Latest news with #TandemDiabetesCare
Yahoo
3 days ago
- Business
- Yahoo
Tandem, Insulet monitoring CMS payment proposal for diabetes tech
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. Medtech executives discussed planned changes to how the Centers for Medicare and Medicaid Services could pay for diabetes technology in earnings calls this week. Insulin pump makers Insulet and Tandem Diabetes Care don't expect much of an impact on their business from the proposed changes, but said they would be monitoring the policy. In June, CMS issued a proposed rule that would seek to include insulin pumps and continuous glucose monitors in a competitive bidding program. The rule would also change payments to a monthly rental schedule instead of a contract where the devices are paid for upfront. RBC Capital Markets analyst Shagun Singh expects Tandem and Medtronic to be impacted the most, 'as the new proposal would allow for competitive switching,' she wrote in a July 1 research note. Singh expects Insulet to see less of an impact as the company already uses a 'pay-as-you-go' model, and Dexcom's and Abbott's CGMs are already sold on a monthly bundle basis. Tandem CFO Leigh Vosseller said on an earnings call Wednesday that the company does not expect the changes to have a material impact on the company's business, and 'we anticipate it could help drive more people to pump therapy.' Currently, traditional Medicare makes up less than 10% of Tandem's sales. Vosseller said the payment change would shift pump reimbursement from a 13-month rental to a pay-as-you-go model. Tandem, which currently sells most of its pumps through a durable medical equipment model, plans to begin selling supplies for its t:slim X2 pump through the pharmacy channel starting in the fourth quarter. 'Transitioning to a pay-as-you-go model is something that we've contemplated anyway from a commercial perspective as we've pursued the pharmacy channel,' Vosseller said. She added that Tandem will be participating in the comment period and anticipates final rulings in November. Tandem lowered its earnings forecast for U.S. sales in 2025 to $700 million for the year, down from a previous range of $725 million to $730 million. CEO John Sheridan said the change was due to a new market entrant that has built a larger-than-expected sales team, and initiatives that are still in progress to modernize Tandem's systems and grow its salesforce. The company also disclosed a recall related to a speaker problem with its devices, which has been associated with 59 injuries. Tandem's stock price was down roughly 20% to $11.52 at market close Thursday. Insulet, Dexcom expect little impact Insulet expects little impact from the CMS changes. CEO Ashley McEvoy told investors Thursday that the company's devices are already sold on a pay-as-you-go basis, as the company does almost all of its sales through the pharmacy channel. Insulet's patch pumps are covered under Medicare Part D, which covers prescription drugs, and McEvoy doesn't think they will be eligible for competitive bidding under Part B, which covers durable medical equipment. 'We are going to continue to engage with CMS to really talk about the benefits of our differentiated Omnipod 5 technology and how we improve care for people with diabetes,' McEvoy said. Insulet raised its sales expectations for 2025, now anticipating growth of 24% to 27%, from a previous range of 19% to 22% Dexcom Chief Operating Officer Jake Leach also addressed the CMS competitive bidding proposal, saying about 15% of the company's business is fee-for-service Medicare. Leach, who will become CEO of Dexcom in January, said on an earnings call in July that 'we feel very comfortable about the value that we bring for the price of our product.' He added that Dexcom also wants to ensure there's not an interruption to care for people on Medicare as has happened in previous versions of competitive bidding. CFO Jereme Sylvain said he expects the bidding process to start no earlier than 2027, based on historical precedent. Recommended Reading Tandem insulin pump malfunction linked to 59 injuries Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
5 days ago
- Business
- Reuters
Tandem Diabetes Care issues voluntary device correction for certain insulin pumps
Aug 7 (Reuters) - Tandem Diabetes Care (TNDM.O), opens new tab issued a voluntary correction for an insulin pump model due to a speaker malfunction that disrupts communication with glucose monitoring systems, potentially causing high blood sugar levels. Shares of the company fell more than 27% in premarket trading, following issues with the t:slim X2 insulin pumps. The firm reported 700 adverse events and 59 injuries associated with the defect, "Malfunction 16", but no deaths. However, in severe cases, users may require hospitalization or medical intervention, Tandem added. As part of the correction, Tandem sent notices to impacted U.S. customers between July 22 and 24, 2025, with instructions on what to do in the event of a malfunction. It will also release a software update to enhance early detection of speaker failures and introduce vibration alerts to help reduce potential safety risks.
Yahoo
5 days ago
- Business
- Yahoo
Insulet Peer Tandem Diabetes Underwhelming Earnings, Dull Outlook Drags Stock
Tandem Diabetes Care Inc.'s (NASDAQ:TNDM) stock plunged on Thursday after the company cut its annual guidance. The diabetes-focused company reported adjusted loss of 78 cents per share, missing the consensus loss of 40 cents. Tandem reported sales of $240.678 million, up 8% year over year, beating the consensus of $238.57 million. Shipments in the United States grew to approximately 21,000 pumps. Shipments outside the United States were approximately 9,000 Tandem Diabetes narrowed fiscal 2025 sales guidance from $997 million-$1.01 billion to $1 billion compared to the consensus of $1.004 billion. 'Our narrowed guidance reflects insights gained in the first half of the year, including our U.S. growth expectations as we progress our commercial transformation, increased benefit from accelerated pharmacy channel initiatives, and greater contributions from international sales,' said Leigh Vosseller, executive vice president and CFO. Updated guidance includes sales in the United States of approximately $700 million. Sales outside the United States of approximately $300 million reflect a $10 million headwind associated with the company's preparation for direct commercial operations in select countries. Gross margin is estimated to be 53% to 54% of sales for the full year. View more earnings on TNDM Adjusted EBITDA margin is being recast from approximately 3% to approximately negative 5% of sales for the full year, which has been updated to include a negative 8 percentage point impact for an acquired in-process research and development charge that occurred in the first quarter of 2025. Medical Device Correction On Thursday, Tandem Diabetes also announced a voluntary medical device correction for select t:slim X2 insulin pumps to address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery. The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device. If not addressed, this could result in hyperglycemia due to discontinuation of insulin delivery, real-time CGM Estimated Glucose Values, and CGM trends. There have been 700 confirmed adverse events, defined as a confirmed high blood sugar and/or an event requiring medical intervention, and 59 reported injuries. No deaths have been reported. Analyst Reaction Piper Sandler downgrades Tandem Diabetes Care from Overweight to Neutral and lowers the price forecast from $30 to $14. Wells Fargo maintains Tandem with an Equal-Weight, lowering the price forecast from $20 to $13. RBC Capital maintains Tandem Diabetes with an Outperform, lowering the price forecast from $45 to $25. Price Action: TNDM stock is down 21.2% at $11.34 at the last check on Thursday. Read Next:Photo via Shutterstock Latest Ratings for TNDM Date Firm Action From To Feb 2022 Wells Fargo Maintains Overweight Feb 2022 Citigroup Maintains Buy Feb 2022 SVB Leerink Maintains Market Perform View More Analyst Ratings for TNDM View the Latest Analyst Ratings UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article Insulet Peer Tandem Diabetes Underwhelming Earnings, Dull Outlook Drags Stock originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
6 days ago
- Business
- Yahoo
Tandem Diabetes (NASDAQ:TNDM) Exceeds Q2 Expectations But Stock Drops 17%
Diabetes technology company Tandem Diabetes Care (NASDAQ:TNDM) reported Q2 CY2025 results topping the market's revenue expectations , with sales up 8.5% year on year to $240.7 million. The company expects the full year's revenue to be around $1 billion, close to analysts' estimates. Its GAAP loss of $0.78 per share was significantly below analysts' consensus estimates. Is now the time to buy Tandem Diabetes? Find out in our full research report. Tandem Diabetes (TNDM) Q2 CY2025 Highlights: Revenue: $240.7 million vs analyst estimates of $237.1 million (8.5% year-on-year growth, 1.5% beat) EPS (GAAP): -$0.78 vs analyst estimates of -$0.39 (significant miss) Adjusted EBITDA: -$1.85 million vs analyst estimates of $2.34 million (-0.8% margin, significant miss) The company reconfirmed its revenue guidance for the full year of $1 billion at the midpoint Operating Margin: -21.5%, down from -13.9% in the same quarter last year Sales Volumes rose 5% year on year, in line with the same quarter last year Market Capitalization: $1.01 billion Company Overview With technology that automatically adjusts insulin delivery based on continuous glucose monitoring data, Tandem Diabetes Care (NASDAQ:TNDM) develops and manufactures automated insulin delivery systems that help people with diabetes manage their blood glucose levels. Revenue Growth Examining a company's long-term performance can provide clues about its quality. Any business can have short-term success, but a top-tier one grows for years. Over the last five years, Tandem Diabetes grew its sales at an impressive 19.5% compounded annual growth rate. Its growth beat the average healthcare company and shows its offerings resonate with customers. We at StockStory place the most emphasis on long-term growth, but within healthcare, a half-decade historical view may miss recent innovations or disruptive industry trends. Tandem Diabetes's annualized revenue growth of 12.4% over the last two years is below its five-year trend, but we still think the results suggest healthy demand. Tandem Diabetes also reports its number of pump shipments, which reached 21,000 in the latest quarter. Over the last two years, Tandem Diabetes's pump shipments averaged 2.9% year-on-year growth. Because this number is lower than its revenue growth, we can see the company benefited from price increases. This quarter, Tandem Diabetes reported year-on-year revenue growth of 8.5%, and its $240.7 million of revenue exceeded Wall Street's estimates by 1.5%. Looking ahead, sell-side analysts expect revenue to grow 4.8% over the next 12 months, a deceleration versus the last two years. This projection is underwhelming and suggests its products and services will see some demand headwinds. Unless you've been living under a rock, it should be obvious by now that generative AI is going to have a huge impact on how large corporations do business. While Nvidia and AMD are trading close to all-time highs, we prefer a lesser-known (but still profitable) stock benefiting from the rise of AI. Click here to access our free report one of our favorites growth stories. Adjusted Operating Margin Adjusted operating margin is one of the best measures of profitability because it tells us how much money a company takes home after subtracting all core expenses, like marketing and R&D. It also removes various one-time costs to paint a better picture of normalized profits. Tandem Diabetes's high expenses have contributed to an average adjusted operating margin of negative 7.9% over the last five years. Unprofitable healthcare companies require extra attention because they could get caught swimming naked when the tide goes out. It's hard to trust that the business can endure a full cycle. Analyzing the trend in its profitability, Tandem Diabetes's adjusted operating margin decreased by 15.6 percentage points over the last five years. The company's two-year trajectory also shows it failed to get its profitability back to the peak as its margin fell by 1.6 percentage points. This performance was poor no matter how you look at it - it shows its expenses were rising and it couldn't pass those costs onto its customers. Tandem Diabetes's adjusted operating margin was negative 13.2% this quarter. Earnings Per Share Revenue trends explain a company's historical growth, but the long-term change in earnings per share (EPS) points to the profitability of that growth – for example, a company could inflate its sales through excessive spending on advertising and promotions. Tandem Diabetes's earnings losses deepened over the last five years as its EPS dropped 34.2% annually. We tend to steer our readers away from companies with falling EPS, where diminishing earnings could imply changing secular trends and preferences. If the tide turns unexpectedly, Tandem Diabetes's low margin of safety could leave its stock price susceptible to large downswings. In Q2, Tandem Diabetes reported EPS at negative $0.78, down from negative $0.47 in the same quarter last year. This print missed analysts' estimates. Over the next 12 months, Wall Street expects Tandem Diabetes to improve its earnings losses. Analysts forecast its full-year EPS of negative $3.09 will advance to negative $1.00. Key Takeaways from Tandem Diabetes's Q2 Results It was encouraging to see Tandem Diabetes beat analysts' revenue expectations this quarter. On the other hand, its EPS missed and its sales volume fell short of Wall Street's estimates. Overall, this was a softer quarter. The stock traded down 17% to $12 immediately after reporting. Tandem Diabetes may have had a tough quarter, but does that actually create an opportunity to invest right now? If you're making that decision, you should consider the bigger picture of valuation, business qualities, as well as the latest earnings. We cover that in our actionable full research report which you can read here, it's free. Inicia sesión para acceder a tu cartera de valores
Yahoo
05-08-2025
- Business
- Yahoo
Tandem Diabetes (TNDM) Q2 Earnings Report Preview: What To Look For
Diabetes technology company Tandem Diabetes Care (NASDAQ:TNDM) will be reporting earnings this Wednesday after the bell. Here's what investors should know. Tandem Diabetes beat analysts' revenue expectations by 6.8% last quarter, reporting revenues of $234.4 million, up 22.3% year on year. It was a strong quarter for the company, with an impressive beat of analysts' sales volume estimates and full-year revenue guidance meeting analysts' expectations. Is Tandem Diabetes a buy or sell going into earnings? Read our full analysis here, it's free. This quarter, analysts are expecting Tandem Diabetes's revenue to grow 6.8% year on year to $237.1 million, slowing from the 13.3% increase it recorded in the same quarter last year. Adjusted loss is expected to come in at -$0.40 per share. The majority of analysts covering the company have reconfirmed their estimates over the last 30 days, suggesting they anticipate the business to stay the course heading into earnings. Tandem Diabetes has missed Wall Street's revenue estimates three times over the last two years. Looking at Tandem Diabetes's peers in the healthcare technology segment, some have already reported their Q2 results, giving us a hint as to what we can expect. Hims & Hers Health delivered year-on-year revenue growth of 72.6%, missing analysts' expectations by 1.1%, and Omnicell reported revenues up 5%, topping estimates by 4.9%. Omnicell's stock price was unchanged following the results. Read our full analysis of Hims & Hers Health's results here and Omnicell's results here. Questions about potential tariffs and corporate tax changes have caused much volatility in 2025. While some of the healthcare technology stocks have shown solid performance in this choppy environment, the group has generally underperformed, with share prices down 3.3% on average over the last month. Tandem Diabetes is down 5.1% during the same time and is heading into earnings with an average analyst price target of $31.10 (compared to the current share price of $15.42). Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. StockStory is growing and hiring equity analyst and marketing roles. Are you a 0 to 1 builder passionate about the markets and AI? See the open roles here. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
