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Pharma Stock Roundup: Lilly, Bristol-Myers, Novartis Q1 Earnings & More
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Earnings season for the pharma sector started in full flow this week with companies like Lilly (LLY - Free Report) , Novartis (NVS - Free Report) , Bristol-Myers (BMY - Free Report) , Roche, AstraZeneca, Glaxo (GSK - Free Report) and Sanofi (SNY - Free Report) reporting results. So far, it looks like a mixed quarter for the sector.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Lilly’s Q1 results were mixed with the company surpassing earnings expectations but missing on the top line (Read more: Lilly Tops Q1 Earnings, Misses Sales, Shares Down). The company’s pipeline was a key focus area of discussion given the recent setback related to baricitinib getting a complete response letter (CRL) from the FDA -- the company plans to meet with the agency to determine a path forward. Swiss drugmaker Novartis also topped earnings expectations (Read more: Novartis Tops Q1 Earnings: Cosentyx, Entresto Boost Sales) while British drugmaker Glaxo’s earnings were in line with expectations (Read more: Glaxo Reports In-Line Q1 Earnings, Reiterates View). Meanwhile, it was a “beat and raise” quarter for Bristol-Myers with immuno-oncology drug, Opdivo, putting in a strong performance (Read more: Bristol-Myers Beats on Q1 Earnings, Ups 2017 View).
Pipeline Updates from BMY: Bristol-Myers had quite a few pipeline updates this week apart from reporting earnings results. The company announced a new clinical research collaboration for the evaluation of the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers’ Opdivo + standard chemo as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1. Initial results from the study are expected in 2018.
Meanwhile, Opdivo got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. BMY said that Opdivo is the first and only PD-1 immune checkpoint inhibitor to receive a positive CHMP opinion for this indication.
Bristol-Myers also presented positive data from a mid-stage study on BMS-986036, which is being evaluated for nonalcoholic steatohepatitis (NASH). Results showed that BMS-986036 had beneficial effects on three important components in the treatment of NASH -- liver fat, liver injury and fibrosis.
Breakthrough Status for Pfizer Cancer Drug: Pfizer (PFE - Free Report) got Breakthrough Therapy designation in the U.S. for its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, for the treatment of patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK inhibitors.
Breakthrough Therapy designation helps fasten the development and review of drugs being evaluated for serious or life-threatening diseases and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments.
Pfizer also got a positive CHMP opinion for Besponsa (inotuzumab ozogamicin) as monotherapy for the treatment of adults with a particular type of leukemia. Besponsa is under regulatory review in the U.S. as well where a response is expected in Aug 2017.
Lilly Cancer Drug Meets Primary Endpoint: Lilly's experimental breast cancer treatment, abemaciclib, met the primary endpoint in a pre-planned interim analysis for MONARCH 3, a phase III study. In addition to meeting the primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS), improvement was seen in a key secondary endpoint of objective response rate (ORR).
Lilly plans to start regulatory submissions of these results in the third quarter of 2017 while MONARCH 1 and MONARCH 2 submissions will commence in the second quarter of 2017.
So far in 2017, Lilly has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 10.6% compared to the industry gain of 5.9%.
May 2017 Response Date for Sanofi RA Drug: Sanofi and partner Regeneron announced that their BLA resubmission for their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab) has been accepted for review by the FDA with a response now expected on May 22, 2017. The companies had got a CRL for the IL-6R antibody in Oct 2016 with the agency citing certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.
The NYSE ARCA Pharmaceutical Index was up 2.2% over the last five trading sessions with most major pharma stocks recording gains. Bristol-Myers was up 4.2% with shares jumping on Q1 results while Lilly’s shares slipped 0.7%. Over the last six months, AstraZeneca was up 8.1% (See the last pharma stock roundup here: J&J Slips on Mixed Q1, Lilly Hit by FDA CRL).
What's Next in the Pharma World?
Companies like Merck (MRK - Free Report) and Pfizer will be reporting Q1 results early next week.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.
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Pharma Stock Roundup: Lilly, Bristol-Myers, Novartis Q1 Earnings & More
Earnings season for the pharma sector started in full flow this week with companies like Lilly (LLY - Free Report) , Novartis (NVS - Free Report) , Bristol-Myers (BMY - Free Report) , Roche, AstraZeneca, Glaxo (GSK - Free Report) and Sanofi (SNY - Free Report) reporting results. So far, it looks like a mixed quarter for the sector.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Lilly’s Q1 results were mixed with the company surpassing earnings expectations but missing on the top line (Read more: Lilly Tops Q1 Earnings, Misses Sales, Shares Down). The company’s pipeline was a key focus area of discussion given the recent setback related to baricitinib getting a complete response letter (CRL) from the FDA -- the company plans to meet with the agency to determine a path forward. Swiss drugmaker Novartis also topped earnings expectations (Read more: Novartis Tops Q1 Earnings: Cosentyx, Entresto Boost Sales) while British drugmaker Glaxo’s earnings were in line with expectations (Read more: Glaxo Reports In-Line Q1 Earnings, Reiterates View). Meanwhile, it was a “beat and raise” quarter for Bristol-Myers with immuno-oncology drug, Opdivo, putting in a strong performance (Read more: Bristol-Myers Beats on Q1 Earnings, Ups 2017 View).
Pipeline Updates from BMY: Bristol-Myers had quite a few pipeline updates this week apart from reporting earnings results. The company announced a new clinical research collaboration for the evaluation of the safety, tolerability and efficacy of Transgene’s investigational therapeutic vaccine TG4010 in combination with Bristol-Myers’ Opdivo + standard chemo as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in patients whose tumors have low or undetectable levels of PD-L1. Initial results from the study are expected in 2018.
Meanwhile, Opdivo got a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. BMY said that Opdivo is the first and only PD-1 immune checkpoint inhibitor to receive a positive CHMP opinion for this indication.
Bristol-Myers also presented positive data from a mid-stage study on BMS-986036, which is being evaluated for nonalcoholic steatohepatitis (NASH). Results showed that BMS-986036 had beneficial effects on three important components in the treatment of NASH -- liver fat, liver injury and fibrosis.
Breakthrough Status for Pfizer Cancer Drug: Pfizer (PFE - Free Report) got Breakthrough Therapy designation in the U.S. for its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, for the treatment of patients with ALK-positive metastatic NSCLC, previously treated with one or more ALK inhibitors.
Breakthrough Therapy designation helps fasten the development and review of drugs being evaluated for serious or life-threatening diseases and where preliminary clinical evidence indicates that the drug may be substantially better than existing treatments.
Pfizer also got a positive CHMP opinion for Besponsa (inotuzumab ozogamicin) as monotherapy for the treatment of adults with a particular type of leukemia. Besponsa is under regulatory review in the U.S. as well where a response is expected in Aug 2017.
Pfizer is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Lilly Cancer Drug Meets Primary Endpoint: Lilly's experimental breast cancer treatment, abemaciclib, met the primary endpoint in a pre-planned interim analysis for MONARCH 3, a phase III study. In addition to meeting the primary endpoint of demonstrating statistically significant improvement in progression-free survival (PFS), improvement was seen in a key secondary endpoint of objective response rate (ORR).
Lilly plans to start regulatory submissions of these results in the third quarter of 2017 while MONARCH 1 and MONARCH 2 submissions will commence in the second quarter of 2017.
So far in 2017, Lilly has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 10.6% compared to the industry gain of 5.9%.
May 2017 Response Date for Sanofi RA Drug: Sanofi and partner Regeneron announced that their BLA resubmission for their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab) has been accepted for review by the FDA with a response now expected on May 22, 2017. The companies had got a CRL for the IL-6R antibody in Oct 2016 with the agency citing certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 2.2% over the last five trading sessions with most major pharma stocks recording gains. Bristol-Myers was up 4.2% with shares jumping on Q1 results while Lilly’s shares slipped 0.7%. Over the last six months, AstraZeneca was up 8.1% (See the last pharma stock roundup here: J&J Slips on Mixed Q1, Lilly Hit by FDA CRL).
What's Next in the Pharma World?
Companies like Merck (MRK - Free Report) and Pfizer will be reporting Q1 results early next week.
Sell These Stocks. Now.
Just released, today's 220 Zacks Rank #5 Strong Sells demand urgent attention. If any are lurking in your portfolio or Watch List, they should be removed immediately. These sinister companies because many appear to be sound investments. However, from 1988 through 2016, stocks from our Strong Sell list have actually performed 6X worse than the S&P 500.
See today's Zacks "Strong Sells" absolutely free >>