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Second-quarter earnings releases picked up for the drug and biotech sector this week, with drugmakers like AstraZeneca (AZN - Free Report) , Sanofi (SNY - Free Report) and AbbVie (ABBV - Free Report) coming up with their reports. Merck’s (MRK - Free Report) late-stage study on respiratory syncytial virus (RSV) treatment for infants met its primary endpoint. The European Commission approved Pfizer’s (PFE - Free Report) Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with hemophilia B and AbbVie’s blockbuster drug Skyrizi for its fourth indication.
Recap of the Week’s Most Important Stories
Earnings Update: AbbVie beat estimates for both earnings and sales. Sales rose 5.6% year over year on an operational basis, driven by higher sales of key drugs like Rinvoq, Skyrizi, Venclexta and Vraylar. Sales of blockbuster immunology drugs Rinvoq and Skyrizi rose 60.4% and 46.6%, respectively, on an operational basis due to label expansions to the drug to include new patient populations. AbbVie raised its EPS guidance for 2024. The company expects adjusted EPS in the range of $10.71-$10.91, up from the previous guidance of $10.61-$10.81.
AstraZeneca beat estimates for both earnings and sales. While sales rose 17% at CER, core earnings fell 3% year over year. Among the key drugs, sales of cancer drugs, Tagrisso and Imfinzi rose 12% and 18%, respectively. Diabetes drug Farxiga rose 32%. Backed by a strong performance in the first half of the year, AstraZeneca raised its sales and earnings growth expectations for the year. Total revenues and core earnings are expected to increase at a mid-teens percentage at CER versus the prior expectation of a low double-digit to low teens percentage range.
Sanofi’s quarterly results were mixed as it beat estimates for earnings while missing the same for sales. Net sales rose 10.2% on a constant currency rate (“CER”) basis. Higher sales of blockbuster drug Dupixent and contributions from new products like Altuviiio and Nexviazyme were partially offset by the impact of generic competition on Aubagio sales and lower Vaccine sales. Sales of Dupixent rose 29.2% year over year at CER while Vaccines declined 4.8%. Sanofi improved its earnings growth expectations for 2024 from a decline in the low single-digit range to be stable at CER.
Pfizer’s Hemophilia B Gene Therapy Gets EU Approval: The European Commission (“EC”) granted conditional marketing authorization to Pfizer’s gene therapy, fidanacogene elaparvovec, for the treatment of severe and moderately severe hemophilia B, a rare genetic bleeding disorder. The drug will be marketed by the name of Durveqtix in the EU.
Fidanacogene elaparvovec was approved by the FDA in the United States by the name of Beqvez in April this year. The therapy has been designed in such a way that it allows hemophilia B patients to produce factor IX (FIX) themselves via a one-time dose rather than frequent intravenous FIX infusions required with standard-of-care therapies. Despite regular intravenous infusions, several hemophilia B patients are at risk of spontaneous bleeding episodes. In clinical studies, Beqvez/Durveqtix has shown the potential to offer long-term bleed protection in a one-time dose, reducing or eliminating bleeds in some hemophilia B patients.
Pfizer’s phase III study evaluating giroctocogene fitelparvovec, its one-time gene therapy candidate for treating moderately severe to severe hemophilia A, met its primary and key secondary endpoints. The study called AFFINE achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate (ABR) from Week 12 through at least 15 months of follow-up post-infusion compared with standard Factor VIII (FVIII) prophylactic treatment. Data from the study showed that a one-time 3e13 vg/kg dose of giroctocogene fitelparvovec by IV infusion led to a statistically significant reduction in ABR compared to the pre-infusion period.
Pfizer’s other hemophilia candidate, marstacimab, a novel subcutaneous therapy for the treatment of people with hemophilia A and B with and without inhibitors, is currently under review in the United States and EU.
AbbVie’s Skyrizi Gets EU Approval for Ulcerative Colitis: The EC also approved AbbVie’s blockbuster drug, Skyrizi, to treat adults with moderately to severely active ulcerative colitis (UC) in the European Union. Skyrizi was approved for the UC indication in the United States in June.
Skyrizi’s approval for the UC indication was based on data from two pivotal phase III studies, a 12-week induction study, INSPIRE1 and a 52-week maintenance study, COMMAND2. Both studies achieved the primary endpoint of clinical remission. The studies also achieved key secondary endpoints, including mucosal healing and histologic endoscopic mucosal healing.
Skyrizi, an interleukin-23 (IL-23) inhibitor, is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis and Crohn's disease. UC becomes the fourth approved indication for Skyrizi.
Merck’s RSV Antibody Meets Goal in Study in Infants: Merck announced positive data from a phase IIb/III study evaluating clesrovimab (MK-1654), its investigational preventive monoclonal antibody designed to protect infants from RSV disease. In the study, clesrovimab met all primary safety and efficacy endpoints. It reduced medically attended lower respiratory infections (MALRI) caused by RSV through Day 150, which was the study’s primary endpoint. Detailed data from the study will be presented at an upcoming medical meeting.
The NYSE ARCA Pharmaceutical Index rose 0.5% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: AZN, SNY, ABBV Q2 Earnings, PFE & MRK's Positive Pipeline News
Second-quarter earnings releases picked up for the drug and biotech sector this week, with drugmakers like AstraZeneca (AZN - Free Report) , Sanofi (SNY - Free Report) and AbbVie (ABBV - Free Report) coming up with their reports. Merck’s (MRK - Free Report) late-stage study on respiratory syncytial virus (RSV) treatment for infants met its primary endpoint. The European Commission approved Pfizer’s (PFE - Free Report) Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with hemophilia B and AbbVie’s blockbuster drug Skyrizi for its fourth indication.
Recap of the Week’s Most Important Stories
Earnings Update: AbbVie beat estimates for both earnings and sales. Sales rose 5.6% year over year on an operational basis, driven by higher sales of key drugs like Rinvoq, Skyrizi, Venclexta and Vraylar. Sales of blockbuster immunology drugs Rinvoq and Skyrizi rose 60.4% and 46.6%, respectively, on an operational basis due to label expansions to the drug to include new patient populations. AbbVie raised its EPS guidance for 2024. The company expects adjusted EPS in the range of $10.71-$10.91, up from the previous guidance of $10.61-$10.81.
AstraZeneca beat estimates for both earnings and sales. While sales rose 17% at CER, core earnings fell 3% year over year. Among the key drugs, sales of cancer drugs, Tagrisso and Imfinzi rose 12% and 18%, respectively. Diabetes drug Farxiga rose 32%. Backed by a strong performance in the first half of the year, AstraZeneca raised its sales and earnings growth expectations for the year. Total revenues and core earnings are expected to increase at a mid-teens percentage at CER versus the prior expectation of a low double-digit to low teens percentage range.
Sanofi’s quarterly results were mixed as it beat estimates for earnings while missing the same for sales. Net sales rose 10.2% on a constant currency rate (“CER”) basis. Higher sales of blockbuster drug Dupixent and contributions from new products like Altuviiio and Nexviazyme were partially offset by the impact of generic competition on Aubagio sales and lower Vaccine sales. Sales of Dupixent rose 29.2% year over year at CER while Vaccines declined 4.8%. Sanofi improved its earnings growth expectations for 2024 from a decline in the low single-digit range to be stable at CER.
Pfizer’s Hemophilia B Gene Therapy Gets EU Approval: The European Commission (“EC”) granted conditional marketing authorization to Pfizer’s gene therapy, fidanacogene elaparvovec, for the treatment of severe and moderately severe hemophilia B, a rare genetic bleeding disorder. The drug will be marketed by the name of Durveqtix in the EU.
Fidanacogene elaparvovec was approved by the FDA in the United States by the name of Beqvez in April this year. The therapy has been designed in such a way that it allows hemophilia B patients to produce factor IX (FIX) themselves via a one-time dose rather than frequent intravenous FIX infusions required with standard-of-care therapies. Despite regular intravenous infusions, several hemophilia B patients are at risk of spontaneous bleeding episodes. In clinical studies, Beqvez/Durveqtix has shown the potential to offer long-term bleed protection in a one-time dose, reducing or eliminating bleeds in some hemophilia B patients.
Pfizer’s phase III study evaluating giroctocogene fitelparvovec, its one-time gene therapy candidate for treating moderately severe to severe hemophilia A, met its primary and key secondary endpoints. The study called AFFINE achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate (ABR) from Week 12 through at least 15 months of follow-up post-infusion compared with standard Factor VIII (FVIII) prophylactic treatment. Data from the study showed that a one-time 3e13 vg/kg dose of giroctocogene fitelparvovec by IV infusion led to a statistically significant reduction in ABR compared to the pre-infusion period.
Pfizer’s other hemophilia candidate, marstacimab, a novel subcutaneous therapy for the treatment of people with hemophilia A and B with and without inhibitors, is currently under review in the United States and EU.
AbbVie’s Skyrizi Gets EU Approval for Ulcerative Colitis: The EC also approved AbbVie’s blockbuster drug, Skyrizi, to treat adults with moderately to severely active ulcerative colitis (UC) in the European Union. Skyrizi was approved for the UC indication in the United States in June.
Skyrizi’s approval for the UC indication was based on data from two pivotal phase III studies, a 12-week induction study, INSPIRE1 and a 52-week maintenance study, COMMAND2. Both studies achieved the primary endpoint of clinical remission. The studies also achieved key secondary endpoints, including mucosal healing and histologic endoscopic mucosal healing.
Skyrizi, an interleukin-23 (IL-23) inhibitor, is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis and Crohn's disease. UC becomes the fourth approved indication for Skyrizi.
Merck’s RSV Antibody Meets Goal in Study in Infants: Merck announced positive data from a phase IIb/III study evaluating clesrovimab (MK-1654), its investigational preventive monoclonal antibody designed to protect infants from RSV disease. In the study, clesrovimab met all primary safety and efficacy endpoints. It reduced medically attended lower respiratory infections (MALRI) caused by RSV through Day 150, which was the study’s primary endpoint. Detailed data from the study will be presented at an upcoming medical meeting.
The NYSE ARCA Pharmaceutical Index rose 0.5% 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.
In the last five trading sessions, AbbVie rose the most (6.4%), while Lilly declined the most (3.3%).
In the past six months, all the stocks were in the green. Lilly has risen the most (27.4%), while J&J has risen the least (0.2%).
(See the last pharma stock roundup here:JNJ, NVS Q2 Earnings, RHHBY’s Positive Obesity Pill Data)
What's Next in the Pharma World?
Watch this space for the second-quarter results of Pfizer, Novo Nordisk and Merck and regular pipeline and regulatory updates next week.
AstraZeneca, Sanofi, Merck and Pfizer have a Zacks Rank #3 (Hold) each, while AbbVie is a #4 Ranked (Sell) stock.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.