EMBC - NASDAQ

Good day, and welcome to the Embecta Fourth Quarter of Fiscal Year 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Pravesh Khandelwal, Vice President of Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone, and welcome to Embecta's Fiscal Fourth Quarter and Full Year 2024 Earnings Conference Call. The press release and slides to accompany today's call and webcast replay details are available on the Investor Relations section of the company's website at www.embecta.com. With me today are Dev Kurdikar, Embecta's President and Chief Executive Officer, and Jake Elguicze, our Chief Financial Officer. Before we begin, I would like to remind you that some of the matters discussed in the conference call will contain forward-looking statements regarding future events as outlined in our slide. We wish to caution you that such statements are, in fact, forward-looking in nature and are subject to risks and uncertainties, and actual events or results may differ materially. The factors that could cause actual results or events to differ materially include but are not limited to factors referenced in our press release today as well as our filings with the SEC which can be accessed on our website. In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in our press release and conference call presentation. Our agenda for today's call is as follows. Dev will start by presenting an overview of our strategic priorities following the spin-off and will highlight key accomplishments to date. He will also share insights into a future strategy and provide details of the restructuring plan announced today. Jake will then review our financial results for the fourth quarter and full fiscal year 2024, as well as discuss the preliminary guidance for fiscal 2025. Following these updates, we will open the call for questions. With that said, I would now like to turn the call over to our CEO.

Good morning, and thank you for taking the time to join us. Since the spin, which occurred on April 1, 2022, our strategic priorities over the past two and a half years have been focused on three areas. These include the need to strengthen and optimize our core business, the requirement to separate and stand up the organization from our former parent, and invest in growth opportunities. I am pleased to report that during the past two and a half years, we made significant progress within each of these objectives. First, we strengthened our core business by securing exclusive and preferred contracts with key Medicare Part D plans as well as establishing our products as a top choice within major national formularies, among other accomplishments. Second, we successfully completed major standard programs including the implementation of our own ERP shared services and distribution network, covering approximately 98% of our revenue base with only India remaining. We also exited the ownership of our manufacturing facility in China. I am proud to say that we completed these activities and more while avoiding interruptions to our customers, as well as avoiding disruptions to the people with diabetes who use our products daily. Finally, we continue to invest in growth. A testament to that is the clearance of our open-loop patch pump, which occurred in Q4, as well as the launch of a small pack GLP-1 pen needle set in Germany, with the intent to address the needs of a growing customer base. This strong execution, which occurred in a challenging macro environment, led to financial outcomes that exceeded 2024 expectations that were set prior to the spin. This included delivering a constant currency compounded annual adjusted revenue growth rate of approximately 1.3% and an adjusted EBITDA margin of approximately 31.4%. This compared to initial pre-spin expectations which called for a flattish constant currency revenue CAGR including significantly higher contract manufacturing revenue of non-diabetic products for BD and an adjusted EBITDA margin of approximately 30%. As a reminder, we provided these initial expectations in March 2022 in a vastly different economic climate, unaware of the unprecedented challenges that would soon follow. Since that time, we navigated historic inflation, a rapidly rising interest rate environment, geopolitical conflicts, and supply chain and labor issues. Despite these factors, which we estimate cost us roughly 500 basis points negative margin impact, our team delivered. Lastly, during this most recent quarter, we initiated a debt pay-down plan. This multi-year commitment to reduce our debt obligations should position Embecta with greater financial flexibility as we move forward. Turning to slide six. As we embark on the next phase of our journey, we recognize that building on our past accomplishments will require both prudent management of our capital structure and thoughtful investments to broaden our product portfolio to support future growth. Hence, this morning, we announced the restructuring plan aimed at streamlining operations and reducing costs. This restructuring program includes the decision to discontinue our insulin patch pump program following the recent US FDA clearance that we received in the open-loop portion of the pump that could be used by people with type 1 or type 2 diabetes. The decision to cease the pump program may come as a surprise. However, it is important to understand that we did not intend to do a full market launch of this product as the open-loop product currently cleared requires additional enhancements to be commercially competitive, including extensions of the product's shelf life as well as enhancements in the form of making the device compatible from a bring-your-own-device perspective. Most importantly, our goal since then was to come to market with a closed-loop version of a patch pump that had a specific label designation for people with type 2 diabetes. While our product development team has executed this program extremely well, achieving all internal milestones to date, it would take several more years of significant investment for us to complete a clinical study, obtain FDA clearance, and build up the necessary commercial and support functions before fully commercializing that product and achieving the scale for it to be accretive. Additionally, we recognize the pump market has continued to evolve and we anticipate that competition in those type 2 indicated products may continue to intensify, and our offering would require incremental investments to be market competitive. I also want to point out that upon FDA clearance of our open-loop pump, which we announced in September, we performed a market check to identify potential opportunities that would allow us to monetize the asset. Since that did not surface any viable options, we acted promptly to discontinue the program. The accompanying reorganization is designed to enhance the organization's profitability and cash flow, create a leaner and more efficient operation that would have greater financial flexibility to take advantage of opportunities that leverage our global commercial channel and strengthen high-volume manufacturing. In terms of financial impact, we currently anticipate that we will incur pre-tax cash charges associated with this reorganization of between $25 million and $30 million. Additionally, we anticipate that there will be non-cash charges associated with asset impairments and asset write-offs, which we currently estimate to be in the range of between $10 million and $15 million on a pre-tax basis. We expect that this restructuring will be largely complete during the first half of fiscal year 2025 and will deliver annualized pre-tax cost savings of between $60 million and $65 million. Lastly, given the recency of this decision, we have postponed our analyst and investor day to the spring of 2025. This delay allows us to fully focus on executing the restructuring plan so that when we come together for our analyst and investor day, we will be able to provide a fuller view of a more streamlined organization. In summary, we believe this strategic reorganization is a proactive step to improve our financial health, enhance profitability, and strengthen the company for the years ahead. Moving to slide seven. Moving forward, our focus will be on the next phase of Embecta's transformation, which will be guided by three key strategic priorities: continuing to strengthen the core business, expanding our product portfolio, and increasing financial flexibility. First, I would like to explain how we are planning to strengthen the core business further. In addition to continuing to deepen our relationships with customers and maintain our leading share of categories, we intend to progress the implementation of our brand transition plan and seek growth opportunities. By advancing our brand transition plan, we are ensuring that Embecta's identity remains strong and resonates across our markets. We have been planning this transition since the spin-off, and we intend for the execution of this program to begin in phases during fiscal year 2025. Notably, we are not changing the product names or color schemes associated with our packaging. This is important as people with diabetes will continue to experience the same look and feel of our boxes that they have been accustomed to for many years. The US will be the first region to undergo this transition, followed by Europe, and then the other regions. We expect to be largely complete in the next couple of years, but successful execution will involve a carefully coordinated transition of packaging, labeling, registrations, and regulatory certificates among other things. As with the separation activities we were discussing a year ago, our continued stand-up and transition activities will involve temporary expansions of our ability to manufacture or promote products in certain markets, which we intend to mitigate through inventory management and other measures that we successfully employed over the past year. Separately, we are actively pursuing other growth opportunities, identifying new areas to expand the reach and increase our impact. This includes both growing within our current markets and exploring untapped potential. One of the most promising opportunities on the horizon for Embecta is the growth for GLP-1 therapy. We believe that while GLP-1s delay the progression to insulin independence, they do not eliminate the need for insulin. Furthermore, as GLP-1 administration methods continue to evolve from auto-injectors to pen injectors, which require pen needles, we anticipate incremental benefit to our business. As noted on an earlier call, we recently launched our new small pack pen needle product in Germany specifically targeted for GLP-1 administration. This product introduction marks an important milestone and we plan to expand this offering to additional markets in the future. We are confident that this will help address the growing demand for pen-based GLP-1 administration, meeting the needs of an increasing number of patients using pens and pen needles. We will share more of our thoughts on the broader GLP-1 market opportunity and how we intend to benefit in the coming years at our investor day in the spring. Our next strategic priority is to widen our product offering by leveraging our core strengths. One of the strongest assets is our global commercial channel comprising of 600 plus commercial resources with deep customer relationships, with over half of these resources serving customers in the past of growing emerging markets. Adding market-appropriate products that can be delivered via existing channels will allow for increased productivity of our commercial resources. Another strength is our expertise in high-volume manufacturing while maintaining robust quality standards. Competency in injection molding and operating highly automated plants can be leveraged into making products that benefit from these competencies. While identifying the right products to manufacture will take time, we intend to start exploring the possibilities now. Lastly, increasing financial flexibility is an important priority for us. We recognize that without that, we are going to be limited in the strategic options available to us that could transition the company towards higher growth markets. Improving operational efficiencies is at the heart of this priority. We are committed to refining our processes, eliminating inefficiencies, and optimizing every aspect of our operations. This approach goes beyond cost-cutting. It ensures we remain lean, agile, and ready to adapt. Additionally, we believe that reducing net leverage and debt creates a stronger financial base that enables us to make strategic investments and remain resilient regardless of market conditions. In summary, by strengthening the core business, expanding our product portfolio, and increasing financial flexibility, our plan is to build a strong foundation for Embecta's future. Now let's review our revenue performance for the quarter and the full fiscal year. Before beginning our normal review, I wanted to highlight an event we worked through during the fourth quarter. The Italian government introduced legislation back in 2015 requiring medical device companies that supply goods and services to the Italian national healthcare system to pay back a portion of their proportional revenues to contribute to any overspend created by government budget overspend for medical devices each year. The payment amounts are calculated based on the amount by which the regional ceilings for that given year are exceeded. Numerous medical device companies challenged the enforceability of the law, primarily on the basis that the legislation was unconstitutional. The Italian administrative courts referred the question regarding the constitutionality of the law to the Italian Constitutional Court, which in July 2024 issued a ruling upholding the law's constitutionality. Following the ruling of the Italian Constitutional Court, the appeal before the Italian administrative court will proceed with respect to the remaining legal arguments asserted by the appellant regarding the enforceability of the payback law. Since the law was enacted, our fourth quarter and full-year revenue includes a reduction to revenue of $4.1 million related to fiscal years 2015 to 2023. Given that this amount relates to prior years, we have normalized for this amount when calculating our adjusted constant currency revenue growth rates for both the quarter and the full year. Additionally, our fourth quarter and full-year results also include a $1.2 million reduction of revenue associated with fiscal year 2024. Given that this amount relates to the current year, we have not normalized for this impact, although it was not something that was previously contemplated in our prior financial guidance. As litigation before the Italian court is still pending, final resolution is unknown at this time, and it is possible that the amount of Embecta's liability could differ from the amount currently accrued. Finally, you will notice that in addition to our typical geographic revenue disclosures, we are also providing a breakdown of our revenue on a product family basis. With that, I will now begin a review of our revenues for the fourth quarter. All amounts that I will refer to are on an adjusted revenue and adjusted constant currency basis unless otherwise noted. In the fourth quarter of fiscal year 2024, Embecta's adjusted revenues totaled $290.2 million, which represents an increase of 4.1% as compared to the prior year period or 3.3% if you were to exclude contract manufacturing revenue. This exceeded our prior expectations, with the outperformance in the quarter primarily related to the timing of orders from some distributors. The additional orders occurred as distributors attempted to mitigate any potential impact from the then-looming US port strike. From a product family perspective, during the quarter, pen needle revenue grew approximately 2.8%, syringe revenue grew approximately 4.8%, safety products grew approximately 5.8%, and contract manufacturing grew approximately 96%. Within the year, during the quarter, revenues totaled $167.4 million, which represented year-over-year growth of 10.3% on an adjusted constant currency basis. The year-over-year growth was primarily driven by the impact of the aforementioned distributor order timing, favorable pricing, and growth in the sales of non-diabetes products that were manufactured and sold to BD. Turning to our international business, during Q4, revenue totaled $122.8 million, which equated to a 3.1% decline on an adjusted constant currency basis as compared to the prior year period. The year-over-year decline within our international business was due to the unexpected timing of orders within China in advance of the ERP implementation as well as absorbing the full-year 2024 $1.2 million impact of the Italian payback measure which was all recorded in the fourth quarter. This was partially offset by year-over-year increases in Canada, Latin America, and Asia.

Meanwhile, international revenues totaled $520 million, which equated to year-over-year adjusted constant currency growth of approximately 1.3%. Growth internationally was driven primarily by volume growth within Canada, China, and Asia, partially offset by declines within India and Latin America. Lastly, and before I turn the call over to Jake, I want to highlight that since then, we have been able to successfully increase the prices of our products, particularly within the US, to help offset inflationary pressures. However, during 2025, we anticipate that pricing will turn into a headwind as we seek to renew agreements whose terms are expiring. With that, let me turn the call over to Jake for him to review other financial highlights as well as to provide preliminary financial guidance for fiscal year 2025. Jake?

Thank you, Dev. Good morning, everyone. Given the discussion that has already occurred regarding revenue, I will start my review of Embecta's financial performance for the fourth quarter at the gross profit line. GAAP gross profit and margin for the fourth quarter of fiscal 2024 totaled $173.8 million and 60.7% respectively. This compared to $181.8 million and 64.5% in the prior year period. While on an adjusted basis, our Q4 2024 adjusted gross profit and margin totaled $178.3 million and 61.4%. This compared to $182.6 million and 64.8% in the prior year period. The year-over-year decrease in adjusted gross profit and margin was expected and was primarily driven by the impact of lower absorption at our plants as we intentionally reduced inventory levels from Q3 to Q4, as we are now substantially complete with our ERP implementations. Additionally, the year-over-year decline in gross margin in the quarter was also due to revenue mix, as well as from the impact of inflation on the cost of certain raw materials, direct labor, freight, and overhead, and the negative impact of foreign currency translation primarily due to the weakening of the US dollar. These headwinds were somewhat offset by favorable pricing. From a sequential basis, we saw a step down in adjusted gross margin from Q3 to Q4. This was something that we expected to occur and is due to the profit and inventory benefit we experienced within our third-quarter results. Turning to our GAAP operating income and margin. During the fourth quarter, they were $26.2 million and 9.2%. This compared to $25.8 million and 9.2% in the prior year period. While on an adjusted basis, our Q4 2024 adjusted operating income and margin totaled $61.2 million and 21.1%. This compared to $65.2 million and 23.1% in the prior year period. The year-over-year decrease in adjusted operating income is due to the adjusted gross profit changes I just discussed as total operating expenses were in line with the year-ago quarter. Importantly, total operating expenses were flat compared to the year-ago period despite absorbing approximately $2.5 million of additional amortization expense associated with the ERP system implementations that occurred during this year. As Dev mentioned earlier, we are continuing to focus on managing operating expenses and becoming a more efficient organization as we move forward. Turning to the bottom line. GAAP net income and earnings per diluted share were $14.6 million and $0.25 during the fourth quarter of fiscal 2024, which compared to $6 million and $0.10 in the prior year period. While on an adjusted basis, net income and earnings per share were $25.9 million and $0.45 during the fourth quarter. This compared to $34.1 million and $0.59 in the prior year period. The decrease in year-over-year adjusted net income and diluted earnings per share is primarily due to the adjusted operating profit drivers I just discussed as well as an increase in year-over-year interest expense associated with the rise in SOFR, and the impact that that had on our variable interest rate debt. This was somewhat offset by a reduction in our adjusted tax rate from approximately 14% in Q4 of 2023 to approximately 9.5% in Q4 of 2024. The lower non-GAAP tax rate was due to certain tax planning initiatives which were completed before year-end, as well as the geographic mix of profitability. Lastly, from a P&L perspective, for the fourth quarter of 2024, our adjusted EBITDA and margin totaled approximately $73 million and 25.2%. This compared to $79.6 million and 28%. Turning to the balance sheet and cash flow. At the end of the fourth quarter, our cash balance totaled approximately $274 million while our last twelve months net leverage as defined under our credit facility agreement stood at approximately 3.8 times. As a reminder, our net leverage covenant requires us to stay below 4.75 times. Our ending cash balance includes a use of cash during the year of approximately $165 million associated with one-time separation activities. Lastly, during both our second and third-quarter earnings calls, I mentioned that we expected to end this year with a cash balance of approximately $300 million and that would have been the case. However, we proactively paid down an additional $25 million of our Term Loan B debt before fiscal year-end. As now that we are substantially complete with separation activities, we want to take steps to pay down debt more aggressively. That completes my comments on our fiscal Q4 results. Next, I'll provide a brief review of our full-year 2024 financial results. GAAP gross profit and margin for fiscal 2024 totaled $735.2 million and 65.5% respectively. This compared to $749.9 million and 66.9% in the prior year. While on an adjusted basis, our 2024 adjusted gross profit and margin were $740.7 million and 65.7%. This compared to $751.2 million and 67% in the prior year. The year-over-year decrease in adjusted gross profit and margin was primarily driven by the impact of inflation on the cost of certain raw materials, direct labor, freight, and overhead, the impact of negative manufacturing variances stemming from the temporary shutdown, and the negative impact of foreign currency translation primarily due to the weakening of the US dollar. These headwinds were somewhat offset by the impact of profit and inventory adjustments resulting from inventory that was sold to external customers, that was manufactured in anticipation of our ERP system and other business continuity processes that went live during fiscal year 2024, and favorable pricing. Turning to GAAP operating income and margin. During 2024 they were $166.8 million and 14.9%. This compared to $221.5 million and 19.8% in the prior year. While on an adjusted basis, our 2024 adjusted operating income and margin totaled $296.9 million and 26.3%. This compared to $331.5 million and 29.6% in the prior year. The year-over-year decrease in adjusted operating income is due to a combination of factors including the adjusted gross profit changes I just discussed, as well as an increase in adjusted SG&A. The increase in SG&A costs were all related to standing up the organization and were associated with increased compensation and benefit costs due to increased headcount as well as increased outbound freight and warehousing costs. These additional costs were somewhat offset by a reduction in TSA expenses. Turning to the bottom line, GAAP net income and earnings per diluted share were $78.3 million and $1.34 during fiscal 2024, which compared to $70.4 million and $1.22 in the prior year. While on an adjusted basis, net income and earnings per share were $143.1 million and $2.45 during fiscal 2024. This compared to $172.6 million and $2.99 in the prior year. Like my comments relating to the fourth quarter, the decrease in year-over-year adjusted net income and diluted earnings per share is primarily due to the adjusted operating profit drivers I just discussed as well as an increase in year-over-year interest expense associated with the rise in SOFR. This was somewhat offset by a reduction in our adjusted tax rate from approximately 23% in 2023 to approximately 20% in 2024. Lastly, from a P&L perspective, during 2024, our adjusted EBITDA and margin totaled approximately $353.4 million and 31.4%. This compared to $378.7 million and 33.8% in the prior year. In closing, during fiscal year 2024, we were pleased with our ability to raise our financial guidance following each quarter of the year, ultimately ending fiscal year 2024 with financial results that were above the high end of our most recently provided guidance ranges for most financial metrics. The ability to generate these results was no small task, particularly given all the separation-oriented activities that we focused on during the year. This is a testament to the resiliency of our products and our people who put in countless hours to make Embecta successful. That completes my prepared remarks on our fourth quarter and full-year 2024 results. Next, I would like to discuss Embecta's preliminary 2025 financial guidance and certain underlying assumptions. Given that we have made the decision to discontinue the insulin patch pump program, our financial guidance metrics for 2025 will exclude all costs associated with the patch pump program for the entirety of the year. As Dev mentioned earlier, we anticipate that this restructuring and shutdown of the program will be largely complete during the first half of fiscal year 2025. Additionally, for comparability purposes, as we move forward during the year, we will also update our prior year 2024 adjusted financial results to also exclude the costs we incurred associated with the patch pump program. As a reminder, during fiscal year 2024, we incurred approximately $63 million of total expense related to the pump program or approximately $16 million per quarter. With that, let me review our initial 2025 financial guidance ranges. Beginning with revenue. On an adjusted constant currency basis, we currently anticipate that our revenues will be down between 1% and 2.5% as compared to 2024. At the high end of our constant currency revenue range, we have factored in that volumes remain relatively flat as declines in the US are offset by continued growth within emerging markets, most notably China and Asia. While from a pricing perspective, during 2025, we currently anticipate that price will be a headwind of approximately 1% due to the pricing concessions that Dev mentioned earlier, related to the renewal of agreements whose terms are expiring. While at the low end, we are assuming all the same facts except for the potential of greater year-over-year headwinds associated with volumes within the US. Turning to our thoughts on FX. Our initial guidance calls for a foreign currency headwind of approximately 0.6% during 2025. This assumption is based on foreign exchange rates in existence around the mid-November time frame including a euro to US dollar exchange rate of approximately 1.08. Somewhat offsetting FX is the fact that our as-reported 2025 GAAP revenue will not be impacted by the 2015 through 2023 amount we needed to accrue associated with the Italian payback measure that impacted our 2024 as-reported GAAP revenue. This equates to a tailwind of approximately 0.4%. On a combined basis, our as-reported revenue guidance calls for a decline of between 1.2% and 2.7%, resulting in an initial revenue guide of between $1.093 billion and $1.110 billion. Turning to adjusted gross margin. We currently anticipate that our 2025 adjusted gross margin will be in the range of between 63.25% and 64.25%, or a decline at the midpoint of approximately 200 basis points as compared to 2024 levels. The largest anticipated year-over-year headwind being that we will not see the same level of benefit in 2025 that we did in 2024 related to profit and inventory, which alone is expected to be a year-over-year headwind of approximately 150 basis points. The additional gross margin headwinds are associated with pricing and inflation, which are somewhat offset by a variety of productivity initiatives identified by our manufacturing team. Continuing down the P&L, given that we are largely complete with separation, including the establishment of necessary internal full-time resources, we expect that our adjusted SG&A as a percentage of revenue will be flattish as compared to 2024 levels. While from an adjusted R&D perspective, which excludes the patch pump program, we expect R&D as a percentage of revenue to approximate 2%. Ultimately, we anticipate that our adjusted operating margin during 2025 will be between the range of 29% and 30%. Moving to earnings, during 2025, our initial guidance calls for an adjusted diluted earnings per share range of between $2.70 and $2.90 and is based on a weighted average diluted share amount of 58.9 million shares. Our initial adjusted earnings per share range includes an assumption that during 2025, we will repay approximately $110 million in debt and that our annual net interest expense will be approximately $107 million. Our guidance assumes that we will use between $50 million during fiscal 2025 associated with separation costs, largely related to brand transition, between $25 million and $30 million in cash usage associated with the discontinuation of our insulin patch pump program, and approximately $20 million in capital expenditures. From a tax perspective, our initial adjusted earnings per share range assumes that our annual adjusted tax rate will be approximately 25%, which includes the impact of Pillar Two. Lastly, our initial guidance for fiscal year 2025 calls for an adjusted EBITDA margin of between 35.5% and 36.5%. Before I turn the call over to the operator for questions, I want to provide some additional context regarding our expectations during 2025. Moving forward, we may not provide any further commentary concerning the quarterly cadence of revenue on an ongoing basis. During fiscal year 2024, we generated approximately 50% of our adjusted revenue dollars during the first half of the year, including approximately 25% during the first quarter. During 2025, we currently anticipate generating a slightly lower percentage of our annual revenue during both the first quarter and first half of 2025, as compared to the prior year periods, since the first half of 2024 revenue was positively impacted by customers buying additional product in advance of our ERP implementations, as well as because of the additional orders we received from some US distributors during Q4 of 2024 due to the then-looming US port strike. That completes my prepared remarks. At this time, I would like to turn the call over to the operator for questions. Operator?

Press star one one again. One moment while we compile the Q&A roster. Our first question will come from the line of Marie Thibault with BTIG. Your line is open.

Hi. Good morning. Congrats on a great quarter and guide. I wanted to ask here about the patch pump program and try to understand a little bit better what's coming next. Congrats on making a decision there. But I want to understand a little bit about what you are hoping to do with the free cash flow generation in addition to paying down debt. Are there other capital allocation priorities that you want to highlight whether that's, I know you pay a dividend, but increasing a dividend or share repurchases or potentially M&A? Anything else to consider there?

Good morning, Marie. Let me maybe I'll kick off and then Jake can augment as needed. So regarding the patch pump, it was truly just a very pragmatic capital allocation decision. It was after achieving a pivotal milestone. As I said in my prepared remarks, we did a market check as well. With regard to capital allocation, our number one priority right now is to pay down debt because we think that being able to do that will actually create the financial flexibility to make some M&A moves. Continuing to invest in the patch pump would have squeezed out any opportunities for us either on the M&A side or frankly even making additional investments in our own manufacturing or commercial capability. So just to be very clear about that, even though I covered it exhaustively, I believe, in the prepared remarks, this was purely a capital allocation decision, had nothing to do with the design of the pump or the performance of our team with respect to meeting internal milestones. As you pointed out, we already pay a dividend to our shareholders. At this point, we do not see any change in that, and our focus is certainly in fiscal 2025 is going to be on paying down the debt, creating the financial flexibility. We still have one separation-related thing to do, which is brand transition. Executing that very well. That's a complex program as well. And certainly, when it comes to M&A, we'll share more of those thoughts at the upcoming Analyst Day. But we certainly intend to find opportunities that are going to allow us to leverage our global commercial channel of 600 plus commercial employees around the world, particularly in emerging markets, which are fast-growing, as well as leverage our manufacturing competencies, particularly in injection molding and the fact that we make eight billion devices a year with robust quality standards. Those are the areas related to which we will look into, but certainly, we'll share more at the Analyst and Investor Day in spring of 2025.

Yeah. Maybe just to add on just briefly here, I think in terms of cash usage, I think the way that you sort of think about it is, you know, we ended 2024 with a cash balance of roughly $274 million on the balance sheet. I think our expectation is that we'll probably end 2025 with a similar, maybe slightly higher amount of cash on our balance sheet. Essentially, any of the savings, if you will, Marie, from not having to spend in those one-time separation costs, we expect to spend about, you know, we spent around $165 million in 2024 related to one-time separation costs. We mentioned that we intend to spend around $50 to $60 million this year largely around brand transition in 2025. So I think those cash savings of around $110 million are really going to get repurposed into debt pay down in 2025. To the extent that we're able to continue to generate more cash, I think we'll be even more aggressive. I think if you think about what our guide implies today in terms of net leverage, it would sort of indicate that by year-end, we would get down to around a three times net levered mark. As we move into 2026, the free cash flow capabilities of the company will even improve more so as we don't see any really meaningful separation-oriented spending. Hopefully, that provides a little bit more detail for you.

Yeah. That's very helpful. Thank you both. And then I guess I'll ask kind of a macro question. We're getting more tariff headlines, of course, this morning. Can you just confirm for us your thoughts on sort of any impacts, if any, from potential tariffs in China and Mexico and elsewhere and any thoughts on, I guess, you're including Pillar Two in your tax? Any thoughts on FX and some of the big moves we've seen recently? Thank you so much for taking the questions.

Yeah. Thanks, Marie. Again, I'll kick off with tariffs and turn it over to Jake to talk about taxes and FX. Look, obviously, tariff policy, we all expect to continue to evolve. But based on what we know today, a very, very small portion of our US revenue is from products manufactured in China. With respect to tariffs from China, it remains to be seen how customers may react to products that they currently source from China that might get tariffed in the future. Supply and certainty of those products might create an opportunity for us that we certainly stand ready to capitalize on. We'll watch this space and respond accordingly. The overnight headlines around Canada and Mexico, we don't manufacture products in Canada and Mexico. Obviously, we would need to review all those guidelines when they come out in more detail. At this point, it's difficult to forecast any retaliatory tariffs that Canada and Mexico may apply. Canada and Mexico are both important markets for us, so we'll certainly watch this space, Marie. I know it's rapidly developing. Certainly, we will update on future calls as our perspective becomes clearer. Jake?

Yeah, Marie, as it relates to the tax rate, I think our non-GAAP tax rate in 2024 was around 20%. I think the team did a very nice job of trying to implement a variety of different planning initiatives, particularly towards the end of the year, that allowed that to continue to go down. Keep in mind that also included any of the expenses in 2024 associated with the patch pump. Meanwhile, in 2025, our guidance obviously excludes any of the expenses associated with the patch pump for the full year. It is somewhat of an apples and oranges comparison, but if I had to try and bridge from the 20% to the 25% in 2025, I would say that around 2.5% of that 5% increase alone is due to the impact of Pillar Two. The remainder is really due to a mix of additional US tax on foreign earnings, as well as just fewer R&D tax credits that we would expect to incur. From an FX standpoint, again, I think we sort of pegged our initial guidance and closed that down a couple of weeks ago with the FX rates that existed in the mid-November time frame, including a euro of 1.08. Obviously, we'll have to continue to keep track of how those FX moves continue along during the course of the year, but in relation to year-over-year, I think our initial guide today would assume a revenue headwind of around $6 million and I think an adjusted earnings per share headwind year-over-year of around, let's call it around five cents.

Very helpful. Thank you, and good luck.

Thank you. One moment for our next question. That will come from the line of Kallum Titchmarsh with Morgan Stanley. Your line is open.

Good morning, guys, and thanks for taking the question. Just on the patch pump, I feel like many of the points you mentioned when it comes to rationalizing the discontinuation were pretty well known for some time. We knew it would require a step up in R&D. We knew you'd need to establish that sales force, and we knew competition had been intense in the space for many years. Why do you think it took this much time to decide to discontinue the program? We'd just love a bit more color on that thought process, if possible, and then I have one follow-up. Thanks.

Yeah. Thanks, Kallum. I'll take that. Look, as I mentioned, at this point, as we look forward over the next several years and want to create opportunities for growth that are perhaps more aligned with the company's core strengths, we decided that taking those savings and focusing on debt pay down was the best option going forward. But with regard to your question of why now, let me say this. If we think about twelve to eighteen months ago, there was certainly deal activity going on around pumps. There was fundraising activity going around pumps. At that time, we were on the doorsteps of submitting our 510(k) application to the FDA. We decided that going through the process, getting clearance, and then looking for ways to monetize that asset was, of course, we decided to pursue, which we did. We got the clearance. As soon as we got the clearance, we did a market check to evaluate opportunities to monetize the asset, none surfaced. Obviously, over this time, the market has continued to evolve not just in the pump space, but also in the drug space. We just made a pragmatic decision that given that the market check had not turned up any alternatives even for a 510(k) cleared pump, given what we saw with respect to how we should allocate our capital in the future, we promptly, after clearance, decided to discontinue the program once the market check was complete.

That's helpful. When thinking about new opportunities to push into, are there any restrictions we should be aware of that relate to BD post-spin? I think maybe auto-injectors were called out historically as something that maybe could have been developed in-house, but correct me if I'm wrong there.

Yeah. Look, from an M&A perspective, certainly, there are no restrictions. Once we have paid down debt and created some financial flexibility for ourselves, we can certainly proceed in any area that makes sense for us as a company. There are certainly, as part of our separation agreements, restrictions on what we can do with the technology that was acquired by us at the point of separation. There are certainly some restrictions around that. But in terms of our go-forward strategy, which is why creating this financial flexibility is so important because it really creates a vast space for us to go exploring that leverages our core competencies.

That's helpful. Thanks a lot.

Thank you. One moment for our next question. That will come from the line of Michael Polark with Wolfe Research.

Good morning. Thank you. Two follow-ups on the patch pump decision. I'll frame the question this way. Do you think there still could be residual value here? I agree that the pump market continues to intensify. However, as it relates to patch options, the US market is still several years away, and you were kind of, I think, as close as anyone. While you said you've conducted a market check, is there a chance that there's interest in absorbing, taking over your product from someone else, or as you restructure here, does that kind of shut the door for that possibility?

Mike, good morning. Thanks for the question. Look, at this point, I would say the market check that we did, we arrived at the conclusion that there wasn't a viable option to monetize the asset. Would I ever rule anything out in the future if somebody approached us? Obviously, we'd be open to it. With the restructure, certainly, we are taking firm steps today to discontinue the program. But if somebody was interested in the value of the asset, the IP, all of that, certainly we'd be open to those discussions, Mike.

Understood. Appreciate that. The follow-up is on the savings from this update. Jake, I heard $63 million of expense on the pump in fiscal 2024. Sounded familiar. The guidance on a pro forma basis for the benefit from this restructuring program is $60 to $65 million. So it kind of captures the spend last year, but it sounds like there might be something more than just the patch pump discontinuation and this restructuring announcement. So is there, or is this really contained to the patch program and therefore that's why the savings numbers align? Thank you so much.

Yeah, Mike, you're correct. The announcement that we made this morning is tied to the discontinuation of the pump, hence the alignment of the figures from 2024 into our thoughts on an annualized basis going forward into 2025 and beyond. Now, that said, I would say that now that we're through separation, I think we're going to continue to look for ways moving forward to continue to reduce costs and just cost optimization. That is certainly nothing that is necessarily factored into our numbers that we put out today in terms of our guidance. But obviously, now that we're through separation, we're going to continue to try and just be as efficient as possible in terms of our operating cost structure.

Thank you. I'm showing no further questions in the queue at this time. I would now like to turn the call back over to Dev for any closing remarks.

Thank you, Operator. As we wrap up the call, I want to extend my heartfelt appreciation to all my colleagues at Embecta across the globe. As we look back over the last two and a half years, our global team has executed complex major separation-related initiatives with dedication and resilience and achieved the expectations that we had laid out even prior to the spin. With that said, I also want to acknowledge the restructuring plan that we announced today and recognize that these changes have impacted many of our valued team members. To those affected, we are sincerely grateful for your contributions and conscious of the difficult transitions that this decision has brought for so many. We believe these changes, though challenging, are necessary steps to strengthen Embecta, setting us up for a stronger, more sustainable future. Finally, we look forward to engaging with all of you at upcoming conferences and at our rescheduled investor day in spring of 2025, where we'll share more about our vision for Embecta. I wish you and your loved ones a happy Thanksgiving. Thank you.