Palbociclib

Focused Execution Drove 18% Operational Revenue Growth of Launched and Acquired Products (1) Advancing Robust Late-Stage Pipeline, with Several Key Pivotal Readouts Expected Over Next 12 Months Announces Expansion of Productivity Enhancement Initiatives NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2026 and raised its full-year 2026 Revenue guidance by $500 million at the midpoint while reaffirming guidance (2) for Adjusted (3) diluted EPS, which absorbs an impact of approximately $0.10 related to the Innovent Biologics, Inc. transaction. EXECUTIVE COMMENTARY Dr. Albert Bourla, Chairman and CEO of Pfizer: “Pfizer had another strong quarter, delivering on our financial commitments and advancing our strategy. Our launched and acquired products (1) performed well, our obesity program is advancing with meaningful momentum and our oncology portfolio remains a source of strength. I am confident we will create substantial future value for patients and shareholders.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Cecile Guegan, Incoming Interim CFO and EVP of Pfizer: “Our second-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the 18% year-over-year operational revenue growth from our launched and acquired products (1) . Our updated full-year 2026 guidance reflects the continued strength of and confidence in our business.” OVERALL RESULTS Second-Quarter 2026 Revenues of $15.0 Billion, Representing 1% Year-over-Year Operational Growth Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 5% Operationally Revenues of Launched and Acquired Products (1) Grew 18% Operationally Second-Quarter 2026 Reported (4) Loss Per Share of $(0.04), and Adjusted (3) Diluted EPS of $0.77 Reported (4) Loss Per Share Reflects $4.3 Billion in Non-Cash Intangible Asset Impairments Announces Additional Anticipated Productivity Enhancement Savings of $2.5 Billion (5) Associated with Ongoing Initiatives, Expected to be Realized From 2027 Through 2029 Raises Full-Year 2026 Revenue Guidance (2) by $500 Million at the Midpoint to a Range of $60.5 to $62.5 Billion Reaffirms Full-Year 2026 Adjusted (3) Diluted EPS Guidance in a Range of $2.80 to $3.00, which Absorbs an Impact of Approximately $0.10 Related to the Innovent Biologics, Inc. Transaction Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates (6) . Results for the second quarter and first six months of 2026 and 2025 (7) are summarized below. ($ in millions, except per share amounts) Second-Quarter Six Months 2026 2025 % Change 2026 2025 % Change Revenues $ 15,034 $ 14,653 3% $ 29,484 $ 28,367 4% Reported (4) Net Income/(Loss) (248 ) 2,910 * 2,440 5,877 (58%) Reported (4) Diluted EPS/(LPS) (0.04 ) 0.51 * 0.43 1.03 (59%) Adjusted (3) Income 4,440 4,434 —% 8,730 9,671 (10%) Adjusted (3) Diluted EPS 0.77 0.78 —% 1.52 1.69 (10%) * Indicates calculation not meaningful or results are greater than 100%. REVENUES ($ in millions) Second-Quarter Six Months 2026 2025 % Change 2026 2025 % Change Total Oper. Total Oper. Global Biopharmaceuticals Business (Biopharma) $ 14,661 $ 14,305 2% 1% $ 28,822 $ 27,746 4% 2% Pfizer CentreOne 373 348 7% 5% 662 622 7% 3% TOTAL REVENUES $ 15,034 $ 14,653 3% 1% $ 29,484 $ 28,367 4% 2% 2026 FINANCIAL GUIDANCE (2) Raises full-year 2026 Revenue guidance (2) by $500 million at the midpoint to a range of $60.5 to $62.5 billion, from $59.5 to $62.5 billion previously. The 2026 full-year Revenue guidance reflects better than expected performance of the non-COVID products by approximately $1.5 billion and the revised revenue expectation for our COVID-19 products, down to approximately $4 billion from approximately $5 billion previously. Reaffirms full-year 2026 Adjusted (3) diluted EPS guidance (2) in a range of $2.80 to $3.00. The 2026 Adjusted (3) diluted EPS guidance takes into consideration our strong year-to-date performance, continued confidence in our business and progress with ongoing cost improvement initiatives. Absorbs a $650 million Acquired In-Process R&D charge related to the completed licensing agreement with Innovent Biologics, Inc. that will be recorded in the third quarter of 2026 with an expected unfavorable impact of approximately $0.10. Previous 2026 Financial Guidance Anticipated Impact of Non COVID-19 Products Anticipated Impact of COVID- 19 Products Anticipated Impact of Innovent Biologics, Inc. Transaction Revised 2026 Financial Guidance (2) Revenues ($ in billions) $59.5 to $62.5 +$1.5 -$1.0 - $60.5 to $62.5 Midpoint $61.0 $61.5 Adjusted (3) SI&A Expenses ($ in billions) $12.5 to $13.5 $12.5 to $13.5 Adjusted (3) R&D Expenses ($ in billions) $10.5 to $11.5 $10.5 to $11.5 Effective Tax Rate on Adjusted (3) Income ~15.0% ~15.0% Adjusted (3) Diluted EPS $2.80 to $3.00 +$0.10 -$0.10 $2.80 to $3.00 CAPITAL ALLOCATION During the first six months of 2026, 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: $5.3 billion invested in internal research and development projects, and Approximately $170 million invested in business development transactions. In addition, on July 10, 2026, we completed the Innovent Biologics, Inc. transaction, which will be recorded in the third quarter of 2026. Returning capital directly to shareholders through $4.9 billion of cash dividends, or $0.86 per share of common stock. Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy. No share repurchases have been completed to date in 2026. As of August 4, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026. For the second-quarter of 2026, basic weighted-average shares outstanding of 5,699 million were used to calculate Reported (4) LPS and diluted weighted-average shares outstanding of 5,734 million were used to calculate Adjusted (3) diluted EPS. Diluted weighted-average shares outstanding of 5,706 million were used to calculate Reported (4) and Adjusted (3) diluted EPS for second-quarter 2025. QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2026 vs. Second-Quarter 2025) Second-quarter 2026 revenues totaled $15.0 billion, an increase of $381 million, or 3%, compared to the prior-year quarter, reflecting an operational increase of $164 million, or 1%, and a favorable impact of foreign exchange of $217 million. The operational increase was driven by an increase in revenues for Eliquis, Padcev, the Vyndaqel family, Lorbrena and several other products across categories, partially offset by a decline in COVID-19 product revenues and several other products across categories. Excluding contributions from Comirnaty and Paxlovid, revenues for the second quarter grew 5% operationally. Additionally, second-quarter revenues of our Launched and Acquired Products (1) grew 18% operationally. Second-quarter 2026 operational revenue growth was driven primarily by: Eliquis globally, up 19% operationally, driven primarily by higher net price in the U.S. primarily due to pricing dynamics, including lower rebates and channel mix favorability, as well as higher demand globally; partially offset by declines due to generic entry and price erosion in certain international markets; Padcev globally, up 23% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as launch uptake in the cisplatin-ineligible indication for muscle-invasive bladder cancer; partially offset by a one-time favorable impact associated with transition to a wholesaler distribution model in the U.S. in the prior-year quarter; Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 8% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across international markets, as well as improved access in certain international markets. In the U.S., growth was primarily driven by continued market expansion, partially offset by net price erosion as a result of new payer contracts; and Lorbrena globally, up 37% 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 primarily by lower revenues for: Paxlovid globally, down 95% operationally, driven primarily by lower COVID-19 infections across the U.S. and international markets and lower government purchases in certain international markets; and Comirnaty globally, down 34% operationally, driven primarily by a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination. GAAP Reported (4) Statement of Operations Highlights SELECTED REPORTED (4) COSTS AND EXPENSES ($ in millions) Second-Quarter Six Months 2026 2025 % Change 2026 2025 % Change Total Oper. Total Oper. Cost of Sales (4) $ 4,092 $ 3,778 8% 7% $ 7,640 $ 6,624 15% 10% Percent of Revenues 27.2 % 25.8 % N/A N/A 25.9 % 23.4 % N/A N/A SI&A Expenses (4) 3,411 3,415 —% (1%) 6,372 6,446 (1%) (3%) R&D Expenses (4) 2,809 2,482 13% 13% 5,299 4,685 13% 12% Acquired IPR&D Expenses (4) 16 2 * * 153 11 * * Other (Income)/Deductions—net (4) 3,716 739 * * 4,577 1,692 * * Effective Tax Rate on Reported (4) Income/(Loss) 62.4 % 4.6 % 2.1 % (0.8 %) * Indicates calculation not meaningful or results are greater than 100%. Second-quarter 2026 Cost of Sales (4) as a percentage of revenues increased by 1.4 percentage points compared to the prior-year quarter, primarily driven by an unfavorable change in sales mix and higher amortization of the fair value step-up of acquired inventory, primarily driven by the Oxbryta impairment. Second-quarter 2026 SI&A Expenses (4) decreased 1% operationally compared to the prior-year quarter, primarily reflecting lower spending in corporate enabling functions, largely offset by an increase in implementation costs associated with our cost realignment program. Second-quarter 2026 R&D Expenses (4) increased 13% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates, which was anticipated. Other (income)/deductions—net (4) was $3.7 billion for the second quarter of 2026. The increase compared to the prior-year quarter is primarily the result of intangible asset impairment charges, and to a lesser extent, charges for certain legal matters, partially offset by a net gain in 2026 from the sale of our previous investment in ViiV Healthcare Limited. Pfizer’s higher effective tax rate on Reported (4) loss for the second quarter of 2026 reflects a tax benefit on the pre-tax loss resulting from changes in jurisdictional mix of earnings, primarily due to intangible asset impairments. Adjusted (3) Statement of Operations Highlights SELECTED ADJUSTED (3) COSTS AND EXPENSES ($ in millions) Second-Quarter Six Months 2026 2025 % Change 2026 2025 % Change Total Oper. Total Oper. Adjusted (3) Cost of Sales $ 3,656 $ 3,503 4% 3% $ 7,061 $ 6,096 16% 10% Percent of Revenues 24.3 % 23.9 % N/A N/A 23.9 % 21.5 % N/A N/A Adjusted (3) SI&A Expenses 3,344 3,395 (1%) (3%) 6,259 6,404 (2%) (4%) Adjusted (3) R&D Expenses 2,730 2,438 12% 12% 5,164 4,611 12% 11% Acquired IPR&D Expenses (3) 16 2 * * 153 11 * * Adjusted (3) Other (Income)/Deductions—net 108 186 (42%) (35%) 496 431 15% 11% Effective Tax Rate on Adjusted (3) Income 14.1 % 13.2 % 15.5 % 10.3 % * Indicates calculation not meaningful or results are greater than 100%. See the reconciliations of certain Reported (4) to non-GAAP Adjusted (3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below. RECENT NOTABLE DEVELOPMENTS (Since May 5, 2026) Product Developments Product/Project Milestone Recent Development Link Braftovi (encorafenib) Phase 3 Results May 2026. Announced detailed progression-free survival (PFS) and overall survival (OS) results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated mCRC with a BRAF V600E mutation. Results for the key secondary endpoint of PFS by blinded independent central review showed a clinically meaningful and statistically significant 56% reduction in the risk of disease progression or death was observed for patients treated with the Braftovi combination regimen versus the comparator (Hazard Ratio [HR] of 0.44; 95% Confidence Interval [CI], 0.27–0.70; p=0.0002). Updated OS, a descriptive secondary endpoint, showed a 44% reduction in the risk of death for patients treated with the Braftovi combination regimen versus the comparator (HR of 0.56; 95% CI, 0.34–0.94) with a median follow-up of approximately 20 months for both arms. The safety pro Braftovi in combination with cetuximab and FOLFIRI in the Cohort 3 analysis continued to be consistent with the known safety pro each respective agent in the regimen, and no new safety signals were identified. Full Release Comirnaty (COVID-19 Vaccine, mRNA) Regulatory July 2026 . Pfizer and BioNTech announced the European Commission (EC) granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. Full Release Regulatory May 2026. Pfizer and BioNTech announced the European Commission approved an update to the marketing authorization for the companies’ COVID-19 vaccine for children aged 6 months through 4 years. With this authorization, the vaccine will be administered as a 10-μg dose for all children aged 6 months through 11 years and reduces the primary vaccination series in this age group to two doses. Full Release Hympavzi (marstacimab) Regulatory June 2026. Announced the U.S. Food and Drug Administration (FDA) approved an expanded indication for Hympavzi to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. Full Release Regulatory May 2026. Announced the European Commission granted marketing authorization to expand the approved indication for Hympavzi to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. Hympavzi is the only once-weekly subcutaneous treatment approved in the European Union for both people living with hemophilia A or B, with or without inhibitors. Full Release Ibrance (palbociclib) Regulatory June 2026. Announced FDA approval of Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment based on data from the collaborative Phase 3 PATINA trial. With this approval, Ibrance is the first and only CDK 4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status. Full Release Litfulo (ritlecitinib) Phase 3 Results July 2026. Announced positive topline results from two Phase 3 trials evaluating the efficacy and safety of Litfulo once daily in patients with both active and stable nonsegmental vitiligo (NSV) and who had a broad range of disease severity. The TRANQUILLO study included patients aged 12 years and older, while TRANQUILLO 2 enrolled adults only. Across the studies, both the 50 and 100 milligram doses of Litfulo delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body Vitiligo Area Scoring Index, or VASI. The safety pro Litfulo in NSV was consistent with the established safety pro alopecia areata. No new safety signals were observed. Based on these results, Pfizer intends to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for NSV for adults. Full Release Lorbrena (lorlatinib) Phase 3 7-Year Analysis May 2026. Announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial evaluating Lorbrena versus Xalkori in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). At seven years, patients treated with Lorbrena had a 55% likelihood of remaining alive without disease progression (95% CI, 46-63) compared to 3% (95% CI, 1-8) in the Xalkori treatment arm. An updated analysis at seven years of median follow-up showed that investigator-assessed median PFS had not been reached with Lorbrena, with an estimated HR of 0.19 (95% CI, 0.13-0.26), representing an 81% reduction in the risk of disease progression or death compared to Xalkori. The safety profiles of Lorbrena and Xalkori were consistent with previous findings, with no new safety signals observed. Full Release Padcev (enfortumab vedotin) Regulatory July 2026. Pfizer and Astellas Pharma Inc. announced FDA approval of Padcev plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility. Approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) and marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility. Full Release Talzenna (talazoparib) Regulatory July 2026 . Announced the FDA accepted for priority review a supplemental New Drug Application (sNDA) for Talzenna in combination with Xtandi which aims to expand use to men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The application is supported by data from the TALAPRO-3 study. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026. Full Release Phase 3 Results May 2026. Announced detailed results from the pivotal, investigational Phase 3 TALAPRO-3 study of Talzenna in combination with Xtandi in men with HRR gene-mutated mCSPC, also known as mHSPC. Talzenna plus Xtandi demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus Xtandi (HR of 0.48; 95% CI, 0.36–0.65; p ˂ 0.0001). At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% in patients treated with Talzenna plus Xtandi versus 56% in patients treated with placebo plus Xtandi. The safety pro Talzenna plus Xtandi in TALAPRO-3 was consistent with the known profiles of each medicine, and no new safety signals were identified. Full Release Pipeline Developments A comprehensive update of Pfizer’s development pipeline was published today and is now available at . It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration. Product/Project Milestone Recent Development Link berobenatide (PF’3944) Phase 2 Results June 2026. Presented detailed results from multiple Phase 2b studies of berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide. Across both weekly and monthly dosing in participants with obesity or overweight, with and without type 2 diabetes, the data from the Phase 2b VESPER-1, 2 and 3 studies provided proof of concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide that can deliver competitive weight loss; showed favorable tolerability for berobenatide, including low gastrointestinal adverse events and discontinuations despite rapid dose escalation and no allowed step-down; and highlighted the potential for monthly delivery in a patient-friendly presentation with a very low 0.5 mL injection volume that provides convenience and scalability advantages. These data support Pfizer’s plans to advance 10 Phase 3 studies for berobenatide in 2026 for chronic weight management and obesity-related comorbidities including knee osteoarthritis and obstructive sleep apnea, as part of a broader program of 20+ obesity trials. Full Release PF-07872412 (25-valent pneumococcal conjugate vaccine candidate) Phase 2 Results May 2026. Announced data from the Phase 2 study (NCT06524414) evaluating the safety, tolerability and immunogenicity of a four-dose series of an investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) in infants compared to four doses of Prevnar 20 at months 2, 4, 6 and 12-15. The Phase 2 data demonstrated robust immunogenicity with 25vPnC, including enhanced response against serotype 3, alongside expanded protection across 25 serotypes and was well-tolerated with no safety concerns identified. Based on the results from the Phase 2 program and discussions with regulatory authorities, a pivotal Phase 3 pediatric program began in May 2026. Also announced a fifth generation 35-valent vaccine adult candidate is expected to enter clinical development by the end of 2026, pending alignment with regulatory authorities. Full Release sigvotatug vedotin Phase 3 Results June 2026. Announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous NSCLC who had received one or more lines of prior therapy. In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of OS compared to docetaxel. The safety pro sigvotatug vedotin was manageable and consistent with prior studies. In patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and PFS for sigvotatug vedotin over docetaxel. In the exploratory analysis, no clear IB6 expression-response relationship was observed. Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors. Full Release Contacts Media PfizerMediaRelations@Pfizer.com 212.733.1226 Investors IR@Pfizer.com Read full story here