This week, Pfizer PFE issued a disappointing guidance for 2024, which includes its expectations from the acquisition of Seagen, closed on Dec 14. AstraZeneca AZN announced that it is buying vaccine company, Icosavax ICVX, for a total deal value of up to $1.1 billion. Merck MRK and partner Moderna MRNA initiated the second pivotal study in the INTerpath program on their personalized mRNA therapeutic cancer vaccine, V940 (mRNA-4157).
Recap of the Week’s Most Important Stories
Pfizer Issues Weak Guidance for 2024: Pfizer announced its revenue and profit guidance for 2024, which was well below investor expectations due to lower-than-expected demand for its COVID products — COVID-19 vaccine, Comirnaty, and its oral antiviral pill for COVID, Paxlovid. Pfizer expects total revenues to be in the range of $58.5 to $61.5 billion in 2024, which is almost flat compared with 2023’s expected range of $58.0 to $61.0 billion.
The 2024 revenue guidance includes $8 billion in potential combined revenues for Paxlovid and Comirnaty, $3.1 billion in expected revenues from Seagen and approximately $1 billion due to the reclassification of Pfizer’s royalty income from Other (Income)/Deductions into the Revenue line. Excluding revenues from Seagen and the abovementioned reclassification, the revenue guidance for legacy Pfizer is $54.5 to $57.5 billion, which indicates a decline from the expected range for 2023.
Adjusted earnings are expected in the range of $2.05 to $2.25 per share including the expected impact of financing costs related to the Seagen acquisition. However, excluding 40 cents dilution from the Seagen acquisition, adjusted earnings for legacy Pfizer are expected in the range of $2.45 to $2.65 per share.
The European Commission granted conditional marketing authorization to Elrexfio (elranatamab), Pfizer’s off-the-shelf fixed-dose, subcutaneous BCMA-directed bispecific antibody immunotherapy, for treating relapsed/refractory multiple myeloma) in heavily pre-treated patients. The approval of Elrexfio is based on data from the pivotal phase II MagnetisMM-3 study. Elrexfio was approved by the FDA in August.
The FDA and European Medicines Agency accepted regulatory applications seeking approval of Pfizer’s anti-TFPI inhibitor, marstacimab, for the treatment of hemophilia A and B. The FDA decision on the biologics license application is expected in the fourth quarter of 2024. The European Commission’s decision on the marketing authorization application (MAA) for marstacimab is expected by the first quarter of 2025.
AstraZeneca to Buy Vaccine Maker Icosavax: AstraZeneca announced a definitive agreement to acquire Icosavax, which makes differentiated vaccines leveraging its innovative, protein virus-like particle (VLP) platform. The deal is valued at up to $1.1 billion, including an upfront cash payment of approximately $0.8 billion plus potential contingent value payments.
Icosavax’s lead pipeline candidate is a phase III ready vaccine, IVX-A12, a combination vaccine for RSV. IVX-A12 is a combination protein VLP vaccine that targets respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), two leading causes of severe respiratory infections.
AstraZeneca claims that IVX-A12 has a differentiated profile versus currently approved monotherapy RSV vaccines. Data from the phase II study of IVX-A12 demonstrated robust immune responses against both RSV and hMPV one month after vaccination. The addition of IVX-A12 to its late-stage vaccine pipeline gives AstraZeneca a platform for further development of combination vaccines against respiratory viruses.
AstraZeneca and partner Sanofi’s RSV antibody Beyfortus was approved by the FDA in July to protect newborns and infants. Beyfortus was approved in Europe in November 2022
Merck/Moderna Begin 2nd Study on mRNA Cancer Vaccine: Merck/Moderna initiated a pivotal phase III study evaluating V940 (mRNA-4157) in combination with Keytruda in earlier-stage non-small cell lung cancer. The primary endpoint of the late-stage study called INTerpath-002 is disease-free survival. Global recruitment in the study has begun and the first patients have been enrolled in Australia. Merck and Moderna are already conducting a phase III study, called INTerpath-001, on V940 (mRNA-4157) in combination with Keytruda for the treatment of adjuvant melanoma.
The FDA approved Welireg, Merck’s novel HIF-2α inhibitor, for treating patients with advanced renal cell carcinoma (RCC) that progressed following PD-1/L1 and VEGF-TKI therapies. The approval was based on data from the phase III LITESPARK-005 study, which showed that treatment with Welireg reduced the risk of disease progression or death compared to everolimus in the abovementioned patient group. Welireg, at present, is approved to treat some von Hippel-Lindau disease-associated tumors.
A phase III study called LEAP-001 evaluating Merck’s Keytruda plus partner Eisai’s Lenvima for the first-line treatment of patients with advanced or recurrent endometrial carcinoma, failed to meet their dual primary endpoints of overall survival (“OS”) and progression free survival (“PFS”).
In the final analysis of the study, the Keytruda/Lenvima combination failed to show a sufficient improvement in OS or PS to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). At present, Keytruda plus Lenvima is approved to treat certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced RCC.
The NYSE ARCA Pharmaceutical Index rose 1.09% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
In the last five trading sessions, AbbVie rose the most (4.8%), while Pfizer declined the most (8.6%).
In the past six months, Lilly has risen the most (26.3%), while Pfizer has declined the most (34.2%).
(See the last pharma stock roundup here: ABBV to Buy CERE, JNJ’s 2024 View, LLY & NVS Get FDA Nod)
What's Next in the Pharma World?
Watch for pipeline and regulatory updates next week.
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