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Pharma Stock Roundup: Big Pharma Q3 Results, FDA Panel's Vote for PFE COVID Jab
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The third-quarter earnings season was in full swing this week, with Novartis (NVS - Free Report) , Eli Lilly (LLY - Free Report) , Sanofi (SNY - Free Report) , Glaxo (GSK - Free Report) and Merck (MRK - Free Report) announcing their results. An FDA panel endorsed Pfizer (PFE - Free Report) /BioNTech’s COVID-19 vaccine for use in kids 5 to 11 years of age.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly’s third-quarter results were mixed as it missed estimates for earnings but beat the same for sales. Importantly, higher demand for Lilly’s COVID-19 therapies benefited sales as the spread of the Delta variant led to a sharp rise in infection rates in the quarter. Lilly also raised its previously issued sales and earnings forecast for 2021 due to additional expected revenues from its COVID-19 antibody medicines.
Merck’s third-quarter results were better than expected as it beat estimates for both earnings and sales. Pharmaceutical segment sales rose 18% year over year due to higher sales of oncology drugs and vaccines. Merck raised its previously issued earnings and sales guidance for 2021.
Novartis reported mixed results for the third quarter as earnings topped expectations while sales missed the same. Sales in Innovative Medicines rose 7% at constant currency driven by the strong performance of drugs like Entresto, Cosentyx, Kesimpta, and Zolgensma. Sales in the Sandoz division declined 2% due to lower sales in the United States. The company still expects net sales in 2021 to grow in low- to mid-single digits.
Glaxo beat estimates for both earnings and sales. While Pharmaceuticals sales were up 10% at CER, sales in the Consumer Healthcare segment increased 8%. Vaccine sales rose 49% at CER, led by a strong recovery in Shingrix sales together with pandemic adjuvant sales. Glaxo raised its earnings growth expectations for the year.
Sanofi’s quarterly results were mixed as it beat estimates for earnings while missing the same for sales. Dupixent continued its outstanding performance in the quarter. The company revised its business earnings guidance for 2021 upward. The company now expects earnings to grow around 14% at CER in 2021 compared with the previous projection of 12%.
FDA Panel Backs Pfizer’s COVID Vaccine for Kids: The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor (17 to 0, with one abstention) of the FDA granting EUA to Pfizer/BioNTech’s COVID-19 vaccine in children 5 to 11 years of age. VRBPAC’s recommendation was based partly on data from a phase II/III study, which showed that its COVID-19 vaccine had a favorable safety profile and generated robust immune responses and a vaccine efficacy rate of 90.7% in kids of this age group. If the FDA grants EUA, Pfizer/BioNTech’s COVID-19 vaccine will be the first to be authorized in the United States for use in this age group
FDA Approves Roche’s Novel Treatment for nAMD: The FDA granted approval to Roche’s Susvimo intravitreal injection, previously called Port Delivery System with ranibizumab (PDS), for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Susvimo is a first-of-its-kind therapeutic approach, offering nAMD patients an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care. Susvimo is marketed under the brand name Lucentis (ranibizumab injection) to treat nAMD and other retinal diseases
EMA Begins Review of Merck’s Oral Pill for COVID: The European Medicines Agency began the rolling review of Merck and partner Ridgeback Biotherapeutics regulatory application for its investigational oral antiviral medicine, molnupiravir, for the treatment of COVID-19 in. An application seeking emergency approval of the COVID pill in the United States has also been filed by the companies. The application was based on positive data from the phase III MOVe-OUT study, which showed that the candidate reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk of progressing to severe COVID-19 and/or hospitalization.
AbbVie’s Parkinson’s Drug Meets Goal in Pivotal Study: AbbVie’s (ABBV - Free Report) 12-week pivotal study evaluating ABBV-951 in comparison to oral levodopa/carbidopa medication in patients with advanced Parkinson's disease met the primary endpoint. Data from the study showed that the 24 hours/day subcutaneous infusion of ABBV-951 led to statistically superior reduction in motor fluctuations compared to oral levodopa/carbidopa in this patient group. Patients given 24 hours/daily ABBV-951 experienced statistically significant increases in hours of "On" time without troublesome dyskinesia (involuntary movements) – the study’s primary endpoint - after 12 weeks, compared to oral levodopa/carbidopa. The increase in "On" time at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa. A significant reduction in hours of "Off" time was also observed
AstraZeneca’s Imfinzi Biliary Tract Cancer Study Meets Goal: AstraZeneca announced positive interim data from the TOPAZ-1 phase III study evaluating Imfinzi plus chemotherapy in first-line advanced biliary tract cancer. In the study, Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone in this patient group. At the interim analysis, the Independent Data Monitoring Committee concluded that the study had met its primary endpoint. by demonstrating an improvement in OS in the Imfinzi plus chemo arm compared to chemo alone. The study also demonstrated an improvement in progression-free survival (PFS) and overall response rate, the key secondary endpoints.
Novartis’ Lung Cancer Study on Canakinumab Fails to Meet Endpoint: Novartis announced top-line data from a phase III study (CANOPY-1) evaluating canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy in patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet its primary endpoints of OS and PFS. However, the study did demonstrate clinically meaningful improvements in both PFS and OS among pre-specified subgroups of patients with inflammatory biomarkers. The data supports further evaluation of canakinumab in lung cancer.
The FDA and European Medicines Agency (EMA) accepted Novartis’ regulatory applications seeking label expansion of CAR-T cell therapy, Kymriah for a third indication - relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment. The FDA granted priority review to the company’s supplemental biologics license application (sBLA) for Kymriah for this new indication.
The NYSE ARCA Pharmaceutical Index rose 1.6% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: Big Pharma Q3 Results, FDA Panel's Vote for PFE COVID Jab
The third-quarter earnings season was in full swing this week, with Novartis (NVS - Free Report) , Eli Lilly (LLY - Free Report) , Sanofi (SNY - Free Report) , Glaxo (GSK - Free Report) and Merck (MRK - Free Report) announcing their results. An FDA panel endorsed Pfizer (PFE - Free Report) /BioNTech’s COVID-19 vaccine for use in kids 5 to 11 years of age.
Recap of the Week’s Most Important Stories
Earnings Update: Lilly’s third-quarter results were mixed as it missed estimates for earnings but beat the same for sales. Importantly, higher demand for Lilly’s COVID-19 therapies benefited sales as the spread of the Delta variant led to a sharp rise in infection rates in the quarter. Lilly also raised its previously issued sales and earnings forecast for 2021 due to additional expected revenues from its COVID-19 antibody medicines.
Merck’s third-quarter results were better than expected as it beat estimates for both earnings and sales. Pharmaceutical segment sales rose 18% year over year due to higher sales of oncology drugs and vaccines. Merck raised its previously issued earnings and sales guidance for 2021.
Novartis reported mixed results for the third quarter as earnings topped expectations while sales missed the same. Sales in Innovative Medicines rose 7% at constant currency driven by the strong performance of drugs like Entresto, Cosentyx, Kesimpta, and Zolgensma. Sales in the Sandoz division declined 2% due to lower sales in the United States. The company still expects net sales in 2021 to grow in low- to mid-single digits.
Glaxo beat estimates for both earnings and sales. While Pharmaceuticals sales were up 10% at CER, sales in the Consumer Healthcare segment increased 8%. Vaccine sales rose 49% at CER, led by a strong recovery in Shingrix sales together with pandemic adjuvant sales. Glaxo raised its earnings growth expectations for the year.
Sanofi’s quarterly results were mixed as it beat estimates for earnings while missing the same for sales. Dupixent continued its outstanding performance in the quarter. The company revised its business earnings guidance for 2021 upward. The company now expects earnings to grow around 14% at CER in 2021 compared with the previous projection of 12%.
FDA Panel Backs Pfizer’s COVID Vaccine for Kids: The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor (17 to 0, with one abstention) of the FDA granting EUA to Pfizer/BioNTech’s COVID-19 vaccine in children 5 to 11 years of age. VRBPAC’s recommendation was based partly on data from a phase II/III study, which showed that its COVID-19 vaccine had a favorable safety profile and generated robust immune responses and a vaccine efficacy rate of 90.7% in kids of this age group. If the FDA grants EUA, Pfizer/BioNTech’s COVID-19 vaccine will be the first to be authorized in the United States for use in this age group
FDA Approves Roche’s Novel Treatment for nAMD: The FDA granted approval to Roche’s Susvimo intravitreal injection, previously called Port Delivery System with ranibizumab (PDS), for the treatment of neovascular or “wet” age-related macular degeneration (nAMD). Susvimo is a first-of-its-kind therapeutic approach, offering nAMD patients an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the current standard of care. Susvimo is marketed under the brand name Lucentis (ranibizumab injection) to treat nAMD and other retinal diseases
EMA Begins Review of Merck’s Oral Pill for COVID: The European Medicines Agency began the rolling review of Merck and partner Ridgeback Biotherapeutics regulatory application for its investigational oral antiviral medicine, molnupiravir, for the treatment of COVID-19 in. An application seeking emergency approval of the COVID pill in the United States has also been filed by the companies. The application was based on positive data from the phase III MOVe-OUT study, which showed that the candidate reduced the risk of hospitalization or death by approximately 50% in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk of progressing to severe COVID-19 and/or hospitalization.
AbbVie’s Parkinson’s Drug Meets Goal in Pivotal Study: AbbVie’s (ABBV - Free Report) 12-week pivotal study evaluating ABBV-951 in comparison to oral levodopa/carbidopa medication in patients with advanced Parkinson's disease met the primary endpoint. Data from the study showed that the 24 hours/day subcutaneous infusion of ABBV-951 led to statistically superior reduction in motor fluctuations compared to oral levodopa/carbidopa in this patient group. Patients given 24 hours/daily ABBV-951 experienced statistically significant increases in hours of "On" time without troublesome dyskinesia (involuntary movements) – the study’s primary endpoint - after 12 weeks, compared to oral levodopa/carbidopa. The increase in "On" time at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa. A significant reduction in hours of "Off" time was also observed
AstraZeneca’s Imfinzi Biliary Tract Cancer Study Meets Goal: AstraZeneca announced positive interim data from the TOPAZ-1 phase III study evaluating Imfinzi plus chemotherapy in first-line advanced biliary tract cancer. In the study, Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone in this patient group. At the interim analysis, the Independent Data Monitoring Committee concluded that the study had met its primary endpoint. by demonstrating an improvement in OS in the Imfinzi plus chemo arm compared to chemo alone. The study also demonstrated an improvement in progression-free survival (PFS) and overall response rate, the key secondary endpoints.
Novartis’ Lung Cancer Study on Canakinumab Fails to Meet Endpoint: Novartis announced top-line data from a phase III study (CANOPY-1) evaluating canakinumab (ACZ885) combined with pembrolizumab plus platinum-based doublet chemotherapy in patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC). The study did not meet its primary endpoints of OS and PFS. However, the study did demonstrate clinically meaningful improvements in both PFS and OS among pre-specified subgroups of patients with inflammatory biomarkers. The data supports further evaluation of canakinumab in lung cancer.
The FDA and European Medicines Agency (EMA) accepted Novartis’ regulatory applications seeking label expansion of CAR-T cell therapy, Kymriah for a third indication - relapsed or refractory (r/r) follicular lymphoma (FL) after two prior lines of treatment. The FDA granted priority review to the company’s supplemental biologics license application (sBLA) for Kymriah for this new indication.
The NYSE ARCA Pharmaceutical Index rose 1.6% 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.
In the last five trading sessions, Merck rose the most (6.6%) while Novartis declined the most (1.6%)
In the past six months, Lilly recorded the maximum gain (38.6%) while Novartis declined the most (2.3%)
(See the last pharma stock roundup here: JNJ Mixed Q3 Results, FDA Nod to Mix & Match COVID Boosters)
What's Next in the Pharma World?
Watch out for the results of Pfizer and regular pipeline and regulatory updates next week.