|Bid||18.36 x 3000|
|Ask||18.60 x 3100|
|Day's range||18.28 - 18.92|
|52-week range||16.63 - 37.56|
|Beta (3Y monthly)||2.04|
|PE ratio (TTM)||300.49|
|Earnings date||4 Nov 2019 - 8 Nov 2019|
|Forward dividend & yield||N/A (N/A)|
|1y target est||26.20|
Mylan (MYL) has an impressive earnings surprise history and currently possesses the right combination of the two key ingredients for a likely beat in its next quarterly report.
Theravance's (TBPH) newly-launched COPD drug Yupelri is witnessing a solid adoption while its pipeline programs are also progressing well. However, excessive reliance on Yupelri for revenues is a woe.
The U.S. Supreme Court on Monday declined to hear Acorda Therapeutics Inc's appeal of a lower court ruling that allowed generic versions of its multiple sclerosis treatment Ampyra and caused the drug's sales to plummet. The justices refused to review a September 2018 decision by the U.S. Court of Appeals for the Federal Circuit to cancel Acorda's patents covering Ampyra, a ruling the Ardsley, New York-based company and the pharmaceutical industry portrayed as a threat to innovation and bad for patients. According to Acorda, Ampyra was the first drug approved to improve walking in people with multiple sclerosis, an incurable and potentially disabling disease of the brain and spinal cord that can lead to symptoms including pain, visual impairments and difficulty walking.
(Bloomberg) -- Mylan NV misled investors for at least a year about a Justice Department investigation into the allergy shot EpiPen that would eventually cost the company nearly $500 million, the U.S. Securities and Exchange Commission said Friday.The settlement appears to close one part of a long-running saga over a product that boosted Mylan’s sales but also brought controversy. Under the agreement with the SEC, first disclosed as a settlement in principle by Mylan in July, the drugmaker will pay $30 million.The SEC lawsuit details years of Mylan’s efforts to fight allegations it overcharged taxpayers, and then negotiating with the government over a settlement. Neither the investigation nor the potential settlement was disclosed to investors while those events were ongoing. The company in October 2016 announced a settlement with the Justice Department for $465 million.“Investors were kept in the dark about Mylan’s EpiPen misclassification and the potential loss Mylan faced as a result of the pending investigations,” said Antonia Chion, associate director of the SEC’s Division of Enforcement.Mylan shares closed down 2.4% to $19.29 in New York.Controversial ProductThe SEC settlement is the latest black eye for a company that’s no stranger to controversy. Mylan has been named in lawsuits by state attorneys general that accuse 20 drugmakers of conspiring to carve up the market and raise price on more than 100 generic drugs. Democratic members of Congress have said the company has stonewalled their inquiries into its conduct. And the company has struggled to resolve a more than a year old supply shortage of EpiPen, even as copycat competitors have come on the market.Mylan has said that it acted properly and that its executives did not conspire to fix prices. It has also said that it is cooperating with investigations. EpiPen is manufactured by a Pfizer Inc. subsidiary and sold by Mylan, and the companies have said they are working on the supply issue. Pfizer and Mylan in July struck a deal to combine Mylan and Pfizer’s older-drugs business.The EpiPen settlement relates to a complex program in Medicaid, the federal-state health program for low-income people, that’s meant to get the government deep discounts on drugs. Under the program, almost all drugs are subject rebates to the government. But generics, which are typically lower-priced and have slim margins, pay a much smaller rebate than brand-name products.Even though EpiPen faced little competition and the company had increased the price by hundreds of dollars, it had been classified as a generic product under the discount program. In 2013, the Centers for Medicare and Medicaid Services told Mylan that EpiPen “has an incorrect drug category” in a government database, and that the company needed to verify and update the information.1997 LetterMylan’s justification for calling EpiPen a generic product was a 1997 letter from the government. But inside the company, executives raised doubts about whether the letter was sufficient, according to the SEC.The 1997 letter was “basically just done as a result of a conversation two guys who were there at the time had,” one Mylan employee said in an internal email to a Mylan executive, according to the SEC lawsuit. If there had been a new review, “they would have been denied given today’s market size and that ours was a loose interpretation to begin with,” said the employee.In November 2014, the SEC said, Mylan received the first Justice Department subpoena as part of a civil investigation into whether the company had misclassified the drug and cost taxpayers millions of dollars. At the time, about 20% of EpiPen’s $1 billion in annual sales came from Medicaid, according to the SEC.For the next year, Mylan argued that the government should drop its investigation. In response, the government sent more subpoenas, and had the company to sign an agreement extending the statute of limitations. In October 2015, however, Mylan began to share estimates of potential damages with the Justice Department, saying that in one quarter in 2015, calling EpiPen a generic had let the company avoid somewhere between $12 million and $42 million in rebates to Medicaid.In 2014 and 2015, Mylan told investors in filings that it was discussing the matter with the Centers for Medicare and Medicaid Services. But the SEC said that the company misrepresented the government’s position, downplaying its risk.Mylan said that it believes the SEC settlement is the right course of action. “The company continues to be committed to the highest levels of integrity with respect to all aspects of its business operations,“ it said in a statement.The company would later produce larger estimates, but still not tell investors that it was under investigation or might have to pay damages, the SEC said. “Mylan knew or should have known that the total possible loss arising from DOJ’s claims was exponentially higher than these amounts,” the SEC said in its lawsuit.Accounting rules say that companies are supposed to disclose liabilities when there’s a reasonable possibility of a loss. The SEC said that because it didn’t tell investors, the company ended up overstating its profits.David Maris, an analyst with Wells Fargo & Co., said the SEC settlement was just the end of one chapter. The company is still facing other government and private inquiries over EpiPen, Maris said. He has a “market perform” rating on the shares.“This does not put the entire EpiPen situation behind Mylan,” he said.(Updates to clarify description of employee in 11th paragraph, and closes shares in fifth paragraph.)To contact the reporters on this story: Riley Griffin in New York at email@example.com;Matt Robinson in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Drew Armstrong at email@example.com, ;David Glovin at firstname.lastname@example.org, Timothy AnnettFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
The SEC on Friday said Mylan kept investors in the dark when it failed to disclose or set aside money for the two-year probe by the U.S. Department of Justice, prior to announcing a $465 million settlement in October 2016. In a statement, Mylan called the SEC civil settlement "the right course of action," and said it was committed to the "highest levels of integrity" when communicating with investors and making disclosures in public filings.
Mylan NV has agreed to pay a $30 million fine to settle U.S. Securities and Exchange Commission charges it hid from investors the impact of a federal probe into the drugmaker's overbilling the government for its EpiPen allergy treatment. The SEC on Friday said Mylan kept investors in the dark when it failed to disclose or set aside money for the two-year probe by the U.S. Department of Justice, prior to announcing a $465 million settlement in October 2016. In a statement, Mylan called the SEC civil settlement "the right course of action," and said it was committed to the "highest levels of integrity" when communicating with investors and making disclosures in public filings.
Pfizer (PFE) sales in the second half may take a hit due to business development activity, incremental currency headwinds and potentially lower sales of key drugs Prevnar and Xeljanz.
Credit Suisse Group AG has brought on three new senior investment bankers as it continues to build out its healthcare investment banking division, according to an internal memo reviewed by Reuters. The three managing directors, Andrew Singer, Lorenzo Paoletti and Liav Abraham, will join Credit Suisse this fall, the memo said.
Acorda's (ACOR) lead MS drug Ampyra is hit by generic rivalry in the United States, which is hurting the company's top line. Parkinson's disease drug Inbrija can be an ideal replacement.
Despite lower demand hurting volumes of Enbrel, it remains the largest drug for Amgen (AMGN). A district court decision prevents Novartis from launching Erelzi, its biosimilar version of Enbrel.
As the Oct. 31 deadline for Britain to leave the European Union approaches, health professionals are warning that shortages of some medicines could worsen in Europe in the event of a no-deal Brexit. Britain's food and drink lobby warned last week that the country would experience shortages of some fresh foods if there is a disorderly no-deal Brexit.