logo
American Cancer Society and Guardant Health Partner to Expand Cancer Screening Access and Advance Health Equity

American Cancer Society and Guardant Health Partner to Expand Cancer Screening Access and Advance Health Equity

Business Wire2 days ago
SAN FRANCISCO--(BUSINESS WIRE)--The American Cancer Society (ACS) today announced a new partnership with Guardant Health (Nasdaq: GH), a leading precision oncology company focused on improving access to cancer screening and advancing health equity.
This collaboration supports ACS's nationwide cancer screening efforts, including the I Love You, Get Screened public awareness campaign; community-based health system partnerships; and state coalition work aimed at removing barriers to lifesaving screenings. ACS and Guardant Health aim to increase awareness, promote early detection, and improve outcomes for individuals in communities that have historically experienced limited access to preventive care.
'Regular cancer screening saves lives by finding certain cancers early, when they are often easier to treat or even prevent altogether,' said Maria Olson, Executive Vice President, American Cancer Society. 'With support from Guardant Health, we can reach more people across the Bay Area with the information, tools, and services they need to take action for their health.'
Despite being a hub of healthcare innovation, California continues to fall behind the national average in key cancer screening rates. Data from the American Cancer Society shows that only 64% of California women aged 45 and older are up to date on screening mammograms, compared to 69% nationally. Colorectal cancer screening rates are also lower, with 60% of eligible Californians screened compared to 62% nationwide. These gaps represent a critical opportunity to expand access and close the screening disparity.
In 2025, an estimated 2,041,910 people in the U.S. will be diagnosed with cancer, and more than 600,000 lives are expected to be lost due to cancer. However, due to reductions in smoking and advances in early detection and treatment, cancer mortality has dropped 34% from 1991 to 2022, averting approximately 4.5 million deaths during that time. This work aims to accelerate that momentum, with a special focus on communities that remain underserved.
Guardant Health will support the following ACS initiatives:
Expanding the reach of the I Love You, Get Screened campaign, which garnered over 313 million impressions in 2024 and delivers culturally relevant education to communities including Black/African American, Hispanic/Latino, and LGBTQ+ populations.
Promoting digital tools on cancer.org, including a locator tool that helps individuals find more than 15,000 screening locations across the U.S.
Supporting community health interventions, such as patient education, navigation to screening appointments, transportation support, and language access services. These efforts contributed to over 555,000 completed screenings and 7,800 cancers detected in 2024.
Collaborating with state coalitions, including those in California, to implement localized strategies that help increase screening rates and reduce disparities.
'Guardant Health is proud to partner with the American Cancer Society in the fight to expand cancer screening access,' said AmirAli Talasaz, Guardant Health co-founder and co-CEO. 'We share a commitment to ensuring that everyone, regardless of race, ethnicity, income, or ZIP code, has access to convenient and timely cancer screening, so we can detect cancer earlier and give them the opportunity for a better outcome.'
Throughout 2025, ACS will engage communities across the nation through impactful campaigns aligned with key cancer awareness months—including cervical cancer awareness in January, colorectal in March, prostate in September, breast in October, and lung in November. These efforts will feature personal stories, local events, and trusted education to empower more people to get screened and take charge of their health. To learn more about ACS screening tools or to find a local screening center, visit www.cancer.org/getscreened.
About the American Cancer Society
The American Cancer Society is a leading cancer-fighting organization with a vision to end cancer as we know it, for everyone. For more than 110 years, we have been improving the lives of people with cancer and their families as the only organization combating cancer through advocacy, research, and patient support. We are committed to ensuring everyone has an opportunity to prevent, detect, treat, and survive cancer. To learn more, visit cancer.org or call our 24/7 helpline at 1-800-227-2345. Connect with us on Facebook, X, and Instagram.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Stoke Therapeutics to Present at the Canaccord Genuity 45 th Annual Growth Conference
Stoke Therapeutics to Present at the Canaccord Genuity 45 th Annual Growth Conference

Business Wire

time29 minutes ago

  • Business Wire

Stoke Therapeutics to Present at the Canaccord Genuity 45 th Annual Growth Conference

BEDFORD, Mass.--(BUSINESS WIRE)-- Stoke Therapeutics, Inc. (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine and has a lead investigational medicine, zorevunersen, in development as a first-in-class potential disease-modifying treatment for Dravet syndrome. The Company today announced that Interim Chief Executive Officer Ian F. Smith will present at the Canaccord Genuity 45th Annual Growth Conference on Wednesday, August 13, 2025, at 11:30 a.m. ET. A live webcast of the presentation, along with an archived replay, will be available in the Investors & News section of Stoke's website at About Stoke Therapeutics Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke's proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit

Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook
Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook

Business Wire

timean hour ago

  • Business Wire

Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook

LOS ANGELES--(BUSINESS WIRE)--Niagen Bioscience, Inc. (NASDAQ:NAGE) today announced financial results for the second quarter of 2025. Niagen Bioscience, Inc. Reports Second Quarter 2025 Financial Results and Increases Full Year Outlook Share Second Quarter 2025 Financial Highlights Compared to Prior Year Period Total net sales increased 37% to $31.1 million, with Tru Niagen® sales reaching $22.7 million, growing 22%. Niagen® ingredient sales increased 135% to $7.4 million including food-grade and pharmaceutical-grade. Gross margin increased 480 basis points to 65.0%. Sales and marketing expense as a percentage of net sales was 26.4%, an improvement of 420 basis points. Net income of $3.6 million or $0.05 earnings per share, up from breakeven in prior year quarter. Adjusted EBITDA, a non-GAAP measure, increased 221% to $5.0 million. Total cash provided by operations of $9.1 million during the six months ended June 30, 2025, ending the quarter with $60.5 million in cash. Increased full year 2025 outlook: Net sales growth expected between 22%–27% (previously between 20%–25%), reflecting continued execution and leadership in the expanding NAD+ market. Recent Operational Highlights On June 9, 2025, the Company announced the publication of the first peer-reviewed clinical study of Niagen® in individuals with Werner syndrome, a rare premature aging disorder in Aging Cell. The 52-week randomized trial showed Niagen® significantly increased NAD+ levels and improved clinical markers of cardiovascular and skin health, supporting further investigation in rare, age-related diseases. On July 8, 2025, the Company entered into a worldwide exclusive license agreement with Haukeland University Hospital in Bergen, Norway, securing proprietary rights to develop and commercialize its patented nicotinamide riboside (Niagen®) as a potential pharmaceutical therapy for Parkinson's disease (PD). This agreement includes access to extensive clinical data, including from the Phase III NOPARK trial, and supports the Company's broader efforts to advance regulated therapeutic applications for neurodegenerative conditions. During June 2025, patient dosing the Phase III NOPARK trial was completed, the largest and most comprehensive clinical study of NAD+ augmentation in persons with early PD to date. NOPARK is a randomized, double-blind, placebo-controlled phase III clinical trial featuring 400 individuals with early-stage PD across 12 sites in Norway. Randomized to receive either 500 mg of nicotinamide riboside (Niagen) twice daily or placebo for 52 weeks, participants had follow-up assessments at five time points in a one-year period. The primary endpoint is the MDS-UPDRS total score, a gold standard measure of PD progression. Data analysis is underway and the data from this phase 3 trial is expected to be published in 2026. On July 14, 2025, the Company announced the launch of Tru Niagen® as an exclusive in-room amenity, and introduced Niagen IV at The Spa by Equinox Hotel New York through NutriDrip, marking Niagen Bioscience's entry into luxury hospitality. While featured at a single location, Equinox's sole hotel property, the launch aligns with a premium, health-conscious demographic and serves as a potential model for broader hospitality partnerships. As of August 2025, Niagen Plus products, including Niagen IV and injectables, are available in over 800 leading wellness clinics in the U.S., up from more than 475 clinics in December 2024. This growth reflects accelerating adoption by clinics and rising demand for clinically administered NAD+ solutions. Niagen Plus products are compounded and distributed through U.S. FDA-registered 503B outsourcing facilities and offered exclusively by prescription through participating wellness clinics. 'We delivered an excellent second quarter, with $31.1 million in net sales, up 37% year-over-year, and $3.6 million in net income,' said Niagen Bioscience CEO Rob Fried. 'As the pioneers of this blossoming NAD+ market, we continue to invest in the future while maintaining our focus on profitable growth." Results of operations for the three months ended June 30, 2025 compared to the prior year quarter Net Sales for Niagen Bioscience increased 37%, or $8.4 million, to $31.1 million. The growth in net sales was driven by combined growth in Tru Niagen® sales and Niagen® ingredient sales, including strong e-commerce channel performance, stronger demand for food-grade Niagen® and the ramp-up of pharmaceutical-grade Niagen® sales, which were not sold in the prior year quarter. Gross Margin improved 480 basis points to 65.0% primarily due to changes in product mix, business mix, the use of lower-cost inventory purchases, and improvements in labor and overhead utilization rates with higher sales. These gross margin improvements may not be indicative of future performance and certain drivers, such as lower-cost inventory purchases, are likely to be temporary in nature. Gross margins are expected to normalize in future periods. Operating Expense increased 22%, or $3.1 million, to $17.0 million reflecting investments for business growth and brand awareness. Selling and marketing expense increased $1.2 million, and improved 420 basis points as a percentage of net sales to 26.4% of net sales, reflecting improved sales efficiency and disciplined investment. The increase in expenses primarily reflects higher investments to support brand growth in our consumer products segment. General and administrative expense increased $1.6 million, or 28%, primarily driven by higher employee-related expenses, share-based compensation, and professional and consulting fees. Research and development expenses increased $0.3 million due to higher professional and consulting fees, as well as higher employee-related expenses. Net Income was $3.6 million, or $0.05 per share, compared to approximately break-even net loss and loss per share for the second quarter of 2024. Adjusted EBITDA, a non-GAAP measure, was $5.0 million, up from $1.6 million for the second quarter of 2024. See 'Reconciliation of Non-GAAP Financial Measures' for a reconciliation of non-GAAP Adjusted EBITDA to net income (loss), the most directly comparable GAAP measure. Cash Flows from Operating Activities had a net cash inflow of $9.1 million for the six months ended June 30, 2025 compared to approximately break-even cash flows in the prior year. The approximately $9.1 million increase in cash provided by operating activities was primarily driven by improvements in net income (loss), relatively higher collections on trade receivables, and a relative increase in accounts payable. These increases were partially offset by a decrease in credit loss expense due to a recovery of previously written-off amounts and higher inventory purchases associated with scaling our inventory reserves. 2025 Full Year Outlook Looking forward, for the full year, the Company is revising its revenue growth expectation from 20% to 25% year-over-year to 22% to 27%. This outlook reflects anticipated continued expansion of the Company's e-commerce business as well as growth through new and established partnerships. Gross margin is expected to improve slightly year-over-year compared to 61.8% in 2024, driven by ongoing supply chain optimization efforts, cost savings initiatives, and overall business scale. The Company is also updating its outlook for sales and marketing expenses. These costs are now expected to increase in absolute dollars compared to $29.5 million in 2024, but decrease as a percentage of net sales compared to 29.6% of net sales in 2024. This compares to the prior guidance of an increase in absolute dollars with a stable percentage of net sales year over year. The updated projection reflects the Company's continued strategic investments to enhance and strengthen brand awareness and support its various business channels while enhancing efficiencies. The Company remains committed to maintaining steady investments in research and development throughout 2025, with spending expected to align closely with fiscal year 2024 levels ($6.0 million), to continue driving future innovation. General and administrative expenses are expected to increase by approximately $7.0 to $8.0 million, primarily due to share-based compensation and investments in business growth and the absence of a $3.5 million royalty expense reversal that occurred in 2024. Investor Conference Call A live webcast will be held Wednesday, August 6, 2025 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss Niagen Bioscience's second-quarter financial results and provide a general business update. To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of Niagen Bioscience's website at The toll-free dial-in information for this call is 1-888-596-4144 with Conference ID: 8584242. The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on August 6, 2025 through 11:59 p.m. Eastern time on August 13, 2025. The replay of the call can also be accessed by dialing 1-800-770-2030, using the Replay ID: 8584242. Important Note on Forward Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as 'expects,' 'anticipates,' 'intends' 'estimates,' 'plans,' 'potential,' 'possible,' 'probable,' 'believes' 'seeks,' 'may,' 'will,' 'should,' 'could,' 'predicts,' 'projects,' 'continue,' 'would' or the negative of such terms or other similar expressions. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the quotation from Niagen Bioscience's Chief Executive Officer, statements related to the Company's 2025 financial outlook including but not limited to revenue growth, gross margin, expenses, investment plans, and the statements regarding Niagen Plus. Risks that contribute to the uncertain nature of the forward-looking statements include: inflationary conditions and adverse economic conditions; our history of operating losses; the growth and profitability of our product sales; our ability to maintain and grow sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; risks of conducting business in China; including unanticipated developments in and risks related to the Company's ability to secure adequate quantities of pharmaceutical-grade Niagen in a timely manner; the Company's ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to compound and distribute pharmaceutical-grade Niagen to clinics; the Company's ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company's ability to maintain and enforce the Company's existing intellectual property and obtain new patents; whether the potential benefits of NRC can be further supported; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities; economic and market instability, including as a result of tariffs or trade conflicts; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and Niagen Bioscience undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. About Niagen Bioscience, Inc.: Niagen Bioscience is a global bioscience company dedicated to healthy aging. The Niagen Bioscience team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), an essential coenzyme that is a key regulator of cellular metabolism and is found in every cell of the human body. NAD+ levels in humans have been shown to decline with age, among other factors, and may be increased through supplementation with NAD+ precursors. Niagen Bioscience is the innovator behind the NAD+ precursor nicotinamide riboside chloride ('NRC' commonly referred to as 'NR'), commercialized as the flagship ingredient Niagen®, available in both food and pharmaceutical grades. Nicotinamide riboside chloride and other NAD+ precursors are protected by Niagen Bioscience's patent portfolio. The Company delivers Niagen® as the sole or principal dietary ingredient in its consumer product line Tru Niagen® available at and through partnerships with global retailers and distributors. The Company also develops and commercializes proprietary-based ingredient technologies, including food-grade Niagen® and pharmaceutical-grade Niagen®, and supplies these ingredients as raw materials to the manufacturers of consumer products and U.S. FDA-registered 503B outsourcing facilities, respectively. The Company further offers natural product fine chemicals, known as phytochemicals, and related research and development services. Follow us on X (formerly Twitter) @NiagenBio and Instagram @TruNiagen and @NiagenPlus and subscribe to our latest news via our website accessible at to which Niagen Bioscience regularly posts copies of its press releases as well as additional updates and financial information about the Company. Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Balance Sheets (In thousands except par values, unless otherwise indicated) June 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents, including restricted cash of $152 for both periods presented $ 60,474 $ 44,660 Trade receivables, net of allowances of $199 and $95, respectively 9,656 7,768 Inventories 14,406 9,192 Prepaid expenses and other assets 2,143 2,482 Total current assets 86,679 64,102 Leasehold improvements and equipment, net 1,632 1,719 Intangible assets, net 284 359 Right-of-use assets 2,525 1,730 Other long-term assets 405 368 Total assets $ 91,525 $ 68,278 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 13,680 $ 8,526 Accrued expenses 7,381 7,817 Current maturities of operating lease obligations 957 982 Current maturities of finance lease obligations 6 12 Customer deposits 303 611 Total current liabilities 22,327 17,948 Deferred revenue 2,674 2,579 Operating lease obligations, less current maturities 2,329 1,657 Total stockholders' equity 64,195 46,094 Total liabilities and stockholders' equity $ 91,525 $ 68,278 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Condensed Consolidated Statements of Cash Flows Six Months Ended June 30, (In thousands) 2025 2024 Net cash provided by / (used in): Operating activities $ 9,133 $ 31 Investing activities (167 ) (53 ) Financing activities 6,848 582 Net increase in cash and cash equivalents 15,814 560 Cash and cash equivalents beginning of period 44,660 27,325 Cash and cash equivalents at end of period $ 60,474 $ 27,885 Expand Niagen Bioscience, Inc. and Subsidiaries Unaudited Reconciliation of Non-GAAP Financial Measures Reconciliation of Net Income (Loss) to Adjusted EBITDA (In thousands) Q2 2025 Q1 2025 Q4 2024 Q3 2024 Q2 2024 Net income (loss), as reported $ 3,609 $ 5,063 $ 7,179 $ 1,878 $ (15 ) Adjustments: Interest income, net (552 ) (459 ) (373 ) (276 ) (241 ) Provision for income taxes 128 168 305 — — Depreciation 158 158 151 164 170 Amortization of intangibles 38 37 38 38 37 Noncash lease expense 159 173 169 164 163 Share-based compensation 1,488 1,075 752 735 1,185 Severance and restructuring 21 4 (4 ) 185 276 Reversal of previously accrued royalties and license maintenance fees (1) — — (3,521 ) — — Recovery of credit losses related to legal settlement (2) — (1,325 ) (1,325 ) — — Adjusted EBITDA $ 5,049 $ 4,894 $ 3,371 $ 2,888 $ 1,575 Expand (1) The reversal of previously accrued royalties and license maintenance fees related to a supplemental agreement with Dartmouth, which waived certain obligations under the exclusive license agreements. (2) The recovery of credit losses relates to the 2024 legal settlement with Elysium Health, LLC, paid in two installments, reversing a bad debt write-off from 2019. Expand Non-GAAP Financial Information: To supplement Niagen Bioscience's unaudited financial data presented in accordance with generally accepted accounting principles (GAAP), the Company has presented Adjusted EBITDA, a non-GAAP financial measure. Niagen Bioscience believes the presentation of this non-GAAP financial measure provides important supplemental information to management and investors and enhances the overall understanding of the Company's historical and current financial operating performance. The Company believes disclosure of the non-GAAP financial measure has substance because the excluded expenses are infrequent in nature, are variable in nature or do not represent current cash expenditures. Further, such non-GAAP financial measure is among the indicators the Company uses as a basis for evaluating the Company's financial performance as well as for planning and forecasting purposes. Accordingly, disclosure of this non-GAAP financial measure provides investors with the same information that management uses to understand the Company's economic performance year-over-year. Adjusted EBITDA is defined as net income (loss) before (a) interest, (b) provision for income taxes, (c) depreciation, (d) amortization, (e) non-cash share-based compensation costs, (f) severance and restructuring expense and (g) other infrequent items, including the reversal of previously accrued royalties and license maintenance fees, and the recovery of previously recognized credit losses from a legal settlement. While Niagen Bioscience believes that this non-GAAP financial measure provides useful supplemental information to investors, there are limitations associated with the use of such measure. This measure is not prepared in accordance with GAAP and may not be directly comparable to similarly titled measures of other companies due to potential differences in the method of calculation. Management compensates for these limitations by relying primarily on the Company's GAAP results and by using Adjusted EBITDA only supplementally and by reviewing the reconciliation of the non-GAAP financial measure to its most comparable GAAP financial measure. Non-GAAP financial measures are not prepared in accordance with, or an alternative for, generally accepted accounting principles in the United States. The Company's non-GAAP financial measure is not meant to be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP.

CareDx Announces Second Quarter 2025 Financial Results
CareDx Announces Second Quarter 2025 Financial Results

Business Wire

timean hour ago

  • Business Wire

CareDx Announces Second Quarter 2025 Financial Results

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company - a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today reported financial results for the second quarter ended June 30, 2025. Second Quarter 2025 Financial Highlights Reported revenue of $86.7 million including a $3.8 million write-off of aged receivables associated with tests performed in prior periods Adjusted revenue of $90.5 million, an increase of 14% year-over-year GAAP testing services revenue of $62.0 million, a decrease of 13% year-over-year Adjusted testing services revenue of $65.9 million, an increase of 14% year-over-year Testing services volume of 49,500, an increase of 13% year-over-year GAAP net loss of $8.6 million, compared to a GAAP net loss of $4.6 million in the second quarter of 2024 Non-GAAP net income of $5.6 million, compared to $13.6 million in the second quarter of 2024 Adjusted EBITDA gain of $9.1 million, excluding a $3.8 million write-off of aged receivables, compared to a loss of $0.3 million in the second quarter of 2024, excluding revenue from tests performed in prior periods Cash, cash equivalents and marketable securities of $186 million as of June 30, 2025, net of a $50 million share repurchase carried out during the quarter; no debt as of June 30, 2025 Narrowed full-year 2025 revenue guidance to $367 million to $373 million Recent Business Highlights Eighth consecutive quarter of sequential growth in testing services volumes First Kidney Allograft Outcomes AlloSure Registry ('KOAR') manuscript published in The American Journal of Transplantation Draft LCD affirms surveillance testing coverage for solid organ transplant rejection; The Company intends to comment on aspects of the draft LCD during the open comment period, which ends August 31, 2025 Launched Increasing Organ Transplant Access ("IOTA") tool in XynQAPI® to help transplant centers track performance under CMS's IOTA model ahead of July 1, 2025, activation date Leading presence with 40 abstracts and 12 oral presentations at 2025 World Transplant Congress in San Francisco, CA Launched AlloSure® Plus (formerly AlloView®), an AI-driven diagnostic platform that combines AlloSure® donor-derived cell-free DNA (dd-cfDNA) analysis with established clinical methods to improve prediction of rejection Successfully installed EPIC environment at CareDx and initiated multiple customer pilots in the third quarter 'CareDx had a strong second quarter. Volume growth accelerated, led by AlloSure kidney testing which was up nearly 20% year-over-year. Our cash collections also improved considerably, and coupled with financial discipline, contributed to a substantial adjusted EBITDA improvement,' said John W. Hanna, CareDx President and CEO. 'We had an exceptional showing at the World Transplant Congress where data supporting the use of AlloSure Kidney was highlighted in large, prospective, multi-center studies as being the most significant biomarker for detecting organ rejection. Our evidence and differentiated products, including the launch of AlloSure Plus, are setting us apart as the leader in transplant care.' Q2 2025 Financial Results Total revenue was $86.7 million compared to $92.3 million in the second quarter of 2024, down 6%. Adjusted revenue was $90.5 million, up 14% compared to $79.1 million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. Testing services revenue was $62.0 million, compared to $70.9 million in the second quarter of 2024, a decrease of 13%. Adjusted testing services revenue was $65.9 million, up 14% compared to adjusted testing services revenue of $57.7 million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. Patient and Digital Solutions revenue was $12.8 million, an increase of 19% compared to $10.7 million in the second quarter of 2024. Product revenue was $11.8 million, an increase of 12% compared to $10.6 million in the second quarter of 2024. GAAP net loss was $8.6 million compared to $4.6 million in the second quarter 2024. Basic and diluted GAAP net loss per share was $0.16 compared to $0.09 in the second quarter of 2024. Non-GAAP net income was $5.6 million compared to $13.6 million in the second quarter of 2024. Diluted non-GAAP net income per share was $0.10 compared to $0.25 in the second quarter of 2024. Adjusted EBITDA gain was $9.1 million compared to an adjusted EBITDA loss of ($0.3) million in the second quarter of 2024, excluding a negative $3.8 million adjustment and a positive $13.2 million adjustment, respectively, related to revenue from tests performed in prior periods. 2025 Guidance For the full year 2025, CareDx now expects revenue to be in the range of $367 million to $373 million, compared to the $365 million to $375 million range that was previously disclosed. The Company continues to expect full year 2025 adjusted EBITDA to be in the range of $29 million to $33 million. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: Forward Looking Statements This press release includes forward-looking statements, including expectations regarding the achievement of CareDx's financial and operational goals and its expectations and prospects for 2025. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx's control, that could cause the actual results to differ materially from those projected, including general economic and market factors, and global economic and marketplace uncertainties, among others discussed in CareDx's filings with the Securities and Exchange Commission (the 'SEC'), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx's actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx's forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Use of Non-GAAP Financial Measures CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP adjusted testing services revenue, non-GAAP adjusted revenue, non-GAAP cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP operating expenses, non-GAAP income tax expense, non-GAAP net income (loss), non-GAAP basic and diluted net income (loss) per share and adjusted EBITDA. These non-GAAP financial measures are not meant to be considered superior to or a substitute for financial measures calculated in accordance with GAAP, and investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool. We define non-GAAP net income (loss) and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation expense; acquisition-related amortization of purchased intangible assets and related tax effects; costs involved with completing an acquisition; changes in estimated fair value of contingent consideration; litigation settlement expense; transformational initiative costs; and certain other charges presented in the reconciliation in this release. We define adjusted testing services revenue and adjusted revenue as GAAP revenue excluding the impact of revenue from tests performed in prior periods. We define adjusted EBITDA as non-GAAP net income (loss) before interest income, income tax (benefit) expense, depreciation expense and other (income) expense, net and revenue from tests performed in prior periods. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods where certain items may vary independent of business performance. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx's operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. A reconciliation of the forecasted range for adjusted EBITDA for 2025 is not included in this release due to the number of variables in the projected range and because we are currently unable to quantify accurately certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation. CareDx, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) December 31, 2024 Assets Current assets: Cash and cash equivalents $68,212 $114,689 Marketable securities 118,043 145,964 Accounts receivable 67,362 64,605 Inventory 27,915 19,503 Prepaid and other current assets 25,764 7,071 Total current assets 307,296 351,832 Property and equipment, net 31,934 33,552 Operating leases right-of-use assets 25,372 24,340 Intangible assets, net 36,037 38,184 Goodwill 40,336 40,336 Restricted cash 551 585 Other assets 2,731 2,221 Total assets $444,257 $491,050 Liabilities and stockholders' equity Current liabilities: Accounts payable $9,863 $7,686 Accrued compensation 19,056 38,333 Accrued litigation settlement expense 20,250 — Accrued and other liabilities 44,011 43,352 Total current liabilities 93,180 89,371 Deferred tax liability 131 164 Contingent consideration 160 174 Operating lease liability, less current portion 22,780 22,263 Other liabilities 636 645 Total liabilities 116,887 112,617 Commitments and contingencies Stockholders' equity: Common stock 53 51 Additional paid-in capital 1,028,591 1,013,193 Accumulated other comprehensive loss (6,113) (8,569) Accumulated deficit (695,161) (626,242) Total stockholders' equity 327,370 378,433 Total liabilities and stockholders' equity $444,257 $491,050 Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Cost of testing services reconciliation: GAAP cost of testing services $15,406 $14,308 Stock-based compensation expense (329) (357) Acquisition related-amortization of purchased intangibles (346) (329) Non-GAAP cost of testing services $14,731 $13,622 Cost of product reconciliation: GAAP cost of product $4,981 $6,298 Stock-based compensation expense (108) (225) Acquisition related-amortization of purchased intangibles (442) (411) Restructuring costs (164) (53) Non-GAAP cost of product $4,267 $5,609 Cost of patient and digital solutions reconciliation: GAAP cost of patient and digital solutions $8,271 $7,393 Stock-based compensation expense (189) (350) Acquisition related-amortization of purchased intangibles (153) (238) Restructuring costs (174) — Non-GAAP cost of patient and digital solutions $7,755 $6,805 Research and development expenses reconciliation: GAAP research and development expenses $16,830 $19,693 Stock-based compensation expense (1,407) (1,628) Restructuring costs — (15) Non-GAAP research and development expenses $15,423 $18,050 Sales and marketing expenses reconciliation: GAAP sales and marketing expenses $24,279 $21,002 Stock-based compensation expense (2,146) (2,927) Acquisition related-amortization of purchased intangibles (648) (628) Restructuring costs 12 — Non-GAAP sales and marketing expenses $21,497 $17,447 General and administrative expenses reconciliation: GAAP general and administrative expenses $28,033 $30,907 Stock-based compensation expense (5,245) (10,912) Change in estimated fair value of contingent consideration (501) (210) Acquisition related fees and expenses (204) (5) Litigation settlement expense (350) — Restructuring costs (34) — Transformational initiative costs* (1,871) — Other (charges) income — (44) Non-GAAP general and administrative expenses $19,828 $19,736 Total other income reconciliation: GAAP other income $2,436 $2,726 Non-GAAP other income $2,436 $2,726 Income tax benefit (expense) reconciliation: GAAP income tax benefit (expense) $117 $(22) Tax effect related to amortization of purchased intangibles (109) (98) Non-GAAP income tax benefit (expense) $8 $(120) * Transformational initiative costs consist of consulting expenses which relate to our ongoing transformation strategy that we have undertaken as a series of initiatives focused on operational excellence, enterprise-wide efficiency, and long-term strategic growth. Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) Three Months Ended June 30, 2025 2024 GAAP total revenue $86,679 $92,274 GAAP cost of sales 28,658 27,999 GAAP gross profit 58,021 64,275 GAAP gross margin % 67% 70% Stock-based compensation expense 626 932 Restructuring costs 338 53 Acquisition related-amortization of purchased intangibles 941 978 Non-GAAP gross profit $59,926 $66,238 Non-GAAP gross margin % 69% 72% Expand CareDx, Inc. Reconciliation of GAAP Revenue to Non-GAAP Adjusted Revenue (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Adjusted revenue reconciliation: Revenue (GAAP) $86,679 $92,274 Revenue from tests performed in prior periods* 3,827 (13,214) Adjusted revenue (Non-GAAP) $90,506 $79,060 * For the three months ended June 30, 2025, the Company reduced revenue by $3.8 million for tests performed in prior periods. For the three months ended June 30, 2024, the Company recognized $13.2 million in revenue for the tests performed in prior periods. Expand CareDx, Inc. Reconciliation of GAAP Testing Services Revenue to Non-GAAP Adjusted Testing Services Revenue (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 Adjusted testing services revenue reconciliation: Testing services revenue (GAAP) $62,033 $70,918 Revenue from tests performed in prior periods* 3,827 (13,214) Adjusted testing services revenue (Non-GAAP) $65,860 $57,704 * For the three months ended June 30, 2025, the Company reduced revenue by $3.8 million for tests performed in prior periods. For the three months ended June 30, 2024, the Company recognized $13.2 million in revenue for the tests performed in prior periods. Expand CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) Three Months Ended June 30, 2025 2024 GAAP net loss $(8,568) $(4,623) Stock-based compensation expense 9,424 16,399 Acquisition related-amortization of purchased intangibles 1,589 1,606 Acquisition related fees and expenses 204 5 Change in estimated fair value of contingent consideration 501 210 Other income and charges — 44 Tax effect related to amortization of purchased intangibles (109) (98) Transformational initiative costs* 1,871 — Restructuring costs 360 68 Litigation settlement expense 350 — Non-GAAP net income $5,622 $13,611 GAAP basic and diluted net loss per share $(0.16) $(0.09) Non-GAAP basic net income per share $0.10 $0.26 Non-GAAP diluted net income per share $0.10 $0.25 54,304,754 52,195,620 56,385,713 54,333,731 * Transformational initiative costs consist of consulting expenses which relate to our ongoing transformation strategy that we have undertaken as a series of initiatives focused on operational excellence, enterprise-wide efficiency, and long-term strategic growth. Expand CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA (Unaudited) (In thousands) Three Months Ended June 30, 2025 2024 GAAP net loss $(8,568) $(4,623) Stock-based compensation expense 9,424 16,399 Acquisition related-amortization of purchased intangibles 1,589 1,606 Acquisition related fees and expenses 204 5 Change in estimated fair value of contingent consideration 501 210 Other income and charges — 44 Tax effect related to amortization of purchased intangibles (109) (98) Transformational initiative costs 1,871 — Restructuring costs 360 68 Litigation settlement expense 350 — Non-GAAP net income 5,622 13,611 Interest income (2,364) (2,826) Income tax (benefit) expense (8) 121 Depreciation expense 2,132 1,937 Other (income) expense, net (72) 100 Adjusted EBITDA 5,310 12,943 Revenue from tests performed in prior periods 3,827 (13,214) Adjusted EBITDA after revenue from tests performed in prior periods $9,137 $(271) Expand

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store