On August 7, 2025 HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:​HCM; HKEX:​13) reported its financial results for the six months ended June 30, 2025 and provides updates on key clinical and commercial developments (Press release, Hutchison China MediTech, AUG 7, 2025, View Source [SID1234654979]).

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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, August 7, 2025, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, August 8, 2025. After registration, investors may access the live webcast at www.hutch-med.com/event.

All amounts are expressed in US dollars unless otherwise stated. A list of abbreviations is in the Glossary at the end of the page.

Global commercial progress and delivery of sustainable growth
ORPATHYS (savolitinib) secured China approval of its third lung cancer indication for EGFRm NSCLC patients with MET amplification after progression on EGFR inhibitor treatment in combination with TAGRISSO (osimertinib) on June 30, 2025, in time to be eligible for potential national reimbursement negotiation towards the end of this year. This combination offers the only oral, chemotherapy-free approach to a sizable percentage (~30%) of these patients. The approval triggered a $11.0 million milestone payment from AstraZeneca which markets both ORPATHYS and TAGRISSO.
FRUZAQLA (fruquintinib ex-China) in-market sales by Takeda were up 25% to $162.8 million (H1-24: $130.5m) as its geographical coverage expanded to more than 30 countries. ELUNATE (fruquintinib China) achieved $43.0 million (H1-24: $61.0m) reflecting intensifying competitive pressures and streamlining of our salesforce structure, but growth has returned recently. Total Oncology/​Immunology consolidated revenue, including milestone and service income, was $143.5 million (H1-24: $168.7m).
Net income attributable to HUTCHMED of $455.0 million was achieved in the first half of 2025 (H1-24: $25.8m), with a cash balance of $1.36 billion as of June 30, 2025, significantly boosted by a $416.3 million divestment gain, net of tax from the disposal of a partial equity stake in a non-core joint venture and divestment proceeds.

Pipeline progress and new technology platform
Positive results from the SACHI China and SAVANNAH global lung cancer trials of ORPATHYS in combination with TAGRISSO were presented at ASCO (Free ASCO Whitepaper) and ELCC conferences. SACHI showed mPFS of 8.2 months with this oral combination compared to 3.0 months with chemotherapy, and SAVANNAH showed 7.4 months with this oral combination. This is the only treatment option that demonstrated statistically significant results in a biomarker-directed pivotal clinical trial in MET amplified, EGFR TKI refractory NSCLC patients. Enrollment in the SAFFRON global Phase III trial is expected to complete in the second half of this year and readout in the first half of 2026.
Phase II/III trial on SULANDA (surufatinib) in combination with AiRuiKa (camrelizumab) and chemotherapy for previously-untreated metastatic pancreatic cancer patients is progressing well, targeting data readout in the second half of 2025. An earlier study presented promising updated data at ASCO (Free ASCO Whitepaper) with ORR of 51.1% (vs 24.4% with chemotherapy) and mPFS of 7.9 months (vs 5.4 months).
Positive FRUSICA-2 Phase III results supported the China approval submission for ELUNATE with TYVYT (sintilimab) in previously-treated kidney cancer. Details to be presented at ESMO (Free ESMO Whitepaper) Congress. Prior Phase Ib/II study showed ORR of 60.0% and mPFS of 15.9 months.
New Antibody-Targeted Therapy Conjugates (ATTC) platform drug candidates have been selected, planning to enter clinical development in late 2025. We also plan to present pre-clinical data at a scientific conference before the end of this year. Successful development of multiple ATTC molecules is expected to lead to collaboration and licensing opportunities in the future. Initial responses from potential partners are very positive.

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "With a strong balance sheet, robust operations and an exciting new ATTC platform, HUTCHMED is ready to enter a new phase of growth. Partnering is still a strategic focus, with multinational pharmaceutical companies remaining favorable towards such licensing opportunities with China biotech companies. In recent months we have seen markets’ sentiment and performance have significantly improved. China domestic drug policy and pricing environment also manifest strengthened support for innovative drug development, with the potential introduction of a commercial insurance drug list later this year, targeting a diversified, multi-layered healthcare social security payment system down the road.

We intend to prudently and actively deploy resources to expedite the development of a series of drug candidates from our novel ATTC platform, including synchronous clinical development in China and overseas. Our 20 years of knowledge of in-house discovery, experience in running large-scale pivotal trials, collaboration with international partners and success in obtaining global regulatory approvals empower us to bring forth more innovative medicines to address large unmet needs around the world."

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "We concluded the first half of 2025 with several important milestones achieved, some earlier than expected. The presentation of SACHI data at ASCO (Free ASCO Whitepaper) in a late-breaking oral presentation at the beginning of June was impressive, validating both the clinical strength and commercial advantages of ORPATHYS in the market. This is the first biomarker-selected pivotal study globally for EGFR TKI refractory lung cancer patients, demonstrating clear clinical benefits for these patients. The China approval of ORPATHYS at the end of June for this indication, six months after filing acceptance, was ahead of schedule and in time to qualify for national reimbursement negotiation. Also in June, the third indication of ELUNATE for kidney cancer was accepted for review by the NMPA, supported by positive data in the FRUSICA-2 Phase III trial, to be presented at ESMO (Free ESMO Whitepaper) Congress. We also launched TAZVERIK (tazemetostat), our first hematological oncology drug, in July following approval in March.

We believe sales growth should improve in second half of 2025, with the help of indication expansion in China and better market penetration overseas. In the near term, we shall start clinical development of multiple drug candidates from our ATTC program, a crucial technology platform, which will enrich our pipeline and provide ample partnership opportunities."

2025 Interim Results & Business Updates
I. COMMERCIAL OPERATIONS
FRUZAQLA in-market sales by Takeda were up 25% in the first half of 2025 at $162.8 million, driven by strong growth following approvals in more than 30 countries to date, including over 10 new markets in 2025. Reimbursement was received in the US, Spain and Japan last year, and, in July 2025, positive recommendation was received for NHS reimbursement in England and Wales.

The China pharmaceutical sector has gone through multifaceted changes. To position HUTCHMED for sustainable long-term growth, HUTCHMED has streamlined its sales force to establish a more efficient commercial organization and enhance productivity. In the face of intensifying competition as its products mature, HUTCHMED has strengthened its strategy to continue to focus on science-driven commercial activities to further differentiate its products. In the first half of 2025, in-market sales in China for ELUNATE, SULANDA and ORPATHYS decreased as compared to the first half of 2024, reflecting competition and the transitional effects of the changes in our sales team and marketing strategy.

Total in-market sales were down 4%. Consolidated revenue dropped 22% due to lower China in-market sales, offset by flat FRUZAQLA revenue.

Other Oncology/​Immunology revenue, consisting of upfront or milestones, R&D services and licensing to our partners increased 9% to $44.4 million. Revenue from Other Ventures, comprising prescription drug distribution, remained flat, leading to total consolidated revenue of $277.7 million, down 9%.

* 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; 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 the HUTCHMED’s sales of the products to third parties.

II. REGULATORY UPDATES
Savolitinib sNDA approved by the NMPA for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO, triggering $11.0 million milestone from AstraZeneca, in June 2025.
Savolitinib sNDA approved by the NMPA for 1L and 2L (converted from conditional to full approval) METex14 NSCLC in January 2025. Savolitinib approved in Hong Kong for METex14 NSCLC under the 1+ Mechanism in February 2025.
Tazemetostat NDA conditionally approved by the NMPA for 3L R/R follicular lymphoma with EZH2 mutation in March 2025.

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET
Presented SACHI China Phase III results at ASCO (Free ASCO Whitepaper) 2025 for 2L EGFRm NSCLC patients with MET amplification, in combination with TAGRISSO, showing mPFS of 8.2 months compared to 4.5 months with chemotherapy in ITT population (HR 0.34), and 6.9 months compared to 3.0 months in post third-generation EGFR TKI-treated subgroup (HR 0.32, both p<0.0001) (NCT05015608).
Presented SAVANNAH global Phase II results at ELCC 2025 for 2L EGFRm NSCLC patients with MET amplification or overexpression, in combination with TAGRISSO, showing ORR of 56%, mPFS of 7.4 months and mDoR of 7.1 months (NCT03778229).
Continued enrolling SAFFRON global Phase III study for 2L EGFRm NSCLC patients with MET amplification or overexpression (NCT05261399) and the study will potentially support global filings; and SANOVO China Phase III study for 1L EGFRm NSCLC patients with MET overexpression (NCT05009836).
Completed enrollment of China Phase II registrational study for 3L gastric cancer patients with MET amplification (NCT04923932).
Potential upcoming clinical milestones for savolitinib:

Complete SAFFRON Phase III enrollment in the second half of 2025, data readout in the first half of 2026.
Complete SANOVO China Phase III enrollment in the second half of 2025.

Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a selective oral inhibitor of VEGFR
Positive results of FRUSICA-2 China Phase III in 2L RCC in March 2025 (NCT05522231).
Presented China Phase II IIT results at AACR (Free AACR Whitepaper), in combination with TUOYI (toripalimab) or TYVYT, in 2L and above MSS/pMMR CRC, showing mPFS of 13.2 months and mOS of 29.0 months (NCT04483219).

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk
Ongoing ESLIM-01 ITP NMPA NDA review stipulates a lower impurity limit, requiring further manufacturing validation and stability test. Target re-submission in first half of 2026, with additional data rolling in during second half of 2026. In the future, the company will look to continue overseas development.
Published China Phase II results in warm AIHA in China at EHA (Free EHA Whitepaper) and in The Lancet Haematology in 2025, demonstrating overall response rate of 66.7% and a favorable safety profile (NCT05535933).
Completed ESLIM-02 China Phase III enrollment for warm AIHA in June 2025 (NCT05535933).
Potential upcoming regulatory milestones for sovleplenib:

ESLIM-01 NMPA NDA re-submission in first half of 2026 (NCT05029635).
ESLIM-02 NMPA sNDA submission in first half of 2026 (NCT05535933).

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR and CSF-1R
Potential upcoming clinical milestone for surufatinib:

Data readout of Phase II part of a China Phase II/III HUTCHMED-sponsored trial for 1L metastatic PDAC patients, in combination with AiRuiKa, nab-paclitaxel and gemcitabine in late 2025 (NCT06361888).

Tazemetostat (TAZVERIK in China), a first-in-class, oral inhibitor of EZH2
TAZVERIK NDA approved by the NMPA for 3L R/R follicular lymphoma with EZH2 mutation.
Continued enrolling SYMPHONY-1 China portion of the Phase III portion of the global study, in combination with lenalidomide and rituximab, in 2L follicular lymphoma patients (NCT04224493).

Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
Completed enrollment of China Phase II registrational trial for IHCC with FGFR fusion / rearrangement in February 2025 (NCT04353375).

Ranosidenib (HMPL-306), an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes
Continued enrolling RAPHAEL China Phase III trial for 2L R/R IDH1/2-mutant AML (NCT06387069).

IV. ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM
New in-house created platform with multiple potential IND candidates
HUTCHMED plans to initiate China and global clinical trials for our first ATTC drug candidate around the end of 2025, followed by multiple global IND filings for more ATTC candidates in 2026.

Our ATTC next-generation technology platform leverages over 20 years of expertise in targeted therapies with small molecules inhibitors. By linking a monoclonal antibody with a proprietary targeted small-molecule inhibitor (SMI) payload, our ATTC platform has the capability to derive multiple drug candidates targeting various oncology indications, including precision medicine against selective sub-types. These ATTC drug candidates enrich the next wave of clinical development with potential key advantages over traditional antibody-drug conjugates and/or small molecule medicines.

Better efficacy through synergistic antibody-small molecule targeted therapy combinations that will target specific mutations; overcome drug resistance to existing treatment.
Improved safety and prolonged treatment given lower off-tumor or off-target toxicity than small molecules, lower risk of myelosuppression and better safety than cytotoxin-based conjugates.
Attractive pharmacokinetics tackles difficult drug targets, enabled by antibody-guided delivery to target sites which will improve bioavailability and reduce drug-drug interactions.
Advantages over existing ADCs due to lower off-tumor toxicities from the SMI payload, released through lysosomal cleavage inside target cells, targets cell signaling pathway driven by mutation specific to tumor cells. It can be used in combination with established standard therapies such as chemotherapy and immunotherapy to further enhance efficacy.
Potential first-line applications, as chemo-free ATTC can potentially support combinations with other targeted therapies, chemotherapy and immunotherapy, in early-line settings with broad market potential.

V. COLLABORATION UPDATES
Further progress of candidate IMG-007, discovered by HUTCHMED
ImageneBio, Inc. (Nasdaq: IMA) – Inmagene and Ikena Oncology, Inc. completed a merger on July 25, 2025 and ImageneBio, Inc., the merged entity, holds the license rights to IMG-007 granted by HUTCHMED. HUTCHMED has an approximate 3.67% shareholding in ImageneBio, Inc.
Announced positive results of a US/Canada Phase IIa study of IMG-007 for atopic dermatitis in April 2025, showing week 16 mean change in EASI of 77% and EASI-75 response of 54% (NCT05984784).
Dosed the first patient in a US Phase IIb randomized, double-blind, placebo-controlled dose-finding study of IMG-007 for moderate-to-severe atopic dermatitis in July 2025, targeting to enroll 220 patients who have had inadequate response to and/or intolerance of topical therapies (NCT07037901).
Announced positive results of a US/Canada Phase IIa study of IMG-007 for severe alopecia areata in January 2025, showing mean reduction from baseline in Severity of Alopecia Tool (SALT) score of 30.1% by week 36 (NCT06060977).

VI. OTHER VENTURES
Other Ventures consolidated revenue, predominantly from the prescription drug distribution business in China, were steady at $134.2 million for the six months ended June 30, 2025.
HUTCHMED divested a 45.0% equity interest in SHPL for $608.5 million in cash in April 2025, retaining a 5.0% equity interest. A divestment gain, net of tax of $416.3 million was recognized during the first half of 2025. As a result, HUTCHMED’s share of equity in earnings of SHPL decreased to $23.1 million for the six months ended June 30, 2025.
Consolidated net income attributable to HUTCHMED from Other Ventures increased to $440.3 million (H1-24: $34.1m), primarily due to the SHPL interest disposal.

VII. SUSTAINABILITY
In April 2025, the 2024 Sustainability Report was published, highlighting the progress made in 11 goals and targets and enhanced climate actions, including improved Scope 3 data, tightened control over air travel and engagement with suppliers. This year, a comprehensive climate risks assessment is being conducted to further understand and quantify the potential financial impacts of climate change, including physical risks brought by flooding and heat stress, and transition risks for HUTCHMED under optimistic and pessimistic scenarios.

HUTCHMED has made notable progress in its ESG ratings, including ratings from CDP Worldwide, the Hang Seng Corporate Sustainability Index Series, ISS ESG, MSCI ESG, Sustainalytics, and S&P Global ESG. In May 2025, HUTCHMED ranked third in ESG Excellence in the Healthcare, Pharmaceutical, and Biotechnology sector in the Extel’s Asia Executive Team survey, reflecting feedback from over 5,400 portfolio managers and analysts. Extel ranked HUTCHMED as one of the Most Honored Companies; ranked it first in Best Board of Directors, Best CEO, Best IR Program and Best IR Professionals; as well as second in Best CFO and Best IR Team in the Healthcare, Pharmaceutical, and Biotechnology sector.

Financial Highlights
Revenue for the six months ended June 30, 2025 was $277.7 million compared to $305.7 million for the six months ended June 30, 2024.
Oncology/​Immunology consolidated revenue amounted to $143.5 million (H1-24: $168.7m):
FRUZAQLA revenue was $43.1 million (H1-24: $42.8m), reflecting continued growth in royalties, offset by reduced manufacturing revenue compared to its launch year. In-market sales by Takeda were $162.8 million (up 25%) driven by strong growth following approvals in more than 30 countries to date, including over 10 new markets in 2025.
ELUNATE revenue decreased to $33.6 million (H1-24: $46.0m) in its seventh year since launch, comprising manufacturing revenue, promotion and marketing services revenue and royalties. In-market sales decreased to $43.0 million, reflecting the intensifying competitive pressures from combination therapies of key competing products and their additional generics and biosimilars entry in 3L CRC. The launch of the entry of the new indication 2L EMC in 2025 and continuous inclusion of ELUNATE in key guidelines are expected to drive future growth.
SULANDA revenue decreased to $12.7 million (H1-24: $25.4m) in the face of strong competition for NET patients from new somatostatin analogues drugs with their inclusion in the NRDL and broader coverage. To counteract this challenge, we continue to drive awareness and product differentiation to uphold SULANDA position in TKI.
ORPATHYS revenue decreased to $9.0 million (H1-24: $13.1m) on in-market sales of $15.2 million, impacted by the launch and NRDL inclusion of several competing drugs for METex14 skipping Such results have not reflected expected growth from the recent approval for the much larger EGFR TKI-refractory, MET-amplified NSCLC patient population at the end of June 2025.
TAZVERIK revenue was $0.7 million (H1-24: $0.5m) mainly from sales in Hainan and Hong Kong. Launched in mainland China in July 2025 following its approval in March 2025.
Takeda upfront, regulatory milestones and R&D services revenue were $29.5 million (H1-24: $33.8m), of which $26.6 million was recognized from Takeda deferred revenue.
Other revenue of $14.9 million (H1-24: $7.1m), includes regulatory milestone of $11.0 million from AstraZeneca following China NDA approval for ORPATHYS combined with TAGRISSO.
Other Ventures consolidated revenue of $134.2 million (H1-24: $137.0m) remained flat.

Net Expenses for the six months ended June 30, 2025 were $239.0 million compared to $279.9 million for the six months ended June 30, 2024, reflecting strong cost control efforts.
Cost of Revenue decreased 7% to $167.6 million (H1-24: $180.1m), which was mainly due to lower Oncology/​Immunology revenue. Cost of revenue as a percentage of oncology product revenue remained stable at 39% (H1-24: 38%).
R&D Expenses reduced by 24% to $72.0 million (H1-24: $95.3m). While R&D investment outside of China reduced to $7.6 million (H1-24: $14.9m) as we continued to integrate our global R&D operations with China, the decrease was mainly driven by China with R&D investment of $64.4 million (H1-24: $80.4m) reflecting lower costs from completed studies which are under NDA review (e.g. ELUNATE in 2L RCC) or already led to NMPA approval in H1-25 (e.g. ORPATHYS in 2L NSCLC). Joint China and global clinical development effort ongoing to gear up for multiple drug candidates from our ATTC
S&A Expenses were $41.6 million (H1-24: $57.8m). The decrease was mainly due to a reduction in S&A expenses for oncology products which was $13.4 million or 13.5% of oncology product revenue (H1-24: $25.1 million or 19.6%) as sales force structure was streamlined and tighter spending controls imposed.
Other Items generated net income of $42.2 million (H1-24: $53.3m), mainly comprised of equity in earnings of SHPL, interest income and expense, foreign exchange and taxes. The decrease was primarily due to lower share of equity in earnings of SHPL at $23.1 million (H1-24: $33.8m) as our share decreased to 5% (H1-24: 50%) after the divestment of a partial stake in SHPL completed in April 2025.

Gain on divestment of SHPL, net of tax was $416.3 million for the six months ended June 30, 2025.

Net Income attributable to HUTCHMED for the six months ended June 30, 2025 was $455.0 million compared to $25.8 million for the six months ended June 30, 2024.
The net income attributable to HUTCHMED for the six months ended June 30, 2025 was $0.53 per ordinary share / $2.65 per ADS (H1-24: $0.03 per ordinary share / $0.15 per ADS).

Cash, Cash Equivalents and Short-Term Investments were $1,364.5 million as of June 30, 2025 compared to $836.1 million as of December 31, 2024.
Adjusted Group (non-GAAP) net cash inflows excluding financing activities in the first half of 2025 were $519.1 million mainly due to the receipt of $608.5 million gross proceeds from the partial divestment of SHPL, offset with the $59.5 million capital gain tax payment for the partial divestment of SHPL, $10.0 million regulatory approval milestone payment and $9.2 million in capital expenditures (H1-24: -$51.3m mainly due to $39.8 million net cash used in operating activities and $10.1 million of capital expenditures).
Net cash generated from financing activities in the first half of 2025 totaled $9.3 million mainly due to drawdowns of bank borrowings of $8.2 million (H1-24: net cash used in financing activities of $32.6m mainly due to purchases for equity awards of $36.1 million).

Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 0.8% during the first half of 2025, which has impacted consolidated financial results as highlighted.

On August 7, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported its second quarter 2025 results of operations (Press release, Gilead Sciences, AUG 7, 2025, View Source [SID1234654978]).

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"This was a very successful second quarter for Gilead, including the FDA approval for Yeztugo as the world’s first twice-yearly HIV prevention option," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "Our strong growth this quarter was driven by Biktarvy, Descovy, Trodelvy and Livdelzi, reflecting the diversity of our portfolio. As we enter the third quarter, we are increasing revenue and earnings guidance for the year, and look forward to delivering continued innovation and growth across our core therapeutic areas."

Second Quarter 2025 Financial Results

•Total second quarter 2025 revenue increased 2% to $7.1 billion compared to the same period in 2024, driven by higher HIV, Livdelzi (seladelpar) and Trodelvy (sacituzumab govitecan-hziy) sales, partially offset by lower chronic hepatitis C virus ("HCV") and Veklury (remdesivir) sales.
•Diluted earnings per share ("EPS") was $1.56 in the second quarter 2025 compared to $1.29 in the same period in 2024. The increase was primarily driven by net unrealized gains on securities compared to net unrealized losses in 2024 and higher product sales, partially offset by a pre-tax in-process research and development ("IPR&D") impairment charge of $190 million related to assets acquired as part of the MYR GmbH ("MYR") acquisition and higher research and development ("R&D") expenses.
•Non-GAAP diluted EPS of $2.01 in the second quarter 2025 remained flat compared to the same period in 2024, with higher product sales offset by higher R&D expenses.
•As of June 30, 2025, Gilead had $7.1 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024.
•During the second quarter 2025, Gilead generated $827 million in operating cash flow, net of a final $1.3 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017.
•During the second quarter 2025, Gilead paid dividends of $994 million and repurchased $527 million of common stock.

Second Quarter 2025 Product Sales

Total second quarter 2025 product sales increased 2% to $7.1 billion compared to the same period in 2024. Total second quarter 2025 product sales excluding Veklury increased 4% to $6.9 billion compared to the same period in 2024, primarily due to higher HIV, Livdelzi and Trodelvy sales, partially offset by lower HCV sales.
HIV product sales increased 7% to $5.1 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by increased demand and higher average realized price.

•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 9% to $3.5 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand.
•Descovy (FTC 200mg/TAF 25mg) sales increased 35% to $653 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand

The Liver Disease portfolio sales decreased 4% to $795 million in the second quarter 2025 compared to the same period in 2024. This was primarily driven by lower HCV sales, partially offset by increased demand for Livdelzi, Hepcludex (bulevirtide) and chronic hepatitis B virus ("HBV") products.
Veklury sales decreased 44% to $121 million in the second quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations.
Cell Therapy product sales decreased 7% to $485 million in the second quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds.
•Yescarta (axicabtagene ciloleucel) sales decreased 5% to $393 million in the second quarter 2025 compared to the same period in 2024, primarily driven by lower demand, partially offset by higher average realized price.
•Tecartus (brexucabtagene autoleucel) sales decreased 14% to $92 million in the second quarter 2025 compared to the same period in 2024, primarily reflecting lower demand, partially offset by higher average realized price.
Trodelvy sales increased 14% to $364 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand and inventory dynamics.
Second Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin was 78.7% in the second quarter 2025 compared to 77.7% in the same period in 2024. Non-GAAP product gross margin was 86.9% in the second quarter 2025 compared to 86.0% in the same period in 2024. The increases were primarily driven by product mix.
•R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.4 billion in the same period in 2024, primarily due to increased clinical manufacturing and study expenses, as well as valuation adjustments to the MYR-related contingent consideration. Non-GAAP R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.3 billion in the same period in 2024, primarily due to increased clinical manufacturing and study activities.
•Acquired IPR&D expenses were $61 million in the second quarter 2025, primarily reflecting expenses related to the strategic partnership with Kymera Therapeutics, Inc. ("Kymera") announced in June 2025.
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses of $1.4 billion in the second quarter 2025 remained flat compared to the same period in 2024, with higher promotional expenses offset by lower corporate expenses.
•The effective tax rate ("ETR") was 19.3% in the second quarter 2025 compared to 21.4% in the same period in 2024, primarily driven by lower non-taxable unrealized losses on securities, partially offset by a beneficial prior year settlement with a tax authority that did not repeat. The non-GAAP ETR was 18.8% in the second quarter 2025 compared to 17.8% in the same period in 2024, primarily reflecting the same non-recurring tax settlement in the prior year.
Guidance and Outlook
For the full-year, Gilead expects:
(in millions, except per share amounts)
August 7, 2025 Guidance
Low End High End Comparison to Prior Guidance
Product sales $ 28,300 $ 28,700
Previously $28,200 to $28,600
Product sales excluding Veklury $ 27,300 $ 27,700
Previously $26,800 to $27,200
Veklury $ 1,000 $ 1,000
Previously $1,400
Diluted EPS $ 5.85 $ 6.15
Previously $5.65 to $6.05
Non-GAAP diluted EPS $ 7.95 $ 8.25
Previously $7.70 to $8.10

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below.

Key Updates Since Our Last Quarterly Release

Virology

•Received U.S. Food and Drug Administration ("FDA") approval for Yeztugo (lenacapavir) for pre-exposure prophylaxis ("PrEP") to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg. Yeztugo is the first and only twice-yearly HIV PrEP option available in the United States.
•Received a positive opinion under accelerated review from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending lenacapavir for use as PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The recommendation will now be reviewed by the European Commission. Lenacapavir for HIV PrEP is not approved for use outside of the United States.
•Announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria ("Global Fund") to accelerate access, subject to regulatory approvals, to twice-yearly lenacapavir for HIV PrEP for up to two million people in primarily low- and lower-middle-income countries over three years, at no profit to Gilead.
•Presented new data at the International AIDS Society conference, including from the PURPOSE 1 and 2 trials evaluating twice-yearly lenacapavir for HIV PrEP in a broad range of populations, including pregnant and lactating women, adolescents, and young people.
•Announced that the World Health Organization released new guidelines recommending the use of twice-yearly lenacapavir for HIV PrEP, as well as new guidelines on HIV testing protocols for long-acting prevention medications.
•Announced that FDA had placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182, including the WONDERS-1 and WONDERS-2 trials. These drug candidates are investigational and not approved anywhere globally.
•Presented final data from the Phase 3 MYR301 study evaluating bulevirtide as a treatment for adults with chronic hepatitis delta virus ("HDV") at the European Association for the Study of the Liver ("EASL") Congress. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S. Additionally, presented clinical and real-world data on HBV and HCV programs.

Oncology

•Announced positive topline results from the Phase 3 ASCENT-03 trial evaluating Trodelvy in patients with 1L metastatic triple-negative breast cancer ("mTNBC") who are not candidates for PD-1/PD-L1 checkpoint inhibitors. Additionally, presented results from the Phase 3 ASCENT-04 trial evaluating Trodelvy plus Keytruda (pembrolizumab) in 1L PD-L1+ mTNBC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") meeting. Trodelvy is not approved in either of these settings.
•Presented new real-world data at ASCO (Free ASCO Whitepaper) supporting the use of Yescarta in outpatient care settings for patients with relapsed or refractory ("R/R") large B-cell lymphoma ("LBCL"), as well as other early-stage investigational CAR T data in glioblastoma and LBCL.
•Presented data in partnership with Arcellx, Inc. ("Arcellx") at the European Hematology Association (EHA) (Free EHA Whitepaper) congress from the iMMagine-1 trial evaluating investigational anitocabtagene-autoleucel ("anito-cel") in R/R multiple myeloma.
•Entered into an exclusive option and license agreement with Kymera to develop novel oral molecular glue CDK2 degraders with broad oncology treatment potential.

Inflammation
•Presented new data from multiple analyses at EASL evaluating Livdelzi for the treatment of primary biliary cholangitis, including interim analysis from the open-label, long-term ASSURE study.
Corporate
•The Board declared a quarterly dividend of $0.79 per share of common stock for the third quarter of 2025. The dividend is payable on September 29, 2025, to stockholders of record at the close of business on September 15, 2025. Future dividends will be subject to Board approval.
•The Board authorized a new $6.0 billion stock repurchase program, with no fixed expiration, which will commence upon the completion of the previously approved program.
•Reached a final settlement agreement with the U.S. Department of Justice resolving a legacy compliance matter. This settlement was accrued in 2024 and reported under SG&A expenses.
•Named by TIME as a 2025 Most Influential Company.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.
Conference Call
At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

On August 7, 2025 Genmab reported interim report for the first half ended June 30, 2025 (Press release, Genmab, AUG 7, 2025, View Source [SID1234654977]).

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Highlights

Epcoritamab advancing to earlier lines of therapy with the submission of a sBLA to the FDA for epcoritamab plus R2 in patients with relapsed or refractory FL
Rinatabart sesutecan (Rina-S) continues to progress, demonstrating encouraging antitumor activity in endometrial cancer in data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
Data from over 40 abstracts highlighting the depth, breadth and strength of Genmab’s comprehensive epcoritamab development program presented at multiple medical conferences
Genmab revenue increased 19% compared to the first six months of 2024, to $1,640 million
"In the first half of the year we continued to make progress towards our strategic priorities as we strive towards our goal of bringing our innovative therapies to additional patients in need. We further maximized the potential of our commercialized medicines with an additional sBLA submission for EPKINLY (epcoritamab-bysp) and the launch of Tivdak (tisotumab vedotin) in Japan. We also accelerated the development of our late-stage pipeline through both encouraging data presentations and, for Rina-S, the announcement of additional planned Phase 3 clinical trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2025

Revenue was $1,640 million for the first six months of 2025 compared to $1,382 million for the first six months of 2024. The increase of $258 million, or 19%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and higher EPKINLY net product sales.
Royalty revenue was $1,378 million in the first six months of 2025 compared to $1,111 million in the first six months of 2024, an increase of $267 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $6,776 million in the first six months of 2025 compared to $5,570 million in the first six months of 2024, an increase of $1,206 million or 22%.
Total costs and operating expenses were $1,092 million in the first six months of 2025 compared to $1,030 million in the first six months of 2024. The increase of $62 million, or 6%, was driven by the expansion of our product pipeline, including advancement of Rina-S, the continued development of Genmab’s broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was $548 million in the first six months of 2025 compared to $352 million in the first six months of 2024.
Net financial items resulted in income of $119 million for the first six months of 2025 compared to $204 million in the first six months of 2024. The decrease was primarily due to a decrease in foreign exchange impacts driven by the change in functional currency of Genmab A/S on January 1, 2025, as well as a decrease in interest income for the first six months of 2025 compared to the first six months of 2024 related to average lower cash balances.

Outlook
Genmab is updating its revenue and operating profit guidance for 2025. The improved guidance is driven by higher total royalty revenues from DARZALEX.

2025 FULL YEAR OUTLOOK

(USD million) Revised Guidance Revised Mid-Point Previous Guidance Guidance Mid-Point
Revenue 3,500 – 3,700 3,600 3,340 – 3,660 3,500
Royalties 2,945 – 3,090 3,017 2,785 – 3,015 2,900
Net product sales/Collaboration revenue* 425 – 465 445 415 – 460 438
Milestones/Reimbursement revenue 130 – 145 138 140 – 185 162
Gross profit** 3,280 – 3,460 3,370 3,120 – 3,420 3,270
Operating expenses** (2,055) – (2,225) (2,140) (2,055) – (2,225) (2,140)
Operating profit 1,055 – 1,405 1,230 895 – 1,365 1,130
Net Product Sales and Collaboration Revenue consists of EPKINLY Net Product Sales in the U.S. and Japan and Tivdak (Genmab’s share of net profits) in the U.S. and Net Product Sales in Japan
Operating Expenses Range excludes Cost of Product Sales Range, which is included in Gross Profit Range

Other Matters
Both the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financials statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly.

Conference Call
Genmab will hold a conference call to discuss the results for the first half of 2025 today, Thursday, August 7, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: View Source A live and archived webcast of the call and relevant slides will be available at View Source

On August 7, 2025 Genmab A/S (Nasdaq: GMAB) reported positive results of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) (Press release, Genmab, AUG 7, 2025, View Source [SID1234654976]). The study met its dual primary endpoints of overall response rate (ORR, p-value < 0.0001) and progression-free survival (PFS, HR 0.21, p-value <0.0001), demonstrating statistically significant and clinically meaningful differences in both endpoints, reducing the risk of disease progression or death by 79%. The results, derived from a pre-planned interim analysis, will be submitted for presentation at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper) and will serve as the basis for global regulatory submissions.

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Separately, on July 24, the U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental Biologics License Application (sBLA) for epcoritamab plus R2 following at least one prior systemic therapy. The sBLA submission was based on data from a first interim analysis that demonstrated statistically significant improvements in ORR (95.7%, p-value < 0.0001) and PFS (HR 0.21, p-value <0.0001, based on the intent-to-treat population). Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of November 30, 2025. If approved, epcoritamab plus R2 would be the first bispecific antibody combination regimen available in the U.S. as a second-line treatment option for patients with R/R FL.

"While therapeutic options exist for patients with relapsed or refractory follicular lymphoma, response rates tend to decline and durability diminishes with each subsequent line of treatment, which can increase the risk of the disease transforming into aggressive large-cell lymphoma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "The results from this trial, and the decision from the FDA to accept the sBLA for priority review, demonstrate the potential of this epcoritamab combination therapy to reshape the treatment landscape and reinforces our shared commitment with AbbVie to advance epcoritamab as a potential core therapy across B-cell malignancies."

The safety profile of epcoritamab in combination with R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The U.S. FDA has granted accelerated approval of single agent epcoritamab for the treatment of adults with R/R FL after two or more lines of systemic therapy. The U.S. FDA also granted Breakthrough Therapy Designation (BTD) to epcoritamab in combination with R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy. The safety and efficacy of epcoritamab in combination with R2 in R/R FL is currently being evaluated in clinical trials and is not approved or established in the U.S., EU or in any other territory.

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases.i About 15,000 people develop FL each year in the U.S.ii and it is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse the remission and time to next treatment is shorter.iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and PFS assessed by independent review committee (IRC) per Lugano criteria.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.

On August 7, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadustat for the treatment of anemia in patients with LR-MDS and high RBC transfusion burden, based on a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial (Press release, FibroGen, AUG 7, 2025, View Source [SID1234654975]).

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"We are very pleased with the feedback we received from the FDA regarding roxadustat in patients with LR-MDS and anemia with high transfusion burden. This indication, despite recent approvals, still represents a patient population with significant unmet need," said Thane Wettig, Chief Executive Officer of FibroGen. "We believe roxadustat’s differentiated mechanism of action, favorable tolerability profile, and oral route of administration can potentially be an important addition to the treatment options for patients with high transfusion burden. We are starting preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late-stage program. We plan to submit the Phase 3 trial protocol to the FDA in the fourth quarter of this year."

"Anemia is a major cause of morbidity and complications in patients with LR-MDS, especially those with high transfusion burden, and is often associated with poor quality of life and shortened survival. While we have recent approvals of injectable drugs for this indication, there is a significant unmet need for novel, effective oral agents for this patient population," added Amer Zeidan, M.B.B.S, M.H.S., Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center, and the global principal investigator of the planned Phase 3 study. "Roxadustat has already shown promising efficacy in this group of patients in the post-hoc analysis of the MATTERHORN study, and I am glad we have agreed on a pathway with the regulators to explore the full potential of roxadustat in the upcoming Phase 3 trial. I am excited by the prospect of roxadustat potentially becoming a novel, safe, convenient, and effective therapy for LR-MDS patients with high transfusion burden."

FibroGen requested the Type C meeting based on the findings of a post-hoc analysis of data from the Phase 3 MATTERHORN trial of roxadustat in anemia-associated with LR-MDS. In patients with high RBC transfusion burden at baseline (≥4 units over 8 weeks1), a pronounced treatment effect was observed: 36% (8/22) of patients achieved transfusion independence (TI) for ≥ 56 days on roxadustat vs 7% (1/15) of patients on placebo within 28 weeks (nominal p-value of 0.041).

The planned Phase 3 trial will assess the safety and efficacy of roxadustat in a randomized, double-blind, placebo-controlled design in approximately 200 patients with LR-MDS. Alignment was reached with the FDA on the patient population (patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization, who are refractory to, intolerant to, or ineligible for prior erythropoiesis-stimulating agents (ESA) therapy), dose regimen, as well as management of potential thrombotic risk through eligibility and dose modification and discontinuation criteria. As the primary endpoint for the study, the Company is considering either 8-week or 16-week RBC TI.

FibroGen plans to submit the full Phase 3 protocol to the FDA in the fourth quarter of 2025.

About Myelodysplastic Syndromes Anemia
Myelodysplastic syndromes (MDS) are a group of disorders characterized by dysfunctional progenitor blood cells and stem cells, resulting in chronic anemia in most patients. Annual incidence rates of MDS are estimated to be 4.9/100,000 adults in the U.S, thereof 77% are considered lower-risk MDS. Approximately 80% of patients with MDS have anemia at the time of diagnosis, and around 60% of patients with MDS will experience severe anemia (hemoglobin <8 g/dL) at some point during the course of their disease. Anemia in patients with MDS is associated with increased risk of cardiovascular complications and the need for blood transfusion. Approximately 50% of patients with MDS require regular red blood cell transfusions. Transfusion dependent MDS patients suffer higher rates of cardiac events, infections, and iron overload with the related complications. In addition, anemia frequently leads to significant fatigue, cognitive dysfunction, and decreased quality of life. Today, patients are routinely treated with erythropoiesis-stimulating agents (ESAs), luspatercept, imetelstat, or lenalidomide in lower-risk MDS with isolated del(5q), and hypomethylating agents (HMAs) in higher-risk disease. Only 35-40% of patients respond to current treatments and the durability of response is short. Moreover, these treatments are challenging to dose-calibrate and can only be administered via subcutaneous injection or through IV infusion. There remains a high unmet need for the treatment of anemia associated with MDS, and new strategies that provide durable response and the convenience of oral administration are highly desired in managing patients with MDS.

About Roxadustat
Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.