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This week, the last of the large drugmakers, AstraZeneca (AZN - Free Report) and Bayer (BAYRY - Free Report) announced their third-quarter results. Pfizer’s (PFE - Free Report) oral antiviral candidate for COVID-19, Paxlovid, was found to reduce the risk of hospitalization or death by 89% compared to placebo in an interim analysis of a phase II/III study. Merck (MRK - Free Report) got a new order for investigation COVID pill, molnupiravir from the U.S government while J&J (JNJ - Free Report) got a favorable ruling from the Oklahoma State Supreme in an opioid litigation.
Recap of the Week’s Most Important Stories
AstraZeneca & Bayer’s Q3 Results: AstraZeneca’s third-quarter results were mixed as it beat estimates for sales but missed the same for earnings. Product sales growth was driven by higher sales of new medicines across Oncology and CVRM units like Tagrisso and Farxiga, which offset the negative impact from slower sales growth in China.
AstraZeneca’s COVID-19 vaccine added $1.05 billion to revenues and one cent to earnings per share in the third quarter. It expects the vaccine to move to “modest profitability” on new orders received after it produced the vaccine at cost amid the pandemic. AstraZeneca maintained its previously issued financial guidance, which includes the impact of the Alexion acquisition.
Bayer beat estimates for third-quarter earnings. Total sales rose 14.3% after adjusting for currency and portfolio effects (Fx & portfolio adjusted). Agricultural business (Crop Science), sales rose 25.8% (Fx & portfolio adjusted) while prescription medicines (Pharmaceuticals) unit sales rose 7.1%. Sales of Bayer’s self-care products (Consumer Health) rose 10.9%. Bayer also raised its sales growth expectations to 7% on an Fx and portfolio adjusted basis, up from 6% previously.
Pfizer COVID Pill Cuts Hospitalization/Death Risk by 89%: Pfizer’s oral antiviral candidate for COVID-19, Paxlovid reduced hospitalizations and deaths substantially in an interim analysis of a phase II/III study. The data from the EPIC-HR study showed that Paxlovid reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness within three days of symptom onset.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. It plans to submit this data as part of a rolling submission to the FDA for seeking Emergency Use Authorization (EUA) for the oral antiviral drug.
U.S. to Buy More Courses of Merck’s COVID-19 Pill, If Approved: Merck along with partner Ridgeback Biotherapeutics announced that the U.S. government will exercise its option to purchase 1.4 million additional courses of oral antiviral medicine for COVID-19, molnupiravir for approximately $1 billion, if authorized by the FDA. Merck has already filed an application seeking EUA for molnupiravir for treating mild-to-moderate COVID-19 in at-risk adults. With the latest option exercise, the U.S. government committed to purchasing a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion from Merck. The government still has options remaining to purchase more than 2 million additional courses.
Japan’s government has also agreed to purchase approximately 1.6 million courses of molnupiravir, if authorized, from Merck for approximately $1.2 billion.Merck’s application seeking the authorized use of molnupiraviris being reviewed by Japan’s Pharmaceuticals and Medical Devices Agency.
Merck and Bayer announced the initiation of a phase III study, VICTOR, evaluating Verquvo (vericiguat) in patients with chronic heart failure and reduced ejection fraction who have not had a recent worsening heart failure event. Verquvo was approved in January 2021 to reduce the risk of cardiovascular death and heart failure hospitalization following hospitalization for heart failure or the need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. This approval was based on data from the VICTORIA study.
Oklahoma Supreme Court Overturns J&J’s Opioid Judgment: The Oklahoma State Supreme Court ruled in favor of J&J by overturning a district court’s ruling in an opioid litigation. In August 2019, J&J was ordered by a district court in Oklahoma to pay $572 million to the state of Oklahoma in connection with a lawsuit filed by the latter. The amount was later reduced to $465 in the final judgment.
The district court, back in 2019, had said that J&J created a public nuisance by marketing, selling, and distributing opioids and thus was liable for contributing to the state’s opioid-addiction crisis. The Supreme Court said that the district court wrongly interpreted the state's public nuisance law
The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: AZN, BAYRY Q3 Results, PFE COVID Pill's Strong Efficacy
This week, the last of the large drugmakers, AstraZeneca (AZN - Free Report) and Bayer (BAYRY - Free Report) announced their third-quarter results. Pfizer’s (PFE - Free Report) oral antiviral candidate for COVID-19, Paxlovid, was found to reduce the risk of hospitalization or death by 89% compared to placebo in an interim analysis of a phase II/III study. Merck (MRK - Free Report) got a new order for investigation COVID pill, molnupiravir from the U.S government while J&J (JNJ - Free Report) got a favorable ruling from the Oklahoma State Supreme in an opioid litigation.
Recap of the Week’s Most Important Stories
AstraZeneca & Bayer’s Q3 Results: AstraZeneca’s third-quarter results were mixed as it beat estimates for sales but missed the same for earnings. Product sales growth was driven by higher sales of new medicines across Oncology and CVRM units like Tagrisso and Farxiga, which offset the negative impact from slower sales growth in China.
AstraZeneca’s COVID-19 vaccine added $1.05 billion to revenues and one cent to earnings per share in the third quarter. It expects the vaccine to move to “modest profitability” on new orders received after it produced the vaccine at cost amid the pandemic. AstraZeneca maintained its previously issued financial guidance, which includes the impact of the Alexion acquisition.
Bayer beat estimates for third-quarter earnings. Total sales rose 14.3% after adjusting for currency and portfolio effects (Fx & portfolio adjusted). Agricultural business (Crop Science), sales rose 25.8% (Fx & portfolio adjusted) while prescription medicines (Pharmaceuticals) unit sales rose 7.1%. Sales of Bayer’s self-care products (Consumer Health) rose 10.9%. Bayer also raised its sales growth expectations to 7% on an Fx and portfolio adjusted basis, up from 6% previously.
Pfizer COVID Pill Cuts Hospitalization/Death Risk by 89%: Pfizer’s oral antiviral candidate for COVID-19, Paxlovid reduced hospitalizations and deaths substantially in an interim analysis of a phase II/III study. The data from the EPIC-HR study showed that Paxlovid reduced the risk of hospitalization or death by 89% in non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness within three days of symptom onset.
At the recommendation of an independent Data Monitoring Committee, Pfizer stopped the study early due to the high efficacy observed in the interim analysis. It plans to submit this data as part of a rolling submission to the FDA for seeking Emergency Use Authorization (EUA) for the oral antiviral drug.
U.S. to Buy More Courses of Merck’s COVID-19 Pill, If Approved: Merck along with partner Ridgeback Biotherapeutics announced that the U.S. government will exercise its option to purchase 1.4 million additional courses of oral antiviral medicine for COVID-19, molnupiravir for approximately $1 billion, if authorized by the FDA. Merck has already filed an application seeking EUA for molnupiravir for treating mild-to-moderate COVID-19 in at-risk adults. With the latest option exercise, the U.S. government committed to purchasing a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion from Merck. The government still has options remaining to purchase more than 2 million additional courses.
Japan’s government has also agreed to purchase approximately 1.6 million courses of molnupiravir, if authorized, from Merck for approximately $1.2 billion.Merck’s application seeking the authorized use of molnupiraviris being reviewed by Japan’s Pharmaceuticals and Medical Devices Agency.
Merck and Bayer announced the initiation of a phase III study, VICTOR, evaluating Verquvo (vericiguat) in patients with chronic heart failure and reduced ejection fraction who have not had a recent worsening heart failure event. Verquvo was approved in January 2021 to reduce the risk of cardiovascular death and heart failure hospitalization following hospitalization for heart failure or the need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. This approval was based on data from the VICTORIA study.
Oklahoma Supreme Court Overturns J&J’s Opioid Judgment: The Oklahoma State Supreme Court ruled in favor of J&J by overturning a district court’s ruling in an opioid litigation. In August 2019, J&J was ordered by a district court in Oklahoma to pay $572 million to the state of Oklahoma in connection with a lawsuit filed by the latter. The amount was later reduced to $465 in the final judgment.
The district court, back in 2019, had said that J&J created a public nuisance by marketing, selling, and distributing opioids and thus was liable for contributing to the state’s opioid-addiction crisis. The Supreme Court said that the district court wrongly interpreted the state's public nuisance law
The NYSE ARCA Pharmaceutical Index declined 0.3% 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, Pfizer rose the most (14.6%) while Merck declined the most (7.2%)
In the past six months, Lilly recorded the maximum gain (34.7%) while Novartis declined the most (6.3%)
(See the last pharma stock roundup here: Big Pharma Q3 Results, FDA Panel’s Vote for PFE COVID Jab)
What's Next in the Pharma World?
Watch out for the results of Pfizer and the regular pipeline and regulatory updates next week.