Q3 2023 Edwards Lifesciences Corp Earnings Call
Greetings and welcome to the Edwards Lifesciences third quarter 2023 earnings Conference call.
At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Mark <unk> Senior Vice President Investor Relations and Treasurer. Thank you you may begin.
Thank you very much Diego and good afternoon, and thank you all for joining US we are coming to you live from San Francisco at the 35th annual TCT Conference with me on today's call is our CEO Bernard will begin and our CFO Scott all of them also joining us for the Q&A portion of the call are Larry Wood, Our group Vice President Group, President excuse me of <unk> and <unk>.
Operator: Greetings and welcome to the Edwards Lifesciences 3rd Quarter, 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation.
Structural heart and Devine Chopra, our global leader of T MTT.
Just after the close of regular trading Edwards Lifesciences released third quarter 2023 financial results. During today's call management will discuss those results included in the press release and accompanying financial schedules and then use the remaining time for Q&A. Please.
Operator: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded.
Mark Wilterding: It is now my pleasure to introduce your host, Mark Wilterding, Senior Vice President, Investor Relations, and Treasurer. Thank you, you may begin. Thank you very much Diego and good afternoon and thank you all for joining us. We are coming to you live from San Francisco at the 35th Annual PCT Conference.
Please note that management will be making forward looking statements that are based on estimates assumptions and projections. 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. These.
Mark Wilterding: With me on today's call is our CEO Bernard Zovighian and our CFO, Scott Ullem.
Speak only as of the date on which they were made and Edwards does not undertake any obligation to update them. After today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially information concerning factors that could cause these differences and important safety information may be found in the press release, our 2020 to annual.
Mark Wilterding: Also joining us for the Q&A portion of the call are Larry Wood, our group president, excuse me, of Taver and surgical structural heart and Davine Chopra, our global leader of TMTT.
Mark Wilterding: Just after the close of regular trading, Edwards Lifesciences released 3rd quarter, 2023 financial results. During today's call, management will discuss those results, included in the press release and accompanying financial schedules, and then use the remaining time for Q&A. Please note that management will be making forward-looking statements that are based on estimates, assumptions, and projections. 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.
Report on Form 10-K, and Edwards' other SEC filings all of which are available on the company's website at Edwards dotcom.
Mark Wilterding: These statements speak only as of the date on which they were made, and Edwards does not undertake any obligation to update them after today. Additionally, the statements involve risks and uncertainties that could cause actual results to differ materially.
Unless otherwise noted our commentary on sales growth refers to constant currency sales growth, which is defined in our quarterly results press release issued earlier today reconciliations between GAAP and non-GAAP numbers mentioned during the call are also included in today's press release with that I'd like to turn the call over to Bernard for his comments.
Good afternoon, everyone.
As Mark said you know we are hosting today's call from TCT in San Francisco.
I am going to start by covering some of the exciting exciting development at the conference.
Mark Wilterding: Information concerning factors that could cause these differences and important safety information may be found in the press release, our 2022 Annual Report on Form 10K, and Edwards other SEC filings, all of which are available on the company's website at edwards.com. Unless otherwise noted, our commentary on sales growth refers to constant currency sales growth which is defined in the quarterly results press release issued earlier today. Reconciliation between gap and non-gap numbers mentioned during the call are also included in today's press release.
Highlights of our significant progress our team.
Made advancing our strategy.
Do you have a strong first quarter results and finally discuss our confidence in the outlook for Edwards.
Yeah, a lot of data being presented this week about technologies at all developed in.
Included among these are results from free late breaking clinical trials, all of which reflects <unk> commitment to generating high quality evidence to advance innovative therapies for patients suffering from structural heart disease.
Bernard Zovighian: With that, I'd like to turn the call over to Bernard for his comments. Good afternoon, everyone. As Mark said, you know, we are hosting today's call from TCT in San Francisco. I am going to start by covering some of the exciting, exciting development of the conference. Share highlights of a significant progress our team has made advancing our strategy, review our strong third quarter results, and finally discuss our confidence in the outlook for Edwards.
Yesterday physicians presented five year data from the pioneer free Lori's pivotal trial.
We believe these data demonstrate that.
The SAP Hana platform should continue to be the prefilled therapy for treating patients who have severe symptomatic aortic stenosis.
Bernard Zovighian: There are a lot of data being presented this week about technologies, Edwards has developed, included among these are results from three late breaking clinical trials, all of which reflects Edwards' commitment to generating high quality evidence to advance innovative therapies for patients suffering from structural health disease. Yes today, physicians presented five year data from the partner free law risk pivotal trial. We believe this data demonstrate a tether with the sapient platform should continue to be the preserved therapy for treating patients who have severe symptomatic aortic stenosis.
Still more than 20, yale's well, if regardless clinical experiences in trials no eight new England journal of medicine publication and over a million patients treated.
Hey, pin technology or first patient unique benefits.
Sapiens free has demonstrated 99% freedom from des and disabling stroke at one year, 90% survival at five Yale's and is the only valve with a th V and THB indication.
This is true lifetime management benefit, which expands options for patients.
Tomorrow at TCT.
We are looking forward to the presentation of a six month analyses of all evoked plus catch it you have twice the like I said was the first of its kind therapy for the millions of patients suffering suffering from tricuspid valve disease. In addition, tomorrow, you'll receive a one year food court.
Bernard Zovighian: After more than 20 years of rigorous clinical experiences in trials, now we have been in our eight New England Journal of Medicine publication and over a million patient treated sapient technology offers patient unique benefits. Sapient Free has demonstrated 99% freedom from death and disabling stroke at one year, 90% survivor at five years and is the only valve with a THV and THV indication. This is true lifetime management benefit, which expands our patients.
The result of a class two deep pivotal trial with Pascal.
We continue to make meaningful progress to advance our vision of offering a portfolio of innovative plus catch at their therapies to treat tricuspid and mitral valve disease.
In the last several weeks, we achieved four important milestones in support of our commitment to patient focus innovation first CE Mark approval for the evoke trends female valve replacement system second CE Mark approval for Nitro.
Bernard Zovighian: Tomorrow at TCT, we are looking forward to the presentation of the six month analysis of our evoked trans-cutter tracusid valve, the first of its kind therapy for the millions of patients suffering from tracusid valve disease. In addition, tomorrow, you will see the one year full cohort result of a class 2D pivotal trial with Pascal. We continue to make meaningful progress to advance our vision of offering a portfolio of innovative trans-cutter therapies to treat tracusid and mitral valve disease.
Resilience surgical mitral valve failed Pascal precision approval in Japan.
Finally, the completion of enrollment in the first ever pivotal trial for Amy Tung symbol mitral replacement therapy, the incessant trialed for SAPIEN three.
Turning now to Q3 financial performance.
Third quarter Global sales grew 11% to one 5 billion led by our differentiated portfolio of innovative therapies. We were pleased with our results which were in line with our expectation and north present, another quarter of double digits.
Bernard Zovighian: In the last several weeks, we achieved four important milestones in support of our commitment to patient focus innovation. First, see mark approval for the evoked trans-femoral replacement system. Second, see mark approval for the mitral resilience surgical mitral valve. Third, Pascal precision approval in Japan. Finally, the completion of the enrollment in the first ever pivotal trial for any trans-femoral mitral replacement therapy, the encircle trial for sapient entry.
This graph.
For the full year, we continue to expect total company sales growth to be in the 10% to 13% range.
Now I will provide an overview of our first quarter sales performance by product group in tavern.
We continue to see strong demand for our leading SAPIEN platform, we felt quality of sales of $961 million up 10% year over year.
Bernard Zovighian: Turning now to two three financial performance. Third quarter, global sales grew 11% to 1.5 billion, led by our differentiated portfolio of innovative therapies. We were pleased with the results, which were in line with our expectation and are present another quarter of double digit sales growth. For the full year, we continue to expect total company sales growth to be in the 10 to 13-person range. Now, I will provide another view of a third quarter sales performance by Prada Group, in TAVR.
Our U S and O U S sales growth rates were comparable at all.
Our U S and O U S competitive positions, we are stable and globally local selling prices were stable.
In the U S.
Our fifth quarter Teva sales were driven by the continued successful launch of SAPIEN three ultra Brasilia.
On the clinical side, we are pleased with the pace of enrollment in our pivotal trial alliance designed to steady Sapient next fall.
Bernard Zovighian: We continue to see strong demand for our leading sapient platform with third quarter sales of $961 million up 10% year over year. Our US and OUS sales growth rates were comparable. Our US and OUS competitive positions were stable and globally local selling prices were stable.
Our groundbreaking next generation technology.
In Europe. It was sales growth was driven by the broad based adoption of our SAPIEN platform.
We look forward to additional data supporting the Edwards benchmark program to be presented at the PCR London valves conference in November.
Our sales in Japan grew year over year.
Bernard Zovighian: Charles. In the US, our first quarter, Tavir Selves, we are driven by the continued successful launch of Sapien-free ultra-vezilia. On the clinical side, we are pleased with the pace of enrollment in our pivotal trial alliance, designed to study Sapien X IV, our groundbreaking next generation Tavir technology.
<unk>, a gradual recovery in market growth and strong adoption of SAPIEN three ultra resilience.
Competitive trialing in the third quarter, where was less pronounced versus sort of a first half of this year and as expected we grew faster than overall paucity of growth.
Bernard Zovighian: In Europe, Edward Selves was driven by the broad-based adoption of our Sapien platform. We look forward to additional data supporting the Edward's benchmark program to be presented at the PCR London Valve's conference in November. Our Selves in Japan grew year-over-year, reflecting a gradual recovery in market growth and strong adoption of Sapien-free ultra-vezilia, competitive trialing in the third quarter, where was less pronounced versus in the first half of this year, and as expected, we grew faster than overall posterior growth.
Around the world, we remain focused on improving diagnosis and treatment of the many more patients who remain under tweak it in.
In summary.
The combination of our global leadership.
Along with the data presented at TCT This week.
The company further confidence in the city of Teva and the company's expectation of a 10 billion dollar opportunity by 2028.
Now turning to T N T G I.
Our commitment to the unmet needs of mitral and tricuspid patients two took a significant step forward with the achievement of several unimportant my distance in this past quarter.
Bernard Zovighian: Around the world, we remain focused on improving diagnoses and treatment of the many more patients who remain under tweeted.
T MTT felt quality global sales of $52 million increased 65% versus the prior year over year.
This performance was driven by accelerating adoption of our differentiated Pascal precision platform the activation of more centers across the U S and Europe as well as T a procedural growth.
Bernard Zovighian: In summary, the combination of our global Tavir leadership, along with the data presented at TCT this week, gives the company the further confidence in the future of Tavir and the company's expectation of a $10 billion opportunity by 2028.
We continue to be pleased with our excellent clinical outcomes, reflecting the impressive performance of Pascal precision and the value brought by hardware comprehensive high touch model.
Bernard Zovighian: Now, turning to TNTT, our commitment to the unmatched needs of Mitreland's participation took a significant step forward with the achievement of several important milestones in this past quarter. TNTT third quarter global sales of $52 million increased 65% versus the prior year. This performance was driven by accelerating adoption of our differentiated Pascal precision platform, the activation of more centers across the U.S, in your growth. We continue to be pleased with our excellent clinical outcomes, reflecting the impressive performance of Pascal precision and the value brought by our comprehensive high-touch model.
We are continuing the expansion of Pascal precision globally with the expected launch in Japan before the end of the year.
In our Mitel clinical trials, we look forward to the one year class two D. A randomized pivotal trial and class two D. Oar registry outcomes with Pascal to be presented as part of a late breaking scientific sessions tomorrow at TCT.
These will add to the body of evidence supporting keel as an effective therapy for patients.
With the earlier than expected completion of enrollment in the encircled pivotal trial for excipient and free.
We believe we are one step closer to offering an important to valve replacement option.
Bernard Zovighian: We are continuing the expansion of Pascal precision globally with the expected launch in Japan before the end of the year. In our vital clinical trials, we look forward to the one-year class 2D randomized pivotal trial and class 2D registry outcomes with Pascal to be presented as part of a late-breaking scientific sessions tomorrow at TCT. This will add to the body of evidence supporting TNTT as an effective therapy for patients. With the earlier expected completion of enrollment in the in-circle pivotal trial for CEP and N3, we believe we are one step closer to offering an important value replacement option beyond tier to serve even more patients. , Suffering from Mitral Value Disease.
Beyond T here to sell even more patients suffering from mitral valve disease.
In tricuspid earlier this month, we received CE Mark approval for evoke we look forward to bringing this new therapy to Europe for disciplined launch that will focus on ensuring excellent patient outcomes.
Now with this approval physicians in Europe will have access to this groundbreaking option in addition to cheer.
As noted tomorrow at TCT.
Breaking data from the twice in two pivotal trial of the evoke replacement technology will be presented on the first 150 randomized patient based on evokes FDA breakthrough pathway designation.
This landmark presentation on a novel therapy demonstrate our leadership and commitment to innovation and science.
Bernard Zovighian: In Pricuspid, earlier this month, we received CMARC Approval for Revoke. We look forward to bringing this new therapy to Europe through discipline launch that will focus on ensuring excellent patient outcomes. Now, with this approval, physicians in Europe will have access to this groundbreaking option in addition to tier.
And our focus on helping large population of patients with unmet needs.
In summary, 40 M. T. T. We are proud of the new therapy introductions clinical trial achievements and geographic expansion, we have achieved towards to advance our vision to build a portfolio of therapies to transform the lives of my turn into like UC patients.
Bernard Zovighian: As noted, tomorrow at TCT, late-breaking data from the Tristan II pivotal trial of the evoke replacement technology will be presented on the first 150 randomized patients based on evokes FDA breakthrough pathway degeneration. This landmark presentation on a novel therapy demonstrate our leadership and commitment to innovation and science and our focus on helping large population of patient with unmanned needs.
In surgical third quarter sales of $247 million increased 11%.
Or even by a balanced combination of stronger global adoption of <unk> premium technology and overall paucity of girls.
We continue to see strong momentum of our resilient portfolio globally, which has been widely adopted because of the excellent durability of his proven tissue technology supported by our recent seven year aortic data in five year mitral data from a commence.
Bernard Zovighian: In summary for TMTT, we are proud of the new therapy and productions, clinical trial achievements and geographic expansion. We have achieved to advance our vision to build a portfolio of therapies to transform lives of mitral entrecicipations.
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We are confident about the future of this technology as we expand the overall body of resilience evidence, including ongoing patient enrollment of our momentous clinical study.
Bernard Zovighian: In surgical, third quarter sales of $247 million increase, 11% driven by a balanced combination of strong global adoption of Edward's premium technology and overall procedure growth. We continue to see strong momentum of a resilient portfolio globally which has been widely adapted because of the excellent durability of this proven tissue technology supported by the recent seven-year eortic data and five-year mitral data from our commens clinical trial. We are confident about the future of this technology as we expand the overall body of resilient evidence, including ongoing patient enrollment of our momentous clinical study.
Finally, we received CE Mark approval.
Nitrous recently, a mitral valve earlier this month, we expect to introduce this valve in the fourth quarter, followed by full European launch in 'twenty 'twenty four.
In critical care.
Third quarter sales of $221 million increased 6% driven by our smart recovery portfolio with strong adoption of our acumen Ecu sensors equipped with the hypotension prediction index algorithm.
We remain confident in our pipeline of critical care innovation as we continue to shift our focus to smart recovery technologies designed to help clinicians make better decision and get patients home to their families faster.
Bernard Zovighian: Finally, we received CMARC approval for our mitrous resilient mitral valve earlier this month. We expect to introduce this valve in the fourth quarter, followed by full European launch in 2024. In critical care, third quarter sales of $221 million increase, 6%, driven by a smart recovery portfolio with strong adoption of our acumenic sensors equipped with the high-potension prediction index algorithm. We remain confident in our pipeline of critical care innovation as we continue to shift our focus to smart recovery technologies designed to help clinicians make better decisions and get patient home to their family faster.
Now I would tell the cologuard to Scott and thanks, a lot of R&R. We were pleased to report third quarter sales performance in line with our expectations with strength across all product groups. We achieved total sales of 1.48 billion, which represents 11% year over year growth.
We achieved adjusted earnings per share of 59, our GAAP earnings per share of <unk> 63 cents benefited from a change in U S tax regulations, a full reconciliation between our GAAP and adjusted earnings per share for this and other items is included with today's release.
Now I'll cover some additional details of our third quarter sales results and full year 2023 outlook by product group.
A continuation of double digit global tavern growth reflected a more balanced hospital staffing environment as well as strong adoption of the SAPIEN family of valves you.
Scott Ullem: And now I will turn the call over to Scott. Thanks a lot Bernard. We are pleased to report third quarter sales performance in line with our expectations with strength across all product groups. We achieved total sales of $1.48 billion, which represents 11% year-over-year growth. We achieved adjusted earnings for share of 59 cents. Our gap earnings for share of 63 cents benefited from a change in US tax regulations, a full reconciliation between our gap and adjusted earnings for share for this and other items is included with today's release.
U S tower sales growth was driven by the launch of SAPIEN, three ultra resilience, which remains on track to represent the majority of our U S tower sales before year end and Europe Edwards sales growth was driven by the continued demand of our SAPIEN platform and was broad based by country and Japan improved growth.
In the third quarter was driven by the ongoing launch of our SAPIEN three ultra resilient valve.
For global Tower sales, we continue to expect full year 2023 sales of $3 $85 billion to $4.0 billion, representing 10% to 13% growth.
Scott Ullem: I'll now cover some additional details of our third quarter sales results and full-year 2023 outlook by product group. A continuation of Double Digit Global Taver growth reflected a more balanced hospital staffing environment, as well as strong adoption of the Sapien family evolves. US Taver sales growth was driven by the launch of Sapien 3 Ultra Resilia, which remains on track to represent the majority of our US Taver sales before your end. In Europe, Edward Sales Growth was driven by the continued demand of our Sapien platform and was broad-based by country.
T M T T growth in Q3 was driven by adoption of our differentiated Pascal precision platform acts.
Activation of more centers across the U S and Europe and strong procedure volumes.
Overall, we are pleased with our continued progress towards establishing a portfolio of TMT T therapies combined with some temporary clinical data in order to achieve our vision of transforming the lives of patients with mitral and tricuspid valve disease. We continue to expect full year 2023 T M T.
Scott Ullem: In Japan, improved growth in the third quarter was driven by the ongoing launch of our Sapien 3 Ultra Resilia valve. For Global Taver sales, we continue to expect full-year 2023 sales of $3.85 to $4.0 billion, representing 10 to 13% growth. TMTT Growth in Q3 was driven by adoption of our differentiated Pascal precision platform, activation of more centers across the US and Europe and strong procedure volumes. Overall, we are pleased with our continued progress towards establishing a portfolio of TMTT therapies combined with temporary clinical data in order to achieve our vision of transforming the lives of patients with mitral and tricuspid valve disease.
T sales of $180 million to $200 million.
In surgical structural heart, 11% sales growth in the quarter was driven by the adoption of Edwards resilient products.
Just on positive year to date performance, we continue to expect that our full year sales will be in the range of 960 million to $1.02 billion, implying low double digit growth in 2023.
And in critical care, we continue to expect full year 2023 sales of $870 million to $940 million.
For total Edwards based upon the performance we have delivered year to date, we continue to expect full year 2023 sales to be in the range of five nine to $6 $1 billion and full year sales growth to be in the 10% to 13% range. Lastly, we continue to expect our full year adjusted earnings per share.
Scott Ullem: We continue to expect full-year 2023 TMTT sales of $180 to $200 million. In surgical structural heart, 11% sales growth in the quarter was driven by the adoption of Edward's Resilia products. Based on positive year-to-date performance, we continue to expect that our full-year sales will be in the range of $960 million to $1.02 billion, implying low double-digit growth in 2023. And in critical care, we continue to expect full-year 2023 sales of $870 million to $940 million.
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We're projecting fourth quarter sales to be between 1.45 and $1.53 billion. We are also projecting fourth quarter adjusted earnings per share to be between 60 and 66 now.
Now I'll cover additional details of our P&L for.
For the third quarter, our adjusted gross profit margin was 76, 4% as expected compared to 81% in the same period last year. This.
Scott Ullem: For total Edwards, based upon the performance we have delivered year-to-date, we continue to expect full-year 2023 sales to be in the range of $5.9 to $6.1 billion and full-year sales growth to be in the 10 to 13% range. Lastly, we continue to expect our full-year adjusted earnings per share to be between $2.50 and $2.60.
This year over year reduction was driven by impacts from foreign exchange remember last year Edwards gross profit margin was lifted by an unusually positive impact from foreign exchange. We continue to expect our full year 2023, adjusted gross profit margin to be between 76 and 78%.
Scott Ullem: We're projecting fourth-quarter sales to be between $1.45 and $1.53 billion. We are also projecting fourth-quarter adjusted earnings per share to be between $0.60 and $0.66.
Selling general and administrative expenses in the quarter were $440 million or 29, 7% of sales compared to $377 million in the prior year.
This increase was driven by investments in Transcatheter field based personnel in support of our growth strategy and performance based compensation. We continue to expect full year 2023 S. G&A as a percent of sales to be 29% to 30% as we invest in field based personnel and our therapy adoption initiatives.
Scott Ullem: Now, we'll cover additional details of our P&L. For the third quarter, our adjusted gross profit margin was 76.4% as expected compared to 81% in the same period last year. This year-over-year reduction was driven by impacts from foreign exchange. Change. Remember last year Edwards gross profit margin was lifted by an unusually positive impact from foreign exchange. We continue to expect our full year 2023 adjusted gross profit margin to be between 76 and 78 percent.
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Research and development expenses in the third quarter grew 16% over the prior year to $270 million or 18, 3% of sales.
This increase was primarily the result of continued investments in our transcatheter valve innovations, including increased clinical trial activity for.
For the full year 2023, we continue to expect R&D to be 17% to 18% of sales as we invest in developing new technologies and generating evidence to support Havre in T. M T.
Turning to taxes, our reported tax rate this quarter was 12, 7% or 18, 8%, excluding the impact of special items, our reported rate benefited from the suspension of certain U S tax regulations surrounding foreign tax credits are slightly higher than expected non-GAAP rate resulted.
Scott Ullem: We continue to expect full year 2023 S-GNA as a percent of sales to be 29 to 30 percent as we invest in field based personnel and our therapy adoption initiatives. Research and development expenses in the third quarter grew 16 percent over the prior year to $270 million or 18.3 percent of sales. This increase was primarily the result of continued investments in our trans-catheter valve innovations, including increased clinical trial activity. For the full year 2023 we continue to expect R&D to be 17 to 18 percent of sales as we invest in developing new technologies and generating evidence to support TAVR and TMTT.
Merrily from income mix, and a lower excess tax benefit from stock based compensation.
We continue to expect our full year tax rate, excluding special items to be between 13 and 17%.
Foreign exchange rates decreased third quarter reported sales growth by 140 basis points or $16 million compared to the prior year.
At current rates, we now expect an approximately $40 million year over year negative impact to full year 2023 sales compared to 2022.
Scott Ullem: Turning to taxes, a reported tax rate this quarter was 12.7 percent or 18.8 percent excluding the impact of special items. Our reported rate benefited from the suspension of certain U.S, tax regulations surrounding foreign tax credits. Our slightly higher than expected non-gap rate resulted primarily from income mix and a lower excess tax benefit from stock based compensation. We continue to expect our full year tax rate excluding special items to be between 13 and 17 percent.
FX rates negatively impacted our third quarter gross profit margin by 410 basis points compared to the prior year.
Relative to our July guidance FX rates had a one penny negative impact on third quarter earnings per share.
Free cash flow for the third quarter was $356 million defined as cash flow from operating activities of $411 million less capital spending of $55 million.
Scott Ullem: For an exchange rate decreased third quarter reported sales growth by 140 basis points or $16 million compared to the prior year. At current rates we now expect an approximately $40 million year over year negative impact to full year 2023 sales compared to 2022. FX rates negatively impacted our third quarter gross profit margin by 410 basis points compared to the prior year. Relative to our July guidance FX rates had a one penny negative impact on third quarter earnings per share.
We continue to expect full year 2023, adjusted free cash flow will be between 1.0 and $1.4 billion.
And before turning the call back over to Bernard I will finish with an update on our balance sheet and share repurchase activities. We continue to maintain a solid and flexible balance sheet with approximately $1 $9 billion in cash cash equivalents and short term investments as of September 30th.
During the third quarter, we repurchased two 2 million shares under our 10 B five plan.
We continue to expect average diluted shares outstanding for 2023 to be between 610 and $615 million.
Scott Ullem: Free cash flow for the third quarter was $356 million defined as cash flow from operating activities of $411 million less capital spending of $55 million. We continue to expect full year 2023 adjusted free cash flow will be between $1.0 and $1.4 billion.
We have approximately $500 million remaining under our current share repurchase authorization and with that back over to you Bernard Thank.
Scott in closing.
After more than 20 years of rigorous clinical experience.
Scott Ullem: Before turning the call back over to Bernard I'll finish with an update on our balance sheet and share of purchase activities. We continue to maintain a solid and flexible balance sheet with approximately $1.9 billion in cash equivalence and short term investments as of September 30. During the third quarter we repurchased 2.2 million shares under our 10B5 plan. We continue to expect average diluted shares outstanding for 2023 to be between $610 and $615 million. We have approximately $500 million remaining under our current share of purchase authorization.
Over 1 million patient waited.
And this week at a five year pioneer free arisen.
He loves tether is position for strong sustainable growth as many patients remain undiagnosed and untreated.
In addition.
We have two strong global business is critical to Kevin Seljuk.
Which are position for durable long term growth driven by portfolios of differentiated technology.
Moreover, we are achieving many many significant milestones in tea and Kiki that gives us the confidence about progressing our vision to treat the many may turn into ruckus had patients in need altogether.
Bernard Zovighian: And with that back over to you Bernard. Thank you Scott, in closing, after more than 20 years of rigorous clinical experience, over 1 million patient waited, and this week's five year partner three results, Edwards Taver is positioned for strong sustainable growth, as many patients remain undagnosed and untreated. In addition, we have two strong global businesses, critical care and surgical, which are positioned for durable long-term growth driven by portfolios of differentiated technology.
We are convinced.
I'll have a tremendous opportunity to drive success in the future through our patient focus breakthrough technologies and leadership.
With that.
Is it back to Mark to open it up to Q&A.
Thank you very much Bernard.
Before we open it up for questions I'd like to remind you about our 2023 Investor Conference, which we will host at our headquarters in Irvine, California on Thursday December 7th. This event will include updates on our latest technologies views on longer term market potential as well as our outlook for 2020 for more information and a registration form.
Bernard Zovighian: Moreover, we are achieving many significant milestones in TNTT that gives us confidence about progressing our vision to treat the many my turn into a few patients in need. All together we are convinced of a tremendous opportunity to drive success in the future through our patient focus, breakthrough technologies, and leadership.
Some are available on our website.
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 Diego. Please go ahead with additional details on accessing the Q&A portion of the call.
Mark Wilterding: With that, pass it back to Mark to open up Q&A. Thank you very much Bernard.
Thank you.
And if you'd like to ask a question. Please press star one on your telephone keypad.
Mark Wilterding: Before we open it up for questions, I'd like to remind you about our 2023 investor conference which we will host at our headquarters in Irvine, California on Thursday, December 7th. This event will include updates on our latest technologies, views on longer-term market potential, as well as our outlook for 2024. More information and a registration form are available on our website.
Confirmation tone will indicate that your line is in the question queue.
You May press Star two if you would like to remove your question from the queue.
For participants using speaker equipment and may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Operator: 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 re-enter the Q and management will answer as many participants as possible during the remainder of the call. Diego, please go ahead with additional details on accessing the Q&A portion of the call. Thank you. And if you'd like to ask a question, please press star one on your telephone keypad.
Our first question comes from Robbie Marcus with Jpmorgan. Please state your question.
Oh, great. Thanks for taking the question maybe to start you guys did 11% tamper growth in the quarter roughly similar U S O U S.
How do we think about what's holding it back here from being faster pre COVID-19. It was growing at much higher rates, it's been one of the slower to recover.
Operator: A confirmation tone will indicate that your line is in the question Q. You may press star two if you would like to remove your question from the Q. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please while we pull for questions.
Subsectors in Med Tech.
Data present, this weekend should be supportive of growth.
What gives you confidence that's going to remain a double digit growth market for the foreseeable future.
Thank you Robbie you know, let me start event I will ask Larry to AR to continue here first we.
Robert Marcus: Our first question comes from Robbie Marcus with JP Morgan.
We are pleased to two this quarter and again it is the fifth quarter in a row of double digit sales growth that we are very pleased about it very balanced between the U S. You know U S.
Robert Marcus: Please state your question. Oh great. Thanks for taking the question. Maybe to start, you guys did 11% of our growth in the quarter, roughly similar USWS. How do we think about what's holding it back here from being faster? You know, pre-COVID, it was growing at much higher rates. It's been one of the slower to recover sub-factors in MedTech. Data present this weekend should be supportive of growth, but what gives you confidence this can remain a double-digit growth market for the foreseeable future?
Bernard Zovighian: Thank you, Robbie.
Okay, Celia adoption is going very well according to plan.
In U S and in Japan, and we look at the opportunity we see.
So many patients are diagnosed and then treated so we feel good about you know what's ahead of US we feel we are well position all of the data presented this week give us even greater confidence, but Larry you want to add anything yeah. I don't have a lot to add you know this is our third straight quarter of double digit growth, which you know coming out of.
Bernard Zovighian: Let me start, then, I will ask Larry to continue here. First, we are pleased to support it. Again, it is the third quarter in a row of double-digit sales growth. We are very pleased about it. Very balanced between US and US. R, Ultra Resilia Adoption is going very well according to plan in US and in Japan, and we look at the opportunity with so many patients are undiagnosed and untreated. So we feel good about what's ahead of us, we feel we are well positioned, all of the data presented this week, give us even greater confidence.
Covid and all the Rockiness there we saw during that period of time, it's actually been really good to see the stability that we've seen in the continued growth even as our business gets larger so I actually feel really good about our growth rate.
Thank you know, we're continuing to work to get patients off the sidelines and our patient activation I think the data hopefully the data here is is reassuring for patients.
Are people worried about a durability signal whatever and now we have really a high quality data published in the New England Journal of Medicine. They chose absolutely no durability signal at five years using bark through definition. So we think all of those are positive and those continue to help us have.
Larry Wood: But Larry, you want to add anything? Yeah, I don't have a lot to add. You know, this is our third straight quarter of double digit growth, which, you know, coming out of COVID and all the rockiness that we saw during that period of time, it's actually been really good to see the stability that we've seen in the continued growth, even as our business gets larger. So I actually feel really good about our growth rate.
You know.
Double digit and sustainable growth over over a long period of time, so I feel great about where we are.
Great and maybe one more product question here for me you just kind of broke approved in Europe with CE, Mark we'll see the data for six months Tomorrow and tricuspid replacement. This is a market we hear from doctors a lot.
Larry Wood: I think, you know, we're continuing to work to get patients off the sidelines and our patient activation. I think the data, you know, hopefully the data here is reassuring for patients. You know, people were worried about a durability signal with TAVR, and now we have, you know, really high quality data published with the New England Journal of Medicine that shows absolutely no durability signal at five years using bark through definitions. So we think all of those are positive and those continue to help us have, you know, double digit and sustainable growth over over a long period of time. So I feel great about where we are.
May not be terribly excited about repair, but replacement could be a really exciting option.
Do you think Edwards needs to do as a company to take this market and accelerate adoption.
Drive uptake here in an area, that's been pretty slow what tricuspid repair. Thanks.
Thank you Robby So we agreed to a to do you know what we have done in time for the last 50 days zero basically.
Focusing in on number one the patient outcomes. So it is why we are being we are going to be focusing on making sure.
Robert Marcus: Great, maybe one more product question here from me. You just got a vote approved in Europe with CEMARC. We'll see the data for six months tomorrow in TriCustom Replacement. This is a market we hear from doctors a lot. It may not be terribly excited about repair, but replacement could be a really exciting option.
Our Tvs well trained well equipped to support those physicians.
We are going to have a disciplined launch in Europe, and we agreed to produce evidence like twice in two.
You are going to want to see grow tomorrow, and we are going to continue to produce more evidence, but maybe David you want to add anything here yeah. No. Thanks, Bernard I appreciate it no I think as Bernardo said, we really do believe that it's the comprehensive high touch model and outstanding outcomes is a key step, but it's it's much more than that.
Robert Marcus: What do you think Edwards needs to do as a company that take this market and accelerate adoption and drive up take here in an area that's been pretty slow with TriCustom Replacement. Thanks. Thank you, Robbie.
Bernard Zovighian: So we are going to do, you know, what we have done in TAVR for the last 50 years, you know, basically focusing on number one of the patient outcomes. So it is why you know, we are being we are going to be focusing on making sure you know, our TV is well-prepared, you know, well-equipped, you know, to support your physicians.
That and us having the ability to take the tavern playbook from from long ago and help apply to this news area is really important and for US that includes not only technology innovation evidence, but also continuing to that overtime work on helping improve diagnosis referral and eventually treatment of patients but for US. This is.
Larry Wood: We are going to have a discipline launch, you know, in Europe. And we are going to produce evidence, like, you know, the tracing to, you know, cohorts, you are going to see, you know, tomorrow. And we are going to continue to produce, you know, more evidence. But maybe the thing you want to add anything here. Yeah, no, thanks, Bernard, I appreciate it. No, I think as Bernard has said, we really do believe that it's the comprehensive high-touch model and outstanding outcomes as a key step.
A comprehensive kind of play.
Play a long term play for us to really build a new therapy that we're really excited about to help patients with and if I may add you'll Robbie here. We also get a lot at the beginning of better understanding the striker speed ease tricuspid disease, we believe that we still and replace of adoption physician, we'd have more options to tweak.
Even more patients. So we are going to learn a lot here about you know what therapy for what patient, but I think to therapy in Europe.
Larry Wood: But it's much more than that. And us having the ability to take the TAVR Playbook from long ago and help apply to this new area is really important. And for us, that includes not only technology, innovation, evidence, but also continuing to then over time work on helping improve diagnosis, referral and eventually treatment of patients. But for us, this is a comprehensive kind of play, long-term play for us to really build a new therapy that we're really excited about to help patients with.
And as you know leading that space, we are going to lay out a lot in the past few years and I'm sure you're a patient who will benefit from that.
Thank you.
Our next question comes from Larry <unk> with Wells Fargo. Please state your question.
Good afternoon. Thanks for taking the question Scott year to date, the cabinet growth is a little over 10% I believe the midpoint of the guidance is about 11, five so should we be thinking about the low end of the Abbott range.
Larry Wood: And if I may add, you know, Robby here, we are also, you know, at the beginning of, you know, better understanding of this practice piece, this practice piece disease. We believe that with tier and replacement option, physician will have, you know, more options to tweet, you know, even more patients. So we are going to learn a lot here about, you know, what therapy for what patient, but having two therapy in Europe. And us, you know, leading that space, we are going to learn a lot in the past few years, and I'm sure that patients will benefit from that.
unknown: Thank you.
10% to 13% for the year end and if not what drives the acceleration implied in Q4 for Kathryn and I had one follow up.
Well I'd take you back to the beginning of the year when our guidance for the full year for both <unk> and Edwards was 9% to 12% we increased it to ultimately 10% to 13% because of the first quarter and second quarter results. So we're coming in about where we thought we would for Q3 and Q4.
Larry Biegelsen: Our next question comes from Larry Biegelsen with Wells Fargo, please say your question. Good afternoon, thanks for taking the question. Scott, you're in a day, the caber growth is a little over 10%, I believe, the mid-point of the guidance is about 11.5. So, should we be thinking about the low end of the caber range of 10 to 13% for the year, and if not, what drives the acceleration applied in Q4 for cabers, then I'd want to follow up.
The 10% to 13% guidance reflects the stronger than expected Q1 and Q2.
In the fourth quarter, our guidance for the full company is about $10 million higher at the midpoint than our results in Q3. So we haven't broken out guidance by business unit, but you can expect that overall, we expect the fourth quarter that looks pretty similar to the third quarter.
You're right I think for the for the full year, we're probably going to end up about in the middle of the range that we do we said, 10% to 13%, but that doesn't mean that it's 10% to 13% for Q4, because again that higher range reflects the increase from the first quarter.
Larry Biegelsen: Well, I'd take it back to the beginning of the year when our guidance for the full year for both caber and Edwards was 9 to 12%. We increased it to ultimately 10 to 13% because of the first quarter and the second quarter results. So, we're coming to about where we thought we would for Q3 and Q4, the 10 to 13% guidance reflects the strong and expected Q1 and Q2. You know, in the fourth quarter, our guidance for the full company is about $10 million higher at the midpoint than our results in Q3.
Thank you for that and obviously people are starting to think about 'twenty four right now so Bernard at our conference you talked about targeting double digit annual revenue growth does that apply to 2024 and Scott you know 23 guidance implies margins are down year over year because of the investments and currency what are some of the puts and takes in the P&L.
That we should be thinking about it any help on FX would be appreciated. Thank you.
Larry Biegelsen: So, we haven't broken out guidance by business unit, but you can expect that overall, we expect a fourth quarter that looks pretty similar to the third quarter. You're right, I think for the full year, we're probably going to end up about in the middle of the range that we said 10 to 13%, but that doesn't mean that it's 10 to 13% for Q4, because again, that higher range reflects the increase from the first quarter.
Thank you Robbie let me take the first part of your question here so for.
'twenty 'twenty four guidance you would get you know all of the details here in December.
At our Investor event.
And the question is about you know my confidence and our confidence is the company. Yes. We are confident as I said during the script I think like we have an amazing opportunity in front of us with so many patients.
Larry Biegelsen: Thank you for that. And obviously, people are starting to think about 24 right now. So, Bernard, at our conference, you talked about targeting double-digit annual revenue growth. Does that apply to 2024? And it's got 23 guidance that applies margins are down here because of the investments and currency. You know, what are some of the puts and takes on the P&L, you know, that we should be thinking about it. Any help on FX would be appreciated. Thank you.
Bernard Zovighian: Thank you, Larry.
All of our businesses are in solid position in global leadership position.
I am confident for the years to come for 'twenty 'twenty four you know more to come in December or Larry.
Larry It's Scott for the second part of your question about FX you know, we'll talk about more of the specifics at the Investor Conference, but if you take our exchange rate environment, right now and our clients of 'twenty 'twenty four it would be a headwind to sales and also a headwind to EPS. So we'll be able to quantify that more specifically.
Scott Ullem: Let me take it over first part of your question here. So, for, you know, 2020-24 guidance, you know, you will get, you know, all of the details, you know, in December, at our investor event. And the question is about, you know, my confidence and our confidence as a company, yes, we are confident. As I said, you know, during the script, you know, I think like we have an amazing opportunity in front of us with so many patients. All of our businesses are in solid position, in global leadership position. So, I am confident for the years to come. For 2024, it'll more to come in December, Larry.
And you know, we'll see what happens to FX rates between now and then as well.
Alright, Thank you guys.
Our next question comes from Vijay Kumar with Evercore ISI. Please state your question.
Hey, guys. Thanks for taking my question.
Bernard maybe first one for you on this that tower five year data that discretionary.
A lot of noise in the street on the lanes crossing for Edwards and you Peter.
Scott Ullem: And Larry, it's got for the second part of your question about FX.
The lines widening between cavern control.
Scott Ullem: You know, we'll talk about more of the specifics at the investor conference. But if you take our exchange rate environment right now and apply it to 2024, it would be a headwind of sales and also a headwind to EPS. So, we'll be able to quantify that more specifically. And, you know, we'll see what happens to FX rates between now and then as well.
No Thats why are you at all just from adverse perspective, when you look at the data and I think.
Larry Biegelsen: All right. Thank you, guys.
You also mentioned walk see definition for.
For durability is that something that your peer also use the same definition or are there some differences here and how.
Durability was defined the needs to across.
Thank you Vijay let me start at a high level I believe you rolled out last night, you know investor event.
Vijay Kumar: Our next question comes from Vijay Kumar with Evercore ISI. Please steer your question. Hey, guys, thanks for taking my question.
As you know very insightful with Doctor Ali on industrial market. If it went to get a very deep into the data. They are going to go very deep into the many remaining of the data and the trial design at the end of the day to for me. It is I like to keep it very simple 90 person. So five survival at five years. That's that's.
Vijay Kumar: Bernard, maybe at first one for you on this tower, five year data that this president. A lot of noise in the street on the lines crossing for Edwards and your pure. The lines widening between tower and control. Does that worry you at all, just from Edwards perspective, when you look at the data, and I think you also mentioned work, three definitions for for durability. Is that something that you appear also use the same definition or there's some differences here and how durability was defined in these two cross. Thank you, Vijay.
It's amazing for a patient that's in my mind, you know, what we should all remember, but I'm going to ask Larry to comment you know and with a greater detail here.
Yeah. Thanks, Bernard Yeah. This this whole thing about the curves continuing to diverge.
It isn't really accurate I think we had a little bit of a catch up but if you'll notice from the new England Journal of Medicine manuscript, we are impacted somewhat by the patients that were drew on the surgical side disproportionately in when we did the phone sweep.
Bernard Zovighian: Let me start at a high level.
Larry Wood: I believe last night, investor event was very insightful with Dr. Leon and Dr. Mark. They went very deep into the data. They went very deep into the meaning of the data and the trial design.
Absolute difference that we're showing at five years is about 1%. When you go into the causes of death yogurt cardiovascular mortality, they're about the same we had I think double the rate of cancer, we had three times as much COVID-19 deaths in the <unk> group as we had in the surgical group and I think a higher rates of sepsis, which were all adjudicated to be <unk>.
Bernard Zovighian: At the end of the day, for me, I like to keep it very simple. 90% survival at 5 years. That's amazing for patients. That's in my mind what we should remember.
Cabot related and I don't think anybody's, suggesting the caveat causes cancer COVID-19. So when you get into the depth of the data I mean, we feel great about the data what's amazing about this dataset.
Larry Wood: But I'm going to ask Larry to comment with a greater detail here. Thanks, Bernard. This whole thing about the curves continuing to diverge just isn't really accurate. I think we had a little bit of a catch up. But if you'll notice from the Journal of Medicine manuscript, we are impacted somewhat by the patients that withdrew on the surgical side disproportionately. And when we did the phone sweep, the absolute difference that we're showing at 5 years.
Is that both groups performed incredibly well and given the prominence of Edwards surgical valves and then obviously you know our tavern cohort you know we're looking at both groups that have over 90% survival at five years and the other thing that people have been worried about recover was durability and you're right. We did use the bark definite.
Larry Wood: 5 years is about 1%. When you go into the causes of death, you look at cardiovascular mortality, they're about the same. We had, I think, double the rate of cancer. We had three times as much COVID death in the Tava group as we had in the surgical group. And I think higher rates of sepsis, which were all adjudicated to be not Tava related. And I don't think anybody suggesting the Tava causes cancer or COVID.
<unk> for durability, which.
I remember isn't what historic what surgeries historically used surgery historically has used freedom from X quant due to structural valve deterioration not EKO derived criteria and so part of what drives the new England Journal of Medicine publication as we used all the contemporary standards all the contemporary things. So I don't want to comment on other People's data.
Larry Wood: So when you get into the depths of the data, I mean, we feel great about the data. What's amazing about this data set is that both groups performed incredibly well. And given the prominence of Edward's surgical valves, and then obviously our Tava cohort, we're looking at both groups that have over 90% survival at 5 years. And the other thing that people have been worried about with Tava was durability. And you're right, we did use the bark definitions for durability, which, remember, isn't what surgery is historically used. [inaudible] people are discussing that somehow tabr has to be better than the surgery.
You can you can ask them about their data and what methodologies they use but I'm very comfortable we applied the highest academic standard Starrs study and again, we feel great about the data and I think Theres <unk>.
There's just a little bit of an oddity here.
People are discussing that somehow tavern has to be better than the surgery. If we have two procedures tavern surgery and we can go to patient and say your results are identical at five years.
Then that's going to automatically default people took a less invasive therapy and now we need to continue to follow these patients we need to follow them all the way out to 10 years, but for a.
Pretty significant in term look at the data at five years.
I don't think we could be any happier about the data than we are.
In addition in addition, VGA you know if you think about what we have been saying all along about the N.
They'll diagnosis and then their treatment of this patient now you look at these powder free five Yale's, we hope we certainly hope that you know that.
That you know very fitting in a network of cardiologist, which said you know more patients because they have options safe options effective options. So we feel good about all of this at.
Bernard Zovighian: If we have two procedures, tabr and surgery, and we can go to patients and say, your results are identical at five years, then that's going to automatically default people to the less invasive therapy. And now we need to continue to follow these patients. We need to follow them all the way out to ten years. But, you know, for a pretty significant in-term look at the data at five years, I don't think we could be any happier about the data than we are.
I'll just add I think this was a great day or a great meeting for the field in general.
If you have patients on the sidelines, who say you know I'm I'm just I just don't want to have opened our tertiary I'm too scared of open heart surgery, but they're being told you know tavern doesn't really have any data behind it and it's still early.
If you if you look at both datasets that were presented there is absolutely no durability signal at five years or four years, depending on which study you are looking at and I think that you just gave the referral community tremendous confidence that they can send patients for this procedure and theyre going to get a durable outcome.
Bernard Zovighian: And in addition, in addition, VGA, you know, if you think about what we have been saying all along about, you know, the under-diagnosis and under-treatment of this patient. Now, you look at this partner three, five years, we hope. We certainly hope that, you know, that, you know, the referring, you know, network of cardiologists will send, you know, more patients, because, you know, they have options, safe options, effective options. So we feel good about all of this.
That's helpful.
And Bernard just one more for you there was some headlines on investigation and.
In Europe, any any financial implications here its just the headlines look.
And I know, it's a silly question, but I have to ask is there any G. L. P. One exposure to cover our caviar patients related to base <unk>. Thank you.
Larry Wood: Yeah, I mean, I'll just add, I think this was a great day. You know, a great meeting for the field in general. You know, if you have patients on the sidelines who say, you know, I'm, I'm just, I just don't want to have open-art surgery. I'm too scared of open-art surgery. But they're being told, you know, Cabra doesn't really have any data behind it and it's still early. You know, if you, if you look at both data sets that were presented, there's absolutely no durability signal at five years or four years, depending on which study you're looking at. And I think that should just give the referral community tremendous confidence that they can send patients for this procedure and they're going to get a durable out. That's helpful, Bernard.
No. Thanks.
No no.
No financial exposure.
A brief statement on that so no expectation here.
With regards to <unk> exposure to Teva, we don't think so you know we have not seen any evidence that you are losing weight as any impact to aortic stenosis disease. We don't we don't know that we don't see that we don't we have not seen any evidence. So that so we don't see any push it plus you what implication here.
Vijay Kumar: Just one more for you. There was some headlines on investigation in Europe, any financial implications here. It's just the headlines look below odd.
Larry anything to add no.
Totally agree I think as it relates to just general things you know, obviously people, losing weight is a good thing, but we've never seen anything related to even.
Bernard Zovighian: And I know it's a silly question, but I have to ask, is there any GLP1 exposures that have or have our patients related to basically in GLP1s? Thank you. No thanks. In Europe, there is no financial exposure. We have a brief statement on that, so no expectation here. With regards to GLP1 exposures to Tyler, we don't think so. We have not seen any evidence that losing weight as any impact to aortic stenosis disease. We don't know that we don't see that. We have not seen any evidence. So we don't see any evidence.
Even even coronary disease you know there are a lot of these things are genetically derived in genetically driven and I don't think youre right theres going to be the determinant of those things. So I don't I don't really see any impact of this.
Thanks, guys.
Our next question comes from Josh Jennings with TD Cowen. Please state your question.
Hi, good afternoon. Thanks for taking my questions I wanted to just ask first on the tricuspid repair and replacement segment and just.
Larry Wood: Any possible implication here. Larry, anything to add? No, I totally agree. I think, you know, as it relates to just general things, you know, obviously people losing weight is a good thing, but we've never seen anything related to even, you know, even coronary disease. You know, there's a lot of these things are genetically derived, genetically driven. And I don't think your weight is going to be the determinant of those things. So I don't, I don't really see any impact of this.
Just get your views on.
Patient reported outcomes driving approvals and potentially reimbursement decision positive reimbursement decisions are patient reported outcomes or quality of life improvements.
<unk> two <unk> to clear the those two hurdles.
So let me start and then I'm sure get Devine cannot you know he's is his thoughts.
It is a good start we have a we have seen a tightly related so far corrected and we believe it'll tell you mean it was that was a good steady good outcome for patients.
Bernard Zovighian: [inaudible] Thanks. Thanks. And ultimately down to the community and the regulators, they're going to keep looking at the benefit and risk trade off to make the decisions that. Thanks, of what they need to make, but we continue to be super excited by what these therapies are doing to start a lot of therapy for what patient, for what anatomy, and so that's a big progress to where we were in a few years ago, even a few months ago. So a great progress here and I see it all more to come. No thanks for that.
Safe, we as you know great quality of life improvements for this patient who have a miserable life, we need to remember all that.
Reis evoke we aren't going to talk about it tomorrow. So it's tough for me to talk about it today, we might talk about it the more we get on the elevated tomorrow at our Investor Conference.
But at the end of the day, though.
Quality of life and pools not that important.
unknown: This one follow up on just the US sales strategy and having two separate teams for Taber and for the TMTT franchise. I just wanted to hear about how that's going and I guess the concern is just are you missing any cross selling synergies that you can potentially garner from the taber sales sales reps and their deep relationships with some of these intervention cardiologists. Thanks for taking the question.
Larry Wood: Thank you. So what about you know, I ask you Larry, we're leaving that to you every day to comment on this. Yeah, you know, it's funny when we launched Taber in the US, if you remember, half of our procedures were trans apical and people were like, you know, hey, you already have a selling organization that's selling the surgeons. Why are you developing this whole new sales organization? You can get a lot of synergy, but it's really all about providing that high touch model and that level of expertise and we built out a completely separate sales force for THB.
Solid safety profile of Sui is important and all of that we see that there's a great deal of start you know for these patients who have no. Other options today, David you want to add anything yes, I mean, I think we continue to see out of our European experience, where we do have Pascal tricuspid approved that we can do say these great outcomes, where the technology is.
Really making a difference in patients' lives. It is taking patients that ultimately can't do the things. They wanted to do in their day to day, they feel really down they have trouble breathing and it really just helps them live the life that they want to lead and so for us to see now in this randomized trial, that's been presented with Tri eliminate to see high quality.
Data, where that you can treat tricuspid regurgitation and randomized trial get safe results and have significant TR reduction with meaningful quality of life Wow I mean, that's just fantastic for patients, it's something we love and ultimately down to the community and the regulators are going to keep looking at the benefit and risk trade off to make the decisions that they need to make.
But we continue to be Super excited by what these therapies are doing for tricuspid patients.
What we are in addition of what David said, you know what we what we like about where we are today is in the past few years. It was only about <unk>. It was really about the repair so physician didnt have a lot of options and what we are doing is now progressing with our vision to being able to offer to physician a toolbox.
So we can decide to watch therapy for what patient for what and that to me and so that's had a big progress to where we were in a few years ago, even in a few months ago. So a great progress here and I see you know more to come.
No. Thanks for that and just one follow up on <unk>.
The U S sales strategy and having two separate teams for <unk> and for the TMT T franchise.
Just wanted to hear about how that's going.
The concern is just are you missing any cross selling synergies that you could potentially garner from from the tavern sales sales reps and their deep relationships with some of these interventional cardiologists. Thanks for taking the question.
So what about you do I ask you to Larry we're living that every day to comment on this yeah. You know it's funny when we launched have or in the U S. If you'll remember half of our procedures were trans apical and people were like Hey, you already have a selling organization that selling to surgeons why are you developing this whole new sales organization you can get a lot of synergy.
But it's really all about providing that high touch model and that level of expertise and we built out a completely separate sales force for THB and I don't think Theres a day, we look back on that and think that that was a bad decision I think we feel that that was the right decision for the therapy.
Vitro patients are different than aortic patients and you know if you ask your clinical specialist and your salespeople to try to be experts in 10 therapies theyre going to be generalists and all of them are not experts and I think one of the reasons. We've had the success. We've had in tavern is you know what.
I think our average field clinical specialist supports about 1200 cases, a year and so you bring that level of expertise to every case and we really drive differentiated outcomes for patients, which I think what's driven the therapy and what's driven our leadership and we like that model of what we think it's been hugely successful just because our team certainty.
Different organizations doesn't mean, they don't talk and Devine and I talk a lot you know I have surgical structural heart now, but I've talked to wean our general manager of that all the time, we look for where are there opportunities for us to work together, but at the same time, we want to make sure. We have focus on these new therapies and we bring the highest level of expertise possible.
Larry Wood: And I don't think there's a day we look back on that and think that that was a bad decision. I think we feel that was the right decision for the therapy. You know, my patients are different than any other patients and you know, if you ask your clinical specialist and your salespeople to try to be experts in 10 therapies, they're going to be generalists in all of them and not experts. And I think one of the reasons we've had the success we've had in Taber is you know, I think our average field clinical specialist supports about 1200 cases a year.
So we drive the best outcomes for patients possible because we believe that is what's going to drive long term success of our of our franchises I'll add one thing on that this is devine even here at TCT as I talked to physicians. The one thing I consistently hear from physicians is they so appreciate our comprehensive high touch.
Larry Wood: And so you bring that level of expertise to every case and you know, we we really drive differentiated outcomes for patients, which I think what's driven the therapy and what's driven our leadership. And we like that model a lot. We think it's been hugely successful just because our teams that in different organizations doesn't mean they don't talk. And you know, Dvene and I talk a lot, you know, I have surgical structural heart now, but I talk to Wayne, our general manager of that all the time.
Model, They love that Theyre Edwards person, who is so deep in the mitral and tricuspid space and that's all they breathe live and really think about and so they can offer the best possible advice the physician in the best possible collaboration to ensure the best possible patient result, and I just love seeing that this week.
Larry Wood: We look for where there are opportunities for us to work together, but at the same time, we want to make sure we have focus on these new therapies and we bring the highest level of expertise possible. So we drive the best outcomes for patients possible because we believe that is what's going to drive long term the success of our of our franchises.
I talked to physicians.
That's helpful. Thanks, so much.
Our next question comes from Travis Steed with Bank of America. Please state your question.
unknown: I'll add one thing on that.
Hey, Thanks for taking the question, maybe just to clarify one clarification when I add your Q4 guide of 60 to 66 cents I'm getting to a full year of $2 47 to $2 53, which is different than your full year guidance I don't know if there was a restatement or just wanted to maybe my math is off but just wanted to clarify that if you don't mind.
Daveen Chopra: This is Dvene. Even here at TCT as I talk to physicians, the one thing I consistently hear from physicians is they so appreciate our comprehensive high touch model. They love that they're Edwards person who is so deep in the micro ultra-custom space. And that's all they breathe, live, and really think about. And so they can offer the best possible advice to the physician, the best possible collaboration to ensure the best possible patient results. And I just love seeing that this week as I talk, of Physicians. That's helpful.
unknown: Thanks so much.
So your math is spot on at the midpoint of the range that that's exactly what it implies and so take the midpoint. It ends up at the lower end of that $2.50 to $2 60 range, but still within the range.
Okay got it.
Then.
The comment on U F and O U S growth rates being comparable is that referring to constant currency or reported it looks like Oh, you off with a little bit lighter this quarter and just wanted to make sure I understood everything going on O U S and some of the Japan comments and.
Travis Steed: Our next question comes from Travis Steed, with Bank of America.
Travis Steed: Please state your question. Hey, thanks for taking the question. Maybe it's to clarify one clarification. When I add your Q4 guide of 60 to 66 cents, I'm getting to a full year of 247 to 253, which is different than your full year guidance. I don't know if there was a restatement or just just one demand, maybe a math is off. Just one to clarify that if you don't mind. So your math is spot on at the midpoint of the range.
Travis Steed: That's exactly what it implies. And so take the midpoint. It ends up at the lower end of that $2.50 to $2.60 range, but still within the range. Okay, got it. And then the comment on U.S, and the U.S, growth rates being comparable, is that referring to constant currency reported? It looks like OUS is a little bit lighter this quarter. And just wanted to make sure I understood everything going on, OUS and some of the Japan comments and what's going on in Japan. So all the growth rates we talked about were underlying constant currency growth rates. Okay, that's fair.
What's going on in Japan.
So all the growth rates, we've talked about where underlying constant currency growth rate.
Okay. That's fair and then my last question was on.
2024, and then you're not going to talk a lot about 2024, but curious if you think you can still hold share stable with new competition coming in or if you think it's fair to assume you know something less than the market growth rates in 2024.
Yeah. It's Scott you know, let's hold off on that question about chair in the environment, new product introductions in all kinds of stuff. There's a lot that we expect to happen in 'twenty 'twenty four and we'll look forward to getting into all of those details and forecast when we get together at our Investor Conference in December.
Alright, great. Thanks, a lot.
Our next question comes from Joanne Wuensch with Citibank. Please state your question.
Good afternoon, and thank you for taking the question.
I know you don't want to talk about.
Scott Ullem: And then my last question was on 2024. I think you're not going to talk a lot about 2024, but curious if you think you can still in a whole chair stable with new competition coming in or if you think it's fair to assume something less than the market growth rates in 2024.
But last year, you did a great job.
The impact of FX on grass.
Martin and it sounds like you are going to happen.
And next year.
Is that a level.
Or how to think about gross margin next year.
Scott Ullem: Yeah, it's it's got you know, let's hold off on that question about chair and the environment, new product introductions and all kind of stuff. There's a lot that we expect to happen in 2024. And we'll look forward to getting into all of those details and forecasts when we get together at our investor conference in December. Very great. Thanks a lot.
I hate to do this to you Joanne, but again, we're going to have to hold off until we get to December really all we can say right. Now is that we think we're going to see some pressure on the top line reported sales dollars.
On impact our underlying growth rates and the reported sales dollars headwind is going to flow right down to earnings per share now again, that's not current foreign exchange rates. So when we get to December and we lay out our full year guidance for 'twenty 'twenty four and we'll go through all the lines of the P&L and take you through all the details but at this point, we really can't tell you more.
Joanne Wuensch: Our next question comes from Joanne Wensh with city bank. Please get your question. Good afternoon, and thank you for taking the question to them. I know you don't want to talk about 2024, but last year, you did a great job of telling us understand the impact of effects on growth margins. And it sounds like you're going to have a bad headwind next year. You said a level set up for how to think about growth margins next year.
Okay. My follow up question, which is completely unrelated.
Another quarter of double digit surgical valve revenue and I'm curious, what's helping to drive that and how much of it is maybe an upcharge from brasilia versus underlying demand. Thank you.
Scott Ullem: I hate to do this to you, Joanne, but again, we're going to have to hold off until we get to December. Really all we can say right now is that we think we're going to see some pressure on the top line reported sales dollars on impact our underlying growth rates and the reported sales dollars headwind is going to flow right down to earnings per share. Now, again, that's not current foreign exchange rates.
Yeah, So let me start here.
So 11 11 person. Obviously you know we are very pleased you know I don't know if you remember that few years ago you know.
Nobody here, believing celgene and we believe in surgical because we have been a pioneer here, we have been a great deal of a two well and you know all innovation is paying off you know what we see in <unk> in Q3 again.
Scott Ullem: When we get to December and we lay out our full year guidance for 2024, and we'll go through all the lines of the PNL and take you through all the detail, but at this point, we really can't tell you more.
In 2020 free we see a balanced combination between adoption of a recently a platform premium pricing and the fleet a paucity of on growth. So altogether, but it is very balanced between paucity on growth in our premium technology.
Bernard Zovighian: Okay, my final question, which is completely unrelated, is you didn't have another quarter of double digit surgical valve revenue, and I'm curious what's helping to drive that and how much of it is maybe an upcharge from Missilia versus underlying demand. Thank you. Yes, so let me start here, you know, so 11, you know, 11% obviously, you know, we are very pleased. You know, I don't know if you remember, but few years ago, you know, nobody you believe in surgical and we believe in surgical because we have been a pioneer here.
Yeah I'll just add it's you know we will try to bring this to life a little bit at the Investor Conference is I almost feel like when we have a good surgical quarter that you guys get mad at us because it comes at the expense of Caviar and I'll tell you is the guy that runs both those business units that gets really frustrating after a while.
The new GM is really mad about it so.
Bernard Zovighian: We have been a great innovator, and you know, our innovation is paying off, you know, what we see, you know, in Q3 again, like in 2023, we see a balanced combination between adoption of a resilient platform, premium pricing, and also the procedural growth. So all together, but it is very balanced between procedural growth and our premium technology.
But where you have to understand is our surgical business isn't 100% aortic stenosis, our surgical business treats aortic, we treat mitral and even in the Arctic space. We don't just treat aortic stenosis, we treat aortic regurgitation, we have products that connect where we're treating aortic aneurysm disease, we have repair products replacement product. So there's just a lot more that goes in.
That business that aortic stenosis, so thinking that's a zero sum game between the two businesses just isn't isn't it the right way to think about it.
Larry Wood: Yeah, I'll just add it, you know, we'll try to bring this to life a little bit at the investor conference, is I almost feel like when we have a good surgical quarter that you guys get mad at us because, you know, you think it comes at the expense of Tavor, and I'll tell you, the guy that runs both those business units, that gets really frustrating after a while, and my new GM is really mad about it, so, but what you have to understand is our surgical business isn't 100% aortic stenosis. Our surgical business treats aortic, we treat my treatment control, and even in the aortic space, we don't just treat aortic stenosis, we treat aortic regurgitation, you know, we have products that connect, where we're treating aortic aneurysm disease, you know, we have repair products, replacement products, so there's just a lot more that goes into that business than a aortic stenosis, so, thinking that the zero sum game between the two businesses just isn't the right way to think about it.
Thank you. Our next question comes from Matt Mexico with Barclays. Please state your question.
Hey, thanks, Thanks for taking the question so.
One if I could.
On the times, Scott Bernard you're able to offer some color as to what.
The different types of centers in the U S. Performing you mentioned staffing stable any color as to which it large small or a <unk>.
Matthew Miksic: Thank you.
<unk> centers, where were additive to growth and what ways and then I have one follow up.
Yeah, maybe you know I'm going to ask Larry to comment on that.
Yeah, well you know we.
We look at this every quarter and I will just tell you just even internally amongst us we we started to see the growth rates by segment and then we sort of.
Matthew Miksic: Our next question comes from Matt Mixick with Barclays, please sit your question. Hey, thanks. Thanks for taking the question, so one, if I could on sometimes Scott and Bernard, you're able to offer some color as to what, you know, how the different types of centers in the US that's been performing, you mentioned staff and stable. Any color as to, you know, which are large, small or, you know, side centers where we're additive to growth in what ways and then I would follow.
Makeup the reasons for why we think there are different a little bit I will tell you. During COVID-19, we saw trends that said when COVID-19 spike people tend to stay a little bit closer to home. We saw maybe some of our smaller vendors grow more.
And larger centers would grow less than that as Covid Wayne, we'd see we'd see larger centers kind of returned to higher growth I think this quarter, we probably saw a little bit more growth in the higher and the bigger centers and the smaller centers, but really I think it's getting a little bit negligible over kind of returning to a little bit of sense of normal fee as it relates to growth.
Matthew Miksic: Yeah, maybe you're going to ask Larry to comment on that with. Yeah, we, you know, we, we look at this every quarter and I will just tell you just even internally amongst us, we, we sort of see the growth rates by segment and then we sort of make up the reasons for why we think they're different a little bit. I will tell you during COVID, we saw trends that said when COVID spiked, people tend to stay a little bit closer to home.
Ross Center size.
That's helpful. Thank you for that and then.
And then just.
One follow up on just maybe.
Segment of the market.
We are getting bigger I guess by this point, but looking forward being the only valve on the market with a valve in valve indication.
How big is that now and how important is that we talk a lot of it about.
Matthew Miksic: We thought maybe some of our smaller centers grow more and larger centers would, would grow less and then it's COVID way we'd see, we'd see larger centers kind of return to higher growth. I think this quarter, we probably saw a little bit more growth and the higher in the bigger centers and the smaller centers, but really I think it's getting a little bit negligible or kind of returning to a little bit of sense of normalcy as it relates to growth across center size.
Expanding indications.
Yes.
Symptomatic moderate as patients over the intermediate and long term, but.
This valve in valve become a factor that you can talk more about her or maybe help us understand how that factors into your growth or the general growth in the market at this point.
Yeah, I think it's a good question I think valve in valve isn't isn't a huge part of our of our of our offering right now it's not a big driver for us.
Matthew Miksic: That's helpful. Thank you for that. And then, and then just one follow up on on just maybe a segment of the market that I've got to be getting bigger, I guess by this point, but looking forward, being the only value on the market with a valid valid indication. You know, how big is that now and how important is that, you know, we talk a lot about the expanding indications into, you know, not symptomatic and moderate as patients over the intermediate long term, but the valid valid become a factor that you can talk more about or maybe help us understand how that factors into your growth or the general growth in the market at this point.
We do do Tabbing fab, so tabbing failed Barbara logical surgical valves and you know as tavern came online we saw more and more biological valves usage and younger patients because they knew they would have this type of option down the road. So we think that that's going to be you know as these patients live longer obviously our surgery.
So valves are very durable, but that was the whole basis for in spirit was creating about that would be a great platform for their type of procedure down the road and that's the whole basis for it and we think that will pay dividends later.
Yeah, we just got the low risk approval you know, it's still fairly new for US. It's you know, it's not something that's been around for forever, but the more and more patients that are younger that are getting tighter eventually those patients will come back and need a second procedure and so for us having a cabin tab option just feeds directly into our lifetime management strategy, which is putting in.
Matthew Miksic: Yeah, I think it's a good question. I think valve and valve isn't isn't a huge part of our of our offering right now. It's not a big driver for us. We do do tab and staff, so tab and failed biological surgical valves. And, you know, as taber came online, we saw more and more biological valve usage in younger patients because they knew they would have this taber option down the road. So we think that that's going to be, you know, as these patients live longer, you know, obviously our surgical valves are very durable, but that was a whole basis for in spirit was creating a valve that would be a great platform for their taber procedure down the road.
First valve and ensuring that you have a strategy for that next intervention and that's true whether it's in spirits or is your first out or whether it's the SAPIEN. Three is your first valve we want to make sure we have an option for that patient when they come back and that's what's great about both of our surgical and <unk> platforms is they're both really a great host for that future valve.
And we do think you know as you advance down the road the cabin tab will become a bigger contributor to our growth over time.
Matthew Miksic: And that's the whole basis for it. And we think that we'll pay dividends later as, you know, we just got the lowest approval. You know, it's still fairly new for us. It's, you know, it's not something that's been around forever. But the more and more patients that are younger that are getting taber, eventually those patients will come back and need a second procedure. And, you know, so for us having a tab and tab option, you just feeds directly into our lifetime management strategy, which is putting in a first valve and ensuring that you have a strategy for that next intervention.
Thanks, so much.
Our next question comes from Danielle <unk> with UBS. Please state your question.
Hey, good afternoon, guys. Thanks, so much for taking the question I was just wondering if I could follow up actually on that date at five year data, we saw yesterday and Larry if theres any read that we can make or something that could that.
That we saw in the data that could give us more confidence in the upcoming Ethan kinetic data readout or is that just too difficult to you know to take anything from yesterday and apply it to that trial.
Matthew Miksic: And that's true, whether it's in spirits or your first valve or whether it's a state being through your first valve. We want to make sure we have an option for that patient when they come back. And that's what's great about both of our surgical and taber platforms is they're both really a great host for that future valve. And we do think, you know, as you advance down the road, the tab and tab will become a bigger contributor to our growth over time, on, thanks so much.
Yeah, you know I.
I appreciate everybody's trying to get an early read on an early tavern and I don't think there's I don't think there's anything that's really from this data that I and I haven't even we haven't even broken apart theory camera data. So I don't even know anything about the data set yet to even talk about and even if I did I Couldnt tell you I think the just broadly speaking the.
Matthew Miksic: Our next question comes from Danielle Antalffy with UBS, please fear questions. Hey, good afternoon guys, thanks so much for taking the question. I was just wondering if I could follow up actually on the data, the five-year data we saw yesterday, and Larry, if there's any read that we can make, or something that could, that we saw in the data that could give us more confidence in the upcoming asymptomatic data readout, or is that just too difficult to, you know, to take anything from yesterday and apply it to that trial?
We show excellent durability out at five years with no durability signal whatsoever.
S. B asymptomatic trial is successful, which we obviously hope it is but if that trial is successful. It just takes one more burden away from people, saying do I want to treat people earlier in the disease state and I think the more durability data we can put on the board will help make that better.
Wildly successful when we do get the indication that that'll be one better that's removed. So I think the long term data continuing to build on the durability and safety and long term results of the platform just continue to be important and it's going to be important long term for the progress trial, if you're going to treat people with moderate disease down. The road you need to make sure you had a durable platform and that it.
Matthew Miksic: Yeah, you know, I appreciate everybody's trying to get an early read on, on early TAVR, and I don't think there's, I don't think there's anything that's really, from this data that I, and I haven't even, you know, I don't even know anything about the data set yet to even talk about, and even if I did, I couldn't tell you. I think the, just broadly speaking, the fact that we show excellent durability out at five years with no durability signal whatsoever, F, F, the asymptomatic trial is successful, which, you know, we obviously hope it is, but FAS trial successful, it just takes one more burden away from people saying, do I want to treat people earlier in the disease state?
Has options down the road for these patients so I think it all as complementary but I don't think anything about this trial informs the early time results.
Okay got it and then just a quick question on you know.
Bernard you mentioned, there's still a lot of these patients untreated out there I mean as far as Edwards progress on getting those patients off the couch into their physician's office diagnosed and referred for caviar I mean, where are we in that process. You know you guys spent a lot of time at the analyst day last December I imagine, we'll get an update too.
Matthew Miksic: And I think the more durability data we can put on the board will help make that, you know, if that trial is successful, and we do get the indication that that will be one better that's removed. So I think the long-term data continuing to build on the durability and safety and long-term results with a platform just continue to be important, and it's going to be important long-term for the progress trial. You know, if you're going to treat people with moderate disease down the road, you need to make sure you have a durable platform, and then it has options, you know, down the road for these patients. So I think it all is complimentary, but I don't think anything about this trial informs the early-tabber results. Okay, got it.
But in December.
Here, but just curious what you can say about are you seeing any real traction in some of the <unk>.
Direct to consumer campaign things like that thanks, so much.
Thanks for the question Yeah, we see with this.
This initiative is super important to us we have the right platform, we have a right science. So how can we get you to more patients and we have done in the last I want to see yields maybe you get a three to four years you know a lot of initiatives a lot of pilots we learned a lot. This year, we scale some of you any.
Matthew Miksic: And then just a quick question on, you know, for an argumentian, there's still a lot of these patients untreated out there. I mean, as far as Edwards progress on getting those patients off the couch into their physician's office diagnosed and referred for cover, I mean, where are we in that process? You know, you guys spent a lot of time at the analyst day last December. I imagine we'll get an update too in December in a few weeks here, but just curious what you can say about, are you seeing any real traction in some of the direct-to-consumer campaigns, things like that?
And so we are going to talk more about it in December that he and his team are going to talk about it but we feel like that.
We have some interesting learning and we believe that we are starting to see some impact also so we feel excited about the potential of that it is why you know we when we see you know we believe are secure even embolic say thing. It is because of this reason. In addition, obviously you know asymptomatic and moderate our indicators.
Matthew Miksic: Thanks so much. Well, you know, thanks for the question. You know, we see this initiative as super important, you know, to us. You know, we have a right platform, we have a right science, so how can we get, you know, more patients? And we have done in the last, I want to see years, you know, maybe, you know, three to four years, you know, a lot of initiative, a lot of pilots.
<unk> will add to all of this but Larry you want to add anything sure.
One thing that I think people are missing a little bit is it's not like we just started doing patient activation stuff you know last year or you know in the last two years I mean, we go all the way back to starting a website with a lot of educational information for patients even things like how to find the <unk> center and questionnaires and patient information kits. So we've been doing a lot of things over there.
Matthew Miksic: We learn a lot. This year, we scale some of the initiatives. And so we are going to talk more about it in December, you know, Larry and his team are going to talk about it. But we feel like, you know, we have some interesting learning, and we believe that, you know, we are starting to see some impact also. So we feel excited about the potential of that. It is why, you know, when we see, you know, we believe the future is even more exciting.
Last several years and I think it was one of the reasons the market has grown and developed the way. It has so I think a lot of our digital and patient activation efforts are paying dividends right now now the deeper you go into the prevalence pool.
Harder it gets and the more activation you have to do so it's sort of it's not.
Matthew Miksic: It is because of its reason. In addition, obviously, you know, asymptomatic and moderate indication will add, you know, to all of this. But Larry, you want to add anything? Sure. You know, I think one thing that I think people are missing a little bit is, it's not like we just started doing patient activation stuff, you know, last year or, you know, in the last two years. I mean, we go all the way back to starting a website with a lot of educational information for patients.
On a light switch, it's a never ending journey that youre going to do to continue to build on the last program with additional programs to try to get people activated and I'll tell you. We have a lot of work streams and we're looking forward to maybe getting into a little bit more detail at the Investor Conference and trying to show you a little bit about.
Matthew Miksic: Even things like how to find a tavern center and, you know, questionnaires and patient information kits. So we've been doing a lot of things over the last several years that I think is one of the reasons the market has grown and developed the way it has. So I think a lot of our digital and patient activation efforts are still our paying dividends right now. Now, the deeper you go into the prevalence pool, the harder it gets and the more activation you have to do.
Other things that we're working on but we have a number of pilots and we have a lot of very mature programs at the same time that we think help us a lot.
Yes.
Thank you and our next question comes from Peter Chickering with Deutsche Bank. Please state your question.
Hey, good afternoon, guys pre scripted tyro market share is stable.
Our competitive accounts with hospitals and doctors that you both safety or Val.
Seeing any market changes and those accounts were resilient competing against FX.
Matthew Miksic: So it's sort of a, you know, it's not a light switch. It's a never-ending journey that you're going to do to continue to build on the last program with additional programs to try to get people activated. And I'll tell you, we have a lot of work streams and we're looking forward to maybe getting in a little bit more detail at the investor conference and trying to show you a little bit about other things that we're working on. But we have a number of pilots and we have a lot of very mature programs at the same time that we think helps us a lot. Thank you.
Yeah.
Yeah, I think market share has been been pretty stable I don't think we've seen big.
Big shifts or big changes.
We're very excited about resilient and I think you know I think it does give people increased confidence and going into younger lower risk patients. So we feel good about that but you know maybe we can try to update that a little bit more at the Investor Conference, but again I think overall I think shares been been generally pretty stable.
Philip Chickering: And our next question comes from Pito Chickering with Deutsche Bank, please sit your question. Hey, I got to do you guys. Prescriptly mention that the Tiver Market Share is stable. You look at it at the head of accounts with hospitals or doctors, they use both safety and core valve. We see any market changes in those accounts where we're really competing against FX. Yeah, I think market shares been been pretty stable. I don't think we've seen big shifts or big changes.
Okay, Great and then a quick follow up however, I think I said that procedure growth is the same as revenue growth, but was there any benefit from positive pricing from brasilia that doesn't help to drive revenue growth above our volume growth. Thanks, so much.
There was a little benefit but it wasn't the big driver of our growth.
Alright, thank you.
Thank you.
And ladies and gentlemen, that's all the time, we have for questions today, I'll hand, the floor back to management for closing remarks.
Philip Chickering: You know, we're we're very excited about resilient. I think, you know, I think it does give people increased confidence in going into younger, lower risk patients. So, you know, we feel good about that. But, you know, maybe we can try to update that a little bit more at the investor conference. But again, you know, I think overall, I think shares been been generally pretty stable.
Thank you. So let me close this meeting by saying I am pleased with our performance in 2020 free beyond the numbers I am excited with the progress we have made reinforcing our leadership position with new clinical evidence and expanding on mitral it.
Scott Ullem: Okay, great. And then it quick follow up. I think it's a bit particular growth of the steam is revenue growth. But was there any benefit from positive pricing from resilient? I thought that would help to drive revenue growth above the following growth. Thanks so much. There was a little benefit that it wasn't the big driver of our growth. Great. Thank you.
If I could speak patient reach with new approved technologies.
A result, we are confident in our long term strategy to add to even more patients around the world. Thanks for your continued interest he did wells the IR team Scott and I welcome any additional question.
Live questions by phone thank you.
Operator: And ladies and gentlemen, that's all the time we have for questions today.
Thank you and with that we conclude today's conference call. All parties may disconnect have a good day.
Bernard Zovighian: I'll hand the floor back to management for closing remarks. Thank you.
Mark Wilterding: So let me close this meeting by saying, I am pleased with our performance in 2023. Beyond the numbers, I am excited with the progress we have made reinforcing our tablet leadership position with new clinical evidence. And, expanding our micro and practice patient reach with new approved technologies. As a result, you know, we are confident in our long term strategy to add even more patients around the world. Thanks for your continued interest in Edwards. The IR team Scott and I welcome any additional questions, any additional questions by phone. Thank you.
Operator: And with that, we conclude today's conference call.
Operator: All parties may disconnect.