Tandem Diabetes Care (TNDM) has achieved a significant milestone by gaining approval for the use of its t:slim X2 insulin pump with Eli Lilly's ultra-rapid acting insulin, Lyumjev, in the European Union (EU). The compatibility with Lyumjev offers new possibilities in the insulin delivery landscape, enhancing the efficacy of Tandem's automated insulin delivery (AID) systems. This latest development strengthens Tandem's position in the diabetes technology market and enhances its offerings for individuals with ...

Tandem Diabetes (TNDM) is gaining from continued product innovations. Yet, ongoing macroeconomic challenges and tough competition pose challenges. The stock carries a Zacks Rank #3 (Hold) currently. Factors Driving TNDM Stock Tandem Diabetes seeks to grow its business through the acquisition of products or technologies or investments in businesses. Last year, it acquired Swiss-based AMF Medical SA — the developer of the Sigi Patch Pump. The company's speed-to-market with Continuous Glucose Monitoring (CGM) ...

Tandem Diabetes Care, Inc.'s (TNDM) flagship t:slim X2 insulin pump with Control-IQ automated insulin delivery (AID) technology is now certified for use with Eli Lilly and Company's (LLY) Lyumjev (insulin lispro-aabc injection) ultra-rapid acting insulin in the European Union (EU). The development follows a clinical study that reported high satisfaction and quality of life benefits by pairing Lyumjev with Control-IQ technology. Ultra-rapid acting insulin is a popular choice for people living with diabetes b ...

At a stroke, it's got a product authorized for a specific use in 27 countries. Tandem Diabetes Care (TNDM 4.25%) had some encouraging news to report on the regulatory front Thursday, and after it hit the headlines investors piled into the stock. At the end of the day the highly specialized healthcare company's share price had risen in excess of 4%, good enough to top the 1.7% rise of the benchmark S&P 500 index. Crucial approval granted Tandem announced Thursday morning that it had won an important approval ...

Tandem Diabetes Care, Inc.'s (TNDM) growth is backed by its impressive range of new products. The flourishing diabetes market provides a favorable opportunity for the company's growth. However, concerns loom over Tandem Diabetes' substantial reliance on insulin pumps and the adverse impact of macroeconomic challenges. In the past year, this Zacks Rank #3 (Hold) company has surged 56.2% compared with 10.9% growth of the industry and a 24.9% rise of the S&P 500 composite. The renowned medical device company h ...

Core Insights - Tandem Diabetes is experiencing growth through product innovations, particularly with its t:slim X2 insulin pump, which has integrated with both Dexcom G6 and G7 CGM systems, enhancing its market position [2][4] - The company is facing rising costs that are putting pressure on its profit margins, with a reported 15.9% increase in cost of sales year-over-year in Q2 2024 [9] Product Innovations - The t:slim X2 insulin pump became compatible with Dexcom G7 in Q2 2023, following its prior compatibility with Dexcom G6, and received approval for sale in Canada [2] - In 2023, t:slim X2 also integrated with Abbott's FreeStyle Libre 2 Plus sensor, allowing users to benefit from a hybrid closed-loop system for better blood sugar management [3] - The new Tandem Mobi insulin pump, launched in February 2024, integrates with both Dexcom G6 and G7, making Tandem the only company to offer such dual compatibility [4] Competitive Landscape - Tandem Diabetes operates in a highly competitive market with significant players like Insulet and Medtronic, which poses challenges for market share and pricing strategies [6][7] - The company is focusing on acquisitions and partnerships to enhance its product offerings and maintain a competitive edge, as seen with its acquisition of AMF Medical SA [5] Market Challenges - The current global economic and political uncertainties are impacting demand predictions for Tandem's products, with many regions experiencing unfavorable economic conditions [8] - Consumers are adjusting spending priorities, which may lead to reduced discretionary spending on medical devices, affecting Tandem's profitability and financial performance [9]

NEW YORK, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Tandem Diabetes Care, Inc. (NASDAQ: TNDM) on behalf of long-term stockholders following a class action complaint that was filed against Tandem on September 8, 2023 with a Class Period from August 3, 2022 to November 2, 2022. Our investigation concerns whether the board of directors of Tandem have breached their fiduciary duties to the company ...

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 ...