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Pharma Stock Roundup: AZN, SNY, ABBV Q2 Results, MRK, MRNA Cancer Jab in Phase III
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This week, AstraZeneca (AZN - Free Report) , Sanofi (SNY - Free Report) and AbbVie (ABBV - Free Report) and Roche announced second-quarter earnings. Merck (MRK - Free Report) and partner Moderna announced that their personalized mRNA-based skin cancer vaccine has entered late-stage development. Eli Lilly’s (LLY - Free Report) obesity candidate, tirzepatide, demonstrated significant and superior weight loss in two more pivotal studies.
Recap of the Week’s Most Important Stories
Earnings Update: 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 some new products were partially offset by the impact of Aubagio generic competition in the United States. Sanofi Specialty Care GBU sales increased 11.8%. Vaccines GBU sales rose 9.1%. Dupixent sales rose 34.2% at CER in the quarter. The company slightly increased its 2023 earnings growth expectations at CER, partly due to approximately €400 million expected to be generated from one-off COVID vaccine revenues in the second half of the year.
AbbVie beat second-quarter estimates for both earnings and sales and also raised its previously issued financial outlook for 2023. While earnings declined 13.6% year over year, sales declined 4.2% on an operational basis mainly due to lower sales of key blockbuster medicine, Humira. The drug’s sales declined 24.8% on an operational basis due to biosimilar competition, both in the United States and ex-U.S. countries. Nonetheless, Humira sales decline wasn’t as severe as expected. Sales of newer immunology medicines, Rinvoq and Skyrizi, continued to remain strong.
Roche’s sales in the first half of 2023 declined 8% in CHF while core earnings per share declined 5%. Sales in the Pharmaceuticals Division were up 8% in CHF, driven by strong global demand for newer drugs. The Diagnostics division’s sales were down 23% in CHF as COVID-19 test sales dropped in the first half of 2023 from the year-ago levels.
Roche maintained its financial guidance for 2023. Its Group sales are expected to decline in the low single-digit range (at CER) due to a decline in sales of its COVID products. Core earnings per share are expected to develop broadly in line with the sales decline (at CER).
AstraZeneca beat estimates for both earnings and sales in the second quarter. Total revenues rose 9%, including revenues from COVID products. Excluding COVID products, total revenues rose 17%. Earnings rose 38% in the quarter. AstraZeneca reiterated its guidance for total revenues and core EPS for 2023.
Merck, Moderna Cancer Vaccine Enters Late-Stage Development: Merck and Moderna announced initiation of a pivotal phase III study on their personalized mRNA-based cancer vaccine (V940/mRNA-4157) in combination with Keytruda for the adjuvant treatment of patients with resected high-risk (Stage IIb-IV) melanoma.
The study, V940-001, has begun recruitment globally. The first patients are now enrolling in sites in Australia. The study will enroll approximately 1,089 patients at more than 165 sites in over 25 countries. The study’s primary endpoint is recurrence-free survival.
The European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending approval of Merck’s pipeline candidate, gefapixant for treating refractory or unexplained chronic cough. A final decision from the European Commission is expected later this year. Gefapixant is approved in Japan by the name of Lyfnua tablets while in the United States, the FDA, last year, issued a complete response letter to Merck’s new drug application, seeking approval of gefapixant.
Merck’s V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed for adults, met key immunogenicity and safety endpoints in two phase III studies. Top-line data from the studies showed that V116 elicited positive immune responses in both vaccine-naïve and vaccine-experienced adult patient populations.
Eli Lilly’s Tirzepatide Succeeds in Two More Obesity Studies: Eli Lilly’s two pivotal phase III studies on its obesity candidate, tirzepatide, SURMOUNT-3 and SURMOUNT-4 met all primary and key secondary objectives compared to placebo. In the SURMOUNT-3 study, participants achieved an additional 21.1% mean weight loss on treatment with tirzepatide, after 12 weeks of intensive lifestyle intervention. Participants in this study achieved a total mean weight loss of 26.6% from study entry over 84 weeks.
In the SURMOUNT-4 study, participants achieved a total mean weight loss of 26.0% with tirzepatide treatment over 88 weeks. In the SURMOUNT4 study, participants in the tirzepatide arm achieved 21.1% weight loss during a 36-week lead-in period and an additional 6.7% weight loss during a 52-week continued treatment period.
Tirzepatide is marketed as Mounjaro for type II diabetes and is already benefiting from strong demand trends. Mounjaro has showed superior weight-loss reduction in clinical studies like SURMOUNT-1 and SURMOUNT-2 for the obesity indication.
J&J Offers to Exchange Shares of Kenvue: J&J has initiated an exchange offer for shares of its divested Consumer Health company, Kenvue, that it currently owns as the form of its next step in the separation.
In May 2023, J&J spun off its Consumer Health segment into a new publicly-traded company. This newly listed company, called Kenvue, began trading on the New York Stock Exchange under the ticker symbol “KVUE” with effect from May 4.
J&J owns 89.6% of total outstanding shares of Kenvue’s common stock and is the majority shareholder. With the exchange offer, J&J intends to split-off at least 80.1% of the shares of Kenvue. As part of the exchange offer, J&J shareholders have the choice to exchange all, some or none of their shares of J&J common stock for shares of Kenvue at a discount of 7%.
With the complete separation of the Consumer Health segment, J&J will become a two-sector company focused on Pharmaceutical and MedTech fields.
AbbVie Begins Phase III Study on Rinvoq for Hidradenitis Suppurativa: AbbVie announced that the first patient has been dosed in a phase III study evaluating Rinvoq (upadacitinib) for treating adults and adolescents with moderate-to-severe hidradenitis suppurativa, a difficult-to-treat chronic, inflammatory disease.
Rinvoq is already approved for treating several immunology indications like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis. Phase III studies are ongoing to evaluate Rinvoq for giant cell arteritis and takayasu arteritis.
The CHMP gave a positive opinion recommending granting conditional marketing authorization to AbbVie’s pipeline candidate epcoritamab to be marketed as Tepkinly. AbbVie is seeking approval in the EU for epcoritamab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Epcoritamab was approved as Epkinly for certain patients with relapsed/refractory DLBCL in the United States in May. DLBCL is a common, aggressive and fast-growing form of non-Hodgkin's lymphoma.
Roche’s Partnership with Alnylam for Hypertension Candidate: Roche entered a joint development and commercialization deal with Alnylam for the latter’s hypertension candidate zilebesiran. The RNAi therapeutic candidate is being developed in a phase II study to treat hypertension in patients with high cardiovascular risk. Roche/Alnylam believe that zilebesiran has the potential to treat the above patients by robustly and durably lowering blood pressure. Alnylam and Roche will co-commercialize zilebesiran in the United States and share cost and profits equally.
The CHMP also recommended expanded use of Roche’s spinal muscular atrophy (SMA) drug, Evrysdi (risdiplam) to treat infants with SMA (from birth to below two months of age). Evrysdi is currently approved in the EU for the treatment of SMA patients aged two months or older.
The NYSE ARCA Pharmaceutical Index declined 0.42% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: AZN, SNY, ABBV Q2 Results, MRK, MRNA Cancer Jab in Phase III
This week, AstraZeneca (AZN - Free Report) , Sanofi (SNY - Free Report) and AbbVie (ABBV - Free Report) and Roche announced second-quarter earnings. Merck (MRK - Free Report) and partner Moderna announced that their personalized mRNA-based skin cancer vaccine has entered late-stage development. Eli Lilly’s (LLY - Free Report) obesity candidate, tirzepatide, demonstrated significant and superior weight loss in two more pivotal studies.
Recap of the Week’s Most Important Stories
Earnings Update: 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 some new products were partially offset by the impact of Aubagio generic competition in the United States. Sanofi Specialty Care GBU sales increased 11.8%. Vaccines GBU sales rose 9.1%. Dupixent sales rose 34.2% at CER in the quarter. The company slightly increased its 2023 earnings growth expectations at CER, partly due to approximately €400 million expected to be generated from one-off COVID vaccine revenues in the second half of the year.
AbbVie beat second-quarter estimates for both earnings and sales and also raised its previously issued financial outlook for 2023. While earnings declined 13.6% year over year, sales declined 4.2% on an operational basis mainly due to lower sales of key blockbuster medicine, Humira. The drug’s sales declined 24.8% on an operational basis due to biosimilar competition, both in the United States and ex-U.S. countries. Nonetheless, Humira sales decline wasn’t as severe as expected. Sales of newer immunology medicines, Rinvoq and Skyrizi, continued to remain strong.
Roche’s sales in the first half of 2023 declined 8% in CHF while core earnings per share declined 5%. Sales in the Pharmaceuticals Division were up 8% in CHF, driven by strong global demand for newer drugs. The Diagnostics division’s sales were down 23% in CHF as COVID-19 test sales dropped in the first half of 2023 from the year-ago levels.
Roche maintained its financial guidance for 2023. Its Group sales are expected to decline in the low single-digit range (at CER) due to a decline in sales of its COVID products. Core earnings per share are expected to develop broadly in line with the sales decline (at CER).
AstraZeneca beat estimates for both earnings and sales in the second quarter. Total revenues rose 9%, including revenues from COVID products. Excluding COVID products, total revenues rose 17%. Earnings rose 38% in the quarter. AstraZeneca reiterated its guidance for total revenues and core EPS for 2023.
Merck, Moderna Cancer Vaccine Enters Late-Stage Development: Merck and Moderna announced initiation of a pivotal phase III study on their personalized mRNA-based cancer vaccine (V940/mRNA-4157) in combination with Keytruda for the adjuvant treatment of patients with resected high-risk (Stage IIb-IV) melanoma.
The study, V940-001, has begun recruitment globally. The first patients are now enrolling in sites in Australia. The study will enroll approximately 1,089 patients at more than 165 sites in over 25 countries. The study’s primary endpoint is recurrence-free survival.
The European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion recommending approval of Merck’s pipeline candidate, gefapixant for treating refractory or unexplained chronic cough. A final decision from the European Commission is expected later this year. Gefapixant is approved in Japan by the name of Lyfnua tablets while in the United States, the FDA, last year, issued a complete response letter to Merck’s new drug application, seeking approval of gefapixant.
Merck’s V116, an investigational, 21-valent pneumococcal conjugate vaccine specifically designed for adults, met key immunogenicity and safety endpoints in two phase III studies. Top-line data from the studies showed that V116 elicited positive immune responses in both vaccine-naïve and vaccine-experienced adult patient populations.
Eli Lilly’s Tirzepatide Succeeds in Two More Obesity Studies: Eli Lilly’s two pivotal phase III studies on its obesity candidate, tirzepatide, SURMOUNT-3 and SURMOUNT-4 met all primary and key secondary objectives compared to placebo. In the SURMOUNT-3 study, participants achieved an additional 21.1% mean weight loss on treatment with tirzepatide, after 12 weeks of intensive lifestyle intervention. Participants in this study achieved a total mean weight loss of 26.6% from study entry over 84 weeks.
In the SURMOUNT-4 study, participants achieved a total mean weight loss of 26.0% with tirzepatide treatment over 88 weeks. In the SURMOUNT4 study, participants in the tirzepatide arm achieved 21.1% weight loss during a 36-week lead-in period and an additional 6.7% weight loss during a 52-week continued treatment period.
Tirzepatide is marketed as Mounjaro for type II diabetes and is already benefiting from strong demand trends. Mounjaro has showed superior weight-loss reduction in clinical studies like SURMOUNT-1 and SURMOUNT-2 for the obesity indication.
J&J Offers to Exchange Shares of Kenvue: J&J has initiated an exchange offer for shares of its divested Consumer Health company, Kenvue, that it currently owns as the form of its next step in the separation.
In May 2023, J&J spun off its Consumer Health segment into a new publicly-traded company. This newly listed company, called Kenvue, began trading on the New York Stock Exchange under the ticker symbol “KVUE” with effect from May 4.
J&J owns 89.6% of total outstanding shares of Kenvue’s common stock and is the majority shareholder. With the exchange offer, J&J intends to split-off at least 80.1% of the shares of Kenvue. As part of the exchange offer, J&J shareholders have the choice to exchange all, some or none of their shares of J&J common stock for shares of Kenvue at a discount of 7%.
With the complete separation of the Consumer Health segment, J&J will become a two-sector company focused on Pharmaceutical and MedTech fields.
AbbVie Begins Phase III Study on Rinvoq for Hidradenitis Suppurativa: AbbVie announced that the first patient has been dosed in a phase III study evaluating Rinvoq (upadacitinib) for treating adults and adolescents with moderate-to-severe hidradenitis suppurativa, a difficult-to-treat chronic, inflammatory disease.
Rinvoq is already approved for treating several immunology indications like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy, Crohn’s disease and ulcerative colitis. Phase III studies are ongoing to evaluate Rinvoq for giant cell arteritis and takayasu arteritis.
The CHMP gave a positive opinion recommending granting conditional marketing authorization to AbbVie’s pipeline candidate epcoritamab to be marketed as Tepkinly. AbbVie is seeking approval in the EU for epcoritamab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Epcoritamab was approved as Epkinly for certain patients with relapsed/refractory DLBCL in the United States in May. DLBCL is a common, aggressive and fast-growing form of non-Hodgkin's lymphoma.
Roche’s Partnership with Alnylam for Hypertension Candidate: Roche entered a joint development and commercialization deal with Alnylam for the latter’s hypertension candidate zilebesiran. The RNAi therapeutic candidate is being developed in a phase II study to treat hypertension in patients with high cardiovascular risk. Roche/Alnylam believe that zilebesiran has the potential to treat the above patients by robustly and durably lowering blood pressure. Alnylam and Roche will co-commercialize zilebesiran in the United States and share cost and profits equally.
The CHMP also recommended expanded use of Roche’s spinal muscular atrophy (SMA) drug, Evrysdi (risdiplam) to treat infants with SMA (from birth to below two months of age). Evrysdi is currently approved in the EU for the treatment of SMA patients aged two months or older.
The NYSE ARCA Pharmaceutical Index declined 0.42% 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, AbbVie rose the most (up 4.7%), while Merck declined the most (2.9%).
In the past six months, Lilly has risen the most (33.6%), while Pfizer has declined the most (16.9%).
(See the last pharma stock roundup here: JNJ, NVS Upbeat Q2 Results, FDA Nod to SNY & AZN RSV Antibody)
What's Next in the Pharma World?
Watch out for earnings updates from Pfizer & Merck and regular pipeline and regulatory updates next week.