This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk04: Ladies and gentlemen, thank you for standing by, and welcome to the Boston Scientific Q1 2020 earnings call. Now at this time, while participants are on a listen-only mode, later we will conduct the question-answer session. If you wish to place yourself in queue for questions at any time, please press 1 and 0. Now repeating the 1 and 0 command will remove you from Q&A. But once again, please press 1 and 0, and then press 1 and 0. Repeat the command to remove yourself from the queue. As a reminder, today's call is being recorded. I will now turn the call over to your host, Susan Lisa. Please go ahead.
spk06: Thank you very much, Kevin, and for those explicit directions. 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 Q1 2020 results, which included reconciliations of the non-GAP measures used in the release. We have posted a copy of that release, as well as reconciliations of the non-GAP measures used in today's call to the investor relations section of our website under the heading, financials and filings. The duration of this morning's call will be approximately one hour. Mike will focus the majority of his comments on the impact of COVID-19, inclusive of April trends and procedural acuity by business. Dan will review the financials for the quarter and our liquidity outlook, 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 that on the call, operational revenue excludes the impact of foreign currency fluctuation, and organic revenue further excludes the impact of certain acquisitions, including Vertiflex and BTG, in the relevant periods for which there are no prior period related net sales, as well as the divestiture of the global embolic microspheres portfolio. On this call, all references to sales and revenue, unless otherwise specified, are organic. Also of 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, the impact of the COVID-19 outbreak on the company's results of operations, 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, and earnings, as well as our tax rates, RMD spend, and other expenses. April trends refer to months to date results, and actual results may differ materially from those discussed in these and any 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.
spk11: Thank you, Susie, and thank you to everyone for joining us today. I hope that you and your families are healthy in braving the COVID-19 pandemic as well as possible. I'm truly honored to be part of Boston Scientific, as I see every day the resilience of our employees across the globe who are helping us to navigate the crisis and emerge stronger on the other side. We're humbled to be able to continue to serve our customers, patients, employees, and community needs in the COVID-19 pandemic. Our focus is to communicate with transparency and take actions consistent with our core values while keeping employees safe and informed, providing patient support to customers, and effectively managing our operations. We've expanded our capabilities in virtual physician education, remote clinical support, digital sales enablement, and training. We're also partnering with our customers to enable a fast recovery, while also acting to reduce operational expenses and preserving our cash position. We have taken these immediate actions with the goal to preserve as many jobs and strategic programs as possible. We've also leveraged our capability to develop countermeasure technologies, such as the Coventor Personal Respirator, which was developed and approved in just four weeks, as well as face shields and donations of personal protective equipment. I'll now provide some highlights on first quarter 20, and we'll focus most of my comments on the impact of COVID-19. While we're not providing specific revenue and EPS guidance at this point, we will offer insights into our segments, along with recent businesses and geographic sales trends, and highlight some 2020 launches. I'll then wrap up with some key sustainability updates as our teams continue their dedication to innovation and long-term commitments to the environment and our communities. For the first quarter of 2020, total company sales grew .2% on an operational basis, with the US up three, and the U.S. up one, and Asia packed down 5% operationally. Total sales declined .9% on an organic basis, reflecting the impact from COVID-19 and in line with our April 2nd pre-announcement. Sales are tracking two expectations of both January and February before significant negative trends kicked in in mid-March. These first quarter sales results were led by low single-digit growth in our MedSurg segment, with Euro Pelvic Health up three, ENDO up two, and both our cardiovascular and rhythm and neuro segments declined organically. Within cardiovascular, interventional cardiology sales were down 3%, peripheral interventions was down 2%. Operationally within PI, BTG interventional medicines contributed 390 basis points to total company growth, led by Therospheres, which grew mid-teens in the quarter. In rhythm and neuro, CRM sales declined 10%, EP dropped 5%, and neuromodulation declined 7%. Neuromod did grow 3% operationally with a 70 basis point contribution to company sales from VertiFlex. In specialty, pharma sales of 41 million in the quarter was ahead of forecast and contributed 160 basis points to total company growth. Despite taking immediate actions to reduce costs, the lower overall sales levels led to a challenging P&L for the quarter, as adjusted operating margin fell to 21.6%, down 400 basis points year over year, and adjusted EPS of 28 cents, which is a 21% decline versus Q119. Now to turn to outlook for the rest of the year. As I mentioned, Q1 sales were tracking the expectations until mid-March, when we started to see significant declines in US and European revenue, as a result of procedure deferrals and those geographies across all of our businesses. Generally, those negative trends in the second half of March have continued in the first three weeks of April. We are currently planning for the most significant negative impact of COVID-19 in Q2, and within Q2, we expect April to be the toughest month, with global revenue for the month of April down approximately 45 to 50%. From a regional perspective, we see varying results based on the different phases of recovery. To the first three weeks of April, regional sales results have trended down 15% in Asia-Pac, down 45% in Europe, Middle East, East Africa, and down 55% in the US versus prior year. Importantly, we've seen a very recent slight improvement in April sales trends, as some facilities to varying degrees have begun to reopen for elective procedures. We anticipate some sequential monthly improvement throughout Q2, but with net sales results still down significantly -over-year for the second quarter. We also expect Q3 revenue will likely contract on a -over-year basis, but improve from Q2 rates of decline. And then we aim to return to growth in Q4, but there are obviously still many uncertainties. Despite the procedure volume impact from COVID-19, the global pipeline across our businesses remain very strong, with several ongoing launches and recent approvals now poised for commercialization as soon as the broader environment improves. I'll also provide color on procedural urgency along with trends in April. We've framed our major product lines across the spectrum from emergent, which is measured in hours to days, to semi-emergent, which is measured in weeks, to elective, which is measured in months. And note that several product families cross over categories, and majority of conditions we treat have a relatively high level of acuity, including those that are elective, and thus generally can't be deferred for extended periods. In addition, when estimating the overall pace of recovery, site of service is an important consideration, and the recent guidelines for reopening from a range of physician societies enable elective outpatient procedures to restart before inpatient procedures. Site of service varies by business, but overall, based on 2018 Medicare claims data, our 2019 U.S. revenue split was approximately one-third inpatient and two-thirds outpatient. The two-thirds mix within the outpatient setting spans across hospital outpatient, physician office labs, and ambulatory surgery centers. Please refer to slide 12 of our Investor Relations website for supporting details to the commentary. For urology public health, given the high mix of deferrable procedures, trends to the first three weeks of April were down roughly 60% versus prior year, with sales from our Stone franchise and Space Orb products showing better resilience and more pressure in our prostate health, prosthetic urology, and pelvic core franchises. We believe Euro pH may have one of the faster potential recovery curves, aided by a higher office AAC mix for our most elective procedures, as well as specific products playing a key role, such as the recent launch of the TRIA Stents in the U.S. and Europe. And Lithovu, which is our single-use urethra scope, could benefit as the current environment supports the speed and utility of single-use scopes. SpaceOAR is also an important technology for the recovery as treatments for cancer patients will be prioritized, and hydrogel spacing is now included in NCCN guidelines. In BPH, RESUME, which is an entirely office-based procedure, recently reported five-year clinical data in which the surgical retreatment rate through five years was 4.4%. Importantly, this is unchanged from the published results of RESUME's four-year data, and it compares to a 13.6 retreatment rate for competitive MIS technology. Finally, given the multiple strategic priorities and investment opportunities within the broad Euro pH portfolio, we're announcing today that we've reached a definitive agreement to divest our commercialized intrauterine health portfolio to Minerva Surgical. In addition, we've made a decision, at least for the near term, to stop funding additional clinical or R&D work for Cytuity. Cytuity is a potential platform for ovarian cancer diagnosis that we acquired from NVISION in 2018. Unfortunately, while we recognize the strong need for improved ovarian cancer detection options, particularly for women who have a high risk, our view of the clinical evidence necessary to establish practical utility to the product, as well as the current reimbursement landscape, have extended the cost and time horizon to realize the commercial potential of Cytuity. Turning to endoscopy, April -to-date trends are down 45% -over-year, reflecting a higher mix of non-deferrable procedures within our med-surg business. ERCP procedures for the pancreas and bile ducts are deferrable. However, patients typically can't wait longer than four to six weeks for stone removal, tumor biopsies, and other related procedures. In single-use scopes, the EXALT-D launch is progressing, albeit slowly, due to COVID-restricted hospital access and capacity. The current pandemic certainly emphasizes the need for infection prevention, and we continue to believe that our therapeutic imaging portfolio of single-use scopes represents a multi-billion dollar market opportunity over time. We're also pleased that the next scope in this franchise, Spyglass Discover, received CE-mark approval in early April, and we're working toward a second half U.S. clearance and a global launch. Also in April, we received FDA clearance for the Wall Flex colonic and duodenal soft stent systems. In our next generation, hemostasis clip, Res360 Ultra remains on track for approval in Q3. Turning to CRM, sales in April are down approximately 50% -over-year, with the Novobrady implants and replacements holding up slightly better than ICDs. And this reflects a slightly higher mix of non-deferrable procedures and pacers, including the majority of patients suffering from heart block and those who more urgently need replacements. In defibrillators, non-deferrable procedures, including secondary prevention, ICD, and CRTD therapy, and a subset of replacements. CRM Recovery will be led by HeartLogic, SICD, and the SICD replacements, as well as the ongoing U.S. launches of our Ingevity Plus Lead and 3300 Programmer, with remote service offerings. Importantly, we continue to expect mid-year FDA launch and clearance of our LuxDX implantable cardiac monitor. We also look forward to two virtual HRS late breakers in our CRM franchise, the Proterian and InTouch trials, which should continue to support the global growth of our SICD franchise. Electrophysiology sales in April are down approximately 65% year over year, as this franchise is a higher-deferrable mix than CRM, with a low double-digit percentage of highly symptomatic and unstable arrhythmias considered non-deferrable. Our EP Recovery will be driven by a strengthening portfolio, including PolarX, which is our second-generation single-shot cryoablation catheter that will resume its European launch in Q3 when access to labs improves. DirectSense, which monitors the effect of our energy delivery via changes in local impedance around the catheter tip, received approval in mid-April. We also anticipate Q3 approval in Europe for a force-sensing stable-point therapeutic catheter. In neuromodulation, the first three weeks of April have seen a decline of 90% in sales versus prior year, given the very high rates of elective deferrability for SCS and DBS procedures. So to offset this, we continue to leverage our digital competencies to maintain connectivity with patients and physicians so we're ready to serve them as procedures resume. Given that a majority of all SCS trial procedures occur in the office or ASC setting, and that many implanting physicians have access to an ASC, we believe SCS procedures will likely experience an earlier and faster recovery than DBS, which is typically 100% hospital-based. For interventional cardiology, April sales are turning down about 40% versus prior year, with coronary therapy sales more resilient and structural heart sales more impacted, which reflects a higher mix of nondeferrable procedures within coronary therapies. Similarly, with structural heart, TAVR procedures are generally less deferrable than Watchman. And overall, the relatively low April sales decline in IC reflects that as one of our highest-mixed franchises, both in terms of emergent and acute procedures. We believe this will drive the recovery curve as the procedures may be deferrable near term, but pose a significant threat for future morbidity or mortality. Importantly, we're planning for eight coronary therapy launches across our major markets later in 2020, highlighted by Synergy XD, Synergy Megatron, and our Synergy 48-millimeter, two enhancements to our rotoblader artherectomy platform and enhancements to our PCI guidance platform. We're also very proud of the team that achieved our accurate NEO2 CE mark approval earlier this month, and we plan to begin a limited market release in Europe as the healthcare systems resume a more regular cadence of TAVR procedures. Similarly, the ongoing launch of Lotus Edge in the US and Japan has been challenged by COVID-19 restrictions that limit proctor travel and the delivery of training, but we do look forward to the recovery and procedure volumes. We also continue to plan for a second half 2020 US launch of WatchmanFlex and await presentation of the PinnacleFlex results in May as an HRS late breaking clinical trial. And although Watchman procedures are largely deferrable, patients seeking this therapy are eligible based on their need for an alternative to blood thinners. And physician operators we've surveyed are confident that postponed procedures will be rescheduled when facility capacity and or protocols allowed for increased elective procedures. Turning to peripheral interventions, April to date revenue is down approximately 30%, and the estimated mix of deferrable to non-deferrable procedures ranges by therapy category. Arterial, venous and interventional oncology in order of highest to lowest mix of deferrable procedures. We have a strong cadence of product launches coming in this PI business. In arterial, we plan US launches of the Ranger DCB and Athletis Balloon, along with a China launch for Lubea in DES in China. In venous, we received approval for the venous indication for wall stents and anticipate approval for a new controller for the Ecos thrombectomy system and a new IVIS catheter. Also the VTE Virto reverse deployable stents and the Angiojet Clock Hunters system all will be launched in 2020. In interventional oncology, we plan to launch the new HEAT FX microwave ablation system and the TrueSelect micro-heat catheter. So a very rich pipeline of launches in PI in 2020. So turning now to lessons learned from our Asia team, Q1 sales in the region declined 5% year over year, mainly driven by declines in China and Korea, which were partially offset by growth in Japan, Australia and New Zealand. In China, we estimated the COVID-19 impact procedures was close to $70 million in the first quarter. And since the government announced on March 18th that the country has passed the peak of the epidemic, we continue to see improvement each week in China. Leading physicians are also citing concerns that patient deaths from referral of elective procedures could outnumber COVID-19 related patient deaths. And bans are now starting to lift on inter-provincial travel. And this is helping larger city hospitals recover as patient flow from lower tier cities is restored. We are leveraging the China team's experience, including customer engagement via online hospital seminars and remote case support. And overall, we believe that China could recover back to its -COVID-19 trajectory in Q3 and potentially be above plan in Q4. Our Japanese business has been less impacted year to date, but remains uncertain. In Japan, we look forward to launching Ranger DCB, Synergy XD, and Lotus Edge in the second half of 2020. So turning to the balance sheet, as we announced last week, we believe that we are in a strong liquidity position with our recent bank deal, resulting in over 2.6 billion in near-term liquidity. And Dale will provide more details on the transaction, as well as commentary on our cost-cutting and cash preservation initiatives. Consistent with the deferral of elective procedures, we've witnessed a slowdown in ongoing clinical trial enrollments, and that's what's expected to delay to many of our clinical timelines of approximately six months. We're also temporarily suspending the quarterly update to our pipeline chart in our financial highlights decks, but we'll reinstate at one of our future earnings calls. Instead, this quarter, we have provided a summary of our important 2020 new product launches on page 13 of the deck. I'd also like to highlight the online release of our 2019 integrated performance report, which combines financial disclosures with our sustainability report, updates on our 2030 carbon-neutral pledge, and reporting on our diversity and inclusion goals. Recall that in 2017, Boston Scientific was the first medical device company to pledge carbon neutrality by 2030. And importantly, we've made significant progress toward this goal, with the latest step being last week's announcement that we have finalized our first virtual power purchase agreement, which is a 15-year solar energy purchase deal to provide 100% renewable energy electricity for our U.S. operations. We've more than doubled the percent of energy use from certified renewable sources in 2019 alone to 11% and achieved a reduction of nearly 34,000 tons of greenhouse gas emissions since 2015. We recycle 80% of all solid waste at manufacturing sites and a 95% rate of landfill avoidance. So in closing, I'm incredibly proud of our team at Boston Scientific. Our fundamentals and long-term outlook remain strong given our people, our pipeline, our high rate of acuity in our portfolio, and our category leadership strategy across diversified markets. I'd like to thank our employees for their winning spirit and commitment to emerge stronger in the recovery post-COVID. And I'd also like to thank the frontline workers for their unwavering commitment, dedication, and selflessness during this time. Now I'll turn the call over to Dan.
spk02: Thanks, Mike, and allow me to echo my gratitude and respect for all of the frontline healthcare workers and members of the Boston Scientific team. The focus of my prepared remarks today will be to provide high-level Q1 financial results, insight into our P&L, cash controls, and leverage, as well as an overview of our strong financial position. Given the challenges the COVID-19 pandemic has brought upon the healthcare community and uncertainty regarding the duration and the impact, we will not be issuing Q2 or full year 2020 guidance at this time, but as Mike said, we will try to provide as much transparency and disclosure as possible. First quarter consolidated revenue of ,000,000 represents 2% reported revenue growth and reflects a $29 million headwind from foreign exchange. On an operational basis, revenue growth was .2% in the quarter. Sales from the Vertiflex and BTG acquisitions contributed 70 and 560 basis points to total company growth, partially offset by the divestiture of our legacy Imbolic Beads portfolio for a net 610 basis point contribution. This resulted in an organic revenue decline of 2.9%, driven by the negative impact of COVID on elective procedures, as Mike detailed. We delivered Q1 adjusted earnings per share of 28 cents, which includes two cents of inventory charges related to near term lower demand and one cent charge related to a discreet tax item in the quarter. Adjusted gross margin for the first quarter was .5% and reflects the impact of the inventory charge. As we face top line headwinds related to COVID, there are some opportunities to leverage cost of goods sold, but not as many as other lines of the P&L, which I will detail shortly. Our tax rate for the first quarter was 10% on an adjusted basis and includes an $11 million discreet tax charge. Our tax rate may have some variability for the remainder of this year, as COVID related uncertainties and different regional and national recovery timelines could materially impact our geographic mix of profits and therefore the tax rate. Adjusted free cash flow for the quarter was $218 million. As of March 31st, 2020, we had cash on hand of $370 million, a purposeful increase of $150 million over the prior quarter. Given the uncertain environment, we intend to maintain approximately $300 million of cash on hand throughout the remainder of the year, roughly $100 million higher than recent historical trends. Turning to our P&L leverage and cost containment initiatives, at a high level in the short term, our spend is roughly 70% fixed, 30% variable. This is based on operating spend structure that's approximately two thirds fixed, with cost of goods sold slightly higher than that. We're currently focused on cutting back approximately two thirds of the targeted variable spend while preserving critical investment spend. As Mike mentioned, to offset the lower expected revenue, spend reductions are already in place, including cutbacks in travel, hiring, clinical programs, and certain longer payoff research and development projects. We've also shifted to a temporary four-day work week for most salaried employees. Sales rep compensation has been evaluated with strategic flexibility, and named executive officer and board salaries have been reduced by 50%, while Mike is foregoing nearly his entire base salary for up to the next six months. In addition, we've temporarily closed some manufacturing sites in an effort to align our build plans to the current demand environment, thus reducing inventory on hand and freeing up working capital. We believe these proactive initiatives will enable us to weather the short term storm, while still being in a strong position to build momentum once the recovery begins. However, given the relatively high fixed cost nature of our business, we would expect a high decremental margin rate on lost revenue, including a sharp decline in adjusted operating margin in Q2 versus Q1. Improving sequentially into Q3, and then Q4, where our goal is to return to revenue growth and ultimately more normalized margins, although certainly uncertain at this time. I can use the month of April using round numbers to illustrate the point. In general terms for April, pre-COVID, we would have expected to be north of 70% adjusted gross margin, with OPEX being SG&A, R&D, and royalties in the mid-40s as a percentage of sales, resulting in an adjusted operating margin in the -20% range. As Mike said, April revenue is down 45 to 50% versus April 2019, which implies roughly $500 million lower revenue versus our pre-COVID expectation of slightly less than a billion for the month. With lower production due to the lower demand, we're not fully absorbing the fixed overhead in the manufacturing plants. As a result, the overall adjusted gross margin rate will be negatively impacted by unfavorable production variances, which will hit the P&L instead of being capitalized with an inventory on the balance sheet. Pre-COVID, we would have expected to spend approximately $450 million in OPEX, with $300 million being fixed, and $150 million being variable. Given the lower sales, we've taken actions to reduce the variable spending by two-thirds, or roughly $100 million in the month. So you're left with $350 million of OPEX, which would be roughly 70% of April sales. When you combine this with an all-in gross margin that's likely to be below 70%, the net is that the month of April could actually see a negative operating margin. We've implemented the same level of spending actions for each of April, May, and June, so as revenue increases, as is planned, in each of those months, as per our recovery scenario, the monthly margin should improve correspondingly. We're working hard to strike the right balance of short-term actions to reduce costs while preserving the development of the long-term portfolio and pipeline to enable us to capitalize as the recovery gains momentum, but there's no doubt short-term operating margins will be under pressure. Again, our expectation is for sequential improvement as revenue increases, resulting in more normalized margins by Q4. Our other key area of focus from a finance perspective has been available liquidity. As a reminder, our largest source of liquidity is our $2.75 billion revolving credit facility, which matures in 2023. We ended the first quarter with $1.36 billion borrowed against the revolver, mostly related to refinancing commercial paper earlier in the quarter due to market volatility. This left $1.39 billion of capacity, resulting in Q1 total available liquidity of $1.76 billion, including the $370 million cash on hand. As announced last week, we've successfully negotiated a $1.25 billion term loan and amendments to the maximum leverage covenants on our existing $1 billion term loan due 2021 and our revolver. The new term loan was used to pay down $850 million of borrowings from the revolver, as well as the $400 million remaining balance on the existing term loan due this December, thus increasing our available liquidity and clearing all 2020 maturities. As of this completed bank deal, we have $2.6 billion in available liquidity with $2.3 billion capacity on the revolver and $300 million cash on hand. The revolver and our term loans, which comprise approximately 25% of our outstanding debt, are the only debt instruments subject to debt covenants. Another important aspect of last week's transaction was the amendment of these covenant calculations to use an average of 2018 and 2019 quarterly EBITDA or approximately $670 million, regardless of reported EBITDA for the remaining three quarters of 2020, as well as to increase the leverage ratio to 4.75 times for the remainder of 2020. The term loans will come due in February and April of 2021. For the revolver, which extends through 2023, this max leverage ratio will continue to step down by a quarter turn, 0.25 times, starting in Q1 2021, continuing each quarter thereafter until reaching 3.75 times in Q4 2021. The remaining 75% of our outstanding debt is comprised of public bonds, which are not subject to any financial covenants related to our operating performance. Our next bond maturity is not until 2022 and is $500 million. Therefore, thereafter, our bonds mature at various times over the next 29 years, and no year's bond debt maturities are expected to exceed more than 50% of available cash flow in any one year, with most significantly less than 50% of expected available cash flow. For note, 2027 has the highest maturity with approximately $1.01 billion due. We believe this represents a very prudent debt maturity profile. With no remaining debt maturities this year, as a result of these transactions, we are prioritizing cash preservation and optimization activities. Beyond the cost containment and inventory initiatives previously discussed, we're also able to delay a material amount of capital expenditures without impacting current business performance. Of our original $450 million to $475 million in 2020 expected capex, we estimate a roughly 50-50 split between maintenance and investment, which we can delay given the temporary reduced need for capacity expansions. We have no plans to initiate a share purchase or a dividend, and with respect to our mesh litigation, there's no change to our reserve, nor to our having settled over 95% of mesh-related claims. For those claims that have not yet settled, we will likely slow the pace of reaching new settlements with plaintiff's attorneys, and thus now expect remaining payments into the qualified settlement fund of approximately $100 million to extend into 2021. Despite current unprecedented challenges, our team has worked diligently and effectively to pursue a prudent strategy to minimize risk and preserve our strong financial profile. We believe we are in a good position with our rating agencies and our lenders based upon frequent communication and our proactive risk mitigation plans, as well as our commitment to our investment grade profile. We believe we are striking the right balance between the need for short-term reductions in spend and preservation of cash, with the ability to capture fully and emerge stronger for the recovery opportunity. Thank you for your time, and thank you again to our stakeholders, our employees, and the global finance team. Please check our investor relations website for Q1 2020 financial and operational highlights, which outlines more detailed Q1 results, our debt maturity and liquidity profile, and the schedules Mike referenced for procedure acuity. With that, I will turn it back to Suzy, who will moderate the Q&A.
spk06: Thanks, Dan. Kevin, let's open it up to questions for the next 25 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. Kevin, please go ahead.
spk04: Thank you. If you wish to ask a question, please press one and zero on your telephone keypad. You may withdraw your question anytime by repeating the one zero command. If you're on a speakerphone, please pick up your handset before pressing the numbers. We will go to the first question. We've had questions from the line of David Lewis, Morgan Stanley. Please go ahead.
spk12: Good morning, and thanks for taking the questions. Mike, I'll just have a couple here on recovery. So thanks for all the detail this morning, very much appreciated by us and investors. So it's pretty clear based on your internal budgeting, you're forecasting growth in the fourth quarter. I wonder, Mike, can you share with us when you're thinking about from a budgeting perspective about, quote, normalcy, can that incur in the first quarter of 21, the first half of 21, and some companies have discussed this notion for capturing procedures or running higher than normal, either in the fourth quarter or next year? Wanted to get your thoughts on that and had a quick follow-up.
spk11: Yeah, good morning, David. Thanks for the question. It's really difficult to call that at this point in time. As you might expect, we have a number of different scenarios that we've laid out and we've looked at various triggers that we would pull to reduce cost or fuel investment faster. But our base case assumption is really what we laid out here, which is the most significant decline in second quarter. Encouragingly, we have seen an improvement recently in April, which gives us some optimism based on new centers opening up. And that sequential improvement, obviously in third quarter, and a goal to get back to growth in fourth quarter. But at this stage, I think it's probably premature to estimate whether there'll be a kind of a surge beyond that. So we'll keep you posted, but it's difficult for us at this point to project kind of the starting point for 2021.
spk12: Okay, and just a kind of related follow-up, Mike. Just as you think about pipeline procedures coming out of COVID, as hospitals resume procedures, when I think about key drivers this year, like Cryo, XUS, Exalt, or even Lotus that was still sort of in a phased rollout, what do you sort of assume in terms of how hospitals or physicians approach sort of new procedures? Do they focus on core procedures first? And how do you think that new procedures, what we prioritized by physicians and the sales team as we come out of COVID? Thanks so much.
spk11: Sure, we spent quite a bit of time trying to create that this chart for you in the investor website on emergent, semi-emergent, and elective. And clearly you're seeing the results in April. Many of our businesses have more highly emergent procedures, particularly in PI, particularly in interventional oncology, and many in interventional cardiology, as well as some in endo. So I think those emergent that we've laid out in this chart will occur most quickly. And then the semi-emergent and elective categories will likely trail those. But I think importantly that we've laid out in our chart, two thirds of our business is done in an outpatient setting, whether it be a outpatient center, OBL, or surgery center. So that two thirds is helpful for us because we believe those procedures will come back more quickly. So thankfully, we have our portfolio that's more heavily weighted towards outpatients. And also, many of our procedures are also, which is helpful, and that's profitable for hospitals. You've seen significant improvement and reimbursement of the procedures like Watchman and others. So I think the focus will be on these emergent procedures, and then followed by the semi-urgent or elective. But we're helped by the mix of the outpatient facility mix that we have.
spk04: OK, next we have Bob Hopkins of Bank of America. Please go ahead.
spk07: Oh, thank you, and good morning, and thank you for taking the questions. Two sort of big picture questions. First one is on your comments on cost cutting. And I realize we haven't heard from the whole medical device universe in the first quarter. But it does seem like the actions that you're taking are perhaps a little more aggressive on the cost cutting front than some of your peers. And I guess that could create at least some concern that it might, for the next, whatever, six to 12 months, set you back a little bit competitively versus those that are willing to just spend right through it. And so Mike or Dan, I was wondering if you could just kind of maybe address that concern and talk a little bit more about exactly where the cuts are and where they are not.
spk11: Yeah, absolutely. We're not concerned at all about the cost cutting and its ability to impact our competitiveness. We actually think it's smart. It's the rational cuts and our employees support it. So we have reduced down some of the inventory builds because we don't want to stack up too much inventory, which makes sense from a cashflow perspective. But we're very mindful of the need for surge capacity. So we ensure that we have ample supply, which we're very comfortable with based on the tracking that we do and the agility of our operations team. So we're doing this with a mindset that we're going to have a stronger recovery as the months move on here in second quarter and third quarter. And we're highly comfortable with ample supply, which is the most important one. Secondly, many of the actions that we've taken, actually we've led in this area, has been to secure our very important sales team. So we won't give the details there. We've ensured certain levels of compensation for our sales teams, despite the significant sales misses that are occurring. So we feel like we've built strong loyalty and support from our sales team by taking those actions earlier than most. And also we have moved to a four-day work week. And the goal for that would be for it to be a second quarter impact only, but we'll see how that progresses as the recovery returns. And quite frankly, that's been met pretty well with our employee base. They're highly engaged, they're working very effectively from home. We're building new capabilities in digital and it's really a one-team approach. And also with the support of the CARES Act, some of those employees are also benefiting from some of the financial relief in certain states in that area. So actually we think all the actions are what smart companies would do. And if anything, I think it's built potentially greater loyalty amongst our employee base within changes we've made.
spk07: Okay, yeah, thanks for that. One other big picture question, Mike, for you is that the Boston Scientific's stock price is down as much as companies with much less defensive mixes of businesses within MedTech. And just curious as to kind of the message to you or from you to investors on that front, it's notable for the relative underperformance this year so far. And just curious as to your kind of messages to investors on the ability of Boston to kind of come back.
spk11: Yeah, well that's why we wanted to lay this out in detail. We want to give you as much transparency as possible. We gave you the APRA results. We've seen some recent improvement and we're quite confident in the recovery plot that we outlined with improvement in third quarter and fourth quarter. And I think that's also what I mentioned with David's comment on the procedure mix that we have heavily weighted towards outpatient procedures is very helpful for us. And I think most importantly, when as procedure volumes get back, it's really about the portfolio that we have. And we have an impressive cadence of launches that we outline many of those across all of our businesses. And we have a very robust pipeline. We're keeping the key R&D projects alive beyond this. And so you'll continue to see us, we believe, having one of the most differentiated MedTech portfolios in the business, a highly engaged workforce, and the financial flexibility to weather the storm. So I would consider it a very good buying opportunity.
spk02: And I think the other thing, Bob, from my perspective is, I think of the conversations I've had with investors over the last 90 days, leverage and liquidity crept into that conversation where it hadn't been before. So we're a little bit more highly leveraged than some of the peers. So I think we took a little bit more of a decline based on that. I'm super proud of what the team did on the bank refinancing last week. I think we've answered that question, have ample liquidity, have things where we need on that front. So I think that's hopefully been asked and answered. And that was a little bit of a concern that folks had over the last quarter as well.
spk04: We'll go to nine of Robbie Marcus, JP Morgan. Please go ahead.
spk01: Thanks. And I wanna say thank you for giving us such great color, both on the top line and down the P&L. I think it'll be helpful for all of us for the rest of earnings. Maybe turning to my question, a big part of the Boston scientific story has always been the pipeline. And that's obviously hit a bump here is running trials is pretty difficult. You pulled the future product launch page. Hopefully it'll come back once you could get trials restarted. But how were you thinking internally about the delays to new product launches and something that was in the pipeline that had a trial involved with it?
spk11: Yeah, so this impact isn't exclusive to Boston scientific. Any company that's in the midst of ongoing clinical trials is gonna see a similar timeframe delay. So I think that's unfortunate, but getting patients to enroll in new clinical trials during the pandemic obviously hasn't been effective. So that's why you see the delay and that'll be consistent with any company who's enrolling any clinical trial. So I think in the near term, that's why we have in the materials, the launches that we had in 2020. So we have some very large launches in 2020 with the Watchman Flex, with the DCB Balloon, with the PolarX product in EP. We've got a number of product launches in Coronary and like eight of them in PI. So there's a significant number of launches that will occur in 2020. And then we've got a rich pipeline of other things, but it's called a three to six month delay, likely based on the clinical timing. So I don't think that'll be unique to Boston. The near term pipeline is strong. We talked about pre-COVID, growing faster than most of our peers, improving operating margins. And in terms of growing faster than peer group, that remains the goal. And we aim to continue to deliver that once the recovery happens. And we have the pipeline to do that. So the near term pipeline looks very good. And the clinical delays, I think you'll see across the board in the industry.
spk01: Great. And maybe as a follow up, maybe a little bit of a moot point here, but I just wanted to check, what were the trends like up through the middle of March in some of the businesses that faced a shortfall in fourth quarter? Believe ICD replacements were one, EP was another. How did those businesses trend before COVID really hit developed markets around the world? Thanks.
spk02: Yeah, I think this is Dan Robbie. Before COVID kind of -mid-March, things were kind of going pretty nicely on the rails. So obviously we saw in Asia, particularly in China, we had the impact that started in January, but for the US and EMEA and unaffected areas in Asia PAC, things were going pretty nicely. So the impact that you saw and the results that you see in Q1 is a China and Asia PAC impact across the full quarter, but really those last two weeks of March where it hit the brakes hard in the US and EMEA. And so those trends have kind of continued into April. As Mike said, we're seeing some signs of encouragement here recently in April and he gave you all the figures of what each business is down in April, but the Q1 results are really defined by the last two weeks of March in the US and Europe.
spk04: And next we'll go to the line of Vijay Kumar, Evercore. Please go ahead.
spk03: Hey guys, thanks for taking my question and again, appreciate all the color. This is probably the most detail we've gotten from any company. Mike, maybe on the second half recovery, I guess one of the questions we're struggling with is you'll have all these social distancing measures. When you think about your Salesforce re-engaging with physicians, how does that dynamic play? Does it have any impact at all? Or I'm just curious on how that impacts your new product that you mentioned, how does it get impacted?
spk11: Yeah, so I would say that clearly the physicians are managing the pandemic on their mind every day, but without a doubt, physicians are very anxious to bring back their procedure volume. They know patients are waiting for it, they're encouraging them to come back to the hospital and you're seeing some hospitals open up. So I think there's a great alignment in terms of hospitals desire appropriately the right time to bring back elective procedures and there's very high alignment by physicians wanting to do that and some physicians and OVLs are talking about working six, seven days a week, multiple shifts to make up for that backlog. So I think there's a lot of industry alignment with the motivations of the hospital and the physician community to bring that back. In terms of our sales reps, we've had excellent retention obviously during this period they wanna support their inherent natures to support their customers and they do it in a safe way. We give them obviously the proper PPE. The local testing will really be a local event in terms of the requirements that our sales reps will go through to work with their physicians in terms of what testing protocols. I think that'll vary by city, by state likely and we obviously have our own internal programs, but I don't see the social distancing as a deterrent in terms of our sales reps collaboration. We'll go through the right testing protocols, we'll have PPE and importantly our ability to work for those who need more remote support. We have excellent capabilities here across CRM, Neuromod, PI across our businesses to support our sales reps remotely with remote proctoring, remote training, remote support, remote device checks. So we have excellent capabilities there, but I don't think the social distancing will be a big impact on the recovery.
spk03: That's helpful and then one follow up maybe on the maybe pricing environment in a post-COVID world maybe general some comments on as you see your customers being under pressure, does it change behavior and maybe thoughts on how the industry is set up to respond to it, thank you.
spk11: Yeah, I think we'll do everything we can to support our customers like we always do with clinical support, with excellent product supply and great innovation. Many of our procedures help support hospitals financially based on the reimbursement that they receive based on the clinical value and pricing is always a topic in Meddevice since I've been in the industry forever and we'll continue to manage that with our VIP cost improvements and bring in new innovation and partnering in many ways with customers beyond just price.
spk04: We'll go to the next in line of Joanne Winch of Citibank. Please go ahead.
spk05: Good morning and thank you very much for all the information you provided. I have two questions, I'll put them right up front. I'm curious how you're doing with some of the integration of the acquisitions you've made over the last 18 months, particularly BTG in this current environment and what you're really seeing there. And then my second question is, I'm looking generally in life right now for silver linings. So during this period of time, what are you learning either about your business or your employees that help you on the other side? Maybe it's telemedicine, maybe it's expenses, maybe it's something else, thank you.
spk11: Sure, on the integration front, the largest one, BTG, has performed extremely well during the pandemic. So if you wanna build a pandemic portfolio, you wanna have Therasphear. So Therasphear is doing extremely well, grew I think mid teens in the quarter, taking share and is really not a procedure that can be deferred. So the interventional oncology business broadly is doing well, really driven by Therasphear. So I'd say on the sales piece of it, and they also saw Spec Pharma do quite well. So from a sales standpoint, the BTG portfolio has been more robust than legacy BSC, which is great news. And integration, we got ahead of that pre-pandemic. So we're very much on track with the cost synergies commitment that we've made, which is the summer. And most of that work had already been done and implemented pre-COVID pandemic. There's a few facility closures that we're working through that may be temporarily delayed, but overall I would say the cost synergies are on track, if not ahead of track. And the integration of the commercial teams is really kind of taking place. I think that's all systems go. And then we'll launch on other deals. VertiFlex performed quite well pre-COVID. In terms of capabilities, it's been a really interesting time and very proud of what we've seen. I would say the people are frustrated because they wanna get out and see customers. And I think most people in this industry don't love social distancing, but we've learned a lot from it. I would say our global capabilities have accelerated. Many of our digital capabilities that maybe were isolated in certain regions or certain businesses have really accelerated in terms of global implementation. So this period where people are working from home really has put a greater emphasis on our digital capabilities internally, our remote training capabilities with physicians, remote training internally. And we're seeing a much, I would say an acceleration of those capabilities over the past 60 days, which quite frankly wouldn't have happened at near that speed in a normal environment. I don't know, Dan, anything else?
spk02: No, I would, selfishly I'd point to finance. If you had said two months ago that we could close the books globally, conduct an earnings call, file our 10Q and then refinance our bank deal all virtually, I think you would have had some doubters. And the team did that. And we've learned a lot of new capabilities that'll serve us well for years to come.
spk11: So. It's also important to note that our R&D teams are still working. And so, they're working from home and they're working from, we have engineers all over the world. So many of our key R&D programs are still in flight. You're still seeing the FDA has been very responsive, I would say during this period. So our regulatory teams are still working on filings for product approvals. You saw a bunch of new approvals just in April. And we will begin opening facilities in Minnesota in May. As well, ideally in Mass and likely in mid-May. And we'll be prioritizing anything that touches product development, quality, and new product development in terms of our opening sequences. So we'll prioritize those. Those that can work from home efficiently will continue to work from home. But those that are involved with product releases or new product development will come back to work in a safe way.
spk04: Next we'll go to the line up Josh Jennings, Cowen. Please go ahead.
spk09: Hi, good morning. Thanks for taking the question. I wanted to just ask about Japan. I apologize if I missed this in the prepared remarks, but you had a nice download in terms of what you experienced in China in February, January, February, March, and now April. Are you able to do the same thing with Japan just to spend some concerns in April about the emergency, state of emergency, and potential second wave there?
spk11: Yeah, so in the first quarter, Japan business is quite strong. It actually had some positive growth in Japan. There has been a little bit of an impact thus far in April, but not to the same levels that we've seen in Western Europe or US. And so we do expect Japan will likely soften a bit more than it did in the first quarter, but their handling of the crisis has been pretty efficient. And in terms of our business, we do expect some softening based on what you just indicated. But thus far, it hasn't been to the same level that we've seen in Western Europe or US.
spk09: Great, and then just to follow up, just with the recovery in the fourth quarter, those expectations, are you baking in any assumptions around a potential seasonal second wave?
spk08: Is
spk09: that excluded from those expectations, or are you assuming that healthcare delivery systems will be able to handle a second wave much more effectively and elective procedures will be able to continue at a higher clip than what we've seen in this first go around? Thanks again.
spk11: Yeah, so we won't go through our eight scenarios we have for the remainder of the year, which I think is important to have for any company, and actions we would take to pin in those scenarios, either positive upside or potentially softening. And so the base case that we believe is what we outlined. If there was an issue where there's additional second waves they likely potentially could be a little bit smaller impact based on the readiness that our facilities have and hospitals have.
spk08: And
spk11: we also would have the cost levers to pull in case that we see that. So we don't discount that additional waves may happen. We don't think it would be near to the same impact that we saw the second half of March or April. But we continue to look at countermeasures we put in place in those cases.
spk04: And our final question will be from the line of Jason Bedford, Raymond James, please go ahead.
spk10: Good morning, thanks for taking the questions. Just a couple of product line questions. It looks like you're losing a bit of share in CRM and I realize there's a lot of noise out there, but can you talk to this dynamic and specifically comment on SICD trends?
spk11: Good morning, thanks for taking the questions. Yeah, we talked about this a little early in the year. We don't believe that we're losing share in CRM, likely holding share. We have lost a little bit of share in pacemakers. We just launched a new lead in pacemakers which will help in that business and we have easier comps although the comps are kind of all messed up now. So I would say in pacemaker business we have lost a little bit of share. In ICD we believe that we've continued to hold share. The prior years we gained share a number of years in a row in ICD and CRTD, but we believe we're maintaining share. And we have a couple of new launches besides the heart logic which I think will really benefit and the capabilities of heart logic will show through in the pandemic. The ability to manage a patient remotely and get a view of their heart failure diagnostics proactively is a beneficial feature to have during a pandemic. So I think those benefits will be seen as well as the longevity benefits. SICD continues to do well and we have two important trials that we'll read out at HRS for SICD. So we're comfortable with our CRM market share broadly.
spk10: Okay, that's helpful. And then maybe Dan, can you just comment on the impact of selling the intrauterine health franchise? How big is that?
spk02: It's about $35 million in annual sales of materials for the overall enterprise.
spk10: Thank
spk06: you. All right, great. With that, we'd like to conclude the call. Thanks for joining us today. We appreciate your interest in Boston Scientific and hope that you all can stay safe and healthy. And again, a thanks to the frontline workers. Before you disconnect, Kevin will give you all the pertinent details for the replay.
spk04: Thank you. And this replay will be available and that's starting today at 10.30 a.m. Eastern Daylight Time. And we'll run through May 13th, midnight. You may dial the AT&T system by dialing -207-1041 and entering the code of 454-3494. International columns may dial -970-0847 with the access code 454-3494. And that does conclude your conference. We do thank you for joining. You may now disconnect.
Disclaimer