Teladoc (NYSE: TDOC) reported Q4 EPS of ($3.07), may not compare to the analyst estimate of ($0.24). Revenue for the quarter came in at $383.3 million versus the consensus estimate of $378.93 million.
GUIDANCE:
Teladoc sees Q1 2021 revenue of $445-455 million, versus the consensus of $446 million.
Teladoc sees FY2021 revenue of $1.95-2 billion, versus the consensus of $1.95 billion.
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced today the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the expanded use of Cabenuva (cabotegravir, rilpivirine). The sNDA seeks to expand Cabenuva’s label to include every 2-months dosing for the treatment of HIV-1 infection in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Cabenuva is a complete long-acting regimen with two separate injectable medicines, ViiV Healthcare’s cabotegravir and rilpivirine, a product of Janssen Sciences Ireland UC. The medication was approved by the FDA in January 2021 as a once monthly treatment for HIV-1 infection in virologically suppressed adults. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1
In the ongoing run-up to her fraud trial, Theranos founder Elizabeth Holmes denies that she destroyed any evidence related to the company’s laboratory tests. It’s the latest pre-trial argument over what evidence a jury will get to hear when the case goes to court.
The prosecution alleged that sometime in 2018, Holmes destroyed a database called the Laboratory Information System (LIS), which contained three years’ worth of accuracy and failure rates of Theranos tests, CNBC reports. Prosecutors have claimed that Holmes had the evidence destroyed because it would prove the company’s blood-testing technology was inaccurate.
This week, attorneys for Holmes argued the government lost the database and wanted to blame it on the embattled chief executive officer.
“… the government has insinuated that the loss of the LIS data reflects on Ms. Holmes’ supposed guilt even though she had nothing to do with it. The reason the government lacks this evidence is because the prosecutors sat on their hands for years before attempting to acquire it, and then sat on their hands again after acquiring it. They are entirely to blame,” Holmes’ attorneys argued in a court filing, according to CNBC. “The reason that the government has built its case on this teetering card house of irrelevant evidence is that it lost—or, worse, did not want to analyze preindictment—the actual evidence of testing results in this case.”
The government first raised questions about the LIS in a court filing last month. The prosecution said the LIS was destroyed in 2018, three months after a grand jury issued a subpoena for a copy of the database. The prosecution has suggested the failure rate of the Theranos blood-testing system was 51.3%. Regarding the failure rate, the government said the tests “were so inaccurate, it was essentially a coin toss whether the patient was getting the right result. The data was devastating.”
According to the CNBC report, the prosecution said internal emails from Theranos leadership “proves” the company and its counsel attempted to “cover-up the test results in the database from the grand jury.” Theranos did provide backup copies of the database, but they were password protected and company executives could not remember the password, the government argued, CNBC said.
The argument over the LIS is only the latest squabble between the prosecution and Holmes’ attorneys. Last week, her attorneys were pushing back against the prosecution’s plan to detail her lavish lifestyle during the upcoming trial. The government has suggested her expensive and extravagant lifestyle “was fueled by her fraud,” CNBC reported. Holmes’ legal team said this type of attack would only invoke “class prejudice.”
Holmes' trial is scheduled to begin in July. The start date has repeatedly been pushed back due to concerns about COVID-19. Before the trial begins, CNBC noted that Holmes and her team are expected to argue over evidence her team does not believe should be introduced during the trial.
Holmes, along with former Theranos President Ramesh “Sunny” Balwani, was initially charged with multiple counts of fraud in 2018 related to the blood-testing company, Theranos. From 2013 to 2015 Holmes and Balwani raised more than $700 million from investors through what the U.S. Securities and Exchange Commission called “years-long fraud” in which they exaggerated or lied about the efficacy of the company’s proprietary technology and the state of its finances, according to the complaint.
The company also made false claims about its relationship with the Department of Defense and its regulatory status with the U.S. Food and Drug Administration during that time period. As a result of the alleged fraudulent promises made to investors, the valuation of Theranos swelled to $9 billion and made Holmes one of the youngest billionaires in the United States.
Bayer AG has decided to sell its Environmental Science Professional business as part of changes to implement the strategy of its Crop Science division
The German pharmaceutical and chemical conglomerate said Wednesday that the business had sales of around 600 million euros ($729.1 million) in 2019, adding that the divestment will help the division focus on its core agricultural business.
The company also announced some leadership changes, including the appointment of Jacqueline Applegate to lead the Crop Science North America region starting in March.
"With the announced portfolio and leadership changes, and important new product approvals for soybeans, corn and cotton in the Americas, we are now shifting gears from integration to growth acceleration," Liam Condon, president of the Crop Science division, said.
Novavax Inc expects data from a late-stage U.S. trial of its COVID-19 vaccine at the start of April, after which it will apply for emergency use authorization, the drug developer’s R&D head Gregory Glenn said on Wednesday.
“We are expecting results right in the beginning of quarter two and shortly thereafter we will be filing for EUA (in U.S.),” he said at a Washington Post online event.
The Novavax executive said the vaccine has shown a great “safety profile” in UK trials and the company might ask the U.S. Food and Drug Administration to consider the UK data for vaccine authorization.
On Monday, Novavax completed enrolling 30,000 volunteers in the late-stage study in the United States and Mexico.
The company said last month its vaccine was 89.3% effective in preventing COVID-19 in a trial conducted in the United Kingdom.
It was nearly as effective against the more highly contagious variant first discovered in the UK.
The United States expects to roll out three to four million doses of Johnson & Johnson’s COVID-19 vaccine next week, pending authorization from the Food and Drug Administration, White House COVID-19 response coordinator Jeff Zients said on Wednesday.
A Johnson & Johnson executive on Tuesday said the company expected to ship nearly 4 million doses of the vaccine once it gained authorization.
The additional vaccine will help President Joe Biden’s administration in its goal of ramping up vaccination across the country as it seeks to control the pandemic that has cost more than 500,000 lives in the United States and pummeled the economy.
Zients described J&J’s manufacturing as being behind schedule when the new president took over from former President Donald Trump.
“It was disappointing when we arrived. I think the progress is real and we look forward to continuing to work with the company to accelerate ... their delivery and their capacity,” Zients told a briefing.
The FDA said on Wednesday that the Johnson & Johnson one-dose vaccine appeared safe and effective in trials, paving the way for its approval for emergency use as soon as this week.
The company has a contract to deliver 100 million doses to the United States by the end of June. Zients said the administration was working to accelerate that timeline.
The Biden administration told governors this week that it would allocate about 2 million doses of the first J&J distribution to states. The remainder will go to federal distribution programs, like the federal pharmacy and community health center programs, Zients said.
Zients told reporters that the government had caught up from a backlog of vaccine distribution caused by the winter storm that hit Texas last week.
Administration officials also shared statistics showing that COVID-19 cases, hospitalizations and deaths in the United States were trending down, though the administration is urging Americans to continue to wear masks and practice social distancing.
Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said daily U.S. cases in the past week declined to approximately 64,000.
Dr. Anthony Fauci, who serves as director of the National Institute of Allergy and Infectious Diseases as well as chief medical advisor to Biden, said the NIH had launched a new initiative to study long term effects of COVID-19 and related disorders.
The White House also announced on Wednesday that it would deliver millions of masks next month to food banks and community health centers to ensure less well-off communities were getting access to a key tool to prevent the spread of COVID-19.
Zients said that effort would cost $86 million.
ITI-1284 is a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet (ODT-SL). ITI-1284 ODT-SL may offer pharmacologic benefits and ease-of-use for patients, particularly in elderly populations.
Phase 1 single ascending dose and multiple ascending dose studies have been completed in healthy volunteers including elderly subjects > than 65 years of age.
Company plans to develop ITI-1284 for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.
