Embecta Corp. (EMBC) reported a revenue increase in its fiscal second quarter 2024 earnings call, noting a 3.6% rise on an as-reported basis and a 4.5% increase on a constant currency basis, totaling $287 million.
Despite surpassing revenue expectations and raising financial guidance, the company faced declines in gross profit, operating income, and net income due to inflation, manufacturing variances, foreign currency impacts, and increased expenses.
Embecta highlighted progress in their strategic initiatives, including the implementation of their ERP system, operationalizing their distribution network, and completing the separation from their former parent company. The company's net leverage stands at 3.8x, with a cash balance of $306.5 million.
Key Takeaways
- Embecta's revenue rose to $287 million in the fiscal second quarter, exceeding expectations.
- The company's gross profit and margin decreased year-over-year due to inflation and other factors.
- Operating income and margin declined as a result of increased SG&A costs.
- Net income and earnings per share also fell compared to the previous year.
- Cash balance remained strong at $306.5 million, with net leverage at 3.8x.
- Embecta raised guidance for adjusted gross margin, operating margin, EBITDA margin, and earnings per share.
- The full year 2024 revenue is expected to be flat to down 0.5%, with currency translation posing a headwind.
- Accounts receivables increased due to ERP system implementation and the exit from factoring agreements.
Company Outlook
- Full year 2024 constant currency revenue projected to be flat to down 0.5% compared to 2023.
- Guidance for adjusted gross margin, operating margin, EBITDA margin, and earnings per share has been increased.
- Cash balance is expected to be comparable to the second quarter at the end of fiscal year 2024.
- Improvements in cash balances anticipated for fiscal year 2025.
Bearish Highlights
- Year-over-year decrease in gross profit and margin, operating income and margin, net income, and earnings per share.
- Increased accounts receivables due to ERP system implementation challenges and the end of factoring agreements.
Bullish Highlights
- Revenue growth and raised financial guidance indicate positive performance.
- Strategic progress in ERP system implementation, distribution network operation, and company separation.
- No disruptions from competitor's sale and transfer of pen needle and blood glucose meter business.
Misses
- Adjusted operating income and margin decreased compared to the prior year, primarily due to changes in adjusted gross profit and increased SG&A costs.
Q&A Highlights
- Embecta is in discussions with potential entrants into the GLP-1 market.
- The company is considering an Investor Day event to discuss long-term financial strategies.
- Embecta is evaluating the Tidepool pipeline algorithm for type 2 diabetes and awaits FDA clearance.
- The potential impact of weekly basal insulin on the market was discussed, considering cost, efficacy, promotional focus, and patient preferences.
Embecta Corp. continues to navigate the complex landscape of diabetes care with strategic initiatives and product development. The company's performance in the fiscal second quarter of 2024 demonstrates resilience amid market challenges, with a focus on long-term growth and innovation in insulin delivery technologies.
InvestingPro Insights
Embecta Corp. (EMBC) has shown notable performance metrics in the last quarter, as highlighted in the fiscal second quarter 2024 earnings call. To provide a more comprehensive view of the company's financial health and stock performance, here are some InvestingPro Insights that could be of interest to investors:
- The company's market capitalization stands at a robust $821.22 million, indicating a significant presence in the market.
- Embecta's price-to-earnings (P/E) ratio has been adjusted to 8.97 for the last twelve months as of Q2 2024, suggesting a potentially more attractive valuation compared to the standard P/E ratio of 11.66.
- The stock has experienced a significant return over the last week, with a 1 Week Price Total Return of 40.3%, reflecting a strong short-term performance that investors may find encouraging.
InvestingPro Tips for Embecta Corp. provide additional insights that may further inform investment decisions:
- The Relative Strength Index (RSI) suggests the stock is currently in overbought territory, which could indicate a need for caution among potential buyers.
- Analysts have revised their earnings downwards for the upcoming period, which may impact future performance expectations.
For those interested in a deeper dive into Embecta's stock analysis, InvestingPro offers additional tips on the company's financials and performance. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and gain access to a total of 7 InvestingPro Tips for Embecta Corp., including insights on profitability projections and liquidity positions.
Full transcript - Embecta (EMBC) Q2 2024:
Operator: Welcome, ladies and gentlemen, to the Fiscal Second Quarter 2024 Embecta Earnings Conference Call. [Operator Instructions] 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 would 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 Second 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 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 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 second quarter of 2024 as well as an overview of our strategic priorities. Jake will then provide a more in-depth review of our Q2 financial results as well as our updated financial guidance for the year. We will then open the call for questions. With that said, I would 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's start with our strategic priorities on Slide 5. We remain committed to the same trio of strategic priorities that have guided us since we established our service as an independent company. These priorities form the basis of our decisions and actions, and they are: remaining focused on strengthening our base business while maintaining our global leadership position in the category of insulin injection devices; separating ourselves from our former parent in a thoughtful manner to mitigate risk and position us for long-term success as an independent company; and finally, investing in 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. During this past quarter, we made significant progress within each of these goals. Turning to some second quarter highlights. The second quarter was a strong quarter for Embecta, one in which we generated approximately $287 million in revenue, which represented an increase of 3.6% on an as-reported basis and 4.5% on a constant currency basis. When normalizing for the transient contract manufacturing revenue that we generate based on sales of non-diabetes products to our former parent, our constant currency revenue grew 4.9% as compared to the prior year period. This solid performance exceeded our expectations and occurred while simultaneously implementing our own ERP system, operationalizing our new distribution network including 7 new distribution centers, and standing up shared services capability in markets comprising 25% of our revenue in over 100 countries and serving approximately 5,000 customers. We also implemented these systems and processes in our third manufacturing plant. Thus, at the end of the second quarter, we have completed the implementation of our ERP system and operationalized our distribution network and shared service capability across approximately 85% of our revenue base, servicing customers in U.S., Canada, EMEA and parts of Asia and at all 3 of our manufacturing plants in the U.S., Ireland and China. Additionally, we successfully completed the remaining steps in the demerger process for our manufacturing entity in China and have transitioned its legal ownership from BD to Embecta. We have also resumed manufacturing at this facility for products for supply to our customers in China. We have previously commented that this facility was producing goods for export to other markets, so now the plant is fully operational. All of these accomplishments were achieved in alignment with our projected timelines. The transfer of ownership of this important plant from BD to Embecta and the restarting of domestic China production marks the completion of a significant separation project that our team has been meticulously working on since prior to our spin-off date. Lastly, as it relates to separation activities, to facilitate the phased implementation of our ERP solution, distribution network and shared services capabilities, we had requested an extension for certain TSAs and related agreements from BD. BD granted that limited extension, which has allowed us to implement our ERP system and associated distribution and shared services capabilities in a phased manner with the goal of completing these implementations in all markets except in certain limited deferred closing jurisdictions by early fiscal year 2025. It goes without saying that these implementations are highly intricate, and I'm proud of our team for bringing these complex projects to near completion. Related to our objective of entering the infusion pump market, we sponsored the publication of a paper titled, Opportunities to Overcome Underutilization of Enhanced Insulin Delivery Technologies in People with Type 2 Diabetes: A Narrative Review. This paper aims to inform health care providers, particularly primary care physicians and those less familiar with technology about the benefits of insulin pumps for people with type 2 diabetes. It highlights the safety and effectiveness of innovative technologies like insulin delivery systems in improving glycemic outcomes. Despite the proven efficacy, these technologies are often overlooked in primary care settings. The review explores the clinical and economic advantages of tubeless insulin delivery devices and explains how this technology can address common challenges associated with traditional insulin delivery methods. And speaking of insulin patch pumps, we continue to make progress in terms of insulin patch pumps that are being developed. I'll share more about these accomplishments in the following slide. To summarize, during the second quarter, strong operational execution led to results that exceeded our internal expectations, and based on these results, we are raising and tightening our guidance range for key financial metrics, which Jake will be discussing later. Turning to the advancements we made in terms of our insulin patch pump program. Our 510(k) application for the open-loop version of our insulin patch pump continues to be under FDA review, and we continue to have ongoing dialogue with the FDA. As a reminder, we submitted our 510(k) application to the FDA in late calendar year 2023. In parallel, during the second quarter, we also continued the development of a closed-loop insulin patch pump that is targeted towards those individuals who have type 2 diabetes, including further collaborating with Tidepool concerning the adaptation of their FDA-approved type 1 algorithm into a type 2 algorithm that could be used in our closed-loop insulin patch pump system. As we continue to progress throughout this year, we will continue to provide updates to the investment community regarding the status of FDA's review at the appropriate time as well as progress we made regarding our closed-loop type 2 patch pump. Lastly, I would like to provide a review of our second quarter revenue performance in a bit more detail. As I mentioned at the outset, during Q2, we generated revenue of $287.2 million, which represented an increase of 3.6% on an as-reported basis and an increase of 4.5% on a constant currency basis or 4.9% when normalizing for the impact of year-over-year changes in the revenue of non-diabetes products that we contract manufacture and sell to BD. Our Q2 revenue exceeded our previously communicated expectations, primarily due to the timing of customer orders in advance of our aforementioned EMEA and parts of Asia focused ERP system and associated capabilities implementations and in advance of a price increase in the U.S. Q2 revenue also benefited from a better-than-expected product and geographic mix. We estimate that the timing of customer orders impacted our second quarter results positively by approximately $16 million and we currently expect that the timing benefit will unwind during fiscal Q3. Within the U.S., during the quarter, revenue totaled $147.6 million, which represented a year-over-year growth of approximately 0.8% on a constant currency basis. When normalizing for year-over-year contract manufacturing revenues, our underlying Q2 constant currency revenue growth within the U.S. was approximately 1.5%. Volume was the primary contributor of growth in the quarter, aided by our contract wins with the top 3 Medicare Part D plans going into effect in January 2024. As we have previously noted, we are the preferred or dual preferred brand on the formularies for these plans. These additional Medicare Part D plan volumes were somewhat offset by the unwinding of certain customer orders that benefited us in our fiscal first quarter as was discussed on our first quarter earnings call. Pricing was flat in the quarter as compared to the year ago period, which was expected. During Q2, our international revenue totaled $139.6 million, which equated to year-over-year constant currency growth of approximately 8.7%. Growth in our international business was due to increased volumes and can be largely attributed to the timing of certain customer orders in advance of previously mentioned ERP and associated capabilities implementations that occurred within the quarter. Pricing within our international business remained relatively flat. That completes my prepared remarks. And with that, let me turn the call over to Jake to take you through our second 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 second quarter at the gross profit line. GAAP gross profit and margin for the second quarter of fiscal 2024 totaled $185.4 million and 64.6%, respectively. This compared to $189.8 million and 68.5% in the prior year period. While on an adjusted basis, our Q2 2024 adjusted gross profit and margin totaled $185.8 million and 64.7%. This compared to $190.1 million and 68.6% in the prior year period. The year-over-year decrease in adjusted gross profit and margin was due to the impact of inflation on the cost of certain raw materials, direct labor, freight and overhead; the impact of negative year-over-year manufacturing variances, primarily attributable to the planned temporary shutdown of our Suzhou, China facility as it relates to production for the domestic Chinese market for part of the quarter; and the negative impact of foreign currency translation, primarily due to the strengthening of the U.S. dollar. As compared to our prior outlook, our adjusted gross margin during the second quarter was better than we previously expected, and this was due to the higher than anticipated revenue that Dev referred to earlier as well as favorable geographic and product mix. Turning to GAAP operating income and margin. During the second quarter, they were $39.2 million and 13.6%. This compared to $55.6 million and 20.1% in the prior year period. While on an adjusted basis, our Q2 2024 adjusted operating income and margin totaled $74.9 million and 26.1%. This compared to $84.9 million and 30.6% in the prior year period. The year-over-year decrease in adjusted operating income and margin is primarily due to the adjusted gross profit changes I just discussed as well as an increase in SG&A costs associated with standing up the organization. These additional costs were somewhat offset by a reduction in year-over-year R&D expense, primarily due to an upfront payment made in the prior year period in connection with the Tidepool algorithm collaboration agreement as well as a reduction in TSA expenses. The adjusted operating Income and ”argi’ performance during Q2 was better than we previously expected, primarily due to the overachievement of the gross margin line, coupled with the timing of R&D spending within the quarter. Turning to the bottom line. GAAP net income and earnings per diluted share were $28.9 million and $0.50 during the second quarter of fiscal 2024, which compared to $14 million and $0.24 in the prior year period. While on an adjusted basis, net income and earnings per share were $38.9 million and $0.67 during the second quarter of fiscal 2024. This compared to $43.3 million and $0.75 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 had on our variable interest rate debt. This was somewhat offset by a reduction in our adjusted tax rate from approximately 25% in Q2 of 2023 to approximately 17.9% in Q2 of 2024. The year-over-year reduction in our adjusted tax rate was expected and was due to certain discrete tax items that occurred during the quarter. For the first 6 months of 2024, our adjusted tax rate was approximately 22%, which is in line with our annual adjusted tax rate expectations. Lastly, from a P&L perspective. For the second quarter of 2024, our adjusted EBITDA and margin totaled approximately $90.8 million and 31.6%. This compared to $96.7 million and 34.9% in the prior year period. Turning to the balance sheet and cash flow. At the end of the second quarter, our cash balance totaled $306.5 million, while our last 12 months net leverage, as defined under our credit facility agreement, stood at approximately 3.8x. As a reminder, our net leverage covenant requires us to stay below 4.75x. From a cash flow perspective, our cash balance as of March 31 is approximately $20 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-related 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 onetime business integration and IT-related costs, primarily associated with our global ERP implementations. We estimate that during the first 6 months of fiscal year 2024, we used approximately $90 million of cash towards the separation activities. As we look forward, we currently estimate that we will end fiscal year 2024 with a cash balance roughly 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 between approximately $180 million and $190 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 complete with most separation projects by the end of this fiscal year, we would 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 debt repayment. Additionally, we now show trade receivables globally on our balance sheet given our previously mentioned ERP implementations and the exit of our factoring agreements with BD. I’m pleased to report that following the implementation of our ERP system and shared service functionality in November of 2023 within North America, that the cash collections associated with those receivables have continued to trend in a positive direction and that this has returned to a more typical levels of accounts receivable within North America. This is important as it will allow us to focus our attention on the newly generated accounts receivable that exists within EMEA and Asia, and turning those receivables into cash following our March of 2024 ERP implementations and shared service capabilities in those regions. That completes my comments on our fiscal Q2 results. Next, I will provide an update on our full year 2024 financial guidance. Beginning with revenue. Given our performance during the first half of the year, we are tightening our constant currency revenue guidance range as we are now calling for full year 2024 constant currency revenue to be flat to down 0.5% as compared to 2023. This compares to our prior guidance range, which called for full year constant currency revenue to be flat to down 2% as compared to the prior year or an increase of approximately 75 basis points at the midpoint. The low end of our updated constant currency revenue growth guidance range is driven entirely by year-over-year headwinds associated with reduced contract manufacturing revenue of non-diabetes products as we now expect our underlying core injection diabetes product revenues to be flat compared to a 1% decline assumed in our prior guidance. While the high end of our constant currency revenue range is unchanged as compared to our prior guidance. Turning to FX. We are reaffirming our previously provided guidance, which called for a foreign currency to be a headwind of approximately 0.4% versus the prior year. These FX assumptions are based on foreign exchange rates that were in existence during the late April time frame, including a euro to U.S. dollar exchange rate of approximately 1.08. On a combined basis, our updated as reported guidance range calls for revenue to be down between 0.4% and 0.9% as compared to 2023, resulting in an updated revenue guide of between $1,111 million and $1,116 million. Turning to margins. We are raising the midpoint of our adjusted gross, adjusted operating and adjusted EBITDA margin guidance by 125 basis points each. As we now expect adjusted gross margin of between 64.5% and 65%, adjusted operating margin of between 25.25% and 25.75%, and adjusted EBITDA margin of between 31% and 31.5%. Finally, due to a combination of improved revenue and margin outlook, we are increasing our adjusted earnings per share guidance from a range of between $1.95 and $2.15 to a new range of between $2.20 and $2.30 or an increase at the midpoint of $0.20. Our updated guidance range continues to assume that our annual net interest expense will be approximately $116 million, that our annual adjusted tax rate will be approximately 22%, and that our weighted average diluted shares outstanding will be approximately 58.1 million. This completes my prepared remarks. And at this time, I would like to turn the call over to the operator for questions. Operator?
Operator: [Operator Instructions] Our first question comes from the line of Travis Steed with Bank of America (NYSE:BAC) Securities.
Unidentified Analyst: This is Caroline on for Travis. I wanted to start out first with the full year guidance. It looks like you beat [indiscernible] expectations by about $8.5 million and then raised the full year guide by $22 million. So I'm wondering if you can speak to any onetime impacts in the quarter? I believe you said previously that about $15 million was pulled forward and then contract manufacturing was a 40 bps headwind. So I just wanted to confirm that I got that right and see if there's anything else that we should be taking into consideration for the full year guidance here. And then I have one follow-up.
Jake Elguicze: Yes. Thanks, Caroline. I think you might have had the numbers just transposed. We did very well in the quarter. I'm not necessarily going to refer to consensus expectations. But I think we did beat our own internal expectations by about $22 million in the quarter, and we did refer to about $16 million of that being attributed to timing. So simply in advance of the ERP implementations, we saw customers order some additional product in our international markets, probably by about $10 million in the quarter. And then in the U.S. in advance of our normal April 1 price increase, we saw some additional volumes in the U.S., and we estimate that to be a timing benefit of about $6 million in the quarter. So $16 million, we would affect to sort of reverse from Q2 into Q3. But then the underlying business did quite well, did about $6 million better than what we had previously internally expected, largely due to the U.S. In relation to the full year, we're raising our midpoint of the guidance range on the top line by about $8.5 million at midpoint, $6 million of which we think occurred in the U.S. in the second quarter. But obviously, we're affecting commissional favorability in the half of the year in relation to the prior guide. So a very strong quarter, I think for us, particularly when you think about all the work that had to occur related to the ERP implementations.
Unidentified Analyst: Yes, that trend so I appreciate that correction there. And then second question, can you provide an update on your plans for entering the GLP-1 market with pen needles. I know recently, it looks like Lilly got an approval for a Kwikpen. I'm not sure if there's anything more you can say there just again on your outlook for entering the GLP-1 market.
Dev Kurdikar: Yes, Caroline, this Dev. I'll take that. Yes, as you correctly pointed out, Lilly did get approval for the Kwikpen. Kwikpen, as you know, is the same pen that's used for insulin delivery. And pen used for insulin delivery, typically use our pen needles in most markets around the world. We do have leading share. Our expectation is as GLP presentation forms continue to evolve and more and more of them become available in pens, certainly, our pen needles can be used with it. We continue to have discussions with other potential entrants into the GLP-1 space, including [generics] now. Admittedly, they are years away. But our hypothesis is as more GLP-1 players enter the market, it's likely that many of them will present their version of the GLP-1 in a multidose pen form and our pen needles will be applicable for it. Now certainly, as these manufacturers work to expand capacity, in some cases, they're also using vials. And with the regulatory approval, our syringes can be used as well. So as more and more GLPs enter the market, more pens will become available and certainly, our pen needles can be used with those pens.
Operator: Our next question comes from the line of Marie Thibault with BTIG.
Marie Thibault: Congrats on a very nice quarter here. I'll leave the guidance questions to others. But I did want to ask a little bit more about accounts receivables. I know with Embecta now responsible for collecting some of those receivables, the plan was to work some of this down in fiscal '24. I know the ERP transition is still happening. Just wanted to try to understand why that receivables number ticked up a little bit, and how we can expect that to look for the rest of the fiscal year?
Jacob Elguicze: Yes. So Marie, the change in the receivable balance from, let's call it, fiscal year-end 9/30/2023 to where we are now entirely has to do with the fact that went live with our ERP implementations, and the factoring agreements that we had previously in place with BD where they would essentially factor those receivables on our behalf went away. And now we're responsible. All those receivables now appear on our balance sheet. And at this point, all of the factoring agreements have now ceased. So the receivables that you see on our balance sheet are 100% representative of what the AR balance is for Embecta look like. There's no additional receivables that we would need to put on to our balance sheet. From the last quarter, from Q1 or fiscal Q1 to where we are right now, we did see an increase in the AR, again, entirely due to now our EMEA and Asia receivables coming on to our balance sheet as a result of those ERP implementations. And I think the way that you should sort of think about this moving forward, maybe just from like a total cash standpoint, I think we said in our prepared remarks that we would expect our overall ending cash balance for fiscal 2024 to be very close to where it is right now from a Q2 standpoint, so somewhere around that kind of $300 million-ish mark. That's down about $20 million from where we were at year-end. And again, that entirely has to do with cash used for separation and stand-up activities. We estimate that we're going to use somewhere between $180 million and $190 million of cash this year related to separation. That comes on top of using about $145 million in the prior year. And I think that's really one of the things that is sort of distorting, if you will, the real free cash flow capabilities of the company. And I think as we move into fiscal 2025 and beyond, now that we're almost past all of the separation work, you're really going to see the true free cash flow potential of this organization.
Marie Thibault: Okay, Jake, that's helpful. And then I wanted to ask a question a little bit about some of the market dynamics, competitive dynamics. I think near the end of your fiscal second quarter, we saw a competitor sell off and transfer its pen needle and blood glucose meter business to another company. I wanted to hear if you've seen any disruption here now in the existing current quarter? And any thoughts on ability to maybe take some market share or make some efforts in those regions where that competitor was very active.
Dev Kurdikar: So we haven't seen any disruption really from our perspective with respect to the transaction you were referring to. And certainly, with respect to our sales force focus on ensuring that we present our products with as much vigor as possible and certainly continue to gain share, I mean that will continue. We find that -- we certainly think that our products that compete with these competitors' products are very well positioned. We have demonstrated continuity of supply, notably even through the ERP transitions that we referred to. And so we'll continue to make efforts in that area. But I'll leave it at that.
Operator: Our next question comes from the line of Kallum Titchmarsh with Morgan Stanley (NYSE:MS).
Kallum Titchmarsh: On the patch pump program, I know we're still in the early stages here. But now you've had some more time to consider the implications, I'm wondering when you expect the costs to begin ramping to support the commercial infrastructure behind the project? It seems, just eyeballing consensus, that there's about flattish OpEx across the next few years. So just curious on how we should be thinking about midterm changes there? And then I have one follow-up.
Dev Kurdikar: Yes, Kallum. So look, our focus right now is just undergoing -- completing the FDA review. We submitted our 510(k) in late calendar 2023, as you know. And so I certainly don't want to comment on either the outcome or the timing of when we would expect a decision from the FDA. And candidly, our focus right now is just completing that review and completing the remaining separation work and closing out FY 2024. So I'll refrain from talking about '25 expenses and beyond. But certainly, we are considering that as we get closer and we get more and more definitive decisions from the FDA, we are thinking about a potential Investor Day event or a call to better provide our thoughts on FY '25 and beyond, particularly as it respect -- as it relates to the patch pump.
Kallum Titchmarsh: That's fair enough. And then I know we've got to keep our eyes on leverage, but any change in your appetite for M&A?
Dev Kurdikar: I think leverage is front and center of our minds here. Jake referred to the fact that we certainly expect our free cash to improve in '25 and beyond. And we are going to be thinking pretty strongly about debt and debt pay down as well. So again, this is something that we will update the investment community on once we've closed out 2024 and finished up the rest of the separation projects. We certainly expect the AR to have normalized. And we'll just have a better sense of the free cash that will be available to the company and talk about our capital allocation priorities going forward from there.
Jacob Elguicze: And Kallum, I think on prior calls, we sort of referred to wanting to keep a larger cash balance on hand as we went through some of these ERP implementations in case something went wrong. Thankfully, everything has gone very, very well. I think the team has done a tremendous job as far as all of that is concerned. And I think that, as we go into the second half of the year and certainly into 2025, that's just going to provide us with a lot more flexibility in order to potentially pay down more material amounts of debt in addition to what we have been doing so far, which is really just paying off the 1% amortization each year for the term loan base.
Operator: [Operator Instructions] Our next question comes from the line of Ryan Schiller with Wolfe Research, LLC.
Ryan Schiller: This is Ryan Schiller on for Mike Polark. I wanted to follow up on the patch pump. It seems to be a product that, if all goes according to plan, could really drive revenue growth. So what changes need to be made to the Tidepool pipeline algo to fit it to type 2? Can you give us your latest expectation on timing to get this to the FDA?
Dev Kurdikar: Yes. So look, from a technical aspect, that type of algorithm, Ryan, that you referred to, obviously, was approved for type 1. We are evaluating how it needs to be adapted for type 2. The way we are proceeding with this is our open-loop, as you know, is under review with the FDA. We are concurrently working with Tidepool on adapting that algorithm for type 2. And our anticipation is when we are ready, and again, this is something we can talk about after we get clearance, assuming we get clearance for FDA -- from FDA for open-loop, we'll certainly talk a little more about the clinical trial that will be required here and the timing of the clinical trial because from our perspective, that's a very critical element of having the Tidepool algorithm adapted for type 2 and really tested in patient use and taking all of the data and then submitting that to the FDA for the eventual clearance of a type 2 closed-loop pump. So more on timing post -- after we finish FY '24 and once we have clarity on FDA's decision on the open-loop.
Ryan Schiller: That's helpful. And then one follow-up. A lot of the major insulin companies have been looking to get approval and to launch weekly basal insulin. How are you guys thinking about this? And what gives you the confidence that Embecta will be able to continue to grow and start to scale up in major geographies?
Dev Kurdikar: Yes, Ryan. So certainly, weekly insulin is something we are watching very closely as well. I think one form of weekly insulin -- certainly folks are expecting will get approved in Europe in the coming months. From what we understand right now, and clearly it's not widely available in most geographies, but it will be in a pen form. It won't be packaged with a pen needle, or at least that's what indications seem to be. And as I mentioned before, if it's a pen, quite possibly our pen needles can be used with it. Some of the factors that need to be considered when you think about the adoption of weekly insulin is obviously cost, right? Insulin, regular insulin costs have come down dramatically over the last few years. And so there's going to be needing to be a trade-off across cost and efficacy, if you will, is there increased efficacy with weekly insulin versus daily insulin. Promotional focus will matter where the pharma and biopharma companies decide to spend their selling dollars, will it be on GLP-1s or weekly insulin. A lot of the basal patients are seen by primary care physicians who may be reluctant to prescribe weekly insulin because obviously, dosing of insulin is tricky. And so they will be maybe, potentially concerned with potentially higher hypoglycemia. I believe in type 1, there is the greater potential for hypoglycemia in type 2, but sort of the fear might remain. People that are using multiple daily injections of insulin, they might just want to stay because they take multiple daily injections every day anyway. So our thinking is that to the extent that weekly insulin gets adopted, it might likely be with new basal patients rather than folks switching over. But look, I mean, these are all sort of hypothesis, right? I mean we don't have enough data of real use in patients to be able to accurately or perhaps more precisely determine the impact of weekly insulin on us. And so it's going to take time to figure all of it out. But some of the factors that I laid out here, Ryan, are those that we are considering certainly as things to watch as weekly insulin gets introduced into the world.
Operator: I'm currently showing no further questions at this time. I'd like to hand the call back over to Dev Kurdikar for closing remarks.
Dev Kurdikar: Thank you, Shannon. As we wrap up the call, I want to extend my heartfelt appreciation to all of my colleagues at Embecta across the globe. In the last 2 years since our spin-off, our team has worked nonstop on executing our strategic priorities, including major separation-related programs while never wavering from our mission of developing and providing solutions that make life better for people living with diabetes. Thank you all for attending the call and for your interest in our business.
Operator: This concludes today's conference call. Thank you for your participation. You may now disconnect.
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