Tandem Diabetes Care, Inc. (TNDM) Business Model Canvas

Tandem Diabetes Care, Inc. (TNDM): Business Model Canvas [Dec-2025 Updated]

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You're looking at the engine room of a major med-tech player, and honestly, the numbers for Tandem Diabetes Care, Inc. this year tell a clear story of aggressive growth. As someone who has mapped out balance sheets for decades, I can tell you their push for $1.0 billion in worldwide sales for fiscal 2025 hinges on two things: making their proprietary Control-IQ algorithm the standard for automated insulin delivery and successfully launching the smaller Tandem Mobi pump, all while balancing high R&D expenses against recurring supply revenue. We've broken down their entire nine-block strategy-from key partnerships like the one with Abbott's CGM to their cost structure, which sees COGS around $460 million-so you can see exactly how they plan to hit that target and what the risks are in their direct-to-clinic channel. Dive in below to see the full, no-fluff canvas.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Key Partnerships

You're looking at how Tandem Diabetes Care, Inc. builds out its ecosystem through strategic alliances. These aren't just handshake deals; they are critical for getting the t:slim X2 and Mobi pumps into more hands and ensuring they work with the best monitoring tech available. The partnerships define access and capability, so let's look at the hard numbers supporting these efforts as of late 2025.

Continuous Glucose Monitor (CGM) integration with Abbott FreeStyle Libre 3 Plus

This integration is a big deal for user choice. Tandem Diabetes Care initiated an early access program in the United States in June 2025 for the t:slim X2 insulin pump with Control-IQ+ technology to work with Abbott's FreeStyle Libre 3 Plus sensor. The plan was to scale availability in the second half of 2025, with a global rollout starting in October 2025.

The FreeStyle Libre 3 Plus sensor itself offers a 15-day wear time and sends glucose readings every minute directly to the pump. This data feeds the Control-IQ+ algorithm, which adjusts or suspends basal insulin delivery every 5 minutes.

Here's a quick look at the technical partnership details:

Metric Value Context
Sensor Wear Time 15-day Extended wear time for the FreeStyle Libre 3 Plus sensor.
Glucose Reading Frequency Every minute Data transmission rate from sensor to pump.
Insulin Adjustment Frequency Every 5 minutes Frequency of Control-IQ+ algorithm action based on predicted glucose.
U.S. Availability Ramp-up Second half of 2025 Target timeframe for scaling the early access program.

Collaboration with the University of Virginia Center for Diabetes Technology

Tandem Diabetes Care signed a multi-year collaboration agreement with the University of Virginia Center for Diabetes Technology (UVA CDT) in January 2025. This is an expansion of a relationship that has spanned over 10 years, including work on the International Diabetes Closed Loop trials.

Under this new agreement, Tandem Diabetes Care provides research funding, technology, and supplies to UVA CDT. The goal is advancing research and development for fully automated closed-loop insulin delivery systems. This partnership is key to accelerating approved uses for Tandem Diabetes Care's next-generation automated insulin delivery (AID) systems.

Pharmacy Benefit Managers (PBMs) for expanded channel access

Expanding access through the pharmacy channel is a major strategic focus. In the fourth quarter of 2024, Tandem Diabetes Care successfully launched its multi-channel strategy for the Tandem Mobi pump in the United States, securing pharmacy rebate agreements covering approximately 20 percent of covered lives.

By the third quarter of 2025, this progress accelerated significantly. Tandem Diabetes Care reported increasing pharmacy benefit coverage for Tandem Mobi to more than 40% of U.S. lives. They also introduced t:slim X2 supplies through a pharmacy benefit during that period.

The overall sales structure shows the importance of different channels:

  • Durable Medical Equipment (DME) distributors accounted for approximately 25% of Tandem Diabetes Care's revenue in 2024.
  • The company's products are available in the U.S. and an additional 24 countries.

Durable Medical Equipment (DME) distributors and suppliers

The traditional DME distributor network remains a core part of the business, though the pharmacy channel is growing fast. For the full year 2024, revenue from the distributor network represented about 25% of the total. This network supports sales across the 25 countries where Tandem Diabetes Care operates.

Insulin manufacturers for pump compatibility

The t:slim X2 insulin pump has specific, tested compatibility requirements for insulin use in the United States. You need to know which insulins are cleared for use with the pump and its Control-IQ+ technology, as clinical studies were only conducted with these specific types.

The indicated insulins for the t:slim X2 insulin pump in the U.S. are:

  • NovoLog / NovoRapid (Novo Nordisk Insulin Aspart) U-100.
  • Humalog (Eli Lilly Insulin Lispro) U-100.

The required infusion set change schedule is tied directly to the insulin used:

  • Change infusion set every 48 hours if using Humalog insulin.
  • Change infusion set every 72 hours if using NovoLog insulin.

Finance: draft Q4 2025 cash flow projection by next Tuesday.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Key Activities

You're looking at the core engine driving Tandem Diabetes Care, Inc. as we head into 2026. These are the things the company absolutely must execute on to hit its targets.

Research and Development (R&D) for Control-IQ+ and fully-closed loop systems

Tandem Diabetes Care's R&D is focused on advancing its automated insulin delivery (AID) technology. Control-IQ technology has been shown in clinical trials to reduce hypoglycemic events by 30%. The company secured U.S. Food and Drug Administration (FDA) clearance for its Control-IQ+ algorithm for people with type 2 diabetes, ages 18 and older, in early 2025, with availability expected in the U.S. by March 2025. This expansion into the Type 2 market targets a segment estimated at $30 billion. The t:slim X2 pump with Control-IQ+ technology also gained clearance for use with Eli Lilly and Company's Lyumjev ultra-rapid acting insulin in the United States. The company completed a feasibility study to advance the development of a fully-closed loop automated insulin delivery system. R&D expenses remained flat year-over-year in the second quarter of 2025. A significant investment was noted with an acquired in-process research and development (IPR&D) charge of $75.2 million in the first quarter of 2025.

Manufacturing and assembly of t:slim X2 and Tandem Mobi insulin pumps

The manufacturing activity supports a dual-platform strategy with the established t:slim X2 and the newer, smaller Tandem Mobi. The t:slim X2 insulin pump is indicated for use in individuals 2 years of age and greater. The Mobi pump is about half the size of the t:slim X2. In the first quarter of 2025, Tandem Diabetes Care dispatched nearly 29,000 pumps globally. The company received CE Mark approval for the Tandem Mobi insulin delivery system with Control-IQ+ technology in May 2025, with plans to begin EU commercial launches by the end of 2025. The t:slim X2 pump cost for the Control IQ version is cited at $5800.

Key pump shipment and sales data for 2025:

Metric Q1 2025 (Units/Value) Full Year 2025 Guidance (Value)
Worldwide Pump Shipments Nearly 29,000 (Units) N/A
U.S. Pump Shipments Over 17,000 (Units) Approximately $700 million (Sales)
International Pump Shipments More than 11,000 (Units) Approximately $300 million (Sales)

Global commercial transformation and international market expansion

Commercial transformation is a major activity, including expanding channel access and geographic footprint. The company is moving towards a direct sales model internationally, aiming for higher average selling prices (ASPs) and improved profitability. Tandem Diabetes Care is preparing for direct commercial operations in select European countries starting in 2026, including the U.K., Switzerland, and Austria in early 2026. This transition is expected to create a $10 million headwind in 2025 sales outside the U.S. The company is also advancing a multichannel reimbursement strategy in the U.S. Pharmacy revenue accounted for 5% of U.S. revenue in the third quarter of 2025. Pharmacy benefit coverage for Tandem Mobi has increased to more than 40% of U.S. lives. The overall 2025 worldwide sales guidance is reaffirmed at approximately $1.0 billion.

The company is working to increase pump penetration in a market where less than 40% of approximately 2 million people with type 1 diabetes in the U.S. use a pump, with international penetration below 20%.

Securing regulatory approvals (FDA, CE Mark) for new products

Regulatory work is central to product lifecycle management and expansion. In addition to the Control-IQ+ for Type 2 clearance, Tandem Diabetes Care received a 510(k) clearance from the FDA for extended wear use of the SteadiSet Infusion Set in the third quarter of 2025. The company also filed a 510(k) with the FDA for Android mobile control of the Tandem Mobi insulin delivery system in the third quarter of 2025. The Tandem Mobi received its CE Mark in May 2025. The t:slim X2 pump with Control-IQ+ technology is classified as a Class II device under regulation number 21 CFR 880.5730.

Software development for the Tandem Source digital ecosystem

Developing the digital ecosystem is key for customer retention and data integration. Tandem Source is a platform designed to connect patients, caregivers, and clinicians, streamlining data management and reporting. The Tandem Mobi system is noted as the only automated insulin delivery system fully controllable via a mobile app. This control is primarily via a compatible iPhone running on iOS 17 or later, spanning from iPhone Xs to iPhone 17 Pro Max. The company announced in November 2025 that it achieved ISO/IEC 27001:2022 Certification, affirming its commitment to global data security standards.

Key software/digital milestones include:

  • Tandem Mobi control via compatible iPhone running iOS 17 or later.
  • FDA filing for Android mobile control of Tandem Mobi in Q3 2025.
  • ISO/IEC 27001:2022 Certification achieved in November 2025.
  • Tandem Source streamlines data sharing for patients and HCPs.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Key Resources

The Key Resources for Tandem Diabetes Care, Inc. center on its proprietary technology, established product lines, and the digital ecosystem supporting them.

Proprietary Control-IQ advanced hybrid closed-loop algorithm

The Control-IQ+ technology is a core asset, intended for the management of Type 1 diabetes mellitus in persons 2 years of age and greater and Type 2 diabetes mellitus in persons 18 years of age and greater.

  • Estimated Userbase for Control-IQ+: Approximately 320,000 users as of late 2025.
  • The algorithm received FDA clearance for people with Type 2 diabetes in March 2025.
  • In a pivotal Type 2 diabetes study, users on Control-IQ+ saw an A1C reduction of 0.9% compared to 0.3% for the control group.
  • Time in range (70-180 mg/dL) improved by 3.8 more hours/day with Control-IQ+ compared to baseline in that study.

Product portfolio: t:slim X2 and miniaturized Tandem Mobi insulin pumps

Tandem Diabetes Care, Inc. manufactures and sells the t:slim X2 insulin pump and the Tandem Mobi system. The t:slim X2 insulin pump holds up to 300 units of insulin.

For the second quarter of 2025, shipments were reported as follows:

Geography Pump Shipments (Units)
United States Approximately 21,000
Outside the United States Approximately 9,000

The Tandem Mobi system achieved increased pharmacy benefit coverage in the U.S. to more than 40% of U.S. lives by the third quarter of 2025.

Intellectual property (IP) protecting device design and software

Intellectual property rights protect the device design and software, which is crucial given the industry's extensive patent litigation environment. As of August 1, 2025, there were 67,569,471 shares of the registrant's Common Stock outstanding.

The company's financial structure, which impacts its ability to defend and expand its IP, included a debt-to-equity ratio of 3.37.

Tandem Source multi-sided digital data platform

Tandem Source is the digital ecosystem platform connecting patients, caregivers, clinicians, and administrators for data management and decision support. The multi-channel initiative progressed with the introduction of t:slim X2 supplies through a pharmacy benefit.

Specialized manufacturing and supply chain for medical devices

The specialized manufacturing and supply chain support the revenue generation, with a projected full-year 2025 GAAP gross margin targeted between 53% and 54%. The company projects total sales for the full year ending December 31, 2025, to be approximately $1 billion.

The revenue stream is heavily weighted toward consumables; more than 70% of U.S. sales are anticipated from recurring revenue streams like supplies and renewals for 2025.

Here's a quick look at recent financial performance:

Metric Q3 2025 Value Full Year 2025 Guidance (Approximate)
Worldwide Sales (GAAP) $249.3 million $1.0 billion
U.S. Sales Implied from $249.3M total and $73.6M Intl. $700 million to $730 million
Gross Margin (GAAP) 54% 53% to 54%

The company held $370 million in cash and investments at the end of the first quarter of 2025.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Value Propositions

Automated Insulin Delivery (AID) for improved time-in-range

Tandem Diabetes Care, Inc. delivers improved glycemic control through its Control-IQ+ technology, which is the latest generation of its advanced hybrid closed-loop algorithm.

The value proposition is quantified by clinical outcomes, such as those seen in the pivotal trial for Type 2 diabetes using Control-IQ+ technology:

Metric Control-IQ+ Group (N=215) Control Group (N=104)
A1C Reduction 0.9% 0.3%
Time in Range Improvement (vs. Baseline) 16% N/A
Additional Hours/Day in Range (vs. Control) 3.4 more hours/day N/A

For children ages 2-5 using Control-IQ technology, the mean time in range increased from 57 percent at baseline to 69 percent during follow-up, representing a mean adjusted difference of 12.4 percent over the control group's 55 percent to 56 percent. Real-world data for Control-IQ shows a Time In Range (TIR) of 71% and a Time Below Range (TBR) of 1.5% in a group of 20,000 users.

Smallest, durable insulin pump on the market (Tandem Mobi)

The Tandem Mobi pump is positioned as the smallest automated insulin delivery device on the current market. It is less than half the size of the t:slim X2 insulin pump and is small enough to fit in the coin pocket of a pair of jeans. The company is seeing early traction from new product offerings, including Mobi, contributing to Q3 2025 performance.

  • Insulin capacity is 200 units.
  • Water-resistant rating of IP28, up to 8 feet for 2 hours.
  • Average user pays less than $2/day for pump and disposables.
  • The system includes a physical button for bolusing without the phone.

Remote software updates to add new features to existing pumps

Tandem Diabetes Care, Inc. enables users to gain new functionality without replacing hardware, a key feature of the Mobi pump and the t:slim X2 pump.

Eligible t:slim X2 users in the United States can add the FreeStyle Libre 3 Plus sensor compatibility feature free of charge via remote software update. This capability is a core feature of the Mobi pump as well. A Control-IQ+ software update allows users to set an extended bolus up to eight hours or a temporary basal rate while Control-IQ+ is active.

User-friendly touchscreen interface for simplified management

The t:slim X2 insulin pump provides a user-friendly touchscreen interface. For the Mobi, management is simplified through complete control via a compatible smartphone app, though it lacks a built-in screen. The technology itself is designed for ease of use; Control-IQ+ showed similar success across users with low and high numeracy scores at baseline.

Broad CGM sensor compatibility (e.g., Abbott, Dexcom)

Tandem Diabetes Care, Inc. emphasizes interoperability, allowing users to select their preferred Continuous Glucose Monitoring (CGM) sensor.

The t:slim X2 pump with Control-IQ+ technology is compatible with:

  • Dexcom G6 sensor (all versions).
  • Dexcom G7 sensor (specific versions).
  • Abbott's FreeStyle Libre 3 Plus sensor, with global commercial rollout initiated in the second half of 2025.

The FreeStyle Libre 3 Plus sensor transmits readings every minute and has an extended 15-day wear time. The Control-IQ+ algorithm adjusts insulin every five minutes based on predicted glucose values. The Mobi pump integrates with Dexcom G6 and G7 sensors, with FreeStyle Libre 3 Plus integration expected in late 2025.

Tandem Diabetes Care, Inc. worldwide sales in Q3 2025 were $249.3 million.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Customer Relationships

Tandem Diabetes Care, Inc. focuses on a high-touch, direct engagement model, which is evolving as they expand sales through pharmacy channels. The relationship strategy centers on ensuring users can effectively manage their therapy with dedicated support and digital tools.

Dedicated customer support and technical service for pump users

Tandem Diabetes Care, Inc. staffs its customer support team, based in the United States, with representatives who receive specialized training. You can reach their 24-hour customer support team by calling (877) 801-6901 and pressing 1 twice for immediate assistance. The relationship requires clear demarcation of support responsibilities; for instance, Technical Support handles pump and sensor connection issues, such as Alert 29, while specific CGM sensor errors require contacting Abbott at (888) 963-8038. The total number of active users supported by this infrastructure is substantial, with Q3 2025 shipments alone totaling more than 20,000 pumps in the United States and more than 9,000 pumps internationally. The company reaffirmed its full-year 2025 sales guidance at approximately $1.0 billion worldwide, indicating a large, ongoing service commitment.

Here is a breakdown of recent shipment volumes, which suggests the scale of the customer base being supported:

Metric Q3 2025 Volume Q2 2025 Volume
U.S. Pump Shipments More than 20,000 units Approximately 21,000 units
International Pump Shipments More than 9,000 units Approximately 9,000 units

Extensive diabetes education and pump training programs

The company supports its user base with educational resources designed to maximize the utility of their devices. This includes an extensive library of educational and self-help materials available for users to browse. Furthermore, Tandem Diabetes Care, Inc. is actively educating healthcare providers on pump therapy, specifically targeting the type 2 diabetes patient segment. The Control-IQ+ technology, which automates glucose levels, is indicated for use in adults with type 2 diabetes aged $\ge \mathbf{18}$ years, as well as people with type 1 diabetes aged $\ge \mathbf{2}$ years, following clearance received in February 2025. In Q1 2025, the company shipped 28,000 new pumps, with a 50% split between new and renewal customers, suggesting a continuous need for training and onboarding support.

High-touch, direct-to-consumer support model

The core relationship model has traditionally been direct, though it is shifting with channel expansion. The company aims for high customer satisfaction and retention, which is supported by the performance of newer products. For example, the Tandem Mobi system achieved 86% satisfaction among early access participants. A key element of the evolving direct relationship is the channel strategy. As of Q3 2025, pharmacy benefit coverage for Tandem Mobi increased to more than 40% of U.S. lives, and the company introduced t:slim X2 supplies through this channel. However, pharmacy revenue accounted for only 5% of U.S. revenue in Q3 2025, showing the direct/traditional channels still dominate the revenue relationship.

The support structure must adapt to this channel mix:

  • Focus on MDI (multiple daily injections) conversions.
  • Educating providers on pump therapy for Type 2 diabetes.
  • Improving customer retention and utilization, which showed significant improvement in Q1 2025.
  • Managing the transition to direct commercial operations internationally starting in 2026.

Digital self-service via the Tandem Source data platform

The Tandem Source platform serves as the central digital hub for both users and healthcare providers (HCPs), consolidating features from legacy systems like t:connect. This platform is available for all Tandem pump users and their HCPs in the United States, with international expansion planned for 2025. The platform facilitates a self-service relationship by providing:

  • Access to important therapy data and visualizations.
  • Convenient ways for pump users to reorder supplies.
  • Tools for users to update their pump software.
  • HCP access to critical patient data and trend identification via three new Tandem Source reports.

The platform supports automatic data transfers from users' pumps using the t:connect mobile app, keeping online data current and removing the need for manual pump uploads. This digital layer helps scale the support model while maintaining data-driven engagement with the clinical team.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Channels

You're looking at how Tandem Diabetes Care, Inc. gets its products-pumps and supplies-into the hands of people managing diabetes. The channel strategy is clearly evolving, moving toward a multi-channel approach to capture more market share, especially in the Type 2 segment and internationally.

Direct sales force to endocrinologists and diabetes clinics

The direct sales force remains key for driving initial pump adoption, focusing on healthcare providers who manage the estimated 2 million people with Type 1 diabetes in the U.S., where pump penetration is less than 40% as of early 2025. This channel also targets the Type 2 insulin-intensive population, where pump use is only about 5% of more than 2 million patients in the U.S..

For context on the overall sales volume these channels contribute to, Tandem Diabetes Care reaffirmed its 2025 full-year worldwide sales guidance at approximately $1.0 billion.

Durable Medical Equipment (DME) channel for pump sales

The DME channel is a foundational route for pump sales, with the company successfully launching a multi-channel strategy that includes DME for the Tandem Mobi system in the U.S. starting in the fourth quarter of 2024. Before the major channel shift, Tandem Diabetes Care sold about 62% of its products through a small number of distributors, which aligns with the traditional DME/distributor model.

Accelerating Pharmacy Channel for supplies and Mobi pump

The pharmacy channel is a significant area of acceleration, with the company starting to offer t:slim X2 supplies through pharmacy benefits in the fourth quarter of 2025. This move follows the successful launch of the multi-channel strategy for the Tandem Mobi pump in the U.S..

Here's the quick math on pharmacy channel progress:

  • As of the fourth quarter of 2024, approximately 20 percent of covered lives were under pharmacy rebate agreements for the Tandem Mobi strategy.
  • By the first quarter of 2025, expansion into the pharmacy channel was covering 30% of U.S. lives.
  • The company anticipates returning to new pump growth driven by increased pharmacy access in 2026.
  • Supply revenue, which benefits from this channel, makes up approximately 55% of total revenue.

Direct international operations in key markets (e.g., Canada, Europe)

Tandem Diabetes Care is actively shifting toward direct international operations to strengthen its financial position, despite anticipating a sales headwind in 2025 because of this transition.

Financial performance shows the scale of international business:

Metric Q3 2025 Actual 2025 Full Year Guidance
Sales Outside the United States (GAAP) $73.6 million Approximately $300 million
Pump Shipments Outside the United States More than 9,000 pumps N/A

The CEO noted plans for expanding direct international operations in Europe, specifically targeting the U.K., Switzerland, and Austria in early 2026. As of the first quarter of 2025, the company had approximately 480,000 in-warranty customers across 25 countries.

Online portal for ordering recurring disposable supplies

While specific transaction volume for the online portal isn't explicitly detailed, the channel supports the recurring revenue stream from disposables. The overall revenue mix indicates that supply revenue accounts for about 55% of total revenue. This recurring revenue stream is essential, as the pricing model generates approximately $7-8K per patient in a four-year reimbursement cycle, split between the initial pump purchase and ongoing supplies.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Customer Segments

You're looking at the core groups Tandem Diabetes Care, Inc. (TNDM) serves with its automated insulin delivery systems. This isn't just one pool of patients; it's a tiered approach, moving from a highly engaged core to a massive, newly accessible segment.

People with Type 1 diabetes (core market)

This group forms the foundation of Tandem Diabetes Care, Inc.'s user base. They are the established users of the t:slim X2 insulin pump, often leveraging the Control-IQ technology. The company was recognized as the #1 recommended insulin pump brand by both healthcare providers and people living with type 1 diabetes. The technology itself has shown strong clinical results, reducing hypoglycemic events by 30% in clinical trials.

People with Type 2 diabetes (newly cleared Control-IQ+ market)

This is the significant growth vector Tandem Diabetes Care, Inc. is aggressively pursuing. The FDA clearance for Control-IQ+ for adults with Type 2 diabetes is a game-changer, as management stated this more than doubles Tandem's addressable market in the U.S. The Type 2 diabetes market represents a substantial opportunity, estimated at a $30 billion segment. The initial pilot launch for Type 2 adoption showed promising results, with greater adoption seen in pilot territories compared to non-pilot areas.

Patients converting from Multiple Daily Injections (MDI)

A key metric for growth within both Type 1 and Type 2 segments is the conversion rate from traditional insulin injections. In the second quarter of 2025, people converting from MDI accounted for about 2/3 of new pump starts. Furthermore, the installed base remains loyal, with renewals tracking through at a historical capture rate of more than 70% of eligible customers within 18 months after warranty expiration.

The customer segments are geographically diverse, though heavily weighted toward the U.S. market, with clear revenue expectations set for 2025:

Customer Segment Focus Geographic Market Projected 2025 Sales Contribution Q3 2025 Sales Achieved
Type 1 Diabetes Core Users United States Approximately $700 million Approximately $176 million
Type 1 & Type 2 Expansion Users Outside the United States (OUS) Approximately $300 million $74 million

Global users across the US, Canada, and European markets

Tandem Diabetes Care, Inc. is a global player, though the U.S. remains the primary revenue driver. The company is actively preparing for a shift in its international strategy, which impacts current customer servicing.

  • The U.S. market is expected to account for approximately 70% of the total projected 2025 worldwide sales of $1 billion.
  • The company is preparing to transition to direct commercial operations in select European countries, including the U.K., Switzerland, and Austria, starting in early 2026.
  • The international segment includes established markets like Canada, alongside European operations.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Cost Structure

You're looking at the expenses Tandem Diabetes Care, Inc. incurs to run its business as of late 2025. Honestly, it's a mix of direct product costs, heavy investment in future tech, and the cost of scaling commercial reach.

The largest component tied directly to sales is the Cost of Goods Sold (COGS). For the full year 2025, COGS for pumps and disposable supplies is estimated at $460 million, which aligns with the projected 54% GAAP gross margin on estimated $1.0 billion in worldwide sales guidance. That 54% gross margin is a key target, with management aiming for a record in the mid- to high-50s for Q4 2025.

Operating expenses reflect significant investment, though R&D spending is being managed tightly. In the third quarter of 2025, R&D costs actually declined year-over-year due to a commitment to disciplined resource allocation while still developing innovative products. Still, the overall cost structure shows a focus on commercial growth.

Selling, General, and Administrative (SG&A) costs are clearly rising to support expansion. Operating expenses increased 4% year-over-year in Q3 2025, primarily attributed to SG&A investments. These investments cover US salesforce expansion and costs to support the move toward direct operations in Europe.

You can see the breakdown of the major non-cash items Tandem Diabetes Care, Inc. expects for the full year 2025:

Cost Component Estimated Full Year 2025 Amount
Total Non-Cash Charges (COGS & OpEx) Approximately $115 million
Stock-Based Compensation Expense Approximately $95 million
Depreciation and Amortization Expense Approximately $20 million

The push into the pharmacy channel is a major operational cost driver right now. Tandem Diabetes Care, Inc. is actively working to increase access, having successfully increased pharmacy benefit coverage for Tandem Mobi to more than 40% of U.S. lives by Q3 2025. This multichannel strategy requires investment in infrastructure and contracting. Furthermore, the company anticipates a $10 million headwind in 2025 associated with preparing for direct commercial operations in select international markets starting in early 2026.

Here are the key cost-related activities shaping the structure:

  • Cost of Goods Sold (COGS) is projected to be 46% of sales based on the 54% gross margin target.
  • SG&A investments support US salesforce expansion and European direct operations setup.
  • R&D spending is being maintained with a focus on disciplined resource allocation.
  • Stock-based compensation is a significant non-cash cost, estimated at $95 million for the year.
  • Pharmacy channel expansion involves costs to secure over 40% U.S. coverage for Mobi.

Finance: draft 13-week cash view by Friday.

Tandem Diabetes Care, Inc. (TNDM) - Canvas Business Model: Revenue Streams

The revenue streams for Tandem Diabetes Care, Inc. are fundamentally built around the sale of their durable insulin delivery hardware and the subsequent, ongoing sale of necessary disposable supplies.

The primary hardware revenue driver involves the sales of insulin pumps, specifically the t:slim X2 and the smaller Mobi system. These devices are typically reimbursed by payers, such as Medicare Part B, which generally covers 80% of the cost, on a cycle approximating every four years for replacement.

A critical component of the recurring revenue model is the sale of disposable pump supplies. This includes items like cartridges and infusion sets, which require regular replacement to maintain therapy. For instance, infusion sets need changing every 2 to 3 days.

Tandem Diabetes Care, Inc. has set a significant financial target for the current fiscal year, reaffirming its full-year 2025 worldwide sales guidance of approximately $1.0 billion.

This projected total revenue is segmented geographically, with international sales expected to contribute approximately $300 million in 2025.

To give you a clearer picture of the current run rate against the annual target, here is a comparison of the latest reported quarterly results against the full-year guidance expectations:

Metric Full-Year 2025 Guidance Q3 2025 Actuals Q2 2025 Actuals
Worldwide Sales Approximately $1.0 billion $249 million (or $249.3 million) $240.7 million
U.S. Sales Approximately $700 million Approximately $176 million $170 million
International Sales Approximately $300 million $74 million $70 million

The company is actively expanding access points, which directly impacts the volume of pump sales. A key part of their commercial transformation involves the pharmacy channel. As of late 2025, Tandem Diabetes Care, Inc. has successfully increased pharmacy benefit coverage for the Tandem Mobi pump to more than 40% of U.S. lives.

The revenue structure relies on these key streams:

  • Sales of insulin pumps (t:slim X2, Mobi), reimbursed approximately every four years.
  • Recurring revenue from sales of disposable pump supplies (cartridges, infusion sets).
  • Geographic expansion contributing to the $300 million international sales expectation for 2025.
  • U.S. pump sales contributing to the overall guidance of approximately $700 million for the full year 2025.

The gross margin expectation for the full year 2025 is reaffirmed in the range of 53% to 54% of sales, with Q4 expected to hit an all-time gross margin record in the mid- to high 50s percent.

Finance: draft 13-week cash view by Friday.


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