New York, New York--(Newsfile Corp. - November 25, 2025) - WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. (NASDAQ: TNDM) resulting from allegations that Tandem Diabetes Care may have issued materially misleading business information to the investing public.SO WHAT: If you purchased Tandem Diabetes Care securities you may be entitled to compensation without payment of any out of pocket fees ...

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Shareholders who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. Group 2: Incident Details - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. - The firm has achieved notable settlements, including the largest securities class action settlement against a Chinese company and has consistently ranked highly in securities class action settlements since 2013 [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering significant amounts for its clients [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Shareholders who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. Group 2: Company Incident and Stock Impact - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company and being ranked highly for the number of settlements [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

Tandem Diabetes Care Q3 2025 Conference Call Summary Company Overview - **Company**: Tandem Diabetes Care (NasdaqGM:TNDM) - **Date**: November 11, 2025 - **Context**: Discussion of Q3 2025 results and future outlook Key Points Financial Performance - Q3 2025 results showed solid performance with outperformance relative to market expectations, primarily driven by pricing strategies [2][4] - U.S. pump sales experienced a slight decline year-over-year, indicating challenges in the market [2][4] - Pricing improved in Q3, with mid-single-digit year-over-year growth attributed to the pharmacy channel [5][13] Sales and Market Dynamics - The company is undergoing a transformation in the U.S. market, which has led to some turbulence but also signs of improved sales rep productivity [4][11] - September 2025 was noted as the strongest month of the quarter, with expectations for continued sales momentum into Q4 [6][12] - Pharmacy sales accounted for 5% of U.S. revenue in Q3, primarily driven by the introduction of t:slim supplies [7][8] Product Pipeline and Innovations - The company is prioritizing the launch of the tubeless Mobi product, expected to be a significant growth driver in 2026 [18][19] - The integration of Mobi with FreeStyle Libre 3 is anticipated, enhancing product offerings [23] - A fully closed-loop pivotal trial is set to begin in 2026, leveraging existing algorithms and clinical data [24][25] Competitive Landscape - The market is characterized by significant growth potential, with new entrants and competition emerging [34][35] - The company acknowledges the presence of competitors but believes in the overall market opportunity for all players [34] Type 2 Diabetes Market Opportunity - The company is expanding its focus on insulin-intensive Type 2 diabetes patients, which represents a significant market opportunity [42][46] - Current penetration of pumps in this segment is around 5%, with expectations to increase to 25-30% over the next few years [47] International Expansion - Tandem is moving towards a direct sales model in certain international markets, anticipating a minimum 30% ASP premium [51][52] - The transition is expected to be accretive to the bottom line, despite initial OPEX increases [52] Operational Efficiency - The company is implementing measures to improve operational efficiency, including automation and process improvements, which are expected to support a larger install base without proportional increases in headcount [56] 2026 Outlook - Gross margins are projected to improve by at least 300 basis points in 2026, driven by increased pump volumes and pricing benefits [54] - The company is optimistic about achieving OPEX leverage through enhanced sales force productivity and restructuring efforts [56] Additional Insights - The company is cautious about the competitive landscape and is monitoring new entrants closely, indicating a need for time to assess their impact [35][37] - The management emphasized the importance of understanding market dynamics and adapting strategies accordingly, particularly in the context of new product launches and market penetration efforts [41][46]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Investigation and Legal Action - Shareholders who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. Group 2: Company Incident - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4]. - The firm has achieved notable settlements, including the largest securities class action settlement against a Chinese company and has consistently ranked highly in securities class action settlements since 2013 [4]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering significant amounts for its clients [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Shareholders who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. Group 2: Company Incident and Stock Impact - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps due to a potential speaker-related issue that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Tandem Diabetes Care, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Investors who purchased Tandem Diabetes Care securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. Group 2: Company Incident and Stock Impact - On August 7, 2025, Tandem Diabetes Care announced a voluntary medical device correction for select t:slim X2 insulin pumps, addressing a potential speaker-related issue that could lead to insulin delivery discontinuation [3]. - Following this announcement, Tandem Diabetes' stock experienced a significant decline of 19.9% on the same day [3]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

Core Insights - Tandem Diabetes Care reported Q3 CY2025 results with revenue of $249.3 million, exceeding analyst expectations by 5.6% and showing a year-on-year growth of 2.6% [1][6] - The company's GAAP loss per share was $0.31, which was 3.6% better than the consensus estimate of $0.32 [1][6] Operational Performance - The third quarter was characterized by improved operational efficiency and commercial execution, leading to a positive market reaction [3] - Management attributed the performance to the modernization of U.S. commercial operations, increased pricing contributions, and early traction from new product offerings [3][5] - Changes in sales processes and organizational restructuring have resulted in better sales productivity and a strong customer mix adopting both t:slim and Mobi pump platforms [3] Future Outlook - The company plans to expand pharmacy access, launch new products, and enhance direct international operations [4] - New product introductions, such as Mobi Tubeless and integration with continuous glucose monitoring systems, are expected to drive customer growth [4] - The focus on a fully closed-loop pump system and a multichannel approach is anticipated to improve both top-line and margin performance as the company enters new international markets [4] Financial Metrics - Adjusted EBITDA was reported at $2.77 million, which was a 50% miss compared to analyst estimates of $5.55 million [6] - The operating margin improved to -9.2%, up from -10.7% in the same quarter last year [6] - Sales volumes fell by 4.8% year on year, compared to a decline of 24.7% in the same quarter last year [6] - The company's market capitalization stands at $900.7 million [6]

Financial Data and Key Metrics Changes - In Q3 2025, Tandem Diabetes Care achieved record sales of $249 million, with U.S. sales approximately $176 million, marking the highest third quarter to date and the second highest quarter ever [15][16] - Gross margin increased by 3 percentage points year over year, reaching 54% in Q3, with adjusted EBITDA returning to positive [15][17] - The company ended the quarter with $319 million in total cash and investments, indicating a strong financial position [19] Business Line Data and Key Metrics Changes - Pump shipments in the U.S. were over 20,000, slightly down from Q2 due to pharmacy stocking benefits recognized in the previous quarter [16] - International sales reached $74 million, also a record for Q3, primarily driven by favorable foreign currency exchange rates [17] - Renewals continue to track to a historical capture rate of over 70% of eligible customers within 18 months after warranty expiration [16] Market Data and Key Metrics Changes - The U.S. market saw a significant contribution from pricing, with a 5% increase in Q3, driven by both DME and pharmacy channels [16] - International sales are expected to grow approximately 12% year over year, despite headwinds from distributor inventory destocking [20] Company Strategy and Development Direction - The company is focused on three primary initiatives: modernization of commercial operations, driving innovation, and reshaping the business model [4][10] - Direct sales initiatives in Europe are set to begin in early 2026, with the aim of strengthening financial position and accelerating sales growth [6][20] - The launch of Mobi Tubeless is prioritized, expected to significantly enhance user preference and market presence [26][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth in 2025, with a target of $1 billion in worldwide sales [20][24] - The company anticipates a strong fourth quarter, with expectations for gross margins in the mid to high 50s [20][59] - Management highlighted the importance of pharmacy access and new product introductions in driving future growth [35][51] Other Important Information - The company has successfully increased pharmacy benefit coverage for Tandem Mobi to over 40% of U.S. lives [11] - A significant focus is placed on enhancing efficiencies and optimizing operations to strengthen operating margins [18][19] Q&A Session Summary Question: Can you provide insights on the cadence of growth for 2026? - Management indicated that multiple initiatives are expected to build momentum throughout 2026, with a focus on Mobi and pharmacy channel expansion [34][36] Question: What is the expected pricing uplift from supplies going through the pharmacy? - Management noted that pricing increases have been a significant contributor to revenue growth, with expectations for continued benefits as pharmacy access expands [39][41] Question: How do you expect Q4 to perform compared to last year? - Management confirmed that Q4 expectations are built on lessons learned from 2024, with a focus on new renewal opportunities [42][44] Question: What percentage of new patient starts were type 2 this quarter? - Management stated that renewals have been slightly more than half of shipments, with MDI conversions making up about two-thirds of new shipments [46][48] Question: Can you clarify the timeline for the Mobi Tubeless launch? - Management confirmed that Mobi Tubeless is expected to enter the market in 2026, pending 510(k) submission approval [90]

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