Defender Introduces Continuous Wound Management (CWM) with the Smart Boot™
The Smart Boot™ merges the Foot Defender®, a scientifically designed protective boot engineered to minimize forces applied to the foot, with patient monitoring wearable technology. Powered by Sensoria's AI-driven software on Microsoft Azure's cloud platform, patients receive coaching via an app that tracks steps taken, active minutes, rest time, and compliance. These real-time updates are sent to their physician's clinical dashboard, allowing for treatment plan adjustments and interventions before complications arise.
The Smart Boot™ connects to a smartwatch app via Bluetooth, monitoring whether the patient is adhering to the treatment protocol. If not, the system triggers feedback to the smartwatch. The AI-driven auto-alert system prompts patients with messages like: 'Why did you take off your boot? Are you going to sleep?' For more serious cases, the system enables nurse calls, telehealth visits, or home care interventions.
The Smart Boot™ sensors offer 98.8% accuracy in tracking patient activity and compliance. It's attached to the boot unlike traditional wearable monitors worn on the wrist, making it nearly impossible to move without detection. Its continuous electrical loop sensor also ensures uninterrupted data collection. It allows patients to maintain mobility – a feature irremovable devices such as casts can't offer.
A medical review underscores the potential of smart sensor technologies in enhancing adherence.
'Patients adhere to protocols when they feel involved in their treatment,' says Dr. Jason Hanft, Defender CEO. 'When they receive real-time feedback and encouragement, we see outcomes that forced compliance can't provide.' The Smart Boot™'s balance of comfort, compliance, and clinical efficacy has demonstrated superior wound healing rates to an irremovable device for the first time in history.
The Smart Boot™ and CWM can improve DFU management by empowering patients and physicians. Defender works on a direct-to-patient subscription model to deliver this innovative care to the patient. The company aims to make cutting-edge care more accessible and affordable.
*This article is for informational purposes only and does not substitute for professional medical advice. If you are seeking medical advice, diagnosis or treatment, please consult a medical professional or healthcare provider.
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Yahoo
2 hours ago
- Yahoo
Simulations Plus Reports Third Quarter Fiscal 2025 Financial Results
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"Our software revenue continued to perform well, increasing 6%, mainly driven by our ADMET Predictor® software and modest growth in our GastroPlus® and MonolixSuiteTM software, partially offset by a decline in our QSP/QST biosimulations software. "Services revenue for the third fiscal quarter grew by 17%, primarily driven by solid performance in our Medical Communications services. However, we experienced a decline in other service areas, largely due to cautious spending behavior, project delays and a cancellation from our BioPharma clients. While the sales pipeline remains robust with healthy client interest, the pace of contractual commitments slowed, impacting third quarter 2025 bookings. "We also recognized a one-time non-cash impairment charge of $77.2 million this quarter. This charge was based on a valuation assessment we made and aligns the book value of our assets to their current market value. It also reflects our commitment to transparency as we streamline our operating structure for greater efficiency and impact. "During the quarter, we also implemented a strategic reorganization, transitioning from a business unit structure to a functionally-driven operating model. This marked the final phase of a multi-year transformation to streamline operations, unlock synergies across teams, and concentrate our resources on the most promising growth opportunities. Additionally, we identified efficiencies in our cost structure that resulted in right-sizing our staffing levels and better aligning our services capacity to match current client needs. "Despite the current macroeconomic environment, our team remains focused on innovation, and we are rolling out a series of new AI-driven initiatives across our product lines. By applying advanced technologies like AI to drive innovation and growth, we believe these new and eagerly anticipated solutions will expand our value proposition and give us a distinct competitive advantage in the biosimulation market. This strategy not only enriches our product ecosystem but also positions Simulations Plus for sustained growth and further solidifies our leadership in model-informed drug development solutions," concluded O'Connor. Fiscal 2025 Guidance Simulations Plus is updating its full fiscal year 2025 guidance as follows: Fiscal 2025 Guidance Fiscal 2025 Guidance Revenue $76M - $80M Revenue growth 9 - 14% Software mix 55 - 60% Adjusted EBITDA margin 23 - 27% Adjusted diluted EPS $0.93 - $1.06 Webcast and Conference Call Details Shawn O'Connor, Chief Executive Officer, and Will Frederick, Chief Financial Officer, will host a conference call and webcast today at 5:00 p.m. Eastern Time to discuss the details of Simulations Plus' performance for the quarter and certain forward-looking information. The call may be accessed by registering here or by calling 1-877-451-6152 (domestic) or 1-201-389-0879 (international) or by clicking on this Call me™ link to request a return call. The webcast can be accessed on the investor relations page of the Simulations Plus website where it will also be available for replay approximately one hour following the call. Non-GAAP Financial Measures This press release contains "non-GAAP financial measures," which are measures that either exclude or include amounts that are not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles ("GAAP"). A further explanation and reconciliation of these non-GAAP financial measures is included below and in the financial tables in this release. The Company believes that the non-GAAP financial measures presented facilitate an understanding of operating performance and provide a meaningful comparison of its results between periods. The Company's management uses non-GAAP financial measures to, among other things, evaluate its ongoing operations in relation to historical results, for internal planning and forecasting purposes and in the calculation of performance-based compensation. Adjusted EBITDA and Adjusted Diluted EPS represent measures that we believe are customarily used by investors and analysts to evaluate the financial performance of companies in addition to the GAAP measures that we present. Our management also believes that these measures are useful in evaluating our core operating results. However, Adjusted EBITDA and Adjusted Diluted EPS are not measures of financial performance under accounting principles generally accepted in the United States of America and should not be considered an alternative to net income, operating income, or diluted EPS as indicators of our operating performance or to net cash provided by operating activities as a measure of our liquidity. We believe the Company's Adjusted EBITDA and Adjusted Diluted EPS measures provide information that is directly comparable to that provided by other peer companies in our industry, but other companies may calculate non-GAAP financial results differently, particularly related to nonrecurring, unusual items. Please note that the Company has not reconciled the adjusted EBITDA or adjusted diluted earnings per share forward-looking guidance included in this press release to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results. Adjusted EBITDA Adjusted EBITDA represents net income excluding the effect of interest expense (income), provision (benefit) for income taxes, amortization expense, intangible asset amortization, equity-based compensation expense, loss (gain) on currency exchange, goodwill impairment, change in fair value of contingent consideration, reorganization expense, acquisition and integration expense and other items not indicative of our ongoing operating performance. Adjusted Net Income and Adjusted Diluted EPS Adjusted net income and adjusted diluted earnings per share exclude the effect of amortization expense, equity-based compensation expense, loss (gain) on currency exchange, goodwill impairment, change in fair value of contingent consideration, reorganization expense, acquisition and integration expense and other items not indicative of our ongoing operating performance as well as the income tax provision adjustment for such charges. The Company excludes the above items because they are outside of the Company's normal operations and/or, in certain cases, are difficult to forecast accurately for future. With more than 25 years of experience serving clients globally, Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization. Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at Follow us on LinkedIn | X | YouTube. Environmental, Social, and Governance We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website to read our 2024 ESG update. Forward-Looking Statements Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like "believe," "will", "can", "believe", "expect," "anticipate" and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our new internal operational structure, our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual and current reports and filed with the U.S. Securities and Exchange Commission. SIMULATIONS PLUS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (Unaudited) Three Months Ended Nine Months Ended (in thousands, except per common share amounts) May 31, 2025 May 31, 2024 May 31, 2025 May 31, 2024 Revenues Software $ 12,615 $ 11,908 $ 36,814 $ 31,111 Services 7,748 6,636 24,905 20,238 Total revenues 20,363 18,544 61,719 51,349 Cost of revenues Software 2,540 1,400 7,765 3,739 Services 4,791 3,887 17,577 11,284 Total cost of revenues 7,331 5,287 25,342 15,023 Gross profit 13,032 13,257 36,377 36,326 Operating expenses Research and development 1,216 1,300 5,207 3,829 Sales and marketing 2,680 2,399 9,248 6,337 General and administrative 6,141 7,678 16,089 18,878 Impairments 77,221 — 77,221 — Total operating expenses 87,258 11,377 107,765 29,044 (Loss) income from operations (74,226 ) 1,880 (71,388 ) 7,282 Other income, net 182 2,010 1,122 4,266 (Loss) income before income taxes (74,044 ) 3,890 (70,266 ) 11,548 Income tax benefit (expense) 6,727 (753 ) 6,229 (2,437 ) Net (loss) income $ (67,317 ) $ 3,137 $ (64,037 ) $ 9,111 (Loss) Earnings per share Basic $ (3.35 ) $ 0.16 $ (3.19 ) $ 0.46 Diluted $ (3.35 ) $ 0.15 $ (3.19 ) $ 0.45 Weighted-average common shares outstanding Basic 20,113 19,995 20,092 19,972 Diluted 20,113 20,433 20,092 20,324 Other comprehensive (loss) income, net of tax Foreign currency translation adjustments 41 (56 ) (27 ) (125 ) Unrealized gains (losses) on available-for-sale securities — (39 ) 4 (39 ) Comprehensive (loss) income $ (67,276 ) $ 3,042 $ (64,060 ) $ 8,947 SIMULATIONS PLUS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share and per share amounts) May 31,2025 August 31,2024 ASSETS Current assets Cash and cash equivalents $ 26,950 $ 10,311 Accounts receivable, net of allowance for credit losses of $255 and $149 14,780 9,136 Prepaid income taxes 954 2,197 Prepaid expenses and other current assets 7,591 7,753 Short-term investments 1,500 9,944 Total current assets 51,775 39,341 Long-term assets Capitalized computer software development costs, net of accumulated amortization of $21,096 and $18,727 11,301 12,499 Property and equipment, net 681 812 Operating lease right-of-use assets 425 1,027 Intellectual property, net of accumulated amortization of $8,754 and $5,490 6,464 23,130 Other intangible assets, net of accumulated amortization of $4,146 and $3,177 12,368 23,210 Goodwill 43,487 96,078 Deferred tax assets, net 7,429 — Other assets 430 542 Total assets $ 134,360 $ 196,639 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Accounts payable $ 1,663 $ 602 Accrued compensation 1,656 4,513 Accrued expenses 2,199 2,043 Contracts payable - current portion — 2,440 Operating lease liability - current portion 269 475 Deferred revenue 4,344 1,996 Total current liabilities 10,131 12,069 Long-term liabilities Deferred tax liabilities, net — 1,608 Operating lease liability - net of current portion 450 531 Total liabilities 10,581 14,208 Commitments and contingencies - Note 4 Shareholders' equity Preferred stock, $0.001 par value — 10,000,000 shares authorized; no shares issued and outstanding $ — $ — Common stock, $0.001 par value; 50,000,000 shares authorized, 20,116,181 and 20,051,134 shares issued and outstanding as of May 31, 2025 and August 31, 2024 20,116 20,051 Additional paid-in capital 137,620 132,277 (Accumulated deficit) retained earnings (33,683 ) 30,354 Accumulated other comprehensive loss (274 ) (251 ) Total shareholders' equity 123,779 182,431 Total liabilities and shareholders' equity $ 134,360 196,639 SIMULATIONS PLUS, INC. Trended Financial Information (1) (Unaudited) (in millions except earnings per share amounts) FY24 FY25 FY24 FY25 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Full Year YTD Revenue Software $ 7.589 $ 11.614 $ 11.908 $ 9.913 $ 10.715 $ 13.484 $ 12.615 $ 41.024 $ 36.814 Services $ 6.911 $ 6.691 $ 6.636 $ 8.751 $ 8.209 $ 8.948 $ 7.748 $ 28.989 $ 24.905 Total $ 14.500 $ 18.305 $ 18.544 $ 18.664 $ 18.924 $ 22.432 $ 20.363 $ 70.013 $ 61.719 Gross Margin Software 86.9 % 88.4 % 88.2 % 72.4 % 75.4 % 80.8 % 79.9 % 84.2 % 78.9 % Services 47.0 % 44.2 % 41.4 % -4.0 % 26.1 % 24.9 % 38.2 % 29.7 % 29.4 % Total 67.9 % 72.2 % 71.5 % 36.6 % 54.0 % 58.5 % 64.0 % 61.6 % 58.9 % Income from operations $ 0.960 $ 4.442 $ 1.880 $ (1.151 ) $ 0.126 $ 2.712 $ (74.226 ) $ 6.131 $ (71.388 ) Operating Margin 6.6 % 24.3 % 10.1 % -6.2 % 0.7 % 12.1 % -364.5 % 8.8 % -115.7 % Net Income $ 1.945 $ 4.029 $ 3.137 $ 0.843 $ 0.206 $ 3.074 $ (67.317 ) $ 9.954 $ (64.037 ) Diluted Earnings Per Share $ 0.10 $ 0.20 $ 0.15 $ 0.04 $ 0.01 $ 0.15 $ (3.35 ) $ 0.49 $ (3.19 ) Adjusted EBITDA $ 3.388 $ 7.135 $ 5.586 $ 4.148 $ 4.493 $ 6.578 $ 7.437 $ 20.257 $ 18.508 Adjusted Diluted EPS $ 0.18 $ 0.32 $ 0.27 $ 0.18 $ 0.17 $ 0.31 $ 0.45 $ 0.95 $ 0.93 Cash Flow from Operations $ 0.162 $ 5.810 $ 5.700 $ 1.600 $ (1.274 ) $ 5.669 $ 8.144 $ 13.320 $ 12.539 Revenue Breakdown by Region Americas $ 10.891 $ 12.461 $ 12.428 $ 14.693 $ 14.469 $ 16.112 $ 14.544 $ 50.473 $ 45.125 EMEA 2.302 4.665 4.513 2.592 2.720 4.806 3.698 14.072 11.224 Asia Pacific 1.307 1.179 1.603 1.379 1.735 1.514 2.121 5.468 5.370 Total $ 14.500 $ 18.305 $ 18.544 $ 18.664 $ 18.924 $ 22.432 $ 20.363 $ 70.013 $ 61.719 Software Performance Metrics Avg. Revenue per Customer (in thousands) Commercial $ 79.0 $ 113.0 $ 97.0 $ 89.0 $ 94.0 $ 124.0 $ 96.0 Services Performance Metrics Backlog (in millions) $ 18.910 $ 18.041 $ 19.602 $ 14.091 $ 17.254 $ 20.379 $ 20.700 (1) Numbers may not foot due to rounding SIMULATIONS PLUS, INC. Reconciliation of Adjusted EBITDA to Net Income (1) (Unaudited) (in millions) FY 2024 FY25 FY24 FY25 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Full Year YTD Net Income $ 1.945 $ 4.029 $ 3.137 $ 0.843 $ 0.206 $ 3.074 $ (67.317 ) $ 9.954 $ (64.037 ) Excluding: Interest income and expense, net (1.292 ) (1.348 ) (1.522 ) (0.213 ) (0.159 ) (0.154 ) (0.170 ) (4.375 ) (0.483 ) Provision for income taxes 0.461 1.223 0.753 0.020 0.064 0.434 (6.727 ) 2.457 (6.229 ) Depreciation and amortization 1.091 1.105 1.263 2.206 2.265 2.274 2.318 5.665 6.857 Stock-based compensation 1.303 1.585 1.665 1.387 1.589 1.557 1.279 5.940 4.425 (Gain) loss on currency exchange (0.044 ) 0.098 (0.009 ) (0.431 ) 0.015 (0.002 ) (0.035 ) (0.386 ) (0.022 ) Impairments — — — — — — 77.221 — 77.221 (Loss) income from disposal of fixed assets — — — — — — 0.023 — 0.023 Change in value of contingent consideration (0.110 ) 0.440 (0.599 ) (1.370 ) — (0.640 ) — (1.639 ) (0.640 ) Reorganization expense — — — — 0.258 0.157 0.845 — 1.260 Mergers & Acquisitions expense 0.034 0.003 0.898 1.706 0.255 (0.122 ) — 2.641 0.133 Adjusted EBITDA $ 3.388 $ 7.135 $ 5.586 $ 4.148 $ 4.493 $ 6.578 $ 7.437 $ 20.257 $ 18.508 (1) Numbers may not foot due to rounding SIMULATIONS PLUS, INC. Reconciliation of Adjusted Diluted EPS to Diluted EPS (1) (Unaudited) (in millions, except Diluted EPS and Adjusted Diluted EPS) FY 2024 FY25 FY24 FY25 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Full Year YTD Net (loss) Income (GAAP) $ 1.945 $ 4.029 $ 3.137 $ 0.843 $ 0.206 $ 3.074 $ (67.317 ) $ 9.954 $ (64.037 ) Excluding: Amortization 0.991 0.991 1.122 2.059 2.130 2.130 2.165 5.163 6.425 Stock-based compensation 1.303 1.585 1.665 1.387 1.589 1.557 1.279 5.940 4.425 (Gain) loss on currency exchange (0.044 ) 0.098 (0.009 ) (0.431 ) 0.015 (0.002 ) (0.035 ) (0.386 ) (0.022 ) Mergers & Acquisitions expense 0.034 0.003 0.898 1.706 0.255 (0.122 ) — 2.641 0.133 Change in value of contingent consideration (0.110 ) 0.440 (0.599 ) (1.370 ) — (0.640 ) — (1.639 ) (0.640 ) Reorganization expense — — — — 0.258 0.157 0.845 — 1.260 Impairments — — — — — — 77.221 — 77.221 (Loss) income from disposal of fixed assets — — — — — — 0.023 — 0.023 Tax effect on above adjustments (0.417 ) (0.746 ) (0.603 ) (0.554 ) (1.007 ) 0.041 (5.153 ) (2.320 ) (6.119 ) Adjusted Net income (Non-GAAP) $ 3.702 $ 6.400 $ 5.611 $ 3.640 $ 3.446 $ 6.195 $ 9.028 $ 19.353 $ 18.669 Weighted-avg. common shares outstanding: Diluted 20,279 20,315 20,433 20,338 20,266 20,277 20,113 20,301 20,092 Diluted EPS (GAAP) $ 0.10 $ 0.20 $ 0.15 $ 0.04 $ 0.01 $ 0.15 $ (3.35 ) $ 0.49 $ (3.19 ) Adjusted Diluted EPS (Non-GAAP) $ 0.18 $ 0.32 $ 0.27 $ 0.18 $ 0.17 $ 0.31 $ 0.45 $ 0.95 $ 0.93 (1) Numbers may not foot due to rounding View source version on Contacts Investor Relations Contact:Lisa FortunaFinancial Profiles310-622-8251slp@
Yahoo
2 hours ago
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Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025
– New Data from PURPOSE Trials Further Demonstrate that Lenacapavir (Yeztugo®) was Effective and Well Tolerated Across a Broad Range of Populations, Including Pregnant and Lactating Women, Adolescents and Young People – – Data Also Showed Twice-Yearly Injectable PrEP was Preferred vs. Daily Oral Medication Among PURPOSE Trial Participants – – Gilead's Research Presentations and Community Events at IAS Reflect Commitment to Partnerships in Developing Person-Centered Options for a Diverse Range of Populations – FOSTER CITY, Calif., July 14, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo®) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions. Researchers will also present new quantitative and qualitative data showing that participants in both Phase 3 PURPOSE trials indicated a preference for twice-yearly PrEP injections over daily oral medication. The new data, from the company's pivotal Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials that assessed the efficacy and safety of twice-yearly Yeztugo for PrEP, will be presented via poster sessions and during a Yeztugo-dedicated oral session at the International AIDS Society (IAS) 2025, the 13th IAS Conference on HIV Science in Kigali, Rwanda on Thursday, July 17. The data presentations come less than a month after the U.S. Food and Drug Administration (FDA) approved Yeztugo as the first and only twice-yearly HIV prevention option. The data underscore Gilead's focus on intentional inclusion in the PURPOSE program to ensure broad and robust population data at the trials' primary analyses, as well as spotlight the community and organizational collaborations that guided the trial design and implementation process. "It's a thrill to be back in Kigali with so many of the community, advocacy and research partners who helped make PURPOSE the most intentionally inclusive HIV prevention trial program ever conducted," said Moupali Das, Vice President of Clinical Development, HIV Prevention & Pediatrics at Gilead Sciences. "As the first and only twice-yearly PrEP option, Yeztugo continues to demonstrate efficacy and tolerability among diverse populations, and we're excited to highlight new data on this breakthrough HIV prevention option here at IAS 2025." Yeztugo was Efficacious and Well Tolerated in Trials Among Pregnant and Lactating Women, Adolescents and Young People, and Can Be Administered in People Receiving Treatment for TB and Other Conditions Pregnant and lactating women—who face a heightened likelihood of acquiring HIV—have historically been excluded from HIV prevention trials. Based on input from community meetings in locations including Kigali, Gilead ensured that pregnant and lactating women were included in the Phase 3 PURPOSE 1 trial, which evaluated twice-yearly Yeztugo in cisgender women and adolescent girls in Sub-Saharan Africa. PURPOSE data presented at IAS 2025 show that Yeztugo was efficacious in pregnant and breastfeeding or lactating women, with no new cases of HIV reported among 184 participants in the Yeztugo group (there were a total of 509 pregnancies among 487 participants in PURPOSE 1). Data also show that Yeztugo was well tolerated by these women, that there were similar safety profiles between pregnant and non-pregnant women, and that there were no clinically significant differences in predicted Yeztugo exposure by pregnancy trimester or postpartum status. Additionally, exposure in breastfed infants was minimal. Young people aged 16-25 years are also at an increased likelihood of experiencing HIV acquisition globally, but, like pregnant women, are often not proactively included in Phase 3 HIV prevention trials. Gilead intentionally included this population in the PURPOSE 1 trial and the PURPOSE 2 trial, which evaluated twice-yearly Yeztugo among a broad and geographically diverse range of cisgender men and gender-diverse people. Data presented at IAS 2025 show that Yeztugo was efficacious in people aged 16-25 years, with zero reported HIV infections in young people receiving Yeztugo in PURPOSE 1 and two HIV infections among young people in PURPOSE 2. Additionally, there were no clinically significant pharmacokinetic differences between the 16-25-year-old group and adults aged over 25 years. Yeztugo was well tolerated across both trials among participants of all ages, with no new safety concerns identified. Globally, those at higher likelihood of HIV acquisition may also be vulnerable to TB, which can be treated by rifamycin-class drugs including rifampin and rifabutin. Yeztugo is a substrate of CYP3A, and strong CYP3A inducers such as rifampin, or moderate inducers such as rifabutin, may potentially lower Yeztugo plasma concentrations. Gilead will present modeling data showing supplemental Yeztugo dosing for strong and moderate CYP3A inducers to allow people receiving Yeztugo to receive rifamycin-containing TB treatment, if necessary. Yeztugo is also a moderate inhibitor of CYP3A and could theoretically increase levels of drugs such as statins for lowering cholesterol or PDE5 inhibitors for treating erectile dysfunction; dosing recommendations for these special situations will also be reviewed. Preference for Twice-Yearly Prevention Option Over Daily Oral PrEP New qualitative and quantitative self-reported data from PURPOSE 1 and PURPOSE 2 show significant preference for twice-yearly injectable PrEP compared with daily oral PrEP among study participants. More than 75% of study participants who were surveyed preferred twice-yearly injectable administration; of these, more than 50% reported a strong preference. Reasons given for favoring twice-yearly injectable PrEP versus daily oral PrEP include feeling more protected from HIV (69%) and feeling more confident about not missing a dose (77%). "Certain groups—including pregnant and lactating women, adolescents and young people—are disproportionately affected by HIV, yet have long been underrepresented in HIV clinical trials," said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society. "The PURPOSE program set a new standard for innovative, intentional inclusion by ensuring we would have safety and efficacy data in these populations from the outset. The results not only show that Yeztugo provides strong protection against HIV and was well tolerated in these groups, but also highlight the critical need for PrEP options that reflect people's preferences—reducing barriers to uptake and helping close persistent gaps in prevention." Continued Global Regulatory Filings for Lenacapavir for PrEP, as Well as Milestone Partnerships On June 18, 2025, Gilead received FDA approval for Yeztugo as PrEP to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. Gilead has also submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada, South Africa and Switzerland. Additionally, now that lenacapavir has received FDA approval for PrEP, Gilead is preparing additional filings in countries that rely on stringent regulatory authority approvals for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. Last week, Gilead announced a strategic partnership agreement with The Global Fund to Fight AIDS, Tuberculosis and Malaria to supply enough doses of lenacapavir, at no profit to Gilead, to reach up to two million people over three years in countries supported by the Global Fund and that are included in Gilead's voluntary licensing agreements for lenacapavir. There is currently no cure for HIV or AIDS. Please see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Yeztugo. About the PURPOSE Program Gilead's landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity. The PURPOSE trials are evaluating the safety and efficacy of the, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead has been recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to realize the anticipated benefits from the collaboration; difficulties or unanticipated expenses in connection with the collaboration and the potential effects on Gilead's earnings; Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yeztugo; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Yeztugo, including Boxed Warning, is available at Gilead and the Gilead logo, and Yeztugo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Sign in to access your portfolio
