Livongo Health (NASDAQ:LVGO): Q2 Non-GAAP EPS of $0.11 beats by $0.10; GAAP EPS of -$0.02 beats by $0.05.
Revenue of $91.92M (+124.8% Y/Y) beats by $5.24M.
Shares +1.7% PM.
Wednesday, August 5, 2020
Switzerland nears deal to get Moderna COVID vaccine
Switzerland is close to signing a deal to secure access for a coronavirus vaccine being developed by Moderna of the U.S., a government official has said.
Switzerland will soon sign a reservation and supply deal, Pascal Strupler, the director of the Federal Office of Public Health, told the Swiss TV programme Club late on Tuesday.
“We are only a few hours away from completing a purchase contract. With this contract we will get it very quickly,” Strupler said.
He declined to give financial details of any deal.
If the vaccine passes trials and is authorised for use, it could be produced in Switzerland under a deal between drugmaker Lonza and Moderna.
BioNTech, Fosun launch another COVID-19 vaccine trial
Germany’s BioNTech and China’s Shanghai Fosun Pharmaceutical on Wednesday announced the start of another COVID-19 vaccine trial in China with a total of 144 participants.
“The study is designed to support the regulatory approval process for the Chinese market and intends to confirm that the safety and immunogenicity profile observed in participants from the German and U.S. trials is comparable to that of Chinese participants,” BioNTech said in a statement.
Zydus Cadila’s COVID vaccine candidate found safe in early-stage human trial
India’s Zydus Cadila said on Wednesday its COVID-19 vaccine candidate was found to be safe and well-tolerated in an early-stage human trial.
The company will now start a mid-stage trial of the vaccine candidate, ZyCoV-D, in over 1,000 healthy adult volunteers from Thursday to test its effectiveness, it said in a regulatory filing.
Zydus plans to complete late-stage trials for ZyCoV-D by February or March and could produce up to 100 million doses a year initially, the company’s chairman told Reuters last month.
The safety of the vaccine candidate in volunteers enrolled in the early-stage trial, who were administered doses since July 15, was endorsed by an independent data safety monitoring board.
Zydus is also among the several Indian generic drugmakers that have licensing agreements with U.S.-based Gilead Sciences to produce remdesivir, the antiviral that has been approved in the country as an emergency treatment to fight the coronavirus outbreak.
India reported a daily jump of more than 50,000 coronavirus infections for the seventh straight day on Wednesday. Total cases now stand at 1.91 million, the third biggest, after the United States and Brazil.
Tuesday, August 4, 2020
Vaccine sales driven down by pandemic’s effects on doctor visits
This week, the world’s four largest vaccine makers each reported hits to their vaccine businesses from the coronavirus pandemic, as public health measures kept people away from their doctor’s offices.
Second quarter sales of Pfizer’s Prevnar 13 pneumococcal vaccine fell 5% compared to last year, while Merck & Co. saw a 26% decline for its Gardasil HPV vaccine.
French pharma Sanofi recorded a 7% overall decline in vaccine sales, in spite of its polio and influenza products sporting double-digit growth. The impact was more universal for U.K.-based GlaxoSmithKline, which had lower sales in every part of its vaccines division. So-called established vaccines dropped 34%, while Shingrix — a shingles vaccine that’s become a key source of revenue for the company — experienced an unprecedented 16% dip.
Declining vaccine sales were to be expected. Earlier in the pandemic, companies warned that shelter-in-place orders and the fears of contracting the virus from doctors’ offices were likely to result in lower vaccine demand for a portion — if not all — of 2020.
Now, however, the big vaccine makers are cautiously optimistic that they’re past the brunt of the pandemic. Sanofi executives said they expect record flu vaccine sales in the Northern Hemisphere this fall, whereas GSK said pediatric vaccinations rebounded considerably in recent weeks.
“We expect to see vaccination rates recover in the second half of the year,” Emma Walmsley, CEO of GlaxoSmithKline, said on an earnings call Wednesday.
“We’re confident it will come,” Walmsley added, “but clearly, there remains a degree of risk on the exact timing.”
A considerable amount of risk comes from uncertainties surrounding the largest pharmaceutical market, the U.S., which has struggled more than any other developed nation to check the coronavirus. As of July 30, the virus had infected at least 4.4 million people in the country and killed more than 150,000, according to the Centers for Disease Control and Prevention.
“There’s a clear difference when you look at the U.S. and Europe,” Luke Meils, GSK’s head of pharmaceuticals, said on the earnings call, noting how most of GSK’s European vaccine business is in pediatrics.
He explained that, in the states, pediatric vaccinations across the industry dropped about 50% over a four-week period from March to April. But by early May, they were quickly rising, as were wellness visits to doctors. Meanwhile, adult vaccinations in the U.S. faced a similar drop but have been “slower to recover.”
For Merck, Gardasil sales in the U.S. fell by nearly two-thirds, a significant drop that executives attributed to reduced access to providers.
Sanofi’s earnings report reflects a similar challenge in the U.S., where the company’s vaccines brought in 41% lower sales than in the second quarter of 2019. The sales hit was less severe in Europe, at 22%. Sanofi vaccine sales in the rest of the world were up 20%, helping offset the declines elsewhere.
Though the second quarter was tough, Sanofi predicts its flu vaccines will have strong performances in the third and fourth quarter. The company’s off to a good start, according to head of vaccines Thomas Triomphe, who said Wednesday that its first shipments of U.S. flu vaccines have gone out. Sanofi estimates it will deliver around 80 million doses to the U.S., “based on the strength of preseason orders.”
“The story is really all about readiness for a record flu season,” Sanofi CEO Paul Hudson said on the company’s earnings call. “Looking ahead, we are planning for a new record flu vaccine sales in the Northern Hemisphere.”
A bad flu season could be disastrous for public health systems already strained by the coronavirus, making vaccinations particularly critical. Depending on the flu strain that’s prevalent each year, however, the effectiveness of flu vaccines can vary.
Medicaid managed care rates on state chopping blocks; Centene, Molina at risk
As states weather the economic hits from the coronavirus pandemic, some are setting their sights on Medicaid, in particular the rates paid to private managed care providers.
California, Michigan and Ohio are among those with plans to cut rates to these payers, and more are likely to weigh that possibility, particularly as big Medicaid players like Centene and Molina post large profits as members delay care.
Ohio cut its Medicaid funding by $220 million, according to the Ohio Capital Journal, largely cuts that private payers will bear. SVB Leerink analysts expect Molina and Centene to be hit the hardest of the MCOs in the states that have announced the cuts, including Ohio.
These rate cuts were heavily discussed on earnings calls this week as analysts peppered executives with questions about the potential headwind. Centene executives declined to quantify how reductions may impact financial performance or guidance, while rival Molina detailed the financial impact so far.
“We’re currently in active discussions with the states and the starting point is rarely the ending result,” Jeff Schwaneke, Centene CFO, told investors Tuesday during the company’s second quarter earnings call. “It really isn’t constructive for us to publicly discuss our individual state expectations. We continue to believe that we’re on a path in many states toward finding actuarially sound solutions toward the budgetary strain.”
Centene reported net earnings of $1.2 billion for the second quarter, more than double its profit from the prior-year period.
“That lack of transparency is understandably frustrating for investors as they contemplate potential cuts from states tightening budgets. It also begs the question, is guidance at risk?” Jefferies analysts commented in a recent note after Centene reported its second quarter results.
Centene CEO Michael Neidorff attempted to assuage investors’ concerns by detailing the discussions with states as they contemplate cuts. Essentially, Neidorff said Centene is encouraging states to take a longer view of the public health crisis, not just making decisions based on a single quarter.
Neidorff seemed to be trying to dispel the narrative that insurers are gaining from the pandemic as they take in per-member-per-month payments, but pay fewer claims as care is prolonged either voluntarily or as a result of stay-at-home mandates.
Centene’s Medicaid segment is its largest with 12.5 million members spread across 24 states, including Ohio and California.
“The states’ issue, when they saw the reduced utilization, [was] ‘Oh, you’re saving all this money’,” Neidorff said during Tuesday’s call.
Neidorff maintained that utilization will come back in the second half of the year. And even though utilization may be down, it’s being offset by COVID-19 costs. Centene has spent $550 million on COVID-19 related claims through the end of June.
Rival Molina also has benefited from the pandemic due to lower utilization and reported its second quarter profit increased more than 40% to $276 million.
COVID-19 caused hospital ED visits to dive more than 40%
- Hospital emergency department visits dropped precipitously during the first weeks of the onset of the COVID-19 pandemic in the United States. Visit rates fell between 41.5% and 63.5% across the hospitals studied, according to research published Monday in JAMA Internal Medicine.
- Meanwhile, hospital admission rates from the ED rose as much as nearly 150% at one facility, according to the study of emergency visit rates and admissions data from five large healthcare systems in five states — Colorado, Connecticut, Massachusetts, New York and North Carolina.
- A JAMA editor suggested those who regularly use the hospital ED as a medical safety net are likely staying away for now. As a result, the changes in ED use caused by the pandemic are “likely to further exacerbate racial/ethnic and socioeconomic level health disparities in the U.S. They also make more apparent the need for universal health insurance coverage.”
While media coverage of the pandemic has focused on overwhelmed hospital workers on the front lines, less attention has been paid to some hospital emergency departments seeing far fewer patients as many avoid the risk of exposure to the novel coronavirus.
Earlier research has shown emergency visits lagged behind recovery of other types as hospitals recapture volume put off when elective procedures were halted in the first weeks of COVID-19 outbreaks in the U.S.
For the new study, researchers with the Mayo Clinic, Yale University, Yale New Haven Health System and several other institutions pored over ED and hospital admission records from 24 hospitals within five major hospital systems throughout the country. Those systems, which included major providers such as Mount Sinai Health in New York, Baystate Health in Massachusetts and Yale-New Haven in Connecticut, saw annual ED visits of between 13,000 and 115,000 patients per year under normal circumstances.
Typical ED and admissions data was compared from Jan. 1 of this year, to April 30. By mid-March, as COVID-19 began to take hold in the U.S., ED visits dropped dramatically. For example, while ED visits dropped by 63.5% at Mount Sinai Health, admissions of patients from the ED rose 149%; nearly 52% at Baystate and between 22% and 36.2% in the other systems studied.
As a result of the drop in ED visits and rise in admissions from those visits, the study’s authors concluded that “public health authorities and healthcare systems should provide guidance and resources to help patients determine the best place to receive care as the available healthcare capacity changes during the pandemic.”
A commentary accompanying the study authored by David Schriger, an associate JAMA editor and a member of the faculty of the emergency medicine department at UCLA School of Medicine, said the study should be considered a starting point about how patients should seek care if they are feeling unwell.
Schriger observed that “many hospitals and clinics rapidly instituted better access to practitioners and care coordinators via the telephone or telemedicine, providing patients with alternatives.” However, he also suggested that many low-income people who have no other provider to turn to other than the hospital ED are forgoing care — requiring a deeper discussion of healthcare inequities in the U.S.
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