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Guardant Health Reports Second Quarter 2025 Financial Results and Increases 2025 Revenue Guidance

On July 30, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended June 30, 2025 (Press release, Guardant Health, JUL 30, 2025, View Source [SID1234654637]).

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Second Quarter 2025 Financial Highlights
For the three-month period ended June 30, 2025, as compared to the same period of 2024:
•Reported total revenue of $232.1 million, an increase of 31%, driven by:
◦Oncology revenue of $158.7 million, an increase of 22%, and approximately 64,000 oncology tests, an increase of 30%
◦Screening revenue of $14.8 million, and approximately 16,000 Shield screening tests
◦Biopharma & Data revenue of $56.0 million, an increase of 28%
•Generated non-GAAP gross margin of 66%, compared to 60% in the second quarter of 2024
•Guardant360 Tissue average selling price increased to approximately $2,000, achieving 2028 target three years ahead of schedule

Recent Operating Highlights
•Introduced 11 groundbreaking Smart Liquid Biopsy applications for Guardant360 Liquid that greatly expands the differentiated clinical utility for therapy selection
•Submitted Reveal breast cancer package to MolDx for Medicare reimbursement following publication in ESMO (Free ESMO Whitepaper) Open
•Published RADIOHEAD immuno-oncology monitoring study for Reveal in Cancer Research Communications, with data from 521 stage IV pan-cancer patients
•Expanded Oncology offerings with launches of Guardant Hereditary Cancer Testing and a suite of immunohistochemistry tests
•Shield included in the updated National Comprehensive Cancer Network, or NCCN, colorectal cancer screening guidelines
•Enrollment commenced for NCI Vanguard study for Shield Multi-Cancer Detection (MCD)
•Shield MCD granted Breakthrough Device Designation from the FDA
•Shield named a winner of Fast Company’s 2025 World Changing Ideas Awards

"Q2 was another exceptional quarter for Guardant and we were able to increase our 2025 revenue guidance yet again. We saw especially strong performance from Guardant360 Liquid, where year-over-year growth accelerated for the fourth consecutive quarter," said Helmy Eltoukhy, co-founder and co-CEO. "In May, we introduced 11 groundbreaking Smart Liquid Biopsy applications for Guardant360 Liquid, significantly expanding the clinical utility. Product innovation built on Smart Liquid Biopsy is integral to our strategy at Guardant and we look forward to continuing a steady cadence of SLB-based applications to further extend our technical leadership in the comprehensive genomic profiling market."
"Shield continued to generate strong demand in its third full quarter of commercial launch. Shield volume, revenue and gross profit grew strongly, ahead of our expectations, paving the path for faster acceleration of commercial infrastructure buildout," said AmirAli Talasaz, co-founder and co-CEO. "Beyond CRC, we are making important progress with Shield as a multi-cancer detection test. Shield MCD test recently received Breakthrough Device Designation from the FDA and surpassed an important milestone with the start of the NCI Vanguard study."

Second Quarter 2025 Financial Results

Revenue was $232.1 million for the second quarter of 2025, a 31% increase from $177.2 million for the corresponding prior year period. Oncology revenue grew 22% to $158.7 million for the second quarter of 2025, from $130.3 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume (Guardant360 Liquid & Tissue, Reveal and Response), which grew 30% over the prior year period. The increase in Oncology revenue was also attributable to an increase in reimbursement for our Oncology tests. Screening revenue was $14.8 million for the second quarter of 2025, generated from approximately 16,000 Shield screening tests. Biopharma and Data revenue grew 28% to $56.0 million for the second quarter of 2025, from $43.9 million for the corresponding prior year period, driven primarily by an increase in volume of tests and an increase in average selling price of our GuardantINFINITY test, as well as an increase in revenue derived from service agreements with biopharmaceutical customers. Licensing and other revenue was $2.6 million for the second quarter of 2025, compared to $3.0 million for the corresponding prior year period.

Gross profit, or total revenue less cost of revenue, was $150.9 million for the second quarter of 2025, an increase of $46.1 million from $104.8 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 59% for the corresponding prior year period.
Non-GAAP gross profit was $153.8 million for the second quarter of 2025, an increase of $47.0 million or 44%, from $106.8 million for the corresponding prior year period. Non-GAAP gross margin was 66% for the second quarter of 2025, as compared to 60% for the corresponding prior year period.
Operating expenses were $257.3 million for the second quarter of 2025, as compared to $205.4 million for the corresponding prior year period. The year-over-year increase in operating expenses was primarily related to commercial team expansion and marketing activities to support the Shield product launch and existing products, as well as an increase in stock-based compensation expense. Non-GAAP operating expenses were $215.3 million for the second quarter of 2025, as compared to $178.8 million for the corresponding prior year period. The year-over-year increase in non-GAAP operating expenses was primarily related to commercial team expansion and marketing activities to support the Shield product launch and existing products.
Net loss was $99.9 million for the second quarter of 2025, as compared to $102.6 million for the corresponding prior year period. Net loss per share was $0.80 for the second quarter of 2025, as compared to $0.84 for the corresponding prior year period.
Non-GAAP net loss was $55.0 million for the second quarter of 2025, as compared to $58.5 million for the corresponding prior year period. Non-GAAP net loss per share was $0.44 for the second quarter of 2025, as compared to $0.48 for the corresponding prior year period.
Adjusted EBITDA loss was $51.9 million for the second quarter of 2025, as compared to a $61.9 million loss for the corresponding prior year period.
Free cash flow for the second quarter of 2025 was $(65.9) million, as compared to $(99.1) million for the corresponding prior year period. The year-over-year reduction was primarily due to a change in timing of the payout of the Company’s annual bonus, which was made in the first quarter of 2025 and in the second quarter of 2024.
Cash, cash equivalents, and restricted cash were $735.5 million as of June 30, 2025.
2025 Guidance
Guardant Health now expects full year 2025 revenue to be in the range of $915 to $925 million, representing growth of 24% to 25% compared to full year 2024. This compares to the prior range of $880 to $890 million, representing annual growth of 19% to 20%.
Within this revenue range:
•Oncology revenue is now expected to grow approximately 20% year over year in 2025, compared to prior guidance of approximately 18% growth. Oncology volume is now expected to accelerate to greater than 27% growth in 2025 compared to 20% growth in 2024.
•Screening revenue is now expected to be in the range of $55 to $60 million, driven by Shield volume of 68,000 to 73,000 tests. This compares to the prior range of $40 to $45 million and 52,000 to 58,000 tests.
•Biopharma & Data revenue growth is now expected to be in the mid-teens range, compared to prior expectations of low double-digits.
Guardant Health now expects full year 2025 non-GAAP gross margin to be in the range of 63% to 64%, an improvement compared to prior expectations of 62% to 63%. Guardant Health now expects total non-GAAP operating expenses to be in the range of $840 to $850 million, an increase compared to the prior range of $830 to $840 million due to the reinvestment of incremental Screening gross profit to accelerate the Screening commercial infrastructure build out. Guardant Health continues to expect free cash flow burn to be in the range of $225 to $235 million, an improvement compared to $275 million for the full year 2024. This includes approximately $200 million of Screening net cash burn. Guardant Health continues to expect the remainder of the business excluding Screening to reach free cash flow breakeven in the fourth quarter of 2025.
Webcast Information
Guardant Health will host a conference call to discuss the second quarter 2025 financial results after market close on Wednesday, July 30, 2025 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

GSK delivers continued strong performance

On July 30, 2025 GSK reported continued strong performance for quarter ending June 30, 2025 (Press release, GlaxoSmithKline, JUL 30, 2025, View Source [SID1234654636]).

Strong Specialty Medicines performance drives sales and core operating profit growth

Total Q2 2025 sales £8.0 billion +1% AER; +6% CER

Specialty Medicines sales £3.3 billion (+15%); Respiratory, Immunology & Inflammation £1.0 billion (+10%); Oncology £0.5 billion (+42%); HIV sales £1.9 billion (+12%)
Vaccines sales £2.1 billion (+9%); Shingrix £0.9 billion (+6%); Meningitis vaccines £0.4 billion (+22%); and Arexvy £0.1 billion (+13%)
General Medicines sales £2.6 billion (-6%); Trelegy £0.8 billion (+4%)
Total operating profit +33% and Total EPS +35% driven by lower CCL charges partly offset by intangible asset impairments
Core operating profit +12% and Core EPS +15% reflecting Specialty Medicines and Vaccines growth, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines
Cash generated from operations of £2.4 billion with free cash flow of £1.1 billion
Q2 2025 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,986 1 6 15,502 2 5
Total operating profit 2,023 23 33 4,239 35 41
Total operating margin % 25.3% 4.5ppts 5.4ppts 27.3% 6.8ppts 7.2ppts
Total EPS 35.5p 23 35 75.3p 38 45
Core operating profit 2,631 5 12 5,164 4 8
Core operating margin % 32.9% 1.1ppts 1.8ppts 33.3% 0.8ppts 1.1ppts
Core EPS 46.5p 7 15 91.4p 6 10
Cash generated from operations 2,433 47 3,734 35

Pipeline progress and investment delivering future growth opportunities:
5 major new product approvals expected in 2025:

3 US Approvals now received for Penmenvy meningitis vaccine, Blujepa first-in-class antibiotic treatment for uUTIs and Nucala, anti-IL5 biologic for COPD

Blenrep (for multiple myeloma) approved in EU, Japan, UK, Canada and Switzerland. Constructive discussion ongoing with FDA with new PDUFA date set for 23 October 2025
US regulatory decision on depemokimab (for asthma with type 2 inflammation, nasal polyps) expected in December 2025
Progress on 14 key opportunities expected to launch 2025-2031 each with PYS potential above £2 billion:
Phase III PIVOT-PO study for tebipenem, a potential new antibiotic for cUTIs, stopped early for efficacy, with filing now planned by year end

Phase III development programme for depemokimab COPD started with launch of ENDURA studies
Pivotal/Phase III trial starts planned in H2 25 for: potential cancer treatments GSK’227 B7H3 ADC for ES-SCLC and GSK’981 IDRx-42 for 2L GIST; efimosfermin for treatment of MASH; and cabotegravir ultra long acting + rilpivirine (Q4M) for HIV treatment

Targeted business development continues strengthening RI&I and Oncology pipeline
Acquisition of efimosfermin a potential best in class specialty medicine for steatotic liver disease from Boston Pharmaceuticals completed

Agreements announced with Hengrui Pharma to develop up to 12 medicines in RI&I and Oncology, including licence for
potential best-in-class PDE3/4 inhibitor in clinical development for treatment of COPD
Continued commitment to shareholder returns
Dividend declared of 16p for Q2 2025; 64p expected for full year 2025
£822 million spent in H1 2025 as part of the £2 billion share buyback programme announced at FY 2024
Confident for delivery of 2025 guidance – towards top of range
Increase towards the top end of range for turnover growth of 3% to 5%; Core operating profit growth of 6% to 8%; and
Core EPS growth of 6% to 8%

mma Walmsley, Chief Executive Officer, GSK:
"GSK’s strong momentum in 2025 continues with another quarter of excellent performance driven mainly by Specialty Medicines, our largest business, with double-digit sales growth in Respiratory, Immunology & Inflammation, Oncology and HIV. We also continue to make very good progress in R&D, with 3 major FDA approvals achieved so far this year, 16 assets now in late-stage development, and 4 more promising medicines to treat cancer, liver disease and HIV expected to enter Phase III and pivotal development by the end of the year. With all this, we now expect to be towards the top end of our financial guidance for 2025 and remain confident in our long-term outlooks."

Assumptions and cautionary statement regarding forward-looking statements
The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in legislation, regulation, government actions, including the impact of any potential tariffs or other restrictive trade policies on the Group’s products, or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, "forward-looking statements". Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, dividend payments and financial results. Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

Posted Financial Results for Q1 YTD/FY2025

On July 30, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "the Company") reported the financial results for the first three months (April 1, 2025 – June 30, 2025) of the fiscal year 2025 ending March 31, 2026 (FY2025) (Press release, Astellas, JUL 30, 2025, View Source [SID1234654635]).

Anixa Biosciences Receives Notice of Allowance from Canadian Intellectual Property Office for Patent Covering Breast Cancer Vaccine Technology

On July 30, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology (Press release, Anixa Biosciences, JUL 30, 2025, https://ir.anixa.com/news/detail/1089/anixa-biosciences-receives-notice-of-allowance-from-canadian-intellectual-property-office-for-patent-covering-breast-cancer-vaccine-technology [SID1234654634]). This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company’s novel immunogenic approach to breast cancer prevention and treatment in Canada.

With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer remains the most commonly diagnosed cancer in women globally and a leading cause of cancer-related death. In Canada, breast cancer accounts for approximately 25% of all new cancer cases in women and 13% of female cancer deaths annually. Despite widespread awareness and screening efforts, there is currently no approved vaccine for the prevention of breast cancer—highlighting a significant and unaddressed need in public health.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

AB Science receives regulatory approval from european countries to initiate third stage of Phase I/II study combining its molecule AB8939 with venetoclax for the treatment of AML

On July 30, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported the approval of the third of four stages of the Phase I/II study (AB18001) with the compound AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) (Press release, AB Science, JUL 30, 2025, View Source [SID1234654633]).

The third stage has been approved in France, Germany, Spain and Greece. The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for different treatment stages of AB8939.

-Stage 1: Determination of the MTD after 3 consecutive days of treatment with AB8939 alone.
-Stage 2: Determination of the MTD after 14 consecutive days of treatment with AB8939 alone.
-Step 3: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax.
-Stage 4: Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.

The first two stages of Phase 1 were completed with 28 and 13 patients enrolled, respectively, and determined the MTD of AB8939 after 3 consecutive days of treatment (21.3 mg/m2 ) and after 14 consecutive days of treatment (21.3 mg/m2 ).

The third stage now consists of evaluating the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, "The approval of this third stage is a key milestone for the Phase I/II study with AB8939 in AML. The combination of AB8939 and venetoclax has the potential to change the standard of care in the treatment of relapsed/refractory AML".

▪Rationale for the AB8939 + venetoclax combination

The combination of AB8939 + venetoclax has several potential benefits:

1 – Both molecules have low hematologic toxicity. This combination could therefore be less toxic than azacitidine + venetoclax as first-line treatment for AML.

2 – These two molecules act on different and complementary targets in cancer cells, which could have an additive or even synergistic effect in terms of efficacy.

-AB8939 has two modes of action:

oMicrotubule destabilization: Microtubules are cellular structures essential for cell division (mitosis). By destabilizing them, AB8939 prevents cancer cells from dividing properly, leading to their death. The advantage is that this type of chemotherapy is independent of the TP53 mutation that creates the most resistance to standard chemotherapies.

oInhibition of ALDH (aldehyde dehydrogenase): ALDH is an enzyme found in cancer stem cells, a subtype of cells in AML that are particularly resistant to treatment and responsible for relapses, as they can survive conventional chemotherapy. By inhibiting ALDH, AB8939 specifically targets these stem cells, reducing resistance to treatment and limiting the risk ofrelapse.

-Mechanism of action of venetoclax: Inhibition of BCL2

oBCL2 is a protein that prevents apoptosis (programmed cell death) in cancer cells.

oBCL2 is another factor in AML resistance, as it allows cancer cells to survive despite treatment.

oBy blocking BCL2, venetoclax promotes apoptosis, making cancer cells more vulnerable.

-There is an additive, even synergistic, potential for the combination By simultaneously targeting these mechanisms, the combination could reduce the chances of cancer cells escaping treatment (resistance). This potential synergistic effect arises from the fact that inhibiting ALDH and BCL2 could weaken the resistance mechanisms of cancer stem cells, while destabilizing microtubules prevents cell proliferation. Together, these actions are more powerful than if each molecule were used alone.

3 – Finally, AML is difficult to treat due to its heterogeneity and resistance mechanisms. AB8939 is effective in vitro and in vivo in animals and generates responses in human patients with the poorest prognostic factors when treated with standard of care chemotherapies, namely TP53 mutation, MECOM and complex karyotype.

▪Non-clinical pharmacology data Animal studies have demonstrated the following properties of AB8939 that are relevant for the treatment of AML: -AB8939 is active ex vivo against AML cancer cells from chemotherapy-naive or chemotherapy-refractory/relapsed patients, particularly those with TP53 mutations or complex karyotypes.

-AB8939 eradicates blasts in the blood and bone marrow in PDX models resistant to 5-AraC (cytarabine), particularly those with MECOM rearrangements. -AB8939 increases survival and has an additive effect in combination with the standard treatments azacitidine and venetoclax. -ALDH expression is a characteristic of cancer stem cells (CSCs), and AB8939 is an ALDH1/2 inhibitor. Therefore, AB8939 is a targeted therapy for leukemic cancer stem cells.

-AB8939 eradicates leukemia cancer stem cells in a human PDX model of AML.

▪Potential market for AB8939 in AML

Treatments for AML represent an estimated market potential of more than €2 billion per year.

AB8939 was entirely discovered by AB Science, which retains full ownership of the intellectual property rights, reflecting AB Science’s priority to develop innovative drugs aimed at improving patients’ lives.

The composition of AB8939, including its use in the treatment of AML, is covered until 2026 by a patent granted in all geographical areas where AB8939 could be marketed, including Europe (patent EP 3253749), the United States (US 10,570,122), Canada (CA 2975644), China (CN 107531685), South Korea (KR 10-2544132), Japan (JP 6713000), Hong Kong (HK 1243700), Israel (IL 253779), Australia (AU 2016214283), Russia (RU 2758259), Brazil (BR 112017016883-9), Mexico (MX 377742), India (IN 480996) and South Africa (ZA 2017/05537). An extension of this protection for 5 years is possible in certain countries.

A second patent application for medical use has been filed to protect the use of AB8939 in the treatment of AML with certain chromosomal abnormalities. If this application is accepted, protection for AB8939 will be extended until 2044 for these subpopulations of AML patients. In addition to patent protection, AB8939 is also eligible for regulatory data protection in numerous countries, preventing generic competition for a period of up to 8 years from product registration.

AB8939 has also received orphan drug designation for AML from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.