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Thursday, July 23, 2020

Lannett launches generic version of BI heart drug

Lannett Company (NYSE:LCI) announces the commercial launch of Mexiletine Hydrochloride Capsules 150 mg, 200 mg and 250 mg, a generic equivalent to Boehringer Ingelheim’s antiarrhythmic drug Mexitil (mexiletine hydrochloride, USP).
Per IQVIA, the U.S. market is ~$16M.

Quest Diagnostics beats Q2 consensus; reinstates FY2020 outlook

Quest Diagnostics (DGX) Q2 results:
Revenues: $1,827M (-6.5%); R&D Expense: $1,764M (-5.8%).
EPS: $1.36 (-9.9%); non-GAAP Net Income: $193M (-18.6%); non-GAAP EPS: $1.42 (-17.9%).
CF Ops: $602M (+1.0%); non-GAAP operating income: $294M (-16.5%).
The company reinstated its FY 2020 outlook after withdrawing it in April 2020. Current estimates are as follows:
Net revenues: $8.0B-8.6B. The average consensus is $8.52B; GAAP EPS: $5.66-7.66; non-GAAP EPS: $6.60-8.60. The average analyst estimate is $8.22; CF Ops: at least $1.25B.

Roche H1 sales and profit decline due to COVID-19 impact

Roche Holding (OTCQX:RHHBY) H1 results (CHF):
Revenues: 30,378M (-4.3%); Pharmaceuticals sales: 23,202M (-4.1%); Diagnostics sales: 6,079M (-3.1%).
Key product sales: Avastin: 2,835M (-22.5%); Herceptin: 2,200M (-32.6%); Perjeta: 1,941M (+10.6%); MabThera/Rituxan: 1,850M (-26.3%); Tecentriq: 1,297M (+65.9%); Kadcyla: 837M (+31.6%); Actemra/RoActemra: 1,461M (+28.7%); Xolair: 958M (-1.4%); MabThera/Rituxan: 590M (-28.9%); Ocrevus: 2,076M (+19.7%); Hemlibra: 1,003M (+87.5%); Lucentis: 728M (-21.6%).
Net Income: 8,465M (-4.9%); EPS: 9.32 (-6.7%); non-GAAP Net Income: 9,443M (-4.6%); non-GAAP EPS: 10.44 (-6.1%).
Non-GAAP Operating Income: 11,766M (-4.8%).


West Pharmaceutical EPS beats by $0.34, beats on revenue

West Pharmaceutical (NYSE:WST): Q2 Non-GAAP EPS of $1.25 beats by $0.34; GAAP EPS of $1.21 beats by $0.31.
Revenue of $527.2M (+12.2% Y/Y) beats by $31.11M.

G1 Therapeutics inks lerociclib deal with EQRx

G1 Therapeutics (NASDAQ:GTHX) +3.5% PM, after the company announces an exclusive license agreement with EQRx, for the development and commercialization of G1’s lerociclib in the U.S., Europe, Japan and all other global markets.
G1 will receive an upfront of $20M and will be eligible to milestone payments of up to $290M plus sales-based tiered royalties.
Last month, the company licensed development and commercialization rights in the Asia-Pacific region (excluding Japan) to Genor Biopharma.
Lerociclib is a differentiated oral CDK4/6 inhibitor under development in combination with other targeted therapies in certain types of breast and lung cancer.

Wednesday, July 22, 2020

LabCorp CEO: Covid spreading faster than it can add testing capacity

  • LabCorp CEO Adam Schechter told CNBC the coronavirus is spreading faster in the U.S. than the company can expand testing capacity, leading to slower turnaround time for results.
  • “We need all states to ensure we’re doing everything we can to better control the virus. If we can do that, then we’ll be able to have the tests that we need,” Schechter said on “Closing Bell.”
  • He said the company is averaging between three to five days to return Covid-19 test results to someone who is not in the hospital.
LabCorp CEO Adam Schechter told CNBC on Tuesday that the coronavirus is spreading faster in the U.S. than the company can expand testing capacity, leading to slower turnaround time for results.
“We need all states to ensure we’re doing everything we can to better control the virus. If we can do that, then we’ll be able to have the tests that we need,” Schechter said on “Closing Bell.”
LabCorp is currently processing about 165,000 tests for Covid-19 per day, translating to more than 1 million per week, he said. In late March during the early stages of the pandemic, LabCorp was running about 20,000 tests per day.
“We’re continuing to increase capacity every single week over week,” he said. “The problem is that the number of tests being asked to be performed each week is growing faster than the capacity that we can build.”
For someone in the hospital, LabCorp is able to return Covid-19 tests results within 1.5 days on average, Schechter said. Average turnaround time is about three to five days for someone who isn’t in the hospital, he said, while a range of about two to three days is needed to have an “effective ability to track and trace people that are sick or have been exposed to people.”
Like LabCorp, Quest Diagnostics also has warned that its turnaround time for testing results has slowed as transmission of the virus spreads in certain parts of the U.S., especially across the American South, Southwest and West.
Testing for Covid-19 in the U.S. has been beset by challenges since the early days of the pandemic, including strains on the supply chain. But daily testing capacity has continued to scale up.
In the last 7 days, the U.S. has averaged nearly 763,000 diagnostic tests per day, according to a CNBC analysis of data from the Covid Tracking Project. The national average in April was about 174,000 diagnostic tests per day, per a CNBC analysis.
The overall rise in new Covid-19 cases in the U.S. can only be partly attributed to added testing capacity. That’s because the test positivity rate also has increased, an indication of how broadly the virus is spreading throughout a community.
The U.S. has an 8.5% positivity rate, based on a seven-day moving average, according to Johns Hopkins University. In early June, the seven-day moving average had dropped below 5% nationally. At times in April, the U.S. positivity rate was around 20%.
Schechter said he believes the U.S. needs to be “really thoughtful” about demand for Covid-19 testing as it approaches the fall — a time when students may be heading back to school and more people potentially ease out of working from home.
“I am concerned about it, but we have to look at it holistically,” he said, stressing the need for American residents to wear face masks and continue practicing social distancing. He added that quicker turnaround time for tests is a part of the solution, along with further progress on research for vaccines and therapeutics.
“If we pull those things together, I believe we can beat this virus and get the country up and running again in a very significant way,” he said.

Glenmark’s favipiravir version shows promise in late-stage COVID-19 trial

India’s Glenmark Pharmaceuticals Ltd said on Wednesday its version of anti-flu drug favipiravir showed promise in a late-stage study of 150 patients with mild to moderate coronavirus infection.
Data showed that patients receiving FabiFlu shook off the virus about 29% faster that those receiving standard supportive care.
About 70% of the patients being treated with the drug achieved “clinical cure” by the fourth day of the study, compared with about 45% in the standard care group, the company said in a statement reut.rs/3eS12Zt.
Clinical cure is defined as a physician’s assessment of the normalization of clinical signs of COVID-19 such as temperature, oxygen saturation, respiratory rate and cough.
FabiFlu was also well tolerated with no serious adverse events or deaths in the treatment arm, the company said, adding that it plans to submit the study data for peer review in the coming weeks.
Glenmark last month received Indian regulatory approval to make and sell FabiFlu for restricted emergency use in patients with mild-to-moderate COVID-19 symptoms, and last week cut the price of the drug to 75 rupees ($1.01) per tablet.