Continuous Glucose Monitoring (CGM)

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Trinity Biotech's Redesigned CGM Sensor Favored by New Clinical Data
ZACKS· 2025-08-15 15:01
Key Takeaways Trinity Biotech's CGM+ trial confirmed accurate 15-day glucose tracking without finger-stick calibration.TRIB's redesigned sensor cuts disposable components, lowering cost compared to current CGM products.TRIB's AI-native CGM+ aims to integrate health metrics and target the $260 billion AI wearables market.Trinity Biotech plc (TRIB) announced compelling positive clinical trial results with respect to its next-generation continuous glucose monitoring (CGM) technology, CGM+, on Tuesday. The tria ...
Abbott's Q2 Diabetes Care Sales Rise 19.6%: What's Backing It?
ZACKS· 2025-08-06 12:46
Core Insights - Abbott Laboratories' Diabetes Care business is experiencing significant growth, primarily driven by the FreeStyle Libre continuous glucose monitoring (CGM) platform, which has achieved global leadership in the CGM market for both Type 1 and Type 2 diabetes users [1][2]. Company Developments - Abbott has received FDA approvals for two new over-the-counter CGM systems, Lingo and Libre Rio, expanding its consumer reach and marking a new era in the U.S. market [2][8]. - In Q2 2025, Abbott's CGM sales exceeded $1.90 billion, reflecting a 19.6% organic growth, with U.S. Libre sales increasing nearly 26% [4][8]. - The upcoming launch of Abbott's dual-analyte sensor, which includes ketone monitoring, is expected to enhance its market share, particularly among intensive insulin users [4][8]. Market Trends - The diabetes care devices market is projected to grow significantly, reaching $99.81 billion by 2035, with a compound annual growth rate (CAGR) of 9.6% from 2025 to 2035 [3]. - The increasing aging population, rising obesity rates, and sedentary lifestyles are driving demand in this fast-growing market [3]. Competitive Landscape - Competitors like DexCom and Tandem Diabetes are also expanding their offerings in the CGM space, with DexCom focusing on its G6 and G7 systems and Tandem enhancing its pump portfolio and digital solutions [5][6]. Financial Performance - Year-to-date, Abbott's shares have increased by 19.7%, outperforming the industry growth of 7.9% and the S&P 500's growth of 21.5% [7]. - Abbott currently trades at a forward 12-month Price-to-Sales (P/S) ratio of 4.84X, below the industry average of 5.63X [10].
DexCom Stock Falls Despite Q2 Earnings Beat & 2025 Sales View Raise
ZACKS· 2025-07-31 13:51
Key Takeaways DXCM Q2 sales rose 15.2% to $1.16B, beating estimates; U.S. and international markets both grew double digits.DXCM gross margin fell 340bps to 60.1% on logistics costs; full-year gross margin guidance remains at 62%.DXCM raised 2025 revenue outlook to $4.6-$4.625B, citing new coverage wins and strong CGM demand momentum.DexCom, Inc. (DXCM) reported second-quarter 2025 adjusted earnings per share (EPS) of 48 cents, which beat the Zacks Consensus Estimate of 45 cents by 6.7%. The company reporte ...
DexCom(DXCM) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:32
Dexcom (DXCM) Q2 2025 Earnings Call July 30, 2025 04:30 PM ET Company ParticipantsSean Christensen - VP - Finance & IRKevin Sayer - President, CEO & Chairman of the Board of DirectorsJereme Sylvain - EVP & CFOJacob Leach - President & Chief Operating OfficerTravis Steed - MD - Equity ResearchJoanne Wuensch. - Managing DirectorMatt Taylor - Managing DirectorDavid Roman - Managing DirectorJayson Bedford - MD - Medical TechnologyIssie Kirby - VP - Equity Research, Medical Technology & Life SciencesJoshua Jenni ...
DexCom(DXCM) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:30
Financial Data and Key Metrics Changes - The company reported worldwide revenue of $1,160 million for Q2 2025, a 15% increase compared to $1,000 million in Q2 2024 [22] - U.S. revenue totaled $841 million for Q2 2025, up 15% from $732 million in Q2 2024 [23] - International revenue grew 16% to $316 million in Q2 2025, with organic revenue growth of 14% [24] - Gross profit was $695.9 million, representing 60.1% of revenue, compared to 63.5% in Q2 2024 [27] - Operating income was $221.8 million, or 19.2% of revenue, compared to $195.4 million, or 19.5% of revenue in Q2 2024 [28] - Adjusted EBITDA was $327.6 million, or 28.3% of revenue, consistent with the previous year [29] Business Line Data and Key Metrics Changes - Strong growth was observed in the type two non-insulin population, contributing to market share gains [11] - The Stello app, an over-the-counter glucose biosensor, has been downloaded over 400,000 times, indicating growing brand awareness [11] - The company introduced a new smart food logging feature across its apps, enhancing user experience [13] Market Data and Key Metrics Changes - The company established reimbursement for nearly six million type two non-insulin lives in the U.S. [9] - Coverage expansion in Canada for insulin users through the Ontario Drug Benefit Program represents a significant market opportunity [25] Company Strategy and Development Direction - The company aims to expand coverage for the entire type two non-insulin population in the U.S. [10] - Focus on long-term platform innovation while embracing rapid software development akin to consumer technology companies [14] - The upcoming launch of the 15-day G7 system is anticipated in the second half of the year [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to capitalize on future opportunities and maintain momentum [30] - The transition of CEO responsibilities to Jake Leach is seen as a strategic move to ensure continued growth [30] - Management is closely monitoring macroeconomic conditions and capital market environments [29] Other Important Information - The company presented nearly 40 studies at the American Diabetes Association's Scientific Sessions, focusing on metabolic health management [19] - The company is working on a randomized controlled trial for type two non-insulin users, with results expected early next year [104] Q&A Session Summary Question: About the ability to raise guidance for the full year - Management noted strong performance in new starts and non-insulin opportunities, leading to increased confidence in revenue guidance [38][41] Question: Exposure to Medicare and potential risks - Management indicated that approximately 15% of the business is fee-for-service Medicare and emphasized the importance of ensuring no interruption to beneficiaries [44][49] Question: Margin progression through the year - Management expects sequential improvement in margins as inventory levels stabilize and operational efficiencies are realized [54][58] Question: Update on G8 and competitive dual analyte sensors - Management expressed excitement about G8's development and emphasized the importance of safety features in their offerings [62][65] Question: Update on FDA progress and 15-day launch - Management reported positive progress with the FDA and confirmed the 15-day product will be launched in the current quarter [71][72] Question: Competitive dynamics with insulin pump integration - Management highlighted their strong position in the market and ongoing innovation to maintain competitive advantages [75][78] Question: Utilization rates for type two non-insulin users - Management reported high utilization rates of 75-80% among covered users, driven by the value of the product [85][86] Question: Update on Stello app and user demographics - Management confirmed the guidance for Stello remains at 2-3% of sales, with a shift in user demographics towards health and wellness [90][92]
TNDM Stock Gains on t:slim X2's Compatibility With FreeStyle Libre 3 +
ZACKS· 2025-06-23 14:51
Company Overview - Tandem Diabetes Care, Inc. (TNDM) has launched its t:slim X2 insulin pump with Control-IQ+ technology, now compatible with Abbott's FreeStyle Libre 3 Plus continuous glucose monitoring sensor in the U.S. An early access program has been initiated, with plans for broader availability in the second half of 2025 [1][9]. Stock Performance - Following the announcement of the new compatibility, TNDM's shares increased by 1.6%, reaching $20.55 [2]. However, over the past year, TNDM shares have experienced a decline of 49.4%, compared to a 14.8% decline in the industry [12]. Financial Metrics - Tandem Diabetes has a market capitalization of $1.35 billion and is projected to have an earnings per share (EPS) growth rate of 28.3% in 2025, significantly higher than the industry's expected growth of 13.8%. Revenue for 2025 is anticipated to rise by 10.6% [4]. Product Features - The t:slim X2 insulin pump utilizes advanced hybrid closed-loop technology, adjusting insulin delivery every five minutes based on predicted glucose values. It features the unique AutoBolus function, which calculates and delivers correction boluses for missed meals [5]. The FreeStyle Libre 3 Plus sensor offers a 15-day wear time and transmits glucose readings every minute to the t:slim mobile app [6]. Industry Insights - The global insulin delivery device market was valued at $16.43 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 7.9% by 2027, driven by the increasing prevalence of diabetes and advancements in technology [7][10]. Strategic Developments - Tandem Diabetes has entered an agreement to develop integrated diabetes solutions that will combine Abbott's future dual glucose-ketone sensor with Tandem's insulin delivery systems, enhancing options for diabetes management [11].
DXCM's Access Gains and Operational Strength Offset Margin Pressures
ZACKS· 2025-06-20 14:26
Core Insights - DexCom (DXCM) reported strong first-quarter 2025 results driven by high demand, record new patient growth, and progress in strategic initiatives [1] - The company’s shares have increased by 18.6% quarter to date, outperforming the industry’s decline of 4.5% [2] - DexCom has a market capitalization of $31.76 billion and projects a 23.1% growth rate over the next five years [2] Access Gain and Market Penetration - Significant expansion in reimbursement coverage for type 2 diabetes (T2D) patients, particularly non-insulin users, is expected to unlock access for nearly 6 million individuals [4] - The first quarter of 2025 saw a record increase in new patient starts from this cohort, the highest in DexCom's history [4] - The over-the-counter CGM, Stelo, is capturing a broader audience, including prediabetes patients and those interested in wellness [5][8] Innovation and Commercial Execution - The launch of the 15-Day G7 system is anticipated to enhance accuracy and product differentiation, potentially improving gross margins [10] - DexCom is optimizing its sales force and expanding its international presence, particularly in France and Japan [11] - The company has a strong cash position of $2.7 billion and announced a $750 million share buyback, indicating confidence in long-term cash flow [12] Estimate Trend - The Zacks Consensus Estimate for 2025 earnings per share remains stable at $2.03, with the second-quarter revenue estimate at $1.12 billion, reflecting an 11.8% year-over-year improvement [13][15] Navigating Near-Term Challenges - Gross margin guidance for fiscal 2025 has been revised down to nearly 62% due to supply-chain disruptions and increased freight costs [16] - DexCom is addressing an FDA warning letter from 2024 inspections, which requires ongoing resource allocation but does not restrict product approvals [17] - The company is advocating for Medicare coverage for non-insulin T2D users, contingent on a trial set to report results in late 2025 or early 2026 [18] CGM Competition on the Rise - DexCom faces increasing competition from Abbott Laboratories, Medtronic, and Senseonics, which are innovating rapidly in the CGM market [19] - Abbott's expansion with its FreeStyle Libre family and OTC devices directly challenges DexCom's Stelo strategy [20] - Medtronic's integration of CGM with insulin pumps and Senseonics' long-wear implantable CGM are also competitive threats [21][22]
Abbott Benefits From Libre & Biosimilars Amid FX, Cost Headwinds
ZACKS· 2025-05-30 15:10
Core Insights - Abbott's diversified business portfolio is positioned for continued growth into 2025 despite foreign exchange challenges [1][7] - The company has seen significant growth in its Diagnostics and Diabetes Care segments, with a strong demand for routine diagnostics and continuous glucose monitoring systems [2][3][4] Business Performance - Abbott's Diagnostics business accounted for 20% of total revenues in Q1 2025, with a 6.5% growth in core laboratory diagnostics, excluding China [2] - The Diabetes Care segment reported sales exceeding $1.7 billion in Q1 2025, growing 21.6%, driven by the success of the FreeStyle Libre system [4] - Established Pharmaceuticals Division (EPD) sales increased 8% organically in Q1 2025, supported by a focus on biosimilars and a licensing model in emerging markets [5] Market Position - Year-to-date, Abbott's shares have gained 18.6%, outperforming the industry average of 5.2%, indicating strong market momentum [6] - Abbott's FreeStyle Libre has achieved global leadership in continuous glucose monitoring systems for both Type 1 and Type 2 diabetes users [3][4] Challenges - Foreign exchange fluctuations negatively impacted Abbott's sales by 2.8% year-over-year in Q1 2025, primarily due to a significant portion of revenues coming from international markets [7] - The company faces increased expenses related to raw materials and freight due to a challenging macroeconomic environment, which may affect future performance [8][9]
Senseonics Holdings, Inc. Announces Closing of Public Offering, Including Exercise in Full of the Underwriters' Option to Purchase Additional Shares, and Closing of Private Placement
GlobeNewswire News Room· 2025-05-21 21:06
Core Viewpoint - Senseonics Holdings, Inc. has successfully closed a public offering of 115 million shares at a price of $0.50 per share, raising gross proceeds of $57.5 million before expenses [1][2]. Group 1: Public Offering Details - The public offering included the full exercise of an option by underwriters to purchase an additional 15 million shares [1]. - The offering was conducted under a "shelf" registration statement that became effective on September 12, 2023 [5]. - The offering was managed by TD Cowen and Barclays as joint book-running managers, with RBC Capital Markets and Lake Street as bookrunners [4]. Group 2: Private Placement with Abbott Laboratories - In conjunction with the public offering, Senseonics entered into a stock purchase agreement with Abbott Laboratories, issuing shares representing 4.99% of its outstanding common stock [3]. - Abbott acquired 40,539,265 shares for approximately $20.3 million before offering expenses [3]. Group 3: Use of Proceeds - The net proceeds from both the public offering and private placement will be used to fund the launch of Eversense 365, ongoing product development, working capital, and general corporate purposes [4][9]. Group 4: Company Overview - Senseonics is focused on developing long-term implantable continuous glucose monitoring systems aimed at improving the lives of individuals with diabetes [7]. - The company's Eversense® CGM systems feature a small sensor that is implanted under the skin and communicates with a smart transmitter, sending glucose data to a mobile app every 5 minutes [7].
Abbott Reveals Positive Outcome From REFLECT Studies, Stock Climbs
ZACKS· 2025-05-19 12:51
Core Insights - Abbott's FreeStyle Libre continuous glucose monitoring technology significantly reduces the risk of hospitalization for heart complications in diabetes patients [1][6] - The REFLECT study showed an 80% reduction in hospitalizations for cardiovascular disease among Type 1 diabetes patients using Libre technology compared to traditional monitors [7] - The global continuous glucose monitoring market is projected to grow at a CAGR of 7.2% through 2030, driven by rising diabetes prevalence [8] Company Performance - Following the announcement of the REFLECT study results, Abbott's stock rose by 1.1%, closing at $134.80 [3] - Abbott has a market capitalization of $234.53 billion and an earnings yield of 3.83%, significantly higher than the industry average of 0.04% [4] - Over the past year, Abbott's shares have increased by 30.6%, outperforming the industry growth of 10.7% [11] Research Relevance - Diabetes affects approximately 589 million people globally, with a high risk of cardiovascular complications [5] - The REFLECT study considered various cardiovascular conditions, indicating that Libre technology could lower healthcare costs by reducing hospital admissions [6] Industry Prospects - The global CGM market was valued at $4.6 billion in 2023, with growth attributed to aging populations and unhealthy lifestyles [8] - Abbott's collaboration with Epic to integrate Libre CGM data into electronic health records aims to enhance workflow efficiency for healthcare providers [10]