Welcome, ladies and gentlemen, to Embecta Corp.'s fiscal second quarter 2025 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 a replay will be available on the Company’s website following the call. I would now like to hand the conference call over to your host today, Mr. Pravesh Khandelwal, Vice President of Investor Relations. Mr. Khandelwal, please go ahead.

Thank you, operator. Good morning, everyone, and welcome to Embecta’s fiscal second quarter 2025 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 2025, as well as an overview of our strategic priorities. Jake will then review our financial results for the fiscal second quarter of 2025, as well as discuss the updated financial guidance for fiscal year 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, Dev Kurdikar.

Good morning and thank you for taking the time to join us. Since we announced the termination of our patch pump program five months ago, we have been advancing the next phase of Embecta’s transformation. At the heart of this transformation are three strategic priorities that are guiding our execution and shaping our future. First, strengthening our core business. We are making solid progress on our global brand transition, with implementation in the US and Canada underway, and on track for substantial completion in the second half of fiscal year 2025. Simultaneously, we are pursuing initiatives within our core portfolio that solidify our customer relationships and reinforce our leadership in insulin injection devices. Second, expanding our product portfolio. We are advancing initiatives to bring market-appropriate products to patients by leveraging our strengths in high-volume manufacturing and global commercial reach. This includes partnerships with generic drug manufacturers to co-package our pen needles with their potential generic GLP-1 drugs, and, expanding availability of our pen needles in appropriately sized retail packaging for use with branded GLP-1 drugs delivered via pen injectors. Third, increasing our financial flexibility. With the insulin patch pump program restructuring plan substantially complete, we remain on track to deliver meaningful cost synergies. In fiscal 2025, we remain committed to our goal of paying down approximately $110 million in debt. With strong free cash flow generation and the majority of the overall separation-related costs behind us, we believe we are well-positioned to strengthen our balance sheet and enhance our financial agility. We believe consistent execution against these priorities will position Embecta for sustainable performance and long-term success. Turning to some fiscal second quarter highlights. Second quarter revenue totaled $259 million, which exceeded our expectations of between $250 million and $255 million that we provided on our last earnings call. As…

Thank you, Dev, and good morning, everyone. Given the discussion that has already occurred regarding revenue, I will start my review of Embecta’s second quarter financial performance at the gross profit line. GAAP gross profit and margin for the second quarter of fiscal 2025 totaled $164.1 million and 63.4%, respectively. This compared to $185.4 million and 64.6% in the prior year period. While on an adjusted basis, our Q2 2025 adjusted gross profit and margin totaled $165 million and 63.7%. This compared to $185.8 million and 64.7% in the prior year period. The year-over-year decline in adjusted gross profit and margin was primarily driven by the impact of net changes in profit-in-inventory adjustments, as well as the lower year-over-year revenue that Dev mentioned earlier. These headwinds were partially offset by manufacturing cost improvement programs, lower supply chain functional spend, lower freight costs, and our ability to drive year-over-year price increases. Turning to GAAP operating income and margin, during the second quarter they were $62.9 million and 24.3%. This compared to $39.2 million and 13.6% in the prior year period. While on an adjusted basis, our Q2 2025 adjusted operating income and margin totaled $81.4 million and 31.4%. This compared to $74.9 million and 26.1% in the prior year period. The year-over-year increase in adjusted operating income and margin is primarily due to lower R&D expenses associated with the discontinuation of our insulin patch pump program; as well as lower SG&A expenses primarily driven by lower TSA costs, as well as lower compensation and marketing expenses. This was offset by the adjusted gross profit changes I outlined. Turning to the bottom line. GAAP net income and earnings per diluted share were $23.5 million and $0.40 during the second quarter of fiscal 2025, as compared to $28.9 million and $0.50 in the…

Thank you. [Operator Instructions] Our first question, go the line of call Kallum Titchmarsh of Morgan Stanley. Your line is now open.

Great. Thank you, guys. Good morning. Would love for you to maybe dig a bit deeper into kind of growth and demand dynamics across pen and syringes. Just walk us through what you're seeing domestically and internationally, how we should think about modeling these products for the remainder of the year. Kind of most keen to get a bit more color on some of those moving parts in the US. You called out the customer inventory bits and store closures. Are you now comfortable that they are kind of isolated issues and behind you? Thanks a lot.

Good morning, Kallum, and thanks for the question. So, maybe some context is in order here. As you may remember, fiscal 2024 we had a number of rolling ERP implementations throughout the year. US and in Canada went live in the first quarter. Then we had EMEA and Asia in quarter two, and then with China and Latin America in the following quarters, Latin America as recent as Q1 2025. And our goal as we did that was to ensure that we maintained product continuity. As you know, these implementations in our case, coupled with changes in distribution network and sending new shared services are pretty complex. And so, we were very careful to make sure that the distributors through which our products flow had enough inventory of these products that they could maintain continuity of supply in case there were any hiccups. Now, the executions went very well. We did not have hiccups, but that leads to unfavorable year-over-year comparisons for both our US business and our international business. That was obviously further compounded by the fact that at the end of last year, as we mentioned on prior calls, there was a looming port strike. And so, particularly in the US, some distributors purchased products ahead of that port strike in in September, and certainly that impacted our Q1 2025 results and year-to-date 2025 results. And then finally, the third effect that just to keep in mind because it does impact certainly geography year-over-year comparisons as well as comparisons for product family, was the shift in price increases, which obviously from a business standpoint is a good thing. Last year, which is in fiscal 2024, we had a US price increase on the 1st of April of 2024. And this year, we had it on January 1st, 2025.…

Great. Just to follow-up there, I think the Street's kind of shaking out I think 7%, 8% quarter-over-quarter growth into fiscal year Q3. Are you happy with that, given the guide cut? Where should we be taking that little guide cut out of our numbers for the year? Thanks a lot.

Yes, Kallum, thanks for the question. This is Jake. Maybe I'll jump in here. I think what - if you think about our guide, for the first half of the year, we always thought, for the reasons that Dev outlined, that the second half of the year was going to be stronger than the first half of the year. And really nothing has necessarily changed in that thought pattern in terms of second half strength versus the first half because of just all the one-off items that sort of impacted the first half of 2024 in terms of the ERP go lives and whatnot. So, we were down - on a six-month basis, I think our constant currency revenues were down around 6.3%. And in the second half of the year, I think it's probably reasonable to think that we would sort of see flat to slightly positive overall constant currency revenue growth in the second half of the year. And probably, I would say low single-digit constant currency revenue growth, if you will, particularly in the third quarter. So, hopefully, that gives a little bit more context into sort of our thoughts in the second half of the year regarding constant currency revenue. So, we certainly expect to see, despite the 150-basis point call down, if you will, to our full-year constant currency revenue guidance range, we certainly do expect there to be an improvement and see some momentum as we move throughout the second half of the year.

Appreciate it, guys. Thank you.

Thank you. One moment for our next question, and our next question comes from the line of Marie Thibault of BTIG. Your line is now open.

Hi, good morning. Thank you for taking the questions. Wanted to ask my first one here on tariffs. I heard you say 25 bps, a full-year adjusted impact to adjusted gross margins there. Wanted to get a little bit more detail on some of this. How much of that impact is coming from sort of the US-China tariffs as we get those trade talks hopefully started here this weekend? And in terms of annualizing some of this, given you're kind of on a different fiscal year, how should we think about this in the next fiscal year? Of course, understand there will be mitigation and a lot of fluid dynamics here.

Yes, Marie, thanks for the question. Yes, so you're correct. I mean, right now, just given our manufacturing footprint and the way that our products flow, we are thinking that there is going to be around a $3 million or 25-basis point impact to our full-year margins, $3 million of incremental expense associated with these tariffs in the second half of the year. That does relate to exactly what you were referring to, the dynamic between China and the US and the reciprocal tariffs with each of those countries. Right now, obviously we're going to try and do whatever it is that we can in order to offset those impacts to the extent possible, whether that's taking costs out of the system or potentially trying to find ways to pass along any of those cost increases in the form of pricing. Based on what we know right now, if we had to provide sort of an estimate for maybe an annualized impact, and again, keep in mind, this is obviously very, very fluid just even given some of the news coming out this morning regarding the talks this weekend, but if we had to think about like an annualized impact, I think it's probably reasonable to think that we would see maybe around call it $8 million to $9 million impact in 2026, based on what we know right now. And that's obviously, a gross number, right? That doesn't take into consideration any potential offsets that we would try and do. And it only really relates to sort of the US-China dynamic. It doesn't take into consideration, if you will, any of the tariffs that have sort of been put on pause right now.

Yes, incredibly helpful, Jake. Thank you for that detail. And then I guess I'll ask my follow-up. I heard you say that Embecta had received several PO from generic GLP-1 makers. Very exciting to see that step. What does that actually mean, a PO? Does that mean they sort of said, hey, we want to work with you and we need to understand how your packaging will work. We can put this together for the regulators, or is it a step further than that? I'm not sure exactly where this falls in kind of the pharma regulatory process.

Yes, good morning, Marie. So, it's a very exciting and a really important strategic milestone in this process. As we've commented before, we've been in discussions with multiple generic drug manufacturers as they're pursuing the generic GLP-1 entry in markets around the world. And this is a substantive step forward of them - several of them actually sending purchase orders for bulk pen needles that they will then acquire and use for their own internal purposes, including any testing they might have to do as part of their regulatory submissions. So, we are very excited about it. It's a very tangible and specific milestone that has been accomplished, and we'll certainly share more about all of this at our Investor Day coming up here in a couple of weeks.

Okay, very good. Looking forward to it. Thanks so much.

Thank you. One moment for our next question. Our next question comes from line of Anthony Petrone of Mizuho Financial Group. Your line is now open.

Thank you and good morning. Maybe just a follow-up on tariffs just in terms of pull forward of stockpiling, did you notice any of that in the first quarter, any of the retail chains sort of buying ahead, and did that sort of flow through to Embecta in terms of the revenue performance in the first quarter here? And then I'll have a couple of follow-ups. Thanks.

Yes. Anthony, maybe I'll take that. So, specifically about - I assume you're specifically talking about the US here. A couple of points to note. The tariffs that we have incorporated into our guidance are really US-China-related for the majority of the impact, vast majority of the impact. In the US, we have historically benefited from certain exemptions that apply to finished goods, that apply to our category of finished goods. So, we don't really pay a tariff currently on those products, given they're for chronic medical use. We did not see any stockpiling in the US as a result of potential tariff impacts. And let me also point out that really the product that's coming from China into the US is very, very limited to begin with. I mean, it's a low single-digit percent of our US revenue. So, for all those reasons, finished good product being imported into China, just being imported from China into the US has been a low, low number in our US - of our US business, and the fact that we do benefit from certain exemptions, help us.

That's helpful. Maybe follow-up would be just on the type two market specifically, and had the pump companies out there with a decent quarter here last night. One reported earlier last week, reported. Maybe just like an update on the dynamic between multiple daily injection and pumps, what you're seeing there. And if you could segment the market in type two where MDI is more sticky, is there a specific segment where you really just see durability there? Thanks for taking the questions.

Yes, Anthony, the best indicator that we track internally to see what's going on for our pen needle business in particular is the PRXs for insulin pens, right? That's something that we've been tracking for a long period of time. And so far, we've seen stability in the US both in insulin pens as well as what we believe the underlying pen needle market to be. And obviously, we have better data on insulin pens than the pen needle market, just given that we are such a large portion of the pen needle market, right? I mean, we see our numbers, but it's hard to get total market numbers. And so, I would say that's the best indicator. Obviously, we follow what market participants are saying. I also want to point out just the vastness of the numbers, right? We are talking about 7, 8 million people on injection in the US, and when you compare to pump numbers, they're typically talking about maybe tens of thousands. So, it's going to take some time before any big change gets reflected in our numbers. Not to mention that the incidence of type two diabetes, I mean, that's still a growth factor here, right? So, all these things wash out, which is why the indicator that we most closely track is the total prescriptions for insulin pens, and we've seen stability so far.

Thank you very much, Dev.

Thank you. One moment for our next question. [Operator instructions]. And our next question comes from the line of Michael Polark of Wolfe Research. Your line is now open.

Hey, good morning. Thank you. I have two. I want to follow-up first on the retail pharmacy store closure call out. I feel like US retail pharmacies have been closing stores for a long time. So, I guess, what's different about this? Is it simply the scale? And I'm curious if you might name the name. I know Walgreens has announced 1,200 store closures expected over the next three years, but CVS also has a large program too. And Rite Aid I think is dealing with BK. So, if it's worth spiking out the brand, I would appreciate that. But any further color on why this is different, given kind of long running trend of store wind-downs?

Yes, Mike, I think it's the scale. And respectfully, I'll avoid naming any specific customers. But it's really the scale and the pace at which it could happen. That's the reason why we called it out. And like I said, we saw a change in the buying pattern, this distributor that serves that particular chain, as well as serves other customers. And we just wanted to make sure that we were prudent in reflecting that as we thought about our guidance for the rest of the year. Now, as you saw in our guidance, I mean, in spite of that, we did raise our adjusted operating margins and adjusted EBITDA margins guidance either. So, everything that we can control to ensure that we still pursue our priorities of maintaining profitability and paying down debt, we're absolutely going to execute on.

For the follow-up, I want to ask on the new efficiency program that was discussed here. Where is it focused? What are you doing? And the savings number, $7 million to $8 million in the second half, is it fair to multiply that by two to get a full-year impact as we think about fiscal 2026? Thank you so much.

Yes, Mike, so regarding the new restructuring program, I think, if you step back over the last several years, as we've sort of been separating from our former parent and standing ourselves up very, very intentionally, we did not make any material changes to the organization. And we've always talked about how we would look for opportunities to continue to sort of right-size the organization to continue to take cost out of the organization. And I think now that we are largely complete with all of the major separation activities, we're continuing to look for ways just to become more efficient. And we're certainly going to continue to do that moving forward as well. So, if you think about the cost that we were able to take out, it's largely, I would say, in sort of the SG&A area. And I think this year, as we said, we would expect to see savings of between $7 million to $8 million in the second half of the year. And I do think it's reasonable on an annualized basis to think about something in or around that kind of $15 million mark as we sort of walk into 2026.

Thank you.

Thank you. I'm showing no further questions at this time. I would now like to turn it back to CEO, Dev Kurdikar, for closing remarks.

Thank you. As we close the call, I just want to express my sincere gratitude to my colleagues at Embecta around the world. Our global team remains focused on executing the priorities we've laid out, even as uncertainty exists in the macroeconomic and the global trade environments. And then finally, we look forward to engaging with all of you at our upcoming conferences and at our Investor Day on May 22nd, where we'll share more our vision for Embecta. Thanks again for calling in and for your interest in Embecta.

Thank you for your participation in today’s conference. This concludes the program. You may now disconnect.