Pyxis Oncology Initiates New PYX-201 Combination Trial and Initiates Cohort Expansions of Ongoing Monotherapy Trial

On February 4, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types (Press release, Pyxis Oncology, FEB 4, 2025, View Source [SID1234650030]).

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Two PYX-201 trials are now actively recruiting and are designed to evaluate PYX-201 as monotherapy in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. The combination trial is part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).

The Phase 1/2 combination study, PYX-201-102, is now actively recruiting and is on track to initiate dosing patients in Q1 2025 as planned. This Pyxis Oncology sponsored trial is investigating the novel extracellular targeting ADC PYX-201 in combination with pembrolizumab in multiple indications including but not limited to:


First-line (1L) and second line + (2L+) R/M HNSCC

Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2- BC) breast cancer

Advanced or metastatic triple-negative breast cancer (TNBC)

"PYX-201 is designed to specifically deliver its AUR-0101 payload within the tumor microenvironment (TME) and has been shown to induce immunogenic cell death. When combined with pembrolizumab, PYX-201 may have the potential to enhance the oncologic responses observed with pembrolizumab, by allowing activated T cells to infiltrate TMEs that are often inaccessible and inhospitable," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. Dr. Sullivan continued, "Treatment options for many patients with advanced solid tumors remain limited, and we are eager to explore this promising therapeutic approach."

In addition, the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 PYX-201-101 study have begun enrolling patients. The expansion phase includes the following cohorts across sites in the US, EU and other countries:


PYX-201 monotherapy for 2L and third line (3L) R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy

PYX-201 monotherapy for 2L and 3L R/M HNSCC patients who have received prior EGFR and PD-1 inhibitor therapy

Pyxis Oncology is committed to delivering innovative therapies for cancer patients with limited treatment options. These ongoing trials represent a critical step forward in advancing PYX-201 as a potential breakthrough treatment for a broad range of cancers.

KEYTRUDAis a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About PYX-201-101 Clinical Study

PYX-201-101 (NCT05720117) is an ongoing Phase 1 dose escalation (Part 1) and dose expansion (Part 2) study evaluating PYX-201 monotherapy in participants with advanced solid tumors predicted to express EDB+FN, an extracellular matrix protein that is highly expressed in tumor stroma across several human cancer types.

About PYX-201-102 Clinical Study

PYX-201-102 (NCT06795412) is a Phase 1/2, open-label, global, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201 in combination with pembrolizumab in participants with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including first-line (1L) R/M head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple-negative breast cancer (TNBC), hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) R/M HNSCC are eligible to enroll.

About PYX-201

PYX-201, an antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), is the company’s lead clinical drug candidate.

Pfizer Reports Strong Full-Year 2024 Results And Reaffirms 2025 Guidance

On February 4, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2024 and reaffirmed its 2025 financial guidance(5) provided on December 17, 2024 (Press release, Pfizer, FEB 4, 2025, View Source [SID1234650029]).

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The fourth-quarter 2024 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: "2024 was a strong year of execution and performance for Pfizer in which we met or exceeded our strategic and financial commitments, strengthened our company and, most importantly, reached millions of patients with our medicines and vaccines. We made great progress with commercial execution and achieved growth across our product portfolio for full-year 2024, including $3.4 billion in revenue from our legacy Seagen portfolio, as well as robust growth from the Vyndaqel family, Eliquis, Xtandi, Nurtec, and several other products across all categories.
"I’m excited for what’s ahead and confident that we will enhance shareholder value as we sharpen our focus to improve the productivity of our R&D pipeline and advance the clear strategic priorities guiding our company in 2025."
David Denton, Chief Financial Officer and Executive Vice President, stated: "We are pleased with the 12% operational revenue growth of Pfizer’s non-COVID products in full-year 2024, demonstrating our continued focus on commercial execution. We successfully delivered on our $4 billion net cost savings target from our ongoing cost realignment program, and, as captured in our 2025 financial guidance, we have increased our overall savings target to approximately $4.5 billion by the end of this year. In addition, we remain on track to deliver $1.5 billion of net cost savings from the first phase of our Manufacturing Optimization Program by the end of 2027, with initial savings expected in the latter part of 2025. We remain confident in our ability to return to pre-pandemic operating margins in the coming years."
OVERALL RESULTS
In the first quarter of 2024, Pfizer reclassified royalty income (substantially all of which is related to our Biopharma segment) from Other (income)/deductions––net to revenues and began presenting Royalty revenues as a separate line item within Total revenues in our consolidated statements of operations. Prior-period amounts have been recast to conform to the current presentation.
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(6).
Results for fourth quarter and full year 2024 and 2023(7) are summarized below.
($ in millions, except
per share amounts) Fourth-Quarter Full-Year
2024 2023 Change 2024 2023 Change
Revenues $ 17,763 $ 14,570 22% $ 63,627 $ 59,553 7%
Reported(2) Net Income/(Loss)
410 (3,369) * 8,031 2,119 *
Reported(2) Diluted EPS/(LPS)
0.07 (0.60) * 1.41 0.37 *
Adjusted(3) Income
3,592 593 * 17,716 10,501 69%
Adjusted(3) Diluted EPS
0.63 0.10 * 3.11 1.84 69%
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Fourth-Quarter Full-Year
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 17,413 $ 14,186 23% 22% $ 62,400 $ 58,237 7% 8%
Pfizer CentreOne (PC1)
325 364 (11%) (11%) 1,146 1,272 (10%) (10%)
Pfizer Ignite
26 20 30% 30% 82 44 85% 85%
TOTAL REVENUES $ 17,763 $ 14,570 22% 21% $ 63,627 $ 59,553 7% 7%

2025 FINANCIAL GUIDANCE(5)
Pfizer’s 2025 financial guidance(5) is presented below.
Revenues
$61.0 to $64.0 billion
Adjusted(3) SI&A Expenses
$13.3 to $14.3 billion
Adjusted(3) R&D Expenses
$10.7 to $11.7 billion
Effective Tax Rate on Adjusted(3) Income
Approximately 15.0%
Adjusted(3) Diluted EPS
$2.80 to $3.00

CAPITAL ALLOCATION
In 2024, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvested capital into initiatives intended to enhance the future growth prospects of the company, including:
•$10.8 billion invested in internal research and development projects, and
•Approximately $300 million invested in business development transactions.
▪Returned capital directly to shareholders through $9.5 billion of cash dividends, or $1.68 per share of common stock.
No share repurchases were completed in 2024. As of February 4, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. Pfizer expects to sufficiently de-lever its balance sheet by the end of 2025 in order to return to a more balanced capital allocation strategy. This includes the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
For the fourth quarter of 2024, diluted weighted-average shares outstanding of 5,703 million were used to calculate Reported(2) and Adjusted(3) diluted EPS. For the fourth quarter of 2023, basic weighted-average shares outstanding of 5,647 million were used to calculate Reported(2) LPS and diluted weighted-average shares outstanding of 5,692 million were used to calculate Adjusted(3) diluted EPS.

QUARTERLY FINANCIAL HIGHLIGHTS (Fourth-Quarter 2024 vs. Fourth-Quarter 2023)
Fourth-quarter 2024 revenues totaled $17.8 billion, an increase of $3.2 billion, or 22%, compared to the prior-year quarter, reflecting an operational increase of $3.1 billion, or 21%, primarily due to a one-time, non-cash Paxlovid revenue reversal(8) of $3.5 billion recorded in fourth-quarter 2023 and, to a lesser extent, growth contributions in fourth-quarter 2024 from the legacy Seagen portfolio, the Vyndaqel family, higher Paxlovid sales year-over-year (when excluding the $3.5 billion revenue reversal(8)), higher sales in several other products across all categories, and a favorable impact of foreign exchange of $62 million (or less than 1%); partially offset by a $2.0 billion decline in Comirnaty(1) revenues. Excluding contributions from Paxlovid and Comirnaty(1), fourth-quarter 2024 revenues totaled $13.7 billion, an increase of $1.3 billion, or 11%, operationally compared with the prior-year quarter.
Fourth-quarter 2024 Comirnaty(1) revenues of $3.4 billion decreased $2.0 billion, or 38%, operationally compared with the prior-year quarter, driven primarily by fewer COVID-19 vaccinations globally as well as lower contracted doses.
Fourth-quarter 2024 Paxlovid revenues of $727 million increased $3.9 billion operationally compared with $(3.1) billion of revenues recorded in the prior-year quarter, primarily driven by the transition to traditional commercial market sales in the U.S. including a one-time, non-cash revenue reversal(8) of $3.5 billion recorded in fourth-quarter 2023.
Excluding contributions from Comirnaty(1) and Paxlovid, fourth-quarter 2024 operational revenue growth was driven primarily by:
▪Global revenues of $915 million from legacy Seagen compared with $132 million of revenue in fourth-quarter 2023 following the completion of the acquisition in mid-December 2023;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 60% operationally, driven largely by strong demand with continuing uptake in patient diagnosis, primarily in the U.S. and international developed markets, as well as increased affordability in the U.S.;
▪Eliquis globally, up 13% operationally, driven primarily by continued oral anti-coagulant adoption and market share gains in the non-valvular atrial fibrillation indication in the U.S. and certain markets in Europe, partially offset by declines due to loss of patent-based exclusivity and generic competition in certain international markets;
▪Nurtec ODT/Vydura globally, up 39% operationally, driven primarily by strong demand in the U.S. and, to a much lesser extent, recent launches in international markets, partially offset by lower net price in the U.S. due to unfavorable changes in channel mix; and ▪Xtandi, up 24% operationally, driven primarily by strong demand due to uptake of the non-metastatic castration-sensitive prostate cancer (nmCSPC) indication following approval in the fourth quarter of 2023 and increased affordability in the U.S.;
partially offset primarily by lower revenues for:
▪Abrysvo globally, down 62% operationally, driven primarily by a significant reduction in vaccination rates in the U.S. for the older adult indication as a result of a narrowing market opportunity given the current recommendations from the Advisory Committee on Immunization Practices (ACIP), partially offset by improved market share for the adult indication and strong demand for the maternal indication (launched in December 2023) as well as launch uptake for both indications in certain international markets;
▪Xeljanz globally, down 29% operationally, driven primarily by lower demand globally resulting from ongoing shifts in prescribing patterns related to label changes, as well as lower net price in the U.S. and the impact of regulatory exclusivity expiry in Canada; and
▪Oncology biosimilars globally, down 35% operationally, driven primarily by supply constraints in certain products, as well as both lower demand and lower net price in the U.S. and, to a lesser extent, in certain international markets.

GAAP Reported(2) Statement of Operations Highlights
SELECTED REPORTED(2) COSTS AND EXPENSES
($ in millions) Fourth-Quarter Full-Year
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Cost of Sales(2)
$ 5,909 $ 7,562 (22%) (22%) $ 17,851 $ 24,954 (28%) (28%)
Percent of Revenues
33.3 % 51.9 % N/A N/A 28.1 % 41.9 % N/A N/A
SI&A Expenses(2)
4,274 4,575 (7%) (7%) 14,730 14,771 — —
R&D Expenses(2)
3,035 2,815 8% 8% 10,822 10,679 1% 1%
Acquired IPR&D Expenses(2)
88 73 21% 21% 108 194 (44%) (44%)
Other (Income)/ Deductions—net(2)
2,358 (159) * * 4,388 222 * *
Effective Tax Rate on Reported(2) Income/(Loss)
* 19.2 % (0.4 %) *

* Indicates calculation not meaningful or results are greater than 100%.
Fourth-quarter 2024 Cost of Sales(2) as a percentage of revenues decreased by 18.6 percentage points compared to the prior-year quarter, driven primarily by favorable changes in sales mix as a result of significantly lower sales of Comirnaty(1), which resulted in a lower related charge for the 50% gross profit split with BioNTech and applicable royalty expenses in the quarter; and the favorable year-over-year impact related to the $3.5 billion non-cash Paxlovid revenue reversal(8) recorded in fourth-quarter 2023.
Fourth-quarter 2024 SI&A Expenses(2) decreased 7% operationally compared with the prior-year quarter, driven primarily by a decrease in marketing and promotional spend for various products, including Comirnaty(1) and Paxlovid, partially offset by an increase in spending for certain oncology and recently launched and acquired products.
Fourth-quarter 2024 R&D Expenses(2) increased 8% operationally compared with the prior-year quarter, driven primarily by a net increase in spending mainly to develop certain product candidates acquired from Seagen, as well as increased compensation-related expenses; partially offset by lower spending on certain ongoing vaccine programs and as a result of our cost realignment program.
The unfavorable period-over-period change in Other (income)/deductions—net(2) of $2.5 billion for the fourth quarter of 2024, compared with the prior-year quarter, was driven primarily by (i) lower net gains on equity securities, (ii) net periodic benefit costs associated with pension and postretirement plans incurred in the fourth quarter of 2024 versus net periodic benefit credits incurred in the fourth quarter of 2023 and (iii) higher net interest expense; partially offset by gains on the partial sale of our investment in Haleon plc (Haleon). Included in Other (income)/deductions—net(2) are total non-cash intangible asset impairment charges of $2.9 billion that were taken in the fourth quarter of 2024 due to changes in development plans and updated long-range commercial forecasts.

Pfizer’s effective tax rate on Reported(2) income for the fourth quarter of 2024 is primarily due to changes in the jurisdictional mix of earnings, partially offset by a tax benefit related to the Transition Tax liability under the Tax Cuts and Jobs Act of 2017.
Adjusted(3) Statement of Operations Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions) Fourth-Quarter Full-Year
2024 2023 % Change 2024 2023 % Change
Total Oper. Total Oper.
Adjusted(3) Cost of Sales
$ 5,742 $ 7,265 (21%) (21%) $ 16,420 $ 23,988 (32%) (31%)
Percent of Revenues 32.3 % 49.9 % N/A N/A 25.8 % 40.3 % N/A N/A
Adjusted(3) SI&A Expenses
4,275 4,471 (4%) (4%) 14,617 14,446 1% 2%
Adjusted(3) R&D Expenses
2,986 2,770 8% 8% 10,694 10,568 1% 1%
Adjusted(3) Other (Income)/Deductions—net
234 (494) * * 1,031 (1,224) * *
Effective Tax Rate on Adjusted(3) Income
18.9%
(24.0 %) 14.5 % 9.0 %
* Indicates calculation not meaningful or results are greater than 100%.

See the reconciliations of certain Reported(2) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release.
FULL-YEAR REVENUE SUMMARY (Full-Year 2024 vs. Full-Year 2023)
Full-year 2024 revenues totaled $63.6 billion, an increase of $4.1 billion, or 7%, compared to full-year 2023, reflecting an operational increase of $4.4 billion, or 7%, partially offset by an unfavorable impact of foreign exchange of $349 million, or approximately 1%. Excluding contributions from Comirnaty(1) and Paxlovid, revenues for the full-year grew 12% operationally.
The operational revenue growth compared to the prior year was driven primarily by significantly higher global revenues for Paxlovid largely due to one-time items(8) recorded in the fourth quarter of 2023 and in 2024, the addition of legacy Seagen revenues in full-year 2024 following the acquisition in December 2023, and continued growth from the Vyndaqel family; partially offset by significantly lower revenues for Comirnaty(1).

RECENT NOTABLE DEVELOPMENTS (Since October 29, 2024)
Product Developments
Product/Project
Recent Development
Link
Braftovi (encorafenib)
February 2025. Announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of Braftovi in combination with cetuximab (marketed as Erbitux(9)) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation. The trial showed a statistically significant and clinically meaningful improvement in PFS, one of its dual primary endpoints, as assessed by blinded independent central review (BICR) compared to patients receiving chemotherapy with or without bevacizumab. Further, the Braftovi combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint in the trial. At the time of the objective response rate (ORR) analysis, the safety profile of Braftovi in combination with cetuximab and mFOLFOX6 continued to be consistent with the known safety profile of each respective agent. No new safety signals were identified. These results will be shared with the U.S. Food and Drug Administration (FDA) to support potential conversion to full approval.
Full Release
December 2024. Announced the FDA granted accelerated approval to Braftovi in combination with cetuximab (marketed as Erbitux(9)) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test. Approval was based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with Braftovi in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. Data from the Phase 3 BREAKWATER trial was recently presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium (ASCO GI) and were simultaneously published in Nature Medicine.
Full Release & Full Release
Hympavzi (marstacimab-hncq)
November 2024. Announced the European Commission (EC) granted marketing authorization for Hympavzi for the routine prophylaxis of bleeding episodes in adults and adolescents 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors, or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors.
Full Release
Ibrance (palbociclib)
December 2024. Pfizer and Alliance Foundation Trials, LLC presented results from the Phase 3 PATINA trial demonstrating that the addition of Ibrance to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in PFS by investigator assessment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). The safety and tolerability of Ibrance in the PATINA study was consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative (HER2-) MBC; 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 www.pfizer.com/science/drug-product-pipeline. 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 Recent Development Link
sasanlimab
January 2025. Announced positive topline results from the pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance). The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors.
Full Release
vepdegestrant
December 2024. Arvinas, Inc. and Pfizer presented preliminary data from the ongoing Phase 1b portion of the TACTIVE-U sub-study of vepdegestrant in combination with abemaciclib among patients with locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer at the 2024 San Antonio Breast Cancer Symposium (SABCS). Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity in patients previously treated with a CDK4/6 inhibitor with safety and tolerability of the combination generally consistent with the profile of abemaciclib and what has been observed in other clinical trials of vepdegestrant; no significant drug-drug interactions were observed between vepdegestrant and abemaciclib. The findings support the ongoing Phase 2 portion of the study, which is evaluating full dose abemaciclib 150 mg twice daily (BID) in combination with vepdegestrant 200 mg once daily (QD) in post-CDK4/6 advanced breast cancer.
Full Release

Corporate Developments
Topic Recent Development Link
Executive Leadership
November 2024. Announced Chris Boshoff, M.D., Ph.D., as Chief Scientific Officer and President, Research & Development effective January 1, 2025. In his new role, Dr. Boshoff remains a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Dr. Albert Bourla, and oversees all functions of R&D across all therapeutic areas.

Pfizer’s Oncology R&D organization maintains its fully integrated structure with Roger Dansey, M.D. serving as Interim Chief Oncology Officer, reporting to Dr. Boshoff. Dr. Dansey will assist Dr. Boshoff in selecting a permanent Chief Oncology Officer, after which time he will retire from Pfizer. Dr. Dansey will also facilitate a smooth transition of his responsibilities as Chief Development Officer, Oncology to his successor, Johanna Bendell, M.D., who will join Pfizer from Roche in 2025.
Full Release
Haleon Stock Sale
January 2025. Pfizer sold 700 million ordinary shares of its investment in Haleon to institutional investors for total net consideration of approximately $3.0 billion. After the share sale, Pfizer’s ownership interest in Haleon was reduced from approximately 15% to approximately 7%.
N/A

Topic Recent Development Link
Sangamo Therapeutics
December 2024. Terminated a global collaboration and license agreement with Sangamo Therapeutics, returning development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy candidate for the treatment of adults with moderately severe to severe hemophilia A, to Sangamo. The agreement will terminate effective April 21, 2025, at which time Pfizer will transition the giroctocogene fitelparvovec program back to Sangamo.
N/A
U.S. Commercial Model
December 2024. Announced Pfizer’s Commercial Oncology organization, previously reporting to Chris Boshoff, M.D., Ph.D., will move into Pfizer’s U.S. Commercial organization under Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer effective January 1, 2025, creating a single U.S. commercial division.
N/A

– 10 –

For additional details, see the attached financial schedules, product revenue tables and disclosure notice.
(1)As used in this document, "Comirnaty" refers to, as applicable, and as authorized or approved, the Pfizer-BioNTech COVID-19 Vaccine; Comirnaty (COVID-19 Vaccine, mRNA) original monovalent formula; the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5); the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula); Comirnaty (COVID-19 Vaccine, mRNA) 2023-2024 Formula; Comirnaty (COVID-19 Vaccine, mRNA) 2024-2025 Formula; Comirnaty Original/Omicron BA.1; Comirnaty Original/Omicron BA.4/BA.5; Comirnaty Omicron XBB.1.5; Comirnaty JN.1 and Comirnaty KP.2. "Comirnaty" includes product revenues and alliance revenues related to sales of the above-mentioned vaccines.
(2)Revenues is defined as revenues in accordance with U.S. generally accepted accounting principles (GAAP). Reported net income/(loss) and its components are defined as net income/(loss) attributable to Pfizer Inc. common shareholders and its components in accordance with U.S. GAAP. Reported diluted earnings per share (EPS) and reported diluted loss per share (LPS) are defined as diluted EPS or LPS attributable to Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(3)Adjusted income and Adjusted diluted EPS are defined as U.S. GAAP net income attributable to Pfizer Inc. common shareholders and U.S. GAAP diluted EPS attributable to Pfizer Inc. common shareholders before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items. See the accompanying reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the fourth quarter and full-year 2024 and 2023. Adjusted income and its components and Adjusted diluted EPS measures are not, and should not be viewed as, substitutes for U.S. GAAP net income/(loss) and its components and diluted EPS/(LPS)(2). See the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2023 Annual Report on Form 10-K and the accompanying Non-GAAP Financial Measure: Adjusted Income section of this press release for a definition of each component of Adjusted income as well as other relevant information.
(4)Approximately $4.5 billion of overall net cost savings from Pfizer’s ongoing cost realignment program are expected to be achieved by the end of 2025. The net cost savings are calculated versus the midpoint of Pfizer’s 2023 SI&A and R&D expense guidance provided on August 1, 2023.
(5)Pfizer does not provide guidance for GAAP Reported financial measures (other than revenues) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP Reported financial measures on a forward-looking basis because it is unable to predict with reasonable certainty the ultimate outcome of unusual gains and losses, certain acquisition-related expenses, gains and losses from equity securities, actuarial gains and losses from pension and postretirement plan remeasurements, potential future asset impairments and pending litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP Reported results for the guidance period.
Financial guidance for full-year 2025 reflects the following:
▪Does not assume the completion of any business development transactions not completed as of December 31, 2024.
▪An anticipated unfavorable revenue impact of approximately $0.6 billion due to recent and expected generic and biosimilar competition for certain products that have recently lost patent or regulatory protection or that are anticipated to lose patent or regulatory protection.
▪Exchange rates assumed are actual rates at mid-January 2025.
▪Guidance for Adjusted(3) diluted EPS assumes diluted weighted-average shares outstanding of approximately 5.74 billion shares, and assumes no share repurchases in 2025.
(6)References to operational variances in this press release pertain to period-over-period changes that exclude the impact of foreign exchange rates. Although foreign exchange rate changes are part of Pfizer’s business, they are not within Pfizer’s control and because they can mask positive or negative trends in the business, Pfizer believes presenting operational variances excluding these foreign exchange changes provides useful information to evaluate Pfizer’s results.
(7)Pfizer’s fiscal year-end for international subsidiaries is November 30 while Pfizer’s fiscal year-end for U.S. subsidiaries is December 31. Therefore, Pfizer’s fourth quarter and full year for U.S. subsidiaries reflects the three and twelve months ended on December 31, 2024 and December 31, 2023, while Pfizer’s fourth quarter and full year for subsidiaries operating outside the U.S. reflects the three and twelve months ended on November 30, 2024 and November 30, 2023.
(8)Paxlovid-specific one-time items in fourth-quarter 2023 and in 2024:
▪Fourth-quarter 2023 Paxlovid revenues included a non-cash revenue reversal of $3.5 billion, of which a portion was associated with sales recorded in 2022, related to the expected return of an estimated 6.5 million treatment courses of Emergency Use Authorization (EUA)-labeled U.S. government inventory; and
▪Full-year 2024 Paxlovid revenues include $1.2 billion from two one-time items: (i) a $771 million favorable final adjustment recorded in first-quarter 2024 to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in fourth-quarter 2023, reflecting 5.1 million Emergency Use Authorization (EUA)-labeled treatment courses returned by the U.S. government through February 29, 2024 versus the estimated 6.5 million treatment courses that were expected to be returned as of December 31, 2023; and (ii) $442 million from the fulfillment of our obligated delivery of one million treatment courses to the U.S. Strategic National Stockpile.

PFIZER INC. AND SUBSIDIARY COMPANIES
CONSOLIDATED STATEMENTS OF OPERATIONS(1)
(UNAUDITED)
(millions, except per share data)

Fourth-Quarter % Incr. / Full-Year % Incr. /
2024 2023 (Decr.) 2024 2023 (Decr.)
Revenues:
Product revenues(1), (2)
$ 15,084 $ 12,339 22 $ 53,816 $ 50,914 6
Alliance revenues(1)
2,248 1,910 18 8,388 7,582 11
Royalty revenues(1)
431 321 34 1,423 1,058 35
Total revenues
17,763 14,570 22 63,627 59,553 7
Costs and expenses:
Cost of sales(3)
5,909 7,562 (22) 17,851 24,954 (28)
Selling, informational and administrative expenses(3)
4,274 4,575 (7) 14,730 14,771 —
Research and development expenses(3)
3,035 2,815 8 10,822 10,679 1
Acquired in-process research and development expenses
88 73 21 108 194 (44)
Amortization of intangible assets 1,359 1,267 7 5,286 4,733 12
Restructuring charges and certain acquisition-related costs(4)
750 2,566 (71) 2,419 2,943 (18)
Other (income)/deductions––net(5)
2,358 (159) * 4,388 222 *
Income/(loss) from continuing operations before provision/(benefit) for taxes on income/(loss)
(10) (4,129) (100) 8,023 1,058 *
Provision/(benefit) for taxes on income/(loss)(6)
(421) (795) (47) (28) (1,115) (97)
Income/(loss) from continuing operations
411 (3,335) * 8,051 2,172 *
Discontinued operations––net of tax
7 (26) * 11 (15) *
Net income/(loss) before allocation to noncontrolling interests
418 (3,361) * 8,062 2,158 *
Less: Net income attributable to noncontrolling interests 8 8 (4) 31 39 (20)
Net income/(loss) attributable to Pfizer Inc. common shareholders $ 410 $ (3,369) * $ 8,031 $ 2,119 *
Earnings/(loss) per common share––basic:
Income/(loss) from continuing operations attributable to Pfizer Inc. common shareholders $ 0.07 $ (0.59) * $ 1.42 $ 0.38 *
Discontinued operations––net of tax — — — — — —
Net income/(loss) attributable to Pfizer Inc. common shareholders $ 0.07 $ (0.60) * $ 1.42 $ 0.38 *
Earnings/(loss) per common share––diluted:
Income/(loss) from continuing operations attributable to Pfizer Inc. common shareholders $ 0.07 $ (0.59) * $ 1.41 $ 0.37 *
Discontinued operations––net of tax — — — — — —
Net income/(loss) attributable to Pfizer Inc. common shareholders $ 0.07 $ (0.60) * $ 1.41 $ 0.37 *
Weighted-average shares used to calculate earnings/(loss) per common share:
Basic 5,667 5,647 5,664 5,643
Diluted(7)
5,703 5,647 5,700 5,709

1)The financial statements present the three and twelve months ended December 31, 2024 and December 31, 2023. Subsidiaries operating outside the U.S. are included for the three and twelve months ended November 30, 2024 and November 30, 2023.
Business development activities, including the December 2023 acquisition of Seagen Inc. (Seagen), impacted financial results in the periods presented. See Note 2 to the condensed consolidated financial statements in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended September 29, 2024, as well as Notes 1A and 2 to the consolidated financial statements in Pfizer’s 2023 Annual Report on Form 10-K.
In the first quarter of 2024, we reclassified royalty income from Other (income)/deductions––net and began presenting Royalty revenues as a separate line item within Total revenues in our consolidated statements of operations. Prior-period amounts have been recast to conform to the current presentation.
Certain amounts in the consolidated statements of operations and associated notes may not add due to rounding. All percentages have been calculated using unrounded amounts.
(2)The amount for full-year 2024 includes (i) a $771 million favorable final adjustment recorded in the first quarter to the estimated non-cash Paxlovid revenue reversal of $3.5 billion recorded in the fourth quarter of 2023, reflecting 5.1 million Emergency Use Authorization (EUA)-labeled treatment courses returned by the U.S. government through February 29, 2024 versus the estimated 6.5 million treatment courses that were expected to be returned as of December 31, 2023 and (ii) $442 million of revenue recorded in the third quarter in connection with the creation of a U.S. Strategic National Stockpile of 1.0 million treatment courses of Paxlovid, which we supplied at no cost to the U.S. government or taxpayers. The amounts for 2023 included a non-cash revenue reversal of $3.5 billion recorded in the fourth quarter, of which a portion was associated with sales recorded in 2022, related to the expected return of an estimated 6.5 million treatment courses of EUA-labeled U.S. government inventory. See Note 13C to the condensed consolidated financial statements in Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended September 29, 2024, as well as Note 17C to the consolidated financial statements in Pfizer’s 2023 Annual Report on Form 10-K.
(3)Exclusive of amortization of intangible assets. For full-year 2023, Cost of sales included a non-cash charge of $6.2 billion for inventory write-offs and related charges ($5.0 billion for Paxlovid and $1.2 billion for Comirnaty).
(4)Restructuring charges and certain acquisition-related costs include the following:
Fourth-Quarter Full-Year
(MILLIONS) 2024 2023 2024 2023
Restructuring charges/(credits)––acquisition-related costs(a)
$ 4 $ 190 $ 82 $ 231
Restructuring charges/(credits)––cost reduction initiatives(b)
653 1,613 1,905 1,738
Restructuring charges/(credits)
657 1,803 1,987 1,968
Transaction costs(c)
— 176 5 190
Integration costs and other(d)
94 587 427 785
Restructuring charges and certain acquisition-related costs
$ 750 $ 2,566 $ 2,419 $ 2,943

(a)Includes charges/(credits) for employee terminations, asset impairments and other exit costs associated with business combinations.
(b)Includes charges/(credits) for employee terminations, asset impairments and other exit costs not associated with acquisitions. The charges for the fourth quarter of 2024 primarily represent asset impairments, exit costs and employee termination costs associated with our enterprise-wide cost realignment program. The charges for full-year 2024 mainly represent employee termination costs associated with our Manufacturing Optimization Program, as well as asset impairments and exit costs associated with our enterprise-wide cost realignment program. The fourth quarter and full-year 2023 included charges of $1.5 billion for employee termination costs associated with our enterprise-wide cost realignment program.
(c)Transaction costs represent external costs for banking, legal, accounting and other similar services.
(d)Integration costs and other represent external, incremental costs directly related to integrating acquired businesses, such as expenditures for consulting and the integration of systems and processes, and certain other qualifying costs.

(5)Components of Other (income)/deductions––net include:
Fourth-Quarter Full-Year
(MILLIONS) 2024 2023 2024 2023
Interest income $ (170) $ (609) $ (545) $ (1,624)
Interest expense 739 689 3,091 2,209
Net interest expense(a)
569 80 2,546 585
Net (gains)/losses recognized during the period on equity securities(b)
(879) (2,299) (1,008) (1,590)
Income from collaborations, out-licensing arrangements and sales of compound/product rights (17) (70) (42) (154)
Net periodic benefit costs/(credits) other than service costs 464 (350) 154 (610)
Certain legal matters, net(c)
145 229 567 474
Certain asset impairments(d)
2,946 2,760 3,295 3,024
Haleon equity method (income)/loss
— (151) (102) (505)
Other, net(e)
(869) (357) (1,022) (1,002)
Other (income)/deductions––net $ 2,358 $ (159) $ 4,388 $ 222

(a)The increase in net interest expense in the fourth quarter of 2024 reflects (i) a decrease in interest income due to lower investment balances after completion of our $43.4 billion Seagen acquisition in December 2023 and (ii) higher interest expense driven by the remaining balance of our $8 billion of commercial paper issued from the end of November to early December 2023 as part of the financing for our acquisition of Seagen. The increase in net interest expense for full-year 2024 reflects (i) a decrease in interest income due to lower investment balances after completion of our $43.4 billion Seagen acquisition in December 2023 and (ii) higher interest expense driven by our $31 billion aggregate principal amount of senior unsecured notes issued in May 2023, as well as the remaining balance of the $8 billion of commercial paper issued from the end of November to early December 2023, both part of the financing for our acquisition of Seagen.
(b)The net gains in the fourth quarter and full-year 2024 primarily include, among other things, an unrealized gain of $1 billion related to our investment in Haleon, which is now carried at fair value. The net gains in the fourth quarter and full-year 2023 primarily included, among other things, a realized gain of $1.7 billion related to our investment in Telavant Holdings, Inc.
(c)The fourth quarter and full-year 2024 primarily include certain product liability expenses related to products discontinued and/or divested by Pfizer. The fourth quarter of 2023 primarily included certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer. Full-year 2023 also included legal obligations related to pre-acquisition matters.
(d)The amount for the fourth quarter of 2024 represents, and for full-year 2024 includes, intangible asset impairment charges of $2.9 billion due to changes in development plans and updated long-range commercial forecasts, composed of: (i) $1.0 billion for B7H4V (felmetatug vedotin), an in-process research and development (IPR&D) asset, (ii) $475 million for Medrol, a finite-lived brand, (iii) $435 million for Zavzpret nasal spray developed technology rights, (iv) $400 million and $200 million for Tukysa and disitamab vedotin, respectively, IPR&D assets reflecting emerging competition, as well as (v) other developed technology rights, IPR&D and a finite-lived licensing agreement totaling $436 million which also includes de-prioritization of certain assets. Full-year 2024 also includes a $240 million intangible asset impairment charge related to IPR&D associated with a Phase 3 study for the treatment of Duchenne muscular dystrophy (DMD), which reflects unfavorable clinical trial results. The amount for the fourth quarter of 2023 represented, and for full-year 2023 included, intangible asset impairment charges of $2.8 billion, composed of: (i) $1.4 billion for etrasimod (Velsipity) IPR&D based on a change in development plans for additional indications and overall revenue expectations, (ii) $964 million for Prevnar 13 developed technology rights, due to updated commercial forecasts mainly reflecting a transition to vaccines with higher serotype coverage, as well as (iii) other IPR&D and developed technology impairments totaling $366 million, due to updated commercial forecasts mainly reflecting competitive pressures. Full-year 2023 also included intangible asset impairment charges of $248 million related to IPR&D and developed technology rights.
(e)The amounts for the fourth quarter and full-year 2024 primarily include, among other things, gains of $795 million and $945 million, respectively, on the partial sales of our investment in Haleon plc (Haleon) in March and October 2024. Full-year 2024 also includes, among other things, (i) dividend income of $272 million from our investment in ViiV Healthcare Limited (ViiV) and (ii) a charge of $420 million recorded in the third quarter related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program. Full-year 2023 included, among other things, (i) dividend income of $265 million from our investment in ViiV and $211 million from our investment in Nimbus Therapeutics, LLC (Nimbus) resulting from Takeda Pharmaceutical Company Limited’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary and (ii) a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC.
(6)Our effective tax rates for income/(loss) from continuing operations were 4,220.5% and (0.4)% in the three and twelve months ended December 31, 2024, respectively, and 19.2% and (105.4)% in the three and twelve months ended December 31, 2023, respectively. The decreases in our tax benefits for the fourth quarter and full-year 2024 were primarily due to changes in the jurisdictional mix of earnings partially offset by a tax benefit related to the Transition Tax liability under the Tax Cuts and Jobs Act of 2017. The positive effective tax rate for the fourth quarter of 2024 reflects the tax benefit on a pre-tax loss and includes changes in the jurisdictional mix of earnings and the impact of the aforementioned tax benefit related to the Transition Tax liability. The positive effective tax rate for the fourth quarter of 2023 reflects the tax benefit on a pre-tax loss and included changes in the jurisdictional mix of earnings and the resolution of uncertain tax positions in various markets.
(7)For the fourth quarter of 2023, basic weighted-average shares outstanding of 5,647 million (excluding common share equivalents) were used to calculate GAAP Reported Loss per common share attributable to Pfizer Inc. common shareholders––diluted.

Adjusted income is an alternative measure of performance used by management to evaluate our overall performance as a supplement to our GAAP Reported performance measures. As such, we believe that investors’ understanding of our performance is enhanced by disclosing this measure. We use Adjusted income, certain components of Adjusted income and Adjusted diluted EPS to present the results of our major operations––the discovery, development, manufacture, marketing, sale and distribution of biopharmaceutical products worldwide––prior to considering certain income statement elements as follows:
Measure Definition Relevance of Metrics to Our Business Performance
Adjusted income
Net income attributable to Pfizer Inc. common shareholders(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items
•Provides investors useful information to:
◦evaluate the normal recurring operational activities, and their components, on a comparable year-over-year basis
◦assist in modeling expected future performance on a normalized basis
•Provides investors insight into the way we manage our budgeting and forecasting, how we evaluate and manage our recurring operations and how we reward and compensate our senior management(b)
Adjusted cost of sales, Adjusted selling, informational and administrative expenses, Adjusted research and development expenses and Adjusted other (income)/deductions––net
Cost of sales, Selling, informational and administrative expenses, Research and development expenses and Other (income)/deductions––net (a), each before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items, which are components of the Adjusted income measure
Adjusted diluted EPS
EPS attributable to Pfizer Inc. common shareholders––diluted(a) before the impact of amortization of intangible assets, certain acquisition-related items, discontinued operations and certain significant items

Adjusted income and its components and Adjusted diluted EPS are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, are limited in their usefulness to investors. Because of their non-standardized definitions, they may not be comparable to the calculation of similar measures of other companies and are presented to permit investors to more fully understand how management assesses performance. A limitation of these measures is that they provide a view of our operations without including all events during a period, and do not provide a comparable view of our performance to peers. These measures are not, and should not be viewed as, substitutes for their most directly comparable GAAP measures of Net income attributable to Pfizer Inc. common shareholders, components of Net income attributable to Pfizer Inc. common shareholders and EPS attributable to Pfizer Inc. common shareholders—diluted, respectively.
We also recognize that, as internal measures of performance, these measures have limitations, and we do not restrict our performance-management process solely to these measures. We also use other tools designed to achieve the highest levels of performance. For example, our R&D organization has productivity targets, upon which its effectiveness is measured. In addition, total shareholder return, both on an absolute basis and relative to a publicly traded pharmaceutical index, plays a significant role in determining payouts under certain of our incentive compensation plans.
See the reconciliations of certain GAAP Reported to Non-GAAP Adjusted information for the fourth quarter and full-year 2024 and 2023 below and the Non-GAAP Financial Measure: Adjusted Income section of Management’s Discussion and Analysis of Financial Condition and Results of Operations in Pfizer’s 2023 Annual Report on Form 10-K for additional information.

Fourth-Quarter 2024
Data presented will not (in all cases) aggregate to totals.
Cost of sales(1)
Selling, informational and administrative expenses(1)
Other (income)/deductions––net(1)
Net income/(loss) attributable to Pfizer Inc. common shareholders(1), (2)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported $ 5,909 $ 4,274 $ 2,358 $ 410 $ 0.07
Amortization of intangible assets — — — 1,359
Acquisition-related items (224) 15 (13) 347
Discontinued operations
— — — —
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(3)
(27) (13) — 711
Certain asset impairments(4)
— — (2,946) 2,946
(Gains)/losses on equity securities(4)
— — 879 (879)
Actuarial valuation and other pension and postretirement plan (gains)/losses — — (570) 570
Other(5)
85 (1) 526 (606)
Income tax provision—non-GAAP items (1,265)
Non-GAAP Adjusted $ 5,742 $ 4,275 $ 234
(6)
$ 3,592 $ 0.63

Full-Year Ended December 31, 2024
Data presented will not (in all cases) aggregate to totals.
Cost of sales(1)
Selling, informational and administrative expenses(1)
Other (income)/deductions––net(1)
Net income/(loss) attributable to Pfizer Inc. common shareholders(1), (2)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported $ 17,851 $ 14,730 $ 4,388 $ 8,031 $ 1.41
Amortization of intangible assets — — — 5,286
Acquisition-related items (1,341) (10) (45) 1,938
Discontinued operations
— — — (14)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(3)
(134) (90) — 2,213
Certain asset impairments(4)
— — (3,295) 3,295
(Gains)/losses on equity securities(4)
— — 1,008 (1,008)
Actuarial valuation and other pension and postretirement plan (gains)/losses — — (579) 579
Other(5)
44 (13) (445) 430
Income tax provision—non-GAAP items
(3,035)
Non-GAAP Adjusted $ 16,420 $ 14,617 $ 1,031
(6)
$ 17,716 $ 3.11

Fourth-Quarter 2023
Data presented will not (in all cases) aggregate to totals.
Cost of sales(1)
Selling, informational and administrative expenses(1)
Other (income)/deductions––net(1)
Net income/(loss) attributable to Pfizer Inc. common shareholders(1), (2)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted(7)
GAAP Reported $ 7,562 $ 4,575 $ (159) $ (3,369) $ (0.60)
Amortization of intangible assets — — — 1,267
Acquisition-related items (269) (4) 130 1,097
Discontinued operations
— — — —
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(3)
(28) (94) — 1,777
Certain asset impairments(4)
— — (2,760) 2,760
(Gains)/losses on equity securities(4)
— — 2,298 (2,298)
Actuarial valuation and other pension and postretirement plan (gains)/losses — — 264 (264)
Other(5)
— (6) (268)

276
Income tax provision—non-GAAP items (653)
Non-GAAP Adjusted $ 7,265 $ 4,471 $ (494)
(6)
$ 593 $ 0.10

Full-Year Ended December 31, 2023
Data presented will not (in all cases) aggregate to totals.
Cost of sales(1)
Selling, informational and administrative expenses(1)
Other (income)/deductions––net(1)
Net income/(loss) attributable to Pfizer Inc. common shareholders(1), (2)
Earnings/(loss) per common share attributable to Pfizer Inc. common shareholders––diluted
GAAP Reported $ 24,954 $ 14,771 $ 222 $ 2,119 $ 0.37
Amortization of intangible assets — — — 4,733
Acquisition-related items (629) (11) (28) 1,874
Discontinued operations
— — — (11)
Certain significant items:
Restructuring charges/(credits) and implementation costs and additional depreciation—asset restructuring(3)
(98) (290) — 2,227
Certain asset impairments(4)
— — (3,024) 3,024
(Gains)/losses on equity securities(4)
— — 1,588 (1,588)
Actuarial valuation and other pension and postretirement plan (gains)/losses — — 265 (265)
Other(5)
(238) (24) (246) 518
Income tax provision—non-GAAP items
(2,131)
Non-GAAP Adjusted $ 23,988 $ 14,446 $ (1,224)
(6)
$ 10,501 $ 1.84

(1)Items that reconcile GAAP Reported to non-GAAP Adjusted balances are shown pre-tax. Our effective tax rates for GAAP Reported income/(loss) from continuing operations were 4,220.5% and (0.4)% in the three and twelve months ended December 31, 2024, respectively, and 19.2% and (105.4)% in the three and twelve months ended December 31, 2023, respectively. See Note (6) to the Consolidated Statements of Operations above. Our effective tax rates for non-GAAP Adjusted income were 18.9% and 14.5% in the three and twelve months ended December 31, 2024, respectively, and (24.0)% and 9.0% in the three and twelve months ended December 31, 2023, respectively.
(2)The amounts for the fourth quarters and full-year 2024 and 2023 include reconciling amounts for Research and development expenses that are not material to our non-GAAP consolidated results of operations.
(3)Includes employee termination costs, asset impairments and other exit costs related to our cost-reduction and productivity initiatives not associated with acquisitions.
(4)See Note (5) to the Consolidated Statements of Operations above.
(5)For the fourth quarter and full-year 2024, the total Other (income)/deductions––net adjustments of $526 million and $445 million, respectively, include (i) net gains of $675 million for the fourth quarter and $825 million for full-year on the partial sales of our investment in Haleon plc (Haleon) in March and October 2024, which are comprised of (a) total gains on the sales of $795 million for the fourth quarter and $945 million for full-year less (b) $120 million recognized in our adjusted income in the fourth quarter representing our pro-rata share of Haleon’s third quarter 2024 adjusted income recorded on a one quarter lag and implicitly included in the gain on the sale of those shares; and (ii) charges of $145 million for the fourth quarter and $567 million for full-year for certain legal matters, primarily representing certain product liability expenses related to products discontinued and/or divested by Pfizer. For full-year 2024, the total Other (income)/deductions––net adjustment of $445 million also includes charges of (i) $420 million recorded in the third quarter related to the expected sale of one of our facilities resulting from the discontinuation of our DMD program and (ii) $312 million mostly related to (a) our equity-method accounting pro-rata share of intangible asset amortization, impairments and restructuring costs recorded by Haleon, as well as (b) adjustments to our equity-method basis differences and (c) Pfizer’s share of investee capital transactions recognized by Haleon. For the fourth quarter of 2023, the total Other (income)/deductions––net adjustment of $268 million included charges of $229 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer. For full-year 2023, the total Cost of sales adjustment of $238 million mainly included $286 million in inventory losses, overhead costs related to the period in which the facility could not operate, and incremental costs resulting from tornado damage to our manufacturing facility in Rocky Mount, NC in July 2023, partially offset by insurance recoveries received in the fourth quarter of 2023. For full-year 2023, the total Other (income)/deductions––net adjustment of $246 million included charges of (i) $474 million for certain legal matters, primarily representing certain product liability and other legal expenses related to products discontinued and/or divested by Pfizer, and to a lesser extent, legal obligations related to pre-acquisition matters and (ii) $127 million mostly related to our equity-method accounting pro-rata share of intangible asset amortization and impairments, costs of separating from GSK plc and restructuring costs recorded by Haleon, partially offset by: (i) a $222 million gain on the divestiture of our early-stage rare disease gene therapy portfolio to Alexion Pharma International Operations Limited, a subsidiary of AstraZeneca PLC and (ii) dividend income of $211 million related to our investment in Nimbus Therapeutics, LLC (Nimbus) resulting from Takeda Pharmaceutical Company Limited’s acquisition of Nimbus’s oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor program subsidiary.
(6)The components of non-GAAP Adjusted Other (income)/deductions––net include the following:
Fourth-Quarter Full-Year
(MILLIONS)
2024 2023 2024 2023
Interest income $ (170) $ (609) $ (544) $ (1,624)
Interest expense 741 691 3,100 2,218
Net interest expense
571 82 2,555 595
Net (gains)/losses recognized during the period on equity securities
— (1) — (2)
Income from collaborations, out-licensing arrangements and sales of compound/product rights
(17) (70) (42) (154)
Net periodic benefit costs/(credits) other than service costs (106) (86) (425) (346)
Haleon equity method (income)/loss
— (186) (414) (632)
Other, net (214) (233) (642) (684)
Non-GAAP Adjusted Other (income)/deductions––net
$ 234 $ (494) $ 1,031 $ (1,224)

See Note (5) to the Consolidated Statements of Operations above for additional information on the components comprising GAAP Reported Other (income)/deductions––net.
(7)For the fourth quarter of 2023, basic weighted-average shares outstanding of 5,647 million (excluding common share equivalents) were used to calculate GAAP Reported Loss per common share attributable to Pfizer Inc. common shareholders––diluted.

– 22 –

PFIZER INC. – REVENUES
FOURTH-QUARTER 2024 and 2023 – (UNAUDITED)
WORLDWIDE UNITED STATES
TOTAL INTERNATIONAL
2024
2023(a)
% Change 2024
2023(a)
% Change 2024
2023(a)
% Change
(MILLIONS) Total Oper. Total Total Oper.
TOTAL REVENUES $ 17,763 $ 14,570 22% 21% $ 9,221 $ 4,912 88% $ 8,542 $ 9,657 (12%) (12%)
GLOBAL BIOPHARMACEUTICALS BUSINESS (BIOPHARMA)
$ 17,413 $ 14,186 23% 22% $ 9,114 $ 4,810 89% $ 8,299 $ 9,376 (11%) (12%)
Primary Care $ 8,911 $ 7,044 27% 26% $ 3,983 $ 845 * $ 4,928 $ 6,200 (21%) (21%)
Eliquis(b)
1,832 1,612 14% 13% 1,126 931 21% 705 681 4% 3%
Paxlovid(c)
727 (3,135) * * 435 (3,249) * 293 114 * *
Prevnar family(d)
1,558 1,624 (4%) (4%) 944 1,012 (7%) 614 612 — —
Comirnaty
3,383 5,361 (37%) (38%) 665 1,064 (38%) 2,718 4,297 (37%) (38%)
Nurtec ODT/Vydura 392 282 39% 39% 373 275 36% 20 7 * *
Abrysvo
198 515 (62%) (62%) 104 513 (80%) 94 2 * *
Premarin family
97 98 (1%) (1%) 86 88 (3%) 11 10 14% 12%
BMP2
105 86 23% 23% 105 86 23% — — — —
FSME-IMMUN/TicoVac
34 30 12% 9% — — 23% 34 30 11% 9%
All other Primary Care 584 571 2% 3% 145 124 16% 439 447 (2%) (1%)
Specialty Care $ 4,438 $ 3,953 12% 12% $ 2,079 $ 1,776 17% $ 2,359 $ 2,178 8% 8%
Vyndaqel family(e)
1,545 961 61% 60% 975 534 83% 570 427 33% 32%
Xeljanz
349 493 (29%) (29%) 221 360 (38%) 128 133 (4%) (4%)
Enbrel (Outside the U.S. and Canada)
183 203 (10%) (9%) — — — 183 203 (10%) (9%)
Sulperazon 170 138 23% 21% — — — 170 138 23% 21%
Zavicefta 159 133 20% 22% — — * 159 133 20% 22%
Octagam
109 81 34% 34% 109 81 34% — — — —
Inflectra 127 117 9% 8% 64 63 2% 64 54 17% 16%
Genotropin 112 160 (30%) (29%) 10 47 (78%) 101 112 (10%) (8%)
Zithromax 122 152 (20%) (20%) — — (45%) 122 152 (20%) (20%)
BeneFIX 87 103 (16%) (14%) 43 54 (20%) 44 49 (11%) (8%)
Oxbryta(f)
8 96 (91%) (91%) 2 94 (98%) 6 2 * *
Cibinqo 64 37 72% 71% 29 20 47% 35 18 * 97%
All other Hospital(g)
1,152 1,062 8% 9% 523 443 18% 629 620 2% 2%
All other Specialty Care 250 217 15% 16% 103 80 28% 147 136 8% 9%
Oncology $ 4,064 $ 3,189 27% 27% $ 3,051 $ 2,190 39% $ 1,012 $ 999 1% 1%
Ibrance 1,095 1,118 (2%) (2%) 713 712 — 382 405 (6%) (6%)
Xtandi(h)
565 457 24% 24% 565 457 24% — — — —
Padcev
444 53 * * 433 53 * 11 — * *
Oncology biosimilars(i)
209 322 (35%) (35%) 116 207 (44%) 93 115 (19%) (18%)
Adcetris(j)
285 56 * * 276 56 * 9 — * *
Inlyta
242 263 (8%) (8%) 145 166 (12%) 97 97 — —
Lorbrena 192 146 32% 31% 95 60 58% 97 86 13% 12%
Bosulif 171 182 (6%) (6%) 128 120 7% 44 62 (30%) (30%)
Braftovi/Mektovi
170 131 30% 30% 163 129 26% 7 2 * *
Tukysa
129 18 * * 106 18 * 23 — * *
Elrexfio
57 6 * * 32 4 * 25 2 * *
Tivdak
36 4 * * 34 4 * 2 — * *
Talzenna
27 22 22% 22% 18 16 14% 9 6 44% 42%
All other Oncology
440 411 7% 7% 228 187 22% 212 224 (5%) (6%)
PFIZER CENTREONE(k)
$ 325 $ 364 (11%) (11%) $ 82 $ 83 — $ 243 $ 281 (13%) (14%)
PFIZER IGNITE
$ 26 $ 20 30% 30% $ 26 $ 20 30% $ — $ — * *
BIOPHARMA $ 17,413 $ 14,186 23% 22% $ 9,114 $ 4,810 89% $ 8,299 $ 9,376 (11%) (12%)
PFIZER U.S. COMMERCIAL DIVISION(l) (U.S. Primary Care and U.S. Specialty Care)
$ 6,062 $ 2,620 *
PFIZER ONCOLOGY DIVISION(l)
$ 3,051 $ 2,190 39%
PFIZER INTERNATIONAL COMMERCIAL DIVISION(l)
$ 8,299 $ 9,376 (11%) (12%)
Total Alliance revenues included above $ 2,248 $ 1,910 18% 17% $ 1,641 $ 1,290 27% $ 607 $ 620 (2%) (4%)
Total Royalty revenues included above
$ 431 $ 321 34% 34% $ 429 $ 321 34% $ 2 $ — * *

PFIZER INC. – REVENUES
TWELVE MONTHS 2024 and 2023 – (UNAUDITED)

WORLDWIDE UNITED STATES
TOTAL INTERNATIONAL
2024
2023(a)
% Change 2024
2023(a)
% Change 2024
2023(a)
% Change
(MILLIONS) Total Oper. Total Total Oper.
TOTAL REVENUES $ 63,627 $ 59,553 7% 7% $ 38,691 $ 28,145 37% $ 24,936 $ 31,408 (21%) (19%)
GLOBAL BIOPHARMACEUTICALS BUSINESS (BIOPHARMA)
$ 62,400 $ 58,237 7% 8% $ 38,332 $ 27,749 38% $ 24,068 $ 30,488 (21%) (20%)
Primary Care $ 30,135 $ 30,799 (2%) (2%) $ 18,783 $ 12,680 48% $ 11,352 $ 18,119 (37%) (37%)
Eliquis(b)
7,366 6,747 9% 10% 4,803 4,228 14% 2,563 2,519 2% 3%
Prevnar family(d)
6,411 6,501 (1%) (1%) 4,233 4,265 (1%) 2,178 2,236 (3%) (1%)
Paxlovid(c)
5,716 1,279 * * 4,616 (1,289) * 1,100 2,568 (57%) (57%)
Comirnaty
5,353 11,220 (52%) (53%) 2,004 2,404 (17%) 3,349 8,816 (62%) (62%)
Nurtec ODT/Vydura 1,263 928 36% 36% 1,193 908 31% 69 20 * *
Abrysvo
755 890 (15%) (15%) 594 888 (33%) 160 2 * *
Premarin family
380 397 (4%) (4%) 341 361 (5%) 39 36 8% 9%
BMP2
352 338 4% 4% 352 338 4% — — — —
FSME-IMMUN/TicoVac
280 268 5% 5% 3 3 12% 277 265 5% 5%
All other Primary Care 2,259 2,233 1% 3% 643 576 12% 1,616 1,657 (2%) (1%)
Specialty Care $ 16,652 $ 14,988 11% 12% $ 7,981 $ 6,619 21% $ 8,671 $ 8,370 4% 6%
Vyndaqel family(e)
5,451 3,321 64% 65% 3,547 1,863 90% 1,904 1,458 31% 32%
Xeljanz
1,168 1,703 (31%) (31%) 680 1,154 (41%) 488 549 (11%) (9%)
Enbrel (Outside the U.S. and Canada)
690 830 (17%) (15%) — — — 690 830 (17%) (15%)
Sulperazon 637 757 (16%) (14%) — — — 637 757 (16%) (14%)
Zavicefta 586 511 15% 17% — — * 586 511 15% 17%
Octagam(m)
509 245 * * 509 245 * — — — —
Inflectra 509 490 4% 4% 268 257 4% 241 233 3% 3%
Zithromax 480 406 18% 21% 1 1 (49%) 479 404 18% 21%
Genotropin 470 539 (13%) (10%) 96 153 (37%) 374 386 (3%) 1%
BeneFIX 381 424 (10%) (8%) 200 225 (11%) 181 200 (9%) (5%)
Cibinqo 215 128 69% 70% 90 46 94% 126 81 54% 57%
Oxbryta(f)
201 328 (39%) (39%) 191 323 (41%) 10 5 * *
All other Hospital(g)
4,448 4,514 (1%) — 2,038 2,065 (1%) 2,410 2,450 (2%) —
All other Specialty Care 907 792 15% 17% 363 286 27% 545 506 8% 11%
Oncology $ 15,612 $ 12,450 25% 26% $ 11,567 $ 8,450 37% $ 4,045 $ 4,000 1% 3%
Ibrance 4,367 4,753 (8%) (8%) 2,849 3,151 (10%) 1,518 1,602 (5%) (4%)
Xtandi(h)
2,039 1,659 23% 23% 2,039 1,659 23% — — — —
Padcev
1,588 53 * * 1,561 53 * 27 — * *
Adcetris 1,089 56 * * 1,059 56 * 30 — * *
Oncology biosimilars(i)
1,037 1,407 (26%) (26%) 628 966 (35%) 409 441 (7%) (5%)
Inlyta 978 1,036 (6%) (5%) 588 642 (8%) 391 394 (1%) 1%
Lorbrena 731 539 36% 37% 306 224 36% 424 314 35% 38%
Bosulif 645 645 — 1% 460 444 4% 185 200 (8%) (5%)
Braftovi/Mektovi
607 477 27% 27% 580 465 25% 27 13 * *
Tukysa
480 18 * * 389 18 * 91 — * *
Elrexfio
133 10 * * 88 7 * 45 2 * *
Tivdak
131 4 * * 126 4 * 5 — * *
Talzenna
117 64 83% 83% 88 40 * 30 24 23% 25%
All other Oncology
1,670 1,729 (3%) (2%) 806 720 12% 864 1,009 (14%) (12%)
PFIZER CENTREONE(k)
$ 1,146 $ 1,272 (10%) (10%) $ 278 $ 352 (21%) $ 868 $ 920 (6%) (5%)
PFIZER IGNITE
$ 82 $ 44 85% 85% $ 82 $ 44 85% $ — $ — — —
BIOPHARMA
$ 62,400 $ 58,237 7% 8% $ 38,332 $ 27,749 38% $ 24,068 $ 30,488 (21%) (20%)
PFIZER U.S. COMMERCIAL DIVISION(l) (U.S. Primary Care and U.S. Specialty Care)
$ 26,765 $ 19,299 39%
PFIZER ONCOLOGY DIVISION(l)
$ 11,567 $ 8,450 37%
PFIZER INTERNATIONAL COMMERCIAL DIVISION(l)
$ 24,068 $ 30,488 (21%) (20%)
Total Alliance revenues included above $ 8,388 $ 7,582 11% 11% $ 6,575 $ 5,628 17% $ 1,813 $ 1,955 (7%) (7%)
Total Royalty revenues included above
$ 1,423 $ 1,058 35% 35% $ 1,418 $ 1,058 34% $ 6 $ — * *

NanoCell Therapeutics Announces Upcoming Participation in Investor Conferences

On February 4, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a company developing a non-viral, DNA-based in vivo gene therapy platform, reported that its CEO, Dr. Maurits Geerlings, will attend two upcoming investor conferences: BIO CEO & Investor Conference in New York City (Feb 10-11, 2025) and BIO-Europe Spring in Milan (March 17-19, 2025) (Press release, NanoCell Therapeutics, FEB 4, 2025, View Source [SID1234650028]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During these events, Dr. Geerlings will provide insights into NanoCell’s latest progress, including advancements in NCTX-1, its dual-CAR CD19/CD22 in vivo CAR-T therapy for B cell malignancies, as well as opportunities for strategic partnerships and investment. One-on-one meetings will be held to discuss NanoCell’s pioneering approach to in-vivo CAR-T cell generation using targeted lipid nanoparticles (tLNPs) and the company’s broader vision for revolutionizing adoptive cell therapy.

Conference Details:

BIO CEO & Investor Conference
Date: February 10–11, 2025
Location: New York, NY
Format: 1×1 Meetings

BIO-Europe Spring
Date: March 17–19, 2025
Location: Milan, Italy
Format: 1×1 Meetings

To learn more about our work and stay updated about our latest developments, please visit our website at View Source

Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results

On February 4, 2025 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the fourth quarter of 2024 (Press release, Merck & Co, FEB 4, 2025, View Source [SID1234650027]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We delivered strong growth in 2024, reflecting demand for our innovative portfolio, including for KEYTRUDA, which continues to benefit more patients with cancer globally, the successful launch of WINREVAIR and strong performance of our Animal Health business," said Robert M. Davis, chairman and chief executive officer, Merck. "We’re continuing to progress our pipeline, advance key clinical programs and augment our pipeline through promising business development. Our business remains well positioned thanks to the dedication of our talented global team, and I am more confident than ever in our long-term growth potential."

Financial Summary

$ in millions, except EPS amounts

Fourth Quarter

Year Ended

2024

2023

Change

Change
Ex-Exchange

Dec. 31,
2024

Dec. 31,
2023

Change

Change
Ex-Exchange

Sales

$15,624

$14,630

7%

9%

$64,168

$60,115

7%

10%

GAAP net income (loss)1

3,743

(1,226)

N/M

N/M

17,117

365

N/M

N/M

Non-GAAP net income that excludes certain items1,2*

4,372

66

N/M

N/M

19,444

3,837

N/M

N/M

GAAP EPS

1.48

(0.48)

N/M

N/M

6.74

0.14

N/M

N/M

Non-GAAP EPS that excludes certain items2*

1.72

0.03

N/M

N/M

7.65

1.51

N/M

N/M

*Refer to table on page 9.

N/M – not meaningful

Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.48 for the fourth quarter and $6.74 for the full year of 2024. Non-GAAP EPS was $1.72 for the fourth quarter and $7.65 for the full year of 2024. GAAP and non-GAAP EPS in the fourth quarter of 2024 include a charge of $0.23 per share related to the execution of licensing agreements with LaNova Medicines Ltd. (LaNova) and Hansoh Pharma (Hansoh). GAAP loss per share and non-GAAP EPS in the fourth quarter of 2023 include a charge of $1.69 per share related to a collaboration with Daiichi Sankyo. GAAP and non-GAAP EPS for the full years of 2024 and 2023 include charges of $1.28 and $6.21 per share, respectively, related to certain collaborations, licensing agreements and asset acquisitions.

Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the fourth quarter and full year of 2024 also exclude a benefit due to a reduction in reserves for unrecognized income tax benefits resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years. Non-GAAP EPS for the full year of 2023 also excludes a charge related to settlements with certain plaintiffs in the Zetia antitrust litigation.

Fourth-Quarter Sales Performance

The following table reflects sales of the company’s top products and significant performance drivers.

Fourth Quarter

$ in millions

2024

2023

Change

Change Ex-Exchange

Commentary

Total Sales

$15,624

$14,630

7%

9%

The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases, consistent with practice in that market.

Pharmaceutical

14,042

13,141

7%

8%

Increase driven by growth in oncology and cardiovascular, partially offset by declines in diabetes, vaccines, immunology and virology.

KEYTRUDA

7,836

6,608

19%

21%

Growth driven by continued strong global demand from metastatic indications, including increased uptake in bladder and endometrial cancers, as well as increased global uptake in earlier-stage indications, including triple-negative breast cancer and non-small cell lung cancer (NSCLC). The negative impact of foreign exchange was primarily due to devaluation of Argentine peso, which was largely offset by inflation-related price increases.

GARDASIL/GARDASIL 9

1,550

1,871

-17%

-18%

Decline primarily due to lower demand in China, partially offset by higher demand in most international regions, particularly in Japan.

PROQUAD, M-M-R II and VARIVAX

594

545

9%

9%

Growth primarily due to higher pricing in the U.S. and higher tenders in certain international markets, partially offset by lower demand in the U.S.

JANUVIA/JANUMET

487

787

-38%

-36%

Decline primarily due to lower pricing in the U.S., as well as ongoing generic competition in many international markets and supply constraints in China.

BRIDION

449

429

5%

5%

Growth primarily due to higher demand in the U.S., partially offset by generic competition in certain international markets, particularly in Japan and Europe.

Lynparza*

365

315

16%

18%

Growth primarily due to higher global demand.

Lenvima*

255

226

13%

14%

Growth primarily due to timing of shipments in certain international markets.

PREVYMIS

215

175

23%

23%

Growth primarily due to higher demand in most markets, particularly in the U.S.

WINREVAIR

200

Represents continued uptake since second-quarter launch in the U.S.

VAXNEUVANCE

161

176

-9%

-9%

Decline primarily driven by lower demand in the U.S. due to competition, partially offset by continued uptake from launches in Europe and the Asia Pacific region.

WELIREG

160

72

122%

123%

Growth primarily driven by higher demand in the U.S., largely attributable to ongoing uptake of a new indication.

SIMPONI

171

N/M

N/M

Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024.

Animal Health

1,397

1,278

9%

13%

Growth primarily driven by higher pricing for both Livestock and Companion Animal product portfolios, as well as sales related to July 2024 acquisition of Elanco aqua business and higher demand for Livestock products. Approximately 3 percentage points of the negative impact of foreign exchange were due to devaluation of Argentine peso, which were largely offset by inflation-related price increases.

Livestock

889

808

10%

14%

Growth primarily driven by higher demand for poultry products, sales related to acquisition of Elanco aqua business, as well as higher pricing across the portfolio.

Companion Animal

508

470

8%

10%

Growth primarily driven by higher pricing across the product portfolio. Sales of BRAVECTO were $209 million and $197 million in current and prior year quarters, respectively, which represented growth of 6%, or 10% excluding impact of foreign exchange.

Other Revenues**

185

211

-13%

3%

Decline primarily due to impact of revenue-hedging activities and lower revenues from third-party manufacturing arrangements, partially offset by payments received for out-licensing arrangements and higher royalty income.

*Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

N/M – not meaningful

Full-Year Sales Performance

The following table reflects sales of the company’s top products and significant performance drivers.

Year Ended

$ in millions

Dec. 31, 2024

Dec. 31, 2023

Change

Change Ex-
Exchange

Total Sales

$64,168

$60,115

7%

10%

Pharmaceutical

57,400

53,583

7%

10%

KEYTRUDA

29,482

25,011

18%

22%

GARDASIL/GARDASIL 9

8,583

8,886

-3%

-2%

PROQUAD, M-M-R II and VARIVAX

2,485

2,368

5%

5%

JANUVIA/JANUMET

2,268

3,366

-33%

-29%

BRIDION

1,764

1,842

-4%

-3%

Lynparza*

1,311

1,199

9%

11%

Lenvima*

1,010

960

5%

6%

LAGEVRIO

964

1,428

-33%

-28%

VAXNEUVANCE

808

665

22%

23%

PREVYMIS

785

605

30%

33%

ROTATEQ

711

769

-8%

-7%

SIMPONI**

543

710

-24%

-23%

WELIREG

509

218

133%

133%

WINREVAIR

419

Animal Health

5,877

5,625

4%

8%

Livestock

3,462

3,337

4%

9%

Companion Animal

2,415

2,288

6%

7%

Other Revenues***

891

907

-2%

4%

*Alliance revenue for this product represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Marketing rights in former Merck territories reverted to Johnson & Johnson on Oct. 1, 2024.

***Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

Full-year 2024 pharmaceutical sales grew 7% to $57.4 billion. Excluding the unfavorable impact of foreign exchange, pharmaceutical sales grew 10%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Pharmaceutical sales growth was primarily driven by higher sales in oncology, particularly KEYTRUDA and WELIREG, as well as increased alliance revenue from Reblozyl and Lynparza. Higher sales in the cardiovascular franchise, reflecting the successful launch of WINREVAIR, as well as higher sales of certain hospital acute care products, particularly PREVYMIS, also drove revenue growth in 2024. Pharmaceutical sales growth in 2024 was partially offset by lower sales of JANUVIA and JANUMET, primarily reflecting lower pricing in the U.S. and generic competition in many international markets, lower sales of the COVID-19 medication LAGEVRIO, lower sales of GARDASIL/GARDASIL 9 and lower sales of SIMPONI and REMICADE, reflecting the transfer of marketing rights in former Merck territories back to Johnson & Johnson.

Full-year 2024 Animal Health sales grew 4% to $5.9 billion. Excluding the unfavorable impact of foreign exchange, Animal Health sales grew 8%. Approximately 2 percentage points of the negative impact of foreign exchange were due to devaluation of the Argentine peso, which were largely offset by inflation-related price increases, consistent with practice in that market. Full-year sales growth was primarily driven by higher pricing across both the Companion Animal and Livestock product portfolios, and higher demand for poultry and swine products, as well as sales related to the acquisition of the Elanco aqua business. Sales of BRAVECTO were $1.1 billion in 2024, which represented growth of 6%, or 8% excluding the impact of foreign exchange.

Fourth-Quarter and Full-Year Expense, EPS and Related Information

The table below presents selected expense information.

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs3

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP2

Fourth Quarter 2024

Cost of sales

$3,828

$701

$121

$-

$3,006

Selling, general and administrative

2,864

29

16

2,819

Research and development

4,585

12

(1)

4,574

Restructuring costs

51

51

Other (income) expense, net

126

(31)

152

5

Fourth Quarter 2023

Cost of sales

$3,911

$454

$117

$-

$3,340

Selling, general and administrative

2,804

24

29

2,751

Research and development

9,628

790

8,838

Restructuring costs

255

255

Other (income) expense, net

78

(35)

(61)

174

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs3

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Certain Other Items

Non-
GAAP2

Year Ended December 31, 2024

Cost of sales

$15,193

$2,409

$495

$-

$ –

$12,289

Selling, general and administrative

10,816

117

83

10,616

Research and development

17,938

72

1

17,865

Restructuring costs

309

309

Other (income) expense, net

(24)

(79)

45

10

Year Ended December 31, 2023

Cost of sales

$16,126

$2,018

$211

$-

$-

$13,897

Selling, general and administrative

10,504

86

122

10,296

Research and development

30,531

819

1

29,711

Restructuring costs

599

599

Other (income) expense, net

466

(47)

(279)

573

219

GAAP Expense, EPS and Related Information

Gross margin was 75.5% for the fourth quarter of 2024 compared with 73.3% for the fourth quarter of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs) and higher amortization of intangible assets. Gross margin was 76.3% for the full year of 2024 compared with 73.2% for the full year of 2023. The increase was primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher amortization of intangible assets, as well as higher restructuring costs (primarily reflecting asset impairment charges) and higher manufacturing-related costs (including inventory write-offs).

Selling, general and administrative (SG&A) expenses were $2.9 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. The increase was primarily due to higher promotional and selling costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs. Full-year 2024 SG&A expenses were $10.8 billion, an increase of 3% compared with full-year 2023. The increase was primarily due to higher administrative, promotional, selling and acquisition-related costs, partially offset by the favorable impact of foreign exchange and lower restructuring costs.

Research and development (R&D) expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 52% compared with the fourth quarter of 2023. R&D expenses were $17.9 billion for the full year of 2024, a decrease of 41% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity, lower intangible asset impairment charges, and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending.

Other (income) expense, net, was $126 million of expense in the fourth quarter of 2024 compared with $78 million of expense in the fourth quarter of 2023. The unfavorability was primarily due to net losses from investments in equity securities compared with net income from investments in equity securities in the prior year quarter, partially offset by lower foreign exchange losses and lower net interest expense. Other (income) expense, net, was $24 million of income in the full year of 2024 compared with $466 million of expense in the full year of 2023, primarily due to a $572.5 million charge in 2023 related to settlements with certain plaintiffs in the Zetia antitrust litigation. The favorability was also due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024. Other (income) expense, net, in the full year of 2024 was unfavorably affected by lower net income from investments in equity securities and higher net interest expense compared with 2023.

The effective tax rates of 10.2% and 14.1% for the fourth quarter and full year of 2024, respectively, include a 6.2 percentage point favorable impact and a 2.6 percentage point favorable impact, respectively, due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to certain federal tax return years.

GAAP EPS was $1.48 for the fourth quarter of 2024 compared with a loss per share of $0.48 for the fourth quarter of 2023, primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, and a benefit from the expiration of the statute of limitations for assessments related to the 2020 federal tax return year. GAAP EPS was $6.74 for the full year of 2024 compared with EPS of $0.14 for the full year of 2023. The increase was primarily driven by lower charges for business development transactions, operational strength in the business, lower intangible asset impairment charges, a benefit from the expiration of the statute of limitations for the 2020 and 2019 federal tax return years, and a charge in the prior year for settlements with certain plaintiffs in the Zetia antitrust litigation, partially offset by the unfavorable effect of foreign exchange.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 80.8% for the fourth quarter of 2024 compared with 77.2% for the fourth quarter of 2023. Non-GAAP gross margin was 80.8% for the full year of 2024 compared with 76.9% for the full year of 2023. The non-GAAP gross margin improvements in both the fourth quarter and full year of 2024 were primarily due to the favorable effects of product mix (including lower royalty rates related to KEYTRUDA and GARDASIL/GARDASIL 9) and foreign exchange, partially offset by higher manufacturing-related costs (including inventory write-offs).

Non-GAAP SG&A expenses were $2.8 billion in the fourth quarter of 2024, an increase of 2% compared with the fourth quarter of 2023. Non-GAAP SG&A expenses were $10.6 billion for the full year of 2024, an increase of 3% compared with the full year of 2023. The increases were primarily due to higher promotional and selling costs and, for the full year, higher administrative costs, partially offset by the favorable impact of foreign exchange.

Non-GAAP R&D expenses were $4.6 billion in the fourth quarter of 2024, a decrease of 48% compared with the fourth quarter of 2023. Non-GAAP R&D expenses were $17.9 billion for the full year of 2024, a decrease of 40% compared with the full year of 2023. The declines in both the fourth quarter and full year of 2024 were primarily due to lower charges for business development activity and the favorable impact of foreign exchange, partially offset by increased compensation and benefit costs and higher clinical development spending.

Non-GAAP other (income) expense, net, was $5 million of expense in the fourth quarter of 2024 compared with $174 million of expense in the fourth quarter of 2023. The favorability was primarily due to lower foreign exchange losses and lower net interest expense. Non-GAAP other (income) expense, net, was $10 million of expense in the full year of 2024 compared with $219 million of expense in the full year of 2023. The favorability was primarily due to $170 million of income related to the expansion of an existing development and commercialization agreement with Daiichi Sankyo, as well as lower foreign exchange losses in 2024, partially offset by higher net interest expense.

The non-GAAP effective tax rate was 16.2% for the fourth quarter and 16.8% for the full year of 2024.

Non-GAAP EPS was $1.72 for the fourth quarter of 2024 compared with $0.03 for the fourth quarter of 2023. Non-GAAP EPS was $7.65 for the full year of 2024 compared with EPS of $1.51 for the full year of 2023. The increase in both periods was primarily driven by lower charges for business development transactions and operational strength in the business. The unfavorable effect of foreign exchange partially offset the increase in the full year.

A reconciliation of GAAP to non-GAAP net income (loss) and earnings (loss) per share is provided in the table that follows.

Fourth Quarter

Year Ended

$ in millions, except EPS amounts

2024

2023

Dec. 31, 2024

Dec. 31, 2023

EPS

GAAP EPS

$1.48

$(0.48)

$6.74

$0.14

Difference

0.24

0.51

0.91

1.37

Non-GAAP EPS that excludes items listed below2

$1.72

$0.03

$7.65

$1.51

Net Income (Loss)

GAAP net income (loss)1

$3,743

$(1,226)

$17,117

$365

Difference

629

1,292

2,327

3,472

Non-GAAP net income that excludes items listed below1,2

$4,372

$66

$19,444

$3,837

Excluded Items:

Acquisition- and divestiture-related costs3

$711

$1,233

$2,519

$2,876

Restructuring costs

187

401

888

933

Loss (income) from investments in equity securities

152

(61)

45

(279)

Charge for Zetia antitrust litigation settlements

573

Decrease to net income/increase to net loss before taxes

1,050

1,573

3,452

4,103

Estimated income tax (benefit) expense4

(421)

(281)

(1,125)

(631)

Decrease to net income/increase to net loss

$629

$1,292

$2,327

$3,472

Pipeline and Portfolio Highlights

Merck made important advancements in its broad, diverse pipeline, meeting significant regulatory and clinical milestones throughout the fourth quarter.

In oncology, Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial evaluating the noninferiority of subcutaneous pembrolizumab and berahyaluronidase alfa, in combination with chemotherapy, versus intravenous (IV) KEYTRUDA administered with chemotherapy, for the first-line treatment of adult patients with metastatic NSCLC. Subcutaneous pembrolizumab and berahyaluronidase alfa has the potential to improve the patient experience and increase access for patients and health care providers compared to IV administration.

Merck presented new data across multiple hematologic malignancies at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2024, including promising Phase 2 data for its investigational antibody-drug conjugate zilovertamab vedotin for the treatment of patients with previously untreated diffuse large B-cell lymphoma. With more than 20 abstracts presented, the data showcased Merck’s continued progress in advancing clinical research for its expanding and diverse hematology pipeline.

Merck also achieved several key regulatory milestones in the U.S., Europe, Japan and China. Highlights include the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of certain patients with previously treated advanced or metastatic nonsquamous NSCLC with epidermal growth factor receptor (EGFR) mutations. Additionally, Merck received new approvals for KEYTRUDA-based regimens in Japan and China, as well as for WELIREG and Lynparza in China.

In vaccines and infectious diseases, the FDA accepted the Biologics License Application (BLA) for clesrovimab, an investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season and set a Prescription Drug User Fee Act (PDUFA) date of June 10, 2025. This regulatory milestone marks important progress toward having clesrovimab available in time for the 2025-26 RSV season. The filing was based on results from the pivotal Phase 2b/3 study of clesrovimab in infants for the prevention of RSV that was presented at ID Week 2024. In addition, Merck announced topline results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in adults with virologically suppressed HIV-1 infection, in line with Merck’s commitment to help address the needs of people living with HIV.

In January 2025, Merck also received expanded approval in China for GARDASIL. It is now the first HPV vaccine approved in China for the prevention of certain HPV-related cancers and diseases in males 9-26 years of age. In addition, the European Union’s (EU) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of CAPVAXIVE for pneumococcal vaccination in adults, with a final decision for EU approval expected in the second quarter of 2025.

In cardiovascular disease, Merck announced positive topline results from the Phase 3 ZENITH study, evaluating WINREVAIR in adults with pulmonary arterial hypertension (PAH) with World Health Organization (WHO) Group 1 functional class (FC) III or IV at high risk of mortality. Based on the positive results of an interim analysis, an independent data monitoring committee recommended that the study be stopped early due to overwhelming efficacy. In addition, in January 2025, Merck announced the Phase 3 HYPERION study evaluating WINREVAIR in newly diagnosed adults with PAH with FC II or III at intermediate or high risk of disease progression was also stopped early based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date. All participants in both the ZENITH and HYPERION studies will be offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA.

Merck continued to execute on its business development strategy. The company announced the closing of an exclusive global license for MK-2010, a novel investigational PD-1/VEGF bispecific antibody from LaNova. Merck also entered into an exclusive global license agreement with Hansoh to evaluate MK-4082, an investigational preclinical oral small molecule glucagon-like peptide (GLP-1) receptor agonist.

Notable recent news releases on Merck’s pipeline and portfolio are provided in the table that follows.

Oncology

FDA Granted Breakthrough Therapy Designation to sac-TMT for the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous NSCLC With EGFR Mutations

FDA Granted Priority Review to Merck’s Application for WELIREG for the Treatment of Patients With Advanced Pheochromocytoma and Paraganglioma

(Read Announcement)

Merck Received Positive EU CHMP Opinion for WELIREG as Treatment for Adult Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors and for Certain Previously Treated Adult Patients With Advanced RCC, Based on Results From Phase 2 LITESPARK-004 and Phase 3 LITESPARK-005 Trials

(Read Announcement)

Merck Received Positive EU CHMP Opinion for KEYTRUDA Plus Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Non-Epithelioid Malignant Pleural Mesothelioma, Based on Results From Phase 2/3 IND.227/KEYNOTE-483 Trial

(Read Announcement)

KEYTRUDA Approved in China in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy After Surgery as Adjuvant Treatment for Patients With Resectable Stage II, IIIA or IIIB NSCLC, Based on Results From Phase 3 KEYNOTE-671 Trial

(Read Announcement)

WELIREG Approved in China for Treatment of Adult Patients With Certain Types of VHL Disease-Associated Tumors, Based on Results From Phase 2 LITESPARK-004 Trial

(Read Announcement)

Merck Announced Phase 3 MK-3475A-D77 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Met Primary Endpoints

(Read Announcement)

Merck Announced Phase 3 KEYLYNK-001 Trial Met Primary Endpoint of Progression-Free Survival in Patients With Advanced Epithelial Ovarian Cancer

(Read Announcement)

Lynparza Demonstrated Clinically Meaningful Prolonged Survival Benefit in Early Breast Cancer, Based on Results From Phase 3 OlympiA Trial

(Read Announcement)

Investigational Zilovertamab Vedotin in Combination With R-CHP Demonstrated Complete Response Rate of 100% at 1.75 MG/KG Dose in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma, Based on Results From Phase 2 WaveLINE-007 Trial

(Read Announcement)

Vaccines

Merck Announced FDA Acceptance of BLA for Clesrovimab (MK-1654), an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants From RSV Disease During Their First RSV Season; FDA Set PDUFA Date of June 10, 2025

(Read Announcement)

Merck Received Expanded Approval of GARDASIL for Males in China

(Read Announcement)

Merck Received Positive EU CHMP Opinion for CAPVAXIVE for Pneumococcal Vaccination in Adults

(Read Announcement)

Merck Presented New Data From GARDASIL 9 Studies Reinforcing Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at International Papillomavirus Conference 2024

(Read Announcement)

Cardiovascular

Merck Announced Pivotal Phase 3 ZENITH Trial Evaluating WINREVAIR Met Primary Endpoint at Interim Analysis

(Read Announcement)

Merck Announced Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR Early and Move to Final Analysis

(Read Announcement)

Infectious Diseases

Merck Announced Topline Results From Pivotal Phase 3 Trials Evaluating Investigational, Once-Daily, Oral, Two-Drug, Single-Tablet Regimen of Doravirine/Islatravir (DOR/ISL) for the Treatment of Adults With Virologically Suppressed HIV-1 Infection

(Read Announcement)

Full-Year 2025 Financial Outlook

The following table summarizes the company’s full-year financial outlook.

Full Year 2025

Sales*

$64.1 billion to $65.6 billion

Non-GAAP Gross margin2

Approximately 82.5%

Non-GAAP Operating expenses2**

$25.4 billion to $26.4 billion

Non-GAAP Other (income) expense, net2

$300 million to $400 million expense

Non-GAAP Effective tax rate2

16.0% to 17.0%

Non-GAAP EPS2***

$8.88 to $9.03

Share count (assuming dilution)

Approximately 2.53 billion

*The company does not have any non-GAAP adjustments to sales.

**Includes $300 million for an anticipated milestone payment to LaNova associated with the technology transfer for MK-2010 expected to be completed in 2025. Outlook does not assume any additional significant potential business development transactions.

***Includes expected one-time charge of approximately $0.09 per share related to the $300 million milestone payment to LaNova upon completion of the technology transfer for MK-2010.

Merck has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the company’s future GAAP results.

Merck anticipates full-year 2025 sales to be between $64.1 billion and $65.6 billion, including a negative impact of foreign exchange of approximately 2% at mid-January 2025 exchange rates. This sales range reflects a decision to temporarily pause shipments of GARDASIL/GARDASIL 9 into China beginning February 2025 through at least mid-year.

Merck’s full-year non-GAAP effective income tax rate is expected to be between 16.0% and 17.0%.

Merck expects full-year 2025 non-GAAP EPS to be between $8.88 and $9.03, including a negative impact of foreign exchange of approximately $0.35 per share. This range includes an expected one-time charge of $300 million, or approximately $0.09 per share, related to a milestone payment to LaNova, which will be recognized upon completion of the technology transfer for MK-2010. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations.

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

Earnings Conference Call

Investors, journalists and the general public may access a live audio webcast of the earnings conference call on Tuesday, Feb. 4, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

Lineage Cell Therapeutics to Present at the Oppenheimer 35th Annual Healthcare Lifesciences Conference

On February 4, 2025 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for serious neurological conditions, reported that Brian M. Culley, Lineage’s Chief Executive Officer, will be presenting at the Oppenheimer 35th Annual Healthcare Lifesciences Conference on February 11, 2025 at 12:40pm ET. The conference is being held virtually February 11-12, 2025 (Press release, Lineage Cell Therapeutics, FEB 4, 2025, View Source [SID1234650026]).

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Interested parties can view a replay of the presentation on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.