On February 24, 2026 Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, reported more than 15 abstracts featuring its urology portfolio will be presented at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU). The abstracts span studies across prostate and bladder cancers, featuring real-world data for Decipher Prostate and new insights from phase II clinical trials, including one utilizing the company’s upcoming TrueMRD Muscle-Invasive Bladder Cancer (MIBC) test. Collectively, these studies highlight how Veracyte’s Decipher and TrueMRD genomic tests are increasingly helping to guide clinical decision-making, advance biological understanding, and accelerate innovation in urologic cancer care. The conference will take place February 26-28 in San Francisco.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The breadth of data at ASCO (Free ASCO Whitepaper) GU shows how our Veracyte Diagnostics Platform is driving meaningful insight across multiple urologic cancers," said Elai Davicioni, Ph.D., Veracyte’s medical director, Urology. "In bladder cancer, Decipher is increasingly being integrated into studies that aim to help guide treatment decisions. With TrueMRD, our whole-genome sequencing minimal residual disease platform, we are extending the understanding of tumor evolution and treatment resistance, while also providing critical information to ensure the earlier detection of recurrent disease when a cure may still be achievable."

One of the key studies being presented is SURE‑02, a phase II trial examining how genomic subtyping with the Decipher Bladder test can inform treatment approaches in bladder cancer.

"The findings underscore the importance of molecular subtyping in muscle‑invasive bladder cancer and support the integration of genomic classifiers, such as the Decipher Bladder test, into clinical trial design, for the first time suggesting a biologically informed strategy for the use of anti-TROP2 ADCs," said Andrea Necchi, M.D., principal investigator of the SURE‑02 trial. "This approach enables a more rational selection of novel treatment strategies and represents an important step in aligning clinical research with precision‑based care."

Other highlights at the conference include an oral presentation with data on Veracyte’s upcoming TrueMRD MIBC test in the HCRN GU 20-444 response guided bladder-sparing trial and results for Decipher Bladder from NURE-combo and BLASST-01 trials:

Title:

Phase 2 trial of pembrolizumab (P) with response-guided bladder-sparing in patients with muscle-invasive bladder cancer (MIBC; HCRN GU 20-444).

Presenter:

Jonathan Anker, M.D., Ph.D., Mount Sinai Tisch Cancer Center

Format:

Rapid Oral Abstract Session

Abstract #:

737

Date/Time:

Friday, February 27, 2026, 4:00 – 4:45 PM PST

Location:

Level 3, Ballroom

Title:

Neoadjuvant sacituzumab govitecan (SG) plus pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant pembro, in patients with muscle-invasive bladder cancer (MIBC): SURE-02 primary analysis and biomarker results.

Presenter:

Andrea Necchi, M.D., IRCCS San Raffaele Hospital, Comprehensive Cancer Center

Format:

Poster (#H1)

Abstract #:

769

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Association of non-luminal subtype with overall survival in high-risk non-muscle invasive bladder cancer patients: Biomarker results from the Bladder Cancer Prognosis Programme.

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster (#K23)

Abstract #:

843

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Association between non-luminal molecular subtypes and complete response rates after neoadjuvant chemo-immune therapy for muscle-invasive bladder cancer: Biomarker analyses of NURE-combo and BLASST-01 phase 2 clinical trials.

Presenter:

Joep J. de Jong, M.D., Erasmus MC Cancer Institute, Rotterdam, Netherlands

Format:

Poster (#K25)

Abstract #:

845

Date/Time:

Friday, February 27, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Additionally, Veracyte continues to strengthen the connection of real-world data and outcomes to the Decipher Prostate test and the Decipher Genomics Research for Intelligent Discovery (GRID) platform, with several abstracts being showcased at the conference including:

Title:

Transcriptomic characterization of prostate cancer in patients with HIV infection.

Presenter:

Michael Leapman, M.D., Department of Urology, Yale School of Medicine

Format:

Poster (#M24)

Abstract #:

396

Date/Time:

Thursday, February 26, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Title:

Comprehensive analysis of androgen production, uptake, and conversion (APUC) genes to highlight SRD5 family diversity in a large localized prostate cancer cohort.

Presenter:

Xiaolei Shi, M.D., University of Maryland School of Medicine

Format:

Poster (#M10)

Abstract #:

382

Date/Time:

Thursday, February 26, 2026, 11:30 – 12:45 PM PST

Location:

Level 1, West Hall

Veracyte’s Decipher team will be at Booth #48 at the 2026 ASCO (Free ASCO Whitepaper) GU Symposium. More information, including a full list of Decipher-focused abstracts being presented, can be found here.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients’ care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found here.

About Decipher Bladder

The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively. More information about the Decipher Bladder test can be found here.

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found here.

About TrueMRD

Veracyte’s TrueMRD testing approach uniquely gives clinicians a comprehensive picture of their patient’s cancer status at every step, enabling them to personalize post-treatment care. From a small blood sample, we use AI and whole-genome sequencing to create a custom, molecular "fingerprint" for each patient’s tumor and then track the cancer’s recurrence and evolution over time. We plan to begin making our first TrueMRD test—for muscle-invasive bladder cancer—available to clinicians in the first half of 2026 and then expand to other cancers. More information about Veracyte’s TrueMRD testing approach can be found here.

(Press release, Veracyte, FEB 24, 2026, View Source [SID1234662933])

On February 24, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter and year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fourth quarter revenue of $367.2 million, up 83.0% year-over-year with 33.5% organic growth (excluding Ambry)
Diagnostics revenue of $266.9 million in the fourth quarter, representing 121.6% growth year-over-year, driven by Oncology volume growth of 29% and Hereditary volume growth of 23%
MRD volume was ~4,700 tests in the fourth quarter, up 56% quarter-over-quarter
Data and Applications revenue of $100.4 million in the fourth quarter, representing 25.1% year-over-year growth, with Insights (data licensing) growing 69.5%, excluding the impact of the AstraZeneca warrant in Q4 of 2024
Ended the year with over $1.1 billion in Total Remaining Contract Value and 126% Net Revenue Retention
$759.7 million in cash and marketable securities as of December 31, 2025
Revenue guidance of $1.59 billion for 2026 and expect full year 2026 Adjusted EBITDA of approximately $65 million
"In 2025, Tempus continued to set the standard for what it means to be a technology company operating in the healthcare space," said Eric Lefkofsky, Founder and CEO of Tempus. "The strength of our unit growth in diagnostics along with the accelerating growth of our data business is proof that we are unique in this space. As the network effects from our investments in AI continue to compound, we expect to not only drive significant growth over the next several years, but to also enhance the lives of millions of patients around the world."

Fourth Quarter Summary Results:

Revenue increased 83.0% year-over-year to $367.2 million in the fourth quarter.
Diagnostics generated $266.9 million of revenue in the quarter, representing 121.6% year-over-year growth, with Oncology volume growth of 29% year-over-year and Hereditary volume growth of 23%.
Data and Applications generated $100.4 million of revenue in the quarter, representing 25.1% year-over-year growth, with Insights growing 69.5% (excluding the impact of the AstraZeneca warrant in Q4 of 2024).
Gross profit increased 94.7% year-over-year to $237.7 million, led by strong performance in Diagnostics.
Net loss was ($54.2 million), which included $48.7 million of stock compensation expense and related employer payroll taxes in the fourth quarter, compared to a net loss of ($13.0 million) in the fourth quarter of 2024 and a net loss of ($80.0 million) in the third quarter of 2025.
Adjusted EBITDA improved to $12.9 million in the fourth quarter, compared to ($7.8 million) in the fourth quarter of 2024 and $1.5 million in the third quarter of 2025.
Full Year 2025 Summary Results:

Revenue increased 83.4% year-over-year to $1.3 billion in 2025.
Diagnostics generated $955.4 million of revenue, or 111.5% year-over-year growth, with Oncology volume growth of 26% year-over-year and Hereditary volume growth of 29%.
Data and Applications generated $316.4 million of revenue, accelerating 30.9% year-over-year, with Insights growth of 38.0%.
Ended the year with over $1.1 billion in remaining Total Contract Value and Net Revenue Retention of 126%.
Gross profit increased to $797.9 million, representing 109.4% growth year-over-year.
Net loss was ($245.0 million), which included $136.3 million of stock compensation expense and related employer payroll taxes.
Adjusted EBITDA improved $97.3 million year-over-year to ($7.4 million), even after the acquisitions of Paige AI and OneOme.
Recent Operational Highlights

Launched Paige Predict, an AI-powered digital pathology suite that analyzes standard H&E slides to predict 123 biomarkers across 16 cancer types, helping clinicians make informed testing decisions even when tissue samples are limited, which improves Tempus’ ability to render insights across its genomic tests.
Announced results from a new study demonstrating that Tempus’ AI-driven Immune Profile Score (IPS) test more accurately predicts immunotherapy outcomes across various cancers than conventional biomarkers, identifying potential responders—including 13% of colorectal and 17% of rare cancer patients—who would otherwise be overlooked by standard testing.
Entered a multi-year strategic collaboration with NYU Langone Health, centered on a prospective observational study that uses serial molecular profiling to track cancer evolution and treatment resistance, with the goal of developing AI-powered diagnostic tools and personalized therapies.
Selected by Northwestern Medicine to expand genomic testing access to oncology patients across the health system, leveraging Tempus’ full suite of DNA, RNA, liquid biopsy, and MRD tests to enable more personalized cancer care and clinical trial design.
Fourth Quarter and Full Year 2025 Financial Results

Three Months Ended
December 31, 2025

Year Ended
December 31, 2025

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

367,211

$

1,271,789

Year-over-year growth

83.0

%

83.4

%

Gross profit

$

237,713

$

797,897

Loss from operations

$

(61,413

)

$

(252,872

)

Net loss

$

(54,166

)

$

(245,028

)

Adjusted EBITDA

$

12,893

$

(7,385

)

Net loss per share attributable to common shareholders, basic and diluted

$

(0.30

)

$

(1.41

)

Non-GAAP net loss per share

$

(0.04

)

$

(0.61

)

Financial Outlook and Guidance

Tempus is providing full year 2026 revenue guidance of approximately $1.59 billion, which represents ~25% annual growth. We expect 2026 Adjusted EBITDA to be ~$65 million.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, February 24, 2026 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 4652845
United States – New York: (646) 307-1963
USA & Canada – Toll-Free: (800) 715-9871
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, FEB 24, 2026, View Source [SID1234662951])

On February 24, 2026 Aktis Oncology, Inc. (NASDAQ:AKTS), a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. Generated using Aktis’ miniprotein radioconjugate platform, AKY-1189 is designed to deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors. Approximately 80 – 90% of urothelial cancer patients show positive expression of Nectin-4.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fast Track designation is an FDA process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to bring important new drugs to patients earlier. A drug that receives Fast Track designation may be eligible for more frequent interactions and communications with the FDA and the ability to submit a Biologics License Application on a rolling basis.

"Patients with locally advanced or metastatic urothelial cancer who progress on systemic therapies, such as PADCEV, have limited treatment options," said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. "The granting of Fast Track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer."

Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027.

About Aktis’ Radioconjugate Platform
Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high penetration, internalization and retention in cancer cells, while quickly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors.

(Press release, Aktis Oncology, FEB 24, 2026, View Source [SID1234662967])

On February 24, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, including two corresponding posters.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The AACR (Free AACR Whitepaper) 2026 conference will be held from April 17-22, 2026. The AACR (Free AACR Whitepaper) plans to publish the abstract titles on March 17, 2026 at 4:30 pm EST, the abstracts on April 17, 2026 at 3:00 pm EST, and the posters on the date of the presentation at the conference.

CEO Snehal Patel commented, "One of these abstracts will be the first abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01."

About the AACR (Free AACR Whitepaper) Annual Meeting 2026

The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR (Free AACR Whitepaper) Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 600 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, FEB 24, 2026, View Source [SID1234662913])

On February 24, 2026 Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, reported its financial results for the full year and net sales for the fourth quarter of 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FINANCIAL RESULTS

FY 2025

FY 2024

change

USD m

USD m

USD %

CC %1,2

CGR %3

Net sales

11,086

10,357

7%

5%

6%

Generics

7,794

7,504

4%

2%

2%

Biosimilars

3,292

2,853

15%

13%

18%

Core EBITDA

2,405

2,080

16%

14%

Core EBITDA margin

21.7%

20.1%

Core diluted earnings per share

USD 3.64

USD 2.71

34%

33%

Management free cash flow

1,547

1,112

39%

Core return on invested capital

14.5%

12.3%

Richard Saynor, Chief Executive Officer of Sandoz, said: "Our strong financial results in 2025 demonstrate the excellent headway we’re making. It was a year marked by the progress of our industry-leading pipeline, a record number of launches and significant investment in securing our biosimilars leadership for years to come. Our unrelenting focus on top-line growth, profitability and cash generation positions Sandoz well to deliver even more for patients and shareholders.

"We will build on this momentum in 2026. Alongside our launch program, we plan to extend patient access, expand the pipeline and make further efficiency gains. As we cement our leadership in affordable medicines, we have an excellent platform to meet the unprecedented opportunities ahead and deliver strong results in a high-growth, attractive market."

1 Constant currencies.

2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025.

3 Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time.

FINANCIAL HIGHLIGHTS

FY 2025 net sales of USD 11.1 billion
Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6%
Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR
The biosimilar share of total net sales increased to 30% (FY 2024: 28%)
The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales
In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter
Core EBITDA-margin expansion in FY 2025 of 160 basis points to 21.7%, driven by a favorable mix of sales, operational efficiencies and cost discipline
Core diluted earnings per share in the year up by 33% at CC to USD 3.64, mainly benefitting from growth in core net income
Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to
USD 1.5 billion (FY 2024: USD 1.1 billion), with the increase primarily driven by the growth in core EBITDA
A core return on invested capital (ROIC) of 14.5% in FY 2025 (FY 2024: 12.3%), principally a result of the strong growth in core operating income
A proposed dividend per share of CHF 0.804 (FY 2024: CHF 0.60), representing 27% of core net income
Full-year 2026 guidance of mid-to-high single-digit net-sales growth5 and core EBITDA-margin expansion of around 100 basis points

BUSINESS HIGHLIGHTS

2025 was a milestone year for Sandoz, marked by a wave of launches across biosimilars and generics, significant progress on the transformation journey and strong financial results. The biosimilars business continued to perform strongly, supported by major launches:

Pyzchiva (ustekinumab) was launched in the US in February 2025, offering new treatment options for around 12 million patients with chronic inflammatory diseases such as psoriasis and psoriatic arthritis. The rollout included a full suite of dosing options and extended stability compared to the reference medicine
The Pyzchiva autoinjector was launched in Europe in May 2025, the first ustekinumab biosimilar in Europe available in a pre-filled pen, with an improved self-administration experience supporting better treatment adherence and quality of life
Wyost & Jubbonti (denosumab) were launched in the US in June 2025 as the first FDA6-approved interchangeable denosumab biosimilars, providing affordable treatment options for osteoporosis and cancer-related skeletal events, cementing Sandoz’s leadership in oncology and immunology biosimilars
Tyruko (natalizumab) was launched in the US in November 2025 as the first and only multiple-sclerosis biosimilar, approved for all indications of the reference medicine
Afqlir (aflibercept) was launched in Europe in November 2025, offering an affordable-treatment option for retinal diseases such as neovascular age-related macular degeneration, expanding Sandoz’s presence in the ~USD 15 billion anti-VEGF7 market
Wyost & Jubbonti were launched in Europe in December 2025

In November 2025, Sandoz signed a global license agreement with EirGenix Inc. to commercialize a proposed biosimilar of pertuzumab for HER2‑positive early and metastatic breast cancer, a market worth approximately USD 4.1 billion8, strengthening the Company’s oncology portfolio and complementing its trastuzumab biosimilars.

In December 2025, Sandoz completed the strategic acquisition of Just-Evotec Biologics EU SAS, including a site in Toulouse, France, expanding in-house development and manufacturing capabilities. In addition, Sandoz acquired an indefinite license to Just-Evotec Biologics, Inc.’s cutting-edge continuous-manufacturing technology. These acquisitions complemented ongoing investments in Slovenia, as Sandoz builds a vertically integrated European biosimilar development and manufacturing network.

In 2025, Sandoz increased the availability of affordable medicines through several important generic launches, including rivaroxaban in Germany, expanding access to high-quality antithrombotic treatment options with multiple dosage forms. In September 2025, Sandoz launched its iron-sucrose injection in the US, broadening access to affordable treatment for iron-deficiency anemia in patients with chronic kidney disease and complementing its injectable iron-therapy portfolio.

The Sandoz pipeline is industry‑leading, with 27 biosimilar assets and around 400 generics in development, targeting around USD 420 billion in originator sales. In 2025, the pipeline benefited from positive shifts in regulatory streamlining across key biosimilar programs – developments that are expected to deliver meaningful advantages for both patients and Sandoz.

4 Subject to approval at the Annual General Meeting on April 9, 2026.

5 At CC.

6 US Food & Drug Administration.

7 Vascular endothelial growth factor.

8 Evaluate Pharma, Summary: worldwide sales (last accessed November 2025).

FULL-YEAR 2026 GUIDANCE

Sandoz anticipates an acceleration of net-sales growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favorable movement in the mix of sales, further operating efficiencies and cost discipline, is expected to result in expansion in the core EBITDA margin.

As a result, the Company provides its financial guidance for 2026:

Net sales to grow at CC by a mid to high single-digit percentage
Core EBITDA-margin expansion of around 100 basis points

No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low to mid single‑digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government.

PENICILLINS: TRADE DISTORTION

As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6‑Aminopenicillanic acid (6‑APA), the foundational compound for all penicillins. This price decline coincided with an increase in global market supply. These dynamics adversely impacted the Sandoz generics net-sales performance in H2 2025; a similar impact is expected in the first half of 2026. No imminent return to prior market conditions is anticipated.

The recently announced introduction of a minimum import price of 6‑APA in India is expected to curb the inflow of low‑priced imports, primarily from China, and support the domestic fermentation‑based antibiotic production in India. This risks a diversion of the supply of low-cost 6-APA towards Europe, which continues to depend on Asia for key intermediates.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here.

(Press release, Sandoz, FEB 24, 2026, View Source [SID1234662935])