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Text: 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 and Filings.
Mike will focus his comments on Q3 performance as well as future catalysts and the outlook for our business, including Q4 full year 2021 guidance.
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 that on the call, 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, Farapulse and Lumenis Surgical, which closed in March, August and September of 2021, respectively, as well as Vertiflex and BTG Interventional Medicines, which closed in May and mid-August of 2019, respectively.
Divestitures include BTG Spec Pharma, which closed on March 1, 2021, and the global embolic microspheres portfolio and intrauterine health franchise, which were divested in August 2019 and second quarter of 2020 respectively.
Guidance excludes the recently announced Devoro Medical and Baylis Medical acquisitions, which are expected to close in Q4 '21 and Q1 '22, respectively.
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.
They 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 expenses.
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.
I'm proud of our global team's execution despite the various challenges presented by the COVID surge in third quarter.
The third quarter was impacted by COVID more than we anticipated as the Delta variant surged globally and some electric procedures were deferred.
While we aren't satisfied with this quarter's sales results, we delivered on our third quarter earnings per share and margin targets.
And we're confident that as global vaccination rates continue to increase and COVID wanes, we are well positioned to achieve our long-term sales goals.
We continue to be excited and confident about the opportunities we laid out at our recent Investor Day, further enabled by our strategy of category leadership, entry into higher adjacent growth markets and tuck-in M&A.
Total company third quarter operational sales grew 10% versus 2020, while organic sales grew 11% versus '20 and 4% versus 2019, just below our guidance of 12% to 14% versus 2020 as Delta impacted procedure volume globally.
Despite the temporary impact of procedure volumes, we saw strength in new product launches, generated robust clinical evidence and executed broadly across the portfolio.
Q3 adjusted earnings per share of $0.41 grew 10.5% versus 2020 and 4% versus 2019, reaching the high end of our third quarter guidance range of $0.39 to $0.41.
Adjusted operating margin at 25.6% continues to improve and was in line with our third quarter expectations.
We continue to be pleased with our cash flow with third quarter free cash flow generation of $360 million and adjusted free cash flow of $525 million.
We're updating our fourth quarter and our full year guidance ranges for both sales and EPS, which assumes some level of impact to procedures from COVID and staffing shortages.
Compared to 2020, we target fourth quarter '21 organic revenue growth of 12% to 16% and full year growth of 18% to 19%.
Compared to 2019, we target fourth quarter '21 organic revenue growth of 4% to 8% and for full year organic revenue growth of 5% to 6% versus 2019.
Our fourth quarter adjusted earnings per share estimate is $0.43 to $0.45, and we're updating full year adjusted earnings per share to a revised range of $1.60 to $1.62.
Dan will provide more details on both sales and earnings per share performance and outlook, including the revenue contribution from our acquisitions this year.
I'll now provide additional highlights in Q3 '21 results along with comments on our fourth quarter and '21 outlook.
Within the regions on an operational basis Q3 2020, the US grew 15%; Europe, Mid-East Africa grew 8%, Asia Pac grew 8% and the emerging market sales grew 18%.
Operationally, despite the impact from Delta, EMEA delivered solid growth in third quarter across the majority of businesses and countries with notable strength in PI, EP and Endo, fueled by new and ongoing product launches like TheraSphere, POLARx and AXIOS.
We [Technical Issues] performance with strong utilization driving double-digit growth versus both '20 and 2019.
Asia Pac was impacted by pandemic-related lockdowns in parts of the region, though growth in China remained very strong.
We're encouraged heading into fourth quarter in 2022 as countries within Asia Pac are reopening as vaccination rates increase and COVID cases decline.
Although Japan was in a state of emergency throughout third quarter, we were able to advance new product launches, achieving Number 1 share position with our Ranger Drug-Coated Balloon as well as launching POLARx in October.
China continues to deliver excellent results and sales grew 14% versus 2020.
We continue to see momentum across the portfolio driven by complex PCI and imaging as well as new product launches like Eluvia and AXIOS.
Digital tools are also playing a role, enabling virtual physician training and allowing us to expand our reach with differentiated products like IVUS.
We continue to expect double-digit full year 2021 growth from China versus both 2020 and 2019.
I'll now provide some additional commentary on the business units.
Urology and Pelvic Health sales grew 7% organically versus 2020.
And the Lumenis acquisition closed in September, which expands the urology portfolio and stone offering to include the MOSES laser, which is complementary to the LithoVue single-use flexible ureteroscope in our broad portfolio of disposables that support kidney stone removal.
The prostate health franchise grew double digits with continued strength in our Rezum and SpaceOAR businesses, and we're excited to initiate two trials in this space within the quarter.
The global SABRE clinical trial, which will examine the effectiveness of SpaceOAR Vue in reducing late toxicity in patients receiving a stereotactic body radiotherapy treatment for prostate cancer; and the VAPEUR trial, which compares Rezum to dual drug therapy for BPH.
Our elective procedures within the pelvic health portfolio were impacted by the third quarter surge in Delta but historical growth trends have shown a quicker recovery as COVID surges wane.
In Endoscopy, sales grew 11% organically versus 2020.
Our market-leading global endoscopy portfolio continues to benefit from differentiated, innovative technology launches, including AXIOS, Resolution Ultra hemostasis clip, and single-use scopes.
During the quarter, EXALT B received FDA clearance and is now available in both US and Europe, with physicians pleased with this image quality and suction capabilities.
We continue to make progress with EXALT-D and are launching the 1.5 enhanced EXALT-D design, which features improved physician ergonomics.
Additionally, we're pleased to now have approximately 40% of ERCP procedures qualify for additional reimbursement with NTAP approval as of October 1.
In Cardiac Rhythm Management, organic sales were flat versus 2020.
S-ICD sales grew mid-single digits versus Q3 '19, supported by the launch of the enhanced electrode.
While core CRM third quarter trends improved over first half '21 across both defib and pacer, we believe that growth likely lagged the market.
Looking ahead, we anticipate stabilization in our core CRM growth exiting 2021 and to early 2022, supported by S-ICD and our differentiated HeartLogic offering.
Within our Diagnostics franchise, our LUX-Dx implantable cardiac monitor continues to gain share as physicians are pleased with the implant experience, technology and remote programming capability.
Our Preventice business remains on track to deliver plus 20% growth for the full year versus 2020 on a pro forma basis, fueled by the broad and differentiated ambulatory ECG portfolio.
Electrophysiology organic sales were up 10% versus 2020, driven by strong international sales in both Europe and Japan.
International growth is well above market, driven by the innovative portfolio, including POLARx and STABLEPOINT.
POLARx was recently approved in Japan with the first cases occurring in October.
In addition, the FROZEN-AF trial completed enrollment, which represents an important step in bringing POLARx to the US with an expected launch in 2023.
We also closed our Farapulse acquisition in third quarter, which is the only commercially available PFA technology, and we are seeing strong early usage in a limited number of launched accounts in Europe.
Finally, we announced our acquisition of Baylis Medical, further enabling our strategy of category leadership with a novel approach to left heart access.
Within the US, the Baylis platform is used in close to 40% of EP ablation procedures on the left side of the heart.
Furthermore, it is used in left atrial appendage closure and mitral valve intervention.
We expect to close this acquisition in first quarter 2022.
In neuromodulation, organic revenue grew 2% versus 2020 as underlying procedure volumes was impacted by the Delta surge throughout much of the quarter.
Within our pain management franchise, we continue to see excitement for our WaveWriter Alpha SCS system and differentiated FAST algorithm as well as our Cognita digital solution.
Within deep brain stimulation, the majority of our accounts have transitioned to Vercise Genus, and we continue to drive new account openings as physicians are pleased with the integrated platform and personalized therapy.
And last week, we received approval for our Essential Tremor indication and are excited to begin our limited launch in fourth quarter 2021, which expand our addressable market by $2 billion.
In Interventional Cardiology, organic sales grew 26% versus 2020, which includes a 1,200 basis point tailwind related to the WATCHMAN consignment sales return reserve taken in third quarter '20.
Our WATCHMAN franchise had another strong quarter of double-digit growth as physicians continue to be pleased with the next-generation of FLX performance and differentiated clinical data.
This positive sentiment has been further supported by ongoing real-world clinical evidence presented at HRS demonstrating the high rates of effective LAA closure and low rates of complications post procedure.
We continue to innovate and are launching our Fixed Curve Sheath, offering greater deployment control and ability to reach an expanded range of anatomies.
We also anticipate enabling our US label to include DAPT to support physician and patient choice in patient implant care by year-end.
In TAVR, ACURATE neo2 continues to do well with physicians pleased with its clinical performance and ease of use, backed by strong real-world clinical data, resulting in approximately 20% market share in open accounts.
Momentum continues with SENTINEL, our cerebral embolic protection device, which is exceeding 20% share in the US, where it's utilized.
Coronary Therapies grew 8% versus 2020 as the China DES tender impact begins to annualize and our portfolio mix shift into higher growth markets continues to strengthen.
We continue to see excellent growth in complex PCI and imaging being driven by ROTAPRO and IVUS.
We also just received FDA clearance for AVVIGO II, our next-generation guidance platform.
Peripheral Interventions consistently delivers with organic sales up 8% versus Q3 2020.
TheraSphere was a standout once again and grew double digits in the quarter with continued momentum for the positive EPOCH trial, a first of its kind where TheraSphere was studied as second-line therapy where the primary endpoint of progression-free survival in patients with mCRC was met.
Additionally, we've begun patient enrollment in the MANDARIN trial, an important first step for bringing HCC treatment to China patients.
In arterial, our drug-eluting portfolio continues to perform well, growing double digits versus 2020 with positive late-breaking clinical data presented at VIVA earlier this month.
Eluvia, our drug-eluting stent exhibited superiority in the EMINENT trial compared to bare metal stents and 2-year data from the RANGER 2 trial demonstrated continued high rates, primary patency and significant reduction in reinterventions with our Ranger DCB.
In venous, we continue to push forward with our first patient enrolled in the HI-PEITHO trial.
We also had late-breaking clinical data from the KNOCKOUT PE registry presented at VIVA confirming the safety and efficacy of EKOS.
Building our strategy of category leadership, we announced our acquisition of Devoro Medical in the WOLF Thrombectomy Platform, which is an innovative technology designed to rapidly capture and extract blood clots in arterial and venous systems while minimizing blood loss.
We look forward to closing this acquisition in fourth quarter '21.
More broadly, we're furthering our commitment to sustainability, and I'm proud to report that Boston Scientific is joining the United Nations Race to Zero campaign.
And since 2017, we've reduced the BSC carbon footprint by 50% and are on track to meet our goal to be carbon neutral in all manufacturing and key distribution sites by 2030.
We're building on this foundation to establish ambitious science-based targets to set us on the path to net zero emissions across our entire value chain.
We are bullish about the future outlook of Boston Scientific.
At our recent Investor Day, we detailed our LRP plans for growth of 6% to 8% growth, operating margin expansion of 50 basis points or more each year and double-digit adjusted earnings per share growth.
And I'll now turn things over to Dan.
Third quarter consolidated revenue of $2.932 billion represents 10.3% reported revenue growth versus the third quarter of 2020 and reflects a $17 million tailwind from foreign exchange.
On an operational basis, revenue growth was 9.7% in the quarter.
Sales from the acquisitions of Preventice, Farapulse and Lumenis contributed 220 basis points more than offset by the divestiture of Specialty Pharmaceuticals, resulting in 10.6% organic revenue growth, slightly below our guidance range of 12% to 14% growth versus 2020.
Compared to the third quarter 2019, organic growth was 4.1%, below our guidance range of 5% to 7%.
This 4.1% growth excludes $35 million in 2019 sales of divested intrauterine health, embolic beads and BTG Specialty Pharmaceuticals businesses as well as $117 million in 2021 sales of acquired businesses, which consists of half a quarter of BTG Interventional Medicines, a full quarter of Preventice and post-close revenue from Farapulse and Lumenis.
Spend controls and a favorable tax rate drove Q3 adjusted earnings per share of $0.41, representing 10.5% growth versus 2020, 4% growth versus 2019 and achieving the high end of our guidance range of $0.39 to $0.41.
Adjusted gross margin for the third quarter was 70.6%, in line with our expectations.
We expect slight sequential improvements to continue in Q4 as some headwinds remain, in particular, the transient cost of running plants with COVID-specific measures, increased freight costs and some price pressures on direct materials and wages.
Third quarter adjusted operating margin was 25.6%, again, in line with our expectations, driven by spend control and lower travel offsetting the revenue headwinds.
We're pleased with our trajectory and continue to target adjusted operating margin to average 26% for the second half of this year.
On a GAAP basis, operating margin was 13.2% and includes a $128 million intangible asset impairment primarily related to VENITI, as we've made the decision to retire the VICI VENOUS STENT venous stent following our voluntary recall earlier this year.
Moving to below the line.
Adjusted interest and other expense totaled $104 million, again, in line with expectations.
Our tax rate for the third quarter was 7.8% on an adjusted basis, favorable to our expectations, driven by the geographic mix of earnings.
We ended Q3 with 1,436 million fully diluted weighted average shares outstanding.
Adjusted free cash flow for the quarter was $525 million, and free cash flow was $359 million with $465 million from operating activities, less $106 million net capital expenditures.
Our goal remains to deliver adjusted free cash flow in line with 2020 approximately $2 billion as we continue to expect increased working capital investments in inventory and accounts receivable during the remainder of 2021.
As of September 30, 2021, we had cash on hand of $1.9 billion.
We continue to expect to close the acquisition of Devoro Medical in Q4 of this year and Baylis Medical Company in Q1 of 2022.
Our top priority for capital remains tuck-in M&A, and we'll continue to assess additional opportunities in conjunction with our financial goals.
I'll now walk through guidance for fourth quarter and full year 2021.
For the full year, we expect 2021 operational revenue growth to be in a range of 18% to 19% versus 2020, which includes an approximate net 30 basis point headwind from the divestiture of our intrauterine health franchise and Specialty Pharmaceuticals, partially offset by the acquisitions of Preventice, Farapulse and Lumenis.
Excluding the impact of closed acquisitions and divestitures, we expect full year organic revenue growth to be in a range of 18% to 19% versus 2020 and 5% to 6% versus 2019.
For the organic comparison to 2019, full year 2019 sales 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 $530 million in sales from recent acquisitions, including [Technical Issues] BTG Interventional Medicines through mid-August, Preventice, Farapulse and Lumenis as well as $13 million of Specialty Pharmaceutical sales prior to divestiture.
For the fourth quarter 2021, we expect operational revenue growth to be in a range of 14% to 18% versus 2020, which includes an approximate net 180 basis point tailwind from the acquisitions of Preventice, Farapulse and Lumenis, partially offset by the divestiture of Specialty Pharmaceutical.
Excluding the impact of acquisitions and divestitures, we expect Q4 organic revenue growth to be in a range of 12% to 16% versus 2020 and 4% to 8% growth versus 2019.
For the Q4 organic comparison to 2019, 2019 sales exclude $67 million in sales of our divested intrauterine health and Specialty Pharmaceuticals businesses.
And at the midpoint of guidance, 2021 sales exclude $90 million -- approximately $90 million in sales from the acquisition of Preventice, Farapulse and Lumenis.
We continue to expect adjusted below-the-line expenses, which include interest payments, dilution from our VC portfolio and costs associated with our hedging program to be approximately $400 million to $425 million for the year.
Based on year-to-date favorability, we now forecast our full year 2021 operational tax rate to be approximately 10% and our adjusted tax rate to be approximately 9%.
We expect fully diluted weighted average share count of approximately 1,439 million shares for Q4 2021 and 1,434 million shares for the full year 2021.
We are narrowing the range for full year 2021 adjusted earnings per share guidance to $1.60 to $1.62, which includes our update to sales guidance and considers Q3 performing at the high end of our guidance range.
For the fourth quarter, adjusted earnings per share is expected to be in a range of $0.43 to $0.45.
Please check our Investor Relations website for Q3 2021 financial and operational highlights, which outlines more detailed Q3 results.
Andrew, let's open it up to questions for the next 35 minutes or so.
In order to enable us to take as many questions as possible, please limit yourself to one question and one related follow-up.

user
q3 sales rose 10.3 percent to $2.932 billion.
q3 adjusted earnings per share $0.41.
saw some softness this quarter.
estimates net sales growth for q4, versus prior year period, to be in a range of about 13 to 17 percent on a reported basis.
sees net sales growth for q4 of 2021, versus prior year period, to be in a range of about 13% to 17% on reported basis.
sees q4 adjusted eps, excluding certain charges (credits), in range of $0.43 to $0.45.

assistant