Boston Scientific Corp (BSX) 2018 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by. Welcome to the Boston Scientific Fourth Quarter 2018 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Susie Lisa. Please go ahead.

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

We issued a press release earlier this morning announcing our Q4 2018 results, which included reconciliations of the non-GAAP measures used in the release. We've 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.

Duration of this morning's call will be approximately 1 hour. Mike will provide strategic and revenue highlights of Q4 '18. Dan will review the financials for the quarter and then provide Q1 '19 and full year 2019 guidance. 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 that on the call, organic revenue growth is defined as year-over-year growth excluding the impact of foreign currency fluctuations and sales from the acquisitions of NxThera, Claret, Augmenix and Symetis in the relevant periods to which there are no prior period-related net sales. Also note this call contains forward-looking statements within the meaning of federal securities laws, which may be identified by words like anticipate, expect, believe, estimate and other similar words. They include, among other things, statements about our growth and market share; new product approvals and launches; clinical trials; cost savings and growth opportunities; our cash flow and expected use; our financial performance, including sales, margins, earnings and other Q1 and full year 2019 guidance as well as our tax rate, R&D spend and other expenses.

Actual results may differ materially from those discussed in the forward-looking statements. 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.

Thank you, Susie. Good morning, everyone. Boston Scientific finished up an excellent 2018 where we delivered on our financial commitments and significantly strengthened our portfolio and capabilities for the future. In fourth quarter '18, we delivered 8% operational revenue growth; 7% organic; roughly flat adjusted operating margin; and adjusted EPS of $0.39, which includes a $0.01 net tax settlement benefit in the quarter.

Our category leadership strategy continues to deliver strong results. In the fourth quarter, 6 of our 7 businesses grew faster than their underlying markets. These Q4 results echo our performance in '18 overall, and for the full year, 8% operational revenue growth, 7% organic, a 50- basis point improvement of profitability and adjusted EPS of $1.47 or 11% adjusted EPS growth to $1.40 when normalized for the $0.07 tax settlement benefit for the year. We delivered these results while also generating $2 billion of free cash flow.

2018 results also extended our track record of excellent performance over the 5-year 2014 to '18 period, where BSC has grown sales at an average rate of 8% operational and 7% organic, improving adjusted operating margin 530- basis points and leveraged that to drive an average 14% growth in adjusted EPS over the 5-year period. And this excludes the net tax benefit in 2018. We believe these 5-year results provide solid evidence that our strategy of category leadership in key markets and portfolio diversification into higher-growth adjacencies continues to deliver differentiated results. Our goal is to continue to execute against our strategic plan objectives and deliver top-tier sales and EPS growth over the next 5 years. The combination of long-term consistent above-market revenue growth, operating margin expansion, targeted double-digit EPS growth and now coupled with the improved ability to deploy our strong free cash flow is what we believe uniquely positions BSC to continue to drive shareholder value.

We're excited about our plans to build upon our global momentum in '19 and beyond. We're targeting 2019 operational revenue growth of 8% to 9.5%, which includes approximately 110- basis points from acquisitions, resulting in organic revenue growth guidance of 7% to 8.5%. We're guiding to adjusted EPS of $1.53 to $1.58, representing a 9% to 13% earnings growth; and approximately $2.2 billion in adjusted free cash flow.

I'll now provide some highlights on Q4 and '18 results, along with some thoughts on our '19 outlook. Our Q4 -- in Q4, 8% operational and 7% organic revenue growth continue to be broad-based across our businesses and regions, led most notably this quarter by 9% operational growth in Europe, Mid East/Africa as well as 7% operational growth in both the U.S. and Asia Pac. Latin American overall emerging markets had outstanding quarters, growing operational revenue 28% and 27%, respectively.

The MedSurg businesses now are 31% of our revenue mix, and they continue to deliver. MedSurg grew 8.9% operationally and 6.2% organically in Q4. And for the full year, sales were up 9.3% operational and 8.2% organic.

In Endo, we posted 6.6% operational and organic in Q4, and our Hemostasis franchise continues to grow double-digits. And infection prevention and pathology also continued to be very strong. Endo delivered 8.3% operational and organic in '18, and we expect continued strength in our global Endo business in 2019.

Endo has a very rich pipeline, and we're launching 4 new products, including ORCAPOD single-use valves, ORISE Gel for endoluminal surgery and SpyGlass DS II, with a broader portfolio of solutions for pancreatic/biliary procedures. We also remain on schedule for the Q4 launch of our single-use duodenoscope, Exalt-D, which represents this exciting new phase of our strategy in the therapeutic imaging market.

Our uro and pelvic health franchise also continues its excellent performance, growing Q4 12% operationally and 5.6% organic. LithoVue, our single-use digital ureteroscope, helped drive double-digit growth in our core Stone franchise. Full year '18 UroPH organic sales grew 8.1%, with an additional 250- basis points from M&A for operational growth of 10.6%. And importantly, the integration work for our tuck-in acquisitions in NxThera, Augmenix and nVision are all tracking as planned.

The Rezûm system for the minimally invasive treatment for BPH had its CPT code take effect January 1 of this year, and we just recently published very compelling 4-year data on durability of symptom relief, with a very low 4.4% rate of surgical retreatment and no new adverse events noted between years 3 and 4. The October acquisition of Augmenix and SpaceOAR Hydrogel, which is used to diminish the side effect risk from prostate cancer radiation, is off to a strong start and we expanded -- as we continue to expand market presence and awareness.

Turning to global Rhythm and Neuro. Operational and organic sales grew 6.6% in Q4 and 7.6% for the full year. Neuromodulation operational and organic revenue growth grew an impressive 18.9% in Q4 and 22.5% for the year on the continued strength of our portfolio and global commercial execution. We remain very positive on the outlook of the neuromod business in '19 due to the continued strength of the underlying markets and our innovative portfolio.

In Spinal Cord Stimulation, WaveWriter is the only platform approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy, targeting 2 different mechanisms of action at the same time for patients suffering chronic pain. This is translating to excellent real-world results. With 312 patients at the last follow-up, 28% were pain-free, which is a 0 pain score; and 67% had minimal pain scores of 2 or less. We also look forward to WaveWriter randomized clinical trial data from the COMBO study in the second half of '19.

Also, in DBS, we're excited that we recently received key FDA approvals for our Vercise platform in primary cell and Cartesia Directional Leads. And Vercise is now offered in both primary cell and rechargeable systems.

CRM grew both operational and organic sales 1.7% in the quarter and 2.1% for the full year. Q4 growth reflects above-market mid-single-digit growth in defib, offset by high single-digit declines in pacing. Our portfolio in defib continued to drive share gains due to the continued rollout of our RESONATE platform with the HeartLogic heart failure alert, multi-point pacing and best-in-class longevity with EnduraLife Battery Technology. Also, EMBLEM S-ICD also continues to perform very well and grew double-digits globally for the full year. And overall, we see continuous growth -- strength in our defib results in '19, albeit against tougher comps and some improvement in pacing trends.

In EP, we grew sales 8% in the fourth quarter; and for the full year, 10.9% operational and organic on the strength of our RHYTHMIA HDx mapping platform. We continue to enhance our catheter pipeline globally, and importantly, our 2 single-shot platforms, Cryterion and Apama, are on track to launch in Europe by the end of this year as well as begin enrollment in their IDEs for U.S. approval

Our Cardiovascular group in Q4 grew 8.6% operationally and 7.7% organically. For the full year '18, growth was 7.4% on an operational basis and 6% organic.

PI grew 11.2% in the quarter and 9.2% for the full year, operational and organic. The U.S. launch of Eluvia was a driver of the double-digit growth in the quarter, and we also grew double digits in RANGER DCB and Interventional Oncology. Regionally, Asia Pac was a standout in the quarter, with mid-teens growth in the region. 2019 will really be an exciting year for PI as we're launching multiple new products and also integrating both VENITI and BTG post closure.

We continue to see strong physician interest in Eluvia due to its compelling IMPERIAL trial data that was presented at TCT. Recall the IMPERIAL study demonstrated that patients treated with Eluvia stent experienced half the rate of target lesion revascularization at 12 months versus -- compared to the Zilver PTX stents and 88.5% patency rate. Significantly, there were no patient deaths in either arm of the study at 12 months.

We believe this is a relevant -- very relevant considering the recent questions generated by the Katsanos meta analysis regarding the use of paclitaxel on peripheral balloons and stents. We believe the FDA's recent letter stating that the benefits of paclitaxel-coated devices outweigh the risk as well as compelling patient-level datasets from BSX and others at the LINC conference and ISMICT symposium will serve to reassure physicians and their patients regarding the safety and efficacy of our DCB and DES platforms.

We're also preparing for the upcoming U.S. launch of our VICI venous stents, which will be the first on-label venous stent in the U.S. market, and we remain on target to close the proposed BTG acquisition in the first half of '19. With BTG, we look forward to enhanced category leadership positions in Interventional Oncology, arterial and venous therapies.

Interventional Cardiology continues to grow above market, delivering 7.5% operational revenue growth and 6.1% organic in the quarter. For the full year, IC revenue grew 6.6% operational and 4.5% organic. IC growth was led worldwide by continued strength in structural heart with WATCHMAN, ACURATE and Sentinel; and double-digit growth in both our Complex PCI and PCI Guidance portfolios. And this more than offset continued weakness in the drug-eluting stent market.

2018 structural heart revenue exceeded our guidance of $475 million for the year, an out-performance across the franchises. We target continued strong WATCHMAN growth in '19 via increasing utilization with existing customers as well as geographic expansion, where Japan anticipates a Q3 launch and China represents a significant growth opportunity.

In the U.S., WATCHMAN recently received an increase in its primary DRG reimbursement starting last October. And we're also pleased that WATCHMAN was just recently included in the new AFib guidelines update, recommending percutaneous LAAO therapy as a Class IIb therapy for patients with AFib at increased risk of stroke with contraindications to long-term anticoagulation.

Turning to the WATCHMAN pipeline. We expect a limited market release of the next-gen WATCHMAN FLX in Europe in the first half of this year. We also continue to invest in WATCHMAN clinical evidence to support and expand the market, including the recent FLX IDE, the ASAP-TOO study and the new OPTION trial. The OPTION trial will begin enrollment in the second half of this year and is a head-to-head study of WATCHMAN versus NOACs in patients following AFib ablation. Study endpoints target non-inferiority on stroke rates and systemic embolism with an additional superiority endpoint in long-term bleeding.

We're also really pleased with our ACURATE TAVR valve performance in '18 and look forward to launching in France with the recent reimbursement approval. We're targeting launch of the next-generation ACURATE neo2 in Europe in the second half of 2019, and we expect to begin enrollment in our U.S. IDE around mid-year. Our cerebral embolic protection device, Sentinel, delivered as planned in Q4 on the back of continued market adoption of protected TAVR and aided by the recently granted new tech add-on payment.

Turning to our LOTUS Edge TAVR platform. We'll begin a limited release in March in Europe. And in the U.S., pending FDA approval, we anticipate initiating a controlled launch in early Q2. We recently began enrolling the Lotus REPRISE IV study in intermediate-risk patients and plan to complete enrollment this year.

Finally in structural heart, we recently closed on the acquisition of Millipede, a company that's developing an innovative mitral repair platform to treat patients with severe mitral regurgitation. So now with our portfolio of WATCHMAN, ACURATE, LOTUS and Sentinel and IRIS, we're excited about our structural heart capabilities and long-term growth prospects. For 2019, we target structural heart revenue of $700 million to $725 million, which represents approximately 50% growth.

So to wrap up, we truly have a very exciting future and believe that we are well positioned to continue and strengthen our performance track record in 2019, '20 and beyond. And for that, I'd really like to thank our employees and their winning spirit and commitment to patients.

Finally, I'd like to announce that our 2019 Investor Day will be held on June 26 in New York. So please look for additional details to follow in the coming months.

Now I'll turn things over to Dan for a detailed review of our financials.

Thanks, Mike. Fourth quarter consolidated revenue of $2,561,000,000 represents 6% reported revenue growth and 8% growth on an operational basis, which excludes the impact of foreign currency fluctuations. Our reported revenue reflects a $43 million headwind from foreign exchange, slightly more than the $30 million to $40 million headwind expected at the time of guidance. Sales from the NxThera, Claret and Augmenix acquisitions contributed approximately 120- basis points, which was in line with our expectations at the time of guidance, resulting in 7% organic revenue growth for the quarter, at the high-end of our organic guidance range of 6% to 7%.

Strong performance for the quarter was once again delivered across the majority of our businesses and regions. On this robust top-line, we delivered Q4 adjusted earnings per share of $0.39, which represents 14% year-over-year growth but, importantly, includes a net tax benefit of $0.01 related to IRS settlement. Excluding this $0.01 net benefit, our adjusted earnings per share for the quarter would have been $0.38.

This $0.01 net benefit in the quarter, which I will detail in a moment, compares to an expected $0.06 charge related to our tax reinvestment strategy that was assumed in our Q4 adjusted earnings per share guidance of $0.30 to $0.32. However, when normalizing for all tax settlement-related benefits and expenses, our underlying adjusted Q4 earnings per share guidance would have been $0.36 to $0.38 for the quarter, on which we delivered at the high end of the range, driven primarily by strong revenue growth. This result reflects neutral FX for the quarter. The $0.01 Q4 net tax benefit is comprised of a $0.05 charge related to our previously communicated tax reinvestment strategy of the Q2 IRS settlement benefit and a $0.06 benefit in the fourth quarter from settling the IRS stipulation of settled issues for the 2011 through 2013 tax years that had not been assumed in our guidance ranges.

Our full year 2018 consolidated revenue of $9,823,000,000 grew 9% on a reported basis, 8% on an operational basis and 7% organically, which excludes 80- basis points of growth related to the acquisitions of Symetis, NxThera, Claret and Augmenix. This growth was right in-line with our full year guidance of approximately 7% and represents strong performance on a 7% comp year in 2017. Full year 2018 adjusted earnings per share of $1.47 represents 17% growth but, importantly, includes $0.07 of net tax benefit related to IRS settlements. This $0.07 benefit for the full year compares to our expectation that the tax settlement would be neutral to EPS for the year.

So excluding this $0.07 net tax benefit, our underlying adjusted earnings per share would have been $1.40, which is at the high-end of our guidance range of $1.38 to $1.40. This $0.07 net tax benefit is comprised of: first, the previously disclosed $0.06 benefit in Q2 from settling the IRS stipulation of settled issues for the 2001 through 2010 tax years; second, the $0.05 charge in Q4 related to the reinvestment of this Q2 benefit; and lastly, the additional $0.06 benefit in Q4 related to the final resolution of the 2011 through 2013 tax years. We're pleased to deliver $1.40, at the high end of our EPS guidance range, while offsetting a $0.04 FX headwind and $0.02 to $0.03 of M&A dilution through operational savings and initiatives.

Turning to the detailed P&L metrics. Adjusted gross margin for the fourth quarter of 72.8%, an increase of 20- basis points over the prior year and slightly above the high-end of our guidance of 72% to 72.5%, primarily due to the benefit from manufacturing cost improvements, with pricing largely as expected. Q4 adjusted gross margin includes a 70- basis point tailwind from foreign exchange, basically in-line with the 60- basis points expected at the time of guidance. For the full year 2018, adjusted gross margin was 72.3%, slightly exceeding the approximately 72% adjusted gross margin guidance for the year and representing 20- basis points of improvement over 2017. We were able to offset 80- basis points of negative impact from foreign exchange with manufacturing cost improvements and a mix benefit from strong performance, particularly in our WATCHMAN and Neuromodulation businesses.

Adjusted SG&A expenses were $915 million or 35.7% of sales in Q4, flat compared to Q4 last year and slightly above our guidance range of 34.5% to 35.5%. We remain committed to and continue to realize the benefit of our targeted initiatives focused on reducing SG&A like end-to-end business process streamlining and automation, including the use of robotic process automation; functional expansion of global shared services; and optimizing back-office centers of excellence. These initiatives plus a strong focus on expense control and improving P&L leverage in Neuromodulation allowed us to decrease our full year 2000 (sic) [2018] adjusted SG&A rate of 35.4% by 20- basis points compared to adjusted SG&A of 35.6% for full year 2017, all while absorbing dilution from M&A and investing in and launching key products for durable long-term revenue growth.

Adjusted research and development expenses were $278 million in the fourth quarter or 10.8% of sales, which was up slightly from Q4 '17, primarily due to clinical requirements for recent acquisitions and other key pipeline projects. For the full year 2018, adjusted R&D expenses were $1,052,000,000 or 10.7% of sales compared to 10.8% of sales in 2017. Royalty expense was 0.7% of sales in Q4 and the full year 2018, roughly flat year-over-year for both periods.

As a result, Q4 2018 adjusted operating margin of 25.5% was roughly flat year-over-year and was within our guidance range of 25.25% to 26%. We also met our full year 2018 adjusted operating margin commitment with a rate of 25.5%, representing an increase of 50- basis points over the full year 2017. We believe this sets us up well to deliver on our additional commitments of 50- to 100- basis points of improvement in both 2019 and 2020 while still investing in acquisitions and key product launches for durable above-market revenue growth.

Below the line, adjusted interest expense for the quarter was $62 million compared to $56 million in Q4 of last year, and it was $239 million for the full year 2018 compared to $229 million for 2017. Our average interest expense rate was 3.5% in Q4 '18 and 3.6% for the full year compared to 3.8% in Q4 last year and for the full year 2017. The increase in interest expense dollars related to additional debt in 2018.

Adjusted other income for the quarter was $4 million compared to adjusted other expense of $31 million a year ago, primarily due to a net gain on certain of our available-for-sale investments in Q4 2018 compared to a net loss a year ago. And both periods also include expenses related to our foreign exchange hedging program. For the full year 2018, adjusted other expense was $55 million, resulting in total below-the-line expenses of $294 million, which is consistent with our 2017 total below-the-line expenses of $286 million.

Our tax rate for the fourth quarter was negative 30.5% on a reported basis and 7.3% on an adjusted basis. On an adjusted basis, the favorability in our tax rate was driven by the $0.01 net tax benefit I mentioned at the start of my remarks. This net benefit is comprised of: first, the $0.05 charge related to our previously communicated tax reinvestment strategy of the Q2 tax benefit; and second, the $0.06 benefit in Q4 related to the 2011 through 2013 tax years that had not been assumed in our guidance ranges. As previously disclosed, we intended to and did reinvest substantially all of the $0.06 Q2 benefit relating to settling the 2001 through 2010 tax years to reduce our operational tax rate in 2019 and beyond by optimizing our structure and leveraging differences in tax rates by jurisdiction. As announced earlier this year, we expect our long-term tax rate before the impact of any stock compensation accounting to be approximately 13% compared to our previously expected rate of 15%.

As I noted, in addition to the benefit received in Q2 and the subsequent reinvestment in Q4, we received a $0.06 benefit in Q4 related to settling the 2011 through 2013 tax years with the IRS. This settlement resulted in a $93 million payment to the IRS in the quarter and a corresponding reserve release that resulted in the $0.06 benefit. This effectively concludes the IRS transfer pricing case, and we do not anticipate any additional payments related to that matter. We encourage you to exclude both tax settlement benefits and related reinvestments when looking at adjusted EPS trends and thus, model $0.38 earnings per share for Q4 and $1.40 for the full year.

Our full year tax rate was negative 17.5% on a reported basis and 6.8% on an adjusted basis. For the full year, the adjusted tax rate includes a net $0.07 benefit as a result of the $0.06 benefit in Q2 related to the 2001 through 2010 tax years, the $0.05 charge in Q4 related to the reinvestment of that Q2 benefit and the additional $0.06 benefit in Q4 related to the 2011 through 2013 tax years. Excluding these amounts, our tax rate was approximately 12%, which includes a roughly 100- basis point stock compensation benefit for the year.

Throughout 2018, we've successfully reduced the approved tax liability on our balance sheet from nearly $2 billion as of December 31, 2017, to just under $700 million as of December 31, 2018. Of the remaining $700 million liability, a little over $400 million relates to the transition tax reserve resulting from U.S. corporate tax reform, which is payable over the next 7 years. Excluding this reserve, a little more than $300 million remains relating to all tax controversies globally.

Finally, Q4 2018 adjusted earnings per share of $0.39 includes the aforementioned net $0.01 tax benefit, for a normalized result of $0.38. On a reported GAAP basis, which includes net charges and amortization expenses totaling $166 million after tax, Q4 earnings per share was $0.27.

For the full year 2018, adjusted earnings per share of $1.47 or $1.40 after normalizing for the $0.07 net tax benefit reflects the high-end of our guidance range of $1.38 to $1.40 and 11% growth over the prior year. Notably, this 11% growth was achieved while operationally offsetting $0.04 of unfavorable FX and absorbing $0.02 to $0.03 of M&A dilution. On a reported GAAP basis, 2018 EPS was $1.19 compared to full year 2017 GAAP income per share of $0.08.

We ended Q4 2018 with 1,406,000,000 and full year 2018 with 1,401,000,000 fully diluted weighted average shares outstanding. On a GAAP basis, we recorded a net litigation-related charge of $85 million in the fourth quarter related primarily to our mesh litigation. To date, we've settled or are in the final stages of settlement with approximately 95% of all our known claims. We believe that the incremental legal reserve recorded in the quarter will allow us to finalize the remaining cases of claims, and we continue to target resolution of the mesh litigation during 2019.

Our total legal reserve, of which mesh is included, was $929 million as of December 31, 2018. In the quarter, we made cash payments of over $180 million into the qualified settlement fund for a total of over $600 million for the full year, which is shown as restricted cash on our balance sheet. Our current balance of restricted cash, which is primarily related to the qualified settlement fund, is $655 million. As a result, for 2019, we have only approximately $250 million left to fund during 2019, and the remaining balance sheet liability will be released as funds are released out of the qualified settlement fund to plaintiffs, which will complete the process.

Adjusted free cash flow for the quarter was $591 million compared to $685 million in Q4 of 2017. In the quarter, we used cash primarily to fund previously agreed-upon legal settlements as well as business development activities, namely the Augmenix acquisition. As of December 31, 2018, we had cash on hand of $146 million.

Our full year 2018 adjusted free cash flow of $2,002,000,000 represents 16% year-over-year growth, a very nice leveraging of our 8% operational revenue growth and 11% adjusted earnings per share growth, excluding the current year net tax benefit. Our 2018 adjusted free cash flow exceeded our full year guidance of $1.9 billion by approximately $100 million due to a focus on working capital metrics and the timing of certain capital expenditures. We now believe that our 2019 full year adjusted free cash flow will be approximately $2.2 billion, representing 10% growth over 2018 and slightly ahead of our revised goal given earlier this year.

With the proposed BTG acquisition, which has not closed, we continue to believe that we have ample capacity to pay-down acquisition-related debt and continue to pursue business development activities. We'll look to pay-down over $1 billion in debt in the 18 months post close of the BTG acquisition, which we believe will put our leverage metrics at approximately 2.6x EBITDA by the end of 2020, consistent with the 2.6x at the end of 2018. And even with the debt pay-down, because of our strong cash flow generation profile, we believe that gives us capability of about $1 billion or more in terms of M&A to continue to evolve our category leadership strategy and do other tuck-in acquisitions such as the recently closed Millipede acquisition.

As it relates to the BTG purchase price, as you would expect, with an exposure to British pound, we put in a hedging strategy in place largely in-line with our deal model. As a reminder, we've suspended the share repurchase program for 2019 as a result of the pending BTG acquisition.

Capital expenditures for the full year 2018 totaled $316 million, slightly below our $350 million target. We expect capital expenditures to be in a range of $375 million to $400 million for 2019 as we continue to build capacity, integrate acquisitions and drive continued growth.

I'll now walk through guidance for Q1 and full year 2019. As a reminder, the guidance I'm providing does not include the proposed BTG acquisition, which has not yet closed. Upon closing, we'll provide revised guidance.

For the full year, we expect 2019 reported revenue to be in a range of approximately 7% to 9%, which corresponds to year-over-year growth of 7% to 8.5% on an organic basis, and we expect an additional 110- basis points contribution from the NxThera, Claret and Augmenix acquisitions. To be clear, this is the only inorganic contribution of each acquisition, and once the acquisition reaches 1 year post close, it is then included in organic. As a result, we expect and have included in our organic guidance range an additional 40- basis points of growth from NxThera post its April anniversary, Claret post the July anniversary and Augmenix post the October anniversary. This 110- basis points plus the 40- basis points is equal to 150- basis points of acquisition-related revenue, which we had been expecting for 2019.

We expect foreign exchange to be a headwind of approximately $80 million to $90 million for the full year 2019. However, as I'll detail next, due to our hedging program, we expect FX to be neutral to earnings per share for the year. We expect adjusted gross margin for the year as a percentage of sales to be approximately 72% to 73% for the full year, which assumes a positive FX impact of 40- basis points.

We expect full year adjusted SG&A to be in a range of 34.5% to 35% of sales as we continue to see benefits of the programs currently underway. Full year adjusted R&D is expected to be in a range of 10.5% to 11%, and we expect our royalty rate to remain at slightly less than 1% of sales for 2019. This implies a full year 2019 adjusted operating margin in a range of 26% to 26.5%, which is consistent with the improvement goal of 50- to 100- basis points we outlined last September and sets us up well to deliver on our long-term goal of 30%-plus adjusted operating margin.

We forecast our full year 2019 adjusted tax rate to be approximately 12%. This assumes an operational tax rate of approximately 13%, consistent with our disclosure earlier this year, plus an approximately -- approximate 100- basis points of benefit from the accounting standard for stock compensation.

We 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 $300 million to $325 million for the year. This represents an increase from 2018 adjusted below-the-line expense of $294 million as a result of slightly higher debt balances. We expect fully diluted weighted average share count of approximately 1,409,000,000 shares for Q1 2019 and 1,410,000,000 shares for the full year 2019.

As a result, we expect full year 2019 adjusted EPS to be in a range of $1.53 to $1.58, representing 9% to 13% adjusted earnings growth using $1.40 as the base. And we expect FX to be neutral for the year if rates were to hold constant. On a GAAP basis, we expect EPS to be in a range of $1.13 to $1.18. Included in our GAAP EPS guidance is our estimate for the Edwards litigation settlement announced in January, though it is subject to change as we finalize the accounting in the quarter.

Now turning to Q1 2019. We expect reported revenue growth to be in a range of approximately 6% to 7%. This represents year-over-year organic growth in a range of 7% to 8% plus an additional 160- basis point contribution from NxThera, Claret and Augmenix. We expect the foreign exchange impact on Q1 revenue to be an approximate $60 million to $65 million headwind.

For the first quarter, adjusted earnings per share is expected to be in a range of $0.35 to $0.36 per share, representing 8% to 11% growth. And GAAP EPS is expected to be in a range of $0.32 to $0.33 per share. Similar to the full year GAAP EPS guidance, included in our Q1 GAAP EPS guidance is our estimate for the Edwards litigation settlement, subject to change as we finalize our accounts. Please check our Investor Relations website for Q4 2018 financial and operational highlights, which outlines Q4 and full year 2018 results as well as Q1 and full year 2019 guidance, including P&L line item guidance.

So with that, I'll turn it back to Susie, who will moderate the Q&A.

Thanks, Dan. Greg, let's open up the questions for the next 20 minutes or so. (Operator Instructions)

Greg, please go ahead.

(Operator Instructions) Your first question comes from the line of David Lewis from Morgan Stanley.

Very constructive guidance to start the year. I guess I'll limit myself to one question, and you'll never get to hear my second. But Mike, I'll start with you on strategic activities. So the M&A pace in '19 -- or sorry, in '18 was probably the biggest debate on Boston. So as I think about '19 and beyond, why should investors not be concerned about the ability to integrate multiple transactions this year, some large, some small? And how should we think about the pace of further M&A here in 2019?

Sure, David. One, I think we've demonstrated a very good track record of our ability to integrate acquisitions, from [Bayer] to AMS to Cameron S-ICD and so forth, and you could also throw ACURATE in there. So we deliver on the -- our deal models, and our team executes them very well. So that's historically. Now going forward, we're on track. So this year, we have 3 or 4 deals that will drive contribution this year with Augmenix, Claret and NxThera, and pleased to say that all those are going as planned. The operations team is doing a great job of ramping up supply. We're driving the appropriate synergies, and then we have a couple that are a little bit farther out in the pipeline that are doing great clinical work this year. Again, they're on track, Cryo and Apama. And we anticipate Q4 approvals for both those platforms as the clinicals readout. And we have 2 that are earlier stage, nVision and Millipede, which are really early stage still in the R&D phase.

So I think a couple of things. One is they're sequenced in terms of, call it, their maturity. They're distributed across our businesses. And we have the infrastructure in place in our operations supply chain, IT, quality to manage these very effectively. So I have more confidence now than I did 3 months ago, given the progress that we continue to make. And also, we are excited about the potential for a BTG closing sometime in second quarter, and a lot of efforts on planning for that have taken place. So I have 0 concerns about our ability to integrate these deals while continuing to fuel the growth in our core business. We will see the pace of M&A slow for us in '19. As we stated before, we do have capacity to do some tuck-in acquisitions, but you won't see the volume of activity in '19 that we had in '18.

Your next question comes from the line of Glenn Novarro from RBC Capital Markets.

It sounds like the LOTUS launch is right around the corner, with Europe next month and U.S. a few months out. So I'm hoping you can talk a little bit about how you're going to be positioning LOTUS given you just have a high-risk label. Your launch of intermediate risk is probably still a few years away, and of course, we've got Edwards and Medtronic launching a low-risk in the second half of this year. So maybe talk to us about how you'll market LOTUS to cardiologists, including pricing strategy and willingness to bundle with Claret.

Glenn, it's Mike here. First of all, we're excited. This has been a journey for us with LOTUS. But the product characteristics are very unique, and we're excited about the long-term growth prospects of this platform. So in Europe, we've got terrific momentum currently with ACURATE. We're also implanting Sentinel. And there's many physicians in Europe who have been waiting for LOTUS for quite a while, who've been part of various clinical trials and registry programs and are excited to implant LOTUS. So we've got a winning formula, we believe, in Europe with both ACURATE and LOTUS, and we'll be able to segment those products appropriately. And physicians are waiting for LOTUS in Europe. In the U.S., we obviously don't have ACURATE. So our 100% focus in the U.S. will be with our protected TAVR with both Claret and also LOTUS.

And similar to previous comments, we think the differentiated features, the reposition ability of it, the best PVL in the marketplace and also just the clinical experience of those who've been involved in our clinical trials, so we believe there will be adequate demand for LOTUS in the marketplace. And we want to, obviously, focus, as we begin to launch this product in the second quarter, on delivering excellent outcomes and strong experiences. This will be a key platform for us for many years. So we think the market's there. And as you look forward with Boston having Claret and the ACURATE platform where we have a number of new enhancements coming and ongoing enhancements to our LOTUS platform in the pipeline, we are uniquely positioned in this marketplace where we're just now entering the U.S. And we're also in the midst of enrolling our intermediate study today. We actually started a couple months ago, and we'll finish enrollment with that -- LOTUS by the end of the year.

Your next question comes from the line of Bob Hopkins from Bank of America.

So if okay, I just actually wanted to follow up on LOTUS Edge given your comments. You're obviously offering some more specific time lines here. So I guess I'm curious what drives the sort of increased specificity on the time lines for approval, both in the U.S. and OUS. And then you mentioned a couple of times sort of a limited launch. And is there something that will hold you back a little bit when you -- from a capacity perspective on LOTUS Edge once you get approval? Just curious why it isn't a full-blown launch immediately upon approval.

Sure, Bob. Yes, so we do have more insight. We think the approval will likely happen potentially early in the second quarter versus mid-year. So that's good, and that's very good. And our team deserves it. And that's reflected in the full structural heart guidance we gave, the $700 million to $725 million. And simply speaking, with our -- with the LOTUS Valve, we want to ensure that we deliver this exceedingly well to get off -- out of the gate strong, to build up a strong reputation for the product in the U.S. And so like we've commented in the past, this is very unlike -- it's not like a DES launch. It's similar to what we did with WATCHMAN, similar to what we've done to ACURATE in Europe, where key training and proctoring will be part of it. And so we're not going to launch in hundreds of centers out of the gate, like we would with a DES launch. So it will be smartly planned, delivering excellent outcomes, building greater confidence with the physician community, leveraging Claret with protected TAVR, we're the only company that can do that, and building momentum. And so you'll see us, much like the WATCHMAN launch, continue to open centers over time, deliver great outcomes. And similar to WATCHMAN, we've increased utilization rates each quarter by doing so.

Your next question comes from the line of Larry Biegelsen from Wells Fargo.

So Mike, you grew about 7.2% organically in 2018, and your 2019 guidance implies about 7.8%, let's call it, at the mid-point, which is quite bullish. So what's giving you the confidence to guide to an acceleration this early in the year? And any color on which businesses get better, which businesses might slow a little bit in 2019 versus 2018?

Sure. So we just have a lot of confidence in our team's ability to deliver. I think we demonstrated that over the past 5 years. I kind of highlighted that in our results. And I think the first thing is we have strong momentum really across the company, MedSurg last year, 8%; rhythm and neuromod, 8%, it's all organic; cardio, 6%. And so we have broad-based strength across the divisions, and we also have very distributed strength across each region. So we're not relying on one region. So we have very good momentum across each region. And we anticipate Japan will be a stronger performance for us as well in 2019. So I think having that momentum and that diversity of strength across businesses and regions is difficult to do, and we have it. And we want to continue to pour fuel there.

And then, secondly, the big thing we have this year is just a lot of momentum in the businesses. Our structural heart guidance of $700 million to $725 million will drive a lot of growth. Our neuromod business has a lot of momentum. And now with the approval of DBS, we like that, although we have tough comps in spinal cord stim. PI has an exciting future ahead and in '19 with the new launches as well as the pending BTG acquisition. Endo and uro have a lot of portfolio launches, and then as well in EP, we're excited about the single-shot capability coming and the ongoing strength of our defib platform. So I think we just have a lot of momentum there, new product launches. And as to David's question earlier, we're very confident that we'll deliver on the integrations, and that sets us up for really exciting 2021 and '22. With those acquisitions and pipeline, we're entering into about $20 billion of unserved markets, where, today, we have about $1 billion in sales. So I think this M&A that we've done on top of it helps fuel the long-term growth that's differentiated for the future.

Your next question comes from the line of Chris Pasquale from Guggenheim.

Mike, can you remind us what your sales strategy will be for LOTUS in the U.S.? Are you going to have a separate group that is responsible for LOTUS and Sentinel? And if so, where are you in the process of building that out?

Yes. We're not going to dig into our commercial strategy in the U.S. We have, as you know, a very broad portfolio and lots of capabilities to leverage where appropriate and also to provide unique clinical specificity where needed. We have a large sales team on core DES, on Complex PCI as well as clinical people involved there. We clearly have a dedicated, strong focus on WATCHMAN with clinical. And you'll also have a lot of focus with dedicated people in TAVR and Claret. So they all come under the umbrella of Interventional Cardiology. It segments differently based on location, but there's a lot of commercial leverage there, synergies with the group but also maintaining unique clinical focus where needed for those specific types of products. So I would say, in general, we're there. We have the commercial team in place. We'll continue to add resources like -- as we have in structural heart with WATCHMAN and TAVI as we grow it. But the foundation of all that's already in place in the U.S. and in Europe.

Your next question comes from the line of Rick Wise from Stifel.

Maybe a topic we haven't touched on a little bit, Rezûm. You've highlighted all the products that are going to continue to drive growth into -- really into the next decade. I'd be curious -- where does Rezûm stack up on the scale of the incredible number of growth-enhancing portfolio options? Is it at the higher end of opportunities? Where are we now? You have great 4-year data in hand. Where does it rank? What could it do? What should we expect from this opportunity?

Thanks, Rick. I think -- I know Rezûm is doing -- we're very -- the team is very committed to Rezûm. We had equity investment via an acquisition, and I think the team smartly acquired Rezûm and recommended it versus a competitor a while ago on the belief that the stim-based ablation would provide longer-term, more durable results. And I think that's exactly what the 4-year data showed. And at the end of the day, many had long-term results and high safety and efficacy, and that's what that data represents versus its primary competitor. So I think with the marketplace, with the ability to be less invasive and to grow the pie for BPH is extremely unique. And then you tuck that into our full portfolio of laser capabilities as well as our urology sales force with other products. It's a very compelling contractual opportunity for us as well. So I think the product stands alone versus competition. And then you wrap around it the complementary portfolio for contracting, it's very helpful. So this will be -- make a big impact for our UroPH business. It's -- I don't want to rack and stack them, but we anticipate this will deliver strong growth for us in 2019. And urology will certainly be accretive to our overall BSX growth profile in '19.

Your next question comes from the line of Vijay Kumar from Evercore ISI.

So one on products and one on cap deployment. DBS, Mike, you sounded optimistic. Can you quantify on what this means to share gain? So on the spinal cord stim side, we've seen 10, 20 points of share shift. Any comments would be helpful. And Dan, on the cap deployment side, $2 billion-plus of free cash. I think you said $1 billion of debt pay-down as well. Are we to assume another $1 billion of that is left out for M&A?

We'll do Dan's question first. He's lonely here. So we're going to turn over to Dan.

Sure. Thanks for the question, Vijay. Yes, the $1 billion of M&A spend in '19 is just the basic math of saying if we did $2.2 billion, a little bit of that goes to the qualified settlement funds for finishing out mesh, $1 billion of debt pay-down, at least $1 billion for M&A. So just simple math, but as Mike said, allows us to do a small handful of tuck-ins, obviously much less than we did in '19 but nice to be able to still do some M&A -- in '18, nice to still be able to do some in '19.

And your first question was on DBS. Was that what it was? I'll make a comment on DBS. So as I mentioned, in the prepared remarks, the full portfolio is recently approved, of the directional lead. And so we just started implanting patients over the past 30 days. So we think that'll be a terrific platform for us. It will complement us, yes. We've got tougher comps in SCS this year. So we think the uniqueness of our SCS platform plus DBS will continue to drive neuromod results accretive to the company.

Your next question comes from the line of Josh Jennings from Cowen.

I wanted just to ask Dan a question on operating margin guidance, 50- to 100- basis points. Just curious -- and also on the bottom-line. Just can you call out what the impact of acquisitions are, what the M&A headwind is in terms of what you had to absorb on the margin line and also on the EPS line in '19?

Yes. Sure, Josh, yes. As you'd expect, there is a little bit of dilution in '19 from M&A, and obviously, since the majority of the acquisitions aren't at our overall adjusted operating margin rate, there is dilution at the OI margin rate as well. Not going to call out the specifics except to say it's all included within what we think is very strong guidance of 9% to 13% adjusted earnings per share growth off the $1.40 base and then included in what we think is, again, very strong operating margin guidance at 26% to 26.5%, which is 50- to 100- basis points off of the base in 2018 and is very consistent with what we've been saying over the last few quarters. So we feel good that the whole entire stew that we have adds up to that and feel like that's very strong guidance.

Your next question comes from the line of Matt Taylor from UBS.

So I know you didn't address this explicitly today, but obviously, with a stronger organic guidance for 2019, you're talking about growth at the upper end of your kind of 2-year range, that 7% to 10% operational and formerly 5.5% to 8.5% organic. You did talk about some qualitative things that give you confidence in 2020 and 2021. Can you say -- with this kind of a guide in '19, does that just give you more confidence in the high-end of the range in '20 and beyond? Or can you update us on what we should expect for organic and operational growth over the next couple of years?

Matt, yes. We're not going to comment on kind of expanding our guidance beyond '19. So it's something we'll consider in the future for Investor Day. But we're confident in the '19 growth rate we gave and certainly hold true to the '19 and '20 CAGR growth of 7% to 10% operational that we gave historically.

Your next question comes from the line of Joanne Wuensch from BMO.

It sounds to me like you are likely to have LOTUS at the booth at ACC. Could you please confirm if that's your thinking and what else we should see from ACC? And then as a secondary, now that Millipede is part of the family, what are your thoughts on Mitral?

So we do anticipate LOTUS approval, as I mentioned, likely early second quarter. Maybe, Ian, you can help me specifically with what -- at ACC. We often showcase WATCHMAN at ACC, and we'll certainly showcase our TAVR portfolio as well as our protected TAVR strategy with Sentinel. Ian, any other comments on ACC and maybe comments on Millipede?

Yes. So the answer to Millipede is yes, we see that Millipede is an important foundation for functional mitral regurgitation. Obviously, it's part of a bigger strategy, but it's a critical part of the strategy being the first and most important step in develop -- in functional mitral regurgitation repair.

Your next question comes from line of Matt Miksic from Crédit Suisse.

So a lot of positive drivers on the top-line that you've talked about and we've covered here in Q&A. I wanted to follow-up with one of the questions -- one of the comments that you made earlier, Dan, in terms of the drivers of your leverage and operating margin improvement in the past and currently around shared services and robotic process automation. Can you maybe speak to, in round numbers, of course, sort of what that does on a gross basis? We can see what your guidance is for 2019. But what kind of benefit are you seeing from that? And then maybe, which of the acquisitions -- recent acquisitions -- thinking of robotic process automation, some of the back office changes that you're making, where does that position you to benefit the most as you go through these integrations? Maybe also looking ahead to BTG and what the opportunities are there.

Sure, Matt, yes. And I would really just ground in guidance for 2019. So if you look at 2018 SG&A, it was -- for the full year, it was 35.4% of sales. The guidance for 2019 is 34.5% to 35%. So at the midpoint, call that kind of 70- basis points of improvement there. Gross margin obviously contributes. It was 72.3% in '18, and the midpoint is 72.5% in '19. So that's kind of the math of how we get to that 50- to 100- basis points of margin expansion.

Specific to SG&A, we have a lot of different initiatives going across the divisions, regions and functions. I would say that RPA is more of a legacy Boston Scientific thing at this point. We don't descend upon the new acquisitions with RPA. It's more of back office, things like finance and IT and other functions where we put that in. It is a big piece of what we're doing relative to reducing our overall SG&A spend, but it's just one of the components in a lot of initiatives and activities in a road map that we have to reduce SG&A as a company over the next 2 to 3 years.

Your final question comes from the line of Isaac Ro from Goldman Sachs.

Dan, a question for you on the tax rate guidance. There's some new regulations coming through that have a varying degree of impact on companies in this space. Was curious if you could maybe try and quantify for us, number one, what's assumed in your tax rate guidance for the year as it relates to some of these changes. And if you could quantify it in any way, that would be awesome.

Sure, Isaac. I think I'm going to give you the short answer on that one, both given time and the magnitude of what would be required to go through things like GILTI and hybrid and BEAT and all that. All of what we know today relative to tax reform is included in our 13% operational and 12% all-in tax rate for 2019.

All right. We'd like to conclude the call now. Thanks for joining us. We appreciate your interest in Boston Scientific.

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