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Text: Just after the close of regular trading, Edwards Lifesciences released first quarter 2021 financial results.
These statements include but aren't limited to, financial guidance and expectations for longer-term growth opportunities, regulatory approvals, clinical trials, litigation, reimbursement, competitive matters and foreign currency fluctuations.
Finally, a quick reminder that when using terms underlying and adjusted, management is referring to non-GAAP financial measures, otherwise, they are referring to GAAP results.
As we anniversary our one year impact of the pandemic on our financial results, I'd like to briefly reflect on the current environment and to discuss our 2021 and longer-term priorities as a company.
I'd also like to touch on Edwards' response to the pandemic and our efforts to better support our patients, employees and the community.
Recall that our sales were dramatically impacted in the last few weeks of Q1 2020 as procedures fell due to COVID disruptions.
One year later, after an extraordinarily difficult global crisis, I'm encouraged by the signs of recovery and although we recognize that many people are still struggling around the world.
Our sales growth this quarter was better than expected across all product lines.
Although we expect the pandemic will impact the global healthcare system based on the environment as we exited the quarter, we have continued confidence in our positive 2021 outlook.
We continue to believe that 2021 will be an important growth year for Edwards with mid-teen sales growth highlighting the importance of treating structural heart patients even during this pandemic.
We also anticipate meaningful progress on expanding large under-appreciated and underserved transcatheter opportunities in 2021.
Recently, we achieved several important milestones.
Let me mention four.
Just last week, in transcatheter aortic valve replacement or TAVR, we received approval to initiate a pivotal trial for patients suffering from moderate aortic stenosis.
Also earlier this month, we received approval to begin treating patients at low surgical risk in Japan with SAPIEN 3.
And in Transcatheter Mitral and Tricuspid Therapies, or TMTT, I'm pleased to announce that the first patients were recently treated with EVOQUE Eos, our next-generation Transcatheter Mitral Replacement System.
Also in TMTT, we initiated the TRISCEND II US pivotal trial for transcatheter tricuspid replacement.
Looking beyond 2021, we remain confident in our long-term strategy and our pipeline of innovative therapies.
Our patient-focused culture drives us and motivates our employees around the world every day.
Our R&D targets breakthrough therapies that can create significant value for patients and health systems enabling strong organic sales growth and exceptional shareholder returns.
Despite COVID disruptions, we've continued to invest aggressively for future growth.
As a reminder, about a third of our research and development investments today are focused on generating a robust body of guideline changing clinical evidence and although clinical studies slowed during the pandemic, our dedicated clinician partners are eager to accelerate enrolment in this important research.
Regulators have also been supported in addressing the impact of the pandemic and its impact on clinical studies.
Finally, I want to provide some perspective on how we've maintained our focus on creating long-term value as we navigated the pandemic over the last year.
We continue to invest in our people, in our infrastructure.
During a time when widespread uncertainty impacted many families across the globe, we have prioritized protecting our employees and have grown our team.
We enhanced employee benefits, rewarded performance and protected incentives.
We also moved ahead on expanding Edwards research and production facilities around the world.
We adjusted our agreements to support hospitals as they navigated COVID and additionally, we provided extra support to the communities where our employees live and work.
In fact, we recently converted one of our facilities into a mass COVID vaccination site to support the community of 3 million people, where our company is headquartered.
As a company, we expect that Edwards will be positioned even stronger and be able to help more patients than ever before as the world emerges from the pandemic.
Now, turning to our first quarter results.
We reported $1.2 billion in sales this quarter, up 5% on a constant currency basis from a year ago.
Recall that our guidance assumed Q1 sales would be in line with the first quarter of last year, which was largely unaffected by COVID.
We were pleased with how sales improved as the quarter progressed.
In TAVR, first quarter global sales were $792 million, up 4% on an underlying basis.
The SAPIEN 3 Ultra platform remains differentiated with low complication rates, ease of use and significant potential for length of stay efficiency.
Our average selling prices were stable and we estimated that global TAVR procedure growth was comparable with our growth.
In the US, our Q1 TAVR sales were flat with fourth quarter and year-ago results and we estimate that overall US procedure growth was comparable.
Consistent with our guidance on the Q4 earnings call in late January, COVID stressed the global healthcare system during the winter months.
We are encouraged, however, that US TAVR procedures grew as COVID hospitalizations decrease and vaccinations increased during the quarter.
Small and medium-sized centers played a valuable role in serving patients during the quarter.
We continue to activate new centers this quarter as we have been throughout the pandemic.
This demonstrates the clear interest of many smaller centers to provide state-of-the-art care for structural heart patients.
Outside the US, in the first quarter, we estimated TAVR procedures grew in the low-double digits on a year-over-year basis and Edwards growth was comparable.
Although we are off to a strong start, the slow vaccination progress outside the US provides uncertainty for the remainder of the year.
Edwards underlying TAVR growth in Europe versus the prior year was in the mid-single digit range.
Edwards growth in countries with lower TAVR adoption rates outpaced countries where the therapy is more established.
Although TAVR centers were more prepared to treat patients, patient flow was disrupted due to regional lockdowns and uncertainty among patients about the urgency of their disease.
Sales growth in Japan and other countries was strong as aortic stenosis remains an immensely undertreated disease and we remain focused on increasing the availability of TAVR therapy.
As previously noted, we received approval earlier this month in Japan for SAPIEN 3 in patients at low surgical risk.
We anticipate increased treatment rates when reimbursement is approved later this year.
In addition to geographic expansion of our TAVR therapies, we remain dedicated to pursuing indication expansions.
Our groundbreaking early TAVR trial is focused on patients who have severe aortic stenosis, but without recognized symptoms and who do not meet the current guidelines for valve replacement.
We expect enrollment to increase as we and participating sites are motivated to complete enrollment of the trial this year.
I'm also pleased to report that we received FDA approval for a pivotal trial for TAVR in moderate AS patients as we expect enrollment to begin later this year.
Based on recent trials, we're learning on what was once thought of as the benign precursor to severe aortic stenosis may actually be associated with higher rates of morbidity and mortality than previously recognized.
Thus, we believe TAVR may be a future treatment option for these patients.
Separately, last week, we received SAPIEN 3 CE Mark approval to begin treating patients with a previously repaired or replaced valve in the pulmonic position.
Looking ahead to the upcoming virtual EuroPCR meeting next month, we expect long-term follow-up data from our European Registry on SAPIEN 3 as well as the late-breaking clinical trial results on low risk bicuspid patients.
In summary, based on the strength we saw at the end of the first quarter, we have confidence that the underlying TAVR sales will grow in the 15% to 20% range in 2021.
We expect continued near-term COVID-related regional disruptions and a more normalized second half of the year.
We remain confident that this large global opportunity will exceed $7 billion by 2024, which implies a compounded annual growth rate in the low double-digits.
We're enrolling five pivotal trials across our differentiated portfolio of technologies to support patients suffering from tricuspid and mitral valve disorders.
This quarter, we progress with the enrollment of our three CLASP pivotal trials for PASCAL.
We continue to expect approval for patients with DMR late next year.
This is expected to be the first commercial approval of the PASCAL system in the US.
We've also begun treating patients with EVOQUE TR in the TRISCEND II randomized pivotal trial in accordance with the FDA's breakthrough pathway designation.
This trial will evaluate the safety and effectiveness of the EVOQUE tricuspid valve replacement system for patients with severe tricuspid regurgitation.
In addition, the first patients were recently treated with our next-generation Transcatheter Mitral Replacement System called EVOQUE Eos through the MISCEND study.
This study will evaluate the safety and performance of EVOQUE Eos, which is designed to advance the treatment of patients with mitral regurgitation with low profile valve delivered through a sub-30 French transfemoral delivery system.
We believe our two platform replacement strategy with SAPIEN M3 and EVOQUE Eos strongly positions us to be the leader in treating these underserved patients.
These include longer-term outcomes for transcatheter mitral repair from our CLASP trial and the first report of 30-day outcomes with EVOQUE tricuspid replacement from our TRISCEND study.
Turning to our results.
First quarter global sales were $16 million, driven by continued adoption of our PASCAL system and activation of more centers across Europe.
Assuming diminishing COVID-related impact, we expect to ramp up sales throughout the year.
We remain confident in our 2021 sales guidance of $80 million as we advance commercialization, staying focused on physician training, procedural success and patient outcomes.
Adoption and favorable real-world clinical outcomes remain key drivers to transforming treatment.
In summary, we are making meaningful progress toward our 2021 milestones and we continue to estimate the global TMTT opportunity to reach approximately $3 billion by 2025.
We remain committed to transforming the treatment of patients with mitral and tricuspid valve disease around the world.
In Surgical Structural Heart, first quarter 2021 global sales was $213 million, increased 7% on an underlying basis over the prior year.
Despite a soft start associated with COVID, we are encouraged by the improvement across all regions over the course of the quarter.
Notably, growth was lifted by premium products and improved as declining COVID cases enabled more hospitals to resume treating surgical structural heart patients.
We remain very encouraged by the steady global adoption of Edwards RESILIA tissue valves, including continued adoption of the INSPIRIS RESILIA aortic surgical valve.
We anticipate that adoption will be bolstered by the five-year data from our COMMENCE clinical trial presented at the recent meeting of the Society of Thoracic Surgeon, which demonstrates the excellent durability of this tissue technology.
And we're pleased that in the first quarter, we initiated sales of INSPIRIS in China.
Sales in the US also continue to gain traction with KONECT RESILIA, the first preassembled aortic tissue valve conduit for patients who require replacement of the valve, route and ascending aorta, a critical unmet patient need.
Finally, we're pleased to announce that we received regulatory approval with reimbursement in Japan for our MITRIS RESILIA valve, a new mitral valve incorporating our newest tissue technology.
Yesterday, in Japan, we performed our first commercial cases with this differentiated innovation.
In summary, we have confidence in our full-year 2021 underlying sales growth in the high single-digit range for Surgical Structural Heart, driven by market adoption of our premium technologies.
We continue to believe the current $1.8 billion Surgical Structural Heart market will grow in the mid-single digits through 2026.
In Critical Care, first quarter sales of $196 million increased 4% on an underlying basis, driven by increased sales of technologies for both the operating room and intensive care units.
HemoSphere orders increased as hospital capital spending began to show signs of recovery.
Demand for our products used in high-risk surgeries remain strong and our ClearSight non-invasive finger cuff used in elective procedures also recovered to near pre-COVID levels.
Our TruWave disposable pressure monitoring devices used in the ICU remained in demand due to elevated hospitalizations in both the US and Europe at the beginning of Q1.
We continue to expect full year 2021 underlying sales growth in the high single-digit range for critical care.
We remain excited about our pipeline of critical care innovations as we continue to shift our focus to smart recovery technologies designed to help clinicians make better decisions for their patients.
Well, we are encouraged by the start to our year.
Despite COVID still impacting the global healthcare system in the first quarter, we were able to post positive year-over-year sales growth across all of our product lines and regions as our advanced therapies helped patients globally.
Total sales grew 5% year-over-year on an underlying basis, which was better than the flat growth we expected when we gave guidance for the first quarter back in January.
This stronger-than-expected sales performance fell through to the bottom line, resulting in adjusted earnings per share of $0.54, which was 8% higher than the first quarter of 2020.
The improvement in our sales performance during the quarter was choppy, but we exited the quarter in a stronger position and that gives us continued confidence in our outlook for the balance of the year.
While macro conditions remain variable across our key geographies, we're projecting total sales in the second quarter to grow sequentially to between $1.25 billion and $1.33 billion resulting in adjusted earnings per share of $0.54 to $0.60.
As our business continues to rebound from the impact of COVID, we expect sales to strengthen and expenses to grow as travel and clinical trials ramp up.
We are maintaining all of our previous sales guidance ranges for 2021.
For total Edwards, we expect sales of $4.9 billion to $5.3 billion; for TAVR, $3.2 billion to $3.6 billion; for TMTT, approximately $80 million; for Surgical Structural Heart, $800 million to $900 million; and for Critical Care, $725 million to $800 million.
And based on our first quarter earnings, we are raising full year adjusted earnings per share guidance to $2.07 to $2.27, up from $2 to $2.20.
So, now I'll cover additional details of our results.
For the first quarter, our adjusted gross profit margin was 76% compared to 76.7% in the same period last year.
This reduction was driven by a negative impact from foreign exchange and incremental costs associated with responding to COVID, partially offset by improved manufacturing efficiencies.
We continue to expect our 2021 adjusted gross profit margin to be between 76% and 77%.
Selling, general and administrative expenses in the first quarter were $331 million or 27.2% of sales compared to $308 million in the prior year.
This increase was primarily driven by the strengthening of OUS currencies, primarily the euro and personnel-related costs, partially offset by reduced travel spending resulting from COVID.
As I mentioned earlier, we anticipate our spending will increase during the year as travel restrictions subside and we resume a more normalized operating environment.
We continue to expect full year 2021 SG&A as a percentage of sales, excluding special items, to be 28% to 29%, similar to pre-COVID levels.
Research and development expenses in the quarter grew 10% to $207 million or 17% of sales.
This increase was primarily the result of continued investments in our transcatheter innovations.
For the full year 2021, we continue to expect R&D as a percentage of sales to be in the 17% to 18% range, similar to pre-COVID levels as we invest in developing new technologies and generating evidence to expand indications for TAVR and TMTT.
Turning to taxes, our reported tax rate this quarter was 13.1%.
This rate included a 290-basis-point benefit from the accounting for stock-based compensation.
We continue to expect our full year rate in 2021, excluding special items, to be between 11% and 15%, including an estimated benefit of 4 percentage points from stock-based compensation accounting.
Foreign exchange rates increased first quarter reported sales growth by 280 basis points or $30 million compared to the prior year.
At current rates, we now expect an approximate $60 million positive impact or about 1% to full year 2021 sales compared to 2020.
FX rates negatively impacted our first quarter gross profit margin by 150 basis points compared to the prior year.
Relative to our January guidance, FX rates positively impacted our first quarter earnings per share by about $0.01.
Free cash flow for the first quarter was $195 million defined as cash flow from operating activities of $301 million, less capital spending of $106 million.
Before turning the call back over to Mike, I'll finish with an update on our balance sheet and share repurchase activities.
We continue to maintain a strong and flexible balance sheet with approximately $2.1 billion in cash and investments as of March 31, 2021.
We repurchased 3.6 million shares for $303 million during the first quarter and have approximately $300 million remaining in our share repurchase authorization.
We plan to continue to execute our strategy of offsetting dilution from incentive stock compensation as well as opportunistically reducing our shares outstanding over time.
Average shares outstanding during the first quarter were 631 million, down approximately 1 million from the prior quarter.
We continue to expect average diluted shares outstanding for 2021 to be between 630 million and 635 million.
So with that, I'll pass it back to Mike.
We remain confident in our long-term patient-focused strategy on our innovation pipeline.
To serve the many patients suffering from structural heart disease, we have never stopped investing in our people, our innovative technologies and our new growth capacity.
As a company, we expect that Edwards will be positioned even stronger and in a position to help more patients than ever as the world fully emerges from this pandemic.
So, Diego, with that, we're ready to take questions now.
In order to allow for broad participation, we ask that you please limit the number of questions to one, plus one follow-up.
If you have additional questions, please reenter the queue and management will answer as many participants as possible during the remainder of the call.

user
compname reports qtrly earnings per share of $0.54.
qtrly earnings per share $0.54.
continued confidence in sales outlook; fy 2021 adjusted earnings per share guidance of $2.07 to $2.27 increased $0.07.
sees q2 2021 total sales to be between $1.25 and $1.33 billion & adjusted earnings per share of $0.54 to $0.60.
qtrly sales grew 8% to $1.2 billion; underlying sales grew 5%.
overall, full year 2021 sales guidance remains at $4.9 to $5.3 billion.
qtrly global transcatheter aortic valve replacement sales of $792 million, up 7% on reported basis.
remains confident that tavr global opportunity will exceed $7 billion by 2024.
continues to anticipate underlying tavr sales growth in 15 to 20 percent range in 2021.

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