Boston Scientific Corp (BSX) 2021 Q2 法說會逐字稿

Good morning, and welcome to the Boston Scientific Second Quarter 2021 Earnings Call. (Operator Instructions) Please note this event is being recorded.

I would now like to turn the conference over to Lauren Tengler, Vice President, Investor Relations. Please go ahead.

Thank you, Andrew. Good morning, everyone, and thanks for joining us. With me on today's call are Mike Mahoney, Chairman and Chief Executive Officer; Dan Brennan, Executive Vice President and Chief Financial Officer.

We issued a press release earlier this morning announcing our Q2 2021 results, which included reconciliations of non-GAAP measures used in the release. We have posted a copy of that release as well as reconciliations of the non-GAAP measures used in today's call to the Investor Relations section of our website under the heading Financials & Filings. The duration of this call will be approximately 1 hour.

Mike will focus his comments on Q2 performance largely compared to 2019 and Q2 '20, including [key] procedural impact from COVID as well as future catalysts and outlook for our business, including Q3 and full year '21 guidance. Dan will review the financials for the quarter, provide more details regarding our Q3 and full year '21 guidance, and then we'll take your questions. During today's Q&A session, Mike and Dan will be joined by our Chief Medical Officers, Dr. Ian Meredith and Dr. Ken Stein.

Before we begin, I'd like to remind everyone on the call that operational revenue growth excludes the impact of foreign currency fluctuation and organic revenue growth further excludes acquisitions and divestitures for which there are less than a full period of comparable net sales. Relevant acquisitions for organic growth versus 2020 and 2019 include Preventice, which closed March 1, 2021; and Vertiflex and BTG Interventional Medicines, which closed in May and mid-August of 2019, respectively. Divestitures include BTG Specialty Pharma due to close -- which closed on March 1, 2021; and the global embolic microspheres portfolio and intrauterine [health] franchise, which were divested in mid-August 2019 and second quarter 2020, respectively.

Guidance excludes the recently announced Lumenis Surgical acquisition, which is expected to close in the second half of 2021; and Farapulse acquisition, which is expected to close in Q3 2021, which are subject to customary closing conditions, including antitrust clearance. For more information, please refer to Slide 9 of our financial operating highlights deck, which may be found on our Investor Relations [website].

On this call, all references to sales and revenue unless otherwise specified are organic. Finally, growth goals of 6% to 8% ex COVID represent comparisons between time periods in which results are not materially impacted by the COVID-19 pandemic.

Of note, this call contains forward-looking statements within the meaning of federal securities laws, which may be identified by words like anticipate, expect, may, believe, estimate and other similar words and include, among other things, the impact of COVID-19 pandemic on the company's operations and financial [results]; statements about our growth and market share; new product approvals and launches; acquisitions; clinical trials; cost savings and growth opportunities; our cash flow and expected use; our financial performance, including sales, margins and earnings; as well as our tax rates, R&D spend and other factors. Factors that may cause such differences include those described in the Risk Factors section of our most recent 10-K and subsequent 10-Qs filed with the SEC. These statements speak only as of today's date, and we disclaim any intention or obligation to update them.

At this point, I'll turn it over to Mike for his comments. Mike?

Thanks, Lauren. Thank you to everyone for joining us today. I'm pleased to report very strong Q2 financial results as the resumption of elective procedures strengthened in the U.S. and improved in many but not all of our regions across the globe. We're well positioned for the second half of '21 and beyond as we continue to execute our category leadership strategy driven by our innovative pipeline, expansion into faster-growth markets, globalization efforts and enhanced digital capabilities.

Total company second quarter operational sales grew 50% versus 2020. Organic sales grew 52% versus 2020 and 9% versus '19, exceeding our expectations as recovery from the pandemic occurred more quickly than expected, particularly in the U.S. Importantly, 6 of the 7 business units grew double digits organically versus 2019. We estimate that 5 of our business units grew faster than their respective markets. We're pleased with our ongoing and new product launches, and we're now enrolling our clinical trials at pre-COVID run rates.

Q2 adjusted EPS of $0.40 grew 378% versus 2020, 3% versus '19, exceeding the high end of the guidance by $0.02 primarily due to sales outperformance and lower spend. Adjusted operating margin of 25.1% was slightly ahead of our expectations as we continue to balance investment with sales recovery. We continue to be pleased with our free cash flow, with second quarter free cash flow generation of $541 million and adjusted free cash flow of [$838 million].

Given the second quarter outperformance, we are increasing and narrowing our guidance ranges for both sales and EPS, which assumes a manageable level of COVID impact in the second half of the year. Compared to 2020, we're targeting in the third quarter of '21 organic revenue growth of 12% to 14%; and full year, 19% to 20%. And compared to '19, we're targeting a third quarter '21 organic revenue growth of 5% to 7%; and for the full year, growth of 6% to 7%.

Our third quarter '21 adjusted EPS estimate is $0.39 to $0.41, and we are updating our full year adjusted EPS to a revised range of $1.58 to $1.62. Dan will provide more details on both sales and EPS performance, including the revenue contribution from Preventice. We continue to expect a third quarter close for Farapulse and a second half '21 close for Lumenis Surgical.

I'll now provide additional highlights for the second quarter '21 results, along with comments on third quarter and '21 outlook. Within the regions, on an operational basis versus second quarter '19, the U.S. grew 22%; Europe, Middle East and Africa grew 9%; Asia Pac grew 4%; and Emerging Markets sales grew 11%.

Organically, in the U.S. -- the U.S. grew 12% versus 2019. The strength was supported by faster-than-anticipated recovery of procedure volume levels, along with ongoing new [product] launches.

Operationally, EMEA delivered an excellent second quarter with broad-based growth across nearly all major markets and franchises, even as some countries experienced COVID-related lockdowns and procedural delays. The EMEA region also had double-digit growth in PI, IP -- sorry, PI, EP, endo and neuromod [driven] by products such as ACURATE neo2, TheraSphere, POLARx, AXIOS and WaveWriter Alpha, with notable strength in Middle East and Africa.

In Asia Pac, although second quarter results included approximately 600 basis points of negative impact from the China tender pricing versus 2019, 5 of our businesses grew double digits with strong growth in China, Australia and Korea. While Japan's second quarter results were impacted by COVID, we've seen success with ongoing and new product launches such as Ranger DCB, StablePoint and WATCHMAN FLX.

China sales grew 16% versus 2019. We saw double-digit growth within all business units with the exception of Interventional Cardiology, which did include the negative impact of the tender pricing. We continue to be pleased with our strong growth in Complex PCI and imaging, enabled by our both innovative portfolio and by the tender win. We continue to expect full year 2021 double-digit growth in China versus both '19 and '20.

Now I'll provide some comments on the business units. Starting with Uro and Pelvic Health. Sales were very strong, growing organically 16% versus '19 with balanced growth across the stone, prostate health and pelvic health franchises. Stone, which is the largest franchise, grew double digits as enthusiasm continues ahead of the Lumenis acquisition, which will expand our category-leading portfolio with its differentiated laser technology.

The prostate health franchise grew strong double digits with continued growth in Rezum and SpaceOAR businesses. Rezum [growth] was driven by further traction of its direct-to-patient efforts in the U.S., global expansion and [continued] appreciation of the long-term durability and cost benefits of this minimally invasive therapy. Within our SpaceOAR business, growth was supported by the ongoing launch of our next-generation SpaceOAR Vue Hydrogel in the U.S. and our recent launch in Europe. SpaceOAR Vue is visible under CT and negates the need for physicians to use MRI. It's an important step to optimize the treatment plan of patients undergoing prostate radiation therapy.

Our Endoscopy team delivered an excellent second quarter with sales growing organically 15% versus 2019. Q2 sales grew double digits across all major franchises with notable strength in biliary, hemostasis and infection prevention, thanks to our [differentiated product] portfolio, including key products such as AXIOS, SpyGlass [DS] and Resolution hemostasis clips. Within the quarter, we completed CE mark for Exalt B, and we're pleased with the early launch feedback highlighting differentiated visualization and suction and remain on track to launch in the U.S. in the second half of this year. We continue to make progress with Exalt-D, with physician peer training program launched in the second quarter as well as the resumption of more normal market development activities as access to hospitals improves.

In Cardiac Rhythm Management, sales were down 6% organically versus '19. We believe that our CRM performance was slightly below the overall market, inclusive of a temporary impact from the recent EMBLEM S-ICD physician advisory. Importantly, we recently began launching our enhanced S-ICD electrode and anticipate improved performance in overall CRM in the second half as we expect S-ICD revenues to rebound.

In our diagnostics franchise, our Lux-Dx implantable cardiac monitor continues to perform very well and gained share in the U.S. We're also pleased with the strong growth and execution of the Preventice team and continue to anticipate full year growth in that business of at least 20% on a pro forma basis versus '20.

Electrophysiology sales were up 10% versus '19. Strong international sales growth of 29% were driven by the ongoing success of POLARx in Europe and StablePoint Force Sensing catheter in Europe and Japan. U.S. EP sales will likely lag market growth until we receive approval for these therapies, which are currently enrolling in their respective U.S. IDE trials.

We also exercised our option to acquire Farapulse, which is a leader in [pulsed field] ablation, which is an emerging field that has the potential to improve safety, efficacy and ease of use for cardiac ablation procedures. Farapulse is the only company with a commercially approved [pulse ablation] product in Europe. It's actively enrolling in its U.S. IDE ADVENT trial. We're excited to bring this differentiated therapy into our EP portfolio in [quarter 3] '21.

In Neuromodulation, organic revenue grew 14% versus '19. Our pain management franchise accelerated growth in the second quarter, supported by an ongoing launch of our next-gen WaveWriter Alpha SCS system, Cognita digital solutions and continued clinical evidence generation. At the NANS midyear meeting, we released 1 year follow-up data for the COMBO study, demonstrating a sustained high level of clinical and functional success at 84% responder rate. We also started reporting on the real-world results of the FAST therapy, which is designed to improve -- provide profound and immediate pain relief.

Beyond advancing outcomes for existing indications, we're pleased with the progress of our SOLIS study, which is focused on a nonsurgical back population, which started in the first quarter of this year, and [look forward] to beginning our diabetic and peripheral neuropathy [clinical] study by the end of the year. In deep brain stimulation, the business continues to gain share globally and deliver strong double-digit growth, driven by the launch of the Vercise Genus platform, expansion of our commercial infrastructure and partnership with [Brainlab].

In Interventional Cardiology, organic sales grew 10% versus 2019, double-digit growth in Structural Heart Valves, WATCHMAN and Complex PCI and [imaging franchises]. The growth of the WATCHMAN franchise accelerated sequentially. The impressive growth was driven primarily by increasing hospital and physician utilization rates in the U.S. and some share gains in Europe. [Importantly], nearly all U.S. accounts have transitioned from WATCHMAN 2.5 and are now using the FLX exclusively.

Additionally, we're pleased with the 2-year results of PINNACLE FLX, which was featured as a late breaker at TVT, which reinforced our positive 1-year primary outcomes and met its secondary effectiveness endpoint. We remain excited about the outlook for the WATCHMAN franchise with our next-generation FLX device, global expansion and continued work toward indication expansion through ongoing clinical trials. Notably, the OPTION trial comparing WATCHMAN FLX to first-line oral anti-coagulants for patients with non-valvular AFib who also undergo cardiac ablation procedure recently completed enrollment ahead of schedule, in spite of challenges presented by the pandemic.

In TAVR, our ACURATE neo2 launch continues to do well in Europe, supported [in part] by real-world data presented at EuroPCR, which demonstrate that the low ACURATE neo2 PVL rate is comparable to contemporary TAVI devices, with continued low permanent pacemaker [implantation rates]. These outcomes were reiterated in the Early neo2 Registry, also presented last week at TVT as a late-breaker. Sentinel, our cerebral embolic protection device, achieved its highest quarterly sales to date with strong new account openings globally. We continue to enroll in the Protected TAVR randomized clinical trial.

Coronary therapies declined mid-single digits versus '19, attributable to drug-eluting stents, which included the impact of the China tenders and global price pressure. We continue to see strong growth in Complex PCI and [imaging, with particular] strength in ROTAPRO and IVUS. Importantly , our global Complex PCI and imaging business is now [about] 50% larger than our DES business. We're advancing opportunities for future growth drivers and within the quarter began enrollment in our AGENT DCB trial, which is a first in the U.S. study of coronary in-stent restenosis.

Peripheral Interventions delivered organic sales up 10% versus second quarter '19. Within interventional oncology, TheraSphere grew by 30% versus 2019 on a pro forma basis in its first full quarter post PMA approval. In venous, Varithena continues to grow double digits and gain share in the varicose vein market. Within arterial, our drug-eluting portfolio achieved record sales in the second quarter, supported by global expansion along with the sector's continuing [recovery]. We're pleased to have started enrollment on the Elegance registry, a study that will gather clinical evidence on the risk of PAD in [previously] underrepresented patient populations. The study will also look at long-term outcomes of patients being treated with Eluvia DES or Ranger DCB.

I'd also like to highlight Boston Scientific's recent inclusion on the JUST Capital Top 100 list of companies which supports healthy families and communities, along with our recognition as a Best Place to Work for Disability Inclusion. We're proud to be recognized for providing our employees an inclusive and supportive environment and remain committed to global sustainable practices.

Overall, we're pleased with our performance through the first half of the year, and we remain bullish on the long-range outlook for Boston Scientific. We look forward to sharing our strategic plan objectives at our hybrid Investor Day event on September 22. I'd like to extend a big thank you to our employees for their contributions and winning spirit.

I'll turn the call over to Dan.

Thanks, Mike. Second quarter consolidated revenue of $3.077 billion represents 53.6% reported revenue growth versus the second quarter of 2020 [and reflects] an $81 million tailwind from foreign exchange. On an operational basis, revenue growth was 49.6% in the quarter. Sales from the Preventice acquisition [contributed] 240 basis points, more than offset by the divestiture of Specialty Pharmaceuticals, resulting in 52.4% organic revenue growth, above our guidance range of [44% to 48%] growth versus 2020.

Compared to the second quarter 2019, organic growth was 8.9%, above our guidance range of 3% to 6%. This 8.9% growth excludes $15 million in 2019 sales of the divested [intrauterine] health and embolic beads business as well as $178 million in 2021 sales of acquired businesses, which consists of 2 months of Vertiflex and a full quarter of BTG Interventional Medicine and Preventice. Top line results drove Q2 adjusted earnings per share of $0.40, representing 378% growth versus 2020, 3% growth versus 2019 and exceeding our guidance range of $0.36 to $0.38.

Adjusted gross margin for the second quarter was 70.5%, slightly above our expectations, driven by sales outperformance in higher-margin business. As expected, we have materially worked through the COVID-driven negative manufacturing variances capitalized in our balance sheet in 2020 and as a result, expect slight improvements in second half gross margin compared to the first half, though still not at full year 2019 level as other headwinds remained, in particular the lingering cost of running plants with COVID-specific measures as well as some impact from inflation. Not unique to us, this inflation [includes] items like increased freight costs, selective wage pressure and some price increase on direct materials.

Second quarter adjusted operating margin was 25.1%, slightly above our expectations, driven by sales outperformance and balanced investment and also includes a reserve for legal settlement that we expect will improve access to additional markets for some of our cardiovascular technology. GAAP charges within the quarter additionally included $298 million in litigation-related expenses to account for incremental costs to resolve newly estimable claims as well as known claims and corresponding legal fees within our legal reserve. Materially, all U.S. claims remain settled or at the final stages of settlement.

Our reserves assumptions are based on full global resolution now in 2023 given recent claim activity and expected litigation. Our total legal reserve was $617 million as of June 30, an increase $162 million versus March 31, driven by the mesh reserve increase and cardiovascular settlement, partially offset by payments to close substantially all of the state attorneys general mesh settlement as well as continuing mesh product liability payments.

Moving to below the line. Adjusted interest and other expense totaled $107 million, in line with expectations. Our tax rate for the second quarter was 11.1% on an adjusted basis, also in line with expectations.

Adjusted free cash flow for the quarter was $838 million, and free cash flow was $541 million, with $643 million from operating activities less $102 million of net capital expenditures. Our goal remains to deliver adjusted free cash flow in line with 2020 of approximately $2 billion as we continue to expect increased working capital headwinds in inventory and accounts receivable during the remainder of the year.

As of June 30, 2021, we had cash on hand of $2.7 billion. Our top priority for capital deployment remains tuck-in M&A, We continue to expect to close the acquisition of Lumenis Surgical i the second half of the year and Farapulse in Q3. We have capacity to pursue additional business development opportunities while continuing to remain active with our venture capital [portfolio] and consider opportunistic share repurchases. We ended Q2 with 1,432 billion fully diluted weighted average shares outstanding.

I'll now walk through guidance for Q3 and full year 2020. In the full year, we expect 2021 operational revenue growth to be in a range of 18.5% to 19.5% versus 2020, which includes an approximate net 50 basis point headwind from divestiture of our intrauterine health franchise and Specialty Pharmaceuticals, partially offset by the acquisition of [Preventice]. Excluding the impact of acquisitions and divestitures, we expect to organic revenue growth to be in the range of 19% to 20% versus 2020 and versus 6% to 7% versus 2019.

For organic comparison to 2019, full year 2019 sales million exclude [$50 million] in sales of our embolic beads portfolio and intrauterine health franchise as well as $81 million in Specialty Pharmaceutical sales. And at the midpoint of guidance, 2021 sales exclude approximately $490 million in sales from recent acquisitions, including Vertiflex through May, BTG Interventional Medicines through mid-August and Preventice as of March as well as $13 million of Specialty Pharmaceutical sales prior to divestiture.

For Q3 2021, we expect operational revenue growth to be in a range 11% to 13% versus 2020, which includes an approximately net 100 basis point headwind from Specialty Pharmaceuticals, partially offset by the acquisition of Preventice. Excluding the impact of acquisitions and divestitures, we expect organic revenue growth to be in a range of 12% to 14% versus 2020 and 5% to 7% growth versus 2019, which includes a 300 basis point sequential comp headwind from Q2 to Q3 2019. Therefore, the midpoint of guidance assumes results in line with Q2 with a continued manageable level of [COVID impact].

For the Q3 organic comparison to 2019, 2019 sales exclude $35 million in sales of our embolic beads portfolio, intrauterine health franchise and Specialty Pharmaceuticals. And at the midpoint of guidance, 2021 sales exclude approximately $110 million in sales from the acquisitions of BTG Interventional Medicines through mid-August and Preventice.

For adjusted operating margin, we continue to target an average of 26% in the back half of 2021 while simultaneously investing to more normalized operating expense level as the first half of 2021 remained below what we would expect for near-term run rate. We continue to forecast our full year 2021 operational tax rate to be approximately 11% and our all-in tax rate to be approximately 10%. We continue to expect adjusted below-the-line expenses, which include interest payments, dilution from our venture capital portfolio and costs associated with our hedging program, to be approximately $400 million to $425 million for the year.

We expect fully diluted weighted average share count of approximately 1, 437 billion shares for Q3 2021 to 1,435 billion shares for the full year 2021. We are raising full year 2021 adjusted EPS guidance to a range of $1.58 to $1.62, which includes our updated sales guidance and considers Q2 results, which remove additional uncertainty from our previously wider range. For the third quarter, adjusted earnings per share is expected to be in a range of $0.39 to $0.41. Please check our Investor Relations website for Q2 '21 financial and operational highlights, which outlines more detailed Q2 results.

With that, I'll turn it back to our newly appointed Vice President of Investor Relations, congratulations, Lauren, very well deserved, to moderate [Q&A].

Thank you, Dan. Andrew, let's open it up for questions for the next 35 minutes or so. (Operator Instructions) Andrew, please go ahead.

(Operator Instructions) The first question comes from Bob Hopkins of Bank of America.

Can you hear me okay?

Yes.

We hear you fine, Bob.

Congrats on the strong quarter, and congrats to Lauren. So first question for Mike and Dan is just wondering if you could talk a little bit more about your back half 2021 assumptions. You mentioned that you assume a manageable level of COVID. I'm wondering if you could help us understand what that means.

Does that mean specifically that you assume things get a little worse from what you're seeing today? Or do you assume things stay about the same?

I think if you look at the numbers, Bob -- and I think a lot of it has to do with the comps, right? If you look at our comps from 2019 quarter by quarter, they're 6%, 6%, 9%, 7%. And so we put up effectively a 9% in Q2 versus a 6% in 2019. If you look at our guidance for Q3, it's 5% to 7%. So just take the midpoint of 6%. That's against the comp of a 6%, which is -- of a 9%, which is 300 basis points harder.

So in theory, the 6% effectively becomes a 9% when you adjust for comps, which is kind of what we did in Q2. And I won't go through the whole process, but the implied Q4 ends up in a similar range. So I think what you're hearing us say is that -- Q2, that the impact of COVID was manageable. You heard Mike's comments that the recovery was very strong, particularly in the U.S. And what our guidance would imply is that for the most part, it continues in the back half. So manageable COVID impact would be a quarter similar to what you saw in Q2.

Okay. So it sounds like you think -- sorry, go ahead, Mike.

No, I just -- does that track and make sense for you?

Yes. It sounds like you're assuming that things will basically stay the same. They don't get worse from what you just said, which...

Correct. That's correct.

Okay. Great. And then just a quick follow-up question is I was wondering if you could talk just a little bit more about WATCHMAN trends in the quarter. It sounds like things went really well, but just curious if you maybe could provide a growth rate over 2019. Just curious for kind of flushing out the experience with WATCHMAN in the quarter a little bit more. And if you can quantify it at all, that would be helpful.

Yes, sure. Yes. We won't be providing a growth rate on '19, but overall, the plans with WATCHMAN FLX have gone exceedingly well. As we mentioned, the U.S. has really been fully converted at this point, which happened ahead of schedule. And we enrolled the OPTION trial ahead of schedule.

But the big benefit we're seeing is with the ease of use and the safety profile of FLX, the utilization of WATCHMAN FLX in the U.S. accounts in particular continues to increase. So we do have some small new incremental account openings. But far and away, the bulk of the growth in the U.S. is being driven by increasing physician utilization and penetration rates. And we recently have some approval in Japan. And so we're starting to get some minor impact from Japan, which will get more so in the second half as well as in 2022.

But it's really being driven by, the utilization rate, the safety profile, physician comfort with the device and training new physicians at existing facilities. So current doctors are doing more WATCHMAN, and new doctors at the same facilities are being trained on WATCHMAN. And the referral base, the physician community is becoming more and more comfortable and aware as are patients with this treatment. So we pegged this growth of this segment to be likely plus 30% growth. And we continue to expect to do well in it, but it's an exciting platform for us.

The next question comes from Robbie Marcus with JPMorgan.

Great. I'll add my congratulations on a really nice quarter. Two for me. First, it looks like you had great growth in the U.S. with 12% organic over 2019. I was wondering. Maybe you could just give us an overview of where you're seeing the recovery.

Are you seeing any lagging trends from Delta variant? And is there any discrepancy in inpatient versus outpatient? You're one of the first to report here with such a global covering and diverse offering. I think it'd be really [instructful] as we think about the rest of the year and the guidance.

Yes. So just broadly, we saw terrific results in the U.S., very strong results in Europe despite the lockdowns in Europe and despite more COVID impact in Europe. That business grew 9% organic. And we had the most significant COVID impacts in Asia, in ASEAN countries and Japan in particular, with Korea, Australia doing well as was China. So we saw more COVID impact broadly in Asia Pac and a strong recovery in the U.S.

And then in terms of the U.S., to your question there, we really -- with the exception of EP, we think every business globally and in the U.S. grew double digit organically versus '19 and likely gained share in their respective markets with the exception of potentially EP and CRM. But EP grew share in international markets.

And in the -- if you break down -- if you look at uro and endo particularly and also PI, where we have a more substantial ASC business and outpatient business, you saw 15% -- 16% growth in uro, 15% in endo and 10% organic in PI with strong growth compares here. So I would say, in the U.S., we saw a nice rebound both in the hospital setting, which I think has been verified by many of the public company hospital chains reporting prior to us, and we saw strong growth in the outpatient/ASC center as well.

Great. And maybe a follow-up for Dan and a suggestion. Dan, I think some of us had a little trouble hearing the nuanced guidance you gave. If you guys want to send out your prepared remarks, I think that'd be really helpful for all the investors.

But maybe just as a quick follow-up, you mentioned higher input costs in COGS, so improving in second half versus first half but maybe not all the way quite up to 2019. How are you thinking about the company's ability to absorb and pass on some of those costs? And do you think that's going to be an issue going into 2022 as we exit the year here? Because you did have great expense control down the P&L, just thinking about the cost component.

Okay. Sure. Thanks, Robbie. Relative to gross margin, so we averaged 69.8% in the first half. And I think we feel comfortable that we'll improve upon that here in the second half of '21.

Specific to what's going on in gross margin, we will have the tailwind of the COVID-related variances that we put on the balance sheet during 2020. Those are amortized over your inventory turns. And so effectively, as of 6/30 this year, the end of Q2, those are gone. So that's good news.

We do still have some COVID-specific lingering costs of running plants in a COVID environment. So COVID is not completely done, obviously, as you know. And so we do have those, and those are adding costs. And then as I mentioned in the prepared remarks, not unique to us, we do have some pockets of inflation, and -- particularly with freight, where we just need more commercial airliners to be flying than are flying today. We have wage pressure in certain locations. And then direct materials, particularly precious metals and things like that, we're seeing inflation there.

So we do have some headwinds. But overall, as we look at the back half of '21, we would assume we would improve versus that 69.8% average in the first half. And then as it relates to '22 and beyond, I would envision we'll give you a more detailed review of that in Investor Day on the 22nd of September.

Our next question comes from Larry Biegelsen with Wells Fargo.

Congrats on the quarter, and congrats to Lauren. Just one follow-up on the investor meeting in September. Maybe Dan or Mike, just level set us kind of what we should expect. Will you provide an update to your financial goals and pipeline? And any reason to think the algorithm of 6% to 8% sales and 50 to 100 basis points margin improvement with double-digit EPS growth has changed? And I have one follow-up.

Oh my gosh, if we give you all this, you're not going to show up.

We'll be there, Mike.

No. We expect to, as we've done in previous years, provide an update on our portfolio across the company, give some visibility to the long-range strategy and financial goals, similar to what we've done historically. So we would look to provide some more updated 3-year sales guidance, what we think margin improvement will look like. But more importantly, you'll hear from the business unit presidents on portfolio and innovation across the company.

Got it. And just for my follow-up, Mike. On Lumenis and Farapulse, why was this the right time to acquire both? What's the outlook for Lumenis? Is -- that $200 million you said for sales in 2021, is that net after your distribution agreement?

Yes. I have to verify that number. We'll get the -- I don't know what you've said about the number in the past in terms of the Lumenis net number, so we'll -- let's circle back on that one.

But the timing just strategically, it makes perfect sense. I think that the group is aware of this. We had a distribution agreement with Lumenis in the U.S., distribution agreement with them in China, which was effective, but therefore, we weren't getting the same level of gross margin benefit that we wanted nor could we innovate on the platform and I guess, tie it more comprehensively into our StoneSmart platform.

So by owning it, we obviously improve our gross margins. We can drive a more robust product road map within our StoneSmart ecosystem, and then we can expand our direct coverage in Europe and especially in China, where they have a very big business. So that makes sense.

And what did we say here, Lauren?

We only disclosed the full year gross number of $200 million for 2021. We did not disclose the net, Larry.

Got it. And Farapulse, Mike?

So Farapulse, we expect that to close pretty soon here early in the third quarter. I won't go too far on it. We're really excited about. It's the only approved platform in Europe in the pulsed field ablation field. And they're enrolling ahead of schedule in the U.S. clinical trial.

The physician community -- and Dr. Stein's on the phone. He can comment on it. I don't know, Ken, if you -- Dr. Stein, if you're on the phone, maybe you want to provide a quick update on Farapulse.

Yes. Absolutely, Mike. I think the pulsed field ablation and particularly, the Farapulse approach to pulsed field ablation is the most exciting thing to come along in ablation really since ablation. What Farapulse has demonstrated in a wealth of clinical data to date, over 100 patients in clinical trials that have been reported out publicly, is a very high expectation that this is going to be safer than other thermal approaches to ablation and because of the safety, a much more straightforward procedure for physicians. So quicker procedure for physicians and is, again, likely to be at least as effective and probably more effective than other technologies.

So given that, we're extremely excited and optimistic about their approach. And as Mike said, given that they are the only approved technology in Europe, given that they're executing so well on their clinical trials, by exercising the option now and again, hopefully closing in the near future, we have the opportunity now to help them scale up distribution and production and again, the ability to help them continue to execute their clinical trials and get to U.S. approval in a timely fashion.

The next question comes from Vijay Kumar with Evercore ISI.

Mike, congrats on the quarter here. One on a high level. If I just look at the 2Q performance in the back half implied guide, we did 9% in 2Q versus pre-pandemic 2019. Back half implied is 7% to 9%. I mean we're already running -- if I look at the 2Q to 4Q performance, we're already running well north of 8%. Preventice, Lumenis, once these deals become organic, they should be incremental, plus you have these pipelines. I guess when I look at the LRP of 6% to 8%, shouldn't these results provide a high degree of confidence in upper end of the LRP on the top line going forward?

Yes. I mean, I think we're not going to comment specifically within the range of 6% to 8%. Obviously, we'll, as Mike said, probably tee that up for an Investor Day conversation relative to the portfolio and the overall results. So I don't think it would serve us well to comment relative to the specifics in there. But the strength of the portfolio and the pipeline is what's given us the confidence to put up the numbers that we put up in the past and obviously, looking forward, give us the confidence in the revenue growth trajectory for the future. So -- but specific to where in the range, I don't think I'll go there.

Understood, Dan. Just one on margins maybe. When should gross margins get back to pre-pandemic levels? Or perhaps on operating margins, just given the commentary around freight inflationary pressures, should '22 operating margins be at 2019 levels?

Yes. I mean if you think of the back half of this year, that's what we're calling for, Vijay. So we're calling for an average in the back half of '21 to be at our full year 2019 level, which was, call it, around 26%. So the goal is to do that in the back half of '21 and set us up for '22 and beyond.

Gross margin, as we said, it was 69.8% in the first half. It will be improving on that in the second half. So when does that get back to specific 2019 levels? We'll -- again, we'll give more details at Investor Day. But if you think at the overall operating margin level, the thing that we've proven time and time again over history is that we make the effective trade-offs through the P&L. So if you think back 4, 5, 6 years ago, gross margin was growing very nicely and -- as a percentage of sales, and we were investing in places like the emerging markets and other areas.

So SG&A was sometimes actually increasing as a percentage of sales, but still delivered very solid operating margin progression through that time frame. So it may shift a little bit as we go forward. Maybe gross margin doesn't pay as many of the bill, so to speak. But SG&A, potentially with lower travel spend and other trade-offs that we'll make in addition to more efficient R&D spend, the goal is always to have operating margins increase year-over-year, and I think our track record speaks for itself on that.

The next question comes from Cecilia Furlong with Morgan Stanley.

I wanted to ask about SCS trialing trends and really just what you've seen from a relative recovery versus other more elective procedures in the quarter. And then kind of tying in also just Vertiflex, what type of traction you've seen recently?

Sure. We haven't had all the competitors report in that field, so we're not exactly sure how we grew versus the competitive set. But we had a strong acceleration in 2Q. U.S. -- overall in the quarter. And I think part of it is a combination of the unique portfolio that we have with the new launches, the new FAST algorithms that I detailed in the script that you may have had difficulty hearing so we're going to send it out to people, but a combination of the new FAST algorithms as well as the clinical work that we're doing.

So SCS overall improved versus first quarter. And then it was augmented, as you've mentioned, with Vertiflex's growth in the quarter as well as continued growth in our RF portfolio. The RF portfolio, although a bit smaller, continues to exceed expectations.

And then the other really big growth driver for neuromod in the quarter was our deep brain stimulation business, and it's really impressive what that group has done. They continue to gain market share, really the #1 de novo player in Europe and close to that now in the U.S. And they continue to accelerate market share gains through the innovation of that business. So the DBS probably had the largest snapback of any business in the second quarter with the COVID impact waning in the U.S. But overall, the SCS market and the pain side did quite well as well. But we'll see the other competitors report, but we're impressed with the sequential growth that we saw.

Yes. And happy overall with the 14% growth versus 2019 for all of that neuromod business that Mike just detailed.

Great. And you also called out Rezum in your prepared remarks. Could you just comment a bit more, just what you've seen from recent procedure trends and procedure recovery trajectory coming out of COVID?

Yes. So I think with our Rezum business, we continue to drive increased growth there. The overall uro business had a big bounce back in the quarter, growing 16%. And the big things that we're focused on with Rezum is we're continuing to drive improved reimbursement rates with some of the specific payers, which is helping.

But it's also the long-term durability data, and that's giving physicians more confidence in the product that's driving the growth. And we've also expanded our international footprint with Rezum, particularly in Europe and also some additional DTP, direct-to-patient and direct-to-physician, marketing campaigns to drive more awareness. So it's really a combination of all those things that's improving the growth profile of Rezum.

The next question comes from Pito Chickering with Deutsche Bank.

Congrats on a nice quarter, and also congrats to Lauren. To follow up on Bob's question, I understand the comps versus 2018 (sic) [2019] for 3Q is a challenging 9%. But we also heard from the public hospitals that June is the best month of the quarter and strong June trends continue into July. So just curious, as you look at your third quarter guidance, are you seeing normal 3Q seasonality? Or are you simply assuming that you'll see it at some point during the quarter?

Yes. I appreciate the question. We're just not going to comment kind of intra quarter as we sit here in the third quarter. I think the answer to Bob's question, the short answer is we're expecting the trends that we saw in the second quarter to continue. We're not going to parse it month by month. We're expecting the overall trend of that growth rate to continue comp adjusted in the back half of '21. But specific to the month versus month, we're not going to get into that -- those specifics.

Okay. Fair enough. A quick question on EXALT-D. I understand the markets have been pretty dynamic sort of last year sort of due to COVID. But sort of 2 questions. How many accounts are you selling EXALT-D into at this point? And those accounts, what is the market share reorder rate of those accounts? And as you watch EXALT-D, how much revenue contribution should we assume in the back half of the year?

Yes. We're probably frustrating you. We're not prepared to share that information with you. On EXALT-D, just as you've heard in previous quarterly updates, the team continues to make progress. As COVID impact is improving, although -- hopefully, the Delta variant isn't too much. But as approved in the U.S., we have seen more of an uptick in traction with EXALT-D as physicians are becoming more comfortable with it. The training and the capital placements have gone well, so you're seeing an uptick in EXALT-D usage.

And then in the second half of '21, you'll see an enhancement, a next release -- or next-generation release, if you will, of EXALT-D to further improve the platform. So we expect to see continued momentum with that. The big news for us is the recent approval of EXALT-D in some sites that tried it for the first time in Europe, and we're really bullish on that platform. That's an established market with a few competitors, but we think we have some differentiated capabilities with EXALT-D. And so in the second half of '21 and much more so in '22, you'll see the impact of that platform as well. So it's all going to plan, but we're all -- we're seeing some improved momentum with EXALT-D in the U.S. as COVID is improving.

The next question comes from Joanne Wuensch with Citi.

Can you hear me okay?

We can.

We hear you fine.

Excellent. It looked to us like when we compare the delivery versus consensus, the 2 areas that might be lagging a little bit are EP and CRM. But I also remember that there are a number of key products in those sections. Can you highlight 1 or 2 that might bring you back into sort of the market taker or gain position?

Yes. Well, you nailed it. We think every one of our businesses with the exception -- well, EP grew double digits versus '19, but likely globally, that's below market. In CRM, we think we're a little bit below market. With the exception of those 2, we think every other one grew faster than market.

On EP, I think you'll see a similar trend likely for the next couple of years in that we expect the -- our EP results in the international markets to exceed market growth, which we think they did in the second quarter on the heels of our cryo platform. We're now the only competitor to the established player in cryo, and we're taking share there. And then our StablePoint, which is our Force Sensing catheters approved in Europe. And as previous question, we'll be closing the Farapulse deal in early third quarter, and they're commercial in Europe. So the 3 distinct technologies that are quite differentiated will be our IRE platform with Farapulse upon closure, our cryo and StablePoint in Europe.

And we also expect to see a benefit of cryo in Japan towards the end of '21 and full year '22. So our international business, which is now bigger than our U.S. business in EP, will grow faster than market. And our U.S. business will likely lag market until we get those products approved. And all those products are in clinical trial right now, and thankfully, as COVID has improved, the clinical trial run rates of those platforms have increased significantly over the past 100 days. So that will be the balance in EP: really strong outside the U.S., less so in the U.S. likely for the coming earnings calls.

In CRM, we think our performance in the second half of this year will improve versus what you saw in the second quarter. And the primary reason for that is the S-ICD advisory that we had, which caused sales to lag a bit in the S-ICD segment for us, which is a big segment for us globally. And now we have a new lead that is being implanted now across -- in Europe and the U.S. And we expect our third quarter and fourth quarter S-ICD results to improve quite a bit versus second quarter, which will improve the overall growth rate of our CRM business and likely take us closer to market growth rates for all of CRM.

And my second question also is product related. If I had to say to you what are the 3 products you want us to focus on over the next 6 to 12 months, what would your answer be?

If I only have to pick 3, I think WATCHMAN is number one given the scale of it, the growth profile we see and this enthusiasm. I would say within PI, the BTG acquisition has exceeded expectations and the TheraSphere segment within -- in particular and Varithena are doing extremely well.

And then if you give me a third one, there's lots of different areas to speak to. I think -- yes. I think just overall in the -- I know it's super early, but we're very bullish on the combination of cryo and Farapulse, although not in the U.S. yet. That market is so large and the growth profile of EP is so good that we'll be the only company that will have IRE and cryo and Force Sensing. So all those smaller dollars now but exciting opportunity for us.

The next question comes from Travis Steed with Barclays.

I appreciate some of the longer-term comments you gave on operating margins. Just curious what the base we should be using for that 50% -- or 50 basis points of margin expansion per year, if we should think about that 26% in the back half here. So thinking about The Street, somewhere in 26.5% next year would be a reasonable place to be at this point?

Yes. I wouldn't comment on '22. But for '21, I think the reasonable basis as a starting point would be that 26%. That's what we're kind of resetting to here in the back half. It's where we were in 2019, and it should be a nice jumping-off point for 2022. Yes, I would agree with you there, Travis.

Okay. Great. And then I just wanted to make sure the message was clear on the full year guidance and the guidance raise. So you're going from 2% to 5% for the full year versus 2019 to 6% to 7%. Is that all coming from the Q2 beat and so basically, the back half expectations are staying the same? Or are you actually seeing more confidence here in the back half versus your original expectations?

No, I think if you go back to the original guidance back in February and for the most part, reiterated in April, it was COVID impact in Q1, less COVID impact in Q2 and then a more -- a return to more normalized procedure volumes in Q3 and Q4. I think we got a little bit of that early as our results would point to versus our guidance ranges for Q2. And then if you take what we're saying about the back half, which we say is the same type of COVID impact and pretty much the same type of results in Q3 and Q4 as in Q2, it's a broad-based story of Q2, Q3, Q4. It's not just Q2.

With that, we would like to conclude the call. Since it was difficult to hear some of the prepared remarks, we will be posting the transcripts or prepared remarks to our Investor Relations website. Before you disconnect, Andrew will give you all the pertinent details for the replay.

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