AZ News from The Street 2014

Discussion in 'AstraZeneca' started by Anonymous, Jan 2, 2014 at 10:34 AM.

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  1. Anonymous

    Anonymous Guest

    Update on AstraZeneca's Crestor
    Zacks
    By Zacks Equity Research December 30, 2013 4:40 PM

    Cholesterol management drug Crestor is a key product at AstraZeneca (AZN). However, Crestor is facing a steep decline in revenues in Canada (down 42% in the third quarter of 2013) and Australia (down 68% in the third quarter of 2013) due to the loss of exclusivity. Additionally, Crestor is slated to lose exclusivity in the U.S. in Jul 2016 (including pediatric exclusivity).

    Last week, AstraZeneca and Shionogi & Co. Ltd. announced that arbitration proceedings related to the treatment of certain excise taxes and other specific items related to the calculation of royalties on Crestor sales have been resolved.

    It was also announced that the licensing agreement for Crestor will extend till 2023. As per the terms of the agreement, AstraZeneca will make payments to Shionogi from 2014 until 2023. AstraZeneca will pay fixed minimum annual royalty (low hundreds of millions of dollars) till 2020 from 2014, apart from royalty payments (during 2016 to 2020).

    Additionally, the companies have modified the royalty structure, which will be effective from Jan 1, 2014. As per the new terms of the agreement, the effective royalty rate for 2014-2015 will be lowered by a low single-digit number.

    Shionogi had initiated the arbitration proceedings in July 2012. We remind investors that Shionogi was also a party to the Mar 2013 settlement agreement between AstraZeneca and Actavis Inc. (ACT) regarding the Crestor patent litigation. Actavis was looking to launch its generic version of Crestor.

    As per the terms of the agreement, Actavis may launch its generic version of Crestor 67 days before Crestor loses exclusivity on paying 39% of net sales to AstraZeneca. Thus, a generic version of Crestor may enter the market in May 2016.

    We believe that the resolution of the arbitration proceedings is a positive for AstraZeneca and removes uncertainty over future Crestor revenues.
     

  2. Anonymous

    Anonymous Guest

    All eyes on Brilinta!
     
  3. Anonymous

    Anonymous Guest

    1/03/2014 @ 10:14AM

    Pharma R&D Cuts Hurting U.S. Competitive Standing


    A recent article in the New England Journal of Medicine (NEJM) should send warning signals to all interested in the state of the biopharmaceutical R&D in the U.S. The article, “Asia’s Ascent – Global Trends in Biomedical R&D Expenditures”, analyzes global biomedical R&D spending for the period between 2007 and 2012. While the article focuses on the relative rise in spending by Japan, China and India, the eye-opening data for me are the numbers from the U.S. The authors point out that the U.S. share of this global spend has fallen from 51.2% in 2007 to 45.4% in 2012. Europe’s investment was essentially unchanged and Asia’s increased from 18.1% to 23.8%. Further digging into the numbers revealed the following.

    “The decline of $12.0 billion in the inflation-adjusted U.S. expenditures from 2007 to 2012 was therefore driven by a $12.9 billion reduction in industry’s investment in R&D. The U.S. share of global industry R&D expenditures decreased from 50.4% in 2007 to 42.3% in 2012.” The authors later say that “The decline is remarkable because the United States has provided a majority of the funding from biomedical R&D globally for the past two decades – a share that some previous analyses suggested was as high as 70 – 80%. Moreover, the decline was driven almost entirely by reduced investment by industry, not the public sector, between 2007 and 2012.”

    Much of the news from the pharmaceutical industry over the past five years has been about scaling back R&D. Companies like Pfizer, AstraZeneca and Merck have done just that, much to the delight of Wall Street analysts who have been urging pharmaceutical companies to rethink reinvesting 17 – 20% of revenues into R&D and to scale this back to 10 – 14%. While such a decrease in spending can bring short-term returns with respect to higher financial returns, such policies have negative long-term consequences. Those companies that aggressively cut their R&D budgets will ultimately experience shrinking pipelines.

    More importantly, for patients, these cuts will lessen the chances of coming up with new medicines for diabetes, Alzheimer’s disease, cancer, etc. Ironically, this is coming at a time when new insights into the cause of disease are occurring on a daily basis. Yet, as part of these cuts, major companies are getting out of research in key areas like antibacterials, depression, schizophrenia and AIDS. While some of this work is being picked up by small biotechs and start-ups, this situation is far from ideal.

    Is there anything that can be done to reverse this trend? The NEJM authors suggest that: “Instead, even as it boosts NIH funding, the U.S. government might also develop strategies to provide incentives to industry for investing in biomedical R&D.” That’s a nice suggestion, but given the current state of pharma’s reputation and the pressures on the U.S. healthcare budget, I find it hard to believe that R&D incentives for pharma will have much traction in Congress. Increased R&D spend will only occur if courageous CEOs decide to do so.
     
  4. Anonymous

    Anonymous Guest

    Crestor: A very good drug, people or managed care will NOT pay for. It's all about the price stupid!!
     
  5. Anonymous

    Anonymous Guest

    Crestor sales continue to be eroded away by generic Lipitor. Pfizer's advertising for Lipitor helped to drive the idea that statins were needed too. The loss of that message is hurting Crestor sales as well. Oh, and you are right about the high price also.
     
  6. Anonymous

    Anonymous Guest

    The Hidden Nasty In AstraZeneca plc’s Latest Results
    By Roland Head - Tuesday, 7 January, 2014

    AstraZeneca (LSE: AZN) (NYSE: AZN.US) is a firm that I rate highly, but I recently discovered a ‘hidden nasty’ in the firm’s operations, which I feel potential shareholders should be aware of.

    In this case, the problem isn’t financial — indeed, Astra’s balance sheet, which has minimal debt and plenty of cash, looks much more attractive than GlaxoSmithKline‘s debt mountain.

    However, Astra’s earnings keep falling, as key products lose patent protection without being replaced by new products. My hidden nasty suggests that Astra is going to have to do some serious spending if it is to overcome this challenge in the next couple of years.
    Phase lag

    When a pharmaceutical company develops a new medicine, it goes through three sets of trials — phase 1, phase 2 and phase 3.

    The majority of phase 1 and 2 trials don’t result in products that make it through to production, so as investors, it makes sense to concentrate our attention on phase 3 trials, around three-quarters of which do result in commercial products.

    I’ve taken a look at the latest published pipeline documents for both AstraZeneca and Glaxo, and I’ve noticed what I believe to be a significant difference.

    Approximately 30% of Glaxo’s current clinical trials are in phase 3, compared to just 15% of Astra’s.

    When you consider that even after a successful phase 3 trial, medicines require regulatory approval, and can take several more years to reach the market, you can see what a mountain AstraZeneca has to climb in order to replace core products such as Nexium and Seroquel IR.

    The fact that such a small proportion of Astra’s trials are in late stages is worrying for future revenues, and to me, this suggests that Astra’s pipeline is lagging significantly behind that of Glaxo.
    Worth the wait?

    AstraZeneca currently trades on a forecast P/E of 11.7 and offers a prospective yield of 4.8%. I think that’s an appealing valuation, despite the fact that Astra’s earnings per share are expected to fall by a further 9% this year, placing it on a 2014 forecast P/E of 12.8.

    As a long-standing Glaxo shareholder, I’m going to sit tight, but if I were starting afresh today, I would almost certainly choose to invest in AstraZeneca, thanks to its strong balance sheet and cheap valuation. Over the medium term, history suggests that these attributes will provide above-average returns.
    A dividend for life?

    Astra's 4.8% prospective yield is one of the main attractions for potential buyers, but the firm's payout has not risen significantly since 2011, and is also expected to remain largely flat this year.

    As a result, high-yielding Astra could fail one of the five 'golden rule' dividends tests detailed in a new Motley Fool special report, "How To Create Dividends For Life".
     
  7. Anonymous

    Anonymous Guest

    Keep in mind that The Motley Fool is PAID to pump AZ stock, as they are other stocks. They have NO credibility whatsoever.
     
  8. Anonymous

    Anonymous Guest


    That is true, and yet they still weren't able to make the article completely positive.
     
  9. Anonymous

    Anonymous Guest

    FDA approves diabetes drug with new approach


    WASHINGTON (AP) - The Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.

    Farxiga is a once-a-day tablet designed to help diabetes patients eliminate excess sugar via their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver.

    The drug is the second product approved in the U.S. from the new class of medicines known as SGLT2 drugs. In March the FDA approved Johnson & Johnson's Invokana, which also works by eliminating excess sugar through patients' urine.

    The agency cleared Farxiga tablets for patients with type 2 diabetes, which affects about 24 million people in the U.S. The approval marks a comeback for the drug, which was previously rejected last year after studies raised concerns about links to bladder cancer and liver toxicity.

    Ten cases of bladder cancer were found in patients taking the drug in clinical trials, so Farxiga's label warns against using it in patients with the disease. A panel of FDA advisers last month said that the uptick in cancers was likely a statistical fluke, and not related to the drug. But the FDA is requiring Bristol and AstraZeneca to track rates of bladder cancer in patients enrolled in a long-term follow up study. The companies will also monitor rates of heart disease, a frequent safety issue with newer diabetes medications.

    The most common side effects associated with Farxiga included fungal and urinary tract infections. The drug can be used as a stand-alone drug or in combination with other common diabetes treatments, such as insulin and metformin.

    http://money.msn.com/business-news/article.aspx?feed=AP&date=20140108&id=17242444
     
  10. Anonymous

    Anonymous Guest

    Fungal infections will get the doc's attention. But what the hell is a little fungal infection if your a1c is looking good!!!
     
  11. Anonymous

    Anonymous Guest

    I didn't think this drug would ever get approved. BMS/AZ rushed to try to get this to be the first in class drug with bad data and ended up losing over a year in the US due to cancer cases for which the numbers were not high powered enough to rule out as chance. JNJ ended up having the first in class drug for this categoryin the US. Competition from Astellas and Lilly is already nipping at its heels. All will have significant side effects from all that glucose lying in the bladder and urinary tract. The only differentiation among the various entries so far seems to be idiosyncratic effects like cancer promotion. More differentiation may eventually be found amongst them as they are used in a greater number of patients. Who knows how that will eventually work out for the AZ entry?

    This drug will probably never be a real big seller, but looking at the AZ pipeline, any seller would be welcome. It will likely outsell Brilinta anyway...but that is a low bar to exceed.
     
  12. Anonymous

    Anonymous Guest

    AZ stock breaks 60 today, another 52 week high and highest it has been over 7 years.
     
  13. Anonymous

    Anonymous Guest

    That is amazing considering that those who work here know that this company is a house of cards.
     
  14. Anonymous

    Anonymous Guest

    AZ still hasn't gone ex-dividend yet. This stock is a dividend play. Some company good news priced on top of the build to the ex dividend date possibly.
     
  15. Anonymous

    Anonymous Guest

    entirely down to Ben Bernanke. The entire stock market jumped 30% in 2013 when the economy is still on life-support - stock prices bear no relation to company performance anymore and are totally driven by central bank policy.
     
  16. Anonymous

    Anonymous Guest

    The entire stock market jumped? Every stock is up 30% in 2013?

    Stock prices bear no relation to company performance anymore? What about IBM, Blackberry, Red Hat, JCPenney, Broadcom....think their company performance had nothing to do with their fall?

    Surely not every pharma company is nearing it's all time stock high is it?
     
  17. Anonymous

    Anonymous Guest

    Come back this summer when the stock price will be back in the high 40s or low 50s. You need to read what the big investment firms have to say about AZ's future. They are estimating this new drug will peak at no more than $280 million with 1/3 of 1 percent market share. Now does that sound like a blockbuster that will support 6 PSSs promoting it for 2 or 3 Rxs per month, tops?
     
  18. Anonymous

    Anonymous Guest

    Share price went up 20% last year when the third quarter results showed a 29% fall in profit. That's not a fair reflection of performance and nor is AZ's share price approaching it's all-time high a reflection of performance.
     
  19. Anonymous

    Anonymous Guest

    If the stock goes down 30% in 2014 and reaches an all-time low, will that be a reflection of poor performance?
     
  20. Anonymous

    Anonymous Guest

    AZ, BMS, Pfizer, GSK, Novartis, Merck, Amgen, Roche all showed double digit share price growth last year……boom-time for pharma, obviously!