upcoming regulatory approvals and growing global adoption, TAVR is well positioned to deliver sustained growth. The TMTT segment is also emerging as a powerful growth driver. With therapies like the PASCAL and EVOQUE systems, Edwards is expanding access to care for patients with limited treatment options. As more hospitals adopt these technologies and new clinical evidence builds, this segment has the potential to become a major contributor to the company’s long-term performance. The strategic focus on structural heart disease strengthens the investment case. By divesting the Critical Care business and acquiring companies like JenaValve, JC Medical, and Endotronix, Edwards is expanding its portfolio in areas such as aortic regurgitation, mitral disease, and heart failure, conditions with large unmet needs. This focus makes the company more agile and better positioned to lead in an expanding market. In my view, Edwards Lifesciences is a high-quality business. Buying shares at around $60, which represents a 20 percent discount to its intrinsic value based on the Payback Time price adjusted for the one-time tax payment, could be a good long-term investment.

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