Continuous Glucose Monitoring (CGM)
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Senseonics Holdings, Inc. Reports First Quarter Financial Results
Globenewswire· 2025-05-08 20:05
Core Insights - Senseonics Holdings, Inc. reported a first quarter revenue of $6.3 million, representing a year-over-year growth of 24% from $5.0 million in Q1 2024 [4] - The company has partnered with Sequel to integrate its twiist™ automated insulin delivery system with the Eversense® 365 continuous glucose monitor, with a launch expected in Q3 2025 [1][9] - The company aims to improve access and flexibility for diabetes patients through its Eversense platform, with significant milestones achieved in reimbursement and product development [3] Financial Performance - Total revenue for Q1 2025 was $6.3 million, with U.S. revenue at $4.5 million and international revenue at $1.8 million, compared to $3.7 million and $1.3 million respectively in Q1 2024 [4] - Gross profit for Q1 2025 was $1.5 million, up from $0.3 million in Q1 2024, driven by increased margins on the 365-day product [5] - The net loss for Q1 2025 was $14.3 million, a reduction from a net loss of $18.9 million in Q1 2024, attributed to improved gross profit margins and reduced R&D costs [7] Expense Management - Selling, general and administrative expenses decreased by $0.4 million year-over-year to $7.7 million, primarily due to lower personnel costs and consulting fees [5] - Research and development expenses decreased by $3.1 million year-over-year to $7.3 million, mainly due to reduced spending on clinical studies following the completion of trials for the 365-day product [6] Future Outlook - The company expects full-year 2025 global net revenue to be approximately $34-38 million, anticipating a doubling of its global patient base [8] - Gross margins are projected to increase throughout 2025, with expectations of reaching between 25% and 30% for the full year [10] - Cash used in operations for 2025 is expected to be between $50 million and $60 million [10]
2 Growth Stocks to Buy and Hold for a Decade
The Motley Fool· 2025-05-02 08:16
Market Overview - Marketwide challenges, such as President Trump's tariff policies, have led to short-term focus among investors, resulting in panic-selling and a declining stock market [1] - Despite these challenges, a long-term investment strategy focusing on top companies remains effective [1] Company Analysis: MercadoLibre - MercadoLibre has seen a stock increase of 25% this year, outperforming broader equities [3] - As the leading e-commerce platform in Latin America, MercadoLibre offers a comprehensive suite of products, including fintech and logistics services [3][4] - The company is less affected by U.S. tariffs due to its focus on South American customers, positioning it well in a volatile environment [4] - Strong revenue growth and significant earnings increases have characterized MercadoLibre's financial performance [5] - The global e-commerce industry is expected to continue growing, benefiting MercadoLibre, which has established logistics and a strong reputation [7] - The company's ability to fend off competition, including from Amazon, suggests it will continue to thrive in the coming decade [9] Company Analysis: DexCom - DexCom specializes in diabetes-focused medical devices, particularly continuous glucose monitoring (CGM) systems, which are crucial for diabetes management [10] - The company has launched innovative products, including the G7 and DexCom One, catering to various customer segments [11] - Key growth drivers for DexCom include increased CGM penetration, expanded coverage from third-party payers, and market expansion into new regions [12][13] - With less than 1% of diabetes patients currently using CGM technology, there is significant growth potential for DexCom [13] - Despite competition from Abbott Laboratories and some impact from tariffs, DexCom's future growth prospects remain strong [15]
DexCom(DXCM) - 2025 Q1 - Earnings Call Transcript
2025-05-01 20:30
Financial Data and Key Metrics Changes - The company reported worldwide revenue of $1,036 million for Q1 2025, a 12% increase compared to $921 million in Q1 2024, with organic revenue growth of 14% [20][21] - U.S. revenue totaled $751 million for Q1 2025, up 15% from $653 million in Q1 2024 [21] - International revenue grew 7% to $286 million, with international organic revenue growth at 12% for the first quarter [24] - Gross profit was $596.2 million, representing 57.5% of revenue, down from 61.8% in Q1 2024 [26] - Operating income was $143.1 million, or 13.8% of revenue, compared to $140.2 million in the same quarter of 2024 [27] - Net income for Q1 was $127.7 million, or $0.32 per share [28] Business Line Data and Key Metrics Changes - The company experienced record new customer demand, particularly from the Type 2 non-insulin using population, indicating strong growth in this segment [10][11] - The introduction of Stello, the first over-the-counter CGM, and the CELLo biosensor has attracted a wide range of new customers [14][15] - The company is focusing on expanding its commercial reach and enhancing customer experience through software updates and broader distribution [15][16] Market Data and Key Metrics Changes - The company secured access at two of the three largest PBMs for diabetes patients, which is expected to cover nearly six million people with Type 2 diabetes by the end of the year [12][13] - International business showed strength in Japan and France, with continued growth in the DexCom One platform [25] Company Strategy and Development Direction - The company aims to build on momentum through targeted awareness campaigns and advocating for broader Type 2 coverage [12] - The introduction of new technologies and broader access is a key focus, with plans to launch the fifteen-day G7 system in the second half of the year [18][19] - The company is committed to addressing FDA recommendations following a warning letter and is working on corrective actions [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating supply dynamics and maintaining customer support during transitions [9][10] - The company is optimistic about future growth, reaffirming its revenue guidance of $4.6 billion for the year, representing 14% growth [29] - Management highlighted the importance of evidence in driving changes to standards of care and unlocking broader access globally [13] Other Important Information - The company announced a $750 million share repurchase program, reflecting confidence in its financial position [28] - Management emphasized the importance of operational efficiency and investments in technology to support growth [100][101] Q&A Session Summary Question: Did supply have any impact on the revenue growth? - Management indicated that they exited the quarter with normal supply levels, and the revenue figures reflect a normalized pattern [38] Question: Why is the full year guidance unchanged despite strong Q1 growth? - Management stated that it is early in the year, and they want to see how the rest of the year unfolds before making changes to guidance [45] Question: What are the trends in Type 2 patient utilization and reorder rates? - Management noted good retention rates in the Type 2 population, particularly with reimbursement, and strong utilization among Stellar users [53][54] Question: How exposed is the company to a potential recession? - Management believes they are well-positioned to weather economic downturns due to the cost-saving benefits of their products [62][64] Question: What is the status of the fifteen-day sensor rollout? - Management confirmed that they are working on compatibility with pump partners and securing coverage for the new product [92][93] Question: What is the path for Medicare coverage for non-insulin using Type 2 patients? - Management is actively working with CMS for approval and gathering evidence to support their case [116][119]
Abbott Integrates Libre's Data with Epic's Electronic Health Record System, Providing Healthcare Professionals Seamless Glucose Monitoring Information
Prnewswire· 2025-04-29 13:05
Core Insights - Abbott has entered a groundbreaking agreement to integrate its Libre continuous glucose monitoring (CGM) data into Epic's electronic health record systems in the U.S. This collaboration aims to enhance workflow efficiency for healthcare providers [1][8] Group 1: Integration and Benefits - The integration allows automatic linking of data from users' LibreView accounts to Epic, enabling clinicians to access glucose data seamlessly during patient interactions [2] - This process is designed to help healthcare providers spend less time searching for data and more time on patient care management, ultimately improving patient outcomes [3][4] Group 2: Market Impact - Over 575,000 healthcare providers in the U.S. serving approximately 280 million patients will benefit from this integration, facilitating better collaboration between patients and providers [3] - The integration is expected to simplify diabetes management for nearly 40 million people living with diabetes in the U.S., focusing on reducing administrative burdens [4] Group 3: Company Background - Abbott is recognized as a global leader in healthcare, with a diverse portfolio that includes diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in over 160 countries [6] - The FreeStyle Libre technology has been a significant advancement in diabetes care, currently used by more than 7 million people across over 60 countries [5]
Nasdaq Sell-Off: 2 Brilliant Stocks to Buy No Matter What the Market Does Next
The Motley Fool· 2025-03-19 14:02
Group 1: Market Overview - Equity markets started 2025 positively, but the Nasdaq Composite index has declined by 8% since the beginning of the year [1] - Uncertainty remains regarding future market movements, with potential for quick recovery or a bear market due to global macroeconomic tensions [1] Group 2: DexCom - DexCom's stock dropped by 37% in 2024 and is down by 8% in 2025, but the company's long-term prospects remain attractive [3][10] - DexCom is a leader in the continuous glucose monitoring (CGM) market, with devices like the G7 that help diabetes patients manage blood glucose levels [4] - The percentage of CGM users in the U.S. is still lower than the covered population, indicating significant growth potential for DexCom [5] - Only 1% of diabetes patients worldwide use CGM devices, suggesting ample opportunity for market expansion [6] - The recent launch of the over-the-counter CGM option, Stelo, adds 25 million type 2 diabetes patients not on insulin to DexCom's market [8] - Increased adoption of CGM devices is expected to drive compatibility with other diabetes management tools, enhancing DexCom's competitive advantage [8][9] Group 3: Vertex Pharmaceuticals - Vertex Pharmaceuticals has seen a 27% increase in share price since the beginning of 2025, defying market trends [11] - The company has received approval for two new medicines, Alyftrek for cystic fibrosis and Journavx, a non-opioid oral pain inhibitor [11][12] - Journavx targets a market of approximately 80 million patients in acute pain, with potential for blockbuster status [13][14] - Vertex's pipeline includes Casgevy, a gene-editing treatment for rare blood diseases, and ongoing development for a potential functional cure for type 1 diabetes [15][16] - The company's innovative capabilities and strong pipeline are expected to drive growth well into the 2030s [17]
DexCom CGM Sensor Sales to Continue Despite FDA Warning Letter
ZACKS· 2025-03-14 13:11
Core Viewpoint - DexCom received a warning letter from the FDA due to deficiencies in manufacturing processes and quality management systems, but it does not restrict the company's operations or require product recalls [1][2] Regulatory Actions - DexCom is committed to corrective measures and continuous updates to the FDA, asserting no material impact from the warning letter and that production and distribution remain unaffected [2] - Further regulatory actions could exacerbate existing supply-chain issues, as DexCom has faced challenges related to inventory management and manufacturing disruptions [3] Competition Landscape - DexCom's market share in the durable medical equipment (DME) channel is expected to remain stable, but rising competition from larger rivals like Abbott and Roche poses a concern [4] - Abbott's FreeStyle Libre CGM system has seen significant growth, with sales exceeding $1.8 billion in Q4 2024, a 22.7% increase year-over-year, and projected annual sales of $10 billion by 2028 [5] - Roche's Accu-Chek SmartGuide, recently receiving CE Mark approval, offers advanced features and is set to launch in select European countries [6] Analyst Perspectives - Analysts expect minimal long-term impact from the FDA warning, referencing iRhythm Technologies as a precedent for minimal disruption after similar warnings [7] - DexCom's revenue guidance for 2025 is projected at $4.6 billion, an increase from $4 billion in 2024, with additional remediation costs anticipated but not expected to significantly impact margins [7] Market Position - DexCom holds approximately 74% of the U.S. CGM market share and has strengthened its position through strategic initiatives, including FDA approval of the first over-the-counter CGM in March 2024 [8] - The company has invested $75 million in smart-ring technology to integrate CGM with wearable health technology, reinforcing its long-term growth strategy [8]