Embecta (ticker: EMBC), a leading medical technology company, reported a revenue decline in its Fiscal Third Quarter 2024, with figures of approximately $272.5 million, marking a 4.8% decrease on an as-reported basis and a 3.9% decrease on a constant currency basis. Despite this, the company has raised and tightened its financial outlook, expressing confidence in its strategic priorities and ongoing projects.
CEO Dev Kurdikar and CFO Jake Elguicze outlined the company's performance and future plans, including the introduction of a new pen needle product and the progress of the insulin patch pump program. Embecta also reported a strong cash position and advancements in its separation activities, aiming to complete them by early fiscal year 2025.
Key Takeaways
- Q3 revenue declined by 4.8% to approximately $272.5 million.
- The company raised and tightened guidance ranges for key financial metrics.
- Adjusted operating income increased primarily due to changes in adjusted gross profit and decreases in SG&A and R&D expenses.
- GAAP net income and earnings per share were $14.7 million and $0.25, respectively.
- Adjusted net income and earnings per share were $43 million and $0.74, respectively.
- The company's adjusted EBITDA margin for the quarter was 36.4%.
- Cash balance at the end of Q3 was approximately $282 million, with net leverage at 3.7 times.
- Embecta plans to launch small pen needle packs in Germany for GLP-1 administration.
- The insulin patch pump program is advancing, with a 510(k) application submitted to the FDA.
Company Outlook
- Embecta expects to complete all separation activities by early fiscal 2025.
- The company reaffirmed its full-year constant currency revenue range to be flat to down 0.5% compared to 2023.
- Adjusted gross margin guidance was raised to between 65.25% and 65.5%.
- Adjusted operating margin guidance was raised to between 25.75% and 26%.
- The company plans to launch small pen needle packs in Germany and expand to other countries.
Bearish Highlights
- The company experienced a revenue decline due to inventory rebalancing with distributors following ERP implementations.
- Cash flow was impacted by separation activities, with an estimated $130 million used in the first nine months of fiscal year 2024.
Bullish Highlights
- Embecta is progressing with its strategic priorities, including the insulin patch pump program.
- The company sponsored two abstracts at the American Diabetes Association scientific sessions, showing the potential for patch pumps in managing insulin delivery for type 2 diabetes patients.
- Embecta is optimistic about the potential entry of biosimilars into the market.
Misses
- Revenue has been inconsistent quarter-to-quarter due to ERP implementations and inventory movements.
Q&A Highlights
- Embecta discussed plans to launch small packs for GLP-1 administration in Germany, with appropriate pricing for the market.
- The company is working on a closed-loop version of their pump in parallel with the open-loop version.
- They mentioned the disposable platform with 300 units and simplicity in design as advantages for the Type 2 pump market.
- More details on the Type 2 plans will be provided at the Investor Day in December.
Embecta's Fiscal Third Quarter 2024 results reflect a period of transition, with the company managing inventory rebalancing and ERP implementations. The leadership remains focused on strengthening the base business and investing in growth opportunities, as evidenced by the raised financial guidance and the advancement of key programs such as the insulin patch pump. The upcoming launch of the pen needle product in Germany and the development of a closed-loop pump system further demonstrate Embecta's commitment to innovation in diabetes care. The company's financial position remains robust, with a healthy cash balance and a strategic approach to managing cash flow and debt. Embecta invites stakeholders to look forward to more detailed updates at the Investor Day event in December.
InvestingPro Insights
Embecta's recent fiscal third-quarter results have presented a mixed picture of the company's performance, with both challenges and opportunities highlighted in the report. To provide a deeper understanding of Embecta's financial health and market performance, here are some key insights based on real-time data and InvestingPro Tips:
- Embecta's market capitalization stands at approximately $826.99 million, reflecting the market's current valuation of the company.
- The company's price-to-earnings (P/E) ratio is 11.39, which gives investors a sense of how much they are paying for a dollar of earnings. Notably, the adjusted P/E ratio for the last twelve months as of Q2 2024 is lower at 9.7, suggesting improved earnings or a more favorable market assessment of the company's prospects.
- A notable InvestingPro Tip is that Embecta has seen a strong return over the last month, with a one-month price total return of 31.09%. This performance is significant as it may indicate investor confidence in the company's strategic initiatives and growth potential.
In addition to these metrics, Embecta's liquid assets exceed its short-term obligations, which is reassuring for investors concerned about the company's ability to meet its immediate financial commitments. Furthermore, analysts predict that Embecta will be profitable this year, a sentiment supported by the company being profitable over the last twelve months.
For investors seeking more in-depth analysis and additional InvestingPro Tips, there are more tips available on the InvestingPro platform specifically for Embecta, which can be found at https://www.investing.com/pro/EMBC. These tips can provide further guidance and insights into Embecta's financial and market performance, helping investors make more informed decisions.
Full transcript - Embecta Corp (EMBC) Q3 2024:
Operator: Please stand by. Welcome ladies and gentlemen to the Fiscal Third Quarter 2024 Embecta Earnings Conference Call. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded and the recording will be available on the company's website for replay following the completion of this call. I will now like to hand the conference call over to your host today, Mr. Pravesh Khandelwal, Vice President of Investor Relations. Please go ahead.
Pravesh Khandelwal: Thank you, operator. Good morning, everyone, and welcome to Embecta's Fiscal Third Quarter 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’d 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 slides. 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 begin by providing some remarks on the overall performance of our business during the fiscal third quarter of 2024, as well as an overview of our strategic priorities. Jake will then provide a more in-depth review of our Q3 financial results, as well as our updated financial guidance for the year. We will then open the call for questions. With that said, I’d now like to turn the call over to our CEO, Dev Kurdikar. Dev?
Dev Kurdikar: Good morning, and thank you for taking the time to join us. Let us start with Slide 5, where you will see the three strategic priorities that we’ve executed since our spin-off in April of 2022. First, we continue to strengthen our base business, while maintaining our global leadership position in the category of insulin injection devices. Second, we have made significant progress in our separation and stand-up activities necessary to establish ourselves as an operationally independent company. And finally, we continue to invest for growth, most notably around our insulin patch pump program that is being developed for the type 2 market, as well as seeking M&A and additional partnership opportunities. I am proud of the significant progress we have made within each of these goals. Turning to some third quarter highlights. During the third quarter, our team's disciplined execution led to financial results that were aligned with our prior expectations. We generated revenue of approximately $272.5 million which represented a decrease of 4.8% on an as-reported basis and a decrease of 3.9% on a constant currency basis. When normalizing for the transient contract manufacturing revenue that we generate based on the sales of non-diabetes products to our former parent, our constant currency core injection business revenue declined by 4.1% as compared to the prior year period. While our revenue during the third quarter was lower year-over-year on a constant currency basis, this was something that we had expected and highlighted on our second quarter earnings call and was primarily due to inventory rebalancing that occurred with some of our distributors following the ERP implementations that occurred during the first six months of our fiscal year. On a year-to-date basis, our core injection business has remained stable, growing 0.4% on a constant currency basis. Over the past year, much news has come out regarding GLP-1 and the impact they might have on people with diabetes and insulin delivery. Based on what we have seen over the past several years, our view is that while GLP-1 may delay the onset of becoming insulin dependent, they do not eliminate the need for insulin. In fact, as the method of GLP-1 administration continues to evolve over the next several years from the use of an auto-injector to that of a pen injector, which requires a pen needle, we expect that we will stand to benefit. To that end, we have identified an opportunity to introduce a new small pack pen needle product that can be used for GLP-1 administration. We intend to first come to market with this product in Germany within the next several months and eventually expand this product offering to other countries in the future. We believe this will help meet the needs of the growing number of people using pens and therefore pen needles for GLP-1 administration. Turning to separation activities. I'm pleased to report that we made significant progress in the implementation of our own ERP system, operationalization of our own distribution network and shared services capabilities. Now our systems and capabilities are operational in regions, which cover approximately 93% of our revenue base. Looking ahead with the exception of a few deferred closing jurisdictions, we remain on track to complete all ERP implementations, distribution network and shared service separation activities by early fiscal year 2025. Once these implementations are complete, the only remaining separation program will be brand transition which entails changing the product packaging from BD's brand to ours. 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 needs or color schemes associated with our packaging. This is important as people with diabetes will continue to experience the same look and feel on our boxes that they have been accustomed to for many years. Regarding our insulin patch pump program, we continue to progress on the open-loop patch pump. As a reminder, we submitted a 510(k) application to the FDA in December of 2023. And earlier this year, we received questions from the FDA concerning that application. We have since responded with the necessary data and await feedback from the FDA. We will continue to provide updates to the investment community on the progress regarding our insulin patch pump at the appropriate times. Relating to our objective of entering the infusion pump market, we sponsored two abstracts at the American Diabetes Association 84 scientific sessions that point to the potential for adults with type 2 diabetes to better manage insulin delivery through a patch pump with a larger 300-unit insulin reservoir, which could provide longer wear times and fewer disposable patches over time. The data presented reaffirms what we've learned from speaking with people living with diabetes and their health care providers and validates our thesis that there is a critical unmet need among the type two diabetes population for pumps with the larger insulin reservoir. So to summarize, we had another good quarter of results and based on the year-to-date performance as well as our expectations for the remainder of the fiscal year we are again raising and tightening our guidance ranges for key financial metrics while reaffirming our revenue guidance range. Now let's review our third quarter and year-to-date revenue performance in a bit more detail. As I mentioned before, during Q3 we generated revenue of $272.5 million, which represented a decrease of 4.8% on an as-reported basis and a decrease of 3.9% on a constant currency basis or 4.1% when normalizing for the impact of year-over-year changes in the revenue of the non-diabetes products that we contract manufacture and sell to BD. Within the US, during the quarter revenue totaled $143.6 million which represented a year-over-year decline of approximately 6.7% on a constant currency basis. When normalizing for year-over-year contract manufacturing revenue, our underlying Q3 constant currency revenue decline within the US was approximately 7.3%. The lower revenue within the US was expected and was primarily due to distributors normalizing their inventory levels after making advanced purchases ahead of our ERP implementation. As well as our annual price increase that went into effect on April 1. This volume decline was partially offset by favorable price and gross to net adjustments. Turning to our international business. During Q3, revenue totaled $128.9 million, which equated to a year-over-year constant currency decline of 0.6%. Like the US, the decline in constant currency revenue within International this quarter was expected and was primarily due to the timing of advanced purchases that customers made in advance of our ERP implementation. Importantly, through all separation activities that occurred during fiscal year 2024, our core injection business remained stable, growing 0.4% year-to-date on a constant currency basis. That completes my prepared remarks. And with that, let me turn the call over to Jake to take you through the third quarter financial results, as well as our updated full year financial guidance in more detail. Jake?
Jake Elguicze: Thank you, Dev, and good morning everyone. Given the discussion that has already occurred regarding revenue, I will start my review of Embecta's financial performance for the third quarter at the gross profit-line. GAAP gross profit and margin for the third quarter of fiscal 2024 totaled $190.1 million and 69.8% respectively. This compared to $189.5 million and 66.2% in the prior year period. While on an adjusted basis, our Q3 2024 adjusted gross profit and margin totaled $190.3 million and 69.8%. This compared to $189.6 million and 66.3% in the prior year period. The year-over-year increase in adjusted gross profit and margin was primarily driven by the impact of inventory revaluation adjustments which positively impacted year-over-year results by approximately 550 basis points, as well as the impact from favorable changes in price and gross to net adjustments that Dev referred to earlier. This was partially offset by lower product volumes, 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. Turning to GAAP operating income and margin. During the third quarter, they were $55.9 million and 20.5%, this compared to $51.3 million and 17.9% in the prior year period. While on an adjusted basis, our Q3 2024 adjusted operating income and margin totaled $83.3 million and 30.6%. This compared to $79.8 million and 27.9% in the prior year period. The year-over-year increase in adjusted operating income is primarily due to the adjusted gross profit changes I just discussed. As well as year-over-year decreases in both SG&A and R&D. The year-over-year decline of approximately $2 million in SG&A was primarily due to cost optimization actions taken in the current period as well as lower TSA costs. These reductions were somewhat offset by increased freight and warehousing costs. While the year-over-year decline of approximately $2 million in R&D was primarily due to lower expenses associated with our insulin patch pump platform. Turning to the bottom-line. GAAP net income and earnings per diluted share was $14.7 million and $0.25 during the third quarter of fiscal 2024, which compared to $15.2 million and $0.26 in the prior year period. While on an adjusted basis, net income and earnings per share were $43 million, and $0.74 during the third quarter of fiscal 2024. This compared to $39.8 million and $0.69 in the prior year period. The increase 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 a reduction in our adjusted tax rate from approximately 25% in Q3 of 2023 to approximately 22% in Q3 of 2024. This was somewhat offset by an increase in year-over-year interest expense associated with the rise in SOFR and the impact that had on our variable interest rate debt. Lastly, from a P&L perspective, for the third quarter of 2024, our adjusted EBITDA and margin totaled approximately $99.2 million and 36.4%. This compared to $92.2 million and 32.2% in the prior year period. Turning to the balance sheet and cash flow. At the end of the third quarter, our cash balance totaled approximately $282 million while our last 12 months net leverage as defined under our credit facility agreement, stood at approximately 3.7 times. As a reminder, our net leverage covenant requires us to stay below 4.75 times. From a cash flow perspective, our cash balance as of June 30 is approximately $45 million lower than the balance that existed as of September 30, and this is largely attributed to cash that has been used related to separation activities. Which include product registration and labeling costs, warehousing and distribution setup costs, legal costs associated with patents and trademark work temporary head count resources within accounting, tax, finance, human resources, regulatory and IT and one-time business integration and IT-related costs, primarily associated with our global ERP implementations. We estimate that during the first nine months of fiscal year 2024 and we used approximately $130 million of cash towards the separation activities. Additionally, we now show trade receivables globally on our balance sheet given our previously mentioned ERP implementations. As such, Embecta now collects receivables from customers directly as compared to prior to the ERP implementations, whereby BD factored those receivables on our behalf. I'm pleased to report that following the implementation of our ERP systems and shared service functionality within approximately 93% of our global revenue base cash collections associated with those receivables have continued to trend in a positive direction. Consistent with the comments I made on our second quarter earnings conference call, we continue to expect that we will end fiscal year 2024 with a cash balance of roughly $300 million, or comparable to the balance that existed at the end of the second quarter. This includes an expectation that for the full year, we will use approximately $180 million of cash towards separation activities. This compares to cash used for separation activities of approximately $145 million during fiscal year 2023. Given that we expect to be largely complete with separation activities by the end of this fiscal year, we expect to see an improvement in our cash balances in fiscal year 2025 and beyond which would allow us additional flexibility in terms of capital allocation, including more material debt repayment. That completes my comments on our fiscal Q3 results. Next, I will provide an update on our full year 2024 financial guidance. Beginning with revenue. Given our performance during the first nine months of the year, as well as our expectations for the fourth quarter, we are reaffirming our full year constant currency revenue range to be flat to down 0.5% as compared to 2023. Likewise, we are reaffirming our previously provided guidance for foreign currency, which called for foreign currency to be a headwind of about 0.4% versus the prior year. These FX assumptions are based on foreign exchange rates that were in existence in the late July time frame, including a Euro to US dollar exchange rate of approximately $1.08. On a combined basis, our as-reported guidance range continues to call for revenue to be down between 0.4% and 0.9% as compared to 2023. We resulting in a revenue guide of between $1.111 billion and $1.116 billion. Turning to margins. We are raising and narrowing our adjusted gross margin guidance from a range of between 64.5% and 65% to a new range of between 65.25% and 65.5%. Similarly, from an adjusted operating margin perspective, we are raising and narrowing that guidance from a range of between 25.25% and 25.75% to a new range of between 25.75% and 26%. While in terms of adjusted EBITDA margin, we are narrowing that guidance from a range of between 31% and 31.5% to a new range of between 31.25% and 31.5%. Lastly due to an improved margin outlook, we are increasing and narrowing our adjusted earnings per share guidance from a range of between $2.20 and $2.30 to a new range of between $2.30 and $2.35 and or an increase at the midpoint of approximately $0.08. This completes my prepared remarks. And at this time, I would like to turn the call over to the operator for questions.
Operator: Thank you. [Operator Instructions] Our first question comes from Marie Thibault with BTIG. Your line is open.
Marie Thibault: Good morning. Thanks for taking my questions. And very nice quarter. I wanted to start here a little bit on guidance and specifically the gross margins, they were very strong this quarter. And I think I heard mention of inventory valuation re-adjustments. Can you help me understand exactly what that is specifically? And then what we should be assuming in the implied step down for fiscal fourth quarter on that gross margin metric?
Jake Elguicze: Sure, Marie. Thanks. I appreciate the question. So let me start by saying that our adjusted gross margin was slightly better than our prior expectations in the quarter. And that's really what's allowing us to once again increase our full year adjusted gross margin guidance range by about 62.5 basis points at the midpoint of our new full-year guidance range. So during the quarter, the year-over-year increase in adjusted gross margin occurred due to a few factors, the largest of which you mentioned was a benefit from inventory revaluation adjustments or what's referred to as, profit and inventory. And that contributed about a 550 basis point year-over-year increase. And I'll come back to that in a moment as to what that was. In addition to the profit and inventory impact, we also had some favorable year-over-year impact from pricing and the gross to net reserve adjustments. That contributed about 140 basis points of the year-over-year increase. And then that was somewhat offset by some headwinds associated with lower product volumes stemming from the customers rebalancing their inventory levels, following the increased purchases that they made during the second quarter in advance of both our international ERP implementations, as well as the April 1 price increase that went into effect in the US. So those items negatively impacted volumes year-over-year by about 210 basis points. In addition, we also saw some year-over-year headwinds associated with inflation of about 120 basis points. So coming back to the -- to your question on inventory revaluation or profit and inventory. So as a result of all the ERP implementations that began in early fiscal year 2024, we had a real concerted effort for us to build up inventory to make sure that there were no issues from a customer standpoint. And that inventory was built in our manufacturing locations in China, in Ireland and in the US. And then we shipped those -- that inventory to a variety of distribution centers and different legal entities. And when that happens, there is intercompany profit that results once things transfer from one legal entity to another. And that intercompany profit needs to be eliminated at a consolidated level, since that product wasn't shipped yet to any type of a third-party customer. So once that inventory is then sold to customers, that profit that was previously on the balance sheet needs to be recognized into the P&L. And that is what happened this quarter. It just so happens that because of all the inventory that we had built up in advance of the ERP implementations, it resulted in a larger amount than what we typically see. So typically, these profit and inventory adjustments range within a few million dollars every quarter. It just happens to be the fact that because we had built up so much inventory and then recognized and then sold that inventory into the market, we needed to release that profit and inventory from the balance sheet into the P&L. And this was something that was previously contemplated within our prior year full year guidance range. It just happens to be -- it's typically much larger than what we would normally see. So as we move into the fourth quarter, we're not going to see -- necessarily see that same level of benefit. And if you go from our Q3 performance into our Q4 performance correct. The gross margins, the implied gross margins would step down from Q3 to Q4. And again, that largely has to do with the inventory revaluation or profit and inventory not recurring in the fourth quarter. So that alone is about a 500 basis point move from Q3 to Q4. And then additionally, I would say now that we've implemented our ERP systems within 93% of our business, and we only have Latin America and India left. Beginning in Q4, we are going to intentionally start to manufacture less product as we attempt to reduce our overall inventory levels and improve our working capital and improve our cash. But because we are doing that, we're going to see some negative manufacturing variances that impact us in Q4. Again, like the positive benefit to our P&L from the profit and inventory that occurred during Q3 the reduction in the manufacturing volumes was something that we had previously contemplated in our prior year guidance.
Marie Thibault: Okay. That all makes sense to me, Jake. Thanks for the level of detail there. Let me ask a follow-up here then on the move to start selling small pen needle packs in Germany for those GLP-1 users. How did you land on starting with that country, Germany. What are the thoughts on marketing those packs? And is there going to be a pricing premium, is there something to look toward on that as well?
Dev Kurdikar: Good morning Marie. We are absolutely excited about our prospects of launching the small pack for GLP-1s in Germany. Germany made sort of a logical first country for us. GLP-1s that are being launched in the form of a pen. So obviously, our pen needles are required. To administer those GLP-1s. The pen needles that we make today are the same pen needles that are required for GLP-1 administration. And so we launched the projects a few months ago to make small packs because as you can imagine, small packs are more patient and customer friendly for GLP-1 administration. The pricing is, I would say, appropriate for the market and appropriate for the use case. I wouldn't talk specifically about pricing premiums, but let me just say that we are pleased with the price that we expect to get. And look more broadly, we are starting with Germany as pen injectors proliferate and expand for the administration of GLP-1, we’ll certainly be there to provide pen needles. We have the capacity and can ramp up production of these small packs quickly to fill demand. And if you really project out over a number of years, if biosimilars enter the market, certainly again, that provides a tailwind for us. So we are excited about Germany. We're going to be launching that product there imminently here in the coming weeks, maybe a couple of months. And we will see where we go from there.
Marie Thibault: Okay. Very good. Thanks for taking the questions.
Dev Kurdikar: Thanks Marie.
Operator: Thank you. Our next question comes from Travis Steed with Bank of America Securities. Your line is open.
Travis Steed: Hi, thanks for taking my question. I guess the first question, I would like to start with when you think about the progress you are making on the pump and the investments that you kind of need to launch that product successfully. How should we think about kind of margins and earnings like that the street's got modeled for kind of going forward. Can you guys expand margins next year? Even with the investments required to launch this product? I just want to make sure we get kind of the models correct kind of going forward for this?
Dev Kurdikar: Thanks Travis. Good morning. So just as a quick reminder, right, for the audience here we made that submission in late calendar 2023. We got some questions from the FDA. It is part of the normal process that we responded in a very timely manner, and we've been progressing on the closed-loop solution as well. So first things first, we need and hope to get clearance on the pump. Obviously, I won't comment on the outcome and the timing of the FDA decision. And when it comes to our plans for the commercial launch for the pump and potential implications for fiscal 2025 respectfully, Travis. At this point, we are not ready to comment on 2025 numbers. I’ll repeat what I have said before. We are very mindful of our net leverage levels. We are very mindful of our debt. You've heard us comment in the past that we do have an increasing focus on cash and debt pay down. And so we'll be very measured and thoughtful in our plans. And what we are thinking right now, Travis, that we would hold an Analyst Day later this year, sometime in December. By that time certainly, we'll have clarity on open loop. We will have confirmed our plans on the pump. We will have made progress in the closed loop. And so we can talk about all of this at that time. In the meantime, we are laser focused on obviously closing out and delivering a successful 2025.
Travis Steed: Okay. Great. Thanks for that color. I look forward to the Analyst Day. And I guess the second question I'd ask is just kind of bigger picture. You guys have been a public company now for a while and kind of gotten independent? And just thinking about like how you maximize shareholder value from this forward point? Are there things that you're thinking about differently just to make sure that the value for shareholders is going to be maximized at this point versus what's reflected in public markets today?
Dev Kurdikar: Travis, look, our focus from day one has been on maximizing shareholder value, right, and we continue to look for ways to do that. We laid out pre-spend sort of a three year plan that we've been executing on, we'll certainly continue to execute that. But really, look I mean, from a everyday as a management team, we really think about all the ways that might be available to us to maximize shareholders' value. So that certainly continues to guide us on all the decisions we make.
Travis Steed: All right Dev. Thanks a lot.
Operator: Thank you. Our next question comes from Kristen Stewart with CL King. Your line is open.
Kristen Stewart: Hi, thanks for taking the question. I was wondering if you could just focus a little bit on free cash flows. I think, Jake, you had mentioned that separation costs are going to be stepping down here. I was wondering if there's any way that you could quantify that or just provide a little bit more color on the cash flow outlook for the company.
Jake Elguicze: Yes. So thanks for the question, Kristen. Again coming back to I think this year, we are going to end the year with around $300 million in cash on the balance sheet for the end of the year. That's going to include using around $180 million of cash in terms of separation activities this year, and that's coming on the heels of using around $145 million of cash in 2023. So I think one of the things that as we've gone through the spin here that I think sort of gets masked is really the free cash flow generation capabilities of the company because it really is quite strong. And I think beginning in 2025, you are going to see a much improved free cash flow generation. This isn't the type of franchise that needs a tremendous amount of capital expenditure investment. Given where we are. I mean we have three highly automated plants that we can put even more capacity through. So as we are thinking about next year, those separation costs are going to materially tick down. So it is going to go from, let's call it somewhere around $180 million this year down to maybe somewhere to the tune of around $50 million or so next year. And that -- the reason why we even have that amount next year largely has to do with the finalization of some brand transition expenses that we are going to have to go through in 2025 and then to a lesser extent in 2026. But as we move forward here, we should start over the next couple of years, our free cash flow generation should really more closely approximate our adjusted EBITDA as a company. So I'm not going to give you a specific number for 2025, but I would tell you that I think our free cash flow beginning in 2025 is going to materially improve from where we were in 2024.
Kristen Stewart: Okay. Thank you. And then, Dev any color that you can provide us on the questions that you received back from the FDA if they were expected? Or any sort of color there would be helpful.
Dev Kurdikar: Hi, Kristen good morning and it's nice to have you on the call and look forward to engaging more with you. Listen, I would say that all the questions we got we were able to, at least from our perspective, adequately and comprehensively respond to and do so in a timely manner. Beyond that, Kristen I wouldn't go into the details, obviously of the feedback. And we are eager to receive the FDA's decision here.
Kristen Stewart: And would you be prepared to go forward with the closed-loop version as soon as you get approval of the open-loop version? How will that work?
Dev Kurdikar: Yes. We've been working on the closed-loop version in parallel. You remember, we signed an agreement with Tidepool and our team has been busy integrating that algorithm with an open loop. So the work on the closed loop has actually been progressing even as we have been working on responding to the FDA on the open loop.
Kristen Stewart: Okay, thank you very much.
Dev Kurdikar: Thanks Kristen.
Operator: Thank you. [Operator Instructions] Our next question comes from Michael Polark with Wolfe Research. Your line is open.
Michael Polark: Hi, good morning. Thank you for taking my questions. I have two. I want to follow up on gross margin and then ask a question about Type 2 pumping. So Jake, I heard your response to Marie. A lot of good color there. But when I do the like 4Q implied gross margin, I get 60% huge step down even taking into account the thematic considerations you flag. It just strikes me as ultra conservative? And then when you run that down in the P&L, you see $0.31, $0.32 of EPS for the quarter which is obviously a huge step down versus where you've been. So can you -- it just -- it's tough to fathom. So I want to -- those are the numbers I see, and I want to confirm that those are the numbers you intend to plan for? And is this just ultra conservatism here sequentially?
Jake Elguicze: Yes. So Mike, thanks for the question. I mean, I think your implied math for Q4 is correct. In terms of -- it really is a gross margin story that is occurring largely associated with the PII that I mentioned, that drives around a 500 basis point move from Q3 to Q4. Additionally as I said, I think in my answer to Marie, we are very intentionally looking to try and right-size our inventory levels now that we are through all of these largely through all of the separation activities. So that is something that we are very intentionally looking to do to drive an improvement in our working capital and what that's going to mean at least in the fourth quarter, is sort of a temporary headwind associated with manufacturing variances. So we're not going to have the same level of absorption. Now all of this was contemplated in our prior guidance and obviously now in our current guidance. and yet we are still able to raise our gross margin guidance by about 62.5 basis points from the midpoint from our prior guide. And that raise really comes down to a few things. It comes down to our ability to continue to drive positive pricing and pricing being a little bit better than what we had previously expected. And then that guidance raise at the gross margin line also comes down to mix, both from a geographic and a product standpoint. So Additionally, I would just say we are also trying to take cost out in terms of regulatory freight and some manufacturing costs. So I think our team has done a tremendous job of trying to drive cost out of the system. That's allowing us to raise our full year guide. But as you think about going from kind of Q3 to Q4. There is some transient things going on, one related to PII, which moving forward isn't going to occur at that same level. And then likewise, from a manufacturing standpoint, a real concerted effort by us to try and reduce inventory levels now that the separation has gone really well. I mean, Mike if you think about this base business, on a full year basis. And there is been noise post spin for the last 2.5 years as we've had to go through all of the separation work. I think as we get into 2025, it is going to -- what you are going to end up seeing is a much more stable quarter-to-quarter performance from the business. And certainly from an annual standpoint. I mean, if you think about what this during 2024, if you look at the different components of the business and you sort of break-down and go from consolidated impact and you look at -- we have a very small contract manufacturing business. That generates around $5 million to $10 million per year in revenue back to BD, that is at gross margins that are around, let's call it, 12%. We have we spend around $60 million to $65 million a year in our insulin pump program. And then you have the core injection business which is a very stable, low to mid-60s typically gross margin business that then at the operating margin line is somewhere in the low 30s. So a much more stable business, I think, is what you should expect as we sort of move forward from 2024 into 2025.
Dev Kurdikar: Mike and if I can just sort of zoom back a little bit, right? I mean FY '24 has been marked with ERP implementations in dozens and dozens of countries right? We went to 93% of our revenue in the background, what that involves is moving products from BD's distribution network into new distribution centers. And you can imagine the inventory that has to be placed in new locations, working with customers to make sure in case there was any disruption, we didn't disrupt product continuity for our patients and customers. And so this year has been particularly lumpy quarter-to-quarter. No question. But I'm very pleased that we had incorporated our thoughts around this in the full year guidance. And frankly, our team has been executing to that. And so while it might appear certainly, the quarter-to-quarter variance that you are seeing, I certainly would urge you to zoom back and look at it over a full year basis and really just look at the performance of this business over a full year basis. So I just wanted to provide a little bit of that context.
Michael Polark: Appreciate all that color. Thank you. I want to ask on Type 2 pumping. So obviously, you have the program you are interested in this market. I've heard the update loud and clear today, but I'm curious how you internally expect the Type 2 pump market to develop Type 1s, 40%, 45% penetrated in the US grinding higher. It is a trend that's been in place for a while now. Type 2 is sub-5% pump penetrated [insulin] (ph) gearing up for the AID push into this market next year. And I'm curious how quickly do you think that ramps? How do you model the curve? Do you follow the Type 1 cadence? Do you think it could be faster, slower? I'd be interested in any color that you'd have to provide on that topic. Thank you so much.
Dev Kurdikar: Yes. Thanks, Mike. Look, it's too early for us to provide sort of any quantitative guidance with respect to what the penetration on Type 2 will be. And while we expect competitors entering Type 2 market as well. I mean I just want to remind everybody that ours would be a disposable platform with 300 units, and that has I would argue, some specific applicability for Type 2 customers. And also, we have designed it with simplicity in mind, which also makes it applicable. So having said all of that, this and we will talk more about our Type 2 plans at this Investor Day, we are planning in December. By that time, as I said we expect to have a FDAs decision. We'll have made some more progress on the closed-loop. So respectfully, Mike, I understand the eagerness to do now our Type 2 plans more, but I suggest we wait until later this year.
Michael Polark: Got it. Thank you.
Operator: Thank you. There are no further questions at this time. I'd like to turn the call back over to Dev for closing remarks.
Dev Kurdikar: Thank you, Michel. As we wrap up this call, I do want to extend my heartfelt appreciation to all my colleagues at Embecta across the globe. Our global team has in this year, executed on complex major separation-related programs while never wavering from our mission of developing and providing solutions that make life better for people living with diabetes. And as I mentioned during the call, we look forward to engaging with all of you at our Analyst and Investor Day in mid-December. Thank you all for attending the call and for your interest in our business.
Operator: Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone have a great day.
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