HUTCHMED Reports 2026 Interim Results

On July 30, 2026 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:HCM; HKEX:13) reported its financial results for the six months ended June 30, 2026 and provides updates on key clinical and commercial developments.

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All amounts are expressed in US dollars unless otherwise stated. A glossary of abbreviations is on page 36.

Global sales growth driven by China rebound and FRUZAQLA geographical expansion

● In-market sales from key China commercial products up over 40% compared to the first half of 2025. ELUNATE (fruquintinib in China) up 41% to $60.8 million as it expanded reimbursement coverage for endometrial cancer and was approved for kidney cancer. SULANDA up 45% to $18.4 million, boosted by upgraded recommendation in Chinese Society of Clinical Oncology guidelines for neuroendocrine tumors.
● In-market sales of FRUZAQLA (fruquintinib ex-China) ex-US up ~70% to $68.9 million during first half of 2026, alongside steady US sales, driven by the need for novel non-chemo treatment options in mCRC and ongoing positive experiences of oncologists in third line setting.
● Profitability maintained amid higher R&D investment, with net income attributable to HUTCHMED at $15.9 million (H1-25: $455.0m including $416.3m gain on divestment of 45% of Shanghai Hutchison Pharmaceuticals Limited (SHPL)), which allowed the Company to maintain a strong cash balance of $1.37 billion.
Multiple first-in-class Antibody-Targeted Therapy Conjugate (ATTC) candidates in clinical trials

● Initiated clinical trial of HMPL-A251 (PI3K/PIKK-HER2) in December 2025 and of HMPL-A580 (PI3K/PIKK-EGFR) in March 2026 and presented preclinical data at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Both ATTCs are progressing through dose escalation as planned.
● HMPL-A830 clinical trial application approved in July 2026, based on a different ATTC payload platform.
Regulatory and clinical achievements across late-stage clinical portfolio

● New Drug Application (NDA) approval of ELUNATE with sintilimab for second-line kidney cancer in China in May 2026, supported by FRUSICA-2 Phase III data showing median progression-free survival (PFS) of 22.2 months vs. 6.9 months in control group.
● NDA acceptance of sovleplenib for warm autoimmune hemolytic anemia (wAIHA) in China in April 2026, supported by ESLIM-02 Phase III data presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress with durable response rate of 66.0%, along with NDA acceptance for immune thrombocytopenia (ITP) in China in February 2026; both wAIHA and ITP indications received priority review status.

● Positive SACHI Phase III data of ORPATHYS in combination with TAGRISSO (osimertinib) sub-group analysis published in The Lancet in January 2026 with median overall survival (OS) of 22.9 months vs. 7.9 months with chemotherapy. NDA approval for third-line MET-amplified gastric cancer in China in June 2026, supported by Phase II data presented at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with objective response rate of 32.3%.
● Positive pivotal Phase II data of fanregratinib (FGFR inhibitor) in intrahepatic cholangiocarcinoma presented at European Society for Medical Oncology Gastrointestinal Cancers Congress.
● Initiated Phase III trial of HMPL-760 (BTK inhibitor) in combination with rituximab and chemotherapy for second-line diffuse large B-cell lymphoma in March 2026.
HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, July 30, 2026, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, July 31, 2026. After registration, investors may access the live webcast at www.hutch-med.com/event.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "HUTCHMED has a clear strategic focus: to build a globally competitive oncology portfolio anchored by differentiated innovation. This future is shaped by our global first-in-class Antibody-Targeted Therapy Conjugate (ATTC) novel payload platforms and other emerging large-molecule modalities. These give us multiple opportunities to pursue first-in-class or best-in-class assets, with potential to be used in combination with standard-of-care or newer medicines, in turn conferring front-line treatment prospects. As these programs advance, multinational partnerships – some presently under discussion – can provide important external validation, broaden development reach and accelerate access to major international markets. We will continue to invest in our world-class R&D organization and deploy our resources in areas where HUTCHMED can create significant impact on the lives of patients globally, harnessing the most advanced scientific modalities, while creating commercial and shareholder value."

Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED, said, "Strong in-market sales growth from ELUNATE and SULANDA in the first half reflects the impact of last year’s streamlining of our salesforce, enhancing productivity with more focused marketing strategies, as we structured our commercial organization to meet the changing China market regulatory guidelines for a sustainable future. We are accelerating ATTC development and strengthening discovery operations through expanding talent and AI capabilities. We are also pursuing business development discussions with multinational partners to expedite global development and commercialization of our most promising programs."

Dr Weiguo Su, Chief Executive Officer (currently on leave of absence) and Chief Scientific Officer of HUTCHMED, said, "The acceptance by the NMPA of the NDA filings for sovleplenib in ITP and wAIHA during the first half of 2026 reflects the strength of the clinical data package, supporting its potential for regulatory and commercial success. Sovleplenib once again attests to the importance of target selectivity, differentiating efficacy and toxicity profiles of our assets. Our ATTC drug candidates are guided by the same principles, designed to navigate our proprietary potent small-molecule targeted therapy payloads to tumor cells while sparing healthy tissues and decreasing side-effects. Pre-clinical data has shown encouraging tumor shrinkage as compared to standard-of-care treatments and emerging therapies recently launched or in development. With three highly novel molecules from two ATTC payload platforms progressing through or about to start first-in-human clinical development, and additional candidates advancing behind them, we are building a science-driven pipeline designed to translate differentiated biology into meaningful clinical benefit."

2026 Interim Results & Business Updates

I. COMMERCIAL OPERATIONS

There was a strong rebound in China in-market sales, achieving $94.4 million in H1 2026, up 32% vs H1 2025 ($71.6 million) as our sales team continues to improve productivity. This contributed to total in-market sales for oncology products of $279.8 million in H1 2026 (H1-25: $234.4 million).

ELUNATE in-market sales were up 41% to $60.8 million, successfully expanded NRDL coverage to include 2L EMC with pMMR in combination with sintilimab. It also renewed coverage in metastatic CRC for patients who have been previously treated with chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF or anti-EGFR (RAS wild-type).

SULANDA in-market sales were up 45% to $18.4 million, driven by an update to Chinese Society of Clinical Oncology guidelines upgrading the usage for SULANDA in neuroendocrine tumors to the highest Level I recommendation standard over competing SSA products. It also benefited from shifting marketing strategies to focus on key hospitals.

FRUZAQLA in-market sales growth was primarily driven by sales outside the US, which had growth of ~70%, contributed by approvals or launches in 41 countries to date, including securing reimbursement in France in Q1 2026 and late 2025 launches in Portugal, Belgium, South Korea and Mexico. This helped boost global in-market sales to $185.4 million.

Total consolidated revenue for oncology products increased 23% to $121.4 million as compared to H1 2025, primarily due to strong in-market sales growth in ELUNATE and SULANDA.

Other Oncology/Immunology revenue, consisting of upfront, regulatory milestones, R&D services and licensing revenue was $40.9 million, including an $18.1 million milestone payment from Eli Lilly, triggered by China approval for 2L RCC. Other Ventures revenue, mainly from prescription drug distribution was $116.0 million, leading to total consolidated revenue of $278.3 million.

($ in millions)

​ ​ ​

In-market Sales*

​ ​ ​

Consolidated Revenue**

​ ​ ​

H1 2026

​ ​ ​

H1 2025

​ ​ ​

%Change (CER)

​ ​ ​

H1 2026

​ ​ ​

H1 2025

​ ​ ​

%Change (CER)

FRUZAQLA

$

185.4

$

162.8

+14%(+14%)

$

43.1

$

43.1

— —

ELUNATE

$

60.8

$

43.0

+41%(+33%)

$

47.1

$

33.6

+40%(+32%)

SULANDA

$

18.4

$

12.7

+45%(+37%)

$

18.4

$

12.7

+45%(+37%)

ORPATHYS

$

15.7

$

15.2

+3%(-3%)

$

13.3

$

9.0

+48%(+39%)

TAZVERIK***

$

(0.5)

$

0.7

— —

$

(0.5)

$

0.7

— —

Oncology Products

$

279.8

$

234.4

+19%(+17%)

$

121.4

$

99.1

+23%(+18%)

Takeda upfront, regulatory milestones and R&D services

$

20.7

$

29.5

-30%(-30%)

Other revenue (R&D services and licensing)

$

20.2

$

14.9

+35%(+35%)

Total Oncology/Immunology

$

162.3

$

143.5

+13%(+10%)

Other Ventures

$

116.0

$

134.2

-14%(-19%)

Total Revenue

$

278.3

$

277.7

— (-4%)

* FRUZAQLA, ELUNATE and ORPATHYS mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively.

** FRUZAQLA represents manufacturing revenue and royalties paid by Takeda to HUTCHMED; ELUNATE represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA and TAZVERIK represent HUTCHMED’s sales of the products to third parties.

*** Ipsen is the Marketing Authorization Holder for TAZVERIK, for which HUTCHMED acts as domestic agent/licensee. In March 2026 Ipsen voluntarily withdrew TAZVERIK from all Ipsen markets, effective immediately, following emerging safety data from the ongoing SYMPHONY‑1 trial.

II. 2026 REGULATORY UPDATES

● Savolitinib sNDA approved by NMPA in 3L MET-amplified GC in June 2026.
● Savolitinib MAA approved (temporary authorization) by Swissmedic in combination with TAGRISSO for 2L EGFRm NSCLC with MET amplification and/or overexpression in February 2026.
● Fruquintinib sNDA approved by NMPA in combination with sintilimab for 2L RCC in May 2026.
● Sovleplenib NDA accepted by NMPA for 2L wAIHA in April 2026.
● Sovleplenib NDA resubmission accepted by NMPA for 2L ITP in February 2026.
● Tazemetostat voluntary withdrawal by Ipsen in China in March 2026.
III. 2026 LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET

● Expecting topline results in H2 2026 for SAFFRON and SANOVO, following full enrollment in H2 2025:
◾ SAFFRON global Phase III study for 2L/3L EGFRm NSCLC patients with MET amplification and/or overexpression could support global filings (NCT05261399).
◾ SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression could support China filing (NCT05009836).
● Published sub-group analysis of SACHI China Phase III study for 2L EGFRm NSCLC patients with MET amplification in The Lancet in January 2026, showing mOS of 22.9 months vs 7.9 months with chemotherapy (HR 0.32) when excluding control group patients who received subsequent MET inhibitor.
● Presented and published positive China Phase II pivotal study data in 3L MET-amplified GC at ASCO (Free ASCO Whitepaper) 2026 and in Nature Medicine in June 2026, respectively, with IRC-assessed ORR of 32.3%, mPFS of 4.0 months and mOS of 6.9 months (NCT04923932).
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk

● Presented positive ESLIM-02 China Phase III study data in 2L wAIHA at EHA (Free EHA Whitepaper) 2026 Congress in June 2026, having met its primary endpoint of durable response rate of 66.0%, showing median time to response of 3.1 weeks and median cumulative duration of response of 16.1 weeks.
Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

● Presented positive China Phase II pivotal study data in 2L FGFR2 fusion/rearrangement ICC at ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress in July 2026, having met its primary endpoint of IRC-assessed ORR of 42.5%, as well as showing mPFS of 6.9 months and mOS of 16.6 months. An NDA for 2L ICC was accepted by NMPA with priority review status in December 2025 (NCT04353375).

HMPL-760, a non-covalent, third generation BTK inhibitor, targeting wild-type and C481S-mutated BTK

● Initiated China Phase III study in combination with R-GemOx (rituximab, gemcitabine and oxaliplatin) in patients with 2L relapsed/refractory DLBCL versus placebo in combination with R-GemOx in March 2026 (NCT07409428). Primary endpoints are investigator-assessed PFS and OS.
IV. ANTIBODY-DRUG CONJUGATES RESEARCH & DEVELOPMENT

HMPL-A251, a first-in-class PI3K/PIKK-HER2 ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to a humanized anti-HER2 IgG1 antibody, via a cleavable linker

● Progressing a dose-escalation and expansion trial for unresectable, advanced or metastatic HER2-expressing solid tumors with first patient dosed in December 2025 (NCT07228247).
● Preclinical data showed anti-tumor activity in DXd-resistant cell line and good efficacy and safety when in combination with chemotherapy via a differentiated mechanism of action.
HMPL-A580, a first-in-class PI3K/PIKK-EGFR ATTC comprising of a highly selective and potent PI3K/PIKK inhibitor payload linked to an anti-EGFR IgG1 antibody, via a cleavable linker

● Progressing a dose-escalation and expansion trial for solid tumors, including NSCLC, CRC, HNSCC and ESCC with first patient dosed in March 2026 (NCT07396584).
● Preclinical data presented at AACR (Free AACR Whitepaper) 2026 showing tumor shrinkage in osimertinib-resistant EGFRm NSCLC cell line and good efficacy and safety when used in combination with osimertinib in EGFRm PAM non-altered NSCLC cell line.
HMPL-A830 China/US INDs cleared

● Plans for global clinical trial initiation in H2 2026. Preclinical data showed superior potency and safety profiles to antibodies or small molecules with the same target, with data to be presented at a scientific conference.

V. COLLABORATION UPDATES

ImageneBio is developing IMG-007, a non-T cell depleting, antibody-dependent cell-mediated cytotoxicity-silenced OX40 antagonist discovered by HUTCHMED

● Phase IIb trial (NCT07037901) in patients with moderate-to-severe atopic dermatitis progressing, with an amended protocol and topline data anticipated in the fourth quarter of 2027.
● Phase II trial initiation in patients with alopecia areata expected in 2026, with initial data expected in 2028.
VI. OTHER VENTURES

● Other Ventures consolidated revenue decreased to $116.0 million for the six months ended June 30, 2026 (H1-25: $134.2 million) which has minimal impact on profitability as the segment is predominantly low-margin prescription drug distribution business in China and HUTCHMED continues to optimize working capital management.
● Consolidated net income attributable to HUTCHMED from Other Ventures decreased to $3.8 million (H1-25: $24.0m), primarily due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025.
VII. SUSTAINABILITY

The 2025 Sustainability Report was published in April 2026 alongside the 2025 Annual Report. We have initiated a new target-setting cycle. A list of potential focus initiatives has been identified under our five sustainability pillars: Innovation, Climate Action, Human Capital, Access to Healthcare, and Ethics and Transparency. In 2026, we will develop this into a final list, including a roadmap for achievement and monitoring.

In 2026, our sustainability initiatives have continued to receive strong recognition. Most recently, our commitment was reflected in an upgraded AA rating by MSCI, recognizing HUTCHMED as a Leader, and placing us among the top 19% of pharmaceutical companies. For its second consecutive year, HUTCHMED was recognized as Most Honored Company and ranked 1st place in ESG in its sector by Extel, formerly Institutional Investor Research, in its 16th Asia Executive Team Survey. It achieved top rankings across several areas – leading CEO, CFO, Investor Relations, ESG and Corporate Governance – earning the Most Honored Company designation. HUTCHMED was the only company to earn these designations in 2026 in All Asia (ex-Mainland China) Biopharmaceuticals.

Financial Highlights

Revenue for the six months ended June 30, 2026 was $278.3 million compared to $277.7 million for the six months ended June 30, 2025.

● Oncology/Immunology consolidated revenue amounted to $162.3 million (H1-25: $143.5m):
◾ ELUNATE revenue was $47.1 million, up 40% (H1-25: $33.6m), comprising manufacturing revenue, promotion and marketing services revenue and royalties, supported by ongoing label expansions.
◾ SULANDA revenue was $18.4 million, up 45% (H1-25: $12.7m), driven by marketing strategies focusing on key hospitals and supported by recent oncology clinical guideline upgrades.
◾ ORPATHYS revenue was $13.3 million, up 48% (H1-25: $9.0m), driven by higher manufacturing sales to AstraZeneca in preparation for the 3L MET-amplified GC launch.
◾ FRUZAQLA revenue was $43.1 million (H1-25: $43.1m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to the prior period, driven by strong in-market sales growth following approvals/launches in 41 countries to date.
◾ Takeda upfront, regulatory milestones and R&D services revenue were $20.7 million (H1-25: $29.5m), due to less R&D and regulatory support services to Takeda.
◾ Other revenue of $20.2 million (H1-25: $14.9m), includes an $18.1 million milestone payment from Eli Lilly triggered by China approval of ELUNATE in combination with sintilimab for 2L RCC (H1-25: $11.1 million regulatory milestone from AstraZeneca following China NDA approval for SACHI).
● Other Ventures consolidated revenue of $116.0 million (H1-25: $134.2m), primarily due to scaling down low-margin logistics distribution sales after considering working capital.
Net Expenses for the six months ended June 30, 2026 were $262.4 million compared to $239.0 million for the six months ended June 30, 2025.

● Cost of Revenue was $152.2 million (H1-25: $167.6m), predominantly due to a lower cost of sales related to the prescription drug distribution business. Cost of revenue as a percentage of oncology product revenue improved to 33% (H1-25: 39%) driven by enhanced productivity and efficiency.
● R&D Expenses were $78.8 million (H1-25: $72.0m) as we initiated early-stage global clinical programs for our ATTC assets and we maintain ongoing investment in discovery to deliver sustained innovation.
● S&A Expenses were $46.5 million (H1-25: $41.6m), driven by strong performance of our Oncology/Immunology commercial operations and enhanced productivity.
● Other Items generated net income of $15.1 million (H1-25: $42.2m), which mainly includes interest income and expense, foreign exchange, equity in earnings of SHPL and taxes. The decrease was mainly due to lower equity earnings from SHPL following our 45.0% equity interest disposal in 2025.

Net Income attributable to HUTCHMED for the six months ended June 30, 2026 was $15.9 million compared to $455.0 million for the six months ended June 30, 2025.

● $0.02 basic earnings per ordinary share / $0.09 basic earnings per ADS in the first half of 2026 (H1-25: $0.53 basic earnings per ordinary share / $2.65 basic earnings per ADS).
Cash, Cash Equivalents and Short-Term Investments were $1,374.8 million as of June 30, 2026 compared to $1,367.3 million as of December 31, 2025.

● Adjusted Group (non-GAAP) net cash inflow excluding financing activities in the first half of 2026 was $10.5 million mainly due to net income of $16.2 million less $5.6 million in capital expenditures (H1-25: net cash inflow of $519.1m mainly due to the $549.0m net proceeds from the partial divestment of SHPL less a $10.0m regulatory approval milestone payment and $9.2m in capital expenditures).
● Net cash used in financing activities in the first half of 2026 totaled $2.9 million mainly due to net repayments of bank borrowings (H1-25: net cash inflow of $9.3m mainly due to proceeds from bank borrowings of $8.2m).
Foreign exchange impact: The RMB appreciated against the US dollar on average by approximately 5% during the first half of 2026, which has impacted consolidated financial results as highlighted.

Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

FINANCIAL GUIDANCE

HUTCHMED reiterates full year 2026 guidance for Oncology/Immunology consolidated revenue in the range of $330 million to $450 million. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities. Shareholders and investors should note that:

● The Company does not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; and
● The Company has in the past revised its financial guidance and reference should be made to announcements it publishes regarding any updates to the financial guidance after the publication of this announcement.

Financial Summary

Condensed Consolidated Balance Sheets Data

(in $’000)

​ ​ ​

As of

​ ​ ​

As of

June 30, 2026

December 31, 2025

Assets

(Unaudited)

Cash and cash equivalents and short-term investments

1,374,817

1,367,275

Accounts receivable

117,556

126,750

Other current assets

61,036

73,317

Property, plant and equipment

93,788

94,623

Investment in equity investees

11,020

10,865

Other non-current assets

78,210

80,267

Total assets

1,736,427

1,753,097

Liabilities and shareholders’ equity

Accounts payable

33,646

45,533

Other payables and accruals

197,627

208,892

Bank borrowings

94,508

93,160

Deferred revenue

27,630

51,547

Other liabilities

108,048

102,703

Total liabilities

461,459

501,835

Company’s shareholders’ equity

1,260,776

1,237,926

Non-controlling interests

14,192

13,336

Total liabilities and shareholders’ equity

1,736,427

1,753,097

Condensed Consolidated Statements of Operations Data

(Unaudited, in $’000, except share and per share data)

​ ​ ​

Six months ended June 30,

​ ​ ​

2026

​ ​ ​

2025

Revenue:

Oncology/Immunology – Marketed Products

121,434

99,039

Oncology/Immunology – R&D

40,887

44,408

Oncology/Immunology Consolidated Revenue

162,321

143,447

Other Ventures

115,966

134,230

Total revenue

278,287

277,677

Operating expenses:

Cost of revenue

(152,158)

(167,577)

Research and development expenses

(78,783)

(71,990)

Selling and administrative expenses

(46,477)

(41,624)

Total operating expenses

(277,418)

(281,191)

Gain on divestment of an equity investee

477,456

Other income, net

12,784

21,650

Income before income taxes and equity in earnings of equity investees

13,653

495,592

Income tax expense

(1,209)

(2,029)

Income tax expense – Divestment of an equity investee

(61,133)

Equity in earnings of equity investees, net of tax

3,798

23,125

Net income

16,242

455,555

Less: Net income attributable to non-controlling interests

(314)

(601)

Net income attributable to HUTCHMED

15,928

454,954

Earnings per share attributable to HUTCHMED (US$per share)

– basic

0.02

0.53

– diluted

0.02

0.52

Number of shares used in per share calculation

– basic

865,770,498

857,038,725

– diluted

872,869,494

872,564,513

Earnings per ADS attributable to HUTCHMED (US$per ADS)

– basic

0.09

2.65

– diluted

0.09

2.61

Number of ADSs used in per ADS calculation

– basic

173,154,100

171,407,745

– diluted

174,573,899

174,512,903

(Press release, Hutchison China MediTech, JUL 30, 2026, View Source [SID1234669532])

Guardant Health Reports Second Quarter 2026 Financial Results and Increases 2026 Revenue Guidance

On July 30, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported financial results for the quarter ended June 30, 2026.

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Second Quarter 2026 Financial Highlights

For the three-month period ended June 30, 2026, as compared to the same period of 2025:
•Reported total revenue of $335.0 million, an increase of 44%, driven by:
◦Oncology revenue of $219.1 million, an increase of 38%, and approximately 104,000 oncology tests, an increase of 63%
◦Biopharma & Data revenue of $60.9 million, an increase of 9%
◦Screening revenue of $52.9 million, and approximately 66,000 Shield screening tests, compared to $14.8 million revenue and 16,000 tests in the prior year period
•Generated non-GAAP gross margin of 67%, compared to 66% for the second quarter of 2025
Recent Operating Highlights
•Received U.S. Food and Drug Administration (FDA) approval for Guardant360 Liquid CDx, the most advanced FDA-approved liquid biopsy panel
•Presented 38 abstracts at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, highlighting the expanding clinical utility of Guardant’s portfolio
•Received FDA approval for Guardant360 CDx as a companion diagnostic for Boehringer Ingelheim’s HERNEXEOS for HER2 (ERBB2)-mutant advanced non-small cell lung cancer
•Achieved inclusion of Shield in the American Cancer Society’s updated colorectal cancer screening guidelines
•Obtained Shield coverage from UnitedHealth Group, the first major commercial insurer to provide coverage
•Received FDA approval for higher-throughput, lower-COGS Shield workflow
"Our second-quarter performance reflected broad-based momentum across the Guardant portfolio, with revenue increasing 44% year over year," said Helmy Eltoukhy, co-founder and co-CEO. "Growth was fueled by strong oncology volume, with acceleration across every product. The landmark FDA approval of Guardant360 Liquid CDx further strengthens our portfolio and positions us to drive sustained growth in the years ahead."
"Our team delivered another quarter of exceptional growth for Shield, and we are excited about several important milestones that reinforce its expanding role in colorectal cancer screening," said AmirAli Talasaz, co-founder and co-CEO. "The inclusion of the Shield blood test in the American Cancer Society’s screening guidelines, together with UnitedHealth Group’s broad coverage decision, represents powerful validation of Shield’s clinical utility and its potential to improve access to screening."

Second Quarter 2026 Financial Results

Revenue was $335.0 million for the second quarter of 2026, a 44% increase from $232.1 million for the corresponding prior year period. Oncology revenue grew 38% to $219.1 million for the second quarter of 2026, from $158.7 million for the corresponding prior year period, driven primarily by an increase in Oncology test volume, which grew 63% over the prior year period. Screening revenue grew over 250% to $52.9 million for the second quarter of 2026, from $14.8 million for the corresponding prior year period, driven primarily by an increase in Shield screening test volume, which grew to approximately 66,000 tests in the second quarter of 2026, from approximately 16,000 tests in the prior year period. Biopharma & Data revenue grew 9% to $60.9 million for the second quarter of 2026, from $56.0 million for the corresponding prior year period. Licensing and other revenue was $2.1 million for the second quarter of 2026, compared to $2.6 million for the corresponding prior year period.

Gross profit, or total revenue less cost of revenue, was $219.0 million for the second quarter of 2026, an increase of $68.1 million or 45%, from $150.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65% for the second quarter of 2026, as compared to 65% for the corresponding prior year period.
Non-GAAP gross profit was $223.1 million for the second quarter of 2026, an increase of $69.3 million or 45%, from $153.8 million for the corresponding prior year period. Non-GAAP gross margin was 67% for the second quarter of 2026, as compared to 66% for the corresponding prior year period.

Operating expenses were $348.1 million for the second quarter of 2026, as compared to $257.3 million for the corresponding prior year period. The year-over-year increase in operating expenses was primarily related to commercial infrastructure expansion and marketing activities to support the Shield and Oncology growth and an increase in stock-based compensation. Non-GAAP operating expenses were $288.3 million for the second quarter of 2026, as compared to $215.3 million for the corresponding prior year period. The year-over-year increase in non-GAAP operating expenses was primarily related to commercial infrastructure expansion and marketing activities to support the Shield and Oncology growth.
Net loss was $120.1 million for the second quarter of 2026, as compared to $99.9 million for the corresponding prior year period. Net loss per share was $0.90 for the second quarter of 2026, as compared to $0.80 for the corresponding prior year period.
Non-GAAP net loss was $56.2 million for the second quarter of 2026, as compared to $55.0 million for the corresponding prior year period. Non-GAAP net loss per share was $0.42 for the second quarter of 2026, as compared to $0.44 for the corresponding prior year period.
Adjusted EBITDA loss was $55.9 million for the second quarter of 2026, as compared to a $51.9 million loss for the corresponding prior year period.
Free cash flow for the second quarter of 2026 was $(69.5) million, as compared to $(65.9) million for the corresponding prior year period.
Cash, cash equivalents, and restricted cash were $1.2 billion as of June 30, 2026.
2026 Guidance
Guardant Health now expects full year 2026 revenue to be in the range of $1.34 to $1.36 billion, representing growth of 36% to 38% compared to full year 2025. This compares to the prior range of $1.30 to $1.32 billion, representing growth of 32% to 34%.
Within this revenue range:
•Oncology revenue is now expected to grow approximately 30% in 2026, compared to prior guidance of 28% to 29%. Oncology volume is now expected to grow to approximately 50% in 2026, compared to prior guidance of approximately 35%.
•Biopharma & Data revenue growth is expected to be in the low double-digit range.
•Screening revenue is now expected to be in the range of $218 to $230 million, driven by Shield volume of 270,000 to 285,000 tests. This compares to the prior guidance of $186 to $198 million revenue and 230,000 to 245,000 tests.
Guardant Health continues to expect full year 2026 non-GAAP gross margin to be in the range of 64% to 65%. Guardant Health now expects total non-GAAP operating expenses to be in the range of $1.08 to $1.10 billion, an increase compared to the prior range of $1.05 to $1.07 billion. Guardant Health now expects full-year free cash flow burn of $195 million to $205 million, compared with its previous outlook of $185 million to $195 million. The revised range reflects accelerated investment in laboratory capacity to support rapid Shield volume growth and represents an improvement from the $233 million of free cash flow burn reported for full-year 2025.
Webcast Information
Guardant Health will host a conference call to discuss the second quarter 2026 financial results after market close on Thursday, July 30, 2026 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.

(Press release, Guardant Health, JUL 30, 2026, View Source [SID1234669531])

Curis Doses First Five Patients in TakeAim CLL Study

On July 30, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported an important enrollment milestone in its TakeAim CLL study in patients with Chronic Lymphocytic Leukemia (CLL).

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Previously, Curis announced that 11 clinical sites had opened for enrollment in the TakeAim CLL study and 10 patients had been consented in that study. Today, Curis is announcing that it has achieved the previously stated goal of dosing the first five patients in the TakeAim CLL study and reaffirmed its expectation to report initial CLL data in 5-10 patients in December 2026.

"We are encouraged by our progress in the CLL study as patient enrollment continues to exceed expectations," said James Dentzer, Chief Executive Officer of Curis. "The excitement among clinicians and patients reflects the clear unmet need in CLL, where emavusertib has the potential to change the treatment landscape when combined with approved BTK inhibitors."

"BTK inhibitors have improved outcomes for patients with CLL; however, most patients still achieve only partial response and continue to have measurable residual disease (MRD) despite continuous, indefinite BTKi therapy," said Ahmed Hamdy, Chief Medical Officer of Curis. "This chronic BTKi dosing can lead to BTKi resistance, bleeding risk, cardiovascular events, and eventual CLL relapse. Combining emavusertib with an approved BTKi offers the potential to deepen responses, promote conversion to complete remission, undetectable MRD, and the potential for fixed-duration treatment. While we are still in the early days of the study, and the number of patients is small, we are greatly encouraged that the combination of emavusertib and zanubrutinib appears to be well tolerated and may be demonstrating early evidence of deepening responses in CLL patients."

In CLL, disease is driven by NF-kB dysregulation, which is in turn driven by two biologic pathways: BCR and TLR1. The goal of combining emavusertib with a BTK inhibitor (BTKi) in the TakeAim CLL Study is to enable a dual blockade of NF-kB, by inhibiting both the BCR and TLR pathways. BTK inhibitors (BTKi) block the BCR pathway; emavusertib blocks the TLR pathway.

BTKi is the current standard of care in CLL. In the registrational study for the BTKi zanubrutinib, 93% of patients were able to achieve an objective response, but only 7% achieved complete response2. More recent clinical studies have demonstrated that adding emavusertib to a BTKi regimen, blocking both the TLR and BCR pathways, can enable patients with NHL to achieve deeper responses, including complete responses or undetectable minimal residual disease (uMRD).

About the TakeAim CLL Study

The TakeAim CLL Study is an open label phase 2 study of emavusertib in combination with zanubrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), with measurable residual disease (MRD+) as determined by the clonoSEQ assay and actively taking zanubrutinib for at least 12 months.

(Press release, Curis, JUL 30, 2026, View Source [SID1234669530])

Cerus Corporation Announces Second Quarter 2026 Financial Results

On July 30, 2026 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"This quarter we made significant progress in expanding patient access to safer blood components around the globe," said Vivek Jayaraman, Cerus’ president and chief executive officer. "I’m particularly pleased with the performance of our INTERCEPT Fibrinogen Complex (IFC) franchise in the U.S. The value proposition for blood centers, hospitals and clinicians is resonating and leading to earlier patient access to fibrinogen across the country. We view IFC as a compelling growth driver for Cerus."

Additional highlights include:

Second-quarter 2026 total revenue comprised of (in millions, except percentages):
Three Months Ended

Six Months Ended

June 30,

Change

June 30,

Change

2026

2025

$

%

2026

2025

$

%

Product Revenue

$

57.4

$

52.4

$

5.0

10

%

$

111.1

$

95.7

$

15.4

16

%

Government Contract Revenue

5.9

7.7

(1.8

)

-24

%

12.1

13.3

(1.2

)

-9

%

Total Revenue

$

63.3

$

60.1

$

3.2

5

%

$

123.2

$

109.0

$

14.2

13

%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

Demand for IFC continued to increase, with second quarter volumes – including kits and finished therapeutic doses (measured in FC15* equivalent units) – up approximately 20% compared to the prior year period. Second quarter U.S. IFC sales totaled $6.7 million, up from $5.6 million in the prior year period.
Submitted PMA for the INTERCEPT Blood System for Platelets with INT200 Illuminator, the Company’s next generation LED-based illumination device, to the FDA as planned. Given review timelines, a regulatory decision is anticipated in early 2027.
Completed debt refinancing, including a $30 million reduction in the outstanding term loan funded with $20 million of cash on hand and $10 million drawn under the new, lower-cost revolving credit facility.
Expanded the Company’s ongoing collaboration with the Biomedical Advanced Research and Development Authority, or BARDA, to further advance the development of the INTERCEPT Red Blood Cell system, increasing the total potential value of the 2024 contract by $21.9 million from $248.6 million to $270.5 million. The BARDA contract is funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Cash, cash equivalents, and short-term investments were $56.3 million at June 30, 2026.
Revenue

Product revenue for the second quarter of 2026 was $57.4 million, compared to $52.4 million for the prior year period, representing year-over-year growth of 10%. Second quarter growth was driven by increases across all product categories.

Government contract revenue for the second quarter of 2026 was $5.9 million, compared to $7.7 million during the prior year period. The decrease reflects the completion of the Company’s FDA contract in 2025, the wind-down of the BARDA 2016 contract, and timing of expenses related to the BARDA 2024 contract.

Product Gross Profit & Margin

Product gross profit for the second quarter of 2026 was $29.5 million, compared to $29.0 million, increasing by 2% over the prior year period. Product gross margin for the second quarter was 51.4% compared to 55.2% in the same period last year. The year-over-year decrease in gross margin was largely driven by a weaker U.S. dollar relative to the Euro and higher product costs driven by inflationary pressures.

Operating Expenses

Total operating expenses for the second quarter of 2026 were $37.3 million, compared to $40.1 million for the same period of the prior year, reflecting a year-over-year decrease of 7%.

R&D expenses for the second quarter of 2026 were $14.4 million, compared to $18.9 million in the second quarter of 2025. The primary contributors to lower R&D expenses were decreased development costs on the INT200, with the U.S. PMA submission completed, as well as lower development costs tied to government-funded projects, as reflected in the government contract revenue.

SG&A expenses totaled $22.9 million for the second quarter of 2026, compared to $21.2 million for the second quarter of 2025. The year-over-year increase in SG&A expenses was due to higher costs across various functions.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2026 was $2.9 million, or $0.01 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $5.7 million, of $0.03 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first half of 2026 was $4.6 million, compared to a net loss attributable to Cerus Corporation of $13.4 million for the first half of 2025.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the second quarter of 2026 was positive $3.0 million, compared to non-GAAP adjusted EBITDA of positive $0.9 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first half of 2026 was a positive $7.0 million compared to non-GAAP adjusted EBITDA of positive $1.1 for the first half of 2025.

Balance Sheet and Cash Flows

At June 30, 2026, the Company had cash, cash equivalents, and short-term investments of $56.3 million, compared to $82.9 million at December 31, 2025.

As of June 30, 2026, the Company had $35.0 million outstanding on its term loan and $30.1 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $14.9 million as of June 30, 2026, which is dependent on eligible assets supporting the borrowing base.

For the second quarter of 2026, cash used in operations totaled $2.7 million, compared to $2.4 million used during the same period of the prior year. Cash use in operations in the second quarter of 2026 was tied to an increase in working capital, namely inventory in support of the expected growth.

Narrowing And Raising Low End of 2026 Product Revenue Guidance

The Company now expects full-year 2026 product revenue to be in the range of $229 million to $231 million, reflecting growth of 11% to 12% from 2025. Included in this range is increased full-year 2026 IFC revenue guidance of $23 million to $25 million. Previously, the Company’s 2026 product revenue guidance range was $227 million to $231 million, including IFC revenue guidance between $22 million to $24 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website and will be available approximately three hours after the call through August 20, 2026.

*FC15 equivalent to a therapeutic dose of a cryoAHF pool.

(Press release, Cerus, JUL 30, 2026, View Source [SID1234669529])

Castle Biosciences Reports Second Quarter 2026 Results

On July 30, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter ended June 30, 2026.

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"The Castle Biosciences team delivered another outstanding quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our strong growth through the first half of 2026 demonstrates the clinical value our tests bring to patient care and the dedication of our talented team to deliver results so that our clinician customers and patients can act with confidence.

"Given this momentum, we are raising our 2026 total revenue guidance to $365-375 million, up from our previous range of $345-355 million. We also now expect to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

"We are also encouraged by an independent study supporting the clinical impact of AdvanceAD-Tx in guiding systemic treatment selection. At the Revolutionizing Atopic Dermatitis meeting in June, data from a multi-center study showed only 54.3% of patients receiving baseline systemic therapy were initially on pathway-concordant treatment; however, following testing with our AdvanceAD-Tx test, 97.8% of patients were initiated on molecularly concordant systemic therapy.

I want to thank the entire Castle team for their focus, commitment and disciplined execution, which continue to advance our mission of improving health through innovative tests that guide patient care."

Second Quarter Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $103.5 million, compared to $86.2 million in the second quarter of 2025. Affecting second quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•Second quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 32% over the second quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,280, compared to 9,981 in the second quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 14,988, compared to 9,170 in the second quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 4,011, compared to 4,762 in the second quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,061, compared to 1,166 in the second quarter of 2025.
◦DecisionDx-UM test reports delivered in the quarter were 482, compared to 468 in the second quarter of 2025.

•Gross margin was 75%, and Adjusted Gross Margin was 76%, compared to 77% and 80%, respectively, for the same periods in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $11.6 million, was $2.1 million, compared to net income of $4.5 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.07, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.16 and $0.15, respectively, for the same period in 2025.
•Adjusted EBITDA was $12.4 million, compared to $10.4 million for the same period in 2025.
•Net cash provided by operations was $15.2 million, compared to net cash provided by operations of $20.8 million for the same period in 2025.

Six Months Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $187.2 million, compared to $174.2 million for the six months ended June 30, 2025. Affecting comparison to 2025 includes the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•First half 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 34% over the six months ended June 30, 2025.
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2026, were 20,301, compared to 18,602 for the same period in 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2026, were 26,733, compared to 16,602 for the same period in 2025.
Additional tests:
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2026, were 7,713, compared to 9,137 for the same period in 2025.
◦MyPath Melanoma test reports delivered in the six months ended June 30, 2026, were 2,034, compared to 2,092 for the same period in 2025.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2026, were 974, compared to 938 for the same period in 2025.

•Gross margin for the six months ended June 30, 2026, was 74%, and Adjusted Gross Margin was 77%, compared to 63% and 81%, respectively, for the same period in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $21.4 million, was $16.6 million, compared to net loss of $21.3 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.55, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.74 and $0.04, respectively, for the same period in 2025.
•Adjusted EBITDA was $7.3 million, compared to $23.4 million for the same period in 2025.

•Net cash used in operations was $6.9 million, compared to $14.8 million net cash provided by operations for the same period in 2025.
Cash, Cash Equivalents and Marketable Investment Securities
As of Jun. 30, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $266.8 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $365-375 million in total revenue in 2026, compared to the previously provided guidance of between $345-355 million. Further, the Company expects to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

Second Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer
•The Company announced the publication of a prospective, multicenter study in Dermatology and Therapy demonstrating that DecisionDx-Melanoma’s integrated sentinel lymph node biopsy test result (i31-SLNB) outperforms the Melanoma Institute Australia (MIA) nomogram in identifying patients at low and high risk of SLN positivity, supporting more informed SLNB decision-making for patients with cutaneous melanoma (CM). This is the second multicenter study showing that the i31-SLNB result outperforms the MIA nomogram in assessing SLN positivity risk. See the Company’s news release from June 25, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced that its AdvanceAD-Tx test has received assay approval from the New York State Department of Health (NYSDOH). With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh. See the Company’s news release from July 14, 2026, for more information.
•The Company announced that its AdvanceAD-Tx test was selected as the winner of the "Genomics Innovation Award" in the 10th annual MedTech Breakthrough Awards program, which recognizes companies driving meaningful progress and improving patient care across the global health and medical technology industry. AdvanceAD-Tx is Castle’s clinically validated gene expression profile (GEP) test designed to guide systemic treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD). This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions. See the Company’s news release from May 12, 2026, for more information.

Pipeline Initiatives
•In June 2026, the first patient was enrolled in DETECT-AD, a multicenter prospective clinical study being conducted through Castle’s collaboration with SciBase, a global medical technology company, specializing in early detection and prevention in dermatology. The study will investigate the ability of Electrical Impedance Spectroscopy (EIS) to predict the onset of flares in patients with AD, with the goal of enabling proactive interventions and improving patient quality of life.

Corporate
•The Company announced that Frank Stokes, its chief financial officer, has been named a 2026 CFO Awards honoree by the Houston Business Journal. Stokes is among 22 chief financial officers from across the Greater Houston area recognized for their financial leadership and contributions to their organizations’ success. See the Company’s news release from June 23, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, July 30, 2026, at 4:30 p.m. Eastern time to discuss its second quarter 2026 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 20, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, JUL 30, 2026, View Source [SID1234669528])