Tandem Diabetes Care, Inc.
15.10+0.16 (+1.07%)
Oct 28, 4:00:00 PM EDT · NasdaqGM · TNDM · USD
Key Stats
Market Cap
1.02BP/E (TTM)
-Basic EPS (TTM)
-3.08Dividend Yield
0%Recent Filings
8-K
FDA clears SteadiSet infusion set
Tandem Diabetes Care secured FDA 510(k) clearance on August 6, 2025, for its SteadiSet infusion set, enabling up to seven days of insulin delivery with a one-handed, hidden-needle inserter for type 1 diabetes patients. The company plans to launch it standalone for t:slim X2 and Tandem Mobi pumps, plus integrate it into the upcoming tubeless Mobi system, while scaling manufacturing over coming quarters. No financial details disclosed yet. Forward-looking plans hinge on regulatory and supply risks.
10-Q
Q2 FY2025 results
Tandem Diabetes Care posted solid Q2 revenue growth, with sales climbing 8.5% year-over-year to $240.7M (derived), driven by higher U.S. pump and supply volumes amid the Tandem Mobi rollout, while international sales rose 8.1% to $70.5M on supply strength despite softer pump shipments. Gross margin edged up to 52.3% from 50.8% (derived), reflecting better pricing, though operating loss widened to $51.8M from $30.8M due to $20.0M in litigation settlement costs with Roche and elevated SG&A from sales expansion. For the half-year, revenue surged 14.9% to $475.1M (derived), but net loss ballooned to $183.0M versus $73.5M last year, fueled by a $75.2M IPR&D charge for the AMF Medical revision and $6.7M lease impairments; diluted EPS fell to $(2.74) on 66,729 weighted shares, consistent with the loss position. Cash and equivalents stood at $64.1M with $251.2M in short-term investments, supporting $309.1M in long-term convertible notes due 2029 at 1.50%, while operating cash used $27.8M and free cash flow (derived) was negative $36.9M after $9.2M capex; the Roche settlement closed in May 2025 for $36.0M over four years (cash), recognizing $13.3M in licensed patents amortized over seven years. Competition from automated insulin rivals remains a key risk.
8-K
Q2 sales hit $240.7M
Tandem Diabetes Care reported Q2 2025 sales of $240.7 million, up 8% from $221.9 million last year, with U.S. revenue hitting $170.2 million and international at $70.5 million. Gross margin improved to 52%, yet operating loss widened to $51.8 million due to $20 million in litigation costs. The company guides for $1.0 billion in full-year sales, targeting 53-54% margins while advancing products like the Tandem Mobi with CE Mark. Litigation expenses dragged profitability.
8-K
Tandem settles Roche patent disputes
Tandem Diabetes Care settled patent disputes with Roche entities on May 21, 2025, terminating all ongoing actions in the Unified Patent Court and granting mutual 10-year licenses to insulin delivery patents. The deal costs Tandem $36 million over five years, starting with an $8 million initial payment. This clears legal overhangs, freeing focus on core operations. Shareholders also re-elected the board and ratified Ernst & Young as auditors at the annual meeting.
8-K
CE mark for Tandem Mobi
Tandem Diabetes Care secured CE mark approval for its Tandem Mobi insulin delivery system featuring Control-IQ+ technology on May 16, 2025, paving the way for European market entry. The company plans regulatory registrations, reimbursement pursuits, and commercial launches across the EU by year-end. Yet regulatory hurdles and reimbursement pressures loom large. Forward-looking plans hinge on navigating these risks.
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