Michael F. Mahoney
Chairman and Chief Executive Officer at Boston Scientific
Thanks, Lauren. Thank you to everyone for joining us today. 2022 represents a return to more durable and consistent procedural growth within the markets we serve, which provided a stronger base for our innovative portfolio. I'm very proud of the resiliency and winning spirit of our global team, delivering on our sales and EPS goals despite the ongoing macroeconomic and supply chain challenges. Importantly, we delivered strong performance across all geographic regions and believe that almost all of our business units gained or maintained market share throughout the year.
In fourth quarter '22, total company operational sales grew 9% and organic sales grew 7% versus fourth quarter '21, which was the low end of our guidance range. However, it's very important to note that these results include an unplanned sales reserve of $60 million, established for an Italian government payback provision, which resulted in a headwind of approximately 200 basis points for the quarter. The underlying fourth quarter performance was strong in both sales, operating margin increases and earnings per share. And without the impact of the Italian sales reserve, we would have achieved the high end of our organic sales guidance range of 7% to 9%.
Full year '22 operational sales grew 11% versus '21, while organic sales grew 9% in line with our guidance of approximately 9%. Fourth quarter adjusted EPS of $0.45 declined minus 2% versus '21, and full year adjusted EPS of $1.71 grew 5% versus '21, both achieved in the low end of the guidance range. Once again, without the impact of the Italian sales reserve, we would achieved the high end of the guidance range for both fourth quarter and full year of $1.71 to $1.74. We generated full year free cash flow of $950 million and adjusted free cash flow of $2.1 billion in line with our expectations.
Now for our outlook for 2023. We are guiding to organic growth of 6% to 8% for both first quarter of '23 and full year of '23, which excludes the acquisition of Apollo Endosurgery and the majority stake investments in M.I.Tech and Acotec, all of which are expected to close in the first half of 2023.
Our first quarter '23 adjusted EPS estimate is $0.42 to $0.44. And we expect our full year adjusted EPS to be $1.86 to $1.93. And despite the ongoing macroeconomic pressures and supply chain headwinds, we remain committed to our goal of plus 50 basis points of operating margin expansion and double-digit adjusted EPS growth in 2023.
Dan will provide more details on our '22 performance, the Italian sales reserve and our '23 outlook.
I'll now provide some additional highlights on '22 results, along with comments on our '23 outlook. Regionally, on an operational basis, the U.S. grew 10% versus fourth quarter '21. Full year '22 grew 11%, inclusive of a 300-basis-point tailwind from acquisitions. With particular strength in our WATCHMAN, Endo and Urology business units. Europe, Middle East and Africa grew 11% on an operational basis versus fourth quarter '21 and 12% on a full year basis. This above-market growth was supported by ongoing investments in emerging markets, new and ongoing product launches across the portfolio, pricing discipline and strong commercial execution. We're excited about the year ahead with ongoing momentum across the region, particularly with our innovative EP portfolio and further opportunity with Baylis and the Access Solutions franchise.
Asia Pacific grew 10% operationally versus fourth quarter '21 and 12% for the full year. On a full year basis, six out of the eight of business units grew double digits supported by ongoing innovation across the region. Full year Japan growth was driven by new products, including POLARx, which has approximately 50% share in open accounts.
We look forward to 2023 with ongoing momentum for both new products and excited about our recent approval and reimbursement received for AGENT DCB, which is a coronary drug-coated balloon for in-stent restenosis in small vessels.
On a full year basis, China grew more than 20%, fueled by 13 [Phonetic] new product launches, ongoing portfolio diversification and the team's resiliency and execution. We continue to expand our presence in the China market with the recently announced acquisition of a majority stake in Acotec. We believe this investment can create strategic value for both companies with opportunities to collaborate in R&D, manufacturing and commercial strategies. We also continue to expect China to be a double-digit grower in '23, despite ongoing VBP pressure and potential impact to procedure volumes in Q1 from COVID.
In Latin America, the momentum continued with operational sales growth of 16% versus fourth quarter of '21 and full year growth of 28% with all business units growing double digits versus '21.
On the business units, starting with Urology. Urology sales grew 12% both operationally and organically versus fourth quarter of '21 and on a full year basis. They grew 15% operationally and 10% organically versus '21. Within the quarter, all franchises grew double digits fueled by new and ongoing product launches and continued global expansion. On a full year basis, global growth was driven by key products such as LithoVue, Rezum and SpaceOAR as well as the acquisition of Lumenis MOSES Laser Technology, further complementing the Urology portfolio.
Endoscopy sales grew 7% organically in the quarter and on a full year basis, grew 8% organically versus '21. In '22, we had global success with innovative products such as AXIOS and Single-Use Imaging both growing over 20% and supporting strong growth across the globe. In fourth quarter, we announced our intent to acquire Apollo Endosurgery, which will add a complementary and innovative endoluminal surgery portfolio. We look forward to closing this acquisition as well as our previously announced majority stake in M.I. Tech, which includes the [Indecipherable] in the first half of '23.
Neuromodulation sales grew 5% organically versus fourth quarter of '21, and on a full year basis grew 3% organically versus '21. Globally, our Spinal Cord Stimulation business grew 4% in fourth quarter with continued physician enthusiasm for WaveWriter Alpha and FAST. We continue to invest in clinical evidence to expand indications and presented three-month data from our non-surgical back study SOLIS at NANS earlier this year. The study comparing SCS to the conventional medical management met its primary endpoints, and we anticipate FDA approval for non-surgical back indication by the end of '23.
Our Brain franchise grew double digits in the quarter and low double digits on a full year basis. This strong performance was aided by continued momentum from new product launches in '22 as well as the recent launch of the Vercise 2-in-1 lead extension.
Peripheral Intervention sales grew 9% organically versus both fourth quarter of '21 and full year of '21. Within Arterial, we are pleased with the performance of our Drug-Eluting portfolio growing strong double digits for the full year and achieving the Number One global position -- I'm sorry, the Number One position within SFA in the U.S.
On a full year basis, our Venous franchise was flat versus prior year with the Varithena, our market-leading varicose vein offering growing over 20% in 2022. Our Interventional Oncology franchise performed well in '22, growing low double digits, led by our portfolio of innovative cancer therapies and suite of embolization tools.
We continue to invest in expanding the potential applications of TheraSphere and enrolled our first patient in our early feasibility study, FRONTIER, evaluating the image of -- the safety of image-guided intra-arterial delivery of TheraSphere GBM in patients with reoccurring glioblastoma.
Cardiology delivered another excellent quarter with operational sales growing 13% and organic sales growing 10% versus fourth quarter of '21. On a full year basis, sales grew up 14% operationally and 10% organically. Our newly aligned Cardiology Group delivered strong growth across its four businesses, as we continue to invest in the higher growth segments and differentiated offerings for our customers that address the areas of greatest cardiac need for patients.
Within Cardiology, Interventional Cardiology Therapy sales grew 5% organically in the fourth quarter and on a full year basis grew 8% organically versus '21. On a full year basis, the Coronary Therapies franchise, which includes both drug-eluting stents and Complex PCI grew 7%, driven by strong performance in our international regions and our Imaging franchise.
Our Structural Heart Valves franchise grew double digits on both fourth quarter and full year basis, outpacing the market in Europe with our ACURATE neo2 Aortic Valve. Ongoing clinical evidences supported growth throughout '22 and in the fourth quarter. Data from the ACURATE neo2 PMCF study was presented as a late breaker at PCR London Valves, demonstrating positive safety and 30-day outcomes with low PVL rates and best-in-class pacemaker implantation rates.
Additionally, we enrolled our first patient in the ACURATE Prime XL Nested Registry, assessing the safety and efficacy of the ACURATE Prime Aortic Valve XL to treat patients with severe aortic restenosis, who need a larger valve size for the TAVR procedure.
WATCHMAN sales grew 22% organically versus fourth quarter '21 and on a full year basis grew 24% organically versus '21. Q4 finished with record sales, strong utilization in the U.S., supported by the DAPT label expansion. Importantly, we completed the enrollment of our CHAMPION-AF trial way ahead of schedule. This head-to-head trial versus novel oral anticoagulation has the potential to more than triple the number of patients indicated for WATCHMAN FLX in 2027 and beyond. We remain excited about this outlook for this business and expect double-digit growth in 2023, fueled by innovation, ongoing clinical evidence and strong commercial execution. CRM sales grew 6%, both operationally and organically versus fourth quarter '21 and on a full year basis grew 8% operationally and 7% organically.
Our Diagnostics franchise had a strong year, growing double digits versus '21. In core CRM, on the full year basis, our high-voltage business grew low single digits, and our low voltage business grew mid-single digits, and we expect that all major markets were in line or slightly above the market.
Electrophysiology sales grew 76% operationally and 25% organically versus fourth quarter '21 and on a full year basis grew 69% operationally and 18% organically versus '21. Importantly, our international EP business continues to outpace the market, growing over 40% organically versus fourth quarter '21.
POLARx continues to perform well in both Europe and Japan [Indecipherable] to treat over 25,000 patients since launch. Momentum in FARAPULSE continues with another strong quarter of growth in Europe. And we continue to invest in clinical evidence and look forward to the readout of the randomized ADVENT U.S. IDE trial in the second half of '23 and are planning to initiate our ADVANTAGE AF trial [Indecipherable] FARAPULSE for patients with persistent Afib imminently.
We've been very pleased with the performance of our Baylis acquisition and the innovative VersaCross platform, which grew 2 times faster than the market in '22. We launched our VersaCross Connect in '22, improving efficiencies in our WATCHMAN procedure.
Earlier this year, we shared our strategy consistent with years past. We continue to position ourselves to win in the markets we play through meaningful innovation by balancing our financial commitments. And in '22, we announced four acquisitions, invested 10% of our sales in internal R&D to fund sustainable growth and advance patient care.
We're extremely excited about the year ahead and remain focused on our people and sustaining a culture that is motivated to drive differentiated performance and achieve our long-term goals, continuing to grow sales faster than markets, continuing to expand operating margins and delivering double-digit adjusted EPS growth and strong adjusted free cash flow generation.
So before I turn it over to Dan, I want to share that with the retirement of Dr. Ian Meredith, Dr. Ken Stein will assume some of the global responsibilities that previously fell under Ian, including total company investor engagement in addition to the CRM, EP and WATCHMAN roles. Please join me in congratulating Ken and thanking Ian for his many contributions.
With that, I'll pass it off to Dan to provide more details on the financials.