Albert Bourla
Chairman and Chief Executive Officer at Pfizer
Thank you, Francesca. Good morning, everyone. Thank you for joining us today. Our team continues to execute, and we are pleased to report another quarter of strong performance. We are guided by our purpose of delivering breakthroughs that change patients' lives and I'm proud that we have reached more than 270 million patients with our medicines and vaccines through the first nine months of 2024. The focus on execution excellence is starting to deliver results with market share gains in the US and International as well as robust growth in revenues and EPS. As a result, we are raising guidance ranges, and for our full year 2024 total revenues and adjusted diluted earnings per share.
In January, we presented the five key priorities that would guide Pfizer during our year of execution. Today, you will hear how we advanced our business in the third quarter with each of these strategic priorities. I will focus on highlights showing our progress with the first three. Dave will discuss our continued work to reduce our cost base, expand our margins and strategically deploy our capital. Then he will review our financial performance during the quarter and explain why we believe we are well positioned to deliver on our financial commitments and create long-term value for shareholders, and then, we will take questions. So with that, I'll turn to our performance against our priorities during the quarter.
Stated simply, oncology is having a great year and delivered another quarter of strong performance with 31% year-over-year performance growth resulting from solid demand across our product portfolio that includes legacy Seagen and legacy Pfizer products. We set a goal to achieve world-class oncology leadership. In the US, we are already the third largest biopharma company in oncology by revenue through the first half of 2024 and we're proud of the progress we are making toward our goal.
Demand continued to increase for Xtandi, the market leader for four types of advanced prostate cancer grew 28% year-over-year. Talzenna grew by 77% in the quarter versus the same quarter from a year ago. We are encouraged by the opportunity to further advance the prostate cancer treatment landscape based on the exciting overall survival data we announced earlier this month from the Phase 3 TALAPRO study. In the study, Talzenna in combination with Xtandi demonstrated statistically significant overall survival benefit in patients with metastatic castration-resistant prostate cancer, becoming the first and only such combination to do so.
Driving scientific breakthroughs in genitourinary [Phonetic] cancers is one of the key areas of focus in oncology. The TALAPRO-2 results show how we continue innovating to improve survival for men with prostate cancer, which is the second most common cancer in men and the fifth most common cause of cancer death among men worldwide.
We saw continued momentum during the quarter with the ongoing launch of Padcev with pembrolizumab for patients with advanced/metastatic bladder cancer, regardless of their eligibility to receive cisplatinbased chemotherapy. This combination has quickly become the most prescribed first-line treatment in the US for locally advanced/metastatic urothelial cancer.
In thoracic cancer, we achieved 31% operational growth this quarter with Lorbrena, a treatment for adults with ALK-positive metastatic non-small [Phonetic] cell lung cancer. Following the release of our five years of CROWN data during the ASCO Annual Meeting, we are observing an acceleration of first-line new patient starts around the world and, in particular, in our key markets of the US, China, Germany and France. Our Braftovi and Mektovi combination also achieved strong year-over-year growth in the third quarter of 32%, primarily driven by growth in the metastatic non-small cell cancer indication.
And, we continue to be pleased by strong performance with the launch of Elrexfio, which had about 80% sequential revenue growth over the second quarter of 2024. In the US, we have more than doubled our new patient starts since January. In Japan, we were able to catch up with competition and launch as the first-to-market BCMA bispecific helping to address an unmet medical need for patients with triple-class exposed multiple myeloma. We believe Elrexfio has the potential to be a transformative treatment option for people with multiple myeloma, and we are continuing to advance development with four ongoing registrational studies in earlier lines of therapy that, if positive and approved, could support serving a way more expanded patient population.
Now I think I will turn to some select highlights of how we continue strategically advancing our pipeline. We are prioritizing opportunities where we have scientific leadership and deep capabilities to address significant unmet patient needs. Earlier, I spoke to the strength of our marketed oncology medicines. Our pipeline, however, is what excites us the most. Lung cancer is the number one cause of cancer-related death around the world. At the recent ESMO Congress we shared longer-term follow-up results from the PHAROS trial evaluating Braftovi and Mektovi in patients with BRAF V600E-mutant metastatic non-small cell lung cancer, which demonstrated compelling efficacy for patients.
We are also rapidly advancing two next-generation ADC candidates with the potential to make significant impact on the more than 300,000 patients with non-small cell lung cancer in the US. The first is sigvotatug vedotin, which is now in Phase 3 and we are planning additional pivotal trials in the coming months. The other one is a PDL1V ADC. We are equally encouraged by the updated Phase 1 data we presented at ESMO for this ADC, and we are planning registration-enabling trials in 2025.
Our genitourinary pipeline is expanding. We are studying another novel ADC, disitamab vedotin, in two ongoing registration-intent trials in urothelial cancer. And mevrometostat, our novel EZH2 inhibitor, is another example of the progress we are making throughout our pipeline. This is being studied as a new potential treatment for men who have metastatic castration-resistant prostate cancer, and we are enrolling currently patients in two Phase 3 studies.
Finally, to build on the foundation for Ibrance, we are making progress with development of two candidates we believe can replace the current backbones of ER-positive/HER2-negative breast cancer. Atirmociclib, our potential first-in-class CDK4 inhibitor, is enrolling a second-line Phase 3 trial and we expect to start a first-line Phase 3 study by early 2025. And, we expect the first Phase 3 data in the coming months for vepdegestrant, an estrogen receptor degrader that we are co-developing right now with Arvinas.
Our fourth-generation PCV candidate, now in Phase 2 adults and pediatrics, covers 25 serotypes, including improved immunogenicity for Serotype 3, very important, which is one of the largest remaining contributors of disease. We are focused on building on our leadership in the industry by continuing to expand valency with our fifth-generation candidate, which in pre-clinical development that covers over 30 serotypes.
In the last several months, we have advanced a potential new vaccine against C. diff, which is considered an urgent public health threat that lacks any approved vaccines. Leveraging experience from our previous C. diff program, we have developed a new formulation for a second-generation candidate. After encouraging Phase 1 data with this new formulation, we have advanced to our Phase 2 study, already.
We are also working to support significant unmet need for about 90 million Americans and 200 million Europeans in areas with high incidence of Lyme disease. VLA15 is a vaccine candidate, we are codeveloping that is intended to protect against the six most prevalent serotypes in North America and Europe. A Phase 3 trial is under way, and, pending positive data and regulatory approval, VLA15 would become the only vaccine available to help prevent the acute, severe and long-term health consequences of Lyme disease globally.
Paxlovid is the standard-of-care COVID-19 oral treatment for those at high risk of progressing to severe disease. We believe, however, there is an opportunity to expand both our therapeutic impact and market position with our next-generation oral anti-viral candidate, ibuzatrelvir. In a Phase 2 [Phonetic] study, we have demonstrated robust anti-viral activity at all doses, and without the need for ritonavir boosting, we have addressed the drug-drug interactions and metallic taste associated with Paxlovid. We expect to start a Phase 3 study in the coming months.
We are also moving forward with our Phase 3 program in non-segmental vitiligo with ritlecitinib, a candidate with a differentiated JAK-TEC mechanism developed in-house at Pfizer that has the potential to be an expansion of indications for Litfulo, which is currently approved in severe alopecia areata. Vitiligo, like alopecia areata, is an autoimmune disease with high unmet need. It is the leading cause for skin depigmentation and affects nearly 3 million patients in the US alone. We are enthusiastic about our two first-in-class tri-specific antibodies with early data demonstrating excellent 3-in-1 potency. We believe this program has the potential to deliver improved efficacy in atopic dermatitis with an ongoing Phase 2 study evaluating safety and efficacy.
We had a Phase 2 readout for ponsegromab, which is another in-house discovered and developed asset. We are encouraged by the potential for a breakthrough for patients with cancer cachexia who lack treatment options for this life-threatening wasting condition that currently has no FDA-approved treatments. The Phase 2 study met its primary endpoint of change from baseline in body weight compared to placebo across all doses tested, and, at the highest dose evaluated, showed improvements from baseline in appetite, cachexia symptoms, physical activity and muscle mass. Based on these positive results, we expect to advance to a registration-enabling study next year. Our Phase 2 study in patients with heart failure-related cachexia is ongoing.
We remain on track with our dose optimization studies for danuglipron, our oral GLP-1 receptor agonist candidate, and look forward to discussing more about this in early 2025. In our broader obesity portfolio, we continue to advance our early-stage candidates, including our oral small molecule GIPR-antagonist, which is advancing to Phase 2 in 2024, this year and an additional oral -- once-daily oral GLP-1 receptor agonist in Phase 1. The highlights I've mentioned today across important therapeutic areas show how we have made meaningful advancements with our pipeline.
As we announced earlier this year, Dr. Mikael Dolsten, Pfizer's Chief Scientific Officer, will depart from Pfizer after 15 years of leading Pfizer's research efforts. Our process for selecting a successor is now quite advanced and we look forward to announcing an update soon.
Now, I will turn to our commercial performance. Another one of our strategic priorities is maximizing the performance of our new products. I am pleased that the decisive actions we took to enhance our commercial organization at the beginning of the year are yielding satisfactory results. With Nurtec, we saw 28% total prescription growth and continued leadership in the oral CGRP class. Importantly, 85% of primary care clinicians writing CGRP prescriptions for the first time chose Nurtec, 85%. This shows the progress we are making in primary care, as well as our work with payers to remove barriers for timely patient access to treatment.
Among our vaccines, we are very pleased with our performance since the launch of Prevnar 20, which has already achieved 83% market share in pediatric and 97% in adults. With last week's recommendation by the Advisory Committee on Immunization Practices to expand adult pneumococcal vaccination to include all adults aged 50 and older, we believe Prevnar 20 is well positioned to serve an expanded population in the United States. Outside of the US, we are predominantly serving the pediatric market and, following the recent first quarter approval in Japan and the EU, we are gaining vaccine technical committee recommendations and several market introductions.
With Abrysvo, we continued improving our US market share position with strong commercial execution. Our market share of sales to retailers and clinics out of wholesalers has exceeded 50% for the quarter and our market share of shots in arms in the retail setting has increased for nine consecutive weeks through mid-October, currently reaching 43%. Last week's FDA approval for Abrysvo for patients 18 through 59 who are at increased risk of lower respiratory tract disease caused by RSV could help us serve an expanded population over time.
With a rise in COVID-19 infections in the summer and early fall, we have responded to increased demand for Paxlovid as we launched in the US commercial market at the beginning of the year. Our better-than-expected growth during the quarter for Paxlovid reflects higher infection rates and the strong commercial execution of our team. Our ability to execute effectively includes improving patient access, raising awareness of this treatment option, expanding use at alternative sites of care and also continuing to educate healthcare providers. The demand for Paxlovid seems to have stabilized. In the slides, you can see, the total number of patients treated with Paxlovid in '24 which is very similar to the same period in '23. It appears to be closely correlated with each wave of COVID-19, but also appear to have very similar for 2023 and '24.
The 63% operational growth in the third quarter of our Vyndaqel family of products is a direct result of our progress in expanding the healthcare provider base and supporting clinicians in identifying more patients who can benefit from this therapy, as well as our work to improve patient access and adherence to therapy. Internationally, Vyndaqel is reimbursed in 44 markets right now and more are expected next year. While diagnostic rates vary across markets, the unmet medical need remains significant as illustrated by the 10% increase of patients on treatment in the third quarter versus the second quarter of 2024 in the US.
We were pleased by the 74% quarterly operational growth and continued progress with expanding patient access with Cibinqo, a treatment for patients 12 and up with moderate-to-severe eczema who didn't respond to other treatments, and 27% growth in the US from the second to third quarters of 2024, with Litfulo, the first and only FDA-approved prescription pill for both adults and adolescents as young as 12 with severe alopecia areata.
Right now, and I will turn it over to Dave.
