Financial Data and Key Metrics - Worldwide sales grew 12% YoY in Q2 2024, reaching $222 million, marking the second-highest sales quarter in the company's history [17] - Year-to-date worldwide sales were $415 million with approximately 55,000 pump shipments, on pace for 15% sales growth in 2024 [17] - US sales grew 20% sequentially and 8% YoY to $157 million, driven by strong pump shipment trends and increased supply sales [19] - International sales grew 22% YoY to $65 million, primarily driven by a 50% increase in supply sales [22] - Gross margin reached 51% in Q2, exceeding initial expectations, with improvements in pricing and cost initiatives [24] - Adjusted EBITDA was negative 4% of sales for H1 2024, with a sequential improvement to negative 1% in Q2 [25] - The company ended Q2 with over $450 million in total cash and investments [26] Business Line Performance - Tandem Mobi, the new pump platform, gained significant momentum, with 86% of users reporting satisfaction or very high satisfaction [7][8] - More than half of Mobi customers were new to Tandem, with over half of these new customers coming from MDI (multiple daily injections) [12] - Mobi attracted a younger demographic compared to t:slim, aligning with market research and product positioning [12] - The company saw strong demand for both t:slim X2 and Mobi, demonstrating the value of its expanding product portfolio [10] - New sensor integrations, including Dexcom and Abbott, were commercial highlights in 2024 [12][13] Market Performance - In the US, total pump shipments surpassed 20,000 in Q2, growing sequentially by more than 30% [18] - Outside the US, the company shipped approximately 10,000 pumps across 25 markets, with actual pump demand growing nearly 10% YoY [23] - The European distribution center transition, completed in 2023, created a sales headwind of approximately $20 million in H1 2023 [23] Strategy and Industry Competition - The company is focused on offering a leading portfolio of automated insulin delivery systems, supported by data-driven products and services [6] - Tandem Mobi is positioned as a catalyst for market penetration, addressing previously unmet needs in the diabetes community [12] - The company is preparing for the integration of Abbott's FreeStyle Libre 3+ sensor, with a scaled launch expected in 2025 [29] - Tandem Source, a data visualization platform, is being scaled internationally, with positive feedback from healthcare providers [13][14] Management Commentary on Operating Environment and Future Outlook - Management highlighted the strong demand for new technologies, particularly Mobi, as a key driver of financial outperformance [7] - The company is focused on expanding its prescriber base and improving customer experience through innovative products and services [11][15] - Management expects to achieve positive EBITDA and free cash flows in H2 2024, driven by increased pump sales [25] - The company raised its 2024 sales guidance to $885-$892 million, reflecting 15% YoY growth, up from the initial 10% growth expectation [26] Other Important Information - The company is advancing its product pipeline, including extended wear infusion sets and a Type 2 pivotal study, targeting FDA filings by the end of 2024 [30] - Tandem Source has collected over 200 million days of real-world patient data on Control-IQ, with nearly 90% of customers uploading their data [14] - The company is investing in digital health platforms, aiming to integrate with EMR systems and demonstrate health economic benefits to payers [31] Q&A Session Summary Question: What is driving the switch from competitors to Mobi? - The primary driver is the Control-IQ algorithm, which users find superior, particularly former patch users who appreciate the improved wearability and performance [34][35] Question: Can you clarify new patient growth trends? - New patient growth is expected to improve in H2 2024, with Mobi driving higher MDI conversions [37][38] Question: How is Mobi performing with G7 integration? - Mobi demand has been steady, with strong growth in June, the first month of G7 availability, though it's too early to attribute this solely to pent-up demand [46] Question: What is the timeline for tubeless Mobi? - The company is prioritizing the development of a tubeless, durable pump but has not provided a specific timeline [48] Question: Were there any supply constraints for Mobi? - There were no supply constraints for Mobi, and the company is confident in meeting aggressive demand [51][52] Question: How is the sales force preparing for type 2 approval? - The company is evaluating its commercial model and sales force effectiveness, with a focus on expanding prescriber reach [53] Question: What is the market growth outlook? - The market remains underpenetrated, with potential for penetration rates to increase from 35-40% to 60-65% in the coming years [88]

Tandem Diabetes Care, Inc. (TNDM) reported $221.91 million in revenue for the quarter ended June 2024, representing a year-over-year increase of 13.3%. EPS of -$0.47 for the same period compares to -$0.30 a year ago. The reported revenue compares to the Zacks Consensus Estimate of $206.43 million, representing a surprise of +7.50%. The company delivered an EPS surprise of +12.96%, with the consensus EPS estimate being -$0.54. While investors closely watch year-over-year changes in headline numbers -- revenu ...

Tandem Diabetes Care, Inc. (TNDM) came out with a quarterly loss of $0.47 per share versus the Zacks Consensus Estimate of a loss of $0.54. This compares to loss of $0.30 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 12.96%. A quarter ago, it was expected that this company would post a loss of $0.80 per share when it actually produced a loss of $0.63, delivering a surprise of 21.25%. Over the last four quarters, the company ...

Financial Performance - Total sales for the three months ended June 30, 2024, were $195,917, compared to $365,300 for the same period in 2023, representing a decrease of 46.3%[6] - Gross profit for the six months ended June 30, 2024, was $207,466, down from $184,642 in 2023, indicating an increase of 12.3%[6] - Operating loss for the three months ended June 30, 2024, was $(38,808), compared to $(166,625) in the same period of 2023, showing an improvement of 76.8%[6] - Net loss for the six months ended June 30, 2024, was $(73,529), compared to $(159,648) in 2023, reflecting a reduction of 53.9%[6] - The company reported a net loss per share of $(0.55) for the three months ended June 30, 2024, compared to $(2.47) for the same period in 2023, indicating an improvement of 77.8%[6] - The net loss for Q2 2024 was $30.8 million, compared to a net loss of $35.8 million in Q2 2023, showing an improvement in financial performance[132] - For the six months ended June 30, 2024, total sales were $413.6 million, an increase from $365.3 million in the same period in 2023, with $127.1 million of sales outside the United States[144] Assets and Liabilities - Total current assets decreased to $733,388 as of June 30, 2024, from $747,989 at December 31, 2023, a decline of 2.0%[4] - Total liabilities increased to $703,628 as of June 30, 2024, from $639,026 at December 31, 2023, an increase of 10.1%[4] - Stockholders' equity decreased to $233,875 as of June 30, 2024, from $313,632 at December 31, 2023, a decline of 25.5%[4] - Cash and cash equivalents were $47,697 as of June 30, 2024, down from $58,868 at December 31, 2023, a decrease of 19.0%[4] - As of June 30, 2024, the total fair value of short-term investments was $404.718 million, down from $409.044 million as of December 31, 2023[41] - The total fair value of outstanding convertible senior notes increased to $477,831 thousand as of June 30, 2024, compared to $271,688 thousand at December 31, 2023[53] Research and Development - Research and development expenses for the six months ended June 30, 2024, were $95,570, compared to $85,093 in 2023, an increase of 12.9%[6] - Research and Development expenses increased by 12% to $95.6 million for the six months ended June 30, 2024, compared to $85.1 million for the same period in 2023, driven by increased personnel and clinical trial costs[150] Sales and Revenue - Revenue for Q2 2024 was $221.9 million, a 13.3% increase from $195.9 million in Q2 2023[92] - Sales of insulin pumps in Q2 2024 reached $107.9 million, up from $101.7 million in Q2 2023, indicating a 6.5% growth[92] - Total sales in the United States for Q2 2024 were $156.7 million, compared to $142.5 million in Q2 2023, marking a 10% increase[90] - Pump sales represented 49% of total worldwide sales in Q2 2024, down from 51% in Q2 2023, indicating a shift in product mix[139] Investments and Impairments - The company made strategic investments totaling $30.4 million in private companies as of June 30, 2024, up from $10.1 million at December 31, 2023[26] - The company recorded an impairment charge of $2.0 million related to one of its investments in a private company during the six months ended June 30, 2024, while no impairment charges were recorded in the same period of 2023[26] Operating Expenses - Selling, general and administrative expenses were $94.2 million in Q2 2024, a decrease from $97.6 million in Q2 2023, which included a one-time lease impairment charge of $14.1 million[140] - Operating expenses decreased to $279.9 million for the six months ended June 30, 2024, down from $351.3 million in the same period in 2023, primarily due to the absence of acquired in-process research and development expenses[149] Market and Competitive Environment - The medical device industry is highly competitive, with major competitors like Insulet, Medtronic, and Ypsomed, which may have advantages in resources and market presence[198] - The company faces risks related to market acceptance of its products and competition from key players like Insulet and Medtronic, which could impact sales[190] - The introduction of superior competing products could create market confusion and negatively impact the company's sales and operating margins[201] Customer and Product Strategy - The company has developed retention programs, such as the Tandem Choice Program, to support customer loyalty and ongoing purchases[195] - The company is focused on achieving market acceptance for its insulin pumps, which requires demonstrating distinct benefits over competitive products[203] - The company expects higher net sales in the third and fourth quarters compared to the first half of the year, influenced by the FDA clearance of Tandem Mobi[121] Cash Flow and Liquidity - As of June 30, 2024, the company had $452.4 million in cash and cash equivalents, which is expected to be sufficient to fund ongoing core business activities for at least the next 12 months[154] - Net cash used in operating activities was $13.3 million for the six months ended June 30, 2024, a decrease from $24.6 million used in the same period in 2023[156] Regulatory and Operational Risks - Regulatory approvals and timely product development are critical for maintaining competitiveness in the rapidly changing medical device industry[197] - The company is dependent on a limited number of third-party suppliers for certain components, and any disruptions could harm its business[174] - The company faces risks from supply chain disruptions that could impact the ability to meet customer demand, potentially magnifying negative effects on sales[193]

Financial Performance - Worldwide GAAP sales increased 13% to $221.9 million compared to Q2 2023; non-GAAP sales increased 12% to $221.8 million[3] - GAAP gross profit was $112.8 million with a gross margin of 51%; non-GAAP gross profit was $112.7 million with a gross margin of 51%[6] - GAAP operating loss was $30.8 million, or negative 14% of sales, compared to a loss of $38.8 million, or negative 20% of sales in Q2 2023[6] - Net loss was $30.8 million compared to $35.8 million in Q2 2023[6] - Adjusted EBITDA was negative $1.9 million, or negative 1% of sales, compared to $5.3 million, or 3% of sales in Q2 2023[7] - Total sales for the three months ended June 30, 2024, were $221,910,000, representing a 13% increase compared to $195,917,000 in the same period of 2023[18] - Gross profit for the three months ended June 30, 2024, was $112,794,000, up from $101,735,000 in the same period of 2023, indicating a strong performance in cost management[18] - Operating loss for the three months ended June 30, 2024, was $(30,774,000), an improvement from $(38,808,000) in the same period of 2023[18] - GAAP sales for Q2 2024 reached $221.91 million, a 13.3% increase from $195.92 million in Q2 2023[22] - Non-GAAP sales for the first half of 2024 were $414.58 million, compared to $369.63 million in the same period of 2023, reflecting a 12.1% growth[22] - GAAP gross profit for Q2 2024 was $112.79 million, up from $101.74 million in Q2 2023, resulting in a gross margin of 51%[22] - Non-GAAP gross profit for the first half of 2024 was $208.49 million, compared to $188.97 million in the first half of 2023[22] - GAAP net loss for Q2 2024 was $30.81 million, an improvement from a net loss of $35.78 million in Q2 2023[22] - Non-GAAP net loss for the first half of 2024 was $72.51 million, compared to a loss of $59.79 million in the same period of 2023[22] - Adjusted EBITDA for Q2 2024 was $(1.90) million, a decrease from $5.27 million in Q2 2023[22] - The company reported a GAAP operating loss of $30.77 million for Q2 2024, compared to a loss of $38.81 million in Q2 2023[22] - Non-GAAP operating loss for the first half of 2024 was $71.43 million, compared to a loss of $66.76 million in the first half of 2023[22] Sales and Market Performance - Over 20,000 pumps shipped in the United States, a sequential increase of 33% compared to Q1 2024[3] - Sales in the United States for the three months ended June 30, 2024, reached $156,711,000, a 10% increase from $142,501,000 in the same period of 2023[20] - Sales outside the United States increased by 22% to $65,199,000 for the three months ended June 30, 2024, compared to $53,416,000 in the same period of 2023[20] Future Guidance - The company increased its worldwide sales expectations to 15% annual growth for 2024[9] - Non-GAAP sales guidance for 2024 is estimated to be approximately $885 million to $892 million[12] - Non-GAAP gross margin is estimated to be approximately 51% for the full year 2024[12] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $49,326,000, up from $42,933,000 in the same period of 2023, reflecting ongoing investment in innovation[18] - The company continues to invest in research and development, with significant expenses related to acquired in-process research and development recorded in connection with acquisitions[23] Balance Sheet and Equity - Total current assets decreased to $733,388,000 as of June 30, 2024, from $747,989,000 as of December 31, 2023[17] - Total liabilities increased to $703,628,000 as of June 30, 2024, compared to $639,026,000 as of December 31, 2023[17] - Total stockholders' equity decreased to $233,875,000 as of June 30, 2024, from $313,632,000 as of December 31, 2023, indicating a decline in shareholder value[17] - Net loss for the six months ended June 30, 2024, was $(73,529,000), compared to $(159,648,000) for the same period in 2023, showing a significant reduction in losses[18] Deferred Revenue - The total Tandem Choice deferral was $31.0 million as of June 30, 2024[11]

Core Viewpoint - Tandem Diabetes Care, Inc. is positioned for growth due to its innovative product lineup and the expanding diabetes market, although it faces challenges from its reliance on insulin pumps and macroeconomic factors [1][10]. Group 1: Company Performance - Tandem Diabetes has experienced a stock surge of 110.9% over the past year, outperforming the industry growth of 6.1% and the S&P 500's rise of 23.5% [2]. - The company has a market capitalization of $3.36 billion and projects an estimated earnings growth rate of 35.2% for 2025, significantly higher than the S&P 500's 9.3% [2]. - In the trailing four quarters, Tandem Diabetes delivered an average earnings surprise of 9.9% [2]. Group 2: Product Innovation - The company has launched the Tandem Source data management application globally in 2023, enhancing diabetes management by providing comprehensive patient data [3]. - The t:slim X2 pump, integrated with Dexcom's G7 sensor, was rolled out internationally in January 2024, following its U.S. launch [3]. - Tandem Diabetes introduced the first AID system that integrates with Abbott's FreeStyle Libre 2 Plus sensor, benefiting U.S. pump users with a hybrid closed-loop system [4]. - The Tandem Mobi, a smaller version of the t:slim X2 pump, was launched in the U.S. in February 2024 and has received 510(k) clearance for pediatric use [4]. Group 3: Market Potential - The global diabetes care device market is projected to grow from $9.7 billion in 2022 to $17.87 billion by 2032, presenting significant opportunities for Tandem Diabetes [5]. - The company aims to expand the adoption of insulin pumps among type 1 diabetes patients and develop products for type 2 diabetes patients requiring insulin therapy [5][6]. Group 4: Financial Health - As of the first quarter of 2024, Tandem Diabetes had cash and cash equivalents of $467.8 million, with no short-term debt, although long-term debt increased to $348 million [7]. - The cost of sales rose by 12.2% compared to the same period in 2023, indicating potential pressure on margins [11]. Group 5: Challenges - The company relies heavily on insulin pump sales, which accounted for 45% of worldwide sales in Q1 2024, posing risks if market acceptance does not improve [10]. - Macroeconomic uncertainties may hinder the company's ability to predict product demand and could lead to increased expenses due to inflation and commodity price fluctuations [11].

Tandem Diabetes Care, Inc.'s (TNDM) Mobi insulin pump with Control-IQ technology is now fully compatible with both Dexcom's (DXCM) G7 and G6 Continuous Glucose Monitoring ("CGM") Systems. The world's smallest, durable, automated insulin delivery system for people living with diabetes was commercially launched in the United States earlier in February. The availability of Tandem Mobi reflects the company's strategic aim to provide a differentiated portfolio of durable insulin pumps, providing choice alongside ...

Keith Lance Investment Overview I last covered Tandem Diabetes Care (NASDAQ:TNDM) in a note for Seeking Alpha back in November 2020, when the automated insulin pump solutions provider's stock price traded at ~$115. I gave the stock a "Buy" recommendation, which initially proved to be the right call, as 12 months on, it had reached a high of $150 per share. In 2020, Tandem delivered revenues of $499m, and an operating loss of $(8m). In 2021, revenues grew to $703m, and a small operating profit of $23m was ac ...

Tandem Diabetes Care, Inc. (NASDAQ:TNDM) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Susan Morrison - Executive Vice President and Chief Administrative Officer. John Sheridan - President and Chief Executive Officer Leigh Vosseller - Executive Vice President and Chief Financial Officer Conference Call Participants Steve Lichtman - Oppenheimer Brooks O'Neil - Lake Street Capital Markets Mike Kratky - Leerink Partners Mathew Blackman - Stifel Chris Pasquale - Nephron Research M ...

[Part I Financial Information](index=3&type=section&id=Part%20I%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Tandem Diabetes Care, Inc. as of March 31, 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets slightly decreased to $941.0 million, liabilities increased to $698.0 million due to convertible notes Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Total current assets | $735,193 | $747,989 | | Total assets | $941,045 | $952,658 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $192,971 | $195,258 | | Convertible senior notes, net - long-term | $347,497 | $285,035 | | Total liabilities | $697,981 | $639,026 | | Total stockholders' equity | $243,064 | $313,632 | | Total liabilities and stockholders' equity | $941,045 | $952,658 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) Sales increased to $191.7 million, with net loss significantly reduced to $42.7 million, due to the absence of a prior R&D charge Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Sales | $191,674 | $169,383 | | Gross profit | $94,672 | $82,907 | | Operating loss | $(41,678) | $(127,817) | | Net loss | $(42,715) | $(123,873) | | Net loss per share - basic and diluted | $(0.65) | $(1.92) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $8.0 million, with financing activities providing $13.6 million, stabilizing cash Summary of Cash Flows (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,996) | $(18,326) | | Net cash used in investing activities | $(5,056) | $(26,329) | | Net cash provided by (used in) financing activities | $13,586 | $(541) | | Net increase (decrease) in cash and cash equivalents | $111 | $(44,755) | | Cash and cash equivalents at end of period | $58,979 | $127,762 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail accounting policies, Tandem Choice revenue, debt financing, segment reporting, and legal proceedings - The Tandem Choice program, which provided a material right for customers to upgrade to the Tandem Mobi pump, resulted in deferred revenue of **$31.5 million** as of March 31, 2024, with eligibility for the program ending in February 2024[29](index=29&type=chunk)[31](index=31&type=chunk)[32](index=32&type=chunk) - In March 2024, the company issued **$316.3 million** of 1.50% Convertible Senior Notes due 2029 and used a portion of the proceeds to repurchase **$246.7 million** of its existing 2025 notes, resulting in a **$1.3 million** loss on debt extinguishment[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) Revenue by Geographic Region (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | United States | $129,761 | $131,242 | | Outside the United States | $61,913 | $38,141 | | **Total Sales** | **$191,674** | **$169,383** | - The company is defending against a putative securities class action lawsuit and two shareholder derivative cases related to alleged false and misleading statements about sales trends and financial forecasts[102](index=102&type=chunk)[103](index=103&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2024 results, highlighting 13% sales growth, Tandem Mobi launch, and narrowed net loss - The company's strategy is to offer flexibility and choice in insulin delivery systems through a portfolio of pumps (t:slim X2, Tandem Mobi), applications, and insights[114](index=114&type=chunk)[122](index=122&type=chunk) - Future technology pipeline includes the t:slim X3, a tubeless option for the Mobi pump, the Sigi Patch Pump, extended wear infusion sets, and advancements in the Control-IQ algorithm[123](index=123&type=chunk)[124](index=124&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) Q1 2024 vs Q1 2023 Results of Operations (in thousands) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total sales | $191,674 | $169,383 | | Gross profit | $94,672 | $82,907 | | Gross margin | 49% | 49% | | Operating loss | $(41,678) | $(127,817) | | Net loss | $(42,715) | $(123,873) | - Sales outside the U.S. grew **62%** to **$61.9 million**, while U.S. sales slightly decreased by **1%** to **$129.8 million**, with international growth attributed to recovery from a distributor transition[149](index=149&type=chunk)[151](index=151&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No material changes in market risk disclosures, primary exposure to fixed-rate convertible notes mitigating interest rate risk - There were no material changes to the company's quantitative and qualitative disclosures about market risk during the three months ended March 31, 2024[171](index=171&type=chunk) - The company's **$357.0 million** in convertible senior notes bear a fixed interest rate of **1.50%** per year, so the company is not subject to interest rate risk on this debt[172](index=172&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2024, with no material changes in internal control - Based on an evaluation as of March 31, 2024, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[174](index=174&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[176](index=176&type=chunk) [Part II Other Information](index=40&type=section&id=Part%20II%20Other%20Information) [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 13 for legal matters, primarily a securities class action and two shareholder derivative cases - Details on legal proceedings are provided in Note 13 of the financial statements, which discusses a securities class action lawsuit and two related shareholder derivative cases[179](index=179&type=chunk)[102](index=102&type=chunk)[103](index=103&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section outlines material risks including operating losses, insulin pump reliance, competition, reimbursement, and regulatory challenges - **Business Risks:** The company has a history of significant operating losses (**$994.5 million** accumulated deficit) and relies heavily on sales of its insulin pump products, facing intense competition from major medical device companies like Insulet and Medtronic[193](index=193&type=chunk)[197](index=197&type=chunk)[205](index=205&type=chunk) - **Market & Reimbursement Risks:** Failure to secure or retain adequate coverage and reimbursement from third-party payors could adversely affect business, with new challenges arising from the multi-channel strategy for the Mobi pump through the pharmacy channel[213](index=213&type=chunk)[215](index=215&type=chunk) - **Operational & Supply Chain Risks:** The company depends on a limited number of third-party suppliers for critical components and products, exposing it to risks of supply disruption, quality issues, and cost fluctuations[238](index=238&type=chunk)[240](index=240&type=chunk) - **Privacy & Security Risks:** The business is subject to stringent data privacy laws (e.g., GDPR, HIPAA, CCPA) and cybersecurity threats, where failure to protect sensitive data could lead to significant fines, litigation, and reputational harm[274](index=274&type=chunk)[291](index=291&type=chunk) - **Regulatory & Legal Risks:** The company's products are subject to extensive regulation by the FDA and other global authorities, with non-compliance potentially leading to recalls, fines, or withdrawal of approvals, and ongoing patent litigation with Roche in Europe[320](index=320&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On March 5, 2024, the company repurchased 1,106,806 shares at $27.105 per share, part of a $30.0 million buyback plan Common Stock Repurchase - March 2024 | Date | Total Shares Purchased | Average Price Paid Per Share | | :--- | :--- | :--- | | March 5, 2024 | 1,106,806 | $27.105 | - The stock repurchase was part of a plan to buy back up to **$30.0 million** of common stock from purchasers of the 2029 Notes in privately negotiated transactions[370](index=370&type=chunk) [Item 6. Exhibits](index=84&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including the 2029 Convertible Notes indenture and CEO/CFO certifications - Key exhibits filed include the indenture for the **1.50%** Convertible Senior Notes due 2029 and CEO/CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[373](index=373&type=chunk)