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spk11: Hello and welcome to BD's third fiscal quarter of 2023 earnings call. At the request of BD, today's call is being recorded and will be available for replay on BD's investor relations website, investors.bd.com, or by phone at 800-695-1564 for domestic calls and area code 402-530-9025 for international calls. For today's call, all parties have been placed in a listen-only mode until the question-and-answer session. I will now turn the call over to Francesca DiMartino, Senior Vice President, Investor Relations. Please go ahead.
spk01: Good morning, and welcome to BD's earnings call. I'm Francesca DiMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at BD.com. Earlier this morning, BD released its results for the third quarter of fiscal 2023. We also posted an earnings presentation that provides additional details on our business, strategy, and performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Poland, BD's chairman, chief executive officer, and president, and Chris Delorifus, executive vice president and chief financial officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 strategy. Chris will then provide additional details on our Q3 financial performance and our updated guidance for fiscal 2023. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, president of the medical segment, Dave Hickey, president of the life sciences segment, and Rick Bird, president of the interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the IR website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I would also call your attention to the basis of presentation slide, which defines terms such as base revenues and the non-GAAP reconciliations included in the appendix. With that, I am very pleased to turn it over to Tom.
spk05: Thanks, Francesca, and good morning, everyone. Thank you for joining us. Earlier today, we reported another consecutive quarter of broad-based strong financial performance and significant progress advancing our innovation pipeline. Before we detail our quarterly performance, I want to highlight the 510 clearance we received on July 21st from the FDA for the updated BD Alaris Infusion System. This has been our number one priority since launching BD 2025, and we're pleased to deliver this important milestone. For more than 20 years, infusion pumps have represented the backbone of hospital operations. Over that time, Alaris was the first product that connected all patient modules into one integrated system and the first platform to introduce medication safety software, which led the way to interoperability with electronic medical records. And later, with the launch of BD HealthSite, Alaris again led the way with integration into the full suite of BD end-to-end connected medication management solutions from the pharmacy to the administration of drugs at the patient's bedside. Today, the Alaris system continues to advance new levels of innovation with enhanced cybersecurity protection, the latest wireless capabilities, and new features that enable various aspects of medication management and ultimately help clinicians deliver the best care. In short, We're proud of the Alaris Power of One that makes medication management safer, simpler, and smarter. With this clearance, we address all open recalls with the latest hardware and a new version of software, as well as provide important cybersecurity updates. We can now focus on bringing the updated system to the market, ensuring our installed base is upgraded so customers can realize the full benefits of our latest technology. As we return to market, we will start with upgrading or replacing the hardware and software of Valeris system devices in the US market with priority towards our existing customers. Given the breadth of our footprint, this effort will happen over a multi-year period. Just two weeks into clearance, we are well prepared. We immediately took action and contacted nearly all of our customers. We activated a dedicated team with daily stand-ups, and have completed product training for our service teams on the cleared Alera system. As we previously shared, we have prepared for clearance and our return to market. We have invested in and developed plans for operational capacity, and we've strengthened our supply chain. We have now activated those plans, which were dependent on clearance, and are moving quickly to help ensure we can reliably supply our market-leading BD Alera system and deliver for our customers. In parallel, We continue to engage with the FDA on how we intend to execute our remediation plans, which includes a combination of upgrades and replacements. We will provide more information as we progress. Before I move on, I would like to thank our customers for their loyalty and patience as we work through this challenging period. Our teams are ready and committed to provide the high-quality service and partnership that you've come to expect from us. And on behalf of the entire BD leadership team, I want to extend our deep appreciation to the BD associates who worked tirelessly to bring the updated BD Alaris system to market for their ongoing commitment to quality and ensuring we achieved this milestone in the right way, in line with our values. We'd also like to thank the FDA for their rigorous review and engagement as we went through the clearance process. Turning to our quarterly financial results, Our strategy and purposeful investments in innovation are driving consistent higher growth and fueling strong results and momentum. Our results are indicative of our leadership position and our durable core and intentional shifts towards higher growth and markets. And a highly motivated and talented global team whose focus on execution is helping our customers provide more efficient and effective care. We delivered another quarter of outstanding results. with 7.9% base revenue growth, or 6.3% base organic, and double-digit adjusted earnings growth. Once again, our results reflect our strategy in action and our strong consistent growth profile, which gives us the confidence to increase our FY23 organic growth rate. We also continue to make strong progress improving our on-time milestones and launches to another record level this year. starting with a few examples of our recent launches. In our medical segment, we introduced the BD Preview 2 system, a first-world technology that magnetizes the tip of certain existing BD catheters and allows them to be seen under the Preview ultrasound device. The software then guides clinicians to enter the vasculature with first-stick success. This novel approach enables BD peripheral IVs to deliver new value to patients and providers. In our biosciences business, we are seeing a super cycle of innovation this quarter with three key new product launches. In mid-May, we began shipping the BD Facts Discover S8 cell sorter. Our customers are utilizing this new standard in flow cytometry to unlock life-changing discoveries across immunology, cancer research, and cell biology by uncovering more detailed information about cells and how they interact that was previously invisible. The first installations are complete, Customer feedback has been excellent, and we are seeing strong demand. We also launched the BD Rhapsody HT Express, which enables access to the fast-growing single-cell multi-omics market with a high-throughput research solution. The HT Express can process up to 320,000 cells per run, eight-fold the throughput of the BD Rhapsody platform, while leveraging Rhapsody's microwell design to ensure high-quality results for all cell types. And most recently, we announced the launch of the BD FACS Duet Premium Sample Preparation System, a new robotic system to automate clinical flow cytometry, enabling the only walk-away automation for both HIV and leukemia and lymphoma testing. And in our BDI segment, we launched the BD-TREC Powered Bone Biopsy System, expanding our presence in oncology beyond the manual biopsy market. The BD-TREC system allows for faster sampling with sizes to accommodate a variety of procedural needs. Our differentiated offering enables the ability to collect large intact samples while providing the clinical versatility to biopsy delicate areas that require precise targeting as well as bones that require power. We've also achieved several crucial development milestones this quarter. These include 510K submission of the SiteRight 9 ultrasound system, which is part of our vascular access management strategy. The SiteRight 9 was developed to be the first integrated system that combines catheter and ultrasound navigation into a single device to simplify workflow, capital management, and training for clinicians for the placement of BD PICs. In our IDS business, we're expanding the strategy for our BD on Clarity HPV franchise to enable patients to self-collect samples with the aim to promote healthcare equity by making cervical cancer screening accessible to women who historically haven't participated or have had limited access to testing. This is already in use across Sweden, Denmark, the Netherlands, Australia, and New Zealand. Clinical trials are set to start in India, Africa, and the U.S. later this year. We are proud of this work and its ability to advance our efforts to reduce healthcare inequities around the world. And in our PI business, we submitted and received IDE approval for our TIPS, venous stent graft, and are on track to enroll the first patient in Q4. Used in the liver, this novel self-expanding covered stent continues to expand our leadership position and builds on our success in launching venous products that help deliver better clinical outcomes for patients. These launches and milestones are good examples of accelerated levels of innovation across our business and how we are strengthening our position in attractive end markets across our portfolio. We continue to simplify our company through programs across our manufacturing network and operating model while actively managing our portfolio. As such, we recently completed the divestiture of our surgical instruments platform. This value-creating transaction supports the achievement of our BD2025 financial goals and further advances the BDI segment's focus on high-growth end markets. This divestiture allows us to focus BD surgery strategic investments in advanced repair and reconstruction and surgical complications, which are driving results and helping to address unmet needs in healthcare. Proceeds from the sale strengthen our cash and net leverage position and support our tuck-in acquisition strategy. We also continue to make progress on our other simplification initiatives, including the reduction of 20% of our SKUs by FY25. ongoing network architecture optimization, and our operating model initiatives to transition certain BD shared service center activities to a third party to optimize our back office processes and services. Looking externally, let me share some perspective on the macro environment. Overall, the macro environment is in line with our view that challenges will persist, not escalate. However, uncertainty remains. We continue to monitor various factors, including how health systems, governments, distributors, and suppliers are managing inflation, inventory, and other supply chain dynamics. Broadly speaking, inflation is moderating but is still elevated. The supply chain has continued to stabilize, and we're very pleased with our progress to reduce back orders. We expect to exit the year at pre-pandemic levels, which is enabling us to shift our focus to reducing raw material and some finished goods inventory, which is contributing to our cash flow improvement. While overall procedure volumes are healthy, our portfolio has been more durable and less impacted by significant short-lived fluctuations in procedure volumes. Overall, the capabilities we have built and the durability of our portfolio have positioned us well. Before I turn it over to Chris, I'd like to share an update on our ESG strategy and goals. We recently issued our 15th annual ESG report that details our progress on the four pillars of our ESG strategy, company health, human health, community health, and planet health. The FY22 report highlights our notable progress in energy and waste reduction, healthcare access, and diversity. Key achievements include a reduction in greenhouse gas emissions of 10% from an FY19 baseline, an increase in the number of locations using renewable energy, the establishment of product recycling pilots around the world, and completion of our baseline assessment for Scope 3 emissions. The report also highlights our ongoing work in advancing health equity in under-resourced communities and the products, solutions, and programs we're investing in that directly address these inequities. BD has always played a tremendous role in addressing health disparities and access to healthcare around the world, and we're proud of our continued focus in this area. We are also proud to receive continued recognition for our commitment to talent and creating an inclusive culture. Most recently, we were recognized as the best place to work for disability inclusion for the fifth consecutive year, achieving a top score on the Disability Equality Index. And we were named to U.S. News & World Report's inaugural Best Companies to Work For list. In summary, we continue to deliver consistent, strong results Our teams are working unwaveringly to achieve key milestones that sets us up for continued growth and consistent performance. And this quarter is another reflection of our focus and determination in achieving our BD 2025 goals. We continue to grow, simplify, and empower BD and evolve into an agile, innovative medical technology company with a durable, compelling growth profile. With that, Let me turn it over to Chris to review our financials, guidance, and outlook.
spk08: Thanks, Tom. Echoing Tom's comments, our BD 2025 strategy is driving consistent performance and an outsized growth profile. We are advancing our innovation pipeline and delivering against our revenue, margin, and EPS goals. We are also making progress strengthening our balance sheet with lower inventory and net leverage consistent with the commitments we made With strong year-to-date results, we are well on track to achieve our updated FY23 guidance, and with the addition of Alaris' return to market, we are increasingly confident in achieving our BD2025 long-term targets of 5.5% plus organic revenue growth and double-digit adjusted EPS growth. Beginning with some color on our revenue performance, we delivered strong Q3 base revenue growth of 7.9%, were 6.3% organic. Base organic growth includes growing over prior year respiratory testing sales, which negatively impacted base growth by approximately 100 basis points. Additionally, our tuck-in acquisition strategy continues to enable profitable growth with organic growth from acquisitions that have anniversary to contributing about 40 basis points in the quarter and are expected to contribute 50 basis points for the full year. COVID-only testing revenues were $8 million in the quarter, which, as expected, declined from $76 million last year. Revenue growth was strong across BD Medical and BD Interventional, with growth of 12.2% and 8.1%, respectively. As expected, BD Life Sciences revenues declined due to lower COVID-only testing revenues compared to the prior year. Life Sciences base revenues, which exclude COVID-only testing, were about flat, given the comparison to prior year respiratory testing sales that negatively impacted base growth by about 400 basis points. On an underlying basis, Life Sciences base revenues grew approximately 4%. Total company base revenue growth was strong across all regions, with high single-digit growth in the U.S. and internationally, including strong double-digit growth in China. Strong performance in our medical segment reflects execution of our growth strategies across our key end markets. This includes in MDS, where we continue to drive growth in vascular access management with our BD PosiFlush vascular care and PIVC catheter solutions. In medication management solutions, our investments in high-growth areas like pharmacy automation are driving strong growth, led by our Parada acquisition and BD Rolla. Our MMS dispensing platform reported double-digit growth, reflecting our continuous innovations in BD Pixis, including the BD HealthSite portfolio. And in farm systems, in the higher-growth pharma and biotech drug delivery end market, our capacity expansion investments and strong leadership position in pre-fillable solutions with BD HyPak and newer innovations in products such as BD Neopak, BD FVACS and BD HILOC are driving our 13th consecutive quarter of double-digit growth while supporting the increased demand in high-growth categories like biologics. Life sciences-based business growth was about flat and approximately 4% underlying when adjusting for the respiratory testing sales comparison. This reflects execution of our growth strategies across our key end markets, including microbiology, molecular diagnostics, and single-cell analysis. It was partially offset by impact of some U.S. distributors' destocking in specimen management. In our IDS business, double-digit growth in microbiology reflects demand for our BD Keister lab automation solution, including continued adoption of the IDENTIFA and total modular tract solutions, and strong demand for our blood culture and IDAST reagents. Continued strong growth in molecular IVD assays reflects leverage of BD-Core and the incremental BD-Max install base. In biosciences, high single-digit growth was driven by our clinical business with strong double-digit growth in cancer reagents, leveraging the growth in our install base of FACS Lyric Analyzers and adoption of FACS Duet Automation. Performance in research solutions reflects continued strong growth in research reagents enabled by our innovative BD Horizon dyes. Strong performance in our interventional segment reflects execution of our growth strategies across our key end markets, including advanced repair reconstruction, PVD, and incontinence, where our newer innovations in high growth areas are continuing to contribute nicely to growth. Our surgery business unit delivered strong double-digit growth driven by continued market adoption of phasic hernia resorbable scaffold. In our PI business unit, double-digit growth in peripheral vascular disease was driven by broad-based strength across the portfolio, including global penetration of Rotarex. In our UCC business unit, high single-digit growth was driven by strength across the portfolio, including strong double-digit growth of our PureWix solutions for addressing chronic incontinence in both the acute in alternate care settings, and double-digit growth in endourology. Further details regarding each segment's performance in the quarter can be found in today's earnings announcement and presentation. Now moving to our P&L. We reported Q3 adjusted diluted EPS of $2.96, which included gross margin of 52.6% and operating margin of 23%. Operating margin improved 100 basis points year over year and includes an unfavorable 100 basis point impact from the accounting treatment of an employee benefit related item that gets recorded in GNA and is fully offset in other income with no resulting impact to EPS. Excluding this item, operating margin increased 200 basis points and was ahead of our expectations driven by strong execution against our margin improvement initiatives. Foreign currency was a 50 basis point headwind to both gross margin and operating margin. Gross margin performance reflects leveraging our strong revenue growth and the benefit of our simplification and inflation mitigation initiatives that enabled us to overcome 200 basis points of outsized inflation. Our Q3 margin drivers are aligned with what we have been anticipating throughout the year which is that most of the full-year margin improvement will come from SSG&A expense leverage. Q3 SSG&A expense increased about 4% year-over-year. Excluding the employee benefit-related item, we drove about 150 basis points of leverage in SSG&A, which reflects shipping efficiency and good leverage in selling and G&A expense. As expected, R&D is a percentage of sales of 5.9% normalized back towards our expected full year average of about 6% in Q3, given our spending was over-indexed in the first half. In summary, we continue to execute well and fully delivered our Q3 operating margin goal, with operating improvement excluding the employee benefit item nicely leveraged by 200 basis points. Below operating margin, the improvement in other income reflects the offset to the employee benefit related expense recorded in GNA. Our tax rate in Q3 was 15.7% due to benefits realized that were not previously contemplated. Regarding our cash and capital allocation, cash flows from operations totaled $1.7 billion year to date. As expected, operating cash flows improved substantially in Q3. including a reduction in inventory from the prior quarter. We anticipate a continued normalization of working capital in Q4, including further improvements in our inventory balance as we trend toward levels that are closer to the prior year. We ended Q3 with a cash balance of approximately $1 billion. During the quarter, we repaid over $1 billion in debt maturities, utilizing the proceeds from the February debt refinancing. We ended the quarter with a net leverage ratio of 2.9 times. We continue to move towards our net leverage target of 2.5 times. In summary, we executed well against our cash and net leverage improvement goals this quarter. We remain committed to enhancing our cash conversion and net leverage positions and expect more progress in Q4, including benefiting from the net proceeds from the divestiture of our surgical instrumentation platform which will increase our capacity to deploy cash towards tuck-in M&A. Moving to our guidance for fiscal 23. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Starting with our updated revenue guidance before the divestiture of the surgical instrumentation platform. Given our strong third quarter performance, we are raising the midpoint of our base revenue guidance by 25 basis points to 7%. and we now expect base revenues to be between 6.8 and 7.1%. This includes increases in the midpoint of both organic and inorganic revenue growth and reflects strong third quarter organic performance as well as inorganic momentum driven by our Parada pharmacy automation solution, demonstrating our strong execution and M&A integration capabilities. Inorganic revenue is now expected to contribute approximately 135 basis points to full year base revenue growth. For the full year, base organic revenue growth is now expected to be 5.5% to 5.8%, which continues to reflect strong fourth quarter organic revenue growth of about 6%. Our guidance continues to include the impact of strategic portfolio exits, which is moderated slightly from our original assumption. Finally, adjusting for the impact of the recently completed surgical instrumentation divestiture adjusts our updated base revenue growth guidance by 20 basis points to a range of 6.6% to 6.9% to reflect net inorganic revenue adjustments to base growth of approximately 115 basis points. Our increased base organic revenue growth guidance of 5.5% to 5.8% is not impacted. Over a two-year period, we were driving strong base organic revenue CAGR of about 7%, which is well above our long-term target. Our segment-specific growth assumptions have not changed. For COVID-only testing, our guidance only includes year-to-date revenues of $56 million. All in, we expect reported revenues to be approximately $19.3 billion, which is an increase from our previous guidance of $19.2 to $19.3 billion. Regarding the Alaris 510 clearance, as previously disclosed, we expect to ramp our return to market in our infusion business over time with our existing customers and remediation taking first priority. As we scale our manufacturing capacity, and ensure we are taking the necessary actions to deliver our products in the right way, we are well positioned to engage with customers and execute as quickly as possible. However, we do not expect any material incremental revenue contribution from Alaris for the remainder of FY23 and we expect to begin a more regular rhythm of shipment and installation of devices and recognizing revenue as we progress through FY24. Within our FY23 guidance range, we expect to absorb any initial investments beyond the sales and service organizations we retained to successfully support our return to market. Regarding our assumptions on earnings, we continue to expect operating margins to improve by at least 100 basis points for the full year. We are executing as planned and have line of sight to our targeted margin improvement. Below operating income, our assumption regarding interest to other remains unchanged. We have lowered our effective tax rate guidance to be between 13% and 13.5%. The midpoint of our updated tax guidance range is essentially equivalent to our FY22 actual effective tax rate of 13.3%, and as a result is not incrementally contributing to FY23 EPS growth. Our adjusted EPS guidance range of $12.10 to $12.32 remains unchanged, but reflects absorbing a two cent negative impact from the divestiture of our surgical instrumentation platform and a five cent negative impact from the latest FX rates. We are raising our base business earnings forecast by seven cents based on our strong third quarter performance, including consistent execution of our margin goals offsetting the impact of the divestiture and FX. On a currency neutral basis, we now expect adjusted EPS growth of about 10% to 11.5%, driven by very strong mid-teens based business growth of approximately 14.5% to 16%, an increase of 50 basis points from our prior expectation. As a result, given our strong growth and execution, On a year-to-date basis versus our original guidance in November, we've increased our adjusted base business earnings per share by about 27 cents, which added 225 basis points to growth, resulting in the 14.5% to 16% growth on our base. This also includes absorbing another year of outsized inflation of about 200 basis points. These strong base business results enabled us to fully absorb an increased earnings headwind associated with the loss of COVID-only revenue as well as lost earnings associated with the recent surgical instrumentation divestiture and still increase our total FXN growth rate by 75 basis points to 10% to 11.5% double-digit earnings growth. As you think about Q4, the following are a few key considerations. We've outlined more detail in the accompanying presentation slides. First, our increased organic guidance continues to reflect strong growth of about 6% in Q4. As a reminder, we've now anniversary the acquisitions of Parada and MedKeeper. Second, as you think about margins, as we've described throughout the year, most of the full year improvement is expected to come from SSG&A expense leverage, with the balance from slight improvement in gross margin, which has been muted year-to-date because of outsized inflation. For operating margin, we continue to expect significant year-over-year margin expansion in Q4. However, versus our last update in May, the amount of expansion needed has been reduced by about 75 basis points, and thus we de-risked our Q4 delivery. There are several factors driving Q4 operating margin, including expense leverage on expected strong revenue performance, inflation mitigation actions to offset outsized inflation in cost of goods sold, SSG&A expense reductions driven by the timing of spend, and the full quarter impact of our more recent simplification initiatives. Also, R&D as a percentage of revenue will continue to moderate lower to about 5% of sales resulting in full year spend of about 6%. Finally, there is also favorable comparison to the prior year reinvestment of COVID-only testing profits. As we look ahead to FY24, we remain confident in our ability to deliver against our BD2025 strategic and financial goals. While it is premature to commit to specifics, I can offer the following thoughts as we look ahead. As discussed, we continue to operate in a macro environment that remains uncertain and an inflationary environment that is moderated but remains elevated. We are especially focused on monitoring how various governments, such as China, respond to economic and other dynamics. With that said, MedTech in general has proven to be much more durable during times of uncertainty, including economic downturns, and certainly BD has a proven strategy and has demonstrated not only the ability to be resilient, but to deliver strong growth and earnings during the most challenging times. Our market leading portfolio, strong innovation pipeline, continued shift into high growth end markets, and track record of execution gives us confidence in delivering against our 5.5% plus target next year. With respect to Alaris, we are excited to shift our focus and re-engage with our customers. The clearance of Alaris offers much needed certainty to our stakeholders. As previously noted, it increases our confidence in executing against our BD 2025 targets. Just two weeks after clearance, it would be premature to provide a range of expected revenue in FY24. However, consistent with what we've shared, we expect to ramp revenues back to our pre-ship hold level of approximately $400 million over time. Our focus will be replacing and upgrading pumps for our existing customers. At this juncture, knowing we have some level of Alaris revenue in our FY23 base of around $100 million, we would anticipate a modest level of revenue above that, which could result in about a 50 basis point tailwind to growth in FY24. As a result, based on current assumptions and the macroenvironment factors I mentioned we are monitoring, Our base growth with Alaris would be approximately 6%. We will share more about other assumptions across our portfolio when we solidify our FY24 plans. As a reminder, if you look outside of our base business, in FY23, we have realized nearly 60 million in COVID-only revenue. Based on current dynamics, we would not expect material revenue in FY24. which results in an expected headwind of about 30 basis points that you need to adjust for. Additionally, the sale of the surgical instrumentation platform will have nearly a 75 basis point impact to total growth. This does not impact our organic growth, which should be considered in your total FXN revenue growth. We will true up for currency when we provide FY24 guidance in November. Regarding earnings, we remain confident in our double-digit earnings growth profile of about 10% currency neutral EPS growth. This includes absorbing the reduction to earnings associated with lower COVID-only testing revenue and the divestiture impact. Combined, these items are worth about 125 basis points. We will share more details when we give our guidance, but given we expect to finish FY23 at 70% of our 25% operating margin goal by 2025. At this point, we are tracking ahead of our 2025 margin goals. Importantly, this gives us the flexibility to deliver on our margin goals while investing to maximize growth and deliver on our double-digit earnings growth target. As we finalize our plans, we will look at optimizing the ratio of growth versus margin increase that delivers against these goals. In summary, we see our value proposition as differentiated and importantly have consistently executed against our commitments, which gives us confidence in our ability to continue to deliver against our future goals. In closing, we are consistently delivering multiple periods of outsized financial performance. I would like to thank our associates around the world who are working hard to deliver on our purpose and help us achieve these results. As we look forward and as reflected in our FY23 guidance and our progress towards our BD2025 long-term targets, we are well positioned for continued growth. With that, let's start the Q&A session. Operator, can you assemble our queue?
spk11: Yes. At this time, if you would like to ask a question, please press star 1. If at any point your question has been answered, you may remove yourself from the queue by pressing star two. In order to allow for broad participation, please limit yourself to one question and one related follow-up. Lastly, to provide optimal sound quality, please pick up your handset while you ask your question. Thank you. We'll go ahead and take our first question from Vijay Kumar with Evercore ISI. Please go ahead.
spk06: Hey, guys. Thanks for taking my question and congrats on a good execution here. Tom, maybe my first question is very hilarious. I think you mentioned 50 basis points contribution to growth in fiscal 24. That would imply, I think, total hilarious revenues of $200 million. Can you talk about, is there any supply chain constraints in terms of delivering pumps for next year? My understanding is the market's hasn't undergone a replacement cycle in three years. So why are we assuming a modest ALERIS contribution or ramp in fiscal 24?
spk05: Good morning and thanks for the recognition of a strong quarter by the team. Just as we get into ALERIS, I just want to take a moment and just reiterate some comments that I made on the prepared remarks, which was to thank our team for the efforts to get it here. This is obviously a tremendous milestone. It's been our number one priority. since we kicked off BD 2025, I also wanna thank our customers for sticking with us through this process. On your question, so first I think it's important, let's keep in perspective, we're two weeks post clearance, right? And our teams have been heads down, reaching out to our customers, getting our service organization trained on the new pump. We're pleased that we've contacted the vast majority of our customers and the feedback is positive. At this time, I think the number that we've shared is the prudent number. We've always said it's going to be a ramp over time and that we will get back to the $400 million we expect, but that it will be ramping over time. And at this point, two weeks into the process, we see that number as appropriate. We have done some pre-buys on materials coming into clearance. We're obviously continuing to do that, but we are scaling up to an unprecedented level as we think about also splitting componentry between people purchasing as well as remediating pumps. So we keep that in mind. That's a process that as it continues to evolve, we'll continue to provide updates. I don't know if there's any other feedback to that here in the room.
spk03: Thanks, Vijay, for the question. This is Mike Garrison. There are no near-term supply chain constraints We were able to secure componentry. We are scaling up manufacturing, as Tom mentioned, from our current run rate up to what we look to supply the entire market, and that will take a little bit of time. We want to make sure that we train people effectively, get all the componentry in place, and get the cells working the right way. But there's no supply chain constraints at this time. Thanks for the question. That's helpful.
spk06: That's helpful comment. And maybe one more on that. And I think you mentioned biotech as being a tailwind. How should we think about GLP-1 opportunities within your pharma portfolio? I think some of your tools peers have made cautious comments on biopharma spending. Is that cause for concern here in biosciences? Thank you.
spk05: Yeah, great question. Obviously, so I'll break that into two questions. On the biopharma side, and Dave can comment further, obviously you saw very strong growth out of our biosciences business. I think the pace of innovation that we're driving in that business across instrumentation and reagents as well as just the customer base being perhaps more research-focused and large pharma-focused than dependent upon the smaller biotech funding that you're seeing impact some other companies. We're seeing strong durability in our performance within the bioscience business. When it comes to specific drug categories, obviously you saw another phenomenal quarter out of farm systems in Q3. We feel really good about the continued momentum of that business. All of our customers there, it's confidential relationships between us and our customers, so we don't comment on any specific molecules or individual customers. But obviously the capacity that we've been adding And as we've said before, we have 5 to 6x the capacity of the nearest competitor in that space. As there's large molecules coming to market, of course, our capacity position is an advantage, and we have discussions with customers around that. So we can't comment on any specific one, but we're certainly in a very good position to serve very large, fast-growing markets. Did you have a comment on bioscience?
spk07: Yeah, just, hey, Vijay, just specifically on biosciences and just, I mean, obviously it was another strong quarter for us at 7%, and we're seeing good continued growth in life science research and clinicals, specifically on biotech, biopharma. We have the advantage that for our own bioscience business, we've got a very broad range of customer segments, right? So academic research, biotech, of course, pharma, CROs, hospitals, So we're not necessarily dependent upon just one or two few customer types. And then given where our specific solutions are used in PharmaBioPharma, you know, primarily used for discovery and translational research and then clinical studies for those new molecules. So it's very much earlier in the discovery process. And those types of companies still need to do that work so that they can identify those molecules for their own future growth. I think given where we apply, we're not seeing as much impact.
spk06: Thanks, guys.
spk07: Thanks for the question, BJ.
spk11: Thank you. We'll take our next question from Larry Bigelson with Wells Fargo. Please go ahead.
spk09: Good morning. Thanks for taking the question, and congrats on the clearance of Alaris. I do want to focus on Alaris and Tom and team. I'll ask a multi-part question here and just one. upfront. So the remediation and replacement plan, Tom, can you talk about the cost and timeline there? And is FDA going to allow you to when is FDA going to allow you to commercialize above the 100 million in medical necessity? Is there, you know, kind of a gating factor here? And how should we think about the pent up demand, Tom? Do you think that at some point, I mean, it's about a billion dollars in backlog, do you think at some point, you'll exceed 400 million per year to to exhaust that backlog and just lastly you know when you when you remove the layers from the market or put it on ship hold i'm sorry you reduce dps by about 70 cents for two-thirds of the year you know so when can investors expect to get back you know what what what they lost in in earnings here thank you hillary great uh great set of questions um so i'll start and we'll turn it over to mike
spk05: So when it comes to remediation and CMN, so first off, the 510K fully replaces the CMN process. So the CMN process essentially ended, and the 510K clearance replaces that program. As we think about moving forward in terms of remediation, of course, our focus is prioritizing existing customers to update or replace existing devices to the cleared version. That's our number one priority now with clearance, and that's the focus of our efforts. is within our existing customer base. To your point, there is a lot of pent-up demand as people have aged fleets. And that is also one of that, among our existing customers, those with older pumps are our top priority to get those upgraded or replaced to the current cleared version. So that's how we view that. And then as we think about EPS, Of course, we've been driving a very strong growth profile. And in our BD 2025 strategy, Chris can add in further here, in our BD 2025 strategy, we had included the relaunch of Alaris in that. That was very clear at the time as we set bold margin goals to reach and later updated those goals and increased them to 25% operating margin by 25. We're obviously very much on track to that goal. And as we think about the EPS and the margin impact, which was about 80 bps, if you recall at the time, that's coming back in and will continue to come back in, in line with the strategy that we've put out. So maybe we start with Chris, anything to add there on the margin side? Delirious, good question. And then Mike, if anything to add on the remediation pent-up demand.
spk08: Yeah, I think on the margin side, Tom, you covered it well. There was the 80 basis points that we talked about that was historic. Obviously, a lot's changed since then, including moving into an inflationary environment. And as you've seen from our performance, we've been taking a lot of actions in our business to drive margin improvement across the board. But that 80 points will certainly come back. It was always part of our 25 by 25 goals. You should really see that more scale increase. as you know we're going to be going through kind of think of a ramp period with alaris and certainly even as you think of the front end around margin right one these are diluted to gp in terms of the bd level right so just keep that in mind and there's going to be investments that we need to make that are incremental above and beyond the investments that we retain. First of all, you do have some variable items such as shipping, communication materials, marketing, customer service, ramp up, all of that. Additionally, in the short term, there's going to be added things we're trying to do as we get back. So certainly it's going to be a contributor. And I would point to our FY24, which is obviously preliminary. We're looking at all the market factors that are out there and geopolitical dynamics, et cetera. But We wanted to be prudent and provide some perspective on the momentum we have on 24 and where we're heading. But you'll notice we committed to around 10% EPS growth, which includes absorbing the divestiture and the further headwinds in terms of COVID-only revenues dropping. So it actually implies a base earnings growth above 11%. Some of that is, of course, the momentum we have in our base business, the margin, Alaris. So I think collectively you see us getting to those goals, and the Alaris margin is certainly part of that.
spk09: Thanks so much, guys.
spk03: The only thing I'd add, Larry, and thanks for the question, is we are cleared to market the BD Alaris system in the United States. It feels really, really good to say that after three and a half years. And we're also really thankful to our customers that throughout this whole process and through a pandemic and through all the challenges they face, they've demonstrated their preference for the Alera system. And so that is our focus and a priority first and foremost is to take care of them and make sure that the improvements that are in the cleared product get to them first. So that's going to be the focus there. We do have the largest fleet in the field, so the size and breadth sort of extends the timeline. It's just going to take a fair amount of time to get through everything, but we're looking to do that as expeditiously as possible and scale up manufacturing to sort of meet that need. And then we also noticed during COVID that you know, interoperability was a real benefit where, you know, nursing and nursing staff didn't have to spend as much time manually programming the pumps, you know, at the bedside. They were able to, you know, utilize the interoperability to interface with the electronic medical record. You know, that has some timeline from an implementation standpoint. It takes a little bit longer to implement to get those advantages. We think there's going to be some increased demand for interoperability from the field, and that may sort of extend implementation times a little bit. So that's another factor to think about as we're doing this upgrade and replacement.
spk05: Maybe just one last thing to add on to Mike's good comments. So it's great to be back. Obviously, we're focused on prioritizing our existing customers and replacing existing devices to the cleared version with a big focus on the older systems But the other big thing that this allows us to do beyond servicing our customers and helping them refresh their fleets and make sure they have the cleared technology, the most modern technology with all the incremental benefits and upgrades that are in this version, which are fantastic, is that we can continue now. We have a basis by which to innovate upon. And that's a big deal. We've had a great track record of being first in a number of areas in infusion. We were the first company with fully integrated system. We still are the only company and will be with one system approach, right? One interface, much easier for clinicians. We led the way with guard rails, with interoperability. Now we have the most advanced wireless cybersecurity on the latest pump, the most modern that's available. And as we think going ahead, we see other innovations that we already have planned to build upon this, which will continue to add value to our customers And we already have planned a cadence of additional 510Ks going forward. And that's a big deal. Of course, we also have, and we're the first company and they're the only company, who have integrated pumps beyond being standalone devices, but making them part of improving the overall medication management ecosystem, right, with Alaris and our software in the pharmacy. And that had been something that customers have significantly valued. It's one of the reasons that, as Mike mentioned, most Alaris customers have stuck with us over this time because of all the value that I described. We're going to now be able to continue to add to that and continue to advance our innovation leadership built upon this 510K. And so our teams are really excited about that, and our R&D teams are already working on what's next. So thanks for the question, Larry.
spk09: Thank you.
spk11: Thank you. We'll take our next question from Robbie Marcus with J.P. Morgan.
spk02: Oh, great. Thanks for the questions and congrats on a nice quarter. Maybe to follow up on Larry's question, a lot of analysts across the street were thinking about how big of a backlog there could be in the market. You were doing about $400 million in run rate of Larry's sales pre-recall. There's been a couple of years where there just hasn't been enough replacement in the market. I've seen estimates anywhere from a few hundred million all the way up to a billion dollars. So to help level set people, you know, is there any number you could put around what you think could have been sold during that time if normal replacement happened but didn't, and how to think about how quickly that can come back into extra sales to replace the fleets out there?
spk05: Robbie, good question, and I appreciate the recognition of the team. At this point, again, we're two weeks into clearance, and I think what we've shared in the preliminary outlook for 24 is what we think is a prudent number to share today. As we continue to advance, we'll continue to update that. I think it's also important to recognize that the last couple of years have not been normal years by any means. There's been a global pandemic and a lot going on in the healthcare system. We also had placed quite a large number of pumps during the global pandemic because Alaris is such a trusted and essential part of delivering health care. It was needed in much more significant levels than it had ever been needed before, and so a number of customers added into their fleets at that point in time. We're going to get a better sense as we continue beyond the two-week period. We get in further periods, get into the months, and we'll continue to update as that moves. Maybe, Chris, any other comments to add there?
spk08: Mike? I mean, I think you answer well. I mean, I just think what you talked about is there's the Alaris benefit that gives us a natural glide path to continue to build on our momentum we've had the past two years, first two years of our BD 2025 strategy. You can see what we put forth in 24, and we're talking about base growth of around 6% now, which is, I think, an exciting commitment at this juncture, and certainly the it'll be a catalyst going forward, and I think beyond, to Tom's point, Alaris in itself, but really capitalizing on the full value proposition of our medical segment.
spk02: Great, and sorry, but one more Alaris question. In the approval, you talked about that some of the pumps out there would have to be replaced and some would have to be remediated. Can you maybe speak to exactly what makes a pump qualify for replacement versus remediation, and what percentage needs to be replaced versus remediated, and the difference in cost associated with it? Thanks.
spk03: Yeah, just the remediation process is very multifaceted, complex. We're working with the agency on this. On a case-by-case basis, it needs to match the 510K, the cleared product, And so that's sort of what we're doing. We'll be going out, doing walkthroughs at the customers. Customers through COVID may have had mixed fleets of different ages of pumps, things like that. So we need to kind of go on a customer-by-customer basis and, in some cases, a pump-by-pump basis. So that's where that stands. Our commitment is mainly to our priorities for our existing customers that have stuck by us. You know, something just to go back to the previous question, you know, the run rate at the, you know, in sort of 2018, 2019, you know, that had a fair amount of competitive position gain. So because, you know, our Laris product was being preferred, you know, at that time, and we were gaining position in the marketplace. You know, probably in the near term here, we'll be focused on remediation and the replacement of our existing customers. So that's something just to think about from a pent up demand perspective.
spk02: Great, thanks a lot.
spk05: Robbie, just the last thing. I think if you refer to the prepared comments as well, we did make the comment that we do continue to engage with the FDA on how we intend to execute those remediation plans and the combination of upgrades and replacements and that we will provide more information as we progress. So just to bring you back to those prepared remarks as well. So great question.
spk11: Thank you. We'll take our next question from Patrick Wood with Morgan Stanley.
spk04: Amazing. Thank you so much. I'll just ask two quick ones up front if that works. Yes, you touched on the, and I appreciate you're not guiding for 24, but the margin expansion. And, you know, if you hit your guide for this year, you'll obviously exit the year with a very strong finish, kind of 26% or so. So I guess, like, how are you thinking about investing to support the launches next year relative to margin gain, given it looks like you're running about a year ahead of schedule potentially? Any call around there would be great. And then the second one is just a quick one, maybe on MMS. I mean, very, very strong underlying growth, and given that drops into organic pretty much next quarter onwards. Just curious what you're hearing from customers, how you think about the durability within whether it's the pharmacy side or anything else. Just any details there would be great.
spk05: Thanks. Thanks, Patrick, for the great questions. We'll start with Chris.
spk08: Yeah, thanks, Patrick. Yeah, regarding margin, to your point, we've executed very strong in a very complex environment right past two years. We've had over 400 basis points of outsized inflation despite that. We've had nearly 400 basis points of base margin expansion. So that puts us 70% of the way on track to the 25% goal. So we feel really good about that if you do sort of the implied kind of math in the next two years, you would need roughly 50 to 75 basis points per year. We didn't want to share specifics at this time as it relates to margin profile. There's lots to consider within the P&L. It's obviously early from a guide, but I think what it offers us, the way you should think of it is, we have a de-risked path to 25 over the next two years. Not only that, it gives us a lot of flexibility to continue to ensure that, to your point, We're balancing an investment posture against continuing to drive outsized top line growth while still achieving our margin goals. So those will be the puts and takes that we'll think about as we move forward. I think the last comment I would make is we have a strong profile and pipeline of margin improvement initiatives that have already been underway now for years. So These aren't just numbers that are on a page to get to an outcome. We have detailed plans that get there and detailed plans that, you know, are de-risked in a way that we would plan knowing that, you know, execution doesn't always happen or you have other headwinds that may happen and gives us confidence to get to that number, but also some of those investments efficiency plans can be reinvested back in the business, too. So I think it's a very good position to be in, and we'll continue to share more as we get closer to 24. Great.
spk05: And obviously on MMS, a really strong quarter prior to a LARIS clearance obviously occurring, and so some really good things happening in the base business there. Mike?
spk03: Yeah, thanks for the question on MMS. A couple things to note. There is a little bit of an easy compare to last year. Last year, if you recall at this time, there were some COVID shutdowns in China that had some implications in terms of supply chain delivery, but that's not the real driver here. The real driver here is pharmacy automation and dispensing, and the value proposition that we have around the combination of patient safety and and clinician productivity. And those two things are resonating with our customers. And the Perot acquisition, our BDROA, both growing double digits and really helping to transform the way healthcare is thinking about the pharmacy and the value that it can provide, moving those pharmacists to work at the top of their license instead of counting the five pills at a time into amber bottles day in, day out. On the dispensing side, we really changed our approach a few years ago around innovation and started to focus on a cadence of innovation in dispensing, making it more connected, making it more focused on controlled substance management, these types of things. And it's really started to pay off in the marketplace. That's really resonating. And it's helping clinicians, especially during labor shortages and nurse shortages and things like that to better effectively do their jobs in the hospitals. So, you know, the dispensing, you know, the organic I think for MMS was quite strong, really driven by dispensing. Some other comments there, you know, from a capital, you know, allocation perspective, I think our flexible models there help for some customers where, Yeah, we can enter into lease agreements and things like that, so that helps for some customers, whereas other customers have the ability and they invest and they partner with us for the long term there.
spk04: Brilliant. Thanks for taking the questions.
spk08: Yeah, and I'm sorry, just one other comment on margins that you made, because I know you mentioned the Q4 exit being high. Remember, there are some, which is important as you think of us delivering and our confidence delivering Q4. There are some timing dynamics in there, right? The phasing of R&D we've talked about. There's some phasing in SSG&A. There's some comp dynamics in there. Those are worth between 150 and 200 basis points, so that's not a pure exit rate that you should think of that's hot. The other nice thing is we actually de-risked our Q4 margin versus last guide. It's about 75 bps, depending on how you look at it, relative to our last planning stance. So we feel really good about this year, then as I had shared before, the momentum beyond.
spk11: Thank you. Thanks. Thank you. We'll take our next question from Matt Taylor with Jefferies.
spk10: Good morning, Matt. Good morning. This is Mike Sarcona for Matt today. Thanks for taking my question. Just another one on the Alaris remediation. I'm just curious, are there any gating factors from the customer side, things that might be out of your control? We're seeing pretty robust procedure volume growth across MedTech. you know, does this plus any remaining staffing constraints, you know, limit customer ability to, you know, take time out to remediate or replace their fleets?
spk05: Sure.
spk10: Turn that to Mike.
spk03: I think maybe in like the acute sense at a particular hospital, but there'd just be, that's a scheduling issue more than their ability to do it at all. So I would just think of it that way that, you know, there may be, we can't do it this week or we can't do it this month, we can do it next month. It's more that planning piece, but that's something that we do anyway, whether it's on the dispensing side, pharmacy automation. We're constantly flexing to optimize and work with our customers based on how they can accept it. It's not our belief at this time that the customer side is going to be a significant barrier in the long run. I think it will be more in the phasing of things over time. Does that help?
spk10: That does help. Thank you. And then just one question on pharma systems. You've been posting some really strong growth there. It looks like you're on a mid-teens growth trajectory. Do you think you can just discuss kind of key drivers and how you view the sustainability of that, the growth in that business, you know, looking out to 2024 and through the 25 plant?
spk03: Sure. So the primary drivers around farm systems are the sort of move towards biologics and the innovation that's coming out of the pharmaceutical industry towards biologics. I think there was a question earlier around GLP-1 and the use of GLP-1s moving from type 2 diabetes to treat a broader population for obesity. That's one driver that's significant, but there's also a wealth of clinical data coming out around Alzheimer's treatment, cancer treatments, things like that, and these are biological molecules that are quite sensitive to the primary container closure device that's used to house them. Our technology is really well-suited for those types of molecules. And so if we think about the end-user population, the obesity, mental decline with age, cancer, these are very broad patient populations. And so the same sort of main driver that pharma is using there, we are able to support that. Yeah, we think that there is a fair amount of durability into the long-term demand here. I think there are also some factors. There is some COVID reset that we are also tracking very closely in the marketplace. The drugs that were used to treat during COVID that went into pre-fill syringes, for example, those are being reset in the marketplace. And so we're watching that to get a good feel for that. But long term, we feel really good about our position in this place. We also just welcome the new president for that business. So we're really happy to have her start, and she's coming up to speed very quickly.
spk05: Mike, and maybe just to compliment the good feedback that Mike gave, is we have a nice cadence of innovation in that business that's supporting innovation. those overall trends, as well as, of course, the over a billion dollars of capacity that we've added. And so you've got these great kind of unmet needs and continued demand cycle that's happening from pharma-driven biologics. We invested ahead of the curve right in the middle of the pandemic, a pretty bold decision to add capacity in that period of time, and you can see that paying off now. And then a series of innovations, not only on our high-pack syringes, but also on the self-injection side. These biologics, people are moving from sitting in a clinic with IV in your arm or going into a clinician to get injections. As these are becoming biologics or addressing chronic disease, the focus is enabling patients to deliver these medications subcutaneously by themselves in the home, not via an infusion or an injection by a clinician. And so Our self-injection business is also doing well and has a number of new innovations. Wearables, as an example, our Libertas platform, we're seeing solid demand. Our auto-infuser that's wearable, our pen, for example, that has quite a number of biosimilar insulins coming to market, and a large percentage of those are coming in our pen format. We're seeing strong demand there in addition to the HIPAC business, and so all that wraps up and supports what Mike said. Thanks for the question.
spk10: Really helpful. Thank you.
spk11: Thank you. At this time, I would like to turn the floor back over to Tom for any closing remarks.
spk05: Okay. Well, thank you, Operator, and thanks, everyone, for joining our call and for all of your questions. Before we sign off, I want to, again, thank our global team. of BD associates who continue to execute against our BD 2025 strategy and are making meaningful impacts for our customers and their patients. Particularly, I want to thank our team for their efforts related to the clearance of the updated BD Alaris infusion system and for all the work ahead as we move forward in working with our customers to update, replace existing devices, and support them in their care for patients. We are meeting our commitments and delivering strong, consistent performance with an increased outlook And we look forward to connecting with everyone again in November. And, operator, with that, we will end today's call.
spk11: Thank you. This does conclude today's audio and webcast. On behalf of BD, we thank you for joining today. Please disconnect your line at this time and have a wonderful day.
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