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GILEAD SCIENCES ANNOUNCES SECOND QUARTER 2025 FINANCIAL RESULTS

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.

Genmab Announces Financial Results for the First Half of 2025

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]).

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

Genmab Announces Phase 3 EPCORE® FL-1 Clinical Trial Met Dual Primary Endpoints in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL)

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.

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.

FibroGen Announces Positive Type C Meeting with the FDA for Roxadustat in Patients with Anemia Associated with Lower-Risk Myelodysplastic Syndromes

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]).

"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.

Lilly reports second-quarter 2025 financial results and raises guidance

On August 7, 2025 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2025 (Press release, Eli Lilly, AUG 7, 2025, View Source [SID1234654974]).

"Lilly delivered another quarter of strong performance, achieving 38% year-over-year revenue growth driven by robust sales of Zepbound and Mounjaro and sustained momentum across our key medicines," said David A. Ricks, Lilly chair and CEO. "Our pipeline continued to advance, highlighted by positive study results in oncology and cardiometabolic health—including Mounjaro’s demonstrated cardio-protective effects in patients with type 2 diabetes and heart disease and strong data for our oral incretin, orforglipron, in obesity. We also expanded manufacturing capacity to meet increasing demand and invested in key R&D initiatives to support our long-term growth."

Financial Results

$ in millions, except

per share data

Second-Quarter

2025

2024

% Change

Revenue

$ 15,557.7

$ 11,302.8

38 %

Net income – Reported

5,660.5

2,967.0

91 %

Earnings per share – Reported

6.29

3.28

92 %

Net income – Non-GAAP

5,679.3

3,541.2

60 %

Earnings per share – Non-GAAP

6.31

3.92

61 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2025, worldwide revenue was $15.56 billion, an increase of 38% compared with Q2 2024, driven by a 42% increase in volume, partially offset by a 6% decrease due to lower realized prices. Key Products1 revenue grew to $10.40 billion in Q2 2025, led by Zepbound and Mounjaro.

Revenue in the U.S. increased 38% to $10.81 billion, driven by a 46% increase in volume, partially offset by an 8% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices was driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 37% to $4.74 billion, driven by a 35% increase in volume and to a lesser extent a 3% favorable impact on foreign exchange rates, partially offset by a 1% decrease due to lower realized prices. The volume increase outside the U.S. was driven primarily by Mounjaro.

Gross margin increased 44% to $13.11 billion in Q2 2025. Gross margin as a percent of revenue was 84.3%, an increase of 3.5 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

In Q2 2025, research and development expenses increased 23% to $3.34 billion, or 21.4% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 30% to $2.75 billion in Q2 2025, primarily driven by promotional efforts supporting ongoing and future launches.

There were no asset impairment, restructuring and other special charges in Q2 2025. In Q2 2024, there was a charge of $435.0 million, which related to litigation.

The effective tax rate was 16.5% in Q2 2025 compared with 15.6% in Q2 2024. The lower tax rate in Q2 2024 reflects the favorable tax impact of asset impairment, restructuring and other special charges in Q2 2024.

In Q2 2025, net income and earnings per share (EPS) were $5.66 billion and $6.29, respectively, compared with net income of $2.97 billion and EPS of $3.28 in Q2 2024. EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

1 The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2025 gross margin increased 43% to $13.23 billion. Gross margin as a percent of revenue was 85.0%, an increase of 3.0 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

On a non-GAAP basis, Q2 2025 net income and EPS were $5.68 billion and $6.31, respectively, compared with net income of $3.54 billion and EPS of $3.92 in Q2 2024. Non-GAAP EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.29

$ 3.28

92 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

—

.38

Net losses (gains) on investments in equity
securities

(.09)

.14

Earnings per share (non-GAAP)

$ 6.31

$ 3.92

61 %

Acquired IPR&D

.14

— %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Second-Quarter

Year-to-Date

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 5,198.9

$ 3,090.8

68 %

$ 9,040.7

$ 4,897.4

85 %

Zepbound

3,381.4

1,243.2

172 %

5,693.3

1,760.6

Verzenio

1,489.3

1,331.9

12 %

2,648.2

2,382.2

11 %

Total Revenue

15,557.7

11,302.8

38 %

28,286.2

20,070.8

41 %

NM – not meaningful

Mounjaro
For Q2 2025, worldwide Mounjaro revenue increased 68% to $5.20 billion. U.S. revenue was $3.30 billion, an increase of 37%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $1.90 billion compared with $677.2 million in Q2 2024, primarily driven by volume growth, including entry into new markets.

Zepbound
For Q2 2025, U.S. Zepbound revenue increased 172% to $3.38 billion, compared with $1.24 billion in Q2 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q2 2025, worldwide Verzenio revenue increased 12% to $1.49 billion. U.S. revenue was $929.0 million, an increase of 8%, driven by increased volume. Revenue outside the U.S. was $560.3 million, an increase of 19%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Donanemab receives positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) in early symptomatic Alzheimer’s disease (announcement)

FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing
in early symptomatic Alzheimer’s disease (announcement).

FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support
diagnosis of Alzheimer’s disease in patients (announcement).

Lilly’s Kisunla (donanemab) receives marketing authorization in Australia for the
treatment of early symptomatic Alzheimer’s disease (announcement).

Clinical

Lilly’s oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs
in first of two pivotal Phase 3 trials in adults with obesity (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated
cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in
patients with type 2 diabetes and heart disease (announcement)

Lilly’s Kisunla (donanemab-azbt) showed growing benefit over three years in early
symptomatic Alzheimer’s disease (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible)
BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus
Imbruvica (ibrutinib) in CLL/SLL (announcement)

Lilly’s once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety
profile consistent with daily insulin in multiple Phase 3 trials (announcement).

Lilly’s oral GLP-1, orforglipron, showed compelling efficacy and a safety profile
consistent with injectable GLP-1 medicines, in complete Phase 3 results published
in The New England Journal of Medicine (announcement).

Lilly presents first clinical data for its investigational, next-generation FRα targeting
ADC in platinum-resistant ovarian cancer at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
(announcement).

Zepbound (tirzepatide) showed superior weight loss over Wegovy (semaglutide) in
complete SURMOUNT-5 results published in The New England Journal of Medicine
(announcement).

Other

Lilly to acquire Verve Therapeutics to advance one-time treatments for people with
high cardiovascular risk (announcement). Lilly and Verve announce expiration of
Verve tender offer (announcement).

Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through
LillyDirect Self Pay Pharmacy Solutions (announcement).

Lilly to expand its pain pipeline with acquisition of SiteOne Therapeutics
(announcement).

Lilly plans to expand Purdue University collaboration with up to a $250 million
investment to accelerate pharmaceutical innovation (announcement).

Lilly announces transitions in executive leadership (announcement).

For information on important public announcements, visit the news section of Lilly’s website.

2025 Financial Guidance
Full year guidance increased to the range of $60.0 billion to $62.0 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 42.0% and 43.5% on a reported basis and 43.0% and 44.5% on a non-GAAP basis. Both ratios reflecting the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $750 million to $650 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate increased from approximately 17% on a reported basis to 19% which reflects an anticipated third quarter charge as a result of recently enacted U.S. tax legislation. The non-GAAP estimated tax rate is still expected to be approximately 17%.

Based on these changes, EPS guidance increased to the range of $20.85 to $22.10 on a reported basis and $21.75 to $23.00 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 8:30 a.m. Eastern time today and will be available for replay via the website.