A Letter from Our Chairman & CEO
To Our Shareholders:
A little more than four years ago, Pfizer unveiled a new purpose: Breakthroughs that change patients’ lives. Pfizer has always had a noble purpose rooted in our commitment to patients, but we wanted to make our purpose more memorable, more inspiring and, most important, more actionable.
I am happy to say that in the 50 months since then, Pfizer’s more than 80,000 colleagues around the world have lived this purpose every day. They have pursued impactful breakthroughs with the goal of dramatically changing the lives of patients for the better. As a result of this unwavering commitment to innovation and patients, 2022 was a simply remarkable year for our company on multiple fronts.
- We secured eight key regulatory approvals, completed 13 regulatory submissions and initiated 10 pivotal study starts, as we continue to advance our robust R&D pipeline of potential breakthrough medicines and vaccines.
- We maintained our industry-leading clinical success rates 1 and further improved our cycle times, which already were among the industry’s best,2 and we did all of this while maintaining our high standards of quality, safety and scientific rigor.
- We completed four acquisitions – Arena Pharmaceuticals, Biohaven Pharmaceuticals, Global Blood Therapeutics, and ReViral – which have further strengthened both our pipeline and our current portfolio of innovative offerings for patients.
- We were named to 10 different “best employer” lists, including those published by Forbes, LinkedIn, Glassdoor, and others.
- We exceeded $100 billion in revenues for the first time in our 174-year history.
- And, most important, more than 1.3 billion patients around the world were treated with our medicines and vaccines.3 A truly humbling achievement.
Maintaining Our COVID-19 Leadership
During the year, we also continued to lead the battle against COVID-19. As the virus continued to evolve, Pfizer scientists were up to the challenge – using our flexible mRNA platform to swiftly create a new vaccine candidate based on the emerging Omicron BA.4 and BA.5 subvariants. By September, our BA.4/BA.5-adapted bivalent vaccine had been authorized by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a booster dose for ages 12 years and older. By November, both agencies had authorized it for 5 years of age and older. Then in December, the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine received FDA authorization as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.
We are proud to have maintained our leadership position throughout the public health booster campaign. As of February 22, 2023, we held a 64% market share of bivalent boosters in the U.S. 4 – which is a significant expansion on the booster share leadership position that we already held before the bivalent booster launch – and our bivalent booster market shares are even higher in several key markets outside the U.S. We believe our best-in-class mRNA capability, coupled with our proven and reliable manufacturing network, will ensure we are well positioned to continue to adapt our vaccine as needed and get it to people around the world.
Our COVID-19 oral treatment, PAXLOVID ® (nirmatrelvir tablets and ritonavir tablets), has shown to be an important complementary tool to vaccination strategies for the estimated 40% of the global population at high risk for progressing to severe disease.5 PAXLOVID has demonstrated robust efficacy, a consistent safety profile, and potential to help mitigate the burden of COVID-19 on patients and their families, health systems and society.6 As of March 1, 2023, we have shipped 44 million treatment courses to 63 countries around the world.
Leading the Charge for Equitable Access
During the year, we also took bold action to help ensure our breakthroughs get into the hands of those who need them.
We’re living in a time when science is increasingly demonstrating the ability to take on the world’s most devastating diseases. Unfortunately, there’s a huge health equity gap in our world that determines which of us can access these innovations – and which of us can’t. At Pfizer, we are committed to helping close this gap as quickly as possible. That’s why we launched An Accord for a Healthier World. Through this groundbreaking initiative, Pfizer now offers on a not-for-profit basis the full portfolio of medicines and vaccines for which we have global rights to 45 lower-income countries – with the hope of giving the 1.2 billion people living in these countries access to hundreds of lifesaving and life-changing products that they couldn’t access before.
But as we learned in the COVID-19 vaccine rollout, ensuring supply is only the first step to helping patients. For this reason, another key element of the Accord is collaborating with global health leaders to make improvements in diagnosis, education, infrastructure, innovative financing, and more. I'm proud to say that the first shipments of our products arrived in Rwanda in September 2022, and we are working with them and other governments – including in Ghana, Malawi, and Senegal – on future deliveries, as well as health system improvements to help make sure our products reach those in need.
Here in the U.S., I’m equally proud of the important work being done by Pfizer’s Multicultural Health Equity Collective, which recently convened more than 100 health equity luminaries from across the U.S. to engage in candid conversations about the drivers and impact of systemic racism on healthcare. The dialogue highlighted creative solutions that are already starting to reduce health disparities in local communities across the country.
A Bright Future for Pfizer and for Patients
Looking ahead, Pfizer’s future appears to be even brighter than our present. We’re in the midst of an 18-month period during which we expect to have up to an unprecedented 19 new products or indications in the market. Fifteen of these 19 are from our internal pipeline with the remaining four coming to Pfizer via recent business development deals. These potential medicines and vaccines cut across a range of therapeutic areas and include candidates for multiple myeloma, prostate cancer, respiratory syncytial virus (RSV), flu, pneumococcal disease, migraine, ulcerative colitis, and sickle cell disease – among others. This represents a tremendous opportunity to improve health outcomes for patients around the world. This is the promise of our science at work.
And, of course, we have many more potential vaccines and medicines in our pipeline, with numerous launches expected in the 2024-2030 timeframe, if successful in clinical trials and approved. Some of the most promising assets include our oral GLP-1 candidate for diabetes and obesity, potential combination vaccines for flu, COVID-19, and RSV, our potential vaccines for Lyme disease and shingles, multiple new oncology product candidates, including ARV-471 and our CDK4 inhibitor for endocrine receptor-positive breast cancer, our gene therapy candidates for hemophilia A, hemophilia B, and Duchenne muscular dystrophy, and many more.
In addition, given the strength of our balance sheet and cash flows, we will continue to leverage business development opportunities to advance our business strategies and objectives. Our business development efforts remain focused on compelling external science in the form of both later-stage assets, as well as earlier medical innovations, that have the potential to be breakthroughs for patients. We will be looking primarily at therapeutic areas and platforms where we believe we have the scientific skills and acumen to add substantial value and select the most successful targets.
In summary, 2022 was an outstanding year for our company, with our key growth drivers providing evidence of the depth and breadth of our portfolio. With the unprecedented wave of innovations expected to emerge from our scientific pipeline in the near term, potential business development activities, our increased investments in our R&D and commercial capabilities, and additional potential new products and indications coming in the second half of the decade, we believe we can build on the momentum we have created to deliver life-changing innovations to even more patients around the world.
Thank you for your continued support of our important work.
Dr. Albert Bourla
Chairman & Chief Executive Officer
Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) with a current diagnosis of mild-to-moderate COVID-19 and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
We encourage you to read our 2022 Annual Report on Form 10-K, which includes our audited consolidated financial statements as of and for the year ended December 31, 2022, and the sections captioned “Risk Factors” and “Forward Looking Information and Factors that May Affect Future Results,” for a description of the substantial risks and uncertainties related to the forward-looking statements included herein. Expected product launches are subject to, among other risks, assumptions and uncertainties, clinical trial, regulatory and commercial success and availability of supply.
- Success rates for Phase 1 are based on a 3-year rolling average (2020-2022); rates for Phase 2 and Phase 3/Registration represent a 5-year rolling average (2018-2022).
- First in Human (FIH) to approval median phase cycle times are based on 3-year rolling cohort for Phase 1 and 5-year rolling cohort for Phase 2 to Registration. The analysis is at the new molecular entity (NME) level. Industry-leading is defined as Top Quartile amongst peer group companies.
- The patients treated metric is calculated from Pfizer and third-party datasets. Figures may be limited given the coverage provided by external sources (e.g., calendar duration, geographic and product coverage). Numbers are estimates and in some cases use global volume, daily dosage and number of treatment days to facilitate calculations. Methodologies to calculate estimates may vary by product type given the nature of the product and available data. Patients taking multiple Pfizer products may be counted as multiple patients towards total. Numbers include estimated patient counts from U.S. Patient Assistance Programs, ex-U.S. access & affordability programs, product donations and Global Commercial Access Partnerships (this does not include An Accord for a Healthier World). Historical estimates may periodically be subject to revision due to restatements in the underlying data source.
- CDC data through Jan 4, 2023.
- Clark A, Jit M, Warren-Gash C, et al. Global, regional, and national estimates of the population at increased risk of severe COVID-19 due to underlying health conditions in 2020: A modeling study. The Lancet Global Health. 2020;8(8):1003-1017. doi:10.1016/s2214-109x(20)30264-3.
- Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death. (2021, December 14). Pfizer. Retrieved November 1, 2022, from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results.