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This week, Merck (MRK - Free Report) , Sanofi (SNY - Free Report) and Novartis (NVS - Free Report) announced their third-quarter results. The FDA approved Pfizer’s (PFE - Free Report) pentavalent meningococcal vaccine, Penbraya and Eli Lilly’s (LLY - Free Report) inflammatory bowel disease (“IBD) drug Omvoh. Roche announced that it is acquiring Telavant, a joint venture of Roivant Sciences and Pfizer. With the acquisition, Roche will get the rights to develop, manufacture and commercialize a new IBD candidate.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s third-quarter results were better than expected as it beat estimates for earnings as well as sales. Strong sales of blockbuster cancer drug Keytruda and surprisingly higher sales of COVID drug Lagevrio drove the top line in the quarter. Keytruda sales rose 17% year over year. Sales of another important product, Gardasil vaccine, missed expectations. Merck raised its full-year sales outlook.
However, the company lowered its earnings guidance for 2023 due to incremental costs related to collaborations and deals and a slightly higher impact of currency.
Novartis’ third-quarter results were mixed as it beat estimates for earnings while missing the same for sales. Its sales rose 12% at constant currency (“cc”) in the quarter, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali, partly offset by generic competition, mainly for Gilenya. Earlier in the month, Novartis completed the spin-off of its generic and biosimilar unit, Sandoz, following which the latter became an independent company. The company raised its operating income growth guidance for 2023 while maintaining top-line expectations. Sales are expected to grow in the high-single-digit range. Core operating income is now projected to grow in the mid-to-high teens range compared to the low double-digit to mid-teens range expected previously.
Sanofi’s quarterly results were mixed as it beat estimates for earnings but missed the same for sales. Higher sales of Dupixent and contributions from new products like Beyfortus RSV vaccine and Altuviiio for hemophilia A were partially offset by the impact of Aubagio generic competition in the United States and lower sales from mature products in the General Medicines segment. The company maintained its 2023 earnings growth expectations at CER, despite reduced potential negative impact from currency.
Along with the earnings release, Sanofi announced that it intends to separate its Consumer Healthcare (CHC) unit by creating a separate publicly listed entity, headquartered in France. Sanofi said the separation is not expected to happen before the fourth quarter of 2024.
Roche Buys Rights to Novel IBD Candidate: Roche announced that it is buying Telavant Holdings, including rights to develop, manufacture and commercialize RVT-3101, a novel phase III ready TL1A-directed antibody being developed for IBD, in the United States and Japan. Telavant Holdings was formed by Roivant Sciences and Pfizer in 2022. RVT-3101 is a new therapy that has the potential to be developed for ulcerative colitis (“UC”) and Crohn’s disease, two forms of IBD, via a novel mechanism of action targeting both inflammation and fibrosis. It has shown encouraging data in a phase IIb study in UC. Roche now has the rights to develop and commercialize RVT-310 in the United States and in Japan, pending clinical and regulatory success. Pfizer holds commercialization rights outside the United States and Japan. Roche will start a global phase III study on RVT-310.
For the deal, Roche is making an upfront payment of $7.1 billion and a near-term milestone payment of $150 million.
FDA Approves Pfizer’s Penbraya & Lilly’s Omvoh: The FDA granted approval to Pfizer’s pentavalent meningococcal vaccine (MenABCWY) called Penbraya. The vaccine is approved for adolescents and young adults, 10-25 years of age, for the prevention of meningococcal disease caused by five meningococcal serogroups that cause the majority of invasive meningococcal diseases, serogroups A, B, C, W and Y.
Penbraya combines the components from Pfizer’s two other meningococcal vaccines, Trumenba and Nimenrix. The approval was based on data from phase II and phase III studies, which showed that Penbraya had robust immunogenicity, which was non-inferior to Trumenba + Menveo for all serogroups.
Pfizer and partner BioNTech announced positive early top-line data from a phase I/II study evaluating a mRNA-based combination vaccine candidate against influenza and COVID-19. The data from the study showed that the lead formulations demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains. The companies plan to start a pivotal late-stage study on the combination vaccine.
The FDA also granted approval to Eli Lilly’s drug, Omvoh (mirikizumab), for treating moderately to severely active UC in adults. The FDA had earlier issued a complete response letter to the biologic license application seeking approval of mirikizumab for UC in April. Back then, the FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. Omvoh’s approval makes it Lilly’s first approved drug for a type of IBD indication. The approval was based on data from two phase III studies under the LUCENT program. In the pivotal studies, Omvoh achieved primary and key secondary endpoints, including sustained clinical remission.
Omvoh has already been launched in Japan and the EU. The drug is in late-stage development for Crohn's disease.
The NYSE ARCA Pharmaceutical Index declined 1.5% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: SNY, MRK, NVS Report Q3 Earnings, FDA Okays PFE, LLY Products
This week, Merck (MRK - Free Report) , Sanofi (SNY - Free Report) and Novartis (NVS - Free Report) announced their third-quarter results. The FDA approved Pfizer’s (PFE - Free Report) pentavalent meningococcal vaccine, Penbraya and Eli Lilly’s (LLY - Free Report) inflammatory bowel disease (“IBD) drug Omvoh. Roche announced that it is acquiring Telavant, a joint venture of Roivant Sciences and Pfizer. With the acquisition, Roche will get the rights to develop, manufacture and commercialize a new IBD candidate.
Recap of the Week’s Most Important Stories
Earnings Update: Merck’s third-quarter results were better than expected as it beat estimates for earnings as well as sales. Strong sales of blockbuster cancer drug Keytruda and surprisingly higher sales of COVID drug Lagevrio drove the top line in the quarter. Keytruda sales rose 17% year over year. Sales of another important product, Gardasil vaccine, missed expectations. Merck raised its full-year sales outlook.
However, the company lowered its earnings guidance for 2023 due to incremental costs related to collaborations and deals and a slightly higher impact of currency.
Novartis’ third-quarter results were mixed as it beat estimates for earnings while missing the same for sales. Its sales rose 12% at constant currency (“cc”) in the quarter, driven by the continued strong performance of Entresto, Pluvicto, Kesimpta and Kisqali, partly offset by generic competition, mainly for Gilenya. Earlier in the month, Novartis completed the spin-off of its generic and biosimilar unit, Sandoz, following which the latter became an independent company. The company raised its operating income growth guidance for 2023 while maintaining top-line expectations. Sales are expected to grow in the high-single-digit range. Core operating income is now projected to grow in the mid-to-high teens range compared to the low double-digit to mid-teens range expected previously.
Sanofi’s quarterly results were mixed as it beat estimates for earnings but missed the same for sales. Higher sales of Dupixent and contributions from new products like Beyfortus RSV vaccine and Altuviiio for hemophilia A were partially offset by the impact of Aubagio generic competition in the United States and lower sales from mature products in the General Medicines segment. The company maintained its 2023 earnings growth expectations at CER, despite reduced potential negative impact from currency.
Along with the earnings release, Sanofi announced that it intends to separate its Consumer Healthcare (CHC) unit by creating a separate publicly listed entity, headquartered in France. Sanofi said the separation is not expected to happen before the fourth quarter of 2024.
Roche Buys Rights to Novel IBD Candidate: Roche announced that it is buying Telavant Holdings, including rights to develop, manufacture and commercialize RVT-3101, a novel phase III ready TL1A-directed antibody being developed for IBD, in the United States and Japan. Telavant Holdings was formed by Roivant Sciences and Pfizer in 2022. RVT-3101 is a new therapy that has the potential to be developed for ulcerative colitis (“UC”) and Crohn’s disease, two forms of IBD, via a novel mechanism of action targeting both inflammation and fibrosis. It has shown encouraging data in a phase IIb study in UC. Roche now has the rights to develop and commercialize RVT-310 in the United States and in Japan, pending clinical and regulatory success. Pfizer holds commercialization rights outside the United States and Japan. Roche will start a global phase III study on RVT-310.
For the deal, Roche is making an upfront payment of $7.1 billion and a near-term milestone payment of $150 million.
FDA Approves Pfizer’s Penbraya & Lilly’s Omvoh: The FDA granted approval to Pfizer’s pentavalent meningococcal vaccine (MenABCWY) called Penbraya. The vaccine is approved for adolescents and young adults, 10-25 years of age, for the prevention of meningococcal disease caused by five meningococcal serogroups that cause the majority of invasive meningococcal diseases, serogroups A, B, C, W and Y.
Penbraya combines the components from Pfizer’s two other meningococcal vaccines, Trumenba and Nimenrix. The approval was based on data from phase II and phase III studies, which showed that Penbraya had robust immunogenicity, which was non-inferior to Trumenba + Menveo for all serogroups.
Pfizer and partner BioNTech announced positive early top-line data from a phase I/II study evaluating a mRNA-based combination vaccine candidate against influenza and COVID-19. The data from the study showed that the lead formulations demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains. The companies plan to start a pivotal late-stage study on the combination vaccine.
The FDA also granted approval to Eli Lilly’s drug, Omvoh (mirikizumab), for treating moderately to severely active UC in adults. The FDA had earlier issued a complete response letter to the biologic license application seeking approval of mirikizumab for UC in April. Back then, the FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. Omvoh’s approval makes it Lilly’s first approved drug for a type of IBD indication. The approval was based on data from two phase III studies under the LUCENT program. In the pivotal studies, Omvoh achieved primary and key secondary endpoints, including sustained clinical remission.
Omvoh has already been launched in Japan and the EU. The drug is in late-stage development for Crohn's disease.
The NYSE ARCA Pharmaceutical Index declined 1.5% 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, Merck rose the most (5.1%), while Lilly declined the most (3.9%).
In the past six months, Lilly has risen the most (43.4%), while Pfizer has declined the most (19.9%).
(See the last pharma stock roundup here: JNJ Posts Upbeat Q3 Earnings, PFE, NVO Revise 2023 View)
What's Next in the Pharma World?
Watch out for LLY, PFE and NVO’s Q3 earnings and pipeline and regulatory updates next week.