AbbVie ( ABBV Quick Quote ABBV - Free Report) , Merck ( MRK Quick Quote MRK - Free Report) , Eli Lilly ( LLY Quick Quote LLY - Free Report) and Novartis ( NVS Quick Quote NVS - Free Report) announced fourth-quarter and full-year 2021 results. Pfizer ( PFE Quick Quote PFE - Free Report) stopped clinical development of vupanorsen, which was being evaluated in cardiovascular risk reduction and severe hypertriglyceridemia indications and returned development rights to partner Ionis. Recap of the Week’s Most Important Stories Merck’s fourth-quarter results were Earnings Update: better than expected as it beat estimates for both earnings and sales. Sales of its blockbuster medicine, Keytruda, rose 15% in the quarter. Its newly authorized COVID-19 antiviral pill, molnupiravir generated sales of $952 million during the fourth quarter. Sales of its key vaccine, Gardasil and Gardasil 9, surged 53% year over year. Merck issued its financial guidance for 2022. It expects revenues to be in the range of $56.1 billion to $57.6 billion in 2022. Adjusted earnings per share are expected to be between $7.12 and $7.27
missed estimates for earnings while beating the same for sales. Lilly’s sales were aided by revenues from its COVID-19 cocktail antibody medicine, which generated $1.06 billion in revenues. Among the key products, Trulicity sales rose 25% year over year, while Taltz was up 31%. Lilly reiterated the financial guidance for 2022, which it had provided in December 2021.
fourth-quarter results were mixed as it beat estimates for earnings while missing the same for sales. Sales of key drug Humira rose 3.5% while that of Botox Cosmetic was up 26.6% on an operational basis. Sales of new inflammatory drugs, Rinvoq and Skyrizi, are growing strong. AbbVie issued EPS guidance for 2022. The company expects adjusted EPS to be in the range of $14.00-$14.20, suggesting year-over-year growth of 10.2%-11.8%.
missed estimates for both earnings and sales in the fourth quarter. Sales in Innovative Medicines rose 7% at constant currency driven by the strong performance of drugs like Entresto, Cosentyx, Kesimpta, and Zolgensma, which made up for generic erosion. Sales in the Sandoz division rose 2%. The company expects sales and core operating income to grow in the mid-single digit range in 2022. Pfizer and Ionis announced that they are Pfizer Ends Vupanorsen Development; Returns Rights to Ionis: discontinuing their partnered program for vupanorsen, which was being developed for cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG). The study met its primary endpoint. Though the study achieved statistically significant reductions in non-high-density lipoprotein cholesterol (non-HDL-C) in triglycerides (TG) and angiopoietin-like 3 (ANGPTL3), the magnitude of reductions in non-HDL-C and TG observed does not support the continuation of the program for the abovementioned indications. In the study, treatment with vupanorsen led to dose-dependent increases in liver fat. Higher doses of the medicine caused elevations in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Pfizer has decided to return development rights to vupanorsen to Ionis. Pfizer bought rights to the candidate from Ionis in November 2019.
The European Commission approved Pfizer’s tyrosine kinase inhibitor (“TKI”) cancer drug, Lorviqua for ALK-positive advanced non-small cell lung cancer (NSCLC) in adults
previously not treated with an ALK inhibitor. Presently, Lorviqua is approved to treat ALK-positive NSCLC in patients previously treated with another ALK TKI therapy. Lorviqua is available as Lorbrena in the United States and is also approved for the treatment of ALK-positive NSCLC in the first-line setting.
Pfizer and BioNTech initiated a rolling submission, seeking approval to expand their COVID-19 vaccine’s Emergency Use Authorization (EUA) to allow their use in children 6 months through 4 years of age. The companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group.
: Lilly said it was Lilly Ends Olumiant Lupus Phase III Studies discontinuing the phase III development program on it and Incyte’s drug, Olumiant (baricitinib) for systemic lupus erythematosus. While one of the two pivotal phase III studies evaluating baricitinib 4-mg oral dose for SLE met the primary endpoint of SRI-4 response, the second study failed to meet the same. Neither of the studies met the key secondary endpoints.
Lilly also said the FDA may issue a complete response letter to its regulatory application seeking approval of Olumiant for moderate-to-severe atopic dermatitis as the company does not have alignment with the FDA on the indicated population. Olumiant is already approved for the disease in Japan and Europe. Olumiant is presently approved to treat rheumatoid arthritis and COVID-19 in hospitalized patients (emergency use).
The NYSE ARCA Pharmaceutical Index rose 2% in the last five trading sessions.
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 (3.5%), while AstraZeneca declined the most (3.7%).
In the past six months, AbbVie has recorded the maximum gain (25%), while Lilly declined the most (6.8%)
(See the last pharma stock roundup here:
J&J Q4 Earnings, FDA’s Rejection of PFE, MRK Pipeline Drugs) What's Next in the Pharma World?
Watch out for Pfizer, AstraZeneca and Glaxo’s Q4 and 2021 results and regular pipeline and regulatory updates next week.