Revenue of $10.43B (+26.3% Y/Y) beats by $290M.
Adj. operating margin of 47.0% vs. guidance of ~47.5%.
Friday, July 31, 2020
Merck plans large trials of antiviral COVID-19 drug in September
Merck & Co Inc (MRK.N) on Friday posted a higher-than-expected quarterly profit and raised its full-year earnings forecast on resilient demand for its blockbuster cancer therapy Keytruda during the COVID-19 pandemic, sending its shares up 3%.
The company said it was planning to begin human studies of an experimental coronavirus vaccine it acquired through its acquisition of Themis Bioscience in the third quarter.
It has lagged some rivals that have already begun late-stage trials with hopes of curtailing a pandemic that has hammered economies around the globe.
Merck is also developing a separate vaccine for the coronavirus in collaboration with research non-profit IAVI and developing an antiviral therapy for COVID-19 in a mid-stage study along with Ridgeback Bio.
Quarterly sales of Keytruda, Merck’s key growth driver, rose nearly 29% to $3.39 billion, beating the average estimate of $3.13 billion, according to Refinitiv data.
However, Merck said sales of its vaccines and other treatments were hurt as patients avoided doctor offices due to the COVID-19 pandemic, leading to a $1.6 billion hit to its second-quarter sales.
Pfizer Inc (PFE.N) and Eli Lilly (LLY.N) also reported second-quarter results this week that highlighted the same impact on sales from a drop in visits to doctors.
Merck sees a $1.95 billion hit to 2020 revenue from the pandemic.
The company said it now expects full-year adjusted profit of between $5.63 to $5.78 per share, compared with its prior forecast of between $5.17 and $5.37.
Excluding items, Merck earned $1.37 per share, beating estimates of $1.04, according to IBES data from Refinitiv.
Total sales fell 7.6% to $10.87 billion, but beat analysts’ estimates of $10.39 billion.
Takeda Pharmaceutical misses on revenue
Takeda Pharmaceutical (NYSE:TAK): Q1 Non-GAAP EPS of ¥122.00; GAAP EPS of ¥53.00.
Revenue of ¥801.9B misses by ¥3.34B.
Pfizer, BioNTech pledge 120M doses of COVID vaccine to Japan
Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) say they will supply Japan with 120M doses of their mRNA-based vaccine candidate against the coronavirus in H1 2021; financial details are not disclosed.
The companies say they are on track to seek regulatory review for the vaccine as early as this October, with a goal of manufacturing up to 100M doses for use globally by the end of 2020.
Earlier this week, Pfizer and BioNTech announced the start of late-stage human trials for their BNT162b2 vaccine candidate.
Tiziana submits patent application for expanded use of Foralumab in COVID-19
Tiziana Life Sciences (NASDAQ:TLSA) soars 48% premarket on the heels of submitting a patent application for the potential use of nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19 alone or in combination with other anti-viral drugs.
The company has a worldwide exclusive license for nasal administration of Foralumab and other anti-CD3 mAbs for the treatment of neurodegenerative and other diseases.
Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of regulatory T-cells.
FDA OKs Roche triplet therapy for certain type of melanoma
Under Priority Review status, the FDA approves Roche’s (OTCQX:RHHBY) triplet therapy of Tecentriq (atezolizumab), Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma.
This is an example of the “cocktail” approach to treating cancer with drugs with different mechanisms of action. Atezolizumab is a PD-L1 blocker and cobimetinib and vemurafenib are kinase inhibitors.
Sanofi/Glaxo join Operation Warp Speed, to supply 100M Covid-19 vax doses to U.S.
Sanofi (NASDAQ:SNY) and development partner GlaxoSmithKline (NYSE:GSK) have joined the U.S. government’s Operation Warp Speed aimed at accelerating the development a COVID-19 recombinant protein-based vaccine.
The feds will provide up to $2.1B to support the effort, more than half to help fund development and the remainder to pay for the delivery of 100M doses. The government will have an option to buy up to an additional 500M doses.
Sanofi is leading development and registration while both companies scaling are up manufacturing of the antigen and adjuvant to produce up to 1B doses per year.
A Phase 1/2 clinical trial will launch in September followed by a Phase 3 by year-end. If all goes well, Sanofi will file a marketing application in H1 2021.
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