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Insulet Corp. (PODD) announced that its Omnipod 5 Automated Insulin Delivery (“AID”) System is now compatible with Abbott’s (ABT) FreeStyle Libre 2 Plus continuous glucose monitoring (CGM) sensor in the United States. The latest development represents a significant step forward in the company’s efforts to expand access to its innovative, tubeless Omnipod 5 AID System for more people.In August 2024, the FDA cleared Omnipod 5 for use by people with type 2 diabetes (18 years and above), expanding the technolog ...

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Insulet Corporation (PODD) reported third-quarter 2024 adjusted earnings per share (EPS) of 90 cents, up significantly 26.8% from the year-ago period’s figure. The bottom line surpassed the Zacks Consensus Estimate by 16.9%.GAAP EPS was $1.08, up 45.9% from the year-ago figure of 74 cents.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.Following the earnings announcement, PODD’s share price surged 2.9% to $275.7 yesterday.PODD’s Q3 RevenuesRevenues totaled $543.9 million, which beat t ...

Core Viewpoint - Insulet's stock surged nearly 10% following a strong Q3 performance, with sales of $544 million and adjusted earnings of $0.90 per share, exceeding consensus estimates [1][2]. Financial Performance - Insulet reported a revenue of $544 million, reflecting a 26% year-over-year growth, with U.S. and International Omnipod sales growing by 23% and 36%, respectively [2]. - The adjusted EBITDA margin increased by 410 basis points year-over-year to 23.2% in Q3, contributing to an adjusted earnings per share of $0.90, up from $0.71 in the prior-year quarter [2]. Future Outlook - The company anticipates sales growth of 20% to 21% in 2024, an increase from the previous outlook of 16% to 19% [2]. Stock Performance - Insulet's stock (PODD) has gained 23%, performing in line with the S&P 500 index, which is up 25% [3]. - The stock's performance has been volatile over the past three years, with returns of 4% in 2021, 11% in 2022, and -26% in 2023 [3]. Valuation Perspective - The stock is currently priced around $270, trading at 11 times trailing revenues, compared to an average price-to-sales ratio of 14 times over the last three years [4]. - The decline in valuation appears justified due to potential long-term impacts from new GLP-1 drugs on Insulet's sales, which may reduce demand for insulin pumps [4].

Financial Data and Key Metrics Changes - Insulet Corporation achieved a record total revenue of over $2 billion for the first time in its history, with Q3 revenue growth of 25% year-over-year, driven by total Omnipod revenue growth of 26% [8][29] - U.S. Omnipod revenue grew by 23%, while international revenue grew by 35% [11][32] - Gross margin improved to 69.3%, up 150 basis points, primarily due to pricing benefits and improved manufacturing efficiencies [34][35] Business Line Data and Key Metrics Changes - Total Omnipod revenue growth was 26%, with U.S. growth at 23% and international growth at 35% [11][32] - Type 2 diabetes users represented over 25% of U.S. new customer starts in Q3, indicating strong adoption following the FDA clearance for the type 2 label expansion [14][15] - Drug Delivery revenue was $10 million, exceeding guidance due to increased orders from partners [34] Market Data and Key Metrics Changes - Omnipod is now the 1 insulin pump for new pump users in Europe, reflecting strong market penetration [9][24] - International markets showed stable sequential new customer starts, with significant growth in the U.K. and Germany, and early traction in France and the Netherlands [9][32] - The company expects to reach over 40% of the 2.5 million type 2 insulin-intensive population in the U.S. by 2025 through expanded sales efforts [17][68] Company Strategy and Development Direction - The company is focused on expanding the Omnipod 5 platform, driving growth in both type 1 and type 2 diabetes markets, and accelerating international growth [10][12] - Insulet plans to expand its sales force and commercial relationships to capture the type 2 diabetes market, which is currently less than 5% penetrated [15][16] - The company aims to maintain its market leadership by leveraging its differentiated product offerings and expanding its manufacturing capabilities [26][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential and year-over-year growth in new customer starts for both U.S. and international markets in Q4 [10][11] - The type 2 label expansion is expected to significantly contribute to revenue growth starting in 2025, with a strong pipeline of new customer starts [31][40] - Management highlighted the importance of operational excellence and margin expansion as key drivers for long-term growth [35][42] Other Important Information - The company ended the quarter with approximately $900 million in cash and full access to a $300 million credit facility, indicating strong liquidity [37] - Insulet is on track to launch Omnipod 5 integrated with Abbott's FreeStyle Libre 2 Plus sensor by the end of the year, enhancing its product offerings [20][23] Q&A Session Summary Question: Insights on European Market Performance - Management confirmed that Omnipod 5 is the 1 pump in the markets served in Europe, with strong growth in new customer starts, particularly in the U.K. and Germany [46][51] Question: Type 2 Market Penetration Potential - Management believes that type 2 penetration can grow significantly, potentially doubling or tripling over the next few years, driven by the unique position of Omnipod 5 in the market [55] Question: Commercial Preparation for Type 2 - Management indicated that they are expanding their sales force to reach over 40% of type 2 insulin-intensive users and are targeting high-prescribing PCP practices [67][68] Question: Q4 Guidance and Seasonal Trends - Management acknowledged that the Q4 guidance reflects a normalized growth rate, considering previous stocking dynamics, and remains confident in achieving over 20% growth [71][72] Question: Initial Feedback from Type 2 Patients - Management reported positive initial feedback from type 2 patients, highlighting the simplicity and effectiveness of Omnipod 5 in managing diabetes [76][78] Question: Impact of CGM Integrations - Management noted that sensor integrations, particularly with G7 and Libre 2 Plus, have positively impacted new customer starts and overall growth [96][98]

| --- | --- | --- | |--------------------|-------------------|-------| | | | | | | Mattie | | | | Podder since 2010 | | | Q3'24 Earnings | | | | November 7, 2024 | | | This presentation contains forward-looking statements regarding, among other things, future operating and financial performance, product success and efficacy, the outcome of studies and trials and the approval of products by regulatory bodies. These forward-looking statements are based on management's current beliefs, assumptions and estimate ...

Core Insights - Insulet reported $543.9 million in revenue for Q3 2024, a year-over-year increase of 25.7% and a surprise of +4.90% over the Zacks Consensus Estimate of $518.5 million [1] - The EPS for the same period was $0.90, compared to $0.71 a year ago, resulting in a surprise of +16.88% over the consensus estimate of $0.77 [1] Revenue Breakdown - International Omnipod revenue reached $138 million, exceeding the six-analyst average estimate of $123.11 million, with a year-over-year change of +36.1% [3] - U.S. Omnipod revenue was $395.60 million, surpassing the six-analyst average estimate of $391.62 million, reflecting a year-over-year change of +23.4% [3] - Total Omnipod revenue amounted to $533.60 million, exceeding the six-analyst average estimate of $514.73 million, with a year-over-year change of +26.5% [3] - Drug Delivery revenue was reported at $10.30 million, compared to the $3.28 million average estimate, showing a year-over-year change of -3.7% [3] Stock Performance - Insulet's shares have returned +3.2% over the past month, matching the Zacks S&P 500 composite's +3.2% change [4] - The stock currently holds a Zacks Rank 2 (Buy), indicating potential for outperformance in the near term [4]

Company Performance - Insulet reported quarterly earnings of $0.90 per share, exceeding the Zacks Consensus Estimate of $0.77 per share, and up from $0.71 per share a year ago, representing an earnings surprise of 16.88% [1] - The company posted revenues of $543.9 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.90%, compared to year-ago revenues of $432.7 million [2] - Insulet has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates four times in the same period [2] Stock Outlook - Insulet shares have increased approximately 10.3% since the beginning of the year, while the S&P 500 has gained 24.3% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the coming quarter is $1.02 on revenues of $564.54 million, and for the current fiscal year, it is $3.04 on revenues of $2.01 billion [7] Industry Context - The Medical - Products industry, to which Insulet belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that the industry outlook can significantly impact stock performance [5][8]

Revenue Growth - Total revenue for Q3 2024 increased by $111.2 million, or 25.7%, to $543.9 million compared to $432.7 million in Q3 2023[68] - U.S. Omnipod revenue for Q3 2024 rose by $75.0 million, or 23.4%, to $395.6 million, driven by higher volume and increased average selling price[70] - International Omnipod revenue for Q3 2024 increased by $36.6 million, or 36.1%, to $138.0 million, primarily due to higher volumes from Omnipod 5 launches in the U.K. and Germany[71] - Total revenue for the nine months ended September 30, 2024, increased by $286.8 million, or 24.2%, to $1,474.1 million compared to $1,187.3 million in the same period of 2023[69] Product Launches and Market Expansion - Omnipod 5 was launched in the Netherlands and France in June 2024, expanding its international market presence[65] - The company submitted a 510(k) for expanded indication of Omnipod 5 for type 2 diabetes to the FDA in June 2024 and received clearance in August 2024[65] Cost and Expenses - Cost of revenue for Q3 2024 increased by $27.4 million, or 19.7%, to $166.8 million, with a gross margin of 69.3% compared to 67.8% in Q3 2023[74] - For the nine months ended September 30, 2024, cost of revenue rose by $70.7 million, or 18.2%, to $459.3 million, with a gross margin of 68.8% compared to 67.3% in the same period of 2023[74] - Research and development expenses for Q3 2024 were $54.9 million, representing 10.1% of revenue, down from 13.4% in Q3 2023[76] - Selling, general and administrative expenses for Q3 2024 increased by $53.4 million, or 29.6%, to $234.1 million, driven by headcount additions and increased advertising expenses[77] Financial Performance - Adjusted EBITDA for Q3 2024 was $126.1 million, compared to $82.8 million in Q3 2023[82] - Interest expense for Q3 2024 increased by $1.9 million to $12.3 million, while interest income rose by $1.9 million to $10.5 million[78][79] - The effective tax rate for Q3 2024 was 6.5%, up from 3.4% in Q3 2023, primarily due to changes in income distribution among jurisdictions[81] Cash and Capital Management - Cash and cash equivalents as of September 30, 2024, were $902.6 million, up from $704.2 million at the end of 2023[86] - The debt-to-total capital ratio improved to 56% as of September 30, 2024, down from 66% at the end of 2023[86] - Net cash provided by operating activities for the nine months ended September 30, 2024, was $282.6 million, compared to $100.5 million for the same period in 2023[89] - The net increase in cash, cash equivalents, and restricted cash for the nine months ended September 30, 2024, was $198.4 million, compared to a decrease of $4.3 million in the same period of 2023[89] Capital Expenditures and Investments - Capital expenditures increased to $71.3 million for the nine months ended September 30, 2024, from $46.3 million in the same period of 2023, primarily for manufacturing capacity expansion[92] - The company made strategic investments in private companies amounting to $7.2 million during the nine months ended September 30, 2023[92] - The company expects capital expenditures to increase in 2024 compared to 2023 due to investments in its new Malaysia manufacturing facility and IT infrastructure[92] Manufacturing and Compliance - The company began producing sellable products at its new manufacturing plant in Malaysia, enhancing global manufacturing capabilities[65] - The company anticipates compliance with new accounting standards starting in 2024 and 2025, which are not expected to impact its financial position[96]