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SAN DIEGO - Tandem Diabetes Care, Inc. (NASDAQ:TNDM), an insulin delivery and diabetes technology company with annual revenues of $940 million and a market capitalization of $1.32 billion, has announced results from a pivotal trial of its Control-IQ+ automated insulin delivery (AID) technology for type 2 diabetes patients. According to InvestingPro data, the company maintains a healthy gross profit margin of 52% while operating with moderate debt levels. Published by The New England Journal of Medicine (NEJM), the trial demonstrated considerable improvements in glycemic control. While the company’s stock has faced challenges, declining over 54% in the past six months, InvestingPro analysis suggests the stock is currently in oversold territory, with 12 analysts actively monitoring the company’s progress.
The randomized controlled study involved 319 participants aged 19 to 87, including a diverse racial and socio-economic demographic. It reported a 0.9% reduction in hemoglobin A1c (A1C) levels for individuals using Control-IQ+ technology versus a 0.3% decrease in the control group using a continuous glucose monitoring (CGM) system. Notably, participants with A1C levels of 9% or higher at the start of the study experienced a 2.3% reduction in A1C.
The 13-week study also showed that time in range (blood glucose levels within the target range) improved by 16% with Control-IQ+, equating to an additional 3.8 hours per day in range compared to baseline, and 3.4 more hours per day than the control group. Insulin use decreased by an average of 8 units per day in the Control-IQ+ group, in contrast to an increase of 2 units per day in the CGM group.
Safety outcomes were positive, with no new safety signals unique to type 2 diabetes users. The frequency of hypoglycemia was low in both groups, with one severe hypoglycemic event occurring in the Control-IQ+ group, which was treated with oral carbohydrates. There were no reported events of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
Additional data presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) highlighted the effectiveness of different meal bolusing strategies and user satisfaction with the device. The study’s broad inclusion criteria and the diverse population it encompassed suggest a wide applicability of Control-IQ+ technology in type 2 diabetes management.
These results underscore the potential of Control-IQ+ technology to improve outcomes for people with type 2 diabetes using insulin, potentially easing daily therapy burdens and enhancing quality of life. The company’s strong liquidity position, with a current ratio of 2.93, provides financial flexibility to support continued innovation. For deeper insights into Tandem Diabetes Care’s financial health and growth prospects, including exclusive ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports and expert commentary. The information in this article is based on a press release statement.
In other recent news, Tandem Diabetes Care has reported significant developments that investors should consider. The company announced fourth-quarter 2024 revenues of $252.4 million, a 20.6% increase that exceeded the consensus estimate of $249.7 million. While international sales showed a robust 48.4% increase to $68.1 million, U.S. sales rose 12.8% to $184.4 million, slightly missing the anticipated $190.3 million. For 2025, Tandem Diabetes provided revenue guidance between $997 million and $1.007 billion, reflecting a 10-11% increase, but this has raised concerns among investors and analysts due to potential international headwinds.
Morgan Stanley downgraded Tandem Diabetes from Overweight to Equalweight, citing concerns over modest growth projections and increased competition. The firm also reduced its price target to $22 from $45. Similarly, Citi downgraded the stock from Buy to Neutral, lowering the price target to $24 from $35, due to uncertainties in the company’s future performance despite the recent revenue growth. Bernstein also adjusted its rating from Outperform to Market Perform, setting a new price target of $25, influenced by Tandem’s loss of market share in the U.S. and increased competition from new entrants like Beta Bionics.
These downgrades reflect a cautious outlook on Tandem Diabetes Care’s ability to navigate a competitive market, with analysts expressing concerns over the company’s growth trajectory and financial performance. The strategic shifts, including a U.S. sales expansion and transition of overseas distributors, are seen as potential challenges for the company in 2025. Despite these challenges, some analysts, like those from Citi, maintain a Buy rating, acknowledging the potential for growth with new products on the horizon, but they anticipate short-term pressure on the stock.
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