Albert Bourla
Chairman and Chief Executive Officer at Pfizer
Thank you very much, Francesca. Good morning, everyone. Thank you for joining us today. 2024 was a strong year of execution and performance for Pfizer. We were guided by clear strategic priorities and we met or exceeded our goals for H1, while also delivering on our financial commitments. I'm pleased with the progress we made in executing transformative changes that strengthened our company.
First, we successfully integrated the business, one of the largest investments we have made in the past decade, creating one of the best oncology companies in the industry. At the start of 2024, we split our commercial operations into two divisions, US and international and appointed two senior commercial leaders to increase focus in both. Amir Malik and Alexander Romez have done a tremendous job to upgrade our commercial capabilities. They consolidated our external agencies now to one powerhouse global advertising company and leveraged the power of AI to transform our marketing and selling engine. New data-driven deployment of our commercial and medical field resources, precision macro targeting in social media and television of the Pfizer brand in commercial communications are some of the strategies that have significantly increased our commercial and medical effectiveness and returns on investment.
We are seeing the impact of these actions in our strong financial performance and in the recognition of our market leaders. We earned the top position in the 2024 IQVIA US field force ranking report and improved our ranking to claim number-one or two spot in 70% of the specialties in which we focus. I'm also proud of our strong year of pipeline progress in 2024, including more than a dozen approvals, seven pivotal study starts and eight key Phase-3 readouts. I'm very excited with the changes in our R&D engine under its new leaders.
Pris moved fast to create four end-to-end R&D units focused on oncology vaccines, internal medicine and inflammation and immunology. This structure fully empowers research units that can operate with the focus and agility of a biotech company while tapping into our differentiated enterprise-wide capabilities such as AI power, drug discovery and development. Our focus on financial discipline also has yielded good results. We ended the year with expanded margins after a series of actions to realign our cost base. And we strategically deployed capital to enhance shareholder value, investing nearly EUR11 billion in support of internal R&D programs, delivering by EUR7.8 billion and returning 9.5 billion directly to shareholders through our dividends. Finally, we also reinforced our commitment to strong governance. Our two new Board members bring deep expertise in financial markets and shareholder value-creation. All these changes have created a strong foundation and allow us to start the new year from a position of strength.
So now let me speak about our 2025 priorities. Last year, we had a significant emphasis on improving our commercial effectiveness. In 2025, the emphasis will move to improving R&D productivity, while maintaining focus on margin expansion, commercial excellence and shareholder capital allocation. Let me start with R&D. Across our pipeline, we believe we have a strong year of catalysts ahead of us and expect our new R&D organization to achieve multiple key milestones, including the possibility of at least four regulatory decisions, up to nine potential Phase-3 readouts and 13 potential pivotal program starts. For example, with, our next-generation highly selective CDK4 inhibitor candidate. Yesterday, we dosed our first patient in a Phase-3 study in first-line metastatic breast cancer. We also anticipate starting an additional first-line study in combination with the, the ER degrader, we are co-developing with Arvivas.
Our ADC,, the dotin continues its Phase-3 study in second-line non-small cell lung cancer. And this year, we expect to start a Phase-3 study in first-line non-small cell CAS. Our candidate, a potential first-in-class PD-L1 targeting ADC is expected to begin two Phase-3 studies this year, one in first-line metastatic head-and-neck square cell carcinoma and one in second-line plus non-small cell lung cancer where the unmet need is significant. We have a robust clinical development program aimed at expanding indications in lung. And this year, we anticipate the readout of a Phase-3 study in double class exposed, relapsed-refractory multiple, but if successful and approved, we'll triple the addressable population versus the currently approved indication.
In vaccines, we expect to start the Phase-3 study this year for our candidate covering 25. This is important foundational work that could help us bridge to and accelerate progress with our fifth-generation PCV candidate covering more than 30 serotypes. This year, we also expect to start a Phase-3 study for our deaf vaccine candidate.
In internal medicines, we remain on-track to provide an upgrade of our dose optimization studies of in the first-quarter of this year. For, we expect to start a pivotal study this year in cancer. And Ibuza Trelvir, our second-generation COVID-19 oral antiviral candidate, continues its Phase-3 study. Within II, we continue to progress a portfolio of medicines that include two potential first-in-class tri-specific antibodies currently in Phase-2. Now let's discuss our commercial strategy. 2024 was a strong year of commercial execution and we are pleased with our progress in improving performance of our newly-launched products and gaining and maintaining market-share for several of our core brands.
I will start by highlighting the strength and impact of our oncology portfolio. Plus pembrolizumab is an important growth driver as it has already become the number-one prescribed first-line treatment for locally advanced metastatic urothelial cancer in the US. We are expecting potential registrational interim data this year from ongoing pivotal studies in muscle invasive bladder cancer, which if successful and approved with nearly triple the total addressable patients in the US. McTovi achieved a 27% year-over-year worldwide operational growth and expanded its leadership position in multiple tumors, which are some of the hardest to treat cancers.
Yesterday, we announced that RAFTOVI in combination with and M4 FOX 6 showed statistical -- statistically significant and clinically meaningful improvement in progression-free survival and overall survival in-patients with metastatic colorectal cancer with a V600E mutation. We are very excited with the robust improvement in PFS and OS and are looking-forward to presenting this data in a scientific conference., a treatment for adults with ALKI outpositive metastatic non-small cell lung cancer achieved 37% worldwide year-over-year operational growth and is emerging as a potential standard-of-care in the first-line setting. Following last June's unprecedented Crown trial data showing 60% of patients were alive without disease progression after five years, Lorbrena has seen a double-digit share increase in the first-line in both new patient starts and new prescribers.
Elorexvio had a strong performance in 2024 with more than EUR130 million in-full year revenues and increasing overall share within the class of BCMA directed by a specific antibodies for patients with triple class exposed relapse or refractory multiple in the United States. I also want to comment about our COVID-19 portfolio. We continue to see stabilizing patterns in the disease burden with a strong correlation between the COVID-19 burden of disease and utilization. We see the same stabilizing patterns in US vaccination rates at relatively low levels. Our assumptions for 2025 are on par with these 2023 and 2024 patterns. And with the multi-year contracts we have secured in international markets, we are confident that our COVID-19 portfolio will continue to be a predictable and durable contributor to our business.
In another key category, our family of products achieved continuing momentum with 90% year-over-year growth in the US and 32% operational growth in international markets. We drove progress in diagnosing more patients and improving access to this treatment from -- for amyloid cardiomyopa. Is a core brand for Pfizer with 10% worldwide year-over-year operational growth. It is prescribed to millions of patients and we continue to strengthen its leadership position in a growing oral and the coagular market. We are also pleased with the ongoing positive momentum for with 36% worldwide year-over-year operational growth, driven by strong commercial execution. Is a leader in the oral CGRP class used for treating and preventing migraine with about 49% market-share and we see opportunities for continued growth.
Our respiratory vaccines, and also are key products in our commercial portfolio. We have achieved a market leadership position for the season in dose for with an approximately 13 percentage points increase in-market share and remain confident in our ability to retain our position through strong commercial execution even as we see a decrease in the total adult RSV market volume, driven by a reduction in vaccination rates in the US for the older adult indication. We achieved positive momentum in key regions such as Europe and Latin-America and are also seeing strong demand for our maternal indication. A season to date cumulative maternal vaccination rate nearly three points compared to last season. With Prevna, we are confident that we are well-positioned for strong sustained leadership with over 87% market-share in the US across indications.
Globally, the pediatric market accounts for approximately two-thirds of our Prevna revenues and we also continue to make progress for the adult indication in key international markets. We are encouraged by opportunities to maintain our leadership in the PCV space with our next-generation BCV25 candidate mentioned earlier. In Phase-1, we demonstrated potentially improving immunogenicity for serotype 3, one of the largest contributors of disease at approximately 20% of invasive disease in adults aged 65 and older in the United States and Europe. Across our commercial portfolio, in 2025, we are confident that we are in a strong position to build-in our 2024 success and achieve commercial excellence in our key categories of oncology, cardiovascular, migraine, vaccines and IMR.
With that, I will turn it over to Dave.
