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Globe and Mail
5 days ago
- Business
- Globe and Mail
Pen Needles Market to Hit USD 3.08 Billion by 2030 with 9.2% CAGR
"Key players in this market are adopting several organic and inorganic growth strategies (such as product launches, agreements, collaborations, acquisitions, and expansions). Prominent players in this market include Embecta Corp. (US), Novo Nordisk A/S (Denmark), Ypsomed AG (Switzerland)" Browse 267 market data Tables and 71 Figures spread through 285 Pages and in-depth TOC on "Pen Needles Market by Type (Standard Pen Needles, Safety Pen Needles), Length (8mm, 5mm), Setting (Home Care Settings), Application (Glucagon-Like Peptide-1 Therapy), Mode of Purchase (Over the Counter Purchase, Online Purchase) - Global Forecast to 2030 The pen needles market valued at US$ 1.69 Billion in 2023, is forecasted to grow at a robust CAGR of 9.2%, reaching US$ 1.81 Billion in 2024 and an impressive US$ 3.08 Billion by 2030. The pen needles market has been segmented based on type, length, application, mode of purchase, setting and region. The key factors driving the market growth of the pen needles market include the rising incidence of chronic diseases, favourable reimbursements in certain countries, and decreasing prices of insulin formulations. Factors that provide opportunities for market players include the growing preference for biosimilar drugs, emerging economies to offer high-growth potential, and rising healthcare expenditure on diabetes. Supportive government regulations, such as rigorous safety standards by the US FDA and favourable reimbursement policies, are also expected to fuel the uptake of technologically advanced products. A combination of these factors is expected to facilitate the increased adoption of pen needles in healthcare systems. Browse in-depth TOC on ' Pen Needles Market' 200 - Tables 80 - Figures 300 - Pages In this report, the pen needles market has been segmented on the basis of type, length, application, mode of purchase, setting and region. The pen needles market is segmented into standard pen needles and safety pen needles on the basis of type. Standard pen needles are budget-friendly needles for insulin delivery, which explains their popularity in low-income markets and among the uninsured. These needles are simple and basic, which makes them easier to manufacture. There is no requirement for ultra-thin design or sophisticated coating that is required for more expensive options. Cost is a major determinant in healthcare in developing nations and low-income brackets. With standard pen needles, accessible options for diabetic patients who need insulin therapy are readily available without worry of financial suffocation. Moreover, for the Grey market practioners in developed countries where people do not have insurance, these needles are a cheap and functional alternative. Thus, standard pen needles are vital because they meet minimum requirements of diabetes control which helps increase the availability of insulin delivery worldwide. The pen needles market is segmented into prescription-based, over the counter (OTC) purchase, online purchase and other modes of purchase on the basis of mode of purchase. Online purchase segment is expected to grow at the highest CAGR during the forecast period of the global pen needles market. As e-commerce grows across the world, the demand for pen needles is also on the rise as new customers are drawn to online shopping. Marketplaces make purchase easier for patients who can now shop for pen needles among other products while sitting in their homes. This is particularly helpful for people with movement disabilities or people living in far flung areas who don't have a ready access to local pharmacies. Businesses engaged in diabetes care and treatment are benefiting enormously as most e-commerce websites offer better rates, promotions, and subscriptions which aid in controlling diabetes. Furthermore, aspects like covert packaging and home delivery make e-commerce users feel more secure and comfortable. The vast variety of products and brands available in these platforms allows customers more purchasing freedom, which aids in increasing their adoption. The pen needles market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East, and Africa and GCC Countries on the basis of geographic region. North America holds the largest share of the pen needles market in 2024. North America sees one of the maximum diabetes prevalence rates of the world with the U.S and Canada heads in the top of the insulin-dependent population. As per CDC, more than 37 million Americans suffer from diabetes, and approximately 1.6 million have type 1 diabetes. Thus, Canada also bears a huge burden of diabetes cases with an estimated total of 11.7 million that are affected by diabetes or prediabetes. The prevalence of such patients is relatively high, thus increasing demand for pen needles since it's the basic need for managing blood glucose. Pen needles require good infrastructure and wide awareness in place with patients desiring easy-to-handle devices such as pen needles, thereby augmenting the uptake of this equipment. Increased concern regarding proper management of diabetes helps in sustaining the demand in the region. Prominent players in this market include Embecta Corp. (US), Novo Nordisk A/S (Denmark), Ypsomed AG (Switzerland), B. Braun SE (Germany), Owen Mumford (UK), Terumo Corporation (Japan), NIPRO Corporation (Japan), Allison Medical, Inc. (US), AdvaCare Pharma (US), Berpu Medical Technology Co., Ltd. (China), ARKRAY, Inc. (Japan), GlucoRx Limited (UK), HTL-STREFA (Poland), UltiMed, Inc. (US), Hindustan Syringes and Medical Devices (India), Artsana Group (Italy), PromiseMed Medical Devices Inc. (Canada), Montmed, Inc. (Canada), Trividia Health, Inc. (US), VOGT Medical Vertrieb GmbH (Germany), Van Heek Medical (Netherlands), Simple Diagnostics (US), IYON Medical (Turkey), Links Medical Products, Inc. (US), and MHC Medical Products, LLC (US). EMBECTA CORP. (US) One of the main products traded by Embecta in the global market is pen needles. The company operates from a US-based facility, as well as having production plants in Ireland and China. The company's vast range of pen needles, syringes, and safety injection devices is a fundamental factor that helps it withstand competition in global market. Alongside the standard pen needles, the company has a safety pen needle portfolio. The company approaches the growth by both inorganic and organic mechanisms to cement its position in the pen needle market. For instance, on November 2022, Embecta Corporation (US) signed a agreement with Intuity Medical, Inc. (US) under which Embecta sales representatives in the US will promote Intuity Medical's high-tech POGO automatic blood glucose monitoring system to healthcare professionals. NOVO NORDISK A/S (DENMARK) The major source of revenue for the company is its Diabetes and Obesity Care segment. The global diabetes market provides an opportunity for the firm to generate revenues through its Diabetes Care segment. The company obtained approximately 40 million diabetic patients in 2022, from 32 million in Nordisk is well poised in production with ~16 production sites across five regions and a growing product portfolio, including pen needles. The R&D centers of the company are set up in China, Denmark, India, the UK, and the US. Novo Nordisk increased R&D investments from 13.6% in 2022 to 14.0% in 2023. The company also announced that it would be expanding its presence in the pen needles market through a research hub in the greater Boston metro area, which was announced in March 2023. B. BRAUN SE (GERMANY) B. Braun SE is another major player of the pen needle market. In terms of product, the group has a comprehensive presence across geographical boundaries. Also, it has recognition for its branded products, notably Omnican Fine and Omnican Fine Plus injection pen needles. The innovations included in the products such as three facet grinding tip and silicone coating or thin-wall technologies used for injecting pen needles will help the firm obtain a strong presence in branding at the overall markets. The company has a huge geographical presence and subsidiaries in 64 countries. Therefore, it is not dependent on a single market, thus sustaining its leading position. The company intends to focus on new technology and digital transformation for healthcare medical devices. 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Yahoo
22-05-2025
- Business
- Yahoo
embecta to Showcase Phased Approach for Value Creation and Present Long Range Financial Plan at 2025 Analyst and Investor Day
PARSIPPANY, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. ("embecta"; "The Company") (Nasdaq: EMBC), a global diabetes care company with a 100-year legacy in insulin delivery, will host its inaugural Analyst and Investor Day today to showcase its phased approach for value creation and present its long range financial plan ('LRP'). "Our Investor Day will provide a comprehensive view of our roadmap for transitioning embecta to growth. We look forward to sharing how we are positioning embecta for long-term success in an evolving healthcare landscape," said Dev Kurdikar, President and Chief Executive Officer. "Today, we reiterate our commitment to maintaining our leadership in insulin injection while outlining our long term vision to transform embecta into a more broad-based medical supplies company, paving the way toward a life unlimited for all." Strategic Prioritiesembecta's core insulin injection business has long provided a stable, recurring, and geographically diversified revenue base with an attractive margin profile. Following a successful three-year effort to establish embecta as an independent, standalone organization, the Company is currently focused on three strategic priorities aimed at positioning embecta for sustainable, long-term success: Strengthening the core business, which includes executing a seamless brand transition to ensure embecta's identity resonates globally while maintaining the trust of customers. At the same time, the company is continuing to identify opportunities within its core portfolio that bolster its leadership position in injection devices. Expanding the Company's product portfolio through the introduction of products that leverage embecta's expertise in high-volume manufacturing and the strength of its global commercial channel. Increasing financial flexibility by generating cost savings through operational efficiencies and prioritizing debt reduction, thereby enhancing the Company's financial agility and ability to make future investments. Fiscal Year 2025 Financial Guidance embecta today reaffirmed its fiscal year 2025 guidance, originally provided in conjunction with its second quarter of fiscal 2025 financial results announced on May 9, 2025. Dollars in millions, except percentages and per share data Reported Revenues $1,073 - $1,090 Reported Revenue Growth (%) (4.4)% - (2.9)% Impact of F/X (%) (0.8%) Impact of Italian Payback Measure (1) (%) 0.4% Adjusted Constant Currency Revenue Growth (%) (4.0)% - (2.5)% Adjusted Gross Margin (%) 62.75% - 63.75% Adjusted Operating Margin (%) 29.75% - 30.75% Adjusted Earnings per Diluted Share $2.70 - $2.90 Adjusted EBITDA Margin (%) 36.25% - 37.25% (1) Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015 recorded in Revenues. Long Range Financial Plan embecta today announced its long range financial plan for fiscal 2025 through fiscal 2028. Over this period, the Company expects to: Maintain a flattish constant currency revenue CAGR Achieve an adjusted operating margin of approximately 28% to 30% Generate approximately $600 million of cumulative free cash flow(1) Repay between $450 million and $500 million of debt We are unable to present a quantitative reconciliation of our expected adjusted gross margin, expected adjusted operating margin, expected adjusted earnings per diluted share, expected adjusted EBITDA margin, expected constant currency revenue CAGR (for the LRP), and expected cumulative free cash flow as we are unable to predict with reasonable certainty, and without unreasonable effort the impact and timing of any one-time items. The financial impact of these one-time items is uncertain and is dependent on various factors, including timing, and could be material to our Condensed Consolidated Statements of Income. 2025 Analyst and Investor Day The Company's inaugural Analyst and Investor day will take place live in New York City and via webcast on May 22, 2025, beginning at 9:00 a.m. EDT. Visit to view the agenda for the event and watch the live webcast. A replay of the webcast, along with the related presentation materials, will be available on the "Events & Presentations" section of the Company's Investor Relations website following the conclusion of the event. (1) Free cash flow defined as cash flow from operations less capital expenditures Forward-Looking StatementsThis press release contains express or implied "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements concern our current expectations regarding our future results from operations, performance, financial condition, goals, strategies, plans, and achievements. These forward-looking statements are subject to various known and unknown risks, uncertainties and other factors, and you should not rely upon them except as statements of our present intentions and of our present expectations, which may or may not occur. When we use words such as "believes,' 'grow,' "expects," "anticipates," "estimates," "plans," "intends," 'pursue,' 'will,' 'expands,' 'opportunity,' 'positioning,' 'strategy,' or similar expressions, we are making forward-looking statements. For example, embecta is using forward-looking statements when discussing our fiscal 2025 financial guidance, expectations concerning our LRP, expectations for value creation, opportunities to transition into a broad-based medical supplies company, ability to increase our financial flexibility, expansion of our product portfolio, expectations related to the impact of incremental tariffs, and execution of our brand transition plan. Although we believe that our forward-looking statements are based on reasonable assumptions, our expected results may not be achieved, and actual results may differ materially from our expectations. In addition, important factors that could cause actual results to differ from expectations include, among others: (i) competitive factors that could adversely affect embecta's operations; (ii) any inability to replace the services provided by Becton, Dickinson and Company ('BD') under the transaction documents; (iii) any failure by BD to perform its obligations under the various separation agreements entered into in connection with the separation and distribution; (iv) any events that adversely affect the sale or profitability of embecta's products or the revenues delivered from sales to our customers; (v) increases in operating costs, including costs incurred from newly instituted tariffs by the U.S. government and certain foreign governments on raw materials and products, fluctuations in the cost and availability of raw materials or components used in our products, the ability to maintain favorable supplier arrangements and relationships, and the potential adverse effects of any disruption in the availability of such items; (vi) the impact of the global trade environment resulting from newly instituted tariffs causing certain foreign governments, private purchasers and others to consider transitioning away from products originating from certain countries (including the U.S.) in favor of buying 'local' products; (vii) changes in reimbursement practices of governments or private payers or other cost containment measures; (viii) the adverse financial impact resulting from unfavorable changes in foreign currency exchange rates, as well as regional, national and foreign economic factors, including inflation, deflation, and fluctuations in interest rates; (ix) the impact of changes in U.S. federal laws and policy that could affect fiscal and tax policies, healthcare and international trade, including import and export regulation and international trade agreements; (x) any new pandemic, or any geopolitical instability, including disruptions in our operations and supply chains; (xi) new or changing laws and regulations, or changes in enforcement practices, including laws relating to healthcare, environmental protection, trade, monetary and fiscal policies, taxation and licensing and regulatory requirements for products; (xii) the expected benefits of the separation from BD; (xiii) risks associated with embecta's indebtedness; (xiv) the risk that ongoing dis-synergy costs, costs of restructuring and other costs incurred in connection with the separation from BD will exceed our estimates of these costs; (xv) the risk that it will be more difficult than expected to effect embecta's full separation from BD; (xvi) the risks related to timely and successfully completing the brand transition, including any resulting regulatory registration and license delays and interruptions in the transition of the rebranded products into commercial operations, networks, administrative operations and end-to-end product flow and user access; (xvii) expectations related to the costs, profitability, timing and the estimated financial impact of, and charges and savings associated with, the restructuring plans we announced; (xviii) risks associated with not completing strategic collaborative partnerships and acquisitions for innovative technologies, complementary product lines, and new markets; and (xix) the other risks described in our periodic reports filed with the Securities and Exchange Commission, including under the caption 'Risk Factors' in our most recent Annual Report on Form 10-K, as further updated by our Quarterly Reports on Form 10-Q we have filed or will file hereafter. Except as required by law, we undertake no obligation to update any forward-looking statements appearing in this release. About embectaembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels on LinkedIn, Facebook, and Instagram. Contacts: MediaChristian GlazarSr. Director, Corporate Communications908-821-6922Contact Media Relations Investors Pravesh KhandelwalVP, Head of Investor Relations 551-264-6547Contact IR Sign in to access your portfolio
Yahoo
22-05-2025
- Business
- Yahoo
embecta to Showcase Phased Approach for Value Creation and Present Long Range Financial Plan at 2025 Analyst and Investor Day
PARSIPPANY, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Embecta Corp. ("embecta"; "The Company") (Nasdaq: EMBC), a global diabetes care company with a 100-year legacy in insulin delivery, will host its inaugural Analyst and Investor Day today to showcase its phased approach for value creation and present its long range financial plan ('LRP'). "Our Investor Day will provide a comprehensive view of our roadmap for transitioning embecta to growth. We look forward to sharing how we are positioning embecta for long-term success in an evolving healthcare landscape," said Dev Kurdikar, President and Chief Executive Officer. "Today, we reiterate our commitment to maintaining our leadership in insulin injection while outlining our long term vision to transform embecta into a more broad-based medical supplies company, paving the way toward a life unlimited for all." Strategic Prioritiesembecta's core insulin injection business has long provided a stable, recurring, and geographically diversified revenue base with an attractive margin profile. Following a successful three-year effort to establish embecta as an independent, standalone organization, the Company is currently focused on three strategic priorities aimed at positioning embecta for sustainable, long-term success: Strengthening the core business, which includes executing a seamless brand transition to ensure embecta's identity resonates globally while maintaining the trust of customers. At the same time, the company is continuing to identify opportunities within its core portfolio that bolster its leadership position in injection devices. Expanding the Company's product portfolio through the introduction of products that leverage embecta's expertise in high-volume manufacturing and the strength of its global commercial channel. Increasing financial flexibility by generating cost savings through operational efficiencies and prioritizing debt reduction, thereby enhancing the Company's financial agility and ability to make future investments. Fiscal Year 2025 Financial Guidance embecta today reaffirmed its fiscal year 2025 guidance, originally provided in conjunction with its second quarter of fiscal 2025 financial results announced on May 9, 2025. Dollars in millions, except percentages and per share data Reported Revenues $1,073 - $1,090 Reported Revenue Growth (%) (4.4)% - (2.9)% Impact of F/X (%) (0.8%) Impact of Italian Payback Measure (1) (%) 0.4% Adjusted Constant Currency Revenue Growth (%) (4.0)% - (2.5)% Adjusted Gross Margin (%) 62.75% - 63.75% Adjusted Operating Margin (%) 29.75% - 30.75% Adjusted Earnings per Diluted Share $2.70 - $2.90 Adjusted EBITDA Margin (%) 36.25% - 37.25% (1) Reflects the recognition of incremental Italian payback accruals resulting from the two July 22, 2024 rulings by the Constitutional Court of Italy relating to certain prior years since 2015 recorded in Revenues. Long Range Financial Plan embecta today announced its long range financial plan for fiscal 2025 through fiscal 2028. Over this period, the Company expects to: Maintain a flattish constant currency revenue CAGR Achieve an adjusted operating margin of approximately 28% to 30% Generate approximately $600 million of cumulative free cash flow(1) Repay between $450 million and $500 million of debt We are unable to present a quantitative reconciliation of our expected adjusted gross margin, expected adjusted operating margin, expected adjusted earnings per diluted share, expected adjusted EBITDA margin, expected constant currency revenue CAGR (for the LRP), and expected cumulative free cash flow as we are unable to predict with reasonable certainty, and without unreasonable effort the impact and timing of any one-time items. The financial impact of these one-time items is uncertain and is dependent on various factors, including timing, and could be material to our Condensed Consolidated Statements of Income. 2025 Analyst and Investor Day The Company's inaugural Analyst and Investor day will take place live in New York City and via webcast on May 22, 2025, beginning at 9:00 a.m. EDT. Visit to view the agenda for the event and watch the live webcast. A replay of the webcast, along with the related presentation materials, will be available on the "Events & Presentations" section of the Company's Investor Relations website following the conclusion of the event. (1) Free cash flow defined as cash flow from operations less capital expenditures Forward-Looking StatementsThis press release contains express or implied "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 and other securities laws. These forward-looking statements concern our current expectations regarding our future results from operations, performance, financial condition, goals, strategies, plans, and achievements. These forward-looking statements are subject to various known and unknown risks, uncertainties and other factors, and you should not rely upon them except as statements of our present intentions and of our present expectations, which may or may not occur. When we use words such as "believes,' 'grow,' "expects," "anticipates," "estimates," "plans," "intends," 'pursue,' 'will,' 'expands,' 'opportunity,' 'positioning,' 'strategy,' or similar expressions, we are making forward-looking statements. For example, embecta is using forward-looking statements when discussing our fiscal 2025 financial guidance, expectations concerning our LRP, expectations for value creation, opportunities to transition into a broad-based medical supplies company, ability to increase our financial flexibility, expansion of our product portfolio, expectations related to the impact of incremental tariffs, and execution of our brand transition plan. Although we believe that our forward-looking statements are based on reasonable assumptions, our expected results may not be achieved, and actual results may differ materially from our expectations. In addition, important factors that could cause actual results to differ from expectations include, among others: (i) competitive factors that could adversely affect embecta's operations; (ii) any inability to replace the services provided by Becton, Dickinson and Company ('BD') under the transaction documents; (iii) any failure by BD to perform its obligations under the various separation agreements entered into in connection with the separation and distribution; (iv) any events that adversely affect the sale or profitability of embecta's products or the revenues delivered from sales to our customers; (v) increases in operating costs, including costs incurred from newly instituted tariffs by the U.S. government and certain foreign governments on raw materials and products, fluctuations in the cost and availability of raw materials or components used in our products, the ability to maintain favorable supplier arrangements and relationships, and the potential adverse effects of any disruption in the availability of such items; (vi) the impact of the global trade environment resulting from newly instituted tariffs causing certain foreign governments, private purchasers and others to consider transitioning away from products originating from certain countries (including the U.S.) in favor of buying 'local' products; (vii) changes in reimbursement practices of governments or private payers or other cost containment measures; (viii) the adverse financial impact resulting from unfavorable changes in foreign currency exchange rates, as well as regional, national and foreign economic factors, including inflation, deflation, and fluctuations in interest rates; (ix) the impact of changes in U.S. federal laws and policy that could affect fiscal and tax policies, healthcare and international trade, including import and export regulation and international trade agreements; (x) any new pandemic, or any geopolitical instability, including disruptions in our operations and supply chains; (xi) new or changing laws and regulations, or changes in enforcement practices, including laws relating to healthcare, environmental protection, trade, monetary and fiscal policies, taxation and licensing and regulatory requirements for products; (xii) the expected benefits of the separation from BD; (xiii) risks associated with embecta's indebtedness; (xiv) the risk that ongoing dis-synergy costs, costs of restructuring and other costs incurred in connection with the separation from BD will exceed our estimates of these costs; (xv) the risk that it will be more difficult than expected to effect embecta's full separation from BD; (xvi) the risks related to timely and successfully completing the brand transition, including any resulting regulatory registration and license delays and interruptions in the transition of the rebranded products into commercial operations, networks, administrative operations and end-to-end product flow and user access; (xvii) expectations related to the costs, profitability, timing and the estimated financial impact of, and charges and savings associated with, the restructuring plans we announced; (xviii) risks associated with not completing strategic collaborative partnerships and acquisitions for innovative technologies, complementary product lines, and new markets; and (xix) the other risks described in our periodic reports filed with the Securities and Exchange Commission, including under the caption 'Risk Factors' in our most recent Annual Report on Form 10-K, as further updated by our Quarterly Reports on Form 10-Q we have filed or will file hereafter. Except as required by law, we undertake no obligation to update any forward-looking statements appearing in this release. About embectaembecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships, and the passion of approximately 2,000 employees around the globe. For more information, visit or follow our social channels on LinkedIn, Facebook, and Instagram. Contacts: MediaChristian GlazarSr. Director, Corporate Communications908-821-6922Contact Media Relations Investors Pravesh KhandelwalVP, Head of Investor Relations 551-264-6547Contact IR
Yahoo
10-05-2025
- Business
- Yahoo
Q2 2025 Embecta Corp Earnings Call
Pravesh Khandelwal; Vice President of Investor Relations; Embecta Corp Devdatt Kurdikar; President and Chief Executive Officer; Embecta Corp Jake Elguicze; Chief Financial Officer; Embecta Corp Kallum Titchmarsh; Analyst; Morgan Stanley Marie Thibault; Analyst; BTIG Anthony Petrone; Analyst; Mizuho Financial Group Michael Polark; Analyst; Wolfe Research Operator Welcome, ladies and gentlemen, to Embecta Corp's Fiscal Second Quarter 2025 Earnings Conference Call. (Operator Instructions) 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. Pravesh Khandelwal 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 With me today are Dev Kurdikar, Embecta's President and Chief Executive Officer; and Jake Elguicze, our Chief Financial 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 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 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. Devdatt 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 strengthening our core business. We are making solid progress on our global brand transition with implementation in the U.S. 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 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 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 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 compared to the midpoint of our prior guidance range, approximately half of the overachievement in the quarter was due to constant currency performance, while the other half was due to foreign exchange being less of a headwind than we previously anticipated. Turning to some additional highlights. During the second quarter, we published the updated FITTER Forward Expert Recommendations in Mayo Clinic is an important milestone in our commitment to improving clinical outcomes as the recommendations support the best global practices for insulin injection technique, device optimization and provider training. Additionally, during Q2, Embecta conducted a company-wide employee engagement survey through Great Place to Work, a global authority on workplace culture, employee experience and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased had a tremendous response rate from our employees worldwide and we are pleased to announce that we have received certification as a Great Place to Work for 2025 in eight countries. This recognition is a testament to the effort our teams have put into building a strong, authentic and inclusive culture. I am also pleased to announce that we are continuing to advance our efforts to co-package our pen needles with potential generic GLP-1 drugs as well as making our pen needles available in retail packaging appropriate for use with branded GLP-1 drugs delivered by pen expect this will enable us to expand into a fast-growing market, while leveraging our world-class distribution and commercial expertise. We have received several purchase orders from generic manufacturers to co-package our pen needles and we look forward to sharing more details about these partnerships and the market potential at our upcoming Analyst and Investor Day. We have completed the majority of the steps required to implement the discontinuation of our insulin patch pump program and the associated restructuring plan announced in November 2024. This progress has occurred within our previously expected time line. Additionally, our stand-up activities are largely complete with only India yet to be transitioned to our ERP system and distribution network within the next few months. Therefore, we continue to be focused on reducing our cost during the second quarter, we initiated a separate restructuring plan aimed at streamlining our organization. We expect the plan to be substantially complete by the end of fiscal year 2025. As a result, we anticipate incurring total pre-tax charges of between $4 million to $5 million, the majority of which are expected to be cash-related. This action is expected to drive meaningful efficiencies with estimated pre-tax cost savings of between $7 million to $8 million during the second half of fiscal to the next slide. In line with our commitment to enhancing financial flexibility, we continued to reduce our debt, making an aggregate principal payment of approximately $27 million on our Term Loan B facility during the quarter. While on a year-to-date basis, we have reduced debt by approximately $60 million, which puts us well on-track to achieve our goal of reducing debt by approximately $110 million during fiscal as we reflect on our second quarter results and look ahead to the remainder of the year, we are updating our fiscal 2025 guidance. While our teams delivered slightly better than expected financial performance during the first six months of the year, we are adjusting our full year 2025 constant currency revenue outlook to account for lower projected U.S. volumes primarily associated with anticipated reductions in customer inventory levels tied to store closures at a specific U.S. retail pharmacy said, our as-reported revenue guidance remains largely intact, supported by favorable foreign exchange movements as compared to our previously provided guidance. In terms of gross margins, we have updated our guidance to reflect the lower constant currency revenue expectations as well as the estimated impact of currently implemented incremental tariffs, which are expected to be a headwind of approximately 25 basis points to our full year adjusted gross even with these headwinds, we are raising our guidance ranges for adjusted operating and adjusted EBITDA margins for the year due to disciplined expense management and the initiation of the previously mentioned restructuring plan in the second quarter. We are also reaffirming our adjusted earnings per share outlook for fiscal year to the next slide, I would like to provide an update on our brand transition plan and walk through the key elements of its execution. This initiative has been in planning since our spin, and I am pleased to report that the transition is now underway in the U.S. and Canada. We are executing the program in phases, as intended, and are preparing to transition most of the remaining markets in the next fiscal year, in line with our original plan. We continue to expect the global transition to be completed within the next couple of the slide, you will see an example of the new Embecta-branded packaging contrasted with the legacy BD Nano 2nd Gen packaging. Importantly, product names and color cues will remain unchanged, a deliberate decision informed by customer research. At the same time, we are introducing a modern, refreshed look, while maintaining the visual elements that help healthcare providers and people with diabetes easily recognize our remain focused on ensuring operational readiness along the supply chain, including inventory management, customer communication and regulatory compliance. This thoughtful, phased approach is designed to ensure a smooth transition, while preserving the trust of those who rely on our products every let's review our revenue performance for the second quarter. During the second quarter of fiscal year 2025, Embecta generated $259 million in revenue, reflecting a 9.8% decline year-over-year on an as-reported basis or a 7.7% decline on an adjusted constant currency basis. Within the U.S., revenue for the quarter totaled $135.2 million, reflecting a year-over-year decline of 8.4% on an adjusted constant currency basis. The year-over-year decline was expected and is primarily due to two factors, both of which relate to the timing of price increases that went into in advance of a price increase that went into effect on April 1st of 2024, we saw certain customers purchase additional products that positively impacted our second quarter of 2024 results. Similarly, in advance of a price increase that went into effect on January 1st of 2025, we saw certain customers purchase additional products and that positively impacted our first quarter of 2025 results and resulted in an offsetting reduction in the second such, the combination of these two factors led to a difficult comparable for our U.S. business. Turning to our international business. During Q2, revenue totaled $123.8 million, which equated to a 7% and a $10 million decline on an adjusted constant currency basis as compared to the prior year period. Like the U.S., this decline was expected and due to certain customers purchasing additional products in advance of ERP implementations in certain regions in the prior year from a product family perspective, during the quarter, pen needle revenue declined approximately 12.1%, syringe revenue grew by approximately 1.7%, safety products grew approximately 4.2% and contract manufacturing grew approximately 73%. The decline in year-over-year pen needle revenue was primarily driven by the timing issues associated with price increases that went into effect within the U.S., coupled with the unfavorable prior-year comparison stemming from ERP-related inventory builds within our international to our syringe products. They grew in the quarter by 1.7%, driven by international markets, specifically Latin America and Asia. While our safety products grew 4.2% as compared to the prior year period due to the annualization of share gains resulting from a competitor discontinuing their product and exiting the market. That completes my prepared with that, let me turn the call over to Jake to review other Q2 financial highlights as well as provide our updated financial guidance for fiscal year 2025. 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 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 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 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 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 just 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 prior year on an adjusted basis, during the second quarter of fiscal 2025, net income and earnings per share were $40.7 million and $0.70 as compared to $38.9 million and $0.67 in the prior year period. The increase in year-over-year adjusted net income and diluted earnings per share is primarily due to the adjusted operating profit drivers I just discussed as well as a reduction in interest expense. This was partially offset by an increase in our adjusted tax rate from approximately 18% in Q2 of 2024 to approximately 25% in Q2 of from a P&L perspective, for the second quarter of 2025, our adjusted EBITDA and margin totaled approximately $97.1 million and 37.5% as compared to $90.8 million and 31.6% in the prior year period. Turning to the balance sheet and cash flow. At the end of the second quarter, our cash balance totaled approximately $212 million, while our last 12 months net leverage as defined under our credit facility agreement stood at approximately 3.7 times. As a reminder, our net leverage covenant requires us to stay below 4.75 Dev mentioned earlier, we continue to be focused on more aggressively delevering. And during the second quarter, we paid down $27.4 million of Term Loan B debt. I'm pleased to say that we remain on track to achieve our goal of reducing our gross debt by $110 million during fiscal 2025 as well as getting our net leverage levels to approach approximately 3 times by completes my prepared remarks on our second quarter 2025 results. Next I would like to discuss Embecta's updated 2025 financial guidance and certain underlying assumptions. Before I begin, I want to acknowledge the evolving tariff landscape and provide some important context regarding our global operations. As a reminder, we manufacture our products across three key facilities: Dun Laoghaire, Ireland; Holdrege, Nebraska; and Suzhou, China. We do not perform any manufacturing in either Canada or important to note that tariff regulations extend beyond manufacturing location and require detailed analysis of trade classifications and rules of origin to determine potential exposure. As it relates to our global operations, we have now incorporated the impact of tariffs currently in effect, notably the incremental 125% tariffs for raw material and finished goods being imported into China with the U.S. as the country of origin, the incremental 145% tariffs for imports into the U.S. from China and incremental baseline 10% tariffs for imports into the U.S. from certain other have also assumed that certain exemptions are applicable to certain materials and finished goods being imported into the U.S. We have not incorporated the potential incremental tariffs that may be implemented after the current pause on tariffs has expired. Given the uncertainties surrounding the evolving global trade environment, our estimates remain subject to change and we will continue to monitor the situation and provide updates when appropriate. As always, we remain committed to mitigating potential impacts where possible to make sure we continue supporting our customers and the people living with diabetes who rely on our let me discuss our updated guidance. Beginning with revenue. On an adjusted constant currency basis, we are lowering our previously provided guidance range by 150 basis points on both the low and high ends as we now call for revenue to decline between 2.5% and 4% as compared to 2024. At the low end of the range, we estimate that volume will be a headwind of approximately 3% and that pricing will be a headwind of approximately 1%. Meanwhile, at the high end of our constant currency revenue guidance range, we estimate that volume will be a headwind of approximately 1.5% and that pricing will be a headwind of approximately 1%. As Dev noted earlier, the additional 1.5% volume headwind which we have incorporated into our outlook is driven by lower projected U.S. volumes, primarily associated with anticipated reductions in customer inventory levels tied to store closures at a specific U.S. retail pharmacy customer. We believe this is transitory and does not reflect any fundamental change in the stability of our base to our thoughts on FX. Since we provided our updated fiscal 2025 financial guidance in early February, the U.S. dollar has weakened against most currencies. And as a result, we currently expect FX to be a headwind of approximately 0.8% as compared to our prior guidance which called for FX to be a headwind of approximately 2.2%. Additionally, our as-reported 2025 GAAP revenue will not be impacted by the 2015 through 2023 amount that we needed to accrue associated with the Italian payback measure which impacted our 2024 as-reported GAAP revenue. This equates to a tailwind of approximately 0.4%. On a combined basis, our as-reported revenue guidance remains largely unchanged at a range of between $1.73 billion and $1.90 to adjusted gross margin. We are lowering our previously provided guidance range by 50 basis points and now expect adjusted gross margin to be in the range of between 62.75% and 63.75%. The reduction in our current versus prior adjusted gross margin guidance is primarily due to the reduction in our constant currency revenue as well as the incremental impact of tariffs. This is somewhat offset by favorable profit in inventory adjustments and cost improvement actions we are taking within cost of sales, while from an adjusted operating margin standpoint, we are raising our guidance from a range of between 29.5% and 30.5% to a new range of between 29.75% and 30.75%. This improvement in adjusted operating margin is primarily driven by the expected cost savings associated with the restructuring plan announced this to earnings. Our better than expected second quarter earnings performance, coupled with the restructuring plan we announced today as well as favorable shifts in foreign exchange, are enabling us to absorb the impact of the lower adjusted constant currency revenues and incremental tariffs, thereby allowing us to maintain our previously provided adjusted diluted earnings per share guidance range of between $2.70 and $2.90. Our updated guidance range continues to assume that our annual net interest expense will be approximately $107 million; that our annual adjusted tax rate will be approximately 25%; and that our weighted average diluted shares outstanding will be approximately 58.9 guidance also continues to assume that we will use between $50 million and $60 million of cash during fiscal 2025 associated with separation costs largely related to brand transition. While as it relates to capital expenditures, we now expect to incur approximately $15 million during the year, down from our prior estimate of approximately $20 cash usage associated with the discontinuation of our insulin patch pump program, our guidance now assumes that we will use between $20 million and $25 million as compared to our previous estimates of between $25 million and $30 million. Lastly, for the same reasons we increased our adjusted operating margin guidance range, we are also raising our adjusted EBITDA margin guidance range from a range of between 36% and 37% to a new range of between 36.25% and 37.25%.And before I turn the call over to the operator, I wanted to take a moment to remind everyone that we will be hosting our inaugural Analyst and Investor Day on May 22 in New York City. We are looking forward to providing a deeper look into our portfolio, value creation opportunities and long-term financial objectives. We hope to see many of you RSVP by following the instructions on this slide. With that, I would like to now turn the call over to the operator for questions. Operator? Operator Thank you. At this time we'll conduct the question and answer session. (Operator Instructions) Our first question comes from the line of Kallum Titchmarsh of Morgan Stanley. Your line is now open. Kallum Titchmarsh 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 U.S. You called out the customer inventory bits and store you now comfortable that they are kind of isolated issues and behind you? Thanks a lot. Devdatt Kurdikar Good morning, Kallum. Thanks for the question. So maybe some context is in the order here. As you may remember, fiscal 2024, we had a number of rolling ERP implementations throughout the year. U.S. and Canada went live in the first quarter, then we had EMEA and Asia in quarter two and then we had China and Latin America in the following quarters, Latin America as recent as Q1 our goal, as we did that was to ensure that we maintain product continuity. As you know, these implementations, in our case, coupled with changes in distribution network and setting up 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 U.S. 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 U.S., some distributors purchased products ahead of that port strike 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 geographic 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 year, which is in fiscal 2024, we had a U.S. price increase on the 1st of April of 2024. And this year, we had it on January 1, 2025. So certainly, that's going to help us through the remainder of the year, but again, leads to unfavorable comparisons. So those were the dynamics that really drive both for the quarter and the year-to-date comparisons for adjusted revenue by geography and in you can imagine with pen needles being approximately 76% of our total revenue, that impacts the pen revenue business quite significantly, particularly when you think about the ERP implementations in which regions they occurred, because in certain regions, they are primarily a pen needle business. So those are really the factors. Now with syringes, we are again, seeing some strength in both Latin America and Asia. And we have the opportunity to optimize our pricing in the U.S. and that has helped our syringe results as second part of your question was about the adjustments that we've made for store closures. So maybe some background there. Obviously, we are aware of some planned store closures at a major U.S. retail pharmacy chain. But I do want to point out that we sell product to a third-party distributor that serves that aforementioned pharmacy chain, but also serves other obviously, we don't have any particular insight into the timing of the planned store closures. But what we did notice was in the late Q2, we noticed a change in the ordering pattern by the distributor that we supply product to. Now we believe it's linked to the planned store closures. And so what we have tried to do is estimate and be prudent in the incorporation of that impact into full year guidance. I should also note that in case of store closures, obviously, the pharmacy chain is going to obviously try to retain those patients within their own these patients might leave and go to other pharmacy chains. But at the end of the day, our products are chronic use, medically necessary products. And so we do expect that these patients, if they are not purchasing it from a store that they used to, but is now closed, will go into other retail outlets to purchase those products. And given our strength in the U.S., it is quite possible that those patients will continue using our products. There might be a timing lag here because, as I mentioned, the product flows through distributors and it takes time for these demand signals to look, I mean, long -- to sort of sum it up, we've tried to be as prudent as we can in estimating this. We recognize it's early in the process of store closures, and certainly, we'll update as we go along here. Kallum Titchmarsh Great. Just a follow-up there. I think the Street is kind of shaking out at, 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. Jake Elguicze 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 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 the -- 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. Kallum Titchmarsh Thank you. Operator Thank you one moment for our next question. Our next question comes from the line of Marie Thibault of BTIG. Your line is now open. Marie Thibault Hi, good morning. Thank you for taking the questions. I wanted to ask my first one here on tariffs. I heard you say 25 bps of 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 U.S. 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, I understand there will be mitigation and a lot of fluid dynamics here. Jake Elguicze Yes. Marie, thanks for the question. Yes, so you're correct. I mean, our -- 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 U.S. and the reciprocal tariffs with each of those 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 U.S. 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. Marie Thibault Yes. Incredibly helpful, Jake. Thank you for the detail. And then I guess I'll ask my follow-up. I heard you say that Embecta had received several POs from generic GLP-1 makers. Very exciting to see that 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 so 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. Devdatt Kurdikar Yes, good morning, Marie. So it is 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 are pursuing a 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 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. Marie Thibault Okay, very good looking forward to it thanks so much. Devdatt Kurdikar Thank you, Mary. Operator Thank you, one moment for our next next question comes from the line of Anthony Petrone of Mizuho Financial Group. Your line is not open. Anthony Petrone 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. Devdatt Kurdikar Yes. Anthony, maybe I'll take that. So specifically about -- I assume you're specifically talking about the U.S. here. A couple of points to note, right? The tariffs that we have incorporated into our guidance are really U.S. China related for the majority of the impact, vast majority of the impact. In the U.S., 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 are for chronic medical did not see any stockpiling in the U.S. as a result of potential tariff impacts. And let me also point out that really the product that's coming from China into the U.S. is very, very limited to begin with. I mean, it's in low-single-digit percent of our U.S. for all those reasons, finished good product being imported into China just being -- being imported from China into U.S. just being a low, low number in our U.S. -- of our U.S. business and the fact that we do benefit from certain exemptions, help us. Anthony Petrone That's helpful. Maybe a follow-up would just be on the type two market specifically. I 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, thanks for taking the question. Devdatt Kurdikar Yes. Anthony, the best indicator that we track internally to see what's going on for our pen needle business, in particular, is the TRxs 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 U.S., 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 million, 8 million people on injection in the 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 in -- before any big changes gets reflected in our numbers, not to mention that the incidence of type 2 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. Anthony Petrone Thank you very much, Deb. Devdatt Kurdikar Yeah. Operator 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. Michael Polark 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 U.S. 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 any further color on why this is different given kind of long-running trend of store wind-downs? Devdatt Kurdikar 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 for 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 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 are absolutely going to execute on. Michael Polark 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 '26? Thank you so much. Jake Elguicze 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 rightsize 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 if you think about the costs 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. Operator Thank you. I'm showing no further questions at this time. I'll now turn it back to CEO, Dev Kurdikar, for closing remarks. Devdatt Kurdikar 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 environment. And then finally, we look forward to engaging with all of you at our upcoming conferences and at our Investor Day on May 22 where we'll share more about our vision for Embecta. Thanks again for calling in and for your interest in Embecta. Operator Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
10-05-2025
- Business
- Yahoo
Q2 2025 Embecta Corp Earnings Call
Pravesh Khandelwal; Vice President of Investor Relations; Embecta Corp Devdatt Kurdikar; President and Chief Executive Officer; Embecta Corp Jake Elguicze; Chief Financial Officer; Embecta Corp Kallum Titchmarsh; Analyst; Morgan Stanley Marie Thibault; Analyst; BTIG Anthony Petrone; Analyst; Mizuho Financial Group Michael Polark; Analyst; Wolfe Research Operator Welcome, ladies and gentlemen, to Embecta Corp's Fiscal Second Quarter 2025 Earnings Conference Call. (Operator Instructions) 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. Pravesh Khandelwal 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 With me today are Dev Kurdikar, Embecta's President and Chief Executive Officer; and Jake Elguicze, our Chief Financial 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 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 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. Devdatt 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 strengthening our core business. We are making solid progress on our global brand transition with implementation in the U.S. 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 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 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 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 compared to the midpoint of our prior guidance range, approximately half of the overachievement in the quarter was due to constant currency performance, while the other half was due to foreign exchange being less of a headwind than we previously anticipated. Turning to some additional highlights. During the second quarter, we published the updated FITTER Forward Expert Recommendations in Mayo Clinic is an important milestone in our commitment to improving clinical outcomes as the recommendations support the best global practices for insulin injection technique, device optimization and provider training. Additionally, during Q2, Embecta conducted a company-wide employee engagement survey through Great Place to Work, a global authority on workplace culture, employee experience and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased had a tremendous response rate from our employees worldwide and we are pleased to announce that we have received certification as a Great Place to Work for 2025 in eight countries. This recognition is a testament to the effort our teams have put into building a strong, authentic and inclusive culture. I am also pleased to announce that we are continuing to advance our efforts to co-package our pen needles with potential generic GLP-1 drugs as well as making our pen needles available in retail packaging appropriate for use with branded GLP-1 drugs delivered by pen expect this will enable us to expand into a fast-growing market, while leveraging our world-class distribution and commercial expertise. We have received several purchase orders from generic manufacturers to co-package our pen needles and we look forward to sharing more details about these partnerships and the market potential at our upcoming Analyst and Investor Day. We have completed the majority of the steps required to implement the discontinuation of our insulin patch pump program and the associated restructuring plan announced in November 2024. This progress has occurred within our previously expected time line. Additionally, our stand-up activities are largely complete with only India yet to be transitioned to our ERP system and distribution network within the next few months. Therefore, we continue to be focused on reducing our cost during the second quarter, we initiated a separate restructuring plan aimed at streamlining our organization. We expect the plan to be substantially complete by the end of fiscal year 2025. As a result, we anticipate incurring total pre-tax charges of between $4 million to $5 million, the majority of which are expected to be cash-related. This action is expected to drive meaningful efficiencies with estimated pre-tax cost savings of between $7 million to $8 million during the second half of fiscal to the next slide. In line with our commitment to enhancing financial flexibility, we continued to reduce our debt, making an aggregate principal payment of approximately $27 million on our Term Loan B facility during the quarter. While on a year-to-date basis, we have reduced debt by approximately $60 million, which puts us well on-track to achieve our goal of reducing debt by approximately $110 million during fiscal as we reflect on our second quarter results and look ahead to the remainder of the year, we are updating our fiscal 2025 guidance. While our teams delivered slightly better than expected financial performance during the first six months of the year, we are adjusting our full year 2025 constant currency revenue outlook to account for lower projected U.S. volumes primarily associated with anticipated reductions in customer inventory levels tied to store closures at a specific U.S. retail pharmacy said, our as-reported revenue guidance remains largely intact, supported by favorable foreign exchange movements as compared to our previously provided guidance. In terms of gross margins, we have updated our guidance to reflect the lower constant currency revenue expectations as well as the estimated impact of currently implemented incremental tariffs, which are expected to be a headwind of approximately 25 basis points to our full year adjusted gross even with these headwinds, we are raising our guidance ranges for adjusted operating and adjusted EBITDA margins for the year due to disciplined expense management and the initiation of the previously mentioned restructuring plan in the second quarter. We are also reaffirming our adjusted earnings per share outlook for fiscal year to the next slide, I would like to provide an update on our brand transition plan and walk through the key elements of its execution. This initiative has been in planning since our spin, and I am pleased to report that the transition is now underway in the U.S. and Canada. We are executing the program in phases, as intended, and are preparing to transition most of the remaining markets in the next fiscal year, in line with our original plan. We continue to expect the global transition to be completed within the next couple of the slide, you will see an example of the new Embecta-branded packaging contrasted with the legacy BD Nano 2nd Gen packaging. Importantly, product names and color cues will remain unchanged, a deliberate decision informed by customer research. At the same time, we are introducing a modern, refreshed look, while maintaining the visual elements that help healthcare providers and people with diabetes easily recognize our remain focused on ensuring operational readiness along the supply chain, including inventory management, customer communication and regulatory compliance. This thoughtful, phased approach is designed to ensure a smooth transition, while preserving the trust of those who rely on our products every let's review our revenue performance for the second quarter. During the second quarter of fiscal year 2025, Embecta generated $259 million in revenue, reflecting a 9.8% decline year-over-year on an as-reported basis or a 7.7% decline on an adjusted constant currency basis. Within the U.S., revenue for the quarter totaled $135.2 million, reflecting a year-over-year decline of 8.4% on an adjusted constant currency basis. The year-over-year decline was expected and is primarily due to two factors, both of which relate to the timing of price increases that went into in advance of a price increase that went into effect on April 1st of 2024, we saw certain customers purchase additional products that positively impacted our second quarter of 2024 results. Similarly, in advance of a price increase that went into effect on January 1st of 2025, we saw certain customers purchase additional products and that positively impacted our first quarter of 2025 results and resulted in an offsetting reduction in the second such, the combination of these two factors led to a difficult comparable for our U.S. business. Turning to our international business. During Q2, revenue totaled $123.8 million, which equated to a 7% and a $10 million decline on an adjusted constant currency basis as compared to the prior year period. Like the U.S., this decline was expected and due to certain customers purchasing additional products in advance of ERP implementations in certain regions in the prior year from a product family perspective, during the quarter, pen needle revenue declined approximately 12.1%, syringe revenue grew by approximately 1.7%, safety products grew approximately 4.2% and contract manufacturing grew approximately 73%. The decline in year-over-year pen needle revenue was primarily driven by the timing issues associated with price increases that went into effect within the U.S., coupled with the unfavorable prior-year comparison stemming from ERP-related inventory builds within our international to our syringe products. They grew in the quarter by 1.7%, driven by international markets, specifically Latin America and Asia. While our safety products grew 4.2% as compared to the prior year period due to the annualization of share gains resulting from a competitor discontinuing their product and exiting the market. That completes my prepared with that, let me turn the call over to Jake to review other Q2 financial highlights as well as provide our updated financial guidance for fiscal year 2025. 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 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 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 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 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 just 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 prior year on an adjusted basis, during the second quarter of fiscal 2025, net income and earnings per share were $40.7 million and $0.70 as compared to $38.9 million and $0.67 in the prior year period. The increase in year-over-year adjusted net income and diluted earnings per share is primarily due to the adjusted operating profit drivers I just discussed as well as a reduction in interest expense. This was partially offset by an increase in our adjusted tax rate from approximately 18% in Q2 of 2024 to approximately 25% in Q2 of from a P&L perspective, for the second quarter of 2025, our adjusted EBITDA and margin totaled approximately $97.1 million and 37.5% as compared to $90.8 million and 31.6% in the prior year period. Turning to the balance sheet and cash flow. At the end of the second quarter, our cash balance totaled approximately $212 million, while our last 12 months net leverage as defined under our credit facility agreement stood at approximately 3.7 times. As a reminder, our net leverage covenant requires us to stay below 4.75 Dev mentioned earlier, we continue to be focused on more aggressively delevering. And during the second quarter, we paid down $27.4 million of Term Loan B debt. I'm pleased to say that we remain on track to achieve our goal of reducing our gross debt by $110 million during fiscal 2025 as well as getting our net leverage levels to approach approximately 3 times by completes my prepared remarks on our second quarter 2025 results. Next I would like to discuss Embecta's updated 2025 financial guidance and certain underlying assumptions. Before I begin, I want to acknowledge the evolving tariff landscape and provide some important context regarding our global operations. As a reminder, we manufacture our products across three key facilities: Dun Laoghaire, Ireland; Holdrege, Nebraska; and Suzhou, China. We do not perform any manufacturing in either Canada or important to note that tariff regulations extend beyond manufacturing location and require detailed analysis of trade classifications and rules of origin to determine potential exposure. As it relates to our global operations, we have now incorporated the impact of tariffs currently in effect, notably the incremental 125% tariffs for raw material and finished goods being imported into China with the U.S. as the country of origin, the incremental 145% tariffs for imports into the U.S. from China and incremental baseline 10% tariffs for imports into the U.S. from certain other have also assumed that certain exemptions are applicable to certain materials and finished goods being imported into the U.S. We have not incorporated the potential incremental tariffs that may be implemented after the current pause on tariffs has expired. Given the uncertainties surrounding the evolving global trade environment, our estimates remain subject to change and we will continue to monitor the situation and provide updates when appropriate. As always, we remain committed to mitigating potential impacts where possible to make sure we continue supporting our customers and the people living with diabetes who rely on our let me discuss our updated guidance. Beginning with revenue. On an adjusted constant currency basis, we are lowering our previously provided guidance range by 150 basis points on both the low and high ends as we now call for revenue to decline between 2.5% and 4% as compared to 2024. At the low end of the range, we estimate that volume will be a headwind of approximately 3% and that pricing will be a headwind of approximately 1%. Meanwhile, at the high end of our constant currency revenue guidance range, we estimate that volume will be a headwind of approximately 1.5% and that pricing will be a headwind of approximately 1%. As Dev noted earlier, the additional 1.5% volume headwind which we have incorporated into our outlook is driven by lower projected U.S. volumes, primarily associated with anticipated reductions in customer inventory levels tied to store closures at a specific U.S. retail pharmacy customer. We believe this is transitory and does not reflect any fundamental change in the stability of our base to our thoughts on FX. Since we provided our updated fiscal 2025 financial guidance in early February, the U.S. dollar has weakened against most currencies. And as a result, we currently expect FX to be a headwind of approximately 0.8% as compared to our prior guidance which called for FX to be a headwind of approximately 2.2%. Additionally, our as-reported 2025 GAAP revenue will not be impacted by the 2015 through 2023 amount that we needed to accrue associated with the Italian payback measure which impacted our 2024 as-reported GAAP revenue. This equates to a tailwind of approximately 0.4%. On a combined basis, our as-reported revenue guidance remains largely unchanged at a range of between $1.73 billion and $1.90 to adjusted gross margin. We are lowering our previously provided guidance range by 50 basis points and now expect adjusted gross margin to be in the range of between 62.75% and 63.75%. The reduction in our current versus prior adjusted gross margin guidance is primarily due to the reduction in our constant currency revenue as well as the incremental impact of tariffs. This is somewhat offset by favorable profit in inventory adjustments and cost improvement actions we are taking within cost of sales, while from an adjusted operating margin standpoint, we are raising our guidance from a range of between 29.5% and 30.5% to a new range of between 29.75% and 30.75%. This improvement in adjusted operating margin is primarily driven by the expected cost savings associated with the restructuring plan announced this to earnings. Our better than expected second quarter earnings performance, coupled with the restructuring plan we announced today as well as favorable shifts in foreign exchange, are enabling us to absorb the impact of the lower adjusted constant currency revenues and incremental tariffs, thereby allowing us to maintain our previously provided adjusted diluted earnings per share guidance range of between $2.70 and $2.90. Our updated guidance range continues to assume that our annual net interest expense will be approximately $107 million; that our annual adjusted tax rate will be approximately 25%; and that our weighted average diluted shares outstanding will be approximately 58.9 guidance also continues to assume that we will use between $50 million and $60 million of cash during fiscal 2025 associated with separation costs largely related to brand transition. While as it relates to capital expenditures, we now expect to incur approximately $15 million during the year, down from our prior estimate of approximately $20 cash usage associated with the discontinuation of our insulin patch pump program, our guidance now assumes that we will use between $20 million and $25 million as compared to our previous estimates of between $25 million and $30 million. Lastly, for the same reasons we increased our adjusted operating margin guidance range, we are also raising our adjusted EBITDA margin guidance range from a range of between 36% and 37% to a new range of between 36.25% and 37.25%.And before I turn the call over to the operator, I wanted to take a moment to remind everyone that we will be hosting our inaugural Analyst and Investor Day on May 22 in New York City. We are looking forward to providing a deeper look into our portfolio, value creation opportunities and long-term financial objectives. We hope to see many of you RSVP by following the instructions on this slide. With that, I would like to now turn the call over to the operator for questions. Operator? Operator Thank you. At this time we'll conduct the question and answer session. (Operator Instructions) Our first question comes from the line of Kallum Titchmarsh of Morgan Stanley. Your line is now open. Kallum Titchmarsh 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 U.S. You called out the customer inventory bits and store you now comfortable that they are kind of isolated issues and behind you? Thanks a lot. Devdatt Kurdikar Good morning, Kallum. Thanks for the question. So maybe some context is in the order here. As you may remember, fiscal 2024, we had a number of rolling ERP implementations throughout the year. U.S. and Canada went live in the first quarter, then we had EMEA and Asia in quarter two and then we had China and Latin America in the following quarters, Latin America as recent as Q1 our goal, as we did that was to ensure that we maintain product continuity. As you know, these implementations, in our case, coupled with changes in distribution network and setting up 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 U.S. 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 U.S., some distributors purchased products ahead of that port strike 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 geographic 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 year, which is in fiscal 2024, we had a U.S. price increase on the 1st of April of 2024. And this year, we had it on January 1, 2025. So certainly, that's going to help us through the remainder of the year, but again, leads to unfavorable comparisons. So those were the dynamics that really drive both for the quarter and the year-to-date comparisons for adjusted revenue by geography and in you can imagine with pen needles being approximately 76% of our total revenue, that impacts the pen revenue business quite significantly, particularly when you think about the ERP implementations in which regions they occurred, because in certain regions, they are primarily a pen needle business. So those are really the factors. Now with syringes, we are again, seeing some strength in both Latin America and Asia. And we have the opportunity to optimize our pricing in the U.S. and that has helped our syringe results as second part of your question was about the adjustments that we've made for store closures. So maybe some background there. Obviously, we are aware of some planned store closures at a major U.S. retail pharmacy chain. But I do want to point out that we sell product to a third-party distributor that serves that aforementioned pharmacy chain, but also serves other obviously, we don't have any particular insight into the timing of the planned store closures. But what we did notice was in the late Q2, we noticed a change in the ordering pattern by the distributor that we supply product to. Now we believe it's linked to the planned store closures. And so what we have tried to do is estimate and be prudent in the incorporation of that impact into full year guidance. I should also note that in case of store closures, obviously, the pharmacy chain is going to obviously try to retain those patients within their own these patients might leave and go to other pharmacy chains. But at the end of the day, our products are chronic use, medically necessary products. And so we do expect that these patients, if they are not purchasing it from a store that they used to, but is now closed, will go into other retail outlets to purchase those products. And given our strength in the U.S., it is quite possible that those patients will continue using our products. There might be a timing lag here because, as I mentioned, the product flows through distributors and it takes time for these demand signals to look, I mean, long -- to sort of sum it up, we've tried to be as prudent as we can in estimating this. We recognize it's early in the process of store closures, and certainly, we'll update as we go along here. Kallum Titchmarsh Great. Just a follow-up there. I think the Street is kind of shaking out at, 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. Jake Elguicze 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 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 the -- 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. Kallum Titchmarsh Thank you. Operator Thank you one moment for our next question. Our next question comes from the line of Marie Thibault of BTIG. Your line is now open. Marie Thibault Hi, good morning. Thank you for taking the questions. I wanted to ask my first one here on tariffs. I heard you say 25 bps of 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 U.S. 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, I understand there will be mitigation and a lot of fluid dynamics here. Jake Elguicze Yes. Marie, thanks for the question. Yes, so you're correct. I mean, our -- 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 U.S. and the reciprocal tariffs with each of those 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 U.S. 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. Marie Thibault Yes. Incredibly helpful, Jake. Thank you for the detail. And then I guess I'll ask my follow-up. I heard you say that Embecta had received several POs from generic GLP-1 makers. Very exciting to see that 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 so 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. Devdatt Kurdikar Yes, good morning, Marie. So it is 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 are pursuing a 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 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. Marie Thibault Okay, very good looking forward to it thanks so much. Devdatt Kurdikar Thank you, Mary. Operator Thank you, one moment for our next next question comes from the line of Anthony Petrone of Mizuho Financial Group. Your line is not open. Anthony Petrone 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. Devdatt Kurdikar Yes. Anthony, maybe I'll take that. So specifically about -- I assume you're specifically talking about the U.S. here. A couple of points to note, right? The tariffs that we have incorporated into our guidance are really U.S. China related for the majority of the impact, vast majority of the impact. In the U.S., 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 are for chronic medical did not see any stockpiling in the U.S. as a result of potential tariff impacts. And let me also point out that really the product that's coming from China into the U.S. is very, very limited to begin with. I mean, it's in low-single-digit percent of our U.S. for all those reasons, finished good product being imported into China just being -- being imported from China into U.S. just being a low, low number in our U.S. -- of our U.S. business and the fact that we do benefit from certain exemptions, help us. Anthony Petrone That's helpful. Maybe a follow-up would just be on the type two market specifically. I 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, thanks for taking the question. Devdatt Kurdikar Yes. Anthony, the best indicator that we track internally to see what's going on for our pen needle business, in particular, is the TRxs 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 U.S., 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 million, 8 million people on injection in the 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 in -- before any big changes gets reflected in our numbers, not to mention that the incidence of type 2 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. Anthony Petrone Thank you very much, Deb. Devdatt Kurdikar Yeah. Operator 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. Michael Polark 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 U.S. 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 any further color on why this is different given kind of long-running trend of store wind-downs? Devdatt Kurdikar 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 for 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 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 are absolutely going to execute on. Michael Polark 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 '26? Thank you so much. Jake Elguicze 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 rightsize 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 if you think about the costs 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. Operator Thank you. I'm showing no further questions at this time. I'll now turn it back to CEO, Dev Kurdikar, for closing remarks. Devdatt Kurdikar 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 environment. And then finally, we look forward to engaging with all of you at our upcoming conferences and at our Investor Day on May 22 where we'll share more about our vision for Embecta. Thanks again for calling in and for your interest in Embecta. Operator Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
