Pfizer, Inc.

Good day, everyone, and welcome to Pfizer's fourth quarter 2021 earnings conference call. Today's call is being recorded. At this time, I would like to turn the call over to Mr. Chris Stilo, Senior Vice President and Chief Investor Relations Officer. Please go ahead, sir.

Thank you, Sylvia. Good morning, everyone. Welcome to Pfizer's fourth quarter earnings call. I'm joined today by Dr. Albert Bourla, our Chairman and CEO, Frank D'Amelio, our CFO, Michael Dolston, President of Worldwide Research and Development in Medical, Angela Huang, Group President, Pfizer Biopharmaceuticals Group, Amir Malik, our Chief Business and Innovation Officer, and Doug Lankler, our General Counsel. We expect this call to last 90 minutes. The materials for this call and other earnings-related materials are on the Investor Relations section of Pfizer.com. We see our forward-looking statements disclaimer on slide three and additional information regarding these statements and our non-GAAP financial measures is available on our earnings release and in our SEC forms 10-K and 10-Q under risk factors. Forward-looking statements on the call are subject to substantial risks and uncertainties. Speak only as of the call's original date, and we undertake no obligation to update or revise any of these statements. With that, I will turn the call over to Albert.

Thank you, Chris. Hello, everyone. 2021 was a watershed year for Pfizer, a year in which we set all-time highs in all major areas of focus for Pfizer. We reached an estimated 1.4 billion patients with our medicines and vaccines. That's more than one out of every six people on Earth. Never before has Pfizer's patient impact been so wide-reaching. we improved our ranking from fourth to second among large biopharma companies in the patient view global survey. According to Morning Consult, 61% of Americans have a favorable view of Pfizer, which is up 33 points since January of 2020. Just last week, Fortune ranked us fourth on its annual world's most admired companies list, the highest ranking we have ever achieved. Ninety-five percent of our colleagues said in an internal survey that they are proud to work for Pfizer, which ranks among the best in corporate America. We increased our investments in research and development from 8.9 billion in 2020 to 10.5 billion in 2021, and we initiated 13 pivotal clinical studies, the highest number ever for Pfizer. Last but not least. We grew revenues by 92% operationally to $81.3 billion and adjusted diluted EPS by 92% operationally to 4.42. Our success in leading the fight against COVID-19 have not only made a positive difference in the world, I believe that have fundamentally changed our company and our culture forever. colleagues across Pfizer are inspired by what we have achieved and more determined than ever to be part of the next potentially game-changing breakthrough. To that end, we are applying the light speed principles developed for our COVID-19 work to our other therapeutic areas to make sure we continue to move at the speed of science for the benefits of all patients. As a result, We believe we can do even better with each of these metrics in 2022, each one of them. Our full year, 2022 financial guidance, for example, includes for the first time ever a forecasted revenue midpoint, but it is triple digit, $100 billion, and adjusted diluted EPS midpoint of 6.45. While Comirnaty is having a significant positive impact on Pfizer's financial performance, it is the tremendous impact that COVID-19 vaccines have had on society that it is most important. In the U.S. alone, the COVID-19 vaccination program is estimated to have saved more than 1 million lives and prevented more than 10 million hospitalizations, according to a December 2021 Commonwealth Fund report. The economic impact is equally astounding. According to a December 2021 Heartland Forward report, the rapid deployment and wide availability of COVID-19 vaccines in the U.S. created an estimated economic savings of $438 billion in 2021 alone, which amounted to U.S. GDP being 2.3% higher than it otherwise would have been, 2.3 points. I'm proud to say that Pfizer contributed significantly to these benefits, given that approximately six out of 10 doses administered in the U.S. as of February 6, 2022, were comirnaty. This is the value of our science, what our culture has enabled, and what drives our people. Now I would like to speak to three factors that will help drive our growth going forward. The first is the long-term outlook for COVID-19 and why we believe we are well positioned to continue to lead the battle against this disease. Second, our thoughtful capital allocation strategy and why we believe it can help drive our growth in the second part of the decade. And third, how our commitment to ESG principles is designed to create sustainable growth for Pfizer to deliver meaningful value to patients and society. Let me start with the COVID-19 pandemic. Our scientists continue to monitor the SARS-CoV-2 virus and believe it is unlikely that it will be fully eradicated in the foreseeable future. They believe this for several reasons. The global distribution of the virus makes it difficult to contain. The virus has shown an ability to mutate often, making it difficult to stay ahead of it. And the data appear to show that natural infections do not lead to the type of durable protection needed to prevent all transmissions and viral mutations. As a result, People can become reinfected by the same or different strains over time. That said, we now have the tools in the form of vaccines and treatments that we believe will help enable us to not only better manage the pandemic, but also help countries move into an endemic phase. In other words, we believe these tools will help allow us to go back to normality and spend time with family and friends, travel, attend indoor dining and concerts, and enjoy many other activities while lowering the risk of overburdening hospitals and healthcare systems around the world. All of us at Pfizer are extremely proud of the role we have continued to play in bringing these tools to the world. Throughout 2021, we continued our efforts to bring our COVID-19 vaccine to more populations and to further ramp up our manufacturing and distribution capabilities. As a result, the market share of our community vaccine has continued to grow, representing 70% of all doses distributed across the U.S. and EU as of February 5th. When it comes to PaxClovid, We expect to produce 6 million treatment courses during the first quarter of 22. Overall, we expect to produce 30 million courses in the first half of 2022 and 120 million courses for the full year, of course, depending on the global need. Having recently received a conditional marketing authorization from the European Medicines Agency, PaxClovid has now received emergency. or conditional authorization for use with certain populations in approximately 40 countries so far. We are in discussions with governments around the world and expect that as the number of authorizations increase, so will the number of contracts for this treatment, which could truly be a game changer. At Pfizer, we are keenly aware of our responsibility to continue to invest in R&D to maintain our leadership in providing these tools and other meaningful solutions to the world. That's why we continue to develop and test different versions of our vaccine to potentially address variants of concern as they emerge, and why we are currently working on a new Omicron-based vaccine candidate and on a bivalent COVID-19 vaccine candidate. It is also why just two months after receiving emergency use authorization from the US Food and Drug Administration for PaxClovid, we are already working on a potential next-generation oral COVID-19 treatment. Going forward, we are confident in our ability to maintain this leadership position because of our significant investments in R&D, combined with our ability to move at the speed of science without compromising quality or safety, the strong credibility we have earned with governments, healthcare providers, and consumers, combined with our extensive global field presence and our unparalleled capabilities for high-quality manufacturing at scale. Now, the second thing I wanted to touch on is how we think about our capital allocation and to repeat once more our strategy. We feel that the entirety of our business continues to demonstrate a robust top line growth trajectory through 2025. Consensus estimates are beginning to slowly recognize this momentum. However, Consensus estimates currently saw our top line shrinking from 2025 to 2030. I want to repeat that this is inconsistent with our own plans. Our goal is to continue to be a growth company from 2025 to 2030, despite the impact of LOEs expected during that period. Our confidence in our ability to achieve that is underpinned by the momentum of our business, the durability of our COVID-19 offerings, which, as I just described, the underestimated strength of our internal pipeline, and of course, by our ability to deploy capital into growth-focused business development to access external science. A few words about that. We leverage business development opportunities to advance our business strategies and objectives. The strength of our balance sheet and cash flows allows us to pursue new business development opportunities going forward that could add at least 25 billions of risk-adjusted revenues to our 2030 top-line expectations. We expect to do this while still maintaining our growing dividend as well as flexibility for other uses of our cash. The focus of our business development efforts will continue to be 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. Our focus will largely be in the therapeutic areas and platforms where we have the scientific skills and acumen to add substantial value and select the most successful targets. In addition, we feel that we have distinctive attributes such as world-class excellence in clinical development and a surpass manufacturing and commercial capabilities at scale. that makes us a very attractive partner across a variety of deal arrangements. We believe the opportunities to deliver on this approach exist, and I will be personally focusing on this execution. I want to emphasize that despite our significant capital flexibility, we will never lower the scientific and financial standards we apply in our business development. As we pursue these opportunities, we will continue to be highly disciplined in our evaluation and prioritization processes. Since 2019, we have already invested almost $25 billion in business development transactions, adding more than $13 billion in consensus, I repeat, in consensus 2030 revenue. I would point out that The $13 billion of consensus currently includes nothing for the Trillium assets, the Bioheaven collaboration, or the recently announced mRNA deals, all of which have substantial potential. I see the space of business development accelerating going forward, and I'm confident it will be an important driver in ensuring Pfizer as a growth company in the back half of this decade. One highly visible example of our approach to business development is the recent investments we are making in mRNA technology and collaboration. mRNA has emerged as a versatile technology with potential application across many infectious diseases, cancer, rare genetic disorders, and even autoimmune diseases. Although mRNA is not the holy grail, We believe that technology has the potential to have a game-changing impact on global health, which is why we have developed a robust mRNA strategy and are aggressively building our platform. While the pandemic has demonstrated that it is not that easy to deliver mRNA vaccines at scale, Pfizer has emerged as a leader in this space. With decades of experience on our side, we have developed what is arguably the most efficient clinical development and vaccine manufacturing capabilities the world has ever seen. We also have rapidly scaled and built out new capabilities in record time by hiring nearly 2,400 new colleagues in these functions in a nine-month timeframe. Going forward, We plan to continue to invest, to capitalize on the leadership we have built in terms of both mRNA R&D and manufacturing. In addition, of course, to these internal investments and improvements, we are also making external investments to build out our capabilities in this space. For example, Pfizer recently has entered into four important business development deals to help advance our mRNA strategy. We are expanding our collaboration with BioNTech to use the existing platform to co-develop an mRNA vaccine candidate for herpes zoster virus to protect against singles. Our agreement with Bean Therapeutics expands our mRNA efforts to another core therapeutic area for Pfizer, a rare disease. With a four-year research collaboration for three targets for rare genetic diseases, of the liver, muscle, and central nervous system. We believe this will give us the potential to use mRNA to treat diseases, not just prevent them, treat them. Our agreement with ACUITAS gives us the ability to collaborate with and license their proprietary lipid nanoparticle technology for up to 10 targets for mRNA vaccines and therapy. We believe this will give us greater independence in this space. And we have signed a strategic collaboration and licensing agreement with CodexDNA, a leader in the development of automated solutions for on-demand synthesis of genes and mRNA, potentially allowing enzymatic assembly of DNA at the front end of the mRNA production process. This could possibly reduce the time to produce a new vaccine from three months down to two months. If successful, this would be an important differentiator when developing a vaccine for the flu, for example, as it would allow us to select a strain much closer to the start of any flu season. These deals represent only four pieces of a much bigger strategic puzzle. As we continue executing on our mRNA strategy, you should expect to see more targeted activity in this area. Of course, our business development activity in the last quarter went beyond executing on our mRNA strategy. This is an update of the slide I showed you last quarter, and I would like to highlight a few of the other recent deals that are marked as new in this slide. The acquisition of Trillium builds on our strong track record of leadership in oncology, enhances our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our strategic collaboration with Biohaven leverages our leading commercial capabilities in pain and women's health. I apologize. We are back. I apologize for the technical issue. I will repeat my script for this last slide, and then we go forward. So, of course, our business development activity in the last quarter went beyond executing on our MRNA strategy. This is an update of the slide I showed you last quarter, and I would like to highlight a few of the other recent deals. You can see them with the indication new. The acquisition of Trillium builds on our strong track record of leadership in oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our strategic collaboration BioHeaven leverages our leading commercial capabilities in pain and women's health, with BioHeaven's groundbreaking oral CGRP receptor antagonist, the only one approved in the U.S. for both acute and preventative treatment of migraine so that we can potentially bring a valuable new treatment option to patients living with this debilitating neurological disease outside the U.S. And through our proposed acquisition of ARENA, we plan to leverage Pfizer's leading research and global development capabilities to accelerate the clinical development of etrosimone for patients with immunoinflammatory diseases. I would like to share some details about Pfizer's enhanced ESD strategy. The strategy is focused on six areas where we see opportunities to create a meaningful and measurable impact over the next decade. Product innovation, equitable access and pricing, product quality and safety, diversity, equity and inclusion, climate change, and business ethics. Each quarter going forward, I will provide examples of how we are embedding ESG into all core areas of our business. This quarter, I would highlight our efforts to improve clinical trial diversity, to improve diversity within our colleagues' base, and help ensure equitable access to our COVID-19 vaccine and treatment. Last year, Pfizer published an industry-first retrospective analysis of demographic data of U.S. participants in 213 of our interventional clinical trials that initiated enrollment from 2011 through 2020. The analysis demonstrated that overall trial participation of black or African American individuals was at the U.S. census level, 14.3 versus 13.4. Participation of Hispanic or Latino individuals was below U.S. Census, 15.9 versus 18.5. And female participation was at U.S. Census, 51.1 versus 50.8. We published this analysis to be transparent and for it to serve as the baseline as we measure progress in this area. We believe that diversity in trials is a matter of equity and good science and are taking decisive steps designed to improve diversity in our tribes. Our goal is to achieve racially and ethnically diverse participation at or above U.S. Census or disease prevalence levels as appropriate in all our tribes. The second item I want to highlight is the significant progress we are making in diversifying our colleague base, particularly at more senior level positions. In the last three years, for example, we have increased the percentage of women at the vice president level and above globally from 32% to 42%. Over the same timeframe, we have increased the percentage of minorities at the vice president level and above in the U.S. from 19 to 25. The third item I wanted to highlight is the progress we are making to help ensure Our COVID-19 vaccine and oral treatment are accessible by everyone, everywhere. I am thrilled to say that we remain on track to meet or exceed our global or our goal of delivering at least 2 billion doses of our vaccine to low- and middle-income countries by the end of 2022, having just met our goal of delivering the first 1 billion by the end of 2021. I also want to highlight two data points about our 2 billion dose commitment. One billion of these doses are being provided to the poorest countries, completely free of charge, thanks to our agreement with the U.S. government. Pfizer is providing these doses to the U.S. government at a not-for-profit price, and the government is then providing them to the poorest countries for free. Also, the one billion doses we delivered in 2021 represented 37% of all doses we delivered this last year. In terms of our oral COVID-19 treatment, we have signed a voluntary license agreement with the medicines patent pool, which we hope will lead to expanded access pending country regulatory authorization or approval in 95 low and middle income countries that account for approximately 53% of the world's population. Lastly, I'm pleased to announce that the compensation committee of our board of directors has been reviewing methods to linking executive compensation with ESG performance, which we expect to begin this year. For details regarding the impact of our ESG strategy had on our business in 2021, please keep an eye out for Pfizer's 2021 ESG report, which will be published online in mid-March. In summary, 2021 was an outstanding year for Pfizer, and we look forward to continuing to apply the lessons learned from COVID-19 to deliver breakthroughs for patients across all our therapeutic areas. We remain focused on being nimble, investing in our R&D organization, and exploring dynamic partnerships that will enable us to fully realize the power of our science. None of this is possible without the contributions of our amazingly purpose-driven colleagues who continue to rise to the challenge of addressing the world's most devastating diseases. In 2021, our colleagues exceeded expectations. Therefore, we will once again use part of the bonus pool that the board approved for bonus eligible colleagues and executives to provide a one-time special COVID-19 circumstances bonus to our non-bonus eligible colleagues across the board to reward them for their hard work and to help them cover personal, family, and living expenses incurred because of the COVID-19 pandemic. With that, I will turn it over to Michael to update you on our R&D efforts after Michael Frank will provide financial details on the fourth quarter and our outlook for 2022. So, Michael.