Reports Q1 revenue $11.9M, consensus $0.7M. Revenue includes an $8.0M development milestone payment upon Lilly’s submission of an investigational new drug application, $3.5M of recognized deferred revenue from our licensing and collaboration agreement with BeiGene, as well as $0.4 million in other research support payments. As of March 31, 2019, Zymeworks had $180.3M in cash and cash equivalents and short-term investments.
Thursday, May 2, 2019
Glaxo 3-in-1 inhalable drug shows promise in asthma study
British drugmaker GlaxoSmithKline Plc said on Thursday that its three-in-one drug Trelegy met the main goal of a late-stage asthma study, signalling a possible boost to its lung medicines division that has been hit by generic competition.
The company, along with co-developer Innoviva Inc, said the once-daily inhaler improved lung function in patients with uncontrolled asthma, compared to its other medicine Relvar/Breo Ellipta.
However, GSK said Trelegy Ellipta did not meet its secondary goal of showing a reduction in the rate of exacerbations.
“We plan to submit these data for regulatory review after the full dataset is available,” said GSK’s Chief Scientific Officer Hal Barron.
The results come at a time when GSK is hit by generic competition for its blockbuster asthma treatment Advair and it looks to newer respiratory drugs to make up for declines in older medicines.
Trelegy Ellipta is already approved for treatment of chronic obstructive pulmonary disease (COPD), a condition that limits airflow to the lungs.
The drug became the first once-daily triple medicine for COPD when U.S. regulators gave it the green light in late 2017, putting GSK ahead of rivals such as AstraZeneca and Novartis.
More than 30 percent of asthma patients cannot fully restore their lung functions with two-drug inhalable combinations such as GSK’s Breo, creating a market opportunity for a more powerful combination therapy.
Trelegy, delivered through GSK’s inhaler Ellipta, generated 156 million pounds ($203 million) in sales last year, from its use against chronic obstructive pulmonary disease (COPD), or smokers’ lung.
Analysts at HSBC project 1.4 billion pounds in Trelegy revenue by 2023, also helped by future use against asthma, though COPD will likely remain the larger commercial opportunity.
Fresenius makes solid start to year after turbulent 2018
Fresenius reported a rise in first-quarter sales and operating profit on Thursday, helped by growth at its generic infusion drugs and dialysis units, as its troubled German hospital business showed signs of stabilisation.
The German group has flagged 2019 as an investment year as it steps up a drive to improve German hospitals that have suffered from declining admissions and high staff turnover. It also wants to scale up its home dialysis business.
Currency-adjusted quarterly sales rose 5 percent to 8.5 billion euros (£7.3 billion), helped by growth at its Kabi infusion unit and separately listed Fresenius Medical Care. Operating profit rose 2 percent to 1.11 billion euros.
“All four Fresenius business segments have developed in line with our expectations, putting us well on course to meet our targets for the year,” Chief Executive Stephan Sturm said.
Fresenius had a turbulent 2018 as it grappled with operating problems at two of its three major businesses and was tied up with a court battle over its aborted takeover of generic drugmaker Akorn, which it won.
Bankhaus Lampe analysts were encouraged the company had managed to stop the margin erosion at its Helios Germany hospitals business, even though sales fell 6 percent and operating profit declined 16 percent, hurt by a nursing shortage and a less pronounced flu season.
“We see our thesis supported that none of the businesses are facing material structural challenges,” wrote analyst Volker Braun, who rates the stock ‘buy’.
But Jefferies analyst James Vane-Tempest said it was too early to call a stabilisation trend at Helios given the company faces challenges from reforms to the German hospital payments system that kick in next year.
Shares in Fresenius, which have surged 19 percent so far this year, outperforming a 9.6 percent increase in the European health sector index, pared early gains to trade 0.1 percent lower at 0942 GMT.
At Fresenius Medical Care, which has faced a slowdown in North America, its most important market, adjusted sales rose 6 percent to 4.13 billion euros, helped by agreements that materialised earlier than planned.
Operating profit increased by 4 percent in constant currencies to 551 million euros.
Adjusted quarterly sales at Kabi rose 4 percent, while revenue at its smallest division Vamed, which manages projects for hospitals and provides post-acute care in central Europe, jumped 33 percent.
Despite expected earnings dilution from its $2 billion acquisition of home dialysis maker NxStage, Fresenius confirmed its guidance for currency-adjusted sales growth of 3-6 percent this year compared with 6 percent last year, while profit is expected to stay around the same level as 2018.
Gilead Q1 Results Above Wall Street Targets
Gilead Sciences Inc.’s results for the first three months of the year beat Wall Street targets, driven by a 28% profit increase.
The company reported a first-quarter profit of $1.98 billion, or $1.54 a share, compared with $1.54 billion, or $1.17 a share, a year earlier. On an adjusted basis, profit rose to $1.76 a share from $1.48 a share a year earlier.
Revenue rose to $5.28 billion.
Analysts surveyed by FactSet had projected $1.26 a share, or $1.61 a share as adjusted, on $5.3 billion in revenue.
Chronic hepatitis C products brought in $790 million in the most recent period, down from $1 billion a year earlier, while HIV product sales rose to $3.6 billion, from $3.2 billion a year earlier.
Sales of its CAR-T therapy Yescarta, which the company had hoped would help offset the hepatitis C drug sales decline.
Yescarta brought in $264 million in 2018, below analysts’ projected $271 million.
In the most recent period, Gilead said Yescarta accounted for $96 million in sales, more than double from the year earlier, but still shy of analysts’ projected $98.5 billion.
Gilead affirmed its annual forecast of $21.3 billion to $21.8 billion in net product sales. The guidance reflects the anticipated entry of generic versions of Letairis and Ranexa in the U.S. and the full-year impact from generic products containing tenofovir disoproxil fumarate in some European countries.
Gilead Sciences Inc.’s results for the first three months of the year beat Wall Street targets, driven by a 28% profit increase.
The company reported a first-quarter profit of $1.98 billion, or $1.54 a share, compared with $1.54 billion, or $1.17 a share, a year earlier. On an adjusted basis, profit rose to $1.76 a share from $1.48 a share a year earlier.
Revenue rose to $5.28 billion.
Analysts surveyed by FactSet had projected $1.26 a share, or $1.61 a share as adjusted, on $5.3 billion in revenue.
Chronic hepatitis C products brought in $790 million in the most recent period, down from $1 billion a year earlier, while HIV product sales rose to $3.6 billion, from $3.2 billion a year earlier.
Sales of its CAR-T therapy Yescarta, which the company had hoped would help offset the hepatitis C drug sales decline.
Yescarta brought in $264 million in 2018, below analysts’ projected $271 million.
In the most recent period, Gilead said Yescarta accounted for $96 million in sales, more than double from the year earlier, but still shy of analysts’ projected $98.5 billion.
Gilead affirmed its annual forecast of $21.3 billion to $21.8 billion in net product sales. The guidance reflects the anticipated entry of generic versions of Letairis and Ranexa in the U.S. and the full-year impact from generic products containing tenofovir disoproxil fumarate in some European countries.
ResMed reports Q3 adjusted EPS 89c, consensus 85c
Reports Q3 revenue $662.2M, consensus $. Q3 gross margin expanded 100bps to 59.2%.
Amgen and Syapse partner in precision oncology medicine
Amgen and Syapse, a company powering precision medicine insights through its global provider network, announced a precision medicine collaboration in oncology. Amgen and Syapse will develop observational research analytics to assess treatment outcomes for areas of unmet need in oncology. This effort will identify existing patients within the Syapse Learning Health Network that could be eligible for Amgen-sponsored clinical trials and seek to bring these trials to community health system sites. The companies will create opportunities for physicians and researchers within the Syapse Network to gain access to analytics, real-world evidence-based insights, and collaborative research opportunities. Amgen will also work with Syapse to develop real-world evidence standards to support the acceleration of therapies to market.
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