Bristol-Myers Tops Q4 Earnings, Pulls FDA Application for Cancer Combination

Bristol-Myers Squibb Co. (BMY) posted stronger-than-expected fourth quarter-earnings Thursday but pulled an application to the U.S. Food & Drug Administration for a blockbuster cancer drug combination in order to collect more data. Bristol-Myers said profits for the three months ending in December came in at $94 cents a share, firmly ahead of the consensus estimate of 85 cents and up 38% from the same period last year. Group revenues, Bristol-Myers said, rose 10% to $5.973 billion, just ahead of the Street forecast of $5.95 billion.

"I am proud of our results in 2018, which were based on superior commercial performance for our prioritized brands and important scientific advances that continue to diversify our R&D pipeline," said CEO Giovanni Caforio. "We are beginning 2019 with good momentum in our current business, with Opdivo and Eliquis continuing as strong and growing franchises." "Our planned acquisition of Celgene will position us to create a leading biopharma company, with best-in-class franchises, significant near-term launch opportunities and a deep and broad pipeline, creating an even stronger foundation for long-term sustainable growth."

Bristol-Myers shares fell 1.9% to close at $49.02 on Thursday. Bristol-Myers agreed to buy Celgene Corp. (CELG) earlier this month in a deal that values the cancer drug specialist at $74 billion. The combined group – which will be 69% owned by Bristol-Myers – would have a portfolio with nine drugs that generate more than $1 billion in sales, the companies said. Bristol-Myers also confirmed preliminary 2019 earnings guidance it published alongside the Celgene merger announcement in early January that looked moderately higher than the Street consensus. The company said it sees non-GAAP earnings of between $4.10 and $4.20 per share, topping the $4.07 estimate from Refinitiv IBES but excluding the impact of the Celgene acquisition, and will plan an accelerated share buyback worth around $5 billion.

Bristol-Myers was told by the FDA in October that the agency extended the approval date for a market approval for its key 'Opdivo plus Yervoy' cancer therapy combination until May 2019. EU regulators asked for more information on the therapy, which is being tested as part of a trial the group calls 'CheckMate -227', including an overall survival (OS) analysis for certain types of patients. Bristol-Myers said an OS analysis for the same patient sub-group was also submitted to the FDA. Opdivo, which Bristol-Myers classifies as a "prioritized brand" that harnesses the body's own immune system to fight cancer, saw sales rise 33% to $443 million over the fourth quarter, while Yervoy revenues grew 43% to $115 million.

https://www.thestreet.com/amp/investing/earnings/bristol-myers-tops-q4-earnings-pulls-fda-application-for-cancer-combination-14844064

Now what? Senate kills GOP, Democratic plans to reopen the government

Now what? Senate kills GOP, Democratic plans to reopen the government

by Susan Ferrechio

| January 24, 2019 03:38 PM

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It was back to the drawing board for Republicans and Democrats on Thursday, after the Senate killed two competing proposals for ending the government shutdown that has stretched for nearly five weeks. Most Senate Republicans blocked a plan introduced by Democrats that would have funded partially closed government entities until Feb. 8, without giving the Trump administration any new money for a border wall. Republicans said President Trump would veto it, and it failed 52-44 — 60 votes were needed to advance the plan toward a final vote.

The Democratic plan did pick up "yes" votes from six Republican senators: Lamar Alexander of Tennessee, Susan Collins of Maine, Cory Gardner of Colorado, Johnny Isakson of Georgia, Lisa Murkowski of Alaska, and Mitt Romney of Utah. Moments earlier, Democrats blocked a bill authored by Republicans and based on a proposal from Trump that would have provided government funding for the remainder of the fiscal year. That measure included $5.7 billion for a wall along the southwest border that Trump said is necessary for him to sign new spending legislation. Trump included in the proposal a three-year extension of legal protections for "Dreamers" and others living in the United States under Temporary Protected Status. Democrats said the measure falls short of providing permanent legal status, and they also oppose changes made to the asylum program that would require applying in the country of origin rather than on the U.S. border. It failed 50-47, as it also couldn't find 60 votes. The Senate votes didn't leave any obvious way forward on how to break the logjam. Trump on Wednesday said he would postpone his State of the Union address after Speaker Nancy Pelosi, D-Calif., rescinded her invitation for him to appear on Jan. 29, and on Friday, hundreds of thousands of federal workers were set to miss their second paycheck under the shutdown.

Republicans and Democrats say they aren’t giving up on a bipartisan bill that can ultimately pass the Senate. “There are a number of us working on compromises to fix this whole problem,” said Sen. Dan Sullivan, R-Alaska. But Trump's demand for border wall funding has provoked a bitter partisan battle between the two parties. Democrats say the wall is “immoral,” “medieval,” and wasteful and are only willing to accept the deployment of technology on the border to boost security. Republicans point out Democrats have backed wall funding in the past and argue they are simply fighting against Trump and his campaign promise to build a wall.

Democrats before the vote blocked a move by the GOP to pass a measure to pay the Coast Guard, which is the only branch of the military not getting paychecks during the shutdown because they fall under the Commerce Department and not the Pentagon. The Commerce Department is among the government entities that has not been funded since Dec. 22. Sen. Michael Bennet, D-Colo., said the shutdown is based on Trump’s unfulfilled promise “over and over again” to have Mexico pay for the wall, and he rejected the idea that Democrats are soft on security. “This idea that Democrats are for open borders is gibberish.

https://www.washingtonexaminer.com/news/congress/now-what-senate-kills-gop-dem-plans-to-reopen-the-government

Lanny Davis: Rudy Giuliani is 'mentally unstable'

Lanny Davis, an adviser for Michael Cohen, questioned Rudy Giuliani's mental health Thursday as the row over President Trump and his legal team's attacks on Cohen's family intensifies. Trump used a recent Fox News appearance and his Twitter account to encourage federal investigators to look into Cohen's father-in-law, Fima Shusterman. In one of his freewheeling interviews over the weekend, Giuliani condoned Trump's behavior on CNN, describing Shusterman as a "criminal."

Davis told MSNBC on Thursday that Cohen's family could take legal action against Giuliani for his remarks. "It's certainly actionable because he just lied," Davis told the network of Giuliani, who is Trump's lead personal lawyer. "He's mentally unstable, you can see it in his face much less his words. He's a prosecutor who would prosecute what he just did." "Mr.Giuliani can be indicted and certainly criminally investigated for doing what he just did, that is prima facie a crime to threaten a witness before Congress," "Mr. Giuliani can be indicted and certainly criminally investigated for doing what he just did, that is prima facie a crime to threaten a witness before Congress," he said later in the segment.

Davis on Thursday called on Congress to officially reprimand Trump for his statements regarding Shusterman. "That is called witness tampering, obstruction of justice, and the House of Representatives and the Senate need to move to protect Mr. Cohen by voting a resolution of censure that you can criticize Mr. Cohen, but don't attack a man's family and intimidate a witness before Congress," he said.

Shusterman reportedly loaned millions to a Chicago cab company owner mentioned in the FBI warrants used to raid Cohen's home, office, and hotel room in April 2017 for an investigation led by the U.S. Attorney's Office in the Southern District of New York. He also pleaded guilty to income tax fraud in 1993.

Cohen was subpoenaed on Thursday to sit down with the Senate Intelligence Committee sometime in mid-February. He was due to appear before the House Oversight Committee on Feb. 7, but on Wednesday postponed his testimony because of "ongoing threats." Trump's former fixer was sentenced to two months in federal prison in December after he pleaded guilty to “knowingly and willfully" making "a materially false, fictitious and fraudulent statement and representation” to the House and Senate Intelligence committees in 2017 about Trump Organization negotiations to build a Trump Tower in Moscow before the 2016 election. Those two months, handed down through a case brought by special counsel Robert Mueller, will be served concurrently with the three years he received as part of the campaign finance violations and tax and bank fraud case he faced last year in New York.

https://www.washingtonexaminer.com/news/lanny-davis-rudy-giuliani-is-mentally-unstable

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