Insulet (PODD)

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Insulet (PODD) - 2023 Q1 - Earnings Call Transcript
2023-05-05 01:15
Financial Data and Key Metrics Changes - The company reported a 23% revenue growth in Q1, finishing above the high end of their guidance range, driven by a total global Omnipod growth of 35% [11][44] - U.S. Omnipod revenue growth was 49%, exceeding guidance, with total revenue impacted by a 210 basis point headwind from foreign currency [44][45] - Gross margin was 67.2%, representing a 380 basis point decrease, influenced by a favorable foreign currency impact of approximately 30 basis points [46] Business Line Data and Key Metrics Changes - Omnipod 5 represented almost 95% of U.S. new customer starts in Q1, with a shift in the mix of new customers coming from multiple daily injections (MDI) and legacy tubed pumps to a 70/30 split [61][62] - Drug delivery revenue declined 98%, within guidance range, while the company expects a continued decline of 55% to 45% for the full year [46][76] Market Data and Key Metrics Changes - International Omnipod revenue increased 10% in Q1, exceeding guidance, driven by ongoing Omnipod DASH adoption [45] - The company expects international Omnipod growth of 13% to 16%, partially offset by AID competitive headwinds [52] Company Strategy and Development Direction - The company is focusing on expanding its international presence and transitioning to a structure with distinct commercial leaders for U.S. and international markets [15][39] - The launch of Omnipod GO is expected in 2024, targeting the type 2 market and potentially doubling the U.S. total addressable market [29][35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong growth trajectory for 2023, with expectations for continued strong Omnipod 5 adoption and new customer starts [8][76] - The company is optimistic about the long-term growth potential, particularly in the type 2 market, where penetration remains low [64][85] Other Important Information - The company ended the quarter with over $620 million in cash, maintaining a strong financial position to invest in growth [47] - Insulet was added to the S&P 500, reflecting the company's growth and operational success [70] Q&A Session All Questions and Answers Question: How is the international business expected to grow given competitive factors? - Management indicated that Q1 performance was strong at 10%, with expectations for higher growth in Q2 due to order timing, projecting full-year growth around 6% to 10% [55] Question: What is needed to make pumps standard of care in the type 1 population? - Management noted that the ease of use of Omnipod 5 is compelling, and they believe it will drive higher adoption rates among patients and prescribers [56][85] Question: How does the company view the future of drug delivery? - Management acknowledged that while drug delivery has been a good business, it is becoming less material as Omnipod 5 grows, and they expect continued decline in drug delivery revenue [90][92]
Insulet (PODD) - 2023 Q1 - Quarterly Report
2023-05-04 16:00
PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2023 report total revenue of **$358.1 million** and net income of **$23.8 million** [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets reached **$2,289.1 million** as of March 31, 2023, with total liabilities at **$1,786.3 million** and stockholders' equity at **$502.8 million** Balance Sheet Items | Balance Sheet Items (in millions) | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total current assets** | $1,330.0 | $1,314.0 | | **Total assets** | $2,289.1 | $2,251.1 | | **Total current liabilities** | $383.3 | $364.7 | | **Total liabilities** | $1,786.3 | $1,774.7 | | **Total stockholders' equity** | $502.8 | $476.4 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2023 total revenue increased **21.2%** to **$358.1 million**, but operating income declined to **$27.7 million** and net income to **$23.8 million** Income Statement Items | Income Statement Items (in millions) | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | **Total revenue** | $358.1 | $295.4 | | **Gross profit** | $240.5 | $209.7 | | **Operating income** | $27.7 | $37.9 | | **Net income** | $23.8 | $27.8 | | **Diluted EPS** | $0.34 | $0.40 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2023 saw **$0.5 million** net cash from operations, **$42.1 million** used in investing, and a **$53.8 million** net decrease in cash Cash Flow Summary | Cash Flow Summary (in millions) | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | **Net cash provided by (used in) operating activities** | $0.5 | $(13.7) | | **Net cash used in investing activities** | $(42.1) | $(46.9) | | **Net cash used in financing activities** | $(12.1) | $(20.3) | | **Net decrease in cash** | $(53.8) | $(81.5) | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, with U.S. Omnipod revenue at **$259.0 million**, a **$25.1 million** patent acquisition, and an **$8.0 million** liability revision Revenue by Segment | Revenue by Segment (in millions) | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | **U.S. Omnipod** | $259.0 | $174.1 | | **International Omnipod** | $98.6 | $95.4 | | **Drug Delivery** | $0.5 | $25.9 | | **Total revenue** | $358.1 | $295.4 | - In February 2023, the company acquired patent assets related to pump-based automated insulin delivery technologies from Bigfoot Biomedical, Inc. for **$25.1 million**[40](index=40&type=chunk) - The company revised its estimated liability for the Omnipod DASH and Omnipod 5 voluntary medical device corrections by **$8.0 million**, primarily due to lower anticipated shipping and distribution costs for replacements[42](index=42&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses **21.2%** revenue growth driven by Omnipod 5, a gross margin decline to **67.2%**, and strategic plans for international expansion and manufacturing capacity [Overview](index=16&type=section&id=Overview) The company focuses on the Omnipod System, planning Omnipod 5 international launches, type 2 diabetes expansion, and a new Malaysian manufacturing facility by 2024 - The company plans to launch Omnipod 5 in the U.K. and Germany in 2023, with a broader international rollout in 2024[60](index=60&type=chunk) - A new manufacturing plant is being constructed in Malaysia, with production expected to begin in 2024 to support international expansion and improve gross margins over time[62](index=62&type=chunk) - In April 2023, the company received FDA clearance for Omnipod GO™, a basal-only Pod for individuals with type 2 diabetes, with commercialization planned for 2024[63](index=63&type=chunk) [Results of Operations](index=16&type=section&id=Results%20of%20Operations) Q1 2023 total revenue grew **21.2%** to **$358.1 million**, driven by U.S. Omnipod, while gross margin declined to **67.2%** due to higher costs Revenue Growth (YoY) | Revenue Growth (YoY) | Q1 2023 vs Q1 2022 | | :--- | :--- | | **Total Revenue Growth** | 21.2% | | **Constant Currency Growth** | 23.3% | | **U.S. Omnipod Growth** | 48.8% | | **International Omnipod Growth** | 3.4% (9.6% constant currency) | | **Drug Delivery Growth** | (98.1)% | - Gross margin decreased to **67.2%** from **71.0%** in Q1 2022, primarily due to higher costs for Omnipod 5 production, increased U.S. manufacturing, and lower Drug Delivery production, partially offset by a **220 basis point** positive adjustment to the warranty accrual for prior MDCs[76](index=76&type=chunk) - Selling, general and administrative (SG&A) expenses increased by **26.4%** to **$162.7 million**, driven by higher customer service costs for Omnipod 5, increased headcount, and investments in new systems[79](index=79&type=chunk) [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) Q1 2023 ended with **$620.7 million** in cash, **$1,396.6 million** in net debt, and **$0.5 million** net cash from operations, with sufficient liquidity Financial Position | Financial Position (in millions) | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $620.7 | $674.7 | | **Total debt, net** | $1,396.6 | $1,401.8 | | **Total stockholders' equity** | $502.8 | $476.4 | - In May 2023, the Company entered into a **$24.0 million** financing transaction for manufacturing equipment in Acton, Massachusetts[57](index=57&type=chunk)[92](index=92&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section refers to the 2022 Annual Report on Form 10-K for detailed disclosures on market risks, providing no new information - The company refers to its 2022 Annual Report on Form 10-K for discussion of its market price sensitive instruments and foreign currency exchange risk[111](index=111&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting - Based on an evaluation as of March 31, 2023, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[113](index=113&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[114](index=114&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in various legal proceedings but does not expect their outcomes to materially adversely affect its results of operations - The company does not expect the outcome of its various legal proceedings, either individually or in the aggregate, to have a material adverse effect on its results of operations[50](index=50&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's 2022 Annual Report on Form 10-K were reported - There have been no material changes to the risk factors disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022[116](index=116&type=chunk) [Other Items (Items 2, 3, 4, 5)](index=25&type=section&id=Other%20Items) The company reported no unregistered sales of equity securities, defaults upon senior securities, mine safety disclosures, or other material information for the quarter - The company reported no unregistered sales of equity securities, defaults upon senior securities, or other material information for the quarter[117](index=117&type=chunk)[118](index=118&type=chunk)[120](index=120&type=chunk) [Item 6. Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including CEO and CFO certifications and iXBRL formatted financial data - The exhibits filed with the report include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act, and iXBRL formatted financial statements[121](index=121&type=chunk)
Insulet (PODD) - 2022 Q4 - Earnings Call Transcript
2023-02-24 01:59
Financial Data and Key Metrics Changes - In Q4, the company achieved revenue growth of 23%, exceeding guidance, driven by total Omnipod growth of 36% [34] - U.S. Omnipod revenue growth was 45%, surpassing guidance, while international Omnipod revenue increased by 19% [35][38] - Adjusted gross margin was 64.5%, reflecting a 480 basis point decrease year-over-year, primarily due to increased costs associated with the ramping of Omnipod 5 [40][42] - The company ended the year with $675 million in cash and increased available borrowings under its credit agreement to $100 million [43] Business Line Data and Key Metrics Changes - The Omnipod platform now has approximately 360,000 active global customers, with over 100,000 on Omnipod 5, which represented over 90% of U.S. new customer starts in Q4 [11][34] - The percentage of customers coming from multiple daily injections (MDI) and traditional tube pumps was an estimated 65-35 split, indicating a shift from the historical 80-20 mix [15] - Drug Delivery revenue declined by 90%, slightly better than guidance, reflecting challenges in that segment [39] Market Data and Key Metrics Changes - The company expects total Omnipod revenue growth of 17% to 22% for 2023, with U.S. Omnipod revenue growth projected at 21% to 26% [44] - International Omnipod revenue growth is expected to be 6% to 10%, driven by ongoing Omnipod DASH adoption [45] - The total addressable market for the new basal-only pod is estimated at approximately 3 million people in the U.S., potentially doubling the U.S. total addressable market [26] Company Strategy and Development Direction - The company is focused on expanding access and awareness through initiatives in the U.S. pharmacy channel, aiming for broad coverage and affordability [20][18] - A commitment to innovation is central to the company's strategy, with a strong pipeline that includes future AID offerings and digital capabilities [25][28] - The company plans to launch Omnipod 5 more broadly internationally in 2024, with initial launches in the U.K. and Germany expected in mid and late 2023, respectively [29][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for Omnipod 5, anticipating that this demand will persist beyond 2023 [54][55] - The company acknowledged that while current growth is driven by converting customers, the overall business is expected to continue performing well with record new customer starts [93][94] - Management highlighted the importance of integrating Omnipod 5 with CGM systems and the ongoing development of an iOS app [68][69] Other Important Information - The company entered into a mutual agreement with Medtronic regarding patent assertions, providing more certainty around covered products for the next seven years [31] - A medical device correction for Omnipod 5 was classified as a Class 2 correction by the FDA, with replacements being provided to customers upon request [16] Q&A Session All Questions and Answers Question: Sustainability of New Patient Growth - Management believes the strong demand for Omnipod 5 is sustainable and indicative of a longer-term trend, not just early adopters [54][55] Question: Volume Benefits from Retail Pharmacy and Upgrades - Management confirmed that conversions from older Omnipod products to Omnipod 5 are significant, with expectations to complete most conversions by the end of 2023 [62][63] Question: G7 Integration Timeline - Management is working closely with partners on CGM integration and is optimistic about progress, though no specific timelines were provided [68][69] Question: Pricing Impact in 2023 - Management noted that pricing is a smaller component of revenue growth, with volume being the primary driver, especially from new customer conversions [70][71] Question: International Launch of Omnipod 5 - Management acknowledged strong pent-up demand for Omnipod 5 internationally and is focused on expediting its launch in various markets [98]
Insulet (PODD) - 2022 Q4 - Annual Report
2023-02-23 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-33462 INSULET CORPORATION (Exact name of Registrant as specified in its charter) Delaware 04-3523891 (State or Other Jurisdiction ...
Insulet (PODD) - 2022 Q3 - Earnings Call Transcript
2022-11-04 00:56
Insulet Corporation (NASDAQ:PODD) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Deborah Gordon - Vice President, Investor Relations Jim Hollingshead - President and Chief Executive Officer Wayde McMillan - Executive Vice President and Chief Financial Officer Bret Christensen - Executive Vice President and Chief Commercial Officer Conference Call Participants Jeff Johnson - Baird Travis Steed - Bank of America Securities Robbie Marcus - JPMorgan Margaret Kaczor - William B ...
Insulet (PODD) - 2022 Q3 - Quarterly Report
2022-11-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-33462 ___________________________________________________________ INSULET CORPORATION (Exact name ...
Insulet (PODD) - 2022 Q2 - Earnings Call Transcript
2022-08-07 16:04
Insulet Corporation (NASDAQ:PODD) Q2 2022 Earnings Conference Call August 4, 2022 4:30 PM ET Company Participants Deborah Gordon - Vice President, Investor Relations Jim Hollingshead - President and Chief Executive Officer Wayde McMillan - Executive Vice President and Chief Financial Officer Bret Christensen - Executive Vice President and Chief Commercial Officer Conference Call Participants Larry Biegelsen - Wells Fargo Robbie Marcus - JP Morgan Travis Steed - Bank of America Steve Lichtman - Oppenheimer C ...
Insulet (PODD) - 2022 Q2 - Quarterly Report
2022-08-04 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-33462 ___________________________________________________________ INSULET CORPORATION Emerging growth ...
Insulet (PODD) - 2022 Q1 - Earnings Call Transcript
2022-05-06 21:23
Financial Data and Key Metrics Changes - The company generated 19% revenue growth in Q1 2022, finishing above the high end of guidance range [48] - U.S. Omnipod revenue grew by 21%, driven by strong new customer starts and increasing volume through the U.S. pharmacy channel [49] - International Omnipod revenue increased by 12%, above guidance, despite pandemic impacts and AID competition headwinds [50] - Gross margin was 71%, representing a 460 basis point increase year-over-year [52] - Operating margin was 12.8%, up 630 basis points, and adjusted EBITDA margin was 21.3%, up 740 basis points [54] Business Line Data and Key Metrics Changes - Drug delivery revenue increased by 36%, exceeding guidance due to production timing [52] - Type 2 users represented approximately 35% of U.S. new customer starts, indicating strong growth in this segment [25] Market Data and Key Metrics Changes - The company is focused on expanding access and awareness of Omnipod in the underpenetrated global diabetes market [27] - The limited market release of Omnipod 5 has received overwhelmingly positive feedback from users and healthcare professionals [23] Company Strategy and Development Direction - The company aims to expand access to Omnipod through the U.S. pharmacy channel, which simplifies access and reduces costs for customers [27] - The launch of Omnipod 5 is a key strategic initiative, with plans for full market release and international expansion [44][39] - The company is committed to innovation, with a robust product pipeline and a focus on sustainability [36][26] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges from the current macroeconomic environment, including inflation and supply chain issues, but expressed confidence in mitigating these risks [42] - The company is well-positioned for continued growth and is excited about the upcoming milestones in 2022, including the full commercial release of Omnipod 5 [44] Other Important Information - The company published its 2021 sustainability report, highlighting progress in gender diversity and environmental initiatives [26] - The transition of leadership from Shacey Petrovic to Jim Hollingshead is expected to be seamless, with both committed to the company's long-term success [12][19] Q&A Session Summary Question: What are Jim's goals for the next year and opportunities outside of diabetes? - Jim emphasized the importance of continuing growth and innovation, building on Shacey's legacy, and focusing on changing lives for people with diabetes [75] Question: Can you provide details on new patient growth in Q1? - Management reported record new customer starts globally and in the U.S., with strong performance attributed to the unique features of Omnipod [80] Question: What is the timeline for the full launch of Omnipod 5? - Management indicated that while a full launch is possible in June, they are cautious and want to ensure readiness based on learnings from the limited market release [82] Question: How is the international market performing ahead of Omnipod 5? - Management expressed optimism about international markets, noting strong interest and demand for Omnipod 5, with plans for a staged launch post-CE mark approval [97] Question: How is the company approaching primary care physicians? - The company is focusing on increasing awareness and education among primary care physicians, particularly for type 2 diabetes management [108]
Insulet (PODD) - 2022 Q1 - Quarterly Report
2022-05-05 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-33462 ___________________________________________________________ INSULET CORPORATION (Exact name of Registrant ...