Welcome, ladies and gentlemen, to the Fiscal Second Quarter 2024 Embecta Earnings Conference Call. 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.

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?

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% 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 the 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 healthcare 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 positively impacted our second quarter results 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?

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 margin 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 one-time 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 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 timeframe, 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.

Our first question comes from Travis Steed with Bank of America Securities.

This is Caroline on for Travis. I wanted to start out first with the full year guidance. It looks like you beat 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.

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 expect 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 the midpoint, $6 million of which we think occurred in the U.S. in the second quarter. But obviously, we're affecting commission 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.

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.

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 the 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.

Our next question comes from the line of Marie Thibault with BTIG.

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?

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 we 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.

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.

We haven't experienced any disruption from our perspective regarding the transaction you mentioned. Our sales team remains focused on presenting our products vigorously and continuing to gain market share. We believe our products that compete against those of our competitors are in a strong position. We have maintained a consistent supply, even during the ERP transitions we've noted. We will keep making efforts in that area. I'll leave it at that.

Our next question comes from the line of Kallum Titchmarsh with Morgan Stanley.

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.

Yes, Kallum. Our current priority is completing the FDA review. We submitted our 510(k) application in late 2023. Therefore, I cannot comment on the outcome or expected timeline for a decision from the FDA. Right now, we are focused on completing that review and finishing the remaining separation work while concluding FY 2024. I won't discuss expenses for 2025 and beyond at this time. However, as we receive more definitive decisions from the FDA, we are considering the possibility of an Investor Day event or call to share our insights on FY 2025 and beyond, especially regarding the patch pump.

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?

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.

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.

Our next question comes from Ryan Schiller with Wolfe Research, LLC.

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?

Yes. So, regarding the algorithm you mentioned, it has been approved for type 1, and we are currently assessing how to adapt it for type 2. Our open-loop system is under FDA review, and we are also working with Tidepool to modify the algorithm for type 2. We anticipate that once we are ready, which will depend on obtaining FDA clearance for the open-loop, we can discuss the clinical trial needed for this adaptation and its timing. This clinical trial is crucial for validating the Tidepool algorithm for type 2, collecting data, and submitting it to the FDA for the approval of a type 2 closed-loop pump. We will provide more details on timing after we complete fiscal year 2024 and once we have a clearer understanding of the FDA's decision on the open-loop.

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?

Yes, Ryan. We are closely monitoring the developments around weekly insulin. There is an expectation that one version will receive approval in Europe in the coming months. Currently, it won't be widely available in most regions and will likely come in a pen form, although it may not include a pen needle. If it is a pen, we believe our pen needles could be compatible with it. When considering the adoption of weekly insulin, cost is a significant factor. Regular insulin prices have significantly decreased in recent years, leading to a trade-off consideration between cost and efficacy, particularly regarding whether weekly insulin offers greater efficacy compared to daily doses. The promotional strategy will also play a role in whether pharmaceutical companies prioritize GLP-1 medications or weekly insulin in their marketing efforts. Many patients using basal insulin are managed by primary care physicians who might be hesitant to prescribe weekly insulin due to the complexities of insulin dosing and the potential for increased hypoglycemia. While type 1 diabetes patients may face a greater risk of hypoglycemia, concerns might still persist among type 2 patients. Those currently using multiple daily injections might prefer to continue with their regimen instead of switching to weekly insulin. We believe that if weekly insulin does gain traction, it is more likely to attract new basal patients rather than convert existing users. However, these are all hypotheses at this point, and we don't have enough patient usage data to accurately assess the potential impact of weekly insulin on our business. It will take time to fully understand this situation, but the factors I've mentioned are definitely on our radar as we anticipate the introduction of weekly insulin.

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.

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.

This concludes today's conference call. Thank you for your participation. You may now disconnect.