On August 5, 2025 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2025 (Press release, Amgen, AUG 5, 2025, View Source [SID1234654776]).

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"We’re delivering strong performance and reaching more patients with innovative medicines and biosimilars that address serious diseases. We continue to invest in science that enables longer, healthier lives and supports sustainable, long-term growth," said Robert A. Bradway, chairman and chief executive officer.

Key results include:

For the second quarter, total revenues increased 9% to $9.2 billion in comparison to the second quarter of 2024.
Product sales grew 9%, driven by 13% volume growth, partially offset by 3% lower net selling price.
Fifteen products delivered at least double-digit sales growth in the second quarter, including Repatha (evolocumab), EVENITY (romosozumab-aqqg), IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab), BLINCYTO (blinatumomab), TEZSPIRE (tezepelumab-ekko), UPLIZNA (inebilizumab-cdon) and TAVNEOS (avacopan).
GAAP earnings per share (EPS) increased 92% from $1.38 to $2.65, primarily driven by higher revenues.
GAAP operating income increased from $1.9 billion to $2.7 billion, and GAAP operating margin increased 6.6 percentage points to 30.3%.
Non-GAAP EPS increased 21% from $4.97 to $6.02, primarily driven by higher revenues, partially offset by higher operating expenses.
Non-GAAP operating income increased from $3.9 billion to $4.3 billion, and non-GAAP operating margin increased 0.7 percentage points to 48.9%.
The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

General Medicine

Repatha (evolocumab) sales increased 31% year-over-year to $696 million in the second quarter, driven by 36% volume growth, partially offset by unfavorable changes to estimated sales deductions.
EVENITY (romosozumab-aqqg) sales increased 32% year-over-year to $518 million in the second quarter, primarily driven by volume growth.
Prolia (denosumab) sales decreased 4% year-over-year to $1.1 billion in the second quarter, driven by lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Rare Disease

TEPEZZA (teprotumumab-trbw) sales increased 5% year-over-year to $505 million in the second quarter, primarily driven by higher inventory levels.
KRYSTEXXA (pegloticase) sales increased 19% year-over-year to $349 million in the second quarter, of which 12% was derived from higher inventory levels and 6% from volume growth.
UPLIZNA (inebilizumab-cdon) sales increased 91% year-over-year to $176 million in the second quarter, driven by 79% volume growth, with 16% derived from higher inventory levels. Year-over-year sales benefited from the timing of shipments to our ex-U.S. partner that occurred in the third quarter of 2024. Excluding these shipments, sales grew by 56% year-over-year in the second quarter.
TAVNEOS (avacopan) sales increased 55% year-over-year to $110 million in the second quarter, driven by volume growth.
Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), QUINSAIR (levofloxacin) and BUPHENYL (sodium phenylbutyrate), generated $183 million of sales in the second quarter. Sales decreased 2% year-over-year for the second quarter, driven by lower net selling price.
Inflammation

TEZSPIRE (tezepelumab-ekko) sales increased 46% year-over-year to $342 million in the second quarter, driven by volume growth.
Otezla (apremilast) sales increased 14% year-over-year to $618 million in the second quarter, driven by 12% favorable changes to estimated sales deductions and 4% volume growth.
Enbrel (etanercept) sales decreased 34% year-over-year to $604 million in the second quarter, driven by 20% unfavorable changes to estimated sales deductions and 19% lower net selling price resulting from increased 340B Program mix and the impact of the U.S. Medicare Part D redesign, partially offset by 3% volume growth.
AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales were flat year-over-year at $133 million in the second quarter.
PAVBLU (aflibercept-ayyh) generated $130 million of sales in the second quarter.
WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $35 million of sales in the second quarter.
Oncology

BLINCYTO (blinatumomab) sales increased 45% year-over-year to $384 million in the second quarter, driven by volume growth.
Vectibix (panitumumab) sales increased 13% year-over-year to $305 million in the second quarter, driven by volume growth.
KYPROLIS (carfilzomib) sales were flat year-over-year at $378 million in the second quarter.
LUMAKRAS/LUMYKRAS (sotorasib) sales increased 6% year-over-year to $90 million in the second quarter, driven by 16% volume growth, partially offset by 10% lower net selling price.
XGEVA (denosumab) sales decreased 5% year-over-year to $532 million in the second quarter, driven by 2% unfavorable changes to estimated sales deductions and volume decline. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Nplate (romiplostim) sales increased 7% year-over-year to $369 million in the second quarter, driven by volume growth.
IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $134 million of sales in the second quarter. Sales increased 65% quarter-over-quarter, driven by volume growth.
MVASI (bevacizumab-awwb) sales increased 22% year-over-year to $191 million in the second quarter, driven by 16% favorable changes to estimated sales deductions, 6% volume growth and 5% higher net selling price, partially offset by lower inventory levels. In the quarter, MVASI benefited from competitor bevacizumab product shortages, and going forward, we expect to return to continued sales erosion driven by competition.
Established Products

Our established products, which consist of Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $533 million of sales in the second quarter. Sales decreased 5% year-over-year for the second quarter, driven by 14% lower net selling price and 4% lower volume, partially offset by favorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q2 ’25

Q2 ’24

YOY Δ

U.S

ROW

TOTAL

TOTAL

TOTAL

Repatha

$ 361

$ 335

$ 696

$ 532

31 %

EVENITY

395

123

518

391

32 %

Prolia

745

377

1,122

1,165

(4 %)

TEPEZZA

466

39

505

479

5 %

KRYSTEXXA

349

—

349

294

19 %

UPLIZNA

132

44

176

92

91 %

TAVNEOS

103

7

110

71

55 %

Ultra-Rare products(1)

175

8

183

187

(2 %)

TEZSPIRE

342

—

342

234

46 %

Otezla

512

106

618

544

14 %

Enbrel

597

7

604

909

(34 %)

AMJEVITA/AMGEVITA

—

133

133

133

— %

PAVBLU

126

4

130

—

N/A

WEZLANA/WEZENLA

—

35

35

—

N/A

BLINCYTO

270

114

384

264

45 %

Vectibix

144

161

305

270

13 %

KYPROLIS

232

146

378

377

0 %

LUMAKRAS/LUMYKRAS

52

38

90

85

6 %

XGEVA

347

185

532

562

(5 %)

Nplate

228

141

369

346

7 %

IMDELLTRA/IMDYLLTRA

107

27

134

12

*

MVASI

142

49

191

157

22 %

Aranesp

107

252

359

348

3 %

Parsabiv

51

41

92

106

(13 %)

Neulasta

63

19

82

105

(22 %)

Other products(2)

278

56

334

378

(12 %)

Total product sales

$ 6,324

$ 2,447

$ 8,771

$ 8,041

9 %

N/A = not applicable

* Change in excess of 100%

(1) Ultra-Rare products consist of RAVICTI, PROCYSBI, ACTIMMUNE, QUINSAIR and BUPHENYL

(2) Consists of Aimovig, KANJINTI, AVSOLA, EPOGEN, RIABNI, BKEMV/BEKEMV, IMLYGIC, NEUPOGEN, Corlanor, RAYOS, DUEXIS, PENNSAID and Sensipar/Mimpara, where Biosimilars total $172 million in Q2 ’25 and $183 million in Q2 ’24

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 1% year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 5.9 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 21% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. Selling, General & Administrative (SG&A) expenses decreased 5% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses. Other operating expenses include litigation expenses.
Operating Margin as a percentage of product sales increased 6.6 percentage points in the second quarter to 30.3%.
Tax Rate increased 2.7 percentage points in the second quarter due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon and current year net unfavorable items, as compared to the prior year.
On a non-GAAP basis:

Total Operating Expenses increased 8% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 0.2 percentage points driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 18% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. SG&A expenses decreased 2% primarily driven by lower commercial product-related expenses.
Operating Margin as a percentage of product sales increased 0.7 percentage points in the second quarter to 48.9%.
Tax Rate decreased 0.7 percentage points in the second quarter due to the change in earnings mix.
$Millions, except percentages

GAAP

Non-GAAP

Q2 ’25

Q2 ’24

YOY Δ

Q2 ’25

Q2 ’24

YOY Δ

Cost of Sales

$ 3,011

$ 3,236

(7 %)

$ 1,551

$ 1,406

10 %

% of product sales

34.3 %

40.2 %

(5.9) pts

17.7 %

17.5 %

0.2 pts

Research & Development

$ 1,744

$ 1,447

21 %

$ 1,685

$ 1,423

18 %

% of product sales

19.9 %

18.0 %

1.9 pts

19.2 %

17.7 %

1.5 pts

Selling, General & Administrative

$ 1,691

$ 1,785

(5 %)

$ 1,650

$ 1,686

(2 %)

% of product sales

19.3 %

22.2 %

(2.9) pts

18.8 %

21.0 %

(2.2) pts

Other

$ 77

$ 11

*

$ —

$ —

N/A

Total Operating Expenses

$ 6,523

$ 6,479

1 %

$ 4,886

$ 4,515

8 %

Operating Margin

Operating income as % of product sales

30.3 %

23.7 %

6.6 pts

48.9 %

48.2 %

0.7 pts

Tax Rate

8.7 %

6.0 %

2.7 pts

14.2 %

14.9 %

(0.7) pts

pts: percentage points

* = Change in excess of 100%

N/A = not applicable

Cash Flow and Balance Sheet

The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by timing of 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
The Company declared a second quarter 2025 dividend on March 4, 2025 of $2.38 per share that was paid on June 6, 2025 to all stockholders of record as of May 16, 2025, representing a 6% increase from the same period in 2024.
The Company retired $1.4 billion of debt during the second quarter of 2025, and $4.3 billion year to date.
During the second quarter of 2025, there were no repurchases of shares of common stock.
Cash and cash equivalents totaled $8.0 billion and debt outstanding totaled $56.2 billion as of June 30, 2025.
$Billions, except shares

Q2 ’25

Q2 ’24

YOY Δ

Operating Cash Flow

$ 2.3

$ 2.5

$ (0.2)

Capital Expenditures

$ 0.4

$ 0.2

$ 0.1

Free Cash Flow

$ 1.9

$ 2.2

$ (0.3)

Dividends Paid

$ 1.3

$ 1.2

$ 0.1

Share Repurchases

$ 0.0

$ 0.0

$ 0.0

Average Diluted Shares (millions)

541

541

0

Note: Numbers may not add due to rounding

$Billions

6/30/25

12/31/24

YTD Δ

Cash and Cash Equivalents

$ 8.0

$ 12.0

$ (3.9)

Debt Outstanding

$ 56.2

$ 60.1

$ (3.9)

Note: Numbers may not add due to rounding

For the full year 2025, the Company expects:

Total revenues in the range of $35.0 billion to $36.0 billion.
On a GAAP basis, EPS in the range of $10.97 to $12.11, and a tax rate in the range of 11.0% to 12.5%.
On a non-GAAP basis, EPS in the range of $20.20 to $21.30, and a tax rate in the range of 14.5% to 16.0%.
Capital expenditures to be approximately $2.3 billion.
Share repurchases not to exceed $500 million.
This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future.

Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

General Medicine

MariTide (maridebart cafraglutide, AMG 133)

MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR).
In June, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85th Scientific Sessions and simultaneously published in the New England Journal of Medicine.
In the Phase 2 study per the efficacy estimand1, MariTide demonstrated:
up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D).
up to ~17% average weight loss in people living with obesity with T2D.
no weight loss plateau by 52 weeks, indicating the potential for further weight reduction.
robust and sustained reduction in hemoglobin A1c (HbA1c) of up to 2.2% in people living with obesity and T2D.
improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP) and select lipid parameters.
No new safety signals were identified in the Phase 2 study and tolerability was consistent with the GLP-1 class. The most frequently reported adverse events (AEs) were gastrointestinal (GI) related, and most were mild to moderate, were predominantly limited to initial dosing and less frequent when dose escalation was used without compromising efficacy.
Discontinuation rates of MariTide due to GI AEs in the dose escalation arms (up to 7.8%) were lower than non-dose escalation arms.
The Phase 1 PK-LDI study showed participants that received 21 mg/70 mg/350 mg had an overall incidence of vomiting of 24.4% and participants that received 35 mg/70 mg/350 mg had an overall incidence of vomiting of 22.5%. There were no discontinuations due to GI AEs at any time during the study.
Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with obesity or overweight, with or without T2D. Data readout is anticipated in Q4 2025.
A Phase 2 study investigating MariTide for the treatment of T2D is ongoing in adults living with and without obesity. Data readout is anticipated in Q4 2025.
MARITIME-1, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, without T2D.
MARITIME-2, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, with T2D.
MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes was initiated and is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, was initiated and is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
The Company is planning to initiate Phase 3 study of obstructive sleep apnea in H2 2025.
AMG 513

A Phase 1 study of AMG 513 is enrolling adults living with obesity.
Repatha

VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Olpasiran (AMG 890)

Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
The OCEAN(a)-outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a first CV event is expected to be initiated in H2 2025/H1 2026.
Rare Disease

UPLIZNA

U.S. Food and Drug Administration (FDA) review of the MINT Phase 3 data in patients with generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025.
TEPEZZA

In June, the European Commission granted marketing authorization approval of TEPEZZA for the treatment of adults with moderate to severe thyroid eye disease (TED). Regulatory review is underway in multiple additional geographies.
A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score TED.
A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab has completed enrollment of patients with TED.
TAVNEOS

A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).
Dazodalibep

Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway. The first study has completed enrollment of patients with moderate-to-severe systemic disease activity. The second study is enrolling patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab

Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
AMG 329

AMG 329 is a fully human monoclonal antibody targeting FMS-like tyrosine kinase 3 (FLT3) ligand.
A Phase 2 study of AMG 329 is ongoing in patients with Sjögren’s disease.
AMG 732

AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
A Phase 2 study of AMG 732 is enrolling patients with moderate-to-severe active TED.
Inflammation

TEZSPIRE

Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
In May, primary results from the Phase 3b WAYFINDER study were presented, showing that TEZSPIRE reduces or eliminates oral cortical steroid (OCS) use in OCS-dependent patients with severe uncontrolled asthma.
FDA review of the WAYPOINT Phase 3 data in patients with chronic rhinosinusitis with nasal polyps is ongoing with a PDUFA date of October 19, 2025.
A Phase 3 study of TEZSPIRE has completed enrollment of patients with eosinophilic esophagitis.
Rocatinlimab (AMG 451/KHK4083)

Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells.
The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies.
Key upcoming milestones from the ROCKET Phase 3 program:
ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
ROCKET ASTRO is a 52-week study of rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Blinatumomab

Blinatumomab is a bispecific T-cell engager (BiTE) molecule targeting CD19.
A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE) and in adults with refractory rheumatoid arthritis.
Inebilizumab

Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis.
AMG 104 (AZD8630)

AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
A Phase 2 study is enrolling patients with asthma.
Oncology

BLINCYTO / blinatumomab

In June, Phase 1b/2 subcutaneous blinatumomab data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in The Lancet Haematology demonstrating 89–92% remission rates (complete remission/complete remission with partial hematological recovery rates/complete remission with incomplete count recovery) and manageable safety in adults with relapsed/refractory CD19-positive Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
The dose-expansion and optimization phase of a Phase 1/2 study of subcutaneous blinatumomab is ongoing in adult patients with relapsed or refractory CD19-positive Ph-negative B-ALL. The Company is planning to initiate a potentially registration-enabling Phase 2 portion of this study in both adults and adolescents in H2 2025.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed CD19-positive Ph-negative B-ALL.
IMDELLTRA / tarlatamab

IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
In June, interim results from the global Phase 3 DeLLphi-304 trial were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper) and simultaneously published in the New England Journal of Medicine. The data showed that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard-of-care (SOC) chemotherapy in patients with small cell lung cancer (SCLC) who progressed on or after one line of platinum-based chemotherapy. Imdelltra significantly improved patient-reported outcomes of dyspnea and cough compared to SOC chemotherapy. The safety profile of IMDELLTRA was consistent with its known profile. Regulatory filing activities are underway.
The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC:
DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC.
DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is enrolling patients with first-line ES-SCLC in the maintenance setting.
DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with LS-SCLC.
DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA in second-line ES-SCLC, is enrolling patients.
DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without a PD-L1 inhibitor, is enrolling patients with ES-SCLC.
DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), was initiated in patients with ES-SCLC.
DeLLphi-312, a Phase 3 study of first-line IMDELLTRA in combination with carboplatin, etoposide and durvalumab, was initiated in patients with ES-SCLC.
Xaluritamig (AMG 509)

Xaluritamig is a first-in-class BiTE targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
XALute, a Phase 3 study of xaluritamig, is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
A Phase 1 study of xaluritamig monotherapy is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy and is ongoing in patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone.
A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
Bemarituzumab

Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
In June, the Company announced the Phase 3 FORTITUDE-101 clinical trial of first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of OS at a pre-specified interim analysis:
Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry testing.
The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.
Detailed results from FORTITUDE 101 will be shared at a future medical meeting.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025/H1 2026.
FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
AMG 193

AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
A Phase 2 study of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract or pancreatic cancers.
Kyprolis

In May, the FDA granted pediatric exclusivity to Kyprolis for studies conducted under a Written Request and approved updates to the "Pediatric Use" subsection of the Kyprolis prescribing information.
LUMAKRAS/LUMYKRAS

In May, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix and FOLFIRI for the first-line treatment of patients with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test. This is the third Breakthrough Therapy Designation granted by the FDA for LUMAKRAS.
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic CRC.
CodeBreaK 202, a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
Nplate

In June, data were presented at ASCO (Free ASCO Whitepaper) from the final analysis of RECITE, a Phase 3 study of Nplate as supportive care for chemotherapy-induced thrombocytopenia (CIT) in gastrointestinal cancers:
the study met its primary endpoint; more patients on Nplate had no chemotherapy dose modifications due to CIT compared to placebo (84.4% vs. 35.7%, Odds Ratio 10.2; P<0.001).
Nplate was well tolerated in a highly comorbid population, with no treatment-related serious adverse events or treatment-related adverse events leading to death or discontinuation of Nplate or chemotherapy.
PROCLAIM, a Phase 3 study of Nplate for the treatment of CIT, is enrolling patients with NSCLC, ovarian cancer, or breast cancer.
Biosimilars

A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) is ongoing in patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) is enrolling patients with early-stage non-squamous NSCLC as adjuvant treatment.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous NSCLC.
A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS (ocrelizumab) is enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective interleukin-2 (IL-2) being developed by Asher Biotherapeutics.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.

1 The efficacy estimand represents the efficacy as if treated participants had adhered to MariTide for the entire 52-week study period. The efficacy estimand includes endpoint data so long as study drug is taken. Where endpoint data is missing with early discontinuation, the endpoint results for the patient are estimated using individual patient response and predicted performance after drug discontinuation.

On August 5, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the second quarter ended June 30, 2025, and recent accomplishments of its "Win-in-MRD" strategy (Press release, Personalis, AUG 5, 2025, View Source [SID1234654792]):

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Second Quarter 2025 and Recent Business Highlights

•
Clinical Adoption Acceleration: Delivered 3,478 clinical tests in the second quarter, a 59% sequential increase over Q1 2025, demonstrating accelerating physician adoption of the NeXT Personal platform

•
Commercial Partnership Expansion: Broadened the strategic collaboration with Tempus AI, Inc. (Tempus) to add colorectal cancer, a major new indication, to the exclusive commercialization agreement, positioning Personalis to win in this attractive market

•
World-Class Clinical Evidence Generation: Presented pivotal data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, including results from the PREDICT and SCANDARE studies showing NeXT Personal’s ability to predict therapy response in breast cancer. Notably, nearly half of all positive detections were found in the ultra-sensitive range

•
Clinical Utility Demonstration: Additional data presented at ASCO (Free ASCO Whitepaper) from the Phase 3 CALLA trial in partnership with AstraZeneca showed NeXT Personal detected cervical cancer progression up to 16 months earlier than standard imaging

"The results of our "Win-in-MRD" strategy are clear, with an impressive 59% sequential growth in our clinical test volume," said Chris Hall, Chief Executive Officer and President of Personalis. "This powerful adoption trend is fueled by a continuous flow of compelling clinical data, like our recent landmark ASCO (Free ASCO Whitepaper) presentations, which prove the unique value of our ultra-sensitive MRD platform in guiding patient care. Steady recognition and growth in the use of our platform continues to support our strategy as we navigate the temporary headwinds in the biopharma sector which have affected our current results. Our fundamental growth engine is accelerating, keeping us firmly on track to achieve our most critical strategic objectives for 2025, including securing Medicare coverage for two indications."

Second Quarter 2025 Financial Results Compared with 2024

•
Revenue of $17.2 million for the second quarter of 2025 compared with $22.6 million, a decrease of 24%, primarily due to the expected decline of $5.6 million in revenue from Natera, and a decrease in revenue from pharma tests and services, and other customers of $2.1 million, partially offset by an increase in population sequencing revenue of $2.0 million

•
Pharma tests and services, and other customers of $11.1 million for the second quarter of 2025 compared with $13.2 million, a decrease of 16%

•
Population sequencing of $3.3 million for the second quarter of 2025 compared with $1.3 million, an increase of 158%

•
Gross margin of 27.6% for the second quarter of 2025 compared with 35.6%, a decrease of 8.0% primarily due to lower revenue volume, customer mix, and increased unreimbursed clinical test costs

•
Net loss of $20.1 million, and net loss per share of $0.23 based on a weighted-average basic and diluted share count of 88.5 million in the second quarter 2025, compared with a net loss of $12.8 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 52.4 million

•
Cash, cash equivalents, and short-term investments of $173.2 million as of June 30, 2025; cash usage of $13.2 million from operations and capital equipment additions in the second quarter of 2025

Third Quarter and Full Year 2025 Outlook

Personalis expects the following for the third quarter of 2025:

•
Total company revenue to be in the range of $12.0 to $14.0 million

•
Revenue from pharma tests and services, and all other customers to be in the range of $11.0 to $13.0 million

•
Revenue from population sequencing and enterprise sales of approximately $1.0 million

Personalis now expects the following for the full year of 2025 (updated guidance):

•
Total company revenue in the range of $70 to $80 million (reduced from $80 to $90 million)

•
Revenue from pharma tests and services, and all other customers in the range of $52 to $58 million (reduced from $62 to $64 million); the lower range is due to variability with biopharma projects and timing of sample receipts

•
Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

•
Revenue from clinical tests reimbursed in the range of $3 to $6 million (narrowed range from $3 to $10 million)

•
Gross margin in the range of 22% to 24%, which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement

•
Net loss of approximately $85 million (increased from $83 million)

•
Cash usage of approximately $75 million, which is an increase from the $47 million used in the full year of 2024 primarily due to investments in the next phase of our "Win-in-MRD" strategy, including growing test volume, expanding clinical evidence generation, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter financial results, as well as plans for 2025, after market close on Tuesday, August 5, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On August 5, 2025 Fapon Biopharma, a biotech in developing therapeutic antibodies and fusion proteins, reported the completion of the first patient enrollment in China for its Phase I clinical trial of FP008 , a first-in-class immunotherapy for solid tumors, at Zhejiang Cancer Hospital (Press release, Fapon Biopharma, AUG 5, 2025, View Source [SID1234654814]). The patient has completed the Dose Limiting Toxicity (DLT) observation period with a favorable safety profile. The trial aims to evaluate the safety and tolerability of FP008 in patients with advanced solid tumors.

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As the latest next generation of immuno-oncology (IO) approach, FP008 is a novel anti-PD-1 × IL-10M fusion protein designed to overcome the limitations of current PD-1 inhibitors by using a proprietary IL-10 mutant that eliminates the toxicity associated with the wild-type protein. It represents a potential new therapeutic option for patients who are refractory to or relapsed from anti-PD-1/PD-L1 therapies. Preclinical studies demonstrated that FP008 significantly reduces PD-1 antibody-mediated CD8⁺ T-cell exhaustion and exhibits potent anti-tumor efficacy. Key findings include:

– Enhanced infiltration of CD8⁺ T-cells into tumors;
– Reduced terminal exhaustion differentiation of CD8⁺ T-cells;
– Increased secretion of IFN-γ and GZMB in terminally exhausted CD8⁺ T-cells.

Additionally, FP008 showed favorable safety and pharmacokinetic (PK) profiles in cynomolgus monkey studies, supporting its clinical potential. FP008 has received Investigational New Drug (IND) approval from both the U.S. FDA and China’s NMPA.

The multi-center Phase I trial in China is led by Zhejiang Cancer Hospital, with two additional sites participating. Professor Zhengbo Song, Principal Investigator at Zhejiang Cancer Hospital, stated: "FP008 offers a promising therapeutic strategy for solid tumor patients resistant to anti-PD-1 antibodies. Its unique mechanism could address a critical unmet clinical need in immuno-oncology. We look forward to further evaluating its safety and efficacy in the clinic."

About FP008

FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation. This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization.

On August 5, 2025 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Biomea Fusion, AUG 5, 2025, View Source [SID1234654777]).

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"In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA, BMF-650, showed encouraging results in a 28-day study in obese cynomolgus monkeys, achieving up to 15% weight reduction and robust dose-dependent appetite suppression. These findings reinforce BMF-650’s potential as an oral GLP-1 RA. With these clinical advances and the completion of our $42.8 million equity financing, we now have the necessary resources to advance these high-priority diabetes and obesity programs."

Second Quarter Highlights:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (T1D))

Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health:
In patients with T2D not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months subsequent to the dosing period, particularly in severe insulin deficient patients enrolled in its Phase II trial; icovamenib was well tolerated across the dosing arms.
In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone:
60% lower fasting blood glucose and 50% lower glucose OGTT AUC
Greater HbA1c decline of >1% by Day 28 and >2% by Day 39
Greater improvement in insulin sensitivity with a 75% lower HOMA-IR (marker of insulin resistance)
2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function
Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone
The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass
Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of 15% at the higher dose of 30 mg/kg/day.
BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations.
These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development and support BMF-650’s potential as a best-in-class oral small-molecule GLP-1 RA.
BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia (AML))

Presented updated Phase I data at EHA (Free EHA Whitepaper) 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib.
The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500.
Financing & Operations

In June 2025, Biomea closed its previously announced underwritten public offering and in July 2025 the underwriters partially exercised their over-allotment option to purchase additional shares of common stock. The aggregate gross proceeds from the offering, including the over-allotment option, were approximately $42.8 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea.

During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately 40% lower than the most recent quarter, depending on study enrollments and expansion.

Key Anticipated 2025 Milestones:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)

52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025.
Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025.
Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

Submission of the IND application for BMF-650 is planned for the second half of 2025.
Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of $56.6 million. The Company expects its cash, cash equivalents, and restricted cash to be sufficient to fund planned operating activities into the second half of 2026.

Net Loss: The Company reported a net loss attributable to common stockholders of $20.7 million for the three months ended June 30, 2025, which included $2.6 million of stock-based compensation, compared to a net loss of $37.3 million for the same period in 2024, which included $4.8 million of stock-based compensation. Net loss attributable to common stockholders was $50.0 million for the six months ended June 30, 2025, which included $5.7 million of stock-based compensation, compared to a net loss of $76.3 million for the same period in 2024, which included $9.9 million of stock-based compensation.

Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024. The decrease of approximately $15.3 million was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount. R&D expenses were $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024. The decrease of $26.1 million was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount.

General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024. The decrease of $2.4 million is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services. G&A expenses were $11.5 million for the six months ended June 30, 2025, compared to $14.4 million for the same period in 2024. The decrease of $2.8 million is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount.

On August 5, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2025 and reaffirmed its 2025 Revenue guidance while raising guidance(1) for Adjusted(2) diluted EPS (Press release, Pfizer, AUG 5, 2025, View Source [SID1234654793]).

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"Pfizer had another strong quarter of focused execution and we’re pleased with our progress in advancing our R&D pipeline, driving our commercial performance and expanding our margins. We continue to strengthen our company for the future and we’re confident in our ability to create further value for patients and our shareholders."
David Denton, CFO and EVP of Pfizer:
"Our robust second-quarter Revenue and EPS performance demonstrates our continued focus on commercial execution and operational efficiency. We raised our full-year 2025 Adjusted diluted EPS guidance, demonstrating confidence in our ability to execute against our strategic priorities and deliver strong results for shareholders."
OVERALL RESULTS
■Second-Quarter 2025 Revenues of $14.7 Billion, Representing 10% Year-over-Year Operational Growth
■Second-Quarter 2025 Reported(3) Diluted EPS of $0.51, and Adjusted(2) Diluted EPS of $0.78
■Reaffirms Full-Year 2025 Revenue Guidance(1) in a Range of $61.0 to $64.0 Billion
■Raises Full-Year 2025 Adjusted(2) Diluted EPS Guidance(1) by $0.10 to a Range of $2.90 to $3.10, which Absorbs a One-Time Impact of Approximately $0.20 Related to 3SBio Transaction
■On Track to Deliver Approximately $7.2 Billion in Overall Anticipated Net Cost Savings from Previously Announced Cost Improvement Initiatives(4) by End of 2027, Driving Productivity Gains and Operating Margin Expansion

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the second quarter and first six months of 2025 and 2024(6) are summarized below.
($ in millions, except per share amounts)
Second-Quarter Six Months
2025 2024
% Change
2025 2024
% Change
Revenues $ 14,653 $ 13,283 10% $ 28,367 $ 28,162 1%
Reported(3) Net Income
2,910 41 * 5,877 3,156 86%
Reported(3) Diluted EPS
0.51 0.01 * 1.03 0.55 86%
Adjusted(2) Income
4,434 3,400 30% 9,671 8,074 20%
Adjusted(2) Diluted EPS
0.78 0.60 30% 1.69 1.42 20%
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Second-Quarter Six Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 14,305 $ 12,991 10% 10% $ 27,746 $ 27,595 1% 1%
Pfizer CentreOne (PC1) 328 278 18% 18% 585 535 9% 10%
Pfizer Ignite 20 15 38% 38% 37 32 16% 16%
TOTAL REVENUES $ 14,653 $ 13,283 10% 10% $ 28,367 $ 28,162 1% 2%
2025 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2025 Revenue guidance and raises Adjusted(2) diluted EPS guidance(1) by $0.10 at the midpoint to a range of $2.90 to $3.10.
■The updated 2025 Adjusted(2) diluted EPS guidance takes into consideration our strong year-to-date performance, continued confidence in our business, a favorable impact from foreign exchange, progress with ongoing cost improvement initiatives, and improvement in our effective tax rate.
–Includes a one-time $1.35 billion Acquired In-Process R&D charge related to the licensing agreement with 3SBio, Inc. that will be recorded in the third quarter of 2025 with an expected unfavorable impact of approximately $0.20.
■The company’s guidance absorbs the impact of the currently imposed tariffs from China, Canada, and Mexico, as well as potential price changes this year based on the letter received on July 31, 2025 from President Trump.
Revenues
$61.0 to $64.0 billion
Adjusted(2) SI&A Expenses
$13.1 to $14.1 billion
(previously $13.3 to $14.3 billion)
Adjusted(2) R&D Expenses
$10.4 to $11.4 billion
(previously $10.7 to $11.7 billion)
Effective Tax Rate on Adjusted(2) Income
Approximately 13.0%
(previously approximately 15.0%)
Adjusted(2) Diluted EPS
$2.90 to $3.10
(previously $2.80 to $3.00)

CAPITAL ALLOCATION
During the first six months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$4.7 billion invested in internal research and development projects, and
•Approximately $150 million invested in business development transactions. Separately, the completed 3SBio transaction will be recorded in third-quarter 2025.
▪Returning capital directly to shareholders through $4.9 billion of cash dividends, or $0.86 per share of common stock.

No share repurchases have been completed to date in 2025. As of August 5, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,706 million and 5,696 million were used to calculate Reported(3) and Adjusted(2) diluted EPS for second-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2025 vs. Second-Quarter 2024)
Second-quarter 2025 revenues totaled $14.7 billion, an increase of $1.4 billion, or 10%, compared to the prior-year quarter, reflecting an operational increase of $1.3 billion, or 10%, as well as a favorable impact of foreign exchange of $22 million. The operational increase was primarily driven by an increase in revenues for the Vyndaqel family, Comirnaty, Paxlovid, Padcev, Eliquis and several other products across categories despite the unfavorable impact of higher manufacturer discounts resulting from the Inflation Reduction Act (IRA) Medicare Part D Redesign.
Second-quarter 2025 operational revenue growth was driven primarily by:
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 21% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign;
▪Comirnaty globally, up 95% operationally, driven primarily by higher net revenues in the U.S. partially due to higher market share, as well as higher contractual deliveries in certain international markets;
▪Paxlovid globally, up 71% operationally, driven primarily by higher net price in the U.S. following the transition from the U.S. government agreement as well as a favorable adjustment of rebate accruals related to prior periods, partially offset by lower COVID-19 infections across the U.S. and certain international markets as well as lower international government purchases;
▪Padcev globally, up 38% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as a one-time favorable impact associated with the transition to a wholesaler distribution model in the U.S.;
▪Eliquis globally, up 6% operationally, driven primarily by higher demand globally; partially offset by lower net price in the U.S., including the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, and price erosion in certain international markets;
▪Abrysvo globally, up 155% (or up $86 million) operationally, driven primarily by higher U.S. revenues from both a favorable net sales adjustment and higher demand for the maternal indication that more than offset ower vaccination rates for the older adult indication following an updated Advisory Committee on Immunization Practices (ACIP) recommendation; as well as launch uptake for both the adult and maternal indications in certain international markets; and
▪Lorbrena globally, up 48% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets, partially offset by lower net price in the U.S. mainly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign;
partially offset primarily by lower revenues for:
▪Ibrance globally, down 8% operationally, driven primarily by lower net price in the U.S. largely due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as generic entry and timing of shipments in certain international markets.
GAAP Reported(3) Statement of Operations Highlights
SELECTED REPORTED(3) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Cost of Sales(3)
$ 3,778 $ 3,300 15% 13% $ 6,624 $ 6,679 (1%) 1%
Percent of Revenues
25.8 % 24.8 % N/A N/A 23.4 % 23.7 % N/A N/A
SI&A Expenses(3)
3,415 3,717 (8%) (8%) 6,446 7,212 (11%) (10%)
R&D Expenses(3)
2,482 2,696 (8%) (8%) 4,685 5,189 (10%) (10%)
Acquired IPR&D Expenses(3)
2 6 (68%) (68%) 11 6 72% 72%
Other (Income)/Deductions—net(3)
739 1,107 (33%) (33%) 1,692 1,787 (5%) —
Effective Tax Rate on Reported(3) Income
4.6 % 130.2 % (0.8 %) 4.8%

Second-quarter 2025 Cost of Sales(3) as a percentage of revenues increased by 0.9 percentage points compared to the prior-year quarter, driven primarily by the non-recurrence of a favorable revision to accrued royalties recorded in the second quarter of 2024, partially offset by lower amortization from the step-up of acquired inventory.
Second-quarter 2025 SI&A Expenses(3) decreased 8% operationally compared with the prior-year quarter, primarily reflecting focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions.
Second-quarter 2025 R&D Expenses(3) decreased 8% operationally compared with the prior-year quarter, driven primarily by a net decrease in spending due to pipeline focus and optimization, as well as lower compensation-related expenses.