PFIZER INC

A comprehensive update of Pfizer’s development pipeline was published as of July 30, 2024 and is available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of our 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.

This section provides information as of the date of this filing about significant marketing application-related regulatory actions by, and filings pending with, the FDA and regulatory authorities in the EU and Japan.

The table below includes filing and approval milestones for products that have occurred in the last twelve months and generally does not include approvals that may have occurred prior to that time. The table includes filings with regulatory decisions pending (even if the filing occurred outside of the last twelve-month period).

Products

*For the U.S., the filing date is the date on which the FDA accepted our submission. For the EU, the filing date is the date on which the EMA validated our submission.

(a)In September 2023, Pfizer and BioNTech announced the FDA granted EUA for the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 6 months through 4 years of age and 5 through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)).

(b)In September 2023, Pfizer and BioNTech announced the FDA approved a regulatory application for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for individuals 12 years of age and older (Comirnaty (COVID-19 Vaccine, mRNA, 2023-2024 Formula)).

(c)For EU, approved indications are pneumococcal invasive disease pneumonia and otitis media. For Japan, approved indication is invasive pneumococcal disease.

(d)Pierre Fabre is the Marketing Authorization Holder for Braftovi (encorafenib) and Mektovi (binimetinib) in the EU.

(e)Listed indication applies to U.S. only. EU indication (all comers): mCRPC in whom chemotherapy is not clinically indicated; Japan indication: BRCA gene-mutated mCRPC.

(f)Being developed in collaboration with Spark Therapeutics, Inc. As of July 2024, Durveqtix has received Conditional Marketing Authorization in the EU.

(g)Being developed in collaboration with Astellas.

(h)Being developed in collaboration with AbbVie. AbbVie has the exclusive commercialization rights to this investigative therapy in the U.S. and Canada; Pfizer leads the joint development program and has commercialization rights in all other countries.

(i)Being developed in collaboration with Astellas.

(j)Keytruda® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

(k)Being developed in collaboration with Genmab A/S.

(l)April 2024 approval date in the U.S. refers to the conversion of a prior accelerated approval to full approval

(m)Being developed in collaboration with OPKO Health, Inc.

(n)Being developed in collaboration with Takeda. Takeda has ex-U.S./Canada rights.

The following provides information about additional indications and new drug candidates in late-stage development:

(a)Being developed in collaboration with The Alliance Foundation Trials, LLC.

(b)Erbitux is a registered trademark of ImClone LLC. In the EU, we are developing in collaboration with the Pierre Fabre Group. In Japan, we are developing in collaboration with Ono Pharmaceutical Co., Ltd.

(c)Being developed in collaboration with BMS.

(d)Being developed in collaboration with Astellas.

(e)Being developed in collaboration with Sangamo Therapeutics, Inc.

(f)Being developed in collaboration with Valneva SE.

(g)Vepdegestrant is being developed in collaboration with Arvinas, Inc.

(h)Being developed in collaboration with RemeGen Co., Ltd.

(i)Being developed in collaboration with BioNTech.

CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with DMD did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo. Key secondary endpoints, including 10-meter run/walk velocity and time to rise from floor velocity, also did not show a significant difference between participants treated with fordadistrogene movaparvovec and placebo. A decision to cease development of fordadistrogene movaparvovec has been endorsed, and it has been removed from the table above.

In July 2024, the EMA initiated a referral procedure under Article 20 of Regulation (EC) No 726/2004 for Oxbryta (voxelotor). This review relates to a potential safety concern arising from observations in two ongoing clinical trials. The EMA will assess the information from these studies, taking into account all the available data on the benefits and risks of Oxbryta. Pfizer will be working with the EMA throughout the review process, and with other regulators globally in relation to this matter.

For additional information about our R&D organization, see Note 13 and the Item 1. Business—Research and Development section of our 2023 Form 10-K. For additional information regarding certain collaboration arrangements see the Item 1. Business—Collaboration and Co-Promotion Agreements section of our 2023 Form 10-K.