|Bid||0.00 x 900|
|Ask||0.00 x 3000|
|Day's Range||18.62 - 19.18|
|52 Week Range||16.63 - 37.56|
|Beta (3Y Monthly)||2.04|
|PE Ratio (TTM)||307.13|
|Earnings Date||Nov 4, 2019 - Nov 8, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||26.20|
The 700+ hedge funds and famous money managers tracked by Insider Monkey have already compiled and submitted their 13F filings for the second quarter, which unveil their equity positions as of June 28. We went through these filings, fixed typos and other more significant errors and identified the changes in hedge fund portfolios. Our extensive […]
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.
Pfizer stock has tumbled, below other pharmaceutical stocks. Recent news has been upbeat with a drug approval and acquisitions. But the question remains: Is Pfizer stock a buy right now?
The pace of acquisitions in the biotech industry is expected to accelerate as big pharma seeks to boost growth Continue reading...
(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 firstname.lastname@example.org;Matt Robinson in New York at email@example.comTo contact the editors responsible for this story: Drew Armstrong at firstname.lastname@example.org, ;David Glovin at email@example.com, Timothy AnnettFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Mylan will pay $30 million to settle a Securities and Exchange Commission lawsuit that claims the pharmaceutical company failed to disclose potential losses in the wake of an EpiPen scandal.
The Securities and Exchange Commission settled charges Friday against Mylan N.V., who agreed to pay $30 million for accounting and disclosure failures relating to a civil investigation over its alleged overcharging of Medicaid for EpiPen, its largest revenue and profit generating product. Mylan did not admit or deny the charges that it classified EpiPen as a "generic" drug under the Medicaid Drug Rebate Program, which resulted in Mylan paying much lower rebates to the government than if EpiPen had been classified as a "branded" drug. Beginning in November 2014, and for nearly two years, the Department of Justice investigated whether Mylan misclassified EpiPen and thereby overcharged the government for EpiPen sales to Medicaid patients. Mylan, however, failed to disclose or accrue for the loss relating to the DOJ investigation until October 2016, when it announced a $465 million settlement with DOJ. As a result, the SEC alleged Mylan's public filings were false and misleading. Further, as alleged in the complaint, Mylan's 2014 and 2015 risk factor disclosures that a governmental authority may take a contrary position on Mylan's Medicaid submissions, when CMS had already informed Mylan that EpiPen was misclassified, were misleading.
HERTFORDSHIRE, England, and PITTSBURGH, Sept. 27, 2019 /PRNewswire/ -- Mylan N.V. (MYL) today announced that it has finalized a previously disclosed civil settlement with the U.S. Securities and Exchange Commission ("SEC"). On July 29, 2019, the Company disclosed in its public filings that it had reached an agreement-in-principle with the SEC's Division of Enforcement to settle the matter. The matter primarily concerns historical disclosures and accrual related to the U.S. Department of Justice's civil investigation concerning the classification of EpiPen® and EpiPen Jr® Auto-Injectors for purposes of the Medicaid Drug Rebate Program.
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 agreed to pay $30 million to settle a Securities and Exchange Commission lawsuit related to a probe of its EpiPen product. The SEC accused the Canonsburg, Pa., pharmaceutical company of failing to disclose to investors a possible loss relating to a Department of Justice investigation regarding the best-selling product. "Mylan believes at this time, taking all other matters into consideration, that this settlement is the right course of action for the company," the company said in a release on Friday.
Coherus Biosciences is the IBD Stock Of The Day as shares of the biotech company flirt with a breakout on expectations for a strong third quarter. Coherus makes biosimilars of branded drugs.
J.P. Morgan’s Chris Schott told a look at what he calls New Pfizer, the biopharma business that will be left after the spinoff of the unit that makes drugs such as Viagra and Lipitor.
[Editor's note: This story was previously published in February 2019. It has since been updated and republished.]Overall, the stock market continued its huge improvement throughout 2019, compared to where it ended in 2018; it has been a complete turnaround from last year's drop, when stocks entered bear-market territory. Markets started slipping again in the month of August, traded in a range, and then turned to rally to new all-time highs.But even though many stocks have completely erased all of their losses and made it back into the green, not all stocks have done so well. What this means is that while there are still plenty of duds out there, there are also a few undervalued stocks to buy; it has just become a little trickier to find them amid all the flashy comeback stories.InvestorPlace - Stock Market News, Stock Advice & Trading TipsTo find the best stocks to buy now, disciplined investors might start with their own watch list, which should contain "wish list" stocks that are usually too expensive or have been put there to be on the back burner for later. Among such stocks, companies that got left out of the rally are the most compelling. Even better, some of the best undervalued stocks to buy are those that dropped by double-digit percentages during the current rally.Why is that?Stocks that have already priced in current and possible negative news typically lower the risk for investors. Such companies may work to resolve the business problem at hand, which improves its prospects and leads to a higher share price in the long run. As long as the bad news reported is a temporary setback and the business model is not broken, the risks behind buying a stock on a dip are lower. * 8 Dividend Stocks to Buy for a Recession With all of that in mind, here are five undervalued stocks to buy that aren't as scary as they seem. Sony (SNE)Investors who held Sony (NYSE:SNE) stock through the Q2 2019 earnings report posted on July 30 enjoyed the rally that followed. The stock rose from $54.50 to nearly $60 recently. The company reported revenue falling just 1.4% year-over-year but operating income rose 18%, up 35.9 billion yen (US $332.2 million).Now that Sony is trading at yearly highs, investors need not sell the stock just yet.Why not?In a Sept 13 report, video game sales in August fell again by 18%, to $666 million. The industry could not count on any big game title hits to lift monthly sales. But the gaming sector has some hope ahead. When Sony's Playstation 5 arrives, SNE will have more power than ever. Though the PS5 release will release no sooner than mid-2020, 8K support and game refreshes should give Sony another boost in revenue when the time comes.Sony faced a few headwinds in the quarter. Contributions from first-party software titles fell. Sales of non-first party titles declined. But PS4 hardware sales rose, as did network service sales, including sales of PlayStation Plus. Celestica (CLS)In July, Celestica (NYSE:CLS) reported weak Q2/2019 results that sent the stock to as low as $6 by the end of August. Celestica reported revenue of $1.45 billion, down 15% from last year. Its aerospace and defense segment etched out a 2% revenue growth in the period, offset by a 23% decline in revenue from its Connectivity and Cloud Solutions (CCS) division. Adjusted EPS was $0.12, down from $0.29 last year. In September, the stock staged a major rally.The company supplies equipment in ATS -- aerospace and defense, industrial, smart energy, health tech and capital equipment. Its enterprise unit consists of servers and storage. Why then, should investors believe the company will offset the weakness it faces in the eroding semiconductor market?Celestica is cutting costs in operations to align the business with the lower revenue. It will continue to build its capital equipment business. Management believes the fundamentals in this space will only improve in the long run. As next-generation adoption in display continues, its OLED business, for example, will add to its bottom line.Celestica stock is still an undervalued play worth considering. The stock may underperform a while longer and risks disappointing investors. Again. Consider watching the stock's next earnings report before committing to a position. * 7 CBD Stocks to Buy That Are Still Worth Your Investment Dollars Celestica stock is an undervalued stock worth considering. AbbVie (ABBV)Back when I first wrote this list of undervalued stocks, Allergan (NYSE:AGN) was the pick in this slot. And it paid off. Investors buying Allergan at the start of 2019 may have made up to $50 a share, peak to trough. In June, the stock fell below $115, only to peak at around $165 in July when my new pick, AbbVie (NYSE:ABBV), agreed to buy out the firm for $63 billion. AbbVie's rationale for acquiring Allergan is two-fold.First, it views Allergan's portfolio of products, including Botox, as attractive. Second, it has the time to use the strong cash flow from Humana to pay off its Allergan acquisition. Once Humana faces fierce competition from generics, AbbVie will have paid off much of the debt related to the AGN buyout. And in a few years time, Allergan's drugs in the development pipeline will be ready for market.AbbVie's long-term future planning through the AGN acquisition makes AbbVie stock appealing for dividend-income investors. Even though shares rose from a $62.66 52-week low to $71.55, the stock still pays a dividend that yields 6%.At a Sep. 10 Healthcare Conference, AbbVie reiterated its commitment to cut debt and to continue growing its dividend. It will also allocate some cash for smaller mid- to late-state pipeline opportunities. Management has a good handle on integrating Allergan into its business but it will not let its existing pipeline suffer in any way.ABBV trades at an ~10% discount to the analyst price target of $79, but I think the AGN acquisition brings ABBV far more upside than that. Innoviva (INVA)Innoviva (NASDAQ:INVA) is another stock in the drug space whose large drop starting in late January continued throughout 2019. The stock may not yet be done falling. Why not?The fell began when the FDA approved Mylan's (NASDAQ:MYL) generic version of Advair, which GlaxoSmithKline (NYSE:GSK) produces. This forced investors to worry about Innoviva's prospects because the company is paid royalties from Glaxo. In the third quarter, Innova received $65.1 million in royalty revenues from Glaxo.Investors appear to be overreacting to the generic competition. If demand for Innoviva's formulation does not drop and prices hold, royalty revenues should not fall as much as markets think, which makes INVA an ideal undervalued stock to buy now.Innoviva shares trended lower throughout 2019, as the stock lost $3 on its stock price by late-July. Investors sold the stock following the company's weak Q2 report. Innoviva reported Glaxo (NYSE:GSK) royalties falling 18% to $313.9 million. Overall, there was a net income decline of 31% (an EPS of $0.34).In its press release, the company said:"Management and the board continue to examine potential strategic actions to maximize future shareholder value." * 7 Momentum Stocks to Buy On the Dip Innoviva incurred expenses related to the evaluation of strategic options. But it will need to deliver on better shareholder value to attract stock buyers. Vodafone (VOD)Telecom stocks were out of favor heading into 2019. Now, telecom stocks are no longer out of favor. But Vodafone (NASDAQ:VOD), which after cratering in May, has just barely climbed back to it's pre-Christmas levels. So VOD is definitely still an undervalued stock.On July 26, Vodafone reported revenue stabilizing, falling just 2.3% Y/Y. The results sent VOD stock up 9% on the day. And ever since the stock bottomed at $16, it continues to run higher, closing recently at close to $20. In the fiscal Q1 2020 report, Vodafone said it enjoyed record low mobile contract churn. The deepening customer engagement will only strengthen as the telecom company launches 5G in all major EU markets.Service revenue in Q1 was mostly flat, down 0.2% and 0.5 pp sequentially.Simplifying the mobile plan offering will likely lead to higher revenue growth ahead. For example, Vodafone migrated 500,000 SIMs to a new unlimited offer. This will also increase ARPU and keep customers from switching to competitor services.Vodafone shares pay a dividend yield of 5.2%. If Vodafone grows its U.K. business as it signs on users to its 5G services and cuts costs as it signs on more customers, VOD stock will finally move higher.As of this writing, Chris Lau owned shares of Innoviva and AbbVie.The post 5 Undervalued Stocks to Buy appeared first on InvestorPlace.
HERTFORDSHIRE, England and PITTSBURGH, Sept. 17, 2019 /PRNewswire/ -- Mylan N.V. (MYL) today announced the U.S. launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, a generic version of AstraZeneca's Faslodex® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is used to treat certain types of advanced breast cancer in women who have experienced menopause as monotherapy and in advanced or metastatic breast cancer in combination with other products. "Mylan's launch of Fulvestrant Injection represents an important addition to our growing oncology portfolio and, more importantly, expands the available treatment options for women who are facing advanced or metastatic stages of breast cancer," said Mylan President Rajiv Malik.
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.
Results for Glatiramer Acetate (GA) Depot 3 year analysis in RRMS, GA Depot safety results in RRMS and PPMS, and novel anti-BMP for remyelination will be presented ECTRIMS 2019.
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.