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This week several large drugmakers, Pfizer (PFE - Free Report) , Merck, (MRK - Free Report) , AbbVie (ABBV - Free Report) Lilly (LLY - Free Report) , Glaxo (GSK - Free Report) and Novo Nordisk announced their fourth-quarter earnings. J&J (JNJ - Free Report) filed an application to seek emergency approval from the FDA for its single-shot COVID-19 vaccine. AstraZeneca’s (AZN - Free Report) COVID-19 vaccine was conditionally approved in EU.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s fourth-quarter results were disappointing as it missed estimates for both earnings and sales. However, its 2021 financial guidance was above investor expectations. Merck announced that its chief executive officer (CEO), Kenneth C. Frazier would retire at the end of June after serving the company for almost a decade. Merck’s current executive vice president, Robert Davis, will succeed him.
Pfizer’s fourth-quarter results were mixed as it missed estimates for earnings while beating the same for sales. Pfizer’s financial outlook for 2021 was quite upbeat. Importantly, the company expects approximately $15 billion in sales from BNT162b2, its COVID-19 vaccine.
Lilly’s fourth-quarter results were strong as it beat estimates for both earnings and sales. Volume-based revenue growth of its newest drugs and initial sales of its COVID-19 antibody therapies drove sales and profits in the quarter. Lilly maintained its financial guidance for 2021, which it had issued in December.
AbbVie also beat estimates for both earnings and sales. Its immunology and cancer drugs drove sales growth. It also issued an encouraging financial guidance for 2021, reflecting robust demand for its products.
Glaxo missed on fourth-quarter earnings while beating on sales. Glaxo expects its adjusted earnings to decline in 2021 year over year by mid to high-single digit percentage at CER.
Novartis’ earnings and sales beat the Zacks Consensus Estimate. Sales in the Diabetes and Obesity Care segment division rose 8% while that in the Biopharma segment were down 9% at constant exchange rates (CER). The company expects 5-9% sales growth at CER in 2021.
Sanofi missed estimates for both earnings and sales. Higher sales of Sanofi’s blockbuster eczema medicine, Dupixent and record influenza vaccine sales drove its top-line growth. Sanofi expects earnings to grow in a high single digit range in 2021.
J&J Seeks Emergency Use of Single-Shot COVID-19 Vaccine Candidate: J&J filed an application to the FDA seeking Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine candidate. J&J will distribute the vaccine to the U.S. government immediately after receiving approval. It also has an agreement to supply 100 million doses to the United States in the first half of 2021. The company has also begun rolling filings in other countries. It intends to file a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks.
Earlier in the week, J&J announced interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The candidate met all primary and key secondary endpoints in the study. The vaccine candidate was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. Meanwhile, the single-shot vaccine was 72% effective in the United States and 85% effective overall in preventing severe disease. Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant. No significant safety concerns were reported, and the vaccine was well-tolerated.
AstraZeneca’s COVID-19 Vaccine Gets Conditional Approval in EU: AstraZeneca/Oxford University’s COVID-19 vaccine candidate (formerly AZD1222) was granted CMA in the European Union (EU). AstraZeneca is working with the EU to begin active immunization across EU member states. Earlier in the same week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had given a positive opinion recommending approval of the vaccine based on evaluation of 23,745 participants from the UK and Brazil phase III studies. AstraZeneca’s COVID-19 vaccine is now approved for emergency/temporary use in around 40 countries including the EU, a number of Latin American countries, India, Morocco and the UK.
AstraZeneca’s primary analysis from phase III studies on its COVID-19 vaccine reconfirmed that the vaccine prevents severe disease and avoids hospitalization. The study demonstrated vaccine efficacy of 76% after the first dose, with protection maintained to the second dose. The vaccine also demonstrated increased efficacy when the dosing interval was extended. The vaccine efficacy increased to 82% with an inter-dose interval of 12 weeks or more,
Glaxo and CureVac Ink Deal to Make COVID-19 Vaccines: Glaxo and CureVac announced a €150 million deal to contribute resources and expertise to jointly develop mRNA vaccines for COVID-19, including multi-valent and monovalent approaches. The companies target to launch the vaccine in 2022. Glaxo will also support manufacturing of CureVac’s first generation COVID-19 vaccine candidate CVnCoV (up to 100 million doses), which is currently in phase IIb/III study.
Roche Begins Gene Therapy Study in Pompe Disease: Roche’s subsidiary Spark Therapeutics announced the dosing of the first participant in a phase I/II study on SPK-3006, its investigational gene therapy, for late-onset Pompe disease. The study is expected to enroll approximately 20 participants.
CHMP Recommendations for Some Drugs: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Novo Nordisk’s once-weekly Sogroya (somapacitan) for the treatment of adults with growth hormone deficiency (AGHD). Sogroya was approved by the FDA in August last year.
The CHMP also recommended approving Novartis’ Kesimpta (ofatumumab), a self-administered targeted B-cell therapy for adult patients with relapsing multiple sclerosis. Kesimpta was approved in the United States in August last year.
The CHMP gave a positive opinion recommending approval of Merck’s Keytruda for certain patients with relapsed or refractory classical Hodgkin lymphoma. The recommendation was based on data from the pivotal phase III KEYNOTE-204 study.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Watch out for fourth-quarter and full-year 2020 earnings of AstraZeneca, and pipeline and regulatory updates next week.
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The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Image: Bigstock
Pharma Stock Roundup: PFE, MRK Q4 Earnings, AZN, JNJ Coronavirus Vaccine Updates
This week several large drugmakers, Pfizer (PFE - Free Report) , Merck, (MRK - Free Report) , AbbVie (ABBV - Free Report) Lilly (LLY - Free Report) , Glaxo (GSK - Free Report) and Novo Nordisk announced their fourth-quarter earnings. J&J (JNJ - Free Report) filed an application to seek emergency approval from the FDA for its single-shot COVID-19 vaccine. AstraZeneca’s (AZN - Free Report) COVID-19 vaccine was conditionally approved in EU.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s fourth-quarter results were disappointing as it missed estimates for both earnings and sales. However, its 2021 financial guidance was above investor expectations. Merck announced that its chief executive officer (CEO), Kenneth C. Frazier would retire at the end of June after serving the company for almost a decade. Merck’s current executive vice president, Robert Davis, will succeed him.
Pfizer’s fourth-quarter results were mixed as it missed estimates for earnings while beating the same for sales. Pfizer’s financial outlook for 2021 was quite upbeat. Importantly, the company expects approximately $15 billion in sales from BNT162b2, its COVID-19 vaccine.
Lilly’s fourth-quarter results were strong as it beat estimates for both earnings and sales. Volume-based revenue growth of its newest drugs and initial sales of its COVID-19 antibody therapies drove sales and profits in the quarter. Lilly maintained its financial guidance for 2021, which it had issued in December.
AbbVie also beat estimates for both earnings and sales. Its immunology and cancer drugs drove sales growth. It also issued an encouraging financial guidance for 2021, reflecting robust demand for its products.
Glaxo missed on fourth-quarter earnings while beating on sales. Glaxo expects its adjusted earnings to decline in 2021 year over year by mid to high-single digit percentage at CER.
Novartis’ earnings and sales beat the Zacks Consensus Estimate. Sales in the Diabetes and Obesity Care segment division rose 8% while that in the Biopharma segment were down 9% at constant exchange rates (CER). The company expects 5-9% sales growth at CER in 2021.
Sanofi missed estimates for both earnings and sales. Higher sales of Sanofi’s blockbuster eczema medicine, Dupixent and record influenza vaccine sales drove its top-line growth. Sanofi expects earnings to grow in a high single digit range in 2021.
J&J Seeks Emergency Use of Single-Shot COVID-19 Vaccine Candidate: J&J filed an application to the FDA seeking Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine candidate. J&J will distribute the vaccine to the U.S. government immediately after receiving approval. It also has an agreement to supply 100 million doses to the United States in the first half of 2021. The company has also begun rolling filings in other countries. It intends to file a Conditional Marketing Authorisation Application (cMAA) with the European Medicines Agency in the coming weeks.
Earlier in the week, J&J announced interim efficacy and safety data from the ENSEMBLE phase III study on the vaccine candidate. The candidate met all primary and key secondary endpoints in the study. The vaccine candidate was 66% effective overall at preventing moderate-to-severe COVID-19, 28 days after vaccination. Meanwhile, the single-shot vaccine was 72% effective in the United States and 85% effective overall in preventing severe disease. Importantly, the protection against severe disease was observed across geographies and against multiple rapidly emerging infectious virus variants including the South African variant. No significant safety concerns were reported, and the vaccine was well-tolerated.
AstraZeneca’s COVID-19 Vaccine Gets Conditional Approval in EU: AstraZeneca/Oxford University’s COVID-19 vaccine candidate (formerly AZD1222) was granted CMA in the European Union (EU). AstraZeneca is working with the EU to begin active immunization across EU member states. Earlier in the same week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had given a positive opinion recommending approval of the vaccine based on evaluation of 23,745 participants from the UK and Brazil phase III studies. AstraZeneca’s COVID-19 vaccine is now approved for emergency/temporary use in around 40 countries including the EU, a number of Latin American countries, India, Morocco and the UK.
AstraZeneca’s primary analysis from phase III studies on its COVID-19 vaccine reconfirmed that the vaccine prevents severe disease and avoids hospitalization. The study demonstrated vaccine efficacy of 76% after the first dose, with protection maintained to the second dose. The vaccine also demonstrated increased efficacy when the dosing interval was extended. The vaccine efficacy increased to 82% with an inter-dose interval of 12 weeks or more,
Glaxo and CureVac Ink Deal to Make COVID-19 Vaccines: Glaxo and CureVac announced a €150 million deal to contribute resources and expertise to jointly develop mRNA vaccines for COVID-19, including multi-valent and monovalent approaches. The companies target to launch the vaccine in 2022. Glaxo will also support manufacturing of CureVac’s first generation COVID-19 vaccine candidate CVnCoV (up to 100 million doses), which is currently in phase IIb/III study.
Roche Begins Gene Therapy Study in Pompe Disease: Roche’s subsidiary Spark Therapeutics announced the dosing of the first participant in a phase I/II study on SPK-3006, its investigational gene therapy, for late-onset Pompe disease. The study is expected to enroll approximately 20 participants.
CHMP Recommendations for Some Drugs: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing authorization for Novo Nordisk’s once-weekly Sogroya (somapacitan) for the treatment of adults with growth hormone deficiency (AGHD). Sogroya was approved by the FDA in August last year.
The CHMP also recommended approving Novartis’ Kesimpta (ofatumumab), a self-administered targeted B-cell therapy for adult patients with relapsing multiple sclerosis. Kesimpta was approved in the United States in August last year.
The CHMP gave a positive opinion recommending approval of Merck’s Keytruda for certain patients with relapsed or refractory classical Hodgkin lymphoma. The recommendation was based on data from the pivotal phase III KEYNOTE-204 study.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
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.
Last week, AbbVie recorded the maximum gain (4.1%) while J&J declined the most (4.3%).
In the past six months, Lilly recorded the maximum gain (32%) while AstraZeneca declined the most (10.4%).
(See the last pharma stock roundup here: JNJ, NVS Q4 Earnings, MRK & LLY’s Coronavirus Updates)
What's Next in the Pharma World?
Watch out for fourth-quarter and full-year 2020 earnings of AstraZeneca, and pipeline and regulatory updates next week.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>