Pfizer Stock Price, News & Analysis

Pfizer Inc. (NYSE: PFE) has announced a public webcast featuring David Denton, Chief Financial Officer and Executive Vice President, at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, at 8:30 a.m. EDT. Investors and the public can access the webcast through www.pfizer.com/investors.

The transcript and replay will be available on Pfizer's website within 24 hours after the live discussion and will remain accessible for at least 90 days. This event aligns with Pfizer's commitment to transparency and its mission to deliver breakthroughs that change patients' lives. As a leading biopharmaceutical company, Pfizer focuses on developing innovative medicines and vaccines, collaborating globally to improve healthcare access and affordability.

Pfizer Inc. (NYSE: PFE) has launched PfizerForAll, a digital platform aimed at simplifying healthcare access for millions of Americans. The platform focuses on patients with migraine, COVID-19, or flu, and adults seeking vaccines for preventable diseases. PfizerForAll offers:

• Same-day appointments with healthcare professionals
• Home delivery of medicines and diagnostic tests
• Vaccine appointment scheduling
• Help with paying for Pfizer medicines
• Access to patient support services

The platform works within the existing healthcare system and partners with organizations like UpScriptHealth, Alto Pharmacy, and Instacart. This initiative responds to the overwhelming nature of the U.S. healthcare system, with 65% of Americans finding healthcare coordination overwhelming and time-consuming.

Pfizer (NYSE: PFE) announced positive top-line results from substudy B of the Phase 3 MONeT trial, evaluating ABRYSVO vaccine in immunocompromised adults at risk of severe RSV-associated lower respiratory tract disease. The study involved 203 adults across four groups: non-small cell lung cancer patients, hemodialysis patients, autoimmune disorder patients on immunomodulator therapy, and solid organ transplant recipients.

Key findings:

• ABRYSVO was well-tolerated with a safety profile consistent with previous studies
• A single 120 µg dose generated strong neutralizing responses against RSV-A and RSV-B across all cohorts and age groups
• Results support ABRYSVO's potential to address unmet needs in vulnerable populations aged 18-59

Pfizer plans to share these findings at an upcoming scientific conference and submit data to regulatory agencies for review.

Pfizer (NYSE: PFE) reported robust second-quarter 2024 financial results, driving a raise in full-year 2024 revenue guidance to $59.5-$62.5 billion and adjusted diluted EPS to $2.45-$2.65. The company's revenue hit $13.3 billion, growing 3% operationally year-over-year, despite a decline in COVID-related revenues. Excluding Comirnaty and Paxlovid, revenues surged by 14%. Reported diluted EPS was $0.01, impacted by $1.3 billion in one-time manufacturing optimization costs, while adjusted diluted EPS was $0.60. Pfizer anticipates $1.5 billion in cost savings from its Manufacturing Optimization Program by 2027.

Key product highlights include a 71% operational growth for the Vyndaqel family, 8% for Eliquis, and 44% for Nurtec ODT/Vydura. However, Xeljanz and Ibrance saw declines of 34% and 8% operationally, respectively. Pfizer also announced advancements in its R&D pipeline and several product developments.

Pfizer's DURVEQTIX® (fidanacogene elaparvovec), a one-time gene therapy for adults with severe and moderately severe hemophilia B, has received conditional marketing authorization from the European Commission. This innovative treatment is designed to enable patients to produce factor IX themselves, potentially eliminating the need for frequent intravenous infusions. Key highlights:

- Demonstrated a median annualized bleed rate of zero bleeds after up to four years of follow-up
- Approved for adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74
- Met primary efficacy endpoint in Phase 3 BENEGENE-2 study
- Generally well-tolerated with a safety profile consistent with Phase 1/2 results
- Builds on Pfizer's 40-year commitment to hemophilia treatment innovation

Pfizer (NYSE: PFE) announced positive topline results from the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, a gene therapy for hemophilia A. The study met its primary objective of non-inferiority and superiority in total annualized bleeding rate (ABR) compared to routine Factor VIII replacement prophylaxis. Key findings include:

- Significant reduction in mean total ABR (1.24 vs 4.73)
- 84% of participants maintained FVIII activity >5% at 15 months post-infusion
- 98.3% reduction in mean treated ABR (4.08 to 0.07)
- Generally well-tolerated safety profile

Pfizer plans to discuss these data with regulatory authorities and advance the therapy to address the treatment burden for hemophilia A patients.

ViiV Healthcare announced positive 48-week results from the PASO DOBLE study, comparing the 2-drug regimen Dovato (dolutegravir/lamivudine) to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) for HIV-1 treatment. The study showed that:

1. Dovato demonstrated non-inferior efficacy in maintaining viral suppression compared to Biktarvy.

2. Participants taking Dovato experienced significantly less weight gain compared to those on Biktarvy.

3. Safety profiles were comparable between both regimens.

These findings support Dovato as an effective treatment option for virologically-suppressed adults living with HIV, addressing concerns about treatment-related weight gain.

CytoReason, a leader in computational disease modeling, has secured $80 million in funding from OurCrowd, NVIDIA, Pfizer, and Thermo Fisher Scientific. The investment will be used to expand disease models, grow proprietary data, and establish a US hub in Cambridge, Massachusetts. CytoReason's technology provides molecular-level insights and AI tools to help pharma companies make data-driven R&D decisions, improving the probability of phase 2 success.

The company has partnerships with six of the world's top ten pharma companies and has published numerous scientific articles in prestigious journals. This funding round highlights the growing importance of AI and data modeling in pharmaceutical R&D, with investors recognizing CytoReason's potential to revolutionize drug development processes.

ViiV Healthcare, majority owned by GSK, will present 25 abstracts at the 25th International AIDS Conference in Munich, including the largest head-to-head randomized clinical trial comparing their 2-drug regimen Dovato against the 3-drug regimen Biktarvy. Key presentations include:

1. PASO-DOBLE study: 48-week findings on treatment efficacy, safety, and weight changes for Dovato vs Biktarvy

2. Pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP

3. Phase I findings of VH184, a third-generation integrase inhibitor with potential for ultra long-acting applications

4. Real-world evidence for long-acting treatment regimen Cabenuva

These presentations underscore ViiV Healthcare's leadership in developing long-acting and 2-drug regimens for HIV treatment and prevention, addressing patient needs beyond viral suppression.