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The fourth-quarter earnings season is in full swing this week.Large drugmakers like Pfizer (PFE - Free Report) , Merck (MRK - Free Report) , Novartis (NVS - Free Report) , Novo Nordisk (NVO - Free Report) and Sanofi (SNY - Free Report) announced fourth-quarter and full-year 2023 results. Most of these companies reported mixed results and either maintained their previously issued guidance for 2024 or issued fresh guidance for the year.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s fourth-quarter results were mixed as it beat estimates for earnings but missed the same for sales. Strong sales of Merck’s blockbuster cancer drug, Keytruda, drove the top line. Keytruda sales rose 21% in the quarter, driven by rapid uptake across earlier-stage indications and continued strong momentum in metastatic indications. Though sales of another key product, its HPV vaccine Gardasil, rose 27% year over year, it missed expectations.
Merck issued an encouraging financial guidance for 2024. Merck expects revenues to be in the range of $62.7-$64.2 billion in 2024. Adjusted earnings per share are expected to be between $8.44 and $8.59.
Sanofi’s quarterly results were weak as it missed estimates for earnings as well as sales. Higher sales of Dupixent and contributions from new products like AstraZeneca-partnered Beyfortus and Altuviiio were partially offset by the impact of generic competition on Aubagio sales in all key markets and lower sales from mature products in the General Medicines segment. Vaccine sales improved from the decline seen in the third quarter, mainly as a result of the strong uptake of Beyfortus. Sales of Dupixent rose 31.3% year over year.
The company maintained its 2024 earnings growth expectations at CER. It expects profits to decline in 2024 due to higher R&D costs and taxes. Adjusted earnings are expected to decline in the low single-digit range at CER in 2024.
Pfizer’s fourth-quarter results were mixed as it beat estimates for earnings while missing the same for sales. With the end of the pandemic, sales of Pfizer’s COVID-19 products declined steeply in 2023. However, sales of some key non-COVID products like Vyndaqel/Vyndamax and Eliquis alliance revenues, newly acquired products like Nurtec and new product launches like Abrysvo provided some top-line support. Revenues from Pfizer’s non-COVID products rose 8% operationally in the fourth quarter.
The company reaffirmed its 2024 sales and earnings guidance provided on Dec 13, 2023.
Novartis’ fourth-quarter results were weak as it missed estimates for both earnings as well as sales. Its sales rose 10% at constant currency (“cc”) in the quarter, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta, Cosentyx and Kisqali, partly offset by generic competition, mainly for Gilenya and Gleevec/Glivec. Novartis expects 2024 net sales to grow in mid-single digits while core operating income is projected to grow in the high single-digit range.
Novo Nordisk beat estimates for both earnings and sales. Revenues rose 43% at a constant exchange rate (CER), driven by strong sales of its diabetes and obesity care products, mainly GLP-1 products. Its GLP-1 diabetes sales increased 62% at CER and Obesity care sales increased 114% at CER. Sales of the diabetes drug Ozempic rose 85%, while Wegovy rose 311% at CER. Rare disease segment sales were down 5%, while rare blood disorder products were up 4%. Sales of hemophilia A products decreased 19%. Hemophilia B products’ sales were, however, up 50%.
In 2024, Novo Nordisk expects sales to grow in the range of 18-26% at CER, while operating profit growth is expected to rise 21-29% at CER.
FDA Nod to Sanofi’s Dupixent for Eosinophilic Esophagitis in Kids: The FDA approved Sanofi’s blockbuster medicine, Dupixent, for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease, in children (aged 1 to 11 years). The approval was based on data from the phase III EoE KIDS study. Dupixent was approved by the FDA for EoE in patients aged 12 years and above in May 2022. Other than EoE, Dupixent is now approved in several countries, including the United States and EU, for four other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis and prurigo nodularis
FDA’s Priority Review Tag to Enhertu sBLA: The FDA granted priority review to AstraZeneca and partner Daiichi Sankyo's supplemental biologics license application (sBLA) seeking approval of Enhertu for treating unresectable or metastatic HER2-positive solid tumors in heavily-pretreated patients. The FDA is expected to give its decision in the second quarter of 2024. The sBLA was based on data from the ongoing phase II DESTINY-PanTumor02 study and data from other studies on Enhertu. If approved by the FDA, Enhertu will become the first HER2-directed medicine to receive a tumour-agnostic indication. Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive breast cancers.
The NYSE ARCA Pharmaceutical Index rose 1.72% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: PFE, MRK, NVO & SNY's Q4 Earnings, FDA Updates
The fourth-quarter earnings season is in full swing this week. Large drugmakers like Pfizer (PFE - Free Report) , Merck (MRK - Free Report) , Novartis (NVS - Free Report) , Novo Nordisk (NVO - Free Report) and Sanofi (SNY - Free Report) announced fourth-quarter and full-year 2023 results. Most of these companies reported mixed results and either maintained their previously issued guidance for 2024 or issued fresh guidance for the year.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s fourth-quarter results were mixed as it beat estimates for earnings but missed the same for sales. Strong sales of Merck’s blockbuster cancer drug, Keytruda, drove the top line. Keytruda sales rose 21% in the quarter, driven by rapid uptake across earlier-stage indications and continued strong momentum in metastatic indications. Though sales of another key product, its HPV vaccine Gardasil, rose 27% year over year, it missed expectations.
Merck issued an encouraging financial guidance for 2024. Merck expects revenues to be in the range of $62.7-$64.2 billion in 2024. Adjusted earnings per share are expected to be between $8.44 and $8.59.
Sanofi’s quarterly results were weak as it missed estimates for earnings as well as sales. Higher sales of Dupixent and contributions from new products like AstraZeneca-partnered Beyfortus and Altuviiio were partially offset by the impact of generic competition on Aubagio sales in all key markets and lower sales from mature products in the General Medicines segment. Vaccine sales improved from the decline seen in the third quarter, mainly as a result of the strong uptake of Beyfortus. Sales of Dupixent rose 31.3% year over year.
The company maintained its 2024 earnings growth expectations at CER. It expects profits to decline in 2024 due to higher R&D costs and taxes. Adjusted earnings are expected to decline in the low single-digit range at CER in 2024.
Pfizer’s fourth-quarter results were mixed as it beat estimates for earnings while missing the same for sales. With the end of the pandemic, sales of Pfizer’s COVID-19 products declined steeply in 2023. However, sales of some key non-COVID products like Vyndaqel/Vyndamax and Eliquis alliance revenues, newly acquired products like Nurtec and new product launches like Abrysvo provided some top-line support. Revenues from Pfizer’s non-COVID products rose 8% operationally in the fourth quarter.
The company reaffirmed its 2024 sales and earnings guidance provided on Dec 13, 2023.
Novartis’ fourth-quarter results were weak as it missed estimates for both earnings as well as sales. Its sales rose 10% at constant currency (“cc”) in the quarter, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta, Cosentyx and Kisqali, partly offset by generic competition, mainly for Gilenya and Gleevec/Glivec. Novartis expects 2024 net sales to grow in mid-single digits while core operating income is projected to grow in the high single-digit range.
Novo Nordisk beat estimates for both earnings and sales. Revenues rose 43% at a constant exchange rate (CER), driven by strong sales of its diabetes and obesity care products, mainly GLP-1 products. Its GLP-1 diabetes sales increased 62% at CER and Obesity care sales increased 114% at CER. Sales of the diabetes drug Ozempic rose 85%, while Wegovy rose 311% at CER. Rare disease segment sales were down 5%, while rare blood disorder products were up 4%. Sales of hemophilia A products decreased 19%. Hemophilia B products’ sales were, however, up 50%.
In 2024, Novo Nordisk expects sales to grow in the range of 18-26% at CER, while operating profit growth is expected to rise 21-29% at CER.
FDA Nod to Sanofi’s Dupixent for Eosinophilic Esophagitis in Kids: The FDA approved Sanofi’s blockbuster medicine, Dupixent, for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease, in children (aged 1 to 11 years). The approval was based on data from the phase III EoE KIDS study. Dupixent was approved by the FDA for EoE in patients aged 12 years and above in May 2022. Other than EoE, Dupixent is now approved in several countries, including the United States and EU, for four other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis and prurigo nodularis
FDA’s Priority Review Tag to Enhertu sBLA: The FDA granted priority review to AstraZeneca and partner Daiichi Sankyo's supplemental biologics license application (sBLA) seeking approval of Enhertu for treating unresectable or metastatic HER2-positive solid tumors in heavily-pretreated patients. The FDA is expected to give its decision in the second quarter of 2024. The sBLA was based on data from the ongoing phase II DESTINY-PanTumor02 study and data from other studies on Enhertu. If approved by the FDA, Enhertu will become the first HER2-directed medicine to receive a tumour-agnostic indication. Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive breast cancers.
The NYSE ARCA Pharmaceutical Index rose 1.72% 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.
Image Source: Zacks Investment Research
In the last five trading sessions, Novo Nordisk rose the most (9.6%), while Novartis declined the most (1.6%).
In the past six months, Lilly has risen the most (47.1%), while Pfizer has declined the most (22.0%).
(See the last pharma stock roundup here: JNJ Reports Q4 Earnings, SNY Inks M&A Deal With INBX)
What's Next in the Pharma World?
Watch this space for fourth-quarter earnings of Lilly and AstraZeneca and regular pipeline and regulatory updates next week.