Collaboration designed to drive measurable return on investment ("ROI") for health plans by reducing falls and improving outcomes for high-risk populations, including those with obesity and Medicare Advantage members with frailty and balance issues Generating more than $50 billion annually in direct medical costs, falls are one of the leading causes of injury among older adults in the U.S. , /PRNewswire/ -- DarioHealth Corp. (NASDAQ: DRIO) ("Dario" or the "Company"), a leader in the global digital health ...

Two under-the-radar health-tech stocks are seeing their Momentum scores surge in Benzinga’s Edge Stock Rankings, showing remarkable strength and fervor over the past week. 2 Health-Tech Stocks With A Surge In MomentumIn Benzinga’s Edge Rankings, the Momentum score basically indicates the strength of a stock relative to all other stocks ranked. It considers price movements and volatility across multiple time frames, before ranking them individually as a percentile against others.See Also: This Chinese Automa ...

Core Insights - DarioHealth Corp. has initiated a strategic review to maximize shareholder value following multiple unsolicited inquiries from interested parties [1][4] - The company has engaged Perella Weinberg Partners as a financial advisor to explore various strategic opportunities, including potential sale or merger [2][4] - Dario recently completed a $17.5 million private placement, enhancing its financial position and providing substantial runway for growth initiatives [1][7] Company Developments - The Board of Directors has formed a Special Committee of independent directors to oversee the strategic review process [2][4] - Dario has optimized its capital structure by converting preferred shares into common shares, creating a clearer equity structure [7] - The company’s pro forma cash position is approximately $40 million as of the end of Q2 2025, positioning it well for future opportunities [7] Market Position - DarioHealth is recognized as a leader in digital health solutions for chronic condition management, offering a comprehensive multi-condition platform supported by clinical evidence [5][6] - The company’s user-centric approach aims to provide continuous and customized care, enhancing user satisfaction and retention [6][7] - Dario's solutions are delivered globally to various stakeholders, including health plans, self-insured employers, and consumers [7]

Core Insights - DarioHealth Corp. is experiencing strategic progress, robust market tailwinds, and accelerating growth opportunities in the digital health market [1][2] Company Overview - DarioHealth Corp. is a leading digital health company focused on managing chronic conditions through a user-centric, multi-chronic condition digital therapeutics platform [3] - The platform provides personalized interventions driven by data analytics and coaching for conditions such as diabetes, hypertension, weight management, musculoskeletal pain, and behavioral health [3][4] Multi-Condition Platform Leadership - Dario addresses five chronic conditions on a single platform, surpassing competitors that typically cover 1-3 conditions [7] - Over 70% of Dario's pipeline and 80% of new contracts are for multi-condition programs, validating the company's strategy [7] Expanding Market Access - Dario's commercial pipeline has increased to $67 million, driven by collaborations with third-party administrators and pharmacy managers representing 87 million member lives [7] - These collaborations are accelerating sales cycles and facilitating seamless onboarding of new large employer and health plan clients [7] Market Demand for Value-Based Care - The industry is prioritizing high ROI solutions that quantify outcomes, which aligns with Dario's offerings [7] - More than 90 clinical studies validate Dario's outcomes, including $5,000 annual payer savings per user, a 23% reduction in hospitalizations, and a 9% reduction in healthcare utilization [7] Velocity and Multiplier Effect - Dario's multi-condition offering combined with expanding market access creates a velocity and multiplier effect, enabling rapid onboarding of more members [7]

Core Insights - DarioHealth Corp. has launched five new contracts with self-insured employers, covering 107,000 lives, which reinforces its B2B2C momentum and recurring revenue growth [1][2] - The company's digital health solutions have demonstrated significant results, including a 23% reduction in hospitalizations, a 9% reduction in healthcare utilization, and a $5,000 reduction in employer costs per user [1] - Dario's pipeline of commercial opportunities has increased to $67 million, with expectations to sign approximately 40 new clients by the end of 2025, representing a 35% increase over 2024 [2] Company Overview - DarioHealth Corp. is a leader in the digital health market, focusing on chronic condition management through a user-centric, multi-chronic condition digital therapeutics platform [3] - The platform provides personalized interventions driven by data analytics and coaching for conditions such as diabetes, hypertension, and weight management [3][4] Product Efficacy - Dario's solutions have shown measurable improvements in health outcomes: a 1.4% reduction in eHbA1c for diabetes management, a 10% reduction in BMI for prediabetes, and 38% of users reducing blood pressure by one stage for hypertension [6]

Core Viewpoint - DarioHealth Corp. is implementing a 20-for-1 reverse stock split of its common stock, effective August 28, 2025, to enhance its stock price and maintain compliance with Nasdaq listing requirements [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 47,996,572 to about 2,399,829 [2]. - The total number of authorized shares remains unchanged at 400,000,000 [2][5]. - No fractional shares will be issued; any resulting fractions will be rounded up to the nearest whole share [2][3]. Group 2: Approval and Impact - The reverse stock split was approved by the board of directors with stockholder authority at the 2025 Annual Meeting held on July 23, 2025 [3]. - The split will not affect stockholders' percentage ownership or voting power, aside from minor adjustments for fractional shares [3]. Group 3: Adjustments to Securities - All outstanding options, convertible securities, and other equity instruments will be adjusted accordingly to reflect the reverse stock split [4]. Group 4: Company Overview - DarioHealth Corp. is a leader in the digital health market, focusing on chronic condition management through a user-centric digital therapeutics platform [6][7]. - The platform provides personalized interventions driven by data analytics for conditions such as diabetes, hypertension, and behavioral health [6][7]. Group 5: Market Position - DarioHealth offers its solutions globally to health plans, self-insured employers, and consumers, aiming to disrupt traditional healthcare approaches [8].

Core Insights - DarioHealth Corp. reported a quarterly loss of $0.12 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.11, and a decline from earnings of $0.06 per share a year ago, indicating an earnings surprise of -9.09% [1] - The company generated revenues of $5.37 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 22.19% and down from $6.26 million year-over-year [2] - DarioHealth shares have decreased by approximately 36% since the beginning of the year, contrasting with the S&P 500's gain of 8.4% [3] Earnings Outlook - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.07 on revenues of $8.52 million, and for the current fiscal year, it is -$0.32 on revenues of $32.24 million [7] Industry Context - The Medical - Instruments industry, to which DarioHealth belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, suggesting that the industry's outlook could significantly impact the stock's performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors or through tools like the Zacks Rank [5][6]

Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $5.4 million, down from $6.3 million in Q2 2024 and $6.8 million in Q1 2025, reflecting a decline due to the non-renewal of a large national health plan and a strategic shift towards a SaaS-like revenue model [29][30] - GAAP gross margin increased to 65% from 44% year over year, while non-GAAP gross margin was maintained at around 80% in the core B2B2C channel [10][30] - Operating expenses were reduced by 36% to $12.2 million from $18.9 million in Q2 2024, resulting in a narrowed operating loss of $9.2 million, down from $16.2 million [30] Business Line Data and Key Metrics Changes - The company signed 21 new clients year-to-date, with 80% of these accounts focused on multi-condition programs, aligning with the company's strategy [8][12] - Committed annual recurring revenue (CARR) increased by $5 million, with a pipeline totaling $53 million, indicating strong future revenue potential [9][17] - The B2B2C business continues to operate at over 80% gross margins on a non-GAAP basis, demonstrating the efficiency of the business model [10][30] Market Data and Key Metrics Changes - The company serves over 100 clients, including four national health plans and six regional health plans, indicating a diversified client base [13] - The pipeline includes more than 25 qualified health plans for 2026, a significant increase from three health plans in the pipeline a year ago [19] - The company is expanding into the $150 billion sleep health market through a partnership, which is expected to enhance its multi-condition model [21] Company Strategy and Development Direction - The company is focusing on sustainable annual recurring revenue (ARR) growth, emphasizing the importance of differentiated solutions and disciplined execution [12] - The strategy includes leveraging AI to enhance operational efficiency and member engagement, which is expected to reduce operating expenses by 15% over the next year [36] - The company aims to build a scalable financial profile with a clear pathway to cash flow positivity, focusing on high-margin, recurring revenues [32][36] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that Q2 revenues were below expectations due to short-term headwinds but expressed confidence in the company's growth trajectory and the quality of new client acquisitions [7][8] - The company is optimistic about closing the revenue gap and accelerating growth, supported by strong metrics in client quality and recurring revenues [10][11] - Management highlighted the importance of AI in driving future growth and operational efficiency, positioning the company as a leader in the digital health space [36] Other Important Information - The company has undergone a full review of its channel partner network, resulting in revitalized partnerships and a stronger value proposition [15] - The company is transitioning from one-time revenues to recurring revenues, which is expected to enhance long-term financial stability [20] - The company ended Q2 2025 with $22.1 million in cash and short-term deposits, bolstered by recent debt restructuring [30] Q&A Session Summary Question: Was there any churn that contributed to the revenue decline in Q2? - Management confirmed that there was no churn in annual recurring revenue, attributing the decline primarily to the non-renewal of a large health plan contract [39][40] Question: Can you provide more details on the services that the health plan decided to discontinue? - The health plan discontinued a Medicaid maternity program, opting to insource it, which was not a reflection of the company's performance [42][43] Question: What differentiates the current health plan reductions from future wins? - Management clarified that the non-renewal was an isolated incident and emphasized the diversification of their client base, with new significant accounts being signed [46][48] Question: Can you elaborate on the restructuring of the partnership program? - The company is focusing on strategic partnerships to enhance service offerings without expanding internal capabilities, particularly in areas like sleep health [49][50] Question: What are the expectations for operating expenses in the next 12 to 15 months? - Management anticipates a 15% reduction in operating expenses, aiming for quarterly expenses to be around $8 million by the end of next year [52][53] Question: What benefits does the claims-based billing infrastructure provide? - The addition of claims-based billing allows the company to tap into a larger profit pool by rendering services as claims, which is a significant shift from the current administrative budget billing [58][60]

Core Insights - DarioHealth Corp. reported second quarter 2025 revenue of $5.4 million, down from $6.3 million in Q2 2024 and $6.8 million in Q1 2025, primarily due to a shift in scope with a large national health plan client that was not renewed [1][10][12] - The company is focusing on signing new B2B2C clients to drive sustainable annual recurring revenue (ARR) growth, rather than relying on one-time revenues, which contributed to the revenue decline [2][3] - DarioHealth has adjusted its cash flow breakeven estimates to late 2026 to early 2027, reflecting slower onboarding and revenue recognition from new clients [2][3] Financial Performance - Revenue for Q2 2025 was $5.4 million, a decrease of 14% year-over-year and 20% quarter-over-quarter [10][12] - Gross profit for Q2 2025 was $3.0 million, an increase of 8% year-over-year, with a gross margin of 55%, up from 44% in Q2 2024 [11][12] - Operating loss narrowed by 43% year-over-year to $9.2 million in Q2 2025, with operating expenses decreasing by 36% to $12.2 million [15][24] Strategic Developments - The company signed 21 new clients year-to-date, including a top U.S. healthcare institution and two regional health plans, and is on track to achieve a total of 40 new clients by the end of 2025 [6][12] - DarioHealth is building a recurring revenue business with a strong pipeline of $53 million in commercial opportunities, with over $5 million in advanced stages towards ARR [5][12] - The company is enhancing its AI capabilities to drive operational efficiencies and improve patient engagement, expecting a 15% reduction in operating expenses over the next 12 to 15 months [9][12] Market Position and Future Outlook - DarioHealth is entering the $150 billion sleep apnea market through a partnership with GreenKey Health and has launched a GLP-1 + cardiometabolic solution deal with a national benefit administrator [12][24] - The company anticipates that two new health plan clients will represent multi-million-dollar opportunities, with a full-suite national health plan set to launch in the second half of 2025 [3][6] - DarioHealth's business model is designed for efficient scaling, supported by operational efficiencies and a focus on high-margin, multi-condition platform contracts [5][7]

[PART 1 - FINANCIAL INFORMATION](index=6&type=section&id=PART%201%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Interim Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Interim%20Financial%20Statements%20(unaudited)) This section presents DarioHealth Corp.'s unaudited condensed interim financial statements, including balance sheets, income, equity, and cash flow statements, highlighting continued net losses and going concern doubts [Condensed Consolidated Interim Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) Balance Sheet Items (in thousands) | Balance Sheet Items (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $21,954 | $27,764 | | Total current assets | $32,170 | $40,529 | | Total assets | $108,325 | $118,884 | | **Liabilities & Equity** | | | | Total current liabilities | $9,754 | $16,635 | | Total liabilities | $44,339 | $46,865 | | Total stockholders' equity | $63,986 | $72,019 | - Total assets decreased from **$118.9 million** at the end of 2024 to **$108.3 million** as of June 30, 2025, primarily driven by a reduction in cash and cash equivalents and trade receivables[16](index=16&type=chunk) [Condensed Consolidated Interim Statements of Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Comprehensive%20Loss) Income Statement (in thousands) | Income Statement (in thousands) | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $5,369 | $6,255 | $12,121 | $12,013 | | Gross profit | $2,964 | $2,756 | $6,846 | $5,188 | | Total operating expenses | $12,164 | $18,947 | $25,455 | $39,234 | | Operating loss | $(9,200) | $(16,191) | $(18,609) | $(34,046) | | Net loss | $(12,990) | $(13,610) | $(22,217) | $(20,785) | | Basic and diluted loss per share | $(0.18) | $(0.08) | $(0.33) | $(0.27) | - Revenues for Q2 2025 decreased by **14.2%** year-over-year, while operating expenses were significantly reduced by **35.8%**, leading to a smaller operating loss compared to Q2 2024[22](index=22&type=chunk) [Condensed Consolidated Interim Statements of Changes in Stockholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$72.0 million** at the end of 2024 to **$64.0 million** as of June 30, 2025. The decrease was primarily driven by the net loss of **$22.2 million** for the six-month period, partially offset by capital raised from stock-based compensation and issuance of preferred stock[24](index=24&type=chunk) [Condensed Consolidated Interim Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Summary (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,704) | $(24,473) | | Net cash used in investing activities | $(75) | $(8,881) | | Net cash provided by financing activities | $6,939 | $20,206 | - Cash used in operating activities for the first six months of 2025 was nearly halved compared to the same period in 2024, reflecting improved operational efficiency. Cash from financing activities decreased significantly, primarily due to lower proceeds from preferred stock issuance in 2025 compared to 2024[30](index=30&type=chunk) [Notes to Condensed Consolidated Interim Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) - The company has incurred recurring losses and negative cash flows since inception, with an accumulated deficit of **$423.0 million** as of June 30, 2025. These conditions raise substantial doubt about its ability to continue as a going concern[35](index=35&type=chunk)[36](index=36&type=chunk) - On April 30, 2025, the company refinanced its debt with a new credit agreement from Callodine Commercial Finance for up to **$50 million**, initially borrowing **$32.5 million**. This new facility matures in April 2030[76](index=76&type=chunk)[172](index=172&type=chunk) - As of June 30, 2025, the company did not meet one of the financial covenants under the new Callodine credit agreement and has notified the lender of its intention to utilize an equity cure to address the event of default[84](index=84&type=chunk)[85](index=85&type=chunk) - Revenue from the Commercial B2B2C channel, a key strategic area, decreased to **$3.5 million** in Q2 2025 from **$5.5 million** in Q2 2024[55](index=55&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=51&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's whole-person digital health platform, analyzing Q2 and H1 2025 financial performance, noting decreased Q2 revenue, improved gross margin, reduced operating expenses, recent debt refinancing, and ongoing liquidity challenges [Business Overview](index=51&type=section&id=Business%20Overview) - DarioHealth operates as a global digital health company with a mission to deliver a comprehensive, whole-person health platform that integrates physical health (chronic conditions like diabetes, hypertension) and mental health needs[159](index=159&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk) - The company's business model targets four primary market segments: Direct-to-Consumer (D2C), medium-to-large employers, health plans, and pharmaceutical companies, with B2B channels now accounting for **three-fourths** of revenues[166](index=166&type=chunk) [Recent Developments](index=53&type=section&id=Recent%20Developments) - The company added **21** new clients in the first half of 2025, progressing towards its annual goal of **40** new clients[171](index=171&type=chunk) - On May 1, 2025, DarioHealth closed a new debt financing facility for up to **$50 million** with Callodine, drawing an initial **$32.5 million** to refinance existing debt and provide operational flexibility[172](index=172&type=chunk) - In June 2025, the company announced a strategic commercial agreement with GreenKey Health to expand its solutions into the sleep apnea market[180](index=180&type=chunk) [Results of Operations](index=57&type=section&id=Results%20of%20Operations) Metric (in thousands) | Metric (in thousands) | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $5,369 | $6,255 | -14.2% | | Gross Profit | $2,964 | $2,756 | +7.5% | | Gross Margin | 55.2% | 44.1% | +11.1 ppt | | Operating Expenses | $12,164 | $18,947 | -35.8% | | Net Loss | $(12,990) | $(13,610) | -4.6% | - The decrease in Q2 2025 revenue was primarily due to a decline in revenues from the pharma channel[182](index=182&type=chunk) - Operating expenses across R&D, Sales & Marketing, and G&A all saw significant year-over-year decreases, attributed mainly to efficiency and post-merger integration activities resulting in lower payroll and consulting expenses[187](index=187&type=chunk)[189](index=189&type=chunk)[191](index=191&type=chunk) [Non-GAAP Financial Measures](index=61&type=section&id=Non-GAAP%20Financial%20Measures) Non-GAAP Adjusted Loss (in thousands) | Non-GAAP Adjusted Loss (in thousands) | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss - as reported | $(12,990) | $(13,610) | $(22,217) | $(20,785) | | Non-GAAP adjusted loss | $(6,363) | $(10,671) | $(12,174) | $(19,749) | - The Non-GAAP adjusted loss, which excludes items like stock-based compensation and revaluation of warrants, showed significant improvement, decreasing by **39%** for the second quarter and **38%** for the first six months of 2025 compared to the prior year periods[203](index=203&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company had **$22.0 million** in cash and cash equivalents, down from **$27.8 million** at the end of 2024[204](index=204&type=chunk) - Management has concluded that the current cash on hand is insufficient to fund projected operating requirements for the next twelve months, which raises substantial doubt about the company's ability to continue as a going concern[235](index=235&type=chunk) - The company has a significant present need for capital and may be unable to continue activities without material alterations to its business plan if additional funding is not secured[235](index=235&type=chunk) [Cash Flows](index=73&type=section&id=Cash%20Flows) Cash Flow (in thousands) | Cash Flow (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Cash used in operating activities | $(12,704) | $(24,473) | | Cash used in investing activities | $(75) | $(8,881) | | Cash provided by financing activities | $6,939 | $20,206 | - Net cash used in operating activities decreased by **48.1%** in the first half of 2025 compared to the same period in 2024, mainly due to a decrease in operating expenses from efficiency and post-merger integration activities[238](index=238&type=chunk) [Item 4. Controls and Procedures](index=73&type=section&id=Item%204.%20Control%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting identified during the quarter - The company's CEO and CFO concluded that as of June 30, 2025, disclosure controls and procedures were effective at a reasonable assurance level[242](index=242&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[243](index=243&type=chunk) [PART II - OTHER INFORMATION](index=76&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1A. Risk Factors](index=76&type=section&id=Item%201A.Risk%20Factors) This section highlights key risks, including revenue concentration, geopolitical risks from Israel operations, substantial doubt about going concern due to insufficient cash, potential debt covenant breaches, and extreme stock price volatility with Nasdaq delisting risk - A major customer accounted for **16.4%** of accounts receivable and **9.3%** of revenue in Q2 2025, posing a significant concentration risk[249](index=249&type=chunk) - The company's current cash on hand is not sufficient to fund projected operating requirements for the next year, raising substantial doubt about its ability to continue as a going concern[255](index=255&type=chunk) - As of June 30, 2025, the company was not in compliance with a financial covenant under its Credit Agreement and is pursuing an equity cure, the success of which is not guaranteed[259](index=259&type=chunk) - The company is not in compliance with Nasdaq's minimum bid price requirement of **$1.00** per share and has until September 15, 2025, to regain compliance or face delisting[264](index=264&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q2 2025, the company issued **525,000** common shares to service providers as compensation, claiming exemption from registration under Section 4(a)(2) of the Securities Act - In Q2 2025, the company issued **525,000** shares of common stock to certain service providers as compensation in lieu of cash, claiming exemption from registration under Section 4(a)(2) of the Securities Act[268](index=268&type=chunk) [Item 5. Other Information](index=82&type=section&id=Item%205.%20Other%20Information.) On August 8, 2025, following stockholder approval, the company increased its authorized common stock from **160 million** to **400 million** shares by filing a Certificate of Amendment - On August 8, 2025, the company increased its authorized common stock from **160 million** to **400 million** shares after receiving stockholder approval[269](index=269&type=chunk)[270](index=270&type=chunk) [Item 6. Exhibits](index=83&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including amendments to the Certificate of Incorporation, preferred stock designations, officer certifications, and XBRL data files - The report includes several filed exhibits, such as the Certificate of Amendment to increase authorized shares, various amended certificates for preferred stock, and required officer certifications under Sarbanes-Oxley[274](index=274&type=chunk)