Embecta Corp.

Welcome, ladies and gentlemen, to Embecta Corporation's first third quarter 2026 earnings conference call. At this time, all participants are 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 turn the call over to your host today, Mr. Pravesh Khandelwal, Vice President of Investor Relations. Mr. Khandelwal, please go ahead.

Good morning, everyone, and welcome to MBECTA's Fiscal Third Quarter 2026 Earnings Conference Call. The press release and slides to accompany today's call, along with webcast replay details, are available on the Investor Relations section of our website at www.embekta.com. With me today are Devdatt Kurdikar, EMBECTA's Chairman 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, including those referenced on slide two of today's conference call presentation. 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. We do not intend to update or revise any forward-looking statements, including any charts, financial projections, or other data referenced in this presentation, whether as a result of new information, future events, or otherwise, except as required by applicable law. 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 comparable GAAP measures is included in our press release and conference call presentation, which are also included in the investor section of our website at www.empecta.com. Our agenda for today's call is as follows. Dev will begin with a review of the company's performance during the third quarter, followed by an update of the Irwin Mumford acquisition, and then a discussion of the progress we have made with our strategic objectives. Jake will then take you through our third quarter financial results in more detail, as well as our updated fiscal year 2026 guidance. We will then open the call for questions. With that, I will now turn the call over to Dev.

Good morning, everyone, and thank you for joining us today. Before I talk about our recent acquisition of Arvind Mumford, let me briefly comment on our third quarter results. During the third quarter, Impecta generated total revenue of approximately $272 million, which is a decrease of 8.1% year-over-year on an as-reported basis and a decline of 8.9% on an adjusted constant currency basis. While on a sequential basis, our third quarter financial performance improved significantly, with revenue increasing approximately $50 million, GAAP operating income increasing approximately $14 million, and adjusted operating income increasing approximately $21 million as compared to our second quarter results. The sequential increase was due to a combination of factors, including improved performance within the US and international, as well as the initial contribution from the Owen Mumford acquisition, which closed midway through the quarter. I will return to our U.S. and international performance for the quarter in more detail, but first let me spend a few minutes on Owen Mumford because we continue to be excited about what this acquisition means for Embecta's future. We closed the transaction on May 15th, and integration is progressing as planned. our conviction in the strategic rationale remains unchanged. As a reminder, Owen Mumford broadens our product offerings well beyond insulin injection devices with the addition of a pharmaceutical services business and a wider portfolio of medical devices. Within pharmaceutical services, the portfolio includes a range of auto-injectors designed to support pharmaceutical partners anchored by the new adaptive platform. while OM's medical devices include those used for point-of-care testing and self-injection, among others. On ADAPTA specifically, it's an award-winning next-generation auto-injector designed with a single form factor that accommodates both 1 mL and 2.25 mL fill volumes. What that practically means is that adapted as a single final assembly process and was designed from the start to address customers' needs for reduced manufacturing changeovers, simplified supply chain logistics, and large-scale production. We estimate the total addressable autoinjector market to be approximately $2.4 billion, growing at a double-digit CAGR, driven by the adoption of biologics, the emergence of generic GLP-1 therapies, and the broader shift towards self-injection as the preferred modality across multiple chronic care categories. ADAPTUS is already supporting customer clinical development programs today and our commercial contract pipeline includes secured long-term agreements with several partners. Stepping back, the addition of auto-injectors to our portfolio significantly expands our addressable market meaningfully broadening our opportunity set well beyond our historical insulin injection footprint and significantly increases our weighted average market growth rate potential. As we expand our work with pharmaceutical companies, from pen needles that can be used with either branded or generic GLP-1 drugs to the development of a multi-dose pen injector and our Mumford's Pharma Services business, We are now serving a different customer base with needs distinct from our legacy insulin injection devices business. This opportunity requires dedicated leadership focus. To that end, I'm pleased to announce that Jeff Mann has been appointed President, Pharma Services and Product Management and Chief Legal Officer. In this expanded role, Jeff will assume responsibility for a new pharma services organization, bringing together a combination of Embecta and Evan Mumford talent dedicated to this important effort. This new organization will have dedicated leadership and staff focused on this important growth platform as we expand our capabilities and strengthen our partnerships across the pharmaceutical industry. Turning to our manufacturing and distribution footprint. As part of the Irwin Mumford acquisition, we added four sites. These include three manufacturing plants, two of which are in the UK and one in Malaysia, as well as a warehousing center in the US. This broadening of our manufacturing and distribution base creates options for future network optimization and further strengthens our presence in emerging markets. Now let me turn to the progress we made against our strategic priorities during the quarter. First, in terms of strengthening our core business, I'm pleased to announce that our market-appropriate pen needles continue to progress through review with the US FDA and with BSI for CE mark certification in Europe. In addition, we expect that we will launch market-appropriate syringes in additional countries in the coming months. Finally, we completed our brand transition in key European, Asian, and Latin American markets during the quarter, and currently more than 90% of MBECTA revenue is now represented by products commercially launched and shipped under the MBECTA label and we remain on track to substantially complete global brand transition by the end of calendar year 2026. Second, expanding our product portfolio. We continue to build commercial momentum with our B2B co-packaging opportunity as generic GLP-1 therapies featuring Embecta pen needles launched in Canada, Brazil, and most recently, South Africa. This follows the initial launch in India. In the coming months, we also expect to launch a pen needle small pack format in the U.S. to support those patients using ZebBound, which was recently made available in a pen injector format. such small packs have already been launched in Canada and Australia. Third, increasing our financial flexibility. During the quarter, we borrowed approximately $180 million under our revolving credit facility to fund the Erwin Mumford acquisition, which included the acquisition of OM's cash. We subsequently repaid approximately $53 million in debt, reflecting our continued commitment to discipline deleveraging. We also returned approximately $9 million of capital to shareholders through share repurchases during the quarter. Moving to slide seven, I want to take a moment to introduce Nimish Muzumdar, who recently joined MBECTA as SVP and President, North America. Nimish brings more than 25 years of experience leading commercial organizations across US retail pharmacy, hospital, and institutional markets. Most recently, he served as SVP and head of generics at Sandoz, where he restored the division to profitable growth and helped lead its commercial strategy through the company's 2023 spin-off from Novartis. His prior experience includes leadership roles across retail generics, OTC, institutional, hospitals, and clinics channels at Sandoz, Ranbaxy USA, Watson Laboratories, and Dr. Reddy's Laboratories. Now turning back to our third quarter revenue performance. Within the U.S., revenue for the quarter totaled approximately $121 million, reflecting a year-over-year decline of 24.6% on both a reported and adjusted constant currency basis. In addition to the effects of favorable one-time contributions in the prior year, as noted at that time, The year-over-year decline was driven by factors largely consistent with those that impacted our fiscal second quarter results. With regard to pen yields, our share of category in Q3 were generally in line with our expectations. Total prescriptions for insulin pens in the retail channel appeared sequentially stable, declined year-over-year in Q3 at a slightly greater rate than in Q2. Customer and payer mix impact on net pricing was greater in Q3 as compared to Q2, Syringes and safety products were generally in line with our expectations. We continue to monitor factors that may be impacting market volume, including trends in the insured population enrolled by ACA marketplaces and Medicaid, as well as the accelerated adoption of GLP-1 therapies. On a sequential basis, U.S. revenue increased by approximately $25 million compared to the second quarter, reflecting a normalization in distributor order timing as well as a modest contribution from Arvind Mumford as the acquisition closed slightly earlier than originally expected. Since joining Embecta, Nimish has brought a fresh perspective and rigorous commercial lens to our North America business. Through a comprehensive assessment of our commercial organization, customer engagement model, and go-to-market capabilities, his initial findings confirm that while our brand equity, customer trust, and product quality remain strong, There are meaningful opportunities to enhance commercial execution by strengthening strategic customer partnerships, anticipating evolving customer needs, and leveraging data-driven insights to inform decision making and drive growth. While this will take time, we expect that the combination of strong leadership, disciplined execution, and a clear strategic focus will strengthen our U.S. business. Turning to our international business, Revenue for the quarter totaled approximately $151 million, representing an increase of 11.5% on a reported basis and 9.7% on an adjusted constant currency basis. Year-over-year growth was driven by continued strength across Latin America and Asia and contribution from Owen Mumford, partially offset by the anticipated softness in China. Meanwhile, from a product family perspective, during the quarter, adjusted constant currency pen needle revenue declined approximately 18.6%, primarily driven by the same US factors just discussed. Turning to our syringe products, revenue was roughly flat year over year, as continued declines in the US, driven by the ongoing long-term shift towards insulin pens, were largely offset by strong performance internationally. particularly in Latin America and Asia. Moving to our safety products, they delivered solid growth of 4.6% in the quarter, driven by grains in the U.S. Finally, contract manufacturing revenue, which we generated through the manufacturing and sale of non-diabetes products back to Becton Dickinson, declined a modest 3.6%, consistent with the continued insourcing of these products by BD. With that, let me turn the call over to Jake.

Thank you, Dev, and good morning, everyone. Given the discussion that has already occurred regarding revenue, I will start my review of Embecta's third quarter financial performance at the gross profit line. GAAP gross profit and margin for the third quarter of fiscal 2026 totaled 153.3 million and 56.4 percent, respectively. This compared to 197.1 million, and 66.7% in the prior year period. While on an adjusted basis, our Q3, 2026 adjusted gross profit and margin totaled 158 million and 58.2%. This compared to 198.6 million and 67.2% in the prior year period. The year-over-year decline in adjusted gross profit was primarily driven by lower year-over-year revenue in the U.S., as well as the impact of net changes from profit and inventory adjustments period over period. This was somewhat offset by the addition of Owen Mumford and our international business. While from a sequential perspective, Q3 2026 adjusted gross profit improved by approximately $26 million from Q2 of 2026, primarily due to improved performance within the U.S. and international, as well as the initial contribution from the Owen Mumford acquisition, which closed midway through the quarter. Turning to GAAP operating income and margin, during the third quarter of 2026, they were $48.7 million and 17.9%. This compared to 94 million and 31.8% in the prior year period. While on an adjusted basis, our Q3, 2026 adjusted operating income and margin totaled 69.4 million and 25.5%. This compared to 109.1 million and 36.9% in the prior year period. The year-over-year decrease in adjusted operating income was driven by the decline in adjusted gross profit as operating expenses remained roughly consistent with the prior year period despite the addition of Owen Mumford due to cost optimization activities identified. Whereas in terms of sequential performance, adjusted operating profit improved by approximately $21 million due to improvement in gross profit. Turning to the bottom line, During the third quarter of 2026, we generated gap net income of 21.1 million and earnings per diluted share of 36 cents. This compared to gap net income of 45.5 million and earnings per diluted share of 78 cents in the prior year period. While on an adjusted basis, during the third quarter of fiscal 2026, net income and earnings per share were 32.6 million and 56 cents, as compared to $65.5 million and $1.12 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 a higher year-over-year adjusted tax rate driven by the lower U.S. revenue in the quarter. In terms of sequential performance, adjusted earnings per share improved by 29 cents due to a combination of the improved revenue and gross profit, as well as a lower share count due to the repurchase of approximately 2.7 million shares during the third quarter. Turning to the balance sheet and cash flow. During the third quarter, we generated approximately 41 million in free cash flow, and we repaid approximately 53 million of outstanding debt. while our last 12 months net leverage as defined under our credit facility agreement was approximately 3.7 times. This compared to our covenant requirement, which requires us to stay below 4.75 times. Finally, after quarter end, we amended and extended our revolving credit facility through December 30th of 2028. That completes my prepared remarks on our third quarter 2026 results. Next, I'd like to discuss our updated 2026 financial guidance and certain underlying assumptions. Beginning with revenue, on an as-reported basis, we are reaffirming our prior revenue guidance range of between $1.15 billion and $1.35 billion, which would represent a year-over-year decline of between 4.2% and 6.1%. In terms of our adjusted organic constant currency assumptions, at the low end, they are unchanged as compared to our prior guidance. While the high end is slightly lower, driven primarily by assumptions regarding customer and payer mix in the US, partially offset by improved international expectations. Turning to M&A, we're raising our expectations for Owen Mumford, primarily driven by the fact that the acquisition closed two weeks earlier than initially expected. Turning to our thoughts on FX, we currently expect foreign currency to be a tailwind of approximately 1.3% as compared to our prior guidance, which calls for FX to be a tailwind of approximately 1.5%. In terms of adjusted operating margin, we are raising our adjusted operating margin guidance from a range of between 22.25% and 23.25% to a new range of between 23.5% and 24%. As we mentioned on our second quarter earnings conference call, we initiated a review of our cost structure and the improvement in our operating margin guidance reflects the implementation of operating expense cost controls and cost optimization efforts, which we expect will generate a further annualized benefit in 2027. We're also raising our adjusted earnings per share guidance from a range of between $1.55 and $1.75 to a new range of between $1.80 and $1.90. This increase is primarily driven by the operating expense cost controls and cost optimization efforts I just mentioned. This updated adjusted earnings per share range also includes the following guidance assumptions. A lower adjusted tax rate of approximately 27% as compared to our prior assumption of approximately 28%. A lower interest expense assumption of approximately $95 million as compared to our prior assumption of approximately $97 million. and a reduction in our weighted average diluted share count to approximately 58.6 million shares as compared to our prior guidance of approximately 59.4 million shares, reflecting share repurchases made under our share repurchase program. Turning to the balance sheet and cash flow, we expect to repay at least $150 million of debt during 2026. As a reference, through the first nine months of 2026, we have repaid approximately $128 million in debt. Lastly, in terms of free cash flow, our thoughts are largely unchanged from our prior expectation of generating free cash flow of approximately $100 million. This includes approximately $18 to $20 million of capital expenditures, a significant majority of which we expect to occur in the fourth quarter of fiscal 2026. That completes my prepared remarks, and at this time, I would like to turn the call over to the operator for questions. Operator?

Thank you so much. And as a reminder, to ask a question, press star 1-1 on your telephone and wait for your name to be announced. To remove yourself, press star 1-1 again. One moment for our first question that comes from Marie Thibault with U.S. Bancorp BTIG. Please proceed.

Hi, good morning. Thank you for taking the questions. I wanted to start here to try to follow up on some of the discussion we had last quarter about competitive share shifts, low-cost competitors, and some of the pressures you were seeing with some of the regional players as well. So, any updates on what you've heard from your customer base and your strategies for sort of offsetting some of this, you know, low-cost competition?

Yes, good morning, Marie, and thanks for the question. Look, we are pleased with our performance in Q3. With respect to the share question, it is tracking within the range of expectations that we laid out in the last quarter. We saw share stability in Q3, and so we were pleased with that. We continue to make progress on our market-appropriate syringes and pen needles, which obviously over time will help us combat some of these low-cost players. Our pen needle is under review with the US FDA. That review is progressing as you might expect. It's also under review with BSI for CE Mark. Our syringes have already launched in China, which is a tough low-cost market, but over time certainly will expand that to other geographies around the world. So overall, I'd say we are tracking within the range of expectations that we laid out 90 days ago and pleased with the progress that we've made on new products.

All right, that's encouraging to hear, Dev. I'm glad to hear it. And then I wanted to follow up. You made some reference to watching trends in the U.S. market overall and Some of the volume lightness that was seen last quarter. What's the latest there? I know you talked about potential impact from maybe insurance headlines or JLP1s, but would love to hear more of what you heard and whether you think that's a trend you'll continue to see or whether we're seeing some improvement there as well. And thanks again for taking the questions.

Yeah, Murray, we continue to watch that. I mean, since we spoke 90 days ago, we've noted with interest other public commentary around AC enrollment trends and Medicaid trends. Obviously, as the insured population changes, that potentially has impact on insulin pen total prescriptions. It's a trend we had noted also 90 days ago that we had seen a decline in insulin pen TRX year over year. I'm pleased to say that in Q3, we saw sequential stability. As I noted in my prepared remarks, the year over year decline in Q3 was slightly greater. then in Q2, but I would say sort of within the range of variability that we've seen in this data in the past. So, you know, our guide continues to assume no further recovery or deterioration, but obviously, you know, these are macro factors that we will continue to monitor closely.

One moment for our next question. That comes from Travis Steed with Bank of America. Please proceed.

Hey, this is Grayshawn for Travis. Thanks for taking the questions. Just kind of wanted to first ask about the revenue guidance. You reiterated it, but beat the street by about $17 million. And I think that means the Q4 guide implies about $270 million, which is just a little bit lower than where the street is today. So any more color on potential changes in expectations for Q4 versus prior expectations on the Q2 call?

Yeah, look, you know, we did reiterate a guide, as you noted. I mean, we are pleased with the progress that we made in Q3 and expect, obviously, to continue making that progress in Q4. You know, we are tracking within the range of all the expectations that we had laid out 90 days ago, Gratia. The Evan Mumford contribution has been tracking along the lines. Our U.S. performance has been tracking along within the range of expectations. International is performing strongly. So at this point, we just thought it was prudent to stick with the guide that we laid out 90 days ago and continue to execute in Q4, hopefully just like we did in Q3. Great. Super helpful.

And then maybe just on how to think about 2027, Revenue Growth, and any preliminary thoughts on how the headwinds that you've seen in 2026 either stay the same or change and how to think about maybe an updated LRP framework. Thank you.

Yeah, thank you, Gratia. Look, in 2027, obviously, I mean, this has been a year of change, so we want to execute Q4, let 2026 play out before we really comment on 2027. and that will give us some time to really understand particularly with some of those macro factors that I laid out before sort of where they level out with respect to our LRP I think our plan right now is to you know update it sometime towards the end of calendar year next year and the idea behind that is certainly we have We have a lot of initiatives going on that will have progress by that time, whether it's our new products on the syringe or pen needle, the GLP-1 opportunities that we've spoken about previously and now particularly with Zeb Bound being launched in QuickPen. That opens up an additional revenue opportunity as well. And obviously with the Urban Mumford acquisition, You know, we are excited about the pen injector that we have in development, the auto injector that we are developing with Owen Mumford. So we want all these initiatives to progress over the next 12 to 18 months or so before we update our LRP.

Makes sense.

Thank you. Thank you. And as a reminder, to ask a question, simply press star 1 1 to get in the queue. We have a question from Ryan Schiller with Wolf Research. Please proceed.

Good morning. Thank you for taking the questions. Two from me. So with the Owen deal now closed and integration work underway, how are you thinking about capital allocation? And then within Owen, can you remind us the timeline that adapters should really start contributing more revenue growth?

So on Owen Mumford, you know, I'll take your second one first, and I'll let Jake comment on capital allocation. On Evan Mumford, look, I mean, it's been six, you know, it closed midway sort of in May, right? So it's been under three months that we've had Evan Mumford, if you will, under our watch. The integration is going well. It's proceeding quite well. The ADAPTUS program is tracking to the R&D timelines that they have. I think, again, as I said before, I would like some more time before we actually lay out revenue expectations for ADAPTUS. But stepping back from, you know, specific expectations for adapters, I mean, let me just again reiterate, I mean, this is a $2 billion plus TAM, right, significant expansion of our TAM, current TAM for insulin injection devices, and it's growing, you know, in the double digit. and many more. Thank you. Let some of the program development continue to proceed as it is before we lay out specific numbers. But Jake, you want to talk about capital allocation?

Sure, Ryan. Yeah, I'd say, look, in terms of capital allocation, it's primarily going to be focused on continued debt reduction. I think at SPIN, we were given a fair amount of debt and leverage. In the years following SPIN, there was a fair amount of cash that we needed to use associated with separation and stand-up work. And then really over the last couple of years, we've been able to make some significant progress in terms of delevering. Now, obviously, we acquired Owen Mumford, but yet we were still able to repay more debt in the quarter than we expected just 90 days ago. And that's really going to be the focus moving forward. It is primarily on continued debt reduction.

Ladies and gentlemen, this will conclude our Q&A session for today, and I will pass it back to Devdatt Kurdikar for final comments.

Devdatt Kurdikar As we close the call, I just want to thank my colleagues across Embecta for their continued focus and commitment. This was a quarter of solid progress, with sequential improvement in our U.S. business, continued strength internationally, and the successful close of the Owen Mumford acquisition. We are not standing still, and the steps we are taking, strengthening our commercial execution in the U.S., integrating Alvin Mumford, and maintaining discipline in our cost structure and capital allocation are purposeful and aligned with our long-term strategic roadmap. Thank you for joining us today and for your continued interest in Embecta.

And this concludes our conference. Thank you all for participating, and you may now disconnect.