Becton Dickinson and Co (BDX) 2021 Q1 法說會逐字稿

Hello, and welcome to BD's First Fiscal Quarter 2021 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 11, 2021, on the Investors page of the bd.com website or by phone at (855) 859-2056 for domestic calls and area code (404) 537-3406 for international calls using confirmation number 6993448.

(Operator Instructions) Beginning today's call is Ms. Kristen Stewart, Senior Vice President of Strategy and Investor Relations. Ms. Stewart, you may begin.

Thanks, Stephanie, and welcome to BD's review of our first fiscal quarter results. Joining me today, we have Tom Polen, Chief Executive Officer and President; Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer.

During the Q&A portion of the call, we will have our 3 segment presidents joining us as well: Alberto Mas, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Simon Campion, President of the Interventional segment.

A few logistics before we get into the call. This call is being made available via webcast at bd.com, where you can also find the accompanying slides for today's call.

During the call, we will be making some forward-looking statements, and it is possible that risks could differ -- sorry, actual results could differ from our expectations. Risks, uncertainties and other factors that could cause such differences can be found in our earnings release and in our SEC filings, including our 2020 Form 10-K and subsequent Form 10-Qs.

In particular, there continue to be significant uncertainties about the duration and contemplated impact of the COVID-19 pandemic. This commentary we are providing today includes our best estimate based upon the information that we currently have. We have made certain assumptions in how we are managing our business, but that could change as we move forward.

We will also be discussing some non-GAAP financial measures with respect to our performance. The reconciliations to GAAP measures that include the details of purchase accounting and other adjustments can be found in our press release and its related financial schedules in the appendix of the Investor Relations slides. These are also available on the bd.com website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus fiscal 2020. When we discuss revenue percent changes, they are on an FX-neutral basis, unless otherwise noted.

With all that said, it is my pleasure to turn it over to BD's CEO and President, Tom Polen. Tom?

Thank you, Kristen, and good morning, everyone, and thank you for joining us. We are very pleased with our Q1 results, which were ahead of our expectations, reflecting the tremendous efforts and execution of BD's 70,000 associates. The essential role of our products and solutions in health care and the greater resiliency of the health care system in treating both COVID and non-COVID patients.

While our fiscal year has just started, I'm proud of the team for the momentum we are building and their dedication to our purpose of advancing the world of health.

Revenues increased 25.8% on a reported basis or 24.3% on an FX-neutral basis, with 20.3 percentage points of growth coming from our COVID-19 diagnostic revenues. While we did see some benefits from timing in the quarter, we are very pleased with the performance of the base business, which was up 4% against the backdrop of COVID resurgences around the world. We are seeing the early benefits of some of the actions we have taken to drive our base performance.

Our adjusted EPS were $4.55 or up 72% versus the prior year. This was also well above our expectations as a result of 3 factors. First, our revenues came in above our plan, driven by higher acuity driving increased demand, greater resiliency and procedural volumes and exceptional execution in COVID diagnostics. Second, we benefited from favorable product mix, like Veritor, but also from our higher-acuity products. Third, our investment spending, such as in R&D, was lighter and earlier in ramping.

So, as you can see, we started this year with strong momentum, and that is despite the COVID resurgence. We did start to see some impact of the resurgence on our more elective procedure-related businesses late in December, and that continued into January. However, we are feeling more confident in the resiliency of our base business relative to what we saw early on in the pandemic. While the health care markets continue to be dynamic with COVID-19, and there are a number of moving parts, the momentum within BD and our conviction in our strategy lead us to raise our financial guidance for fiscal 2021. Our focus is not only on fulfilling our near-term commitments, but also on advancing our strategy and creating value for our shareholders over the longer term. And I'm feeling even greater confidence with the progress the BD team is making in advancing the BD 2025 Grow, Simplify and Empower initiatives and our ability to create substantial shareholder value.

Today, I want to focus my remarks on 3 key topics, and then I'll turn it over to Chris, who will provide additional remarks on our quarter's performance and comment on our outlook, then we'll take your questions. So, let's jump right in.

First, let me start with the Alaris remediation and our overall quality and compliance initiatives. Alaris remediation has and continues to be my #1 priority, and the team is making strong progress. Our focus remains on submitting a comprehensive 510(k) filing for the Alaris system, and we remain on track to submit it in late fiscal Q2 or early fiscal Q3 2021. We also continue to make progress on executing our holistic Inspire Quality initiatives throughout the organization. Second, as you know, we have a very strong focus on growth and ensuring a durable mid-single-digit revenue growth profile, so let me share some of the exciting highlights in our pipeline and other growth initiatives.

We continue to increase our investments and strengthen our pipeline across 3 innovation themes that leverage our core strengths. First, we're applying smart devices, robotics, analytics, and AI to improve care processes. Second, we're enabling new care settings to enhance patient experience and lower costs. This includes investing in products designed for use in the home markets and in sales channels to support these patients. And third, we're investing to improve diagnosis and treatment of chronic disease.

So, in line with these innovation and investment priorities, in Q1, we acquired the medical assets of CUBEX, which expands our medication management offering by combining a cloud-based, easy-to-deploy analytics platform with a smart tabletop dispensing device to create solutions for the fast-growing non-acute care market. This extends our medication management solution from the hospital into the long-term care surgery centers and other non-acute locations. Another smart device we plan on launching this quarter is the Sensica automated urine output system, which leverages BD's leading position in acute urology, along with BD's broad EMR interoperability capabilities and installed base.

Also, within BD Interventional, the BD PureWick urine collection system and catheter continues to be a significant driver of growth for our urology and critical care business. PureWick is a female external urinary catheter and urine collection system that we sell into the acute care and long-term care settings, but we're now actively extending that directly to patients with our new PureWick dry dock system for the home. And this launch is exceeding our expectations, and in fact, PureWick revenues now exceed Lutonix.

An exciting launch later this year, designed to improve the diagnosis and treatment of cervical cancer, is the U.S. launch of our new BD COR with our BD Onclarity HPV assay with extended genotyping. With BD COR, BD is going to enter the high-throughput molecular testing market with a very unique, fully automated sample-to-answer platform in a highly differentiated assay with unique claims that can improve risk stratification and support risk-based patient management. The system has been CE Mark-ed and has been very well received by our customers during our launch in Europe.

These are just a few of the many products in our pipeline, and you can find further details on our new innovations in the supplemental earnings presentation posted to our website.

As we've previously shared, we're investing a portion of our Veritor profits to advance our BD 2025 strategy. We expanded the size of the BD Innovation and Growth Fund and additional innovation projects are being initiated on a rolling basis. We are investing to accelerate our simplification initiatives, including RECODE and enhancing our quality and compliance programs. We're also increasing funding in our BD University, to support advanced employee education and leadership development, as part of our strategy. As we always do with our spending, we're taking a disciplined approach, and the timing of the spending was lighter in Q1, and we expect it to step up in Q2 and remain higher for the balance of the fiscal year.

As we've mentioned before, we continue to actively evaluate tuck-in acquisitions to supplement our growth strategy. And we executed on 3 strategic tuck-in transactions so far this year, including CUBEX's medical assets that I mentioned earlier. We continue to apply a disciplined financial and strategic evaluation process to these transactions and have a robust funnel.

Lastly, I'd like to update you on our COVID diagnostics outlook and specifically Veritor. Antigen testing continues to become more widely used in both traditional and nontraditional settings. We have been highly successful with our BD Veritor Plus COVID-19 launch. Veritor has been well received for the ease of use, performance and automated digital data and informatics capabilities that are provided with our handheld platform. We've nearly tripled our active reader base since the pandemic and now have more than 70,000 BD Veritor analyzers globally, which we intend to leverage in the future with planned non-COVID menu expansion, which we've already begun investing behind. As previously shared, we continue to make good progress on advancing new COVID diagnostics in our pipeline, including combination flu A/B and COVID-19 assays on both BD MAX and Veritor. We also continue to explore home testing on BD Veritor, and has been our practice, we'll provide updates to these programs upon launch.

Turning to the quarter's performance: Our Q1 COVID-19 diagnostics revenues were higher than we expected at $867 million, which included better-than-expected BD Veritor rapid point-of-care antigen test revenues of $688 million and higher BD MAX COVID assays and collection swabs and transport devices. The higher-than-expected Veritor revenues were the result of our ability to scale our manufacturing faster, which is a testament to our manufacturing excellence, as well as realizing higher pricing than we anticipated.

However, since we've been saying since last fall, we do expect pricing to move lower as capacity came online, and this is what's playing out. We recently lowered our pricing to allow the broadest patient access to our best-in-class BD Veritor Plus System. We believe this price adjustment is in the best interest of our customers and patients around the world as we've now ramped our manufacturing capacity, and there are emerging mutations that are making it more transmissible. We also believe this is in the best interest of our shareholders as we believe this move allows us to maintain a leadership position in the point-of-care market.

With respect to our fiscal 2021 Veritor revenue guidance, as we've been discussing, there continues to be many variables at play besides the evolving pricing environment, including the rollout and adoption of vaccines and the circulation of new COVID variants. It's also difficult to pinpoint when the market supply for antigen tests will exceed market demand. For modeling purposes, we would suggest using an ASP in the low to mid-teens. Given all this, we expect Veritor revenues to be toward the high end of our previous range of $1 billion to $1.5 billion. We continue to expect Veritor revenues to be more weighted to the first half of our fiscal year. And given the evolving pricing and capacity environment, we would expect our fiscal Q2 revenues to be lower than our just reported Q1 results.

Before turning it over to Chris to review the financials, I want to close with a few thoughts. While we were very pleased with the performance of Veritor and other COVID diagnostic revenues in the quarter, what excites us more was the improving momentum and resiliency of the base business. While we saw some headwinds in our procedure-based businesses from the resurgence late in December and that continued into January, the impact was much more limited than at the start of the pandemic. Moreover, given the momentum in our base business, the investments we are making in our BD 2025 strategy, we believe we are positioned to emerge strong. We remain on track to submit our Alaris 510(k) filing in late fiscal Q2 or early Q3, and we're making great progress in advancing our BD 2025 strategy, and I'm particularly pleased with the investment programs we've identified and initiated. These investments allow us to further fulfill our purpose of advancing the world of health, bringing new innovations to patients and expand access. Increased spending will be more evident in our P&L later in this fiscal year, but we believe these initiatives will translate into revenue accretion beginning in late FY '22 and beyond.

The investments we are making are also towards simplification initiatives, which reduce complexities, drive cost efficiencies, enhance our quality programs and improve cash flows. This quarter, we made several advancements on this front, including inventory reductions that we absorbed in our gross margin in the quarter that helped us strengthen our cash flows. Our RECODE efforts are on track to achieve our targeted $300 million in cost savings by the end of fiscal 2024.

We're also advancing our sustainability initiatives because we view sustainability as a strategic imperative. And we recently announced the first of our 2030 and beyond goals, our climate change targets. We're committed to reducing Scope 1 and 2 greenhouse gas emissions 46% by 2030 and to be carbon-neutral across direct operations by 2040. The science-based target is aligned with the 1.5-degree C global emissions reduction pathway. And we look forward to sharing more detail behind our 2030 sustainability plan with you in future engagements.

And finally, I'm very proud of the organization for being named for 4 consecutive years to The Human Rights Campaign Foundation's 'Best Place to Work for LGBTQ Equality' list and for the second straight year to the Gender-Equality Index. Inclusion & diversity is an important focus for BD as we continue to attract, develop, and retain the best talent as well as benefit from diversity of background and thought.

I look forward to answering your questions during the Q&A portion of this call, and I'll turn it over to Chris now.

Thanks, Tom, and good morning, everyone, and thanks for joining us today. We are very pleased with our fiscal first quarter revenue and adjusted earnings per share performance, both of which exceeded our expectations. Total revenues were over $5.3 billion, in line with our January 12 pre-announcement. Revenues increased 25.8% on a reported basis and 24.3% on an FX-neutral basis. COVID-19 diagnostic revenues accounted for 20.3 percentage points of growth.

The better-than-expected performance came from 3 areas: first, our base business performed better than expected. This was a result of stronger execution from our associates, greater resiliency and procedure volumes as health care facilities manage both COVID and non-COVID patients, and higher acuity resulted in both favorable product mix and increased demand for several product lines. Keep in mind, though, that some of our business segments are still operating below pre-COVID volume levels. Second, our COVID diagnostic revenues were higher than expected. This included not only Veritor revenues but also MAX and swab and transport revenues. Lastly, we estimated about $100 million in revenues were attributable to stocking and timing. As COVID-19 surges were occurring, we observed some of our customers moving to more of a just-in-case level of inventory and maintaining higher levels of our critical-need products on hand. We also saw some of our U.K. customers buying more ahead of Brexit. The $100 million includes higher-than-expected revenues in our MMS Infusion Systems business due to COVID-19.

BD Medical revenues totaled nearly $2.3 billion and grew 6.9% on an FX-neutral basis. Our outperformance was primarily in Medication Delivery Solutions as well as in Medication Management Solutions. MDS revenues were up 5.6%. While hospital utilization remains below pre-COVID levels and has been an ongoing headwind, we benefited from the acuity of care associated with the treatment of COVID patients. We saw increased demand for PICC's vascular prep and maintenance. As I mentioned, we believe stocking of critical-need products helped the quarter. Finally, as expected, there was $37 million in revenues associated with COVID vaccination syringes and needles.

Now turning to our MMS business. Revenues grew 8.4%, with growth in both medication dispensing and infusion systems. In dispensing, we had strong growth internationally and once again exited the quarter with strong committed contracts in the U.S. In infusion systems, we continue to support U.S. customers' response during the pandemic on the medical necessity and experienced another quarter of strong demand in Europe. In Diabetes Care, revenue growth of 5.4% was above our expectations, reflecting distributor inventory stocking in addition to an easy comparison to last year. We still view this business to be more of a flattish business on a normalized basis. Pharm systems sales remained strong, growing 9.5%, driven by ongoing demand for our market-leading prefilled syringe portfolio.

BD Life Science revenues totaled nearly $2 billion and were up 74.1% on an FX-neutral basis. As I mentioned previously, COVID diagnostic revenues were $867 million in the quarter. Excluding COVID diagnostic revenues, BD Life Sciences revenues were down 2.4%, which was better than we expected.

Integrated Diagnostic Solution revenues increased by 106% due to COVID-19 diagnostic testing revenues. Excluding these COVID diagnostic testing revenues, IDS revenues were down just 1.2%.

There were several puts and takes in the base business. We saw a stronger-than-expected performance in our specimen management, blood culture and women's health and cancer product lines. We also saw some element of distributor stocking that's critical to health care testing. However, while we have seen improvements, routine diagnostic testing activities are not fully back to pre-COVID-19 levels and a significantly lighter flu season negatively impacted the base revenue growth in the quarter on a year-over-year basis.

Now turning to Biosciences: revenue declined by 5.2% due to a difficult comparison as a result of prior year licensing revenue. In addition, clinical and research activities are not yet fully back to pre-COVID-19 levels. Overall, operational performance in Biosciences was better than expected.

BD interventional revenues totaled nearly $1.1 billion and were up 5% on an FX-neutral basis, with all business units posting growth. We observed that elective procedures, particularly those conducted in an outpatient setting, had greater resiliency in Q1 compared to the initial wave of COVID. This was likely driven by processes and care settings that enable elective procedures to continue despite the resurgence and a greater willingness on the part of patients to attend to their scheduled elective procedures.

Surgery sales were up 1.3% as strong sales growth in our infection prevention business was offset by the ongoing headwinds related to lower procedures due to the pandemic.

Peripheral Intervention sales were up 5.9%. Growth was driven by strong performance across our peripheral arterial disease platforms.

Urology and Critical Care turned in another quarter of strong growth, with revenues up 8%. PureWick continues to fuel the growth in our acute urology franchise while our new connected Arctic Sun System is driving double-digit growth in our targeted temperature management business. This is another example of BD leveraging our digital capabilities and broad EMR interoperability footprint to bring new innovations to market.

Now turning to the P&L. We were really pleased with our gross margin performance in the quarter. Our adjusted gross margins were 58.2%, which expanded 170 basis points year-over-year on a reported basis. On an FX-neutral basis, our gross margin expanded 250 basis points, which was primarily driven by COVID diagnostics and higher-acuity products.

While SSG&A and R&D spending were both higher on a year-over-year basis, the level of spending was lower than we anticipated, particularly R&D, reflecting mainly timing. Operating margins were 31.6%, up 830 basis points on an FX-neutral basis, which was driven by higher gross margins and reduced SG&A and R&D spending.

Net interest expense was $118 million, down slightly on a sequential basis. Other income was $30 million versus $27 million a year ago. And the adjusted tax rate came in at 14.6%, which was in line with our expectations. Our adjusted non-GAAP EPS were $4.55.

In fiscal Q1, the preferred shares are dilutive. Therefore, in calculating the adjusted non-GAAP EPS, preferred dividends amount of $23 million was excluded from the numerator, while the diluted share count would be adjusted to include the dilutive impact of the convertible preferred shares and would be 299.1 million.

As we've been discussing, our BD 2025 strategy includes a focus on driving cash flow, and we were really pleased with the continued progress of these initiatives and our cash flow performance. We generated $1.5 billion in cash flow from operations in the quarter and $1.3 billion in free cash flows. We have also been focused on strengthening our balance sheet. As we previously communicated, we paid down $265 million of debt in the first fiscal quarter. Our net leverage ratio declined to 2.5x as of December 31, 2020, from 3.0x at the end of September 2020. A few weeks ago, Moody's upgraded our credit to an investment-grade rating, and we are committed to maintaining a full investment-grade credit rating across the major credit rating agencies.

We believe we are approaching a turning point in our capital allocation. In the past, a significant amount of our cash was dedicated to repaying the debt. But looking ahead, we expect to have greater flexibility to refocus our cash deployment on growth opportunities, including tuck-in M&A and other capital deployment options.

Next, I want to address fiscal 2021 guidance. While we observed greater resiliency in Q1 as it relates to procedure volumes, we still view COVID-19 resurgences to be a significant risk factor to our forward outlook as it could impact general health care utilization, procedure volumes and diagnostic testing, including COVID testing. In the latter weeks of December, as the resurgence has picked up, we started to see pressure on some of our procedure-based products. This trend continued into January. We have updated our guidance to incorporate some impact from the resurgence into our forecast for fiscal Q2, and we continue to monitor the trends.

Our guidance continues to assume no major system-wide shutdowns of elective procedures. Now given the strength of our Q1 performance, along with our outlook for the remainder of the fiscal year, we are comfortable forecasting FX-neutral revenue growth in the range of 10% to 12% compared to our prior range of high single to low double digits. This would include our assumption of Veritor revenues being towards the high end of our original guidance range of $1 billion to $1.5 billion.

Using current exchange rates, we expect FX to add approximately 200 basis points to revenue growth versus our prior year guidance of about 100 basis points. We expect our non-GAAP EPS for fiscal 2021 to be in the range of $12.75 to $12.85, which is above our prior guidance range of $12.40 to $12.60, a raise of $0.30 at the midpoint of the range. So, for these reasons, while we are extremely pleased with our strong execution in fiscal Q1, we want to caution against extrapolating our fiscal Q1 revenue, margin and EPS performance going forward. While we are not giving quarterly guidance, we thought it might be helpful to provide some context on this quarter's strength as you contemplate phasing for the rest of the year.

Our Q1 revenues, operating margins and adjusted EPS are likely to be the highest absolute levels for the year due to 2 factors: Veritor pricing and the ramp of our planned investment spending. In addition, the stocking of $100 million will unwind in the remainder of the year. As Tom mentioned, we expect Veritor revenues in fiscal Q2 to be lower than Q1. As we have discussed in the past, we expected our COVID test pricing to decline, and this is playing out. We expect Veritor to be well positioned for broad access as we look ahead.

Regarding our operating margins, our fiscal Q1 EPS benefited from the higher Veritor revenues and margin profile as well as the timing of investment spending. We expect investment spending, particularly in R&D, to be meaningfully stepped up in Q2. The combination of these 2 factors will result in our operating margins moving into the low to mid-20s in our fiscal Q2.

In the second half of the year, given our expectations for lower Veritor revenues and for investment spending to continue to ramp at a similar rate to fiscal Q2, we would expect operating margins in the low 20s. We're also seeing some impact from the resurgence in January. And like many others, we are also continuing to see pressure from higher shipping costs as well as some other headwinds. However, due to the strength of our Q1 results, we're able to offset these headwinds and raise our full year EPS guidance.

With that, I'll turn it back to Kristen, who will help moderate our Q&A.

Thanks so much, everybody. And with that, I'm going to open it up to the operator, Stephanie. Stephanie, could you please read the instructions?

(Operator Instructions) Our first question is coming from David Lewis from Morgan Stanley.

Congrats on a nice start to the year. Just two for me, team. So, first is just earnings reconciliation, Chris, obviously, beat by more than $1.50, raised by $0.30. And I know you gave some parameters there. But we had pricing reductions in our model. We had 20% reinvestment of that upside in the model. Even when you make those kind of adjustments as well as stocking, it's still a little hard to reconcile the upside in the quarter relative to the guide. So, I appreciate it's a less visible environment. But is there anything else? Is that investment going higher? Or anything else we may not be thinking about that would explain why we're not getting this sort of that pull-through in the second & third quarter? Because I think that's going to be the key question this morning of the call.

Sure, David. Thanks for the question. And I would say, first of all, it's early in the year, obviously, so we're raising -- but some of the factors that you mentioned we do see playing out in the remainder of the year. So, we had a few things going on. Obviously, we mentioned that Veritor, we would expect that revenue to come down in the remainder of the year and moderate, as we talked about. We also had timing in the base business that we would expect to moderate. And to your point, we do expect the investment spending both in the Veritor reinvestment program that we've discussed as well as R&D and quality to ramp. So, we started those programs in Q1. We watch those -- that spending with some prudence as we looked at the pandemic playing out. And so we got started, but the ramp really comes in the second, third and fourth quarter.

And so when you put all of that into context, you also have to take into consideration a little bit of impact from the resurgence that we saw that we mentioned we have playing out in Q2. So, with all of those factors coming into play, we felt that the -- it was prudent to think about the guidance that we gave as appropriate at this point.

Dave, this is Tom. Thanks for the comment. Just to reiterate what Chris mentioned, that other topic, is that we still are in the middle of a pandemic. We want to be prudent, right? We did see some increases on impacts in procedure volumes in this late December and throughout January. It was certainly less than what we had seen earlier in the pandemic. But there are new strains underway, et cetera. And when we gave guidance at the beginning of the year, we said it excluded, right, the impact of a resurgence. Well, there's been a resurgence. And we've been navigating that very well and actually are raising our outlook in the middle of a resurgence. So we'll continue to evaluate as things go forward, but we're certainly pleased with how we started the year.

Okay. So the state of factors you've mentioned, but we're not missing anything, it doesn't sound like. Okay. The second question for you, maybe Tom, more strategic. This is obviously going to be very good year. We'll see significant upside. The balance sheet is obviously in dramatically better shape now than it was a year ago. As you think about 2022, Tom, how are you thinking about the durability of COVID testing? I know it's a challenging question. And then the ability to sort of manage through what's likely going to be sort of a volatile or void-driven earnings period as you head into '22. And how are you thinking about sort of '22 and beyond COVID-wise and sort of managing the earnings process?

Yes, I'll start on that, and then I'll turn it to Chris as well to share some comments. Let me maybe focus on specifically COVID testing, and then Chris can make some broader comments on the broader business. And we've shared, by the way, in the past, we still remain very confident and expect our revenues, excluding COVID diagnostic testing, and Alaris pump revenues to grow in those mid-single digits on an FX-neutral basis for '22, and that remains our aim and our expectation.

In terms of COVID testing as we go into '22, certainly, as I'd shared before, as we got into COVID rapid testing last July, obviously, we didn't have a high expectation that there would be much testing in '22. And as kind of each quarter has gone -- has passed since that launch in July, we've said we're feeling more confident there's going to be some level of testing in FY '22, and that certainly remains the case.

I think what -- one of the ways to think about, as our capacity has gone up in the space, as we recognize the new strains coming in the market, as antigen testing continues to increase in its receptivity and people understand now the value in increasing ways of getting a test result in 15 minutes, you saw us take some actions this quarter to get pricing in that low to mid-teen level, which we think will be more -- actually position us well to, as I said, maintain a leadership position for whatever market continues to evolve going into FY '22, right? That's part of the thinking. Where the actual market ends up in '22? I don't know at this point in time. I think that there definitely should be some level of testing. And our aim is to make sure that we're positioned to be a leader in however that testing evolves. And other things that we're investing in as well; be it our combination assay, which is progressing well in our pipeline, the flu COVID assay, or our exploration of home testing; are all aimed with that thought in mind as well. So maybe, Chris, just maybe some broader comments on FY '22.

So yes, obviously, we're not going to go through '22 with any level of precision, but I think it is important to give some high-level comments on it. And as Tom mentioned, the level of COVID testing is a variable that will have a big impact on '22. We do see the sustainability of testing, but at what level? --- It's really hard to guess at this point. In addition, there's a lot of other uncertainty around COVID in general; the resurgences, mutations, the uptake of the vaccines. And in our business, obviously, Alaris and when that comes back in '22, will have an impact.

I would remind you that on our November call we said we expected our revenues, excluding COVID diagnostic testing and the Alaris pump revenues, to grow in mid-single digits on an FX-neutral basis. And we continue to see that as a reasonable assumption. We can't predict when the FDA clearance for Alaris and our focus on making a comprehensive filing to support a timely approval is there, but we would expect some clearance sometime in fiscal '22.

We'd also not look at the second half of '21 as a proxy of what to expect in '22 because both the gross and operating margins are impacted by several factors. Our operating margin in fiscal '21 reflects these incremental investments we're making as part of the investment program of Veritor that really helps drive durable growth aligned with our 2025 strategy. And we don't expect those investments to continue into '22, so they'll exit. Exiting '21, they'll roll off and that should help margins going into '22.

The other thing I'd point out is that Q1 fiscal '22 will obviously be the most difficult comp from a margin perspective, given the very strong quarter we just reported. For example, most likely face the most difficult comparison with COVID revenues as well as from the impact of the timing and stocking that we talked about. So, we would expect our operating margin to compress year-over-year from the 31.6% that we just achieved. So, we'll update you more on our thoughts on '22 as we progress through the year, but we just thought it's important to provide some of those highlights.

Yes. And as you mentioned, Dave, we feel really good about the progress of our strategy overall and the underlying business momentum that we continue to build upon.

Your next question comes from Robbie Marcus with JPMorgan.

Great. Congrats on a good quarter also. I wanted to touch on one of the slides in the back you have, that the underlying basis ex COVID grew 4% in the quarter, which was a really healthy rate. How are you thinking about that base business ex-COVID growth through the cadence of the year here? That's a pretty healthy start in what was a tough quarter. How should we think about that component of the business throughout fiscal '21?

Okay. Thanks, Robbie. I'll let Chris answer that.

Yes. I think one way to think about that is what I mentioned about '22, is that we expect the base business to be ramping at a mid-single-digits [growth rate] (added by company after the call). So that's consistent with that. So, I think that we feel the underlying business is solidly in that kind of perspective. And as we talked about the base business, we expect to be kind of in that low to mid-single-digit level for the full year. And so, there is some pressures in the second half of the year on a business-by-business basis. As you think about MMS, there will be some issues. It's going to be lumpy in the remaining quarters. MMS had a significant amount of revenue in the third quarter during the pandemic last year. Other parts of the business will ramp nicely. China, for example, as we lap the COVID impact that really was in Q2 there in China, so we'll start seeing some revenue growth from that. But again, that's more of a compare. It's not an indication of the underlying business. But the underlying business really is in that low- to mid-single-digit basis. We have some general issues with compare to the -- based on the Alaris ship hold. Some of that's been negated by medical necessity. So, there are a number of factors going on. But the bottom line of it all is: think about the base business, for the remainder of this year, in that low- to mid-single digits and exiting into '22 in the mid-single-digit basis.

Great. Maybe just a quick follow-up. You're generating a pretty significant amount of cash here. You got the balance sheet in a great spot last year when things were looking pretty down for COVID, and now things are looking up. So how are you approaching the uses of this cash, particularly as we go into next year? And to follow up on the last question, there is a question mark about how to bridge some of the earnings. What are you thinking about uses of cash, M&A opportunities across the business? And how much of that might get returned to shareholders?

Robbie, I'll start with it and turn it over to Chris for some further details. Obviously, from -- you see us investing behind our growth strategy. You see us making investments in capacity, for example, capacity investments in rapid testing, capacity investments in helping the vaccination campaigns, whether or not that's with needles and syringes or the $1.2 billion investment you saw us announce last quarter related to our pharmaceutical systems pre-fillable devices. We're going to continue to invest in growth. Part of that investing for growth is also our tuck-in M&A strategy, and you saw us begin to accelerate our efforts in that. Last quarter, you're seeing that continue into this fiscal year. And you heard me mention we have a robust funnel to continue that. We remain very focused with an emphasis on tuck-in M&A as I've been iterating since transitioning into the role that I'm in today. As we think about more broad deployment of capital to create shareholder value, maybe Chris, comment on that?

Sure. Absolutely. And I would just say a few things first. We were very proud of the fact that we really focused on cash during the pandemic. And if you look back, in fact, at the third quarter of last year, our cash flow actually increased year-over-year despite the fact that the revenues were suppressed from COVID. And that was the result of a number of actions that we took in the business around inventories, receivables, payables. And so, we're very proud of that. We're really focused on cash.

As we mentioned at your conference last month, Robbie, we paid down $265 million of debt. That kind of gets us down to the target. So, we see the leverage ratio floating down naturally without the need to pay down debt, which really says that the $5 billion-ish that we've paid down debt over the last couple of years, that strong cash flow that we're generating will be available to allocate to other value enhancements. So, we've talked about primarily the tuck-in M&A and share repurchase. And as we get through this pandemic, and as that safety net of cash that we've had to ride out the pandemic isn't as necessary, we'll have the ability towards the end of this year. And you've seen our tuck-in M&A ramping up, the pipeline is good. We continue to look at a number of opportunities. And by the end of this year, I think we'll be also talking about giving that cash back to shareholders. Because once we get through this period, we don't see the need to build up cash on the balance sheet. And so, we would be returning that to shareholders after a certain amount of tuck-in M&As. So, this puts us in a very good position. We've got great cash flow generation and -- better than ever -- and that puts us in a great position to allocate that appropriately.

Yes. And we continue -- just as Chris mentioned -- these are all programs with momentum. We have a cash committee that meets basically every week, and we continue to have teams dedicated to that work. So, I appreciate the recognition there, Robbie, and we're going to continue that as well.

I think that recognition also came from Moody's. We felt really good about the fact that they upgraded us to investment grade. In fact, not only did they upgrade us, but they kept the positive outlook, which we really appreciated as well. And so that puts us full investment grade across all 3 rating agencies, and we fully intend to stay that way.

(Operator Instructions) Your next question comes from the line of Vijay Kumar with Evercore ISI.

Congrats on a solid print, here, Tom. So maybe I'll limit to one question, perhaps a 2-parter. On the revenue guidance, Tom, did anything change out of -- outside of the Veritor coming in at the high end? And the reason I ask is, you guys just did $680 million in Q1. The guide of $1.5 billion implies a pretty drastic fall off in Veritor revenues in the back half. And Chris, the margins here, I think, would imply a sub-25% op margins for 2Q to 4Q to get to the guide. That's below your pre-pandemic levels. I'm curious if there are any incremental expenses in the back half.

Vijay, a nice approach with the 2-part 1 question. So, on the revenue side on Veritor, so I think the key thing to talk about there is the pricing comment that I made is one big piece that drives that, right? We said we were above 20% in the last quarter. And as we think about looking forward, we talked about modeling low to mid-teens. So that's the #1 adjustment there. And again, we've been -- that's not new news at all and in fact that we've been talking about that we expect pricing to head in that level as our capacity comes online and we're in a better cost position, et cetera, and as more capacity is coming into the marketplace. And so, we've taken actions as planned and that is why we gave guidance that said expect, "the revenues to be highly weighted to the first half of the year," and we've said that from day one. I think there remains uncertainty around the effectiveness and timing of the vaccines, especially with additional variants that are out there, et cetera. But we can't predict what's going to happen there on the second half of the year. And so, we remain projecting that there will be very strong demand for antigen testing in the first half of the year and that the second half of the year is less certain. Obviously, if demand stays very high and depending on the dynamics with capacity and demand and how those curves cross over, maybe there could be an opportunity in the back half of the year, but it's way too early for us to think about that as -- because it's far from certain or able to be confirmed. So, our aim is to position ourselves to be a leader in the space however it ends up evolving. And as we go forward, there'll be more clarity there, but certainly a very dynamic environment. Maybe, Chris, on part 2.

Yes. Sure. On margins, Vijay, Q1 margins were obviously very, very strong. And that was a function of a number of things. First, the COVID testing, obviously. But the base business was very, very strong as well. And we drove some synergy and continuous improvement margin improvements as well. So, all things were positive in Q1.

As we think about the rest of the year, you would expect that COVID testing to moderate as you model that out, obviously. And then don't forget you also have the unwind of the timing that we saw of the $100 million in Q1. That unwinds in the remainder of the year. But the most important thing is the ramping of investments that we have discussed. So, we're investing in R&D. We're investing in quality. We're investing in the Veritor reinvestment program. And all of those things kind of ramp in Q2, Q3 and Q4. And so, don't think about that as an indication of our pre-pandemic margins. It's just completely different. And then, those investments go away into '22. The beauty of it is they begin to drive improvements in growth, in revenue generation, in margin expansion, and those things will kick in towards the latter half of FY '22. So, you get the pickup in margins by them going away and then the benefit of those investments in driving revenue growth and margin improvement going forward. So, you can't look at that as -- well, those are different than pre-pandemic margins. So that's the way to think about '21 as it plays out.

Your next question is from Bob Hopkins with Bank of America.

I'll just stick to one topic, especially, Tom, since you mentioned it's still your #1 priority. On Alaris refiling, are you guys just waiting on FDA at this point? Or is there more work that BD needs to do? And if there's more work, what still needs to be done? I'm just looking for a little bit more detailed update there.

Sure. And thanks, Bob, and good to connect. So, as I mentioned, we remain on track for the submission in late fiscal Q2 or early Q3. And we're not waiting on anything specific from the FDA. These are very comprehensive submissions, right, think 1,000-plus page filings that take time to prepare and have a lot of comprehensive data in them. And so right, we've always said from the start, our focus isn't in rushing into a submission, but it's around ensuring a comprehensive submission that is going to achieve our ultimate goal, which is a timely FDA review and clearance. And so that remains our focus from that perspective. Obviously, Q2, Q3 is coming up upon us here. The teams are making great progress, and we continue to iterate that timeline. We'll continue, as we have in the past, as we get to that date -- those dates, we'll provide updates at public conferences or as appropriate.

Okay. So not that everything is into the agency and you're just waiting to hear back from them? You guys are still putting the package together to submit?

Correct. You can expect that, once we submit, we'll communicate that in appropriate form. But we haven't -- we're preparing to submit in the timeline that I mentioned.

Your next question is from Richard Newitter with SVB Leerink.

Just given that you're clearly accelerating tuck-in M&A from the capital deployment standpoint -- makes a ton of sense -- especially with the COVID windfall and your free cash flow generation -- should we be thinking about the contribution for what you might do on a more aggressive M&A front going forward as bringing you more towards upper mid-single-digit growth profile? Or even maybe high single digits? I'm just trying to think through the shift in the reprioritization here, clearly, more aggressive, more on offense. Is that where we're headed once we return to a more normalized environment?

Okay. Thanks for your question. Obviously, our #1 focus is on durable mid-single-digit revenue growth, and that's our aim here. And so we really see -- we often refer to it inside as inorganic innovation. We look at our pipeline. We look at the market spaces that we participate in. I walk through 3 of our 3 key areas of innovation focus earlier in the call, and we evaluate constantly what products and initiatives we can fund organically and drive in-house to advance that strategy and create shareholder value and value for patients and providers. And we also are constantly looking at the external landscape as well to see how -- what may be out there that could get to market sooner than we could or maybe has some great talent that created some really exciting innovations outside of BD that we can bring in-house. And so, we're going to continue to do that, but it's all in line with, I'd say, a more holistic approach to driving that durable mid-single-digit revenue growth profile that people really have come to appreciate from BD. Thanks for the question.

Your next question comes from the line of Brian Weinstein with William Blair.

Just some things on Veritor. Can you just talk about your capacity now? And you mentioned that making additional investments in testing, so where was that in capacity there? Where would that get you? And just how to reconcile the capacity expansion that you're going through with the thoughts on the slowdown in demand? How do I reconcile this? Is this also about building for at-home testing and you tee some thoughts on exploration there? Can you just tell me what that means?

Sure, Brian, and good to connect, as always. So, the capacity is, as we've communicated in the past, right, that we are at -- going to 12 million tests in March is what we communicated on our last earnings call. And we're on track for that. And we're also on track for the MAX capacity expansion that we had described before.

Now I don't think it's a fair thing to say that we continue to sell all of that capacity as we look forward. That's not known to us, particularly in the back half of the year. But we're positioned. This is a global pandemic that's going on in the world. As we think about opening up businesses and schools and other things, people are going to look at what different types of testing technology they can use, and our aim is to make sure that things are available to health care systems as needed. So we're doing that. And we've also shared, right, we're actually depreciating those assets within the year. So that as things unfold in '22 and '23, those assets won't be burdened on our P&L because we're able to fund that within the profits that are generated within this fiscal year. So that's our approach. Nothing more than that. We -- at this point, we probably don't want to comment more on the home space other than to mention that we are actively exploring that, has been our practice as we advance our work in that and the combination assays that we've shared that are in development. We'll really end up sharing more about those as we actually gain EUA and head towards launch if those occur. So, I think that's it. Maybe we do have Dave Hickey on the phone. I can pause. And Dave, I don't know if there's any other comments to add from you.

No. I mean, Tom, you've captured it eloquently. I think capacity, we moved to 12 million tests per month from next month. You mentioned MAX. So MAX, actually, we did increase capacity to 1.9 million tests per month for the molecular assay from last month actually. And there are a variety of additional topics like the claims, home testing, OTC that we're exploring right now as well as additional menu to leverage the 70,000-plus Veritors that are going to be out there. And as those decisions take place, we'll share more details as we get those decisions.

Yes. And those markets still are not well-defined today, as you know, Brian. So, thanks for the question.

Your next question comes from Larry Biegelsen with Wells Fargo.

Just one for me on -- you have the BTK panel coming up on February 17. As you guys know, that tends to get outsized attention by investors. So, it sounds like you guys requested the panel. What do you think the hot topics or key issues are going to be? Every panel has them. Do you expect FDA and the panel to debate whether it should be 6-month efficacy, that's the focus or 12-month data? Your level of confidence in the outcome? And do you still see this as kind of a $150 million opportunity, which is kind of what Bard thought it was before the acquisition.

Thanks, Larry, and great question. Let me maybe make a short comment here, and then we have Simon Campion on the phone, and we'll turn it over to him, who's obviously much -- who's deeply versed in this. So first off, just as a reminder, we have nothing in our forward-looking plan for BTK approval, right? It's not in our '21 plan. It's in no forward-looking outlook that we have as we think about how we model things within the company. Today, Lutonix revenues are less than 1% of our overall BD revenue. And this indication, specifically, again, is not included in our forecast.

As we go into the panel, and Simon will share more detail on this, the one thing that we have is we know this is a highly underserved market, and we know that our clinical trial data shows very strongly that it's safe, that Lutonix is safe in this patient population. I think it's the first product that's gone through a trial in the U.S. that has the ability to do that. Now the question is, are the clinical outcomes that were shown in our trial sufficient enough for it to be warranted for an approval? And so Simon, let me turn it over to you to talk a little bit more about that.

Yes. Thanks, Tom. So as Tom just reiterated, the safety profile of DCBs and the BTK in particular has been, I think, has been well discussed. And the data that we're providing is demonstrating continued safety of the Lutonix product.

In relation to -- we did request the panel meeting, as you know, below-the-knee patients with critical limb ischemia are in a very bad way. It's the most serious form of peripheral arterial disease. They have multiple co-morbidities. And some of the most important things for this patient population are: (a), options; and (b), an opportunity to expand the gap between these frequent interventions that they will have. So, as we move into panel, certainly, there will be a debate around the clinical data that we've acquired. But I think, more importantly, this is another tool in armamentarium of tools that clinicians have for BTK intervention. If you think back 20 years ago, an SFA or popliteal intervention, there were PTA balloons and off-label stents. And today, there's a wide range of technology available to them all the way up to drug-coated balloons and drug-eluting stents. But in BTK today, as I said, the most serious form of peripheral arterial disease, there is one product available, and that's PTA. So, we're not suggesting this is the silver bullet for all BTK patients. We're suggesting that this is another tool that can enhance the outcomes for different patients and equip physicians to assess each and every patient and have yet another tool to treat them with. So, the panel is on February 17. We've gone through a comprehensive preparation for it, and we'll absolutely put our best foot forward on that day to commence panel in the merits of our application.

Your next question is from Larry Keusch with Raymond James.

So Tom, I wanted to just touch on the investment spend that you guys talked a lot about. And certainly, you've really amped up the conversation around that over the past couple of quarters. And I guess I'm really focused in on the R&D side of things. I feel like I've heard this story in the past here at BD, and there's been some challenges with innovation and really getting products out onto the market that were considered to be more than just evolutionary. So, I get the sense that things are probably different this time around, but I'm just trying to understand if there's a new approach or are you investing differently or anything that you can kind of speak to help us get comfortable that these investments hopefully can lead to visible new product introductions.

Truly. Good and fair question. So, let me start with just overall R&D effectiveness, and I can get a little bit of color on the types of initiatives that we're investing in here, and also, how we think about our overall innovation system. So, as you know, John DeFord joined us as our Chief Technology Officer about 3 years ago. And really, under his leadership, there's been tremendous progress within the organization and with the segment teams, the business teams in advancing our ability to drive innovation. Actually, over that time period, we've gone from kind of the midpoint of not being where we wanted in terms of on-time milestone delivery or on-time launches, to being -- as we benchmark ourselves -- to being in a top quartile within the industry of hitting our milestones and, most importantly, hitting our launches, right? Our launches are now about 80%-plus of our launches are on time, which is up very notably over the last 3 years, up over 30 percentage points, or around 30 percentage points, in fact.

So, we see the progress being made. And that's the result of a lot of system improvements, new capabilities brought in, taking some of the best practices, actually from Bard the acquisition, and applying those across the company. So that's something we're going to continue to build upon.

As we think about the innovations that we're investing in, as we look at those, there's not -- there's a few, as I think about them, kind of "New to World" innovations that are in our pipeline. I mean, one is some of the ones we've already talked about, right: non-COVID menu expansion on Veritor and MAX to take -- to capitalize on our expanded footprint. We have a strong track record of developing new assays on MAX and Veritor, right? It's just examples of that.

Other initiatives are accelerating programs that we already had in our pipeline and allowing them to come to market a year or 2 earlier than we originally projected. That's an area of investment that we're making, and there are a number of areas in each of the segments which we're accelerating new products into the pipeline, but they're all very much in line with our strategy and areas that we're confident that we have internal capabilities in.

Of course, what we are also doing, that's complementing that, is that tuck-in M&A strategy that I mentioned before. And we do think about often, and we'll have those discussions internally, if technologies are better developed in-house or that we should be going outside because we have -- we don't have those capabilities in-house. And we'll either look at: Do they exist today in someone else's pipeline? -- and -- Is that an opportunity for tuck-in M&A? Or -- Do we need to be doing collaborations with outside groups? And many of -- there are many R&D programs that we have today -- I think probably a record level of R&D programs -- where we have external partnerships in place. Actually, the BD COR would be one that I mentioned before. We have very strong external partnerships with the robotics because that's a very advanced automation system. And so, we brought in robotic experts that helped us with that launch, and it's going really well in Europe. And we'll bring it to the U.S. here, but that's one that we probably wouldn't have been able to develop in the same way if we had tried to do it on our own. But we're seeing successes with that approach, and we're seeing it in many other areas as well.

So that's kind of maybe just a little bit of color, Larry, in how we think about it overall. But with that progress that we've made and the way that we've thought through making these investments and how we also think about where it's smarter for us to do tuck-in M&A, we're confident in those investments.

Your next question comes from Matt Taylor with UBS.

So I just wanted to ask about the Veritor pricing from the standpoint of how that came about. I usually would think about it as being more of a competitive dynamic, but it seems like, for your comments, you're being a little bit more proactive to lower price to make it a better value proposition for stakeholders. And so, I wanted to understand: (a), How did that come about? and (b), Do you expect it to go down further in the future -- or - do you think this is a point of equilibrium?

Yes. Good question, Matt. So yes, you're right. It's a combination of -- we do -- we've always said that we believe the pricing would head in this direction. Our capacity is increasing, and we want to be proactive in maintaining that leadership position. There is -- but there is additional capacity coming in the industry now as well, too. And there will be further capacity coming in. We're not the only company who's adding in capacity. And so we think about that holistically and where pricing as a result of that is going today and where we best position our products to remain a leader in that, and that's how we develop it, and we spend a lot of time thinking those things through as to when and how we optimize our pricing, again, to also serve what is a continued evolving customer base as more non-traditional areas of health care get into wanting to do antigen testing and making sure that it's appropriately priced to enable the broadest access to the product while we're still in the middle of a pandemic. And so, we've gotten very positive receptivity so the pricing. We've already started to roll that out a couple of weeks ago of last month. And so good question. Thank you, Matt.

Your next question is from Josh Jennings with Cowen.

Just one quick one on Veritor, just with the U.K. and South African variants. I think the U.K. ran some studies on rapid antigen testing and confirmed that there was no change in sensitivity or specificity. If we think about the South African variant and the U.K. variant and future variants, what is Becton doing to just monitor those variants and ensure that the sensitivity and specificity aren't altered by some of the mutations in the virus and then the subsequent antigens that you guys are testing for?

Good question, Josh. And that's certainly something that our teams are all over. Let me turn it over to Dave Hickey, who we've got on the line, the President of our Life Science segment.

Right. Thank you, Tom. And Josh, great question. So, to your point, there have been obviously several newly identified variants reported recently, and there could well be others, right, recognizing that this is an RNA virus, very much like influenza and HIV that are known to mutate. And for us, we've got 2 different types of platforms, right? So, we've obviously got the BD Veritor antigen test. We've got the BD MAX and molecular PCR test.

So, let me take MAX first. So, for BD MAX and for the assays that we have on the MAX, we've already completed an in silico analysis, which is a computer model based on sequencing, to look at those mutations. And from everything that we can see around those mutations and the lineage of the sequence, we have no impact on the BD MAX assays.

For BD Veritor, which is obviously more a minor assay based on the top of the protein, based on early analysis again there, we have no evidence to show that the U.K., South African and, indeed, Brazilian variant will have an impact on the test. But we continue to take actions to look at that, further confirm and monitor the performance. And again, we've done that for the ones that are already out there and any potential new emerging strains. And this is a critical topic for us because I think the thing to remember here is as these variants come online and come out, which are reportedly more transmissible, it makes the importance of rapid testing and access to testing as important, if not more important, than ever.

There are no further questions at this time. I would like to turn the floor back over to Tom Polen for closing remarks.

Okay. Well, thank you, and thanks, obviously, to everyone for your questions. Just before we sign off, I would be remiss if I did not thank BD's 70,000 associates around the globe who, every day, rally around our purpose of advancing the world of health. Your efforts and achievements this quarter were noticed. You continue to work tirelessly to make sure that our needed products reach the frontline to combat this pandemic while executing on our strategic agenda. I'm proud of how we've started our fiscal 2021, and I'm looking forward to continuing to deliver on our goals of developing innovative devices and making meaningful health impacts to people around the world. On behalf of the entire executive team, thank you for your efforts and sacrifices.

Onward we go together. And like you, I'm proud to be BD. Thank you for listening today, and we look forward to connecting at future investor meetings with everyone who's joined the call. And until then, I hope everyone stays safe and healthy. Thank you.

Thanks, everyone.

Thank you.

Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.