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Amgen, Inc. (AMGN) Message Board

Rob_Cos 104 posts  |  Last Activity: Apr 16, 2014 3:37 PM Member since: Dec 31, 1997
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  • Piper raising ACAD target from $28 to $42 - Pipeline Progress Should Enhance Conviction in PDP This Year

    COMPANY NOTE PIPER JAFFRAY March 7, 2014 ACADIA Pharmaceuticals (ACAD) Overweight

    Pipeline Progress Should Enhance Conviction in PDP This Year
    Current OverweightPrice Tgt Raise from US$28.00 to US$42.00
    ACADIA recently reported 4Q13 results and provided pipeline updates, as well as completed an equity raise netting ~$197mn. Guidance for a "near YE" NDA filing for pimavanserin (pima') in PDP remain intact. Management indicated NDA preparatory activities, stability testing and drug-drug interaction studies are progressing well, and we believe these timelines may accelerate. ACADIA ended the year with $186mn. With the recent raise and despite anticipated expenses for establishing a US commercial infrastructure, we see current cash as sufficient to fund to profitability, contingent on our revenue projections being met.

    • ADP thoughts. The company is constructive on the conduct of the Alzheimer's dependent psychosis (ADP) Phase II study, however, will not provide enrollment updates (we suspect it may be ahead of schedule given the trial design and patient cohort). Based on our diligence on pima’s potential beyond PDP, we are moving to a DCF-based valuation (Exhibit 1 vs. prior sales multiple in Exhibit 2) of the PDP and ADP indications to better capture ACADIA's intrinsic value, resulting in an increase of price target to $42 from $28, while use in schizophrenia remains as upside to our model.

    • Measured progress. ACADIA provided updates to the pima' clinical program, with everything conservatively remaining on track to previously guided timelines. That said, we have enhanced conviction on the ability of this team to execute as a result of recent hiring of management with commercial experience. As a result of ongoing diligence on pima’ and the ADP study design, we are increasingly opt

  • ACAD CEO presents tomorrow before the bell at NeedhamHealthcare Conference at 8:40 am in NYC at Westin Grand Central

    see ACAD investor relations section for link to webcast

    Event Details
    ACADIA Pharmaceuticals at Needham Healthcare Conference
    Tuesday, April 8, 2014 8:40 a.m. ET
    Webcast PresentationHelp Help

    Event Details

    Title ACADIA Pharmaceuticals at Needham Healthcare Conference
    Date and Time Tuesday, April 8, 2014 8:40 a.m. ET
    Location The Westin Grand Central
    New York City, NY US

  • Reply to

    ACAD multiple catalysts- adding here

    by rob_cos Apr 6, 2014 10:45 PM
    rob_cos rob_cos Apr 7, 2014 3:08 PM Flag

    Added 5000 here 20.xx

  • Reply to

    Acadia's $28.50 fund raise

    by investormdpart2 Mar 24, 2014 1:29 PM
    rob_cos rob_cos Apr 7, 2014 3:03 PM Flag

    Was brilliant Adding 5000 ACAD near 20 here - Already had enough cash for commericallization & then did an additional secondary near 30 - lots of visibility this qtr - a double in 18 months imo....could rise 50% if IBB reverses & positive FD discussions....

    ACAD's Q2 Events -


    4-1-14 Uli presents on Acadia in Sweden

    4-7-14 ACADIA management to meet with Piper in Chicago on April 7

    04-08-14
    Needham Conf

    04-27-14 AAN Meeting (Pima presented by Dr Cummings in 2013 as a hot topic here)
    05-07-14

    ACAD Q1 Results

    06-02-14
    Jefferies Conf

    6-8-14 MDS Conference (ACAD presented Pima's P3 here in 2013)

    06-24-14 JMP Healthcare Conf

  • Reply to

    Potential suitors for CELG

    by jdjunk70 Apr 4, 2014 5:27 PM
    rob_cos rob_cos Apr 7, 2014 2:04 AM Flag

    NVS, Roche, PFE, MRK, JNJ, AZN, - CELG now trading at a discount to their PE - instantly accretive stock for stock acquisition

  • Just out - Barclays "unmatched growth potential yet trade at attractive valuations following the recent sell-off. We do not see further downside in the large-cap biotech group"

    Barclays Capital Inc.

    U.S. Biotechnology

    Ying's Weekly Dose


    What We Heard/Sentiment: Weakness in biotech continued last week with the Nasdaq Biotech Index (NBI) down 1.7% vs. S&P500 up 0.4%. NBI has now hiven up all the lead over S&P500 year-to-date. However, the biotech bellwether GILD was able to buck the trend and was up 5.3% for the week. The "sector rotation" trade remains a theme among the generalist investors as money flows out of healthcare and within healthcare we are seeing biotech as a source-of-fund for "safer" investments in med-tech, HMOs, and distributors. In our view, the large-cap biotech stocks offer unmatched growth potential yet trade at attractive valuations following the recent sell-off. We do not see further downside in the large-cap biotech group while the s/mid biotech group may experience more volatility.

    company detail on Investorvillage CELG board

  • Reply to

    Firsthand account of Pima's potential

    by golfmaniac93 Apr 6, 2014 10:04 AM
    rob_cos rob_cos Apr 6, 2014 10:46 PM Flag

    Great post

  • see investorvillage ACAD board for the near term catalysts and presentations - there are many - this is just Q2 - since links don't post you have to go to IV board to see them

    4-1-14 Uli presents on Acadia in Sweden

    4-7-14 ACADIA management to meet with Piper in Chicago on April 7

    04-08-14 Needham Conf
    (needham=USER/ healthcare13=Password to view all presenters)

    04-27-14 AAN Meeting (Pima presented by Dr Cummings in 2013 as a hot topic here)

    05-07-14
    ACAD Q1 Results

    06-02-14
    Jefferies Conf

    6-8-14 MDS Conference (ACAD presented Pima's P3 here in 2013)

    06-24-14 JMP Healthcare Conf

  • ACAD now "Stupid cheap" FDA on its side-multi-billion PDP/ADP blockbuster

  • IOC relative Strength amazing w NASDAQ & DOW both down over 100 points

    I see 70s soon and a close of the gap in the 80s on any positive news - as a start - old days on a weekly friday expiration shorts would have taken us down to 65 - now they are using the market weakness to cover a little. GREAT SIGN IMO....something positive is coming imo.

  • Barclays Celgene- CELG has no obligation to provide Revlimid to generic manufacturers..we do not expect MYL challenge to be successful...reiterate overweight & $185 target...

    Stock Rating/Industry View: Overweight/Neutral - Price Target: USD 185.00

    MYL accuses CELG of blocking Thalomid and Revlimid generics. Mylan has filed a suit against CELG in the U.S. District Court in Newark, New Jersey alleging the use of federal limits on distribution to prevent generic manufacturers from obtaining samples of Thalomid and Revlimid. The suit accused CELG of having unlawful monopolies over Revlimid and for stopping the sale of both Revlimid and Thalomid to MYL for bioequivalence testing, which is required by the FDA to approve a generic.

    Revlimid is protected by composition-of-matter patent till 2019. The focus here is on Revlimid, as Thalomid is now a small product for CELG with 2013 global sales of $244.6mn. TEVA (formerly Barr Laboratories) had filed for a generic version of Thalomid in September 2006 but ultimately withdrew its application. Revlimid is protected by a composition-of-matter patent till 2019 (with polymorph patents protecting the product until 2027) and we do not expect MYL to challenge or be successful in challenging the composition-of-matter patent.

    CELG has no obligation to provide Revlimid to generic manufacturers. It is our understanding that CELG has no obligation to provide samples of Revlimid to generic manufacturers. The Risk Evaluation and Mitigation Strategies (REMS) program required by the FDA for Revlimid also makes it difficult to obtain the product on the open market. Patients and physicians are required under REMS to register in a database administered by CELG before Revlimid is distributed. We note the REMS program argument has been upheld by the court in previous generic litigation cases.

  • Baird Equity Research
    Health Care / Life Sciences April 1, 2014
    Biotechnology
    Latest Biotech Additions to Baird’s Focus List – CELG, GEVA

    CELG, GEVA buyers. We’re adding CELG, GEVA to Baird’s Focus Idea List, with
    attractive entry points for both names following recent sector weakness. We view investor
    concerns over CELG’s Revlimid patent lawsuit as overdone and anticipate focus returning
    to a positive commercial story. Approaching pivotal readout for GEVA’s lead product
    sebelipase alfa marks the start of a critical, value-creating period and like the setup into
    2015. Remain confident in CELG’s and GEVA’s long-term potential and remain buyers
    right here.

    n Adding CELG, GEVA to Baird’s Focus Idea List. We believe recent biotech
    weakness (NBI –11% in March vs. +1% S&P) provides an attractive buying opportunity
    for investors looking for longer-term, quality holdings.

    o Like CELG’s robust, long-term commercial outlook paired with promising pipeline.

    - Sector weakness, generic Revlimid concerns bit overdone. CELG shares have been negatively impacted by two drivers: the long-term sector outlook, and the ongoing Revlimid patent challenge lawsuit, with concern that the latter will bring earlier generic competition. We continue to believe sector fundamentals look strong and that a near-term correction is necessary and helpful. Additionally, we view Revlimid’s intellectual property position as strong enough to withstand the current legal action.

    -Weakness brings attractive valuation. CELG now trades at a current- near P/E of 19.2 and PEG of 0.7. Compare this to large-cap peers trading at 24.0 and 1.2, respectively, and we think this makes for a compelling entry point.

    - Commercial momentum looking good in our view. Once the macro, legal overhangs subside, we think focus will return to the commercial outlook which we view as strong. Our latest survey suggests recent front-line Revlimid data from the MM-020 trial has reinvigorated maintenance use, duration, while Abraxane

  • RBC"Large Cap Bio Trading @ Pharma P/E despite 3x's EPS growth.Expect Markman Judge to rule in favor of CELG polymorph patent-settlement by yr end-remove overhang & lead to P/E expansion to 17-20x's for CELG"

    RBC Capital Markets

    April 1, 2014

    Large Cap Biotech Trading At Pharma P/E ...April 'Events' to Watch

    AMGN, BIIB, CELG, GILD, ISIS, PRTA

    With the 17% pullback in the IBB since the February 25th peak reminiscent to August 2011 when USA got its debt downgraded (biotech got hit hard but it wasn't anything industry specific either), large-cap biotech now trades near pharma multiples yet has three times the earnings growth: 25% 3-yr EPS CAGR from 2014-16 vs pharma at 7%. Biotech is now at a median of 14x 2015 consensus estimates, basically lower than versus pharma's median of 15x. Because of a 25% CAGR for the group, 2016 is even cheaper for biotech now: trading at a low 12-13x P/E vs pharma at 14-16x (pharma has minimal growth, so P/E stays similar). We find this very attractive and for many investors we think this should be near a "floor" valuation - trading at the same as pharma.

    The most compelling: GILD now trades at 10x 2016 consensus EPS of $7 but the reality is the buyside 2016 EPS is even higher towards $8-9, so GILD really trades at like 8-9x earnings - very, very cheap and near 2009-10 "Viread patent cliff" concern days. CELG trades at 15x 2015 and 11x 2016 - these are multiples it saw back during Obamacare days and Revlimid "SPM" days. We also like BIIB a lot here, not as cheap at 18x on 2016E but the best late-stage pipeline that could have the stock up well over $400-500 if Tysabri hits.

    Events this month we're following closely:

    EASL April 9-13: Merck will report Phase II C-WORTHY combo data in GT1a "without RBV" and if 95-100% SVR, GILD might trade down a bit but this drug wouldn't get to market until 2016+ after GILD has treated 100-200k pts already. Contact us for our EASL Data Planner and invitation for Saturday Doc Dinner.

    Large cap ear

  • ISI just out - -FYI - Biotech PEs have contracted 15% and are *NOW THE SAME AS PHARMA* for first time in 10 years..
    -FYI - Biotech PEs have contracted 15% and are *NOW THE SAME AS PHARMA* for first time in 10 years

    · Biotech larger cap PEs have contracted 15% since Feb 25 (biotec 2014 high point). This compares to flat PEs for pharma and the S&P 500 since Feb 25.

    · The larger cap biotech median PE is now ~19 vs pharma/S&P500 of around 19/16.

    · This is the first time in our 10 year data that larger cap biotech has traded at parity to US pharma.

    CHART DOESN'T PRINT BUT HOPEFULLY U GUYS REC'D IT

    Below, please find 10+ year historical PE and PEG data.

  • JMP - Biotech Group is in the Best shape it has ever been - We have ultimate confidence that the biotech sector will return to its previous luster. (Full story on investorvillage CELG board

    Biotech Balance Sheet -- INDUSTRY OVERVIEW

    After largely ignoring the positive performance of the biotech sector in 2012 and 2013, the media television, press, and social media-have made sport over the recent plunge in the space. If only this chatter was informative; instead, in our opinion, it amounts to little more than standing on the sidelines at a game and pointing at the player that got hurt. Ergo, the piling-on takes place on shows such as Fast Money or in Barron’s when columnists run stories on the dire predictions made by cynical buy- or sell siders.

    The action last week left few stocks intact and represents the most significant correction in the past two years. The BioCentury 100™ saw only six gainers and 94 losers. This kind of extreme action suggests a selling climax to us, but exactly if, when, and for how long the group bounces remains to be seen. Our guess is that we will get a trading bounce this week, but it will likely be just that as damage of the magnitude the group has undergone usually takes a while to heal. A quick scan of sector pull-backs in the past two years suggests a period of about 5-6 weeks over which the decline takes place, and then roughly a 3-4 week period before the sector recovers and historically, the BTK index has moved back to a new high.

    Recent action may cause many to question if the back of the group is broken. As we have enumerated in many of our writings this year, in our opinion, the group is in the best shape it has ever been. We believe the low probability, low expectation view is working. The FDA is on our side, and we see little chance of that turning on a dime. This past week was actually fairly good for the sector from a newsflow perspective; however, it appears to us that many investors chose to ignore this and listen to
    the mainstream media instead.

    In addition to FDA approval of Biogen’s Alprolix for hemophilia B, there is a barrage of data coming out of the ongoing American College of Cardiology (ACC) with respect to the PCSK9 antibodies from Amgen (AMGN, NC), Regeneron (REGN, CIT), and Pfizer (PFE, NC), and the risk/benefit ratio is
    heavily skewed toward use of these agents as either monotherapy or on top of standard lipid-lowering therapies. Amgen, which has provided the most thorough accounting of its data, both in terms of number of patients, as well as simultaneous publication of its data in peer-reviewed journals, has also thankfully alleviated most concerns about the neurocognitive side effects that have surrounded the space in recent weeks. While the news wasn’t as positive for Novartis’ (NVS, NC) serelaxin for heart failure that received an 11-0 decision at the hands of the CRDAC, nor for Exelixis’ (EXEL, NC) Cometriq that received a recommendation from the study’s DSMB to continue the COMET-1 trial, the news was more positive for
    Exact Sciences’ (EXAS, MO, $25 PT, Haresco) and the FDA briefing documents for Cubist’s (CBST, MO, $80 PT, Bayko) tedizolid (Sivextro) and dalbavancin (Dalvance) from Durata (DRTX, MO, $18 PT, Bayko).
    This coming week, eyes will be on MannKind (MNKD, MP, Butler), whose Afrezza inhaled insulin will go before the FDA on Tuesday and Gilead (GILD, NC), whose “deadline” to respond to the House Committee on Energy and Commerce is April 3.

    While the events of this week may not be enough to provide a turn for the group, valuations should begin to matter more and perhaps some of the large cap names will get traction. We draw attention to Figure 4 for the current (as of Friday’s close) valuations for the profitable mega cap names. In our opinion, a number of the stocks are attractively valued now on both an absolute and relative basis, with names such as Amgen trading at 15x and 14x FY14 and FY15 consensus, respectively, Biogen at 26x
    and 21x (with PEGs of 1.13 and 0.91), Celgene (CELG, MO, $205 PT) at 19x and 14.5x (and PEGs of 0.64 and 0.48), and even Gilead at 18x and 12x (with PEGs of 0.48 and 0.32).

    One closing thought, from a Barron’s column (author Ben Levisohn, who has written on biotech in recent weeks) regarding the sell-off in names such as Netflix (NFLX, NC) and Chipotle (CMG, NC) having to do with the air coming out of momentum names (we would add Amazon (AMZN, MP, Josey)). Levisohn uses a sports analogy to remind the reader that, like a championship baseball team, the leaders tend to stay the leaders year in and year out. We would concur with this view, and our only disappointment is the lack of recognition that many biotech names have been leaders over the past two years plus, in terms of earnings growth as well as price performance. We have ultimate confidence that the biotech sector will return to its previous luster.

  • Legendary investor Warren Buffett advises to be fearful when others are greedy, and be greedy when others are fearful. One way we can try to measure the level of fear in a given stock is through a technical analysis indicator called the Relative Strength Index, or RSI, which measures momentum on a scale of zero to 100. A stock is considered to be oversold if the RSI reading falls below 30.

    In trading on Friday, shares of Celgene Corp. (NASD: CELG) entered into oversold territory, hitting an RSI reading of 29.7, after changing hands as low as $139.05 per share. By comparison, the current RSI reading of the S&P 500 ETF (SPY) is 53.1. A bullish investor could look at CELG’s 29.7 RSI reading today as a sign that the recent heavy selling is in the process of exhausting itself, and begin to look for entry point opportunities on the buy side. The chart below shows the one year performance of CELG shares:

    See chart and rest on investorvillage CELG boarf

  • Reply to

    Mutual funds are window-dressing

    by jdjunk70 Mar 28, 2014 5:45 PM
    rob_cos rob_cos Mar 28, 2014 7:10 PM Flag

    Yep - time to load - CELG forward PE less than LLY, BMY, MRK, PFE, etc

  • Starting to hear mild uncomfirmed buzz from some very good investors that Big Pharma is looking @ CELG....given Big Pharma PE's vs CELG a stock for stock deal would be easily accretive (add to EPS)...now I ....

    am not saying it will lead to anything - but they have to be looking - especially the ones that looked before like Novartis, Merck, PFE, JNJ....AMGN looked also previously....

    Remember CELG was number one on the probable healthcare acquisitions.

    With this ridiculous PE of 11.5 and 9 on 2016 and 2017 conservative numbers - and the fact that all the major Big Pharma's with 1/2 to 1/3 the EPS growth - this would be easily accretive imo even at $225....

    Not saying it would happen - but there always is a possibility that a Sanofi type of announcement (GENZ) could come out of nowhere....

    We are better off independent but don't rule it out - CELG is not too big - a Big Pharma Stock for Stock deal would add to Big Pharma EPS - there has to be some truth that they are at least looking. CELG likely would not even be aware of it yet.

  • Barclays - HALO - SC MabThera Receives EU Approval (My bet is Kirk will sell HALO this yr)
    Halozyme Therapeutics Inc.

    SC MabThera Receives EU Approval

    What’s New? Roche and Halozyme just announced that the subcutaneous (SC)

    formulation of MabThera for the treatment of non-Hodgkin Lymphoma has been

    approved in Europe. This is a positive for HALO and was largely expected following the

    positive opinion and recommendation by the EU Committee for Medicinal Products for

    Human Use (CHMP) in January.

    SC MabThera significantly reduces administration time: This approval was based on

    Phase III data from the SABRINA trial, which demonstrated equivalent efficacy and

    safety between the previously-approved IV formulation of MabThera versus SC

    MabThera. There were no issues with antibody titers. This SC formulation reduces the

    administration time from approximately 2.5 hours with the IV formulation to only 5

    minutes.

    Royalties expected in a couple quarters: Roche will start launching SC MabThera in

    different countries in Europe throughout 2014. We expect pricing for SC MabThera to

    be comparable to MabThera (IV formulation) and estimate that HALO will receive a 5%

    royalty from Roche. We believe meaningful royalties will take a couple quarters to kick

    in as Roche works through pricing and reimbursement negotiations. We are currently

    modeling $2.1mn in 2014 and $2.7mn in 2015.

    Upcoming catalysts for HALO: Top-line data from the CONSISTENT-1 trial with

    Hylenex in type 1 diabetics should be released in the near-term, followed by detailed

    results at an upcoming medical meeting, likely the American Diabetes Association

    (ADA) meeting in June. In addition, Baxter expects to receive FDA approval for HyQvia

    around mid-2014.

  • Reply to

    CELG '16 PE 11.5

    by rob_cos Mar 27, 2014 11:47 AM
    rob_cos rob_cos Mar 27, 2014 4:42 PM Flag

    Disagree - I think CELG, ACAD, IBB and others bottomed today. CELG is now a value stock trading at 1.5 yr forward PE of 11.5 - lower than every major Big Pharma stock and CELG has 2 to 3 times their growth rate.

AMGN
115.46-0.08(-0.07%)Apr 17 4:00 PMEDT

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