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Text: Just after the close of regular trading, Edwards Lifesciences released third 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 the terms underlying and adjusted, management is referring to non-GAAP financial measures.
Otherwise, they're referring to GAAP results.
Let me begin by expressing appreciation for our global teams who have been highly engaged throughout the pandemic.
We're also pleased that our supply chain remained resilient during these challenging times to meet the needs of the patients we serve.
Turning to results, third quarter total Company sales of $1.3 billion increased 14% on a constant-currency basis versus the year-ago period.
Strong mid-teens growth was driven by our innovative platforms, although lower than our July expectations due to the significant impact COVID had on U.S. hospitals.
Although we experienced encouraging signs of patient confidence and continued willingness to seek medical care in July, the Delta variant had a significant impact on hospital resources during the last two months of the third quarter, especially in the U.S. Despite the pronounced impact of the Delta variant in the U.S. in Q3, we're encouraged by the recent decline in hospital COVID admissions.
We believe some procedures were unfortunately deferred in the third quarter.
And based on what we saw in Q2, we expect many of these patients who deferred treatment in Q3 will be treated in the future.
We continue to expect total Company sales growth to be in the high teens for the full year.
In TAVR, third quarter global sales were $508 and $58 million dollars, up 14% on an underlying basis versus the year-ago period.
We estimate global TAVR procedure growth was comparable with our growth in the third quarter.
Globally, our average selling price remained stable.
In the U.S., our TAVR sales grew 12% on a year-over-year basis and we estimate that our share of procedures was stable.
Growth was broad-based across both high and low volume centers.
As you might expect procedure volumes in Q3 were affected by seasonality and varied by geography and even by hospital, as patients and providers turn their focus again to the pandemic.
Our TAVR sales in July benefited from encouraging signs of continued recovery from the pandemic, however procedures were negatively impacted in the last two months of Q3 due to the significant impact Delta had on hospital resources.
Outside the U.S. in the third quarter, our sales grew approximately 20% on a year-over-year basis, and we estimate total TAVR procedure growth was comparable.
We continue to be encouraged by strong international adoption of TAVR, broadly, in all regions.
And despite the impact of Delta, the TAVR market in Europe showed relative resilience with strong growth in procedure volumes.
Growth was broad-based across Europe and driven by continued strong adoption of our SAPIEN three Ultra platform.
We were pleased with the growth rate considering that in Q3 of 2020 centers in Europe had already recovered from pandemic lows.
Longer-term, we see excellent opportunities for continued OUS growth, as we believe global adoption of TAVR therapy remains quite low.
It's worth noting that recently, published guidelines from the European Association of Cardiothoracic Surgery not definitively recommend TAVR for patients over the age of 75.
The acknowledgment by the Surgical society the TAVR is preferred for those over 75 is a significant development.
We believe these guidelines represent an important long-term opportunity and although transcatheter valves have been commercially available for over a decade in Europe, it remains clear that there is still a large, unmet need for this therapy.
Strong TAVR adoption continued in Q3 in Japan.
As expected, we received reimbursement approval in Q3 for treatment of patients at low surgical risk.
We remained focus on expanding the availability of TAVR therapy throughout this country, driven by the fact that AS remains a significantly under-treated disease among this large elderly population.
At the upcoming TCT meeting, there's a planned late-breaking update on the economic outcomes of PARTNER three at two years.
In summary, based on October procedure trends, we expect Q4 growth for TAVR to be similar to Q3.
We continue to expect underlying TAVR sales growth of around 20% in 2021.
We remain as confident as ever, about the long-term potential of TAVR because of its transformational impact on the many patients for suffering from aortic stenosis and because many remained untreated.
The long-term potential reinforces our view that this global TAVR opportunity will exceed $7 billion by 2024, which implies a low double-digit compound annual growth rate.
Now, turning to TMTT, we've made meaningful progress across all our platforms with over 6000 patients treated to date, to transform treatment and unlock the significant long-term growth opportunity.
We remain focused on three key value drivers.
A portfolio of different shaded therapies, positive pivotal trial results to support approvals and adoption, and favorable real-world clinical outcomes.
This quarter we progressed on the enrollment of five pivotal trials across our portfolio to support therapies for patients suffering from mitral and tricuspid regurgitation.
We are gaining experience with a PASCAL precision platform as part of our class trials, and physician feedback continues to be positive.
We look forward to presenting randomized data from the class 2D pivotal trial next year and remain on track for the U.S. approval of PASCAL for patients with DMR late next year.
This important milestone will mark a transition from large single-arm studies through significant pivotal trial results that support approval and adoption and will be the first of several key datasets from our class of trials.
We continue to treat patients with both of our mitral -- our transcatheter mitral replacement therapies through the ENCIRCLE pivotal trial SAPIEN M3 and MISCEND study of EVOQUE Eos.
We are ramping up enrollment with our novel EVOQUE tricuspid replacement therapy as part of the TRISCEND II Pivotal Trial.
These processing transfemoral therapies are critical for many patients without treatment options today and exemplify the importance of a comprehensive portfolio.
As we continue to expand our body of clinical evidence, we look forward to presenting meaningful data at TCT and PCR London Valves next month.
In addition, 30-day outcomes for mitral repair with PASCAL from our Miclast, post-market clinical follow-ups study of over 250 patients.
We also anticipate several live case demonstrations of our differentiated therapies.
Turning to the financial performance in TMTT, despite the impact of Delta in summer seasonality, global sales of $22 million were driven by the continued adoption of PASCAL in Europe.
As we expanded commercially, we continue to experience high procedural success rates and excellent clinical outcomes for patients.
And we remain committed to employing our high-touch clinical support model.
We are pleased with our level of site activation during the quarter.
We continue to expect to achieve our previous full-year guidance of $80 million to $100 million and estimate the global TMTT opportunity to triple to approximately $3 billion by 2025.
And we're pleased with our progress toward advancing our vision to transform the lives of patients with mitral and tricuspid valve disease.
In Surgical Structural Heart, third quarter global sales were $217 million, up 6% on an underlying basis versus the year-ago period.
Despite the Q3 resurgence and COVID cases we were encouraged to see continued SABR procedure growth across most regions.
We remain encouraged by the steady global adoption of Edwards RESILIA tissue valves, including INSPIRIS RESILIA aortic valve, the KONECT RESILIA valves conduit and our MITRIS RESILIA mitral valve.
This advanced tissue treatment is increasing supported by growing body of real-world evidence as demonstrated at the European Association of Cardiothoracic Surgeons annual meeting earlier this year.
Registry data confirmed excellent real-world outcomes with INSPIRIS RESILIA in patients under the age of 60.
As patients increase their awareness of surgical valve choices, we believe that they are learning about the durability potential of RESILIA and engaging with their positions to choose this technology.
In summary, we have confidence that our full year 2021 underlying sales growth will be in the mid-teens for Surgical Structural Heart, driven by market growth and adoption of our premium technologies.
We continue to believe the Surgical Structural Heart market that we serve will grow mid-single-digits through 2026.
In Critical Care, third quarter global sales were $213 million up 17% on an underlying basis versus the year-ago period.
Growth was driven by contributions from all product lines led primarily by strong HemoSphere capital sales in the U.S.
Our True Wave disposable pressure monitoring devices used in the ICU remained in demand due to the elevated hospitalizations in the U.S. and demand for products used in high-risk surgery also grew year-over-year in addition to demand for the ClearSight non-invasive finger cup used in elective procedures.
In summary, we continue to believe the Critical Care will grow revenue in the low double-digit range in 2021.
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.
Today, I'll provide additional perspective on the third quarter, along with how we anticipate the rest of the year may unfold and some color on what to expect at the investor conference on December 8th.
Total sales in the third quarter grew 14% on an underlying basis over the prior year.
As indicated earlier, this strong sales growth is lower than we expected in July before the U.S. Delta surge.
Earnings in the quarter of $0.54 met our expectations as COVID -related constrained spending more than offset lower-than-expected sales.
As Mike mentioned, based on the improving trends with the Delta variant.
And our October procedure trends, we're projecting total Q4 sales of between 1.30 billion and 1.38 billion.
A as it relates to each product line, we are forecasting fourth quarter TAVR sales of $850 million to $910 million and still have the potential to reach underlying TAVR sales growth of around 20% for the full-year 2021.
We're also maintaining our previous ranges for TMTT, Surgical Structural Heart, and Critical Care.
We continue to expect our full-year adjusted earnings per share guidance at the high-end of $2.07 to $2.27 with fourth-quarter adjusted earnings per share of 53 to 59 cents.
And now I will cover additional details of our third quarter results.
Our adjusted gross profit margin was 76.3% up from 75.5% in the same period last year when we experienced substantial costs responding to COVID, the improvement was also driven by a more profitable product mix, partially offset by a negative impact from foreign exchange.
Like most companies, we are seeing signs of inflation, generally, in things like some of the raw materials we use in production, as well as shipping and logistics.
With that said, some of the extraordinary costs we incurred when COVID hit last year have lessened.
And the net result is no material impact to our gross profit margin performance or guidance for 2021.
More broadly, we're continuing our investments to ensure that our supply chain is strong and resilient and capable of delivering life-saving products for our patients.
We continue to expect our 2021 adjusted gross profit margin to be between 76% and 77%.
Selling general and administrative expenses in the third quarter were $364 million or 27.8% of sales compared to $307 million in the prior year.
This increase was primarily driven by personnel-related costs and increased commercial activities compared to the COVID impacted prior year.
We are planning a sequential ramp up of expenses in the fourth quarter as COVID related restrictions continued to subside.
We still expect full-year 2021 SGNA expenses as a percentage of sales excluding special items to be 28% to 29%.
Research and development expenses in the quarter grew 22% over the prior year to $238 million or 18.2% of sales.
This increase was primarily the result of continued investments in our transcatheter innovations, including increased clinical trial activity.
We are planning to increase these expenses in the fourth quarter as we invest in developing new technologies and generating evidence to expand indications for TAVR and TMTT.
For the full-year 2021, we continue to expect R&D expenses as a percentage of sales to be 17% to 18%.
Our reported tax rate this quarter was 13% or 13.9%, excluding the impact of special items.
This rate included a 320-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 four percentage points from stock-based compensation accounting.
Foreign exchange rates increased third quarter reported sales growth by 70 basis points for $8 million compared to the prior year.
At current rates, we continue to expect an approximate $70 million positive impact, or about 1.5%, to full-year 2021 sales, compared to 2020.
Foreign exchange rates negatively impacted our third quarter gross profit margin by 30 basis points compared to the prior year.
And relative to our July guidance, FX rates positively impacted our third quarter earnings per share by less than a penny.
Free cash flow for the third quarter was $471 million, defined as cash flow from operating activities of $532 million less capital spending of $61 million our year-to-date free cash flow was $1.1 billion.
The strong cash flows are a reflection of our exceptional portfolio of patient-focused technologies that are generating returns from previous investments, which allows us to fund future internal and external opportunities.
We continue to maintain a strong and flexible Balance Sheet with approximately $3 billion in cash and investments as of September 30th.
Average shares outstanding during the third quarter were 632 million and we continue to expect our average diluted shares outstanding for 2021 to be at the lower end of our 630 to 635 million guidance range.
We have approximately $1.2 billion remaining under the share repurchase program.
Before turning the call back over to Mike, I'll make a quick comment about our outlook for 2022.
It's premature to offer detailed guidance today, but we will provide 2022 financial guidance at our Investor Conference on December 8th.
In general, in 2022, we're planning on less disruption from COVID, as we assume the resumption of more normalized sales and earnings growth, we will provide guidance for gross profit and operating margins, as well as more visibility into any potential impact from changes in corporate tax rates.
And with that, I'll pass it back to Mike.
We're very pleased with our strong year-to-date performance despite the headwinds associated with the pandemic.
And as patients and clinicians increasingly choose transcatheter valve therapy, we remain optimistic about the long-term growth opportunity.
We are committed to aggressively investing in our focused innovation strategy, because we believe there is a broad group of patients still suffering from Structural Heart disease and the pandemic's impact will wane.
We remain confident that the innovative therapies resulting from our investments will continue to drive strong organic growth in the years to come.
And as you heard from Scott earlier, our 2021 Investor Conference will take place on Wednesday, December 8th, here at our headquarters in Irvine, California.
Either way, we really hope you can be a part of it.
In addition to our 2022 financial guidance, you'll hear more about Edwards focused innovation strategy and our comprehensive and exciting product pipeline.
For more information, please visit the Investor Relations section of the Edwards website at ir.
As a reminder, please limit the number of questions to one, plus one follow-up, to allow for broad participation.
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 says qtrly sales grew 15% to $1.3 billion.
qtrly sales grew 15% to $1.3 billion; underlying sales grew 14%.
q3 earnings per share was $0.54.
full year 2021 sales, earnings per share guidance range unchanged.
qtrly tavr sales of $858 million, up 15% on a reported basis.
tavr sales negatively impacted in last two months of q3 due to significant impact covid had on hospital resources.

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