Tandem Diabetes Care (TNDM) investor relations material

Market opportunity and growth drivers

• Diabetes pump therapy remains under-penetrated, with only 40% of type 1 and 5% of type 2 patients in the U.S. using pumps, and even lower adoption internationally.

• Expansion into new product categories, including the upcoming launch of a tubeless pump platform, aims to address diverse patient needs and increase market share.

• Affordability is being tackled through a pay-as-you-go pharmacy model, reducing upfront costs and making pump therapy more accessible.

• The company currently serves about 500,000 users globally and is focused on clinical outcomes, wearability, and affordability as key competitive differentiators.

• Key initiatives include pharmacy channel conversion, Mobi tubeless pump clearance, and transitioning international markets from distributor to direct sales.

Product innovation and competitive landscape

• The Mobi tubeless pump, filed with the FDA in Q2, is expected to launch in a scaled manner, with 2027 as the first full year of material impact.

• Differentiation is driven by features like extended wear, flexible tube/tubeless options, and advanced algorithms such as Control-IQ+ and the upcoming fully closed loop system.

• The fully closed loop system, designed for both type 1 and type 2 patients, will eliminate meal announcements and is expected to enter pivotal trials soon, with a roughly 18-month study timeline.

• The company sees GLP-1 therapies as complementary to pump therapy, especially for type 2 patients, and expects continued growth despite increased competition.

• The competitive market is addressed through ongoing improvements in affordability, clinical outcomes, and product wearability.

Business model transformation and operational execution

• The pharmacy pay-as-you-go model launched in March, with about 45% formulary coverage achieved off-cycle, aiming for 80% of pumps through pharmacy in 2–3 years.

• Transitioning international markets to direct sales is underway, starting with the UK, Switzerland, and Austria, with France and more markets planned.

• Direct sales internationally yield at least a 30% price step-up and improved margins, with enhanced customer and physician engagement.

• Operational learnings from both pharmacy and international transitions are improving efficiency and scalability.

• The company is implementing new CRM and ERP systems to support direct international operations and leveraging shared resources across markets.