This week, large drugmakers
Eli Lilly ( LLY Quick Quote LLY - Free Report) , Merck ( MRK Quick Quote MRK - Free Report) , Sanofi ( SNY Quick Quote SNY - Free Report) , Glaxo ( GSK Quick Quote GSK - Free Report) , AstraZeneca ( AZN Quick Quote AZN - Free Report) and Novartis ( NVS Quick Quote NVS - Free Report) reported their first-quarter results. Most of them reported disappointing results this time around due to the pandemic, and the presence of a related stocking benefit in the year-ago quarter. J&J ( JNJ Quick Quote JNJ - Free Report) was allowed to resume vaccinations with its single-shot COVID-19 vaccine in the United States. Recap of the Week’s Most Important Stories Lilly’s first-quarter results were disastrous as it Earnings Update: missed estimates for both earnings and sales. Lilly also narrowed its previously issued earnings and sales forecast for 2021 due to lower-than-expected demand for its COVID-19 antibody medicines and higher R&D costs.
results were disappointing as it missed estimates for both earnings and sales. A decent performance of Keytruda, Lynparza, Bridion and Animal Health was offset by business disruption due to the pandemic, which particularly impacted vaccines. The company maintained its sales and earnings outlook for the year
first-quarter earnings matched estimates while sales missed the same, reflecting COVID-19 related disruptions across all markets. Glaxo maintained its previous guidance for adjusted earnings to decline in 2021 by mid- to high-single digit percentage at CER.
Sanofi’s results were strong as it
beat estimates for both earnings and sales. Dupixent continued its outstanding performance in the quarter. The Vaccines unit also delivered growth in its core segments in the quarter. Sanofi continues to expect earnings to grow in a high single-digit range in 2021.
Novartis’ earnings and sales missed the Zacks Consensus Estimate. The
pandemic hurt demand for Novartis’ products. Sales in the Innovative Medicines were flat at constant currency while that in the Sandoz division declined 9%. The company expects net sales in 2021 to grow in low- to mid-single digits.
AstraZeneca beat estimates for earnings as well as sales. The company’s COVID-19 vaccine added $275 million to revenues from delivery of 68 million doses in several countries. The company maintained its financial outlook for revenues and core earnings in 2021.
J&J announced that theFDA and U.S. Centers for Disease Control and Prevention (“CDC”) has allowed it to resume vaccinations with its single-shot COVID-19 vaccine J&J COVID-19 Vaccination Resume in the United States.:
Earlier this month, the FDA and U.S. Centers for Disease Control and Prevention (“CDC”) had
jointly issued a statement to recommend a temporary pause in the use of J&J’s vaccine in the United States as they reviewed six reports of “rare and severe” blood clots in a few individuals who had taken the J&J vaccine.
The decision to resume vaccinations followed a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP). The committee reviewed some cases of adverse events involving blood clots in combination with low platelet counts in some people one to three weeks after receiving J&J’s vaccine. J&J has updated the Emergency Use Authorization Fact Sheets to include important information about diagnosis and management of the blood clot issues.
Pfizer acquired private biotech, Amplyx Pharmaceuticals, which has expanded its anti-infectives pipeline with the addition of novel antifungal candidate, fosmanogepix. Fosmanogepix is in a phase II study for the treatment of invasive fungal infections. In addition, the acquisition adds Amplyx's early-stage pipeline that includes potential antiviral and antifungal therapies to Pfizer’s portfolio. Pfizer Buys Amplyx Pharmaceuticals, Expands Anti-Infectives Pipeline: Sanofi to Sanofi announced an agreement with Moderna to help manufacture the latter’s COVID-19 vaccine. Sanofi will manufacture up to 200 million doses of Moderna’s vaccine in the United States,starting in September 2021 by leveraging its infrastructure at its site in Ridgefield, NJ. Sanofi is presently supporting manufacture of three different COVID-19 vaccines, the other two companies being BioNTech and J&J. Provide Manufacturing Support for Moderna’s COVID-19 Vaccine:
Sanofi’s phase III study evaluating its extended half-life RSV monoclonal antibody (mAb), nirsevimab as a passive immunization to help prevent RSV in healthy preterm and term infants met its primary endpoint. The data showed that nirsevimab led to a statistically significant reduction in respiratory tract infections (LRTI) infections requiring medical care, in the above patient population compared to placebo through a typical RSV season.
Merck Deals With India-Based Drugmakers Merck announced non-exclusive voluntary licensing agreements with five India-based generic drugmakers to accelerate availability of molnupiravir, its investigation oral antiviral for COVID-19, in the country and other low- and middle-income countries once the candidate gets emergency approval from the FDA. Merck is developing molnupiravir in partnership with Ridgeback Biotherapeutics in a phase III study for the treatment of non-hospitalized patients with confirmed COVID-19 to Expand COVID Drug Production: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency gave a positive opinion recommending conditional marketing approval of AstraZeneca’s Koselugo (selumetinib) for the treatment of pediatric patients with neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), a rare and debilitating genetic condition. Koselugo was approved by the FDA for the same indication in April 2020. CHMP Nods for AstraZeneca’s Cancer Drugs:
The CHMP also recommended approval of blockbuster medicine, Tagrisso for adjuvant early-stage EGFR-mutated lung cancer based on data from the ADAURA phase III study. A similar label expansion approval in the United States was granted by the FDA in December 2020.
The NYSE ARCA Pharmaceutical Index declined 1.3% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks were in the red except
AbbVie, which recorded a gain of 0.8%. Merck declined the most (5.5%).
In the past six months, Lilly recorded the maximum gain (38.4%) while Merck declined the most (4.0%).
(See the last pharma stock roundup here:
JNJ’s Q1 Earnings & Sales Beat, RHHBY Sales, & Other Updates) What's Next in the Pharma World?
Watch out for Pfizer’s first-quarter results and regular pipeline and regulatory updates next week.
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