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Amgen, Inc. (AMGN) Message Board

Rob_Cos 347 posts  |  Last Activity: Oct 28, 2014 9:45 AM Member since: Dec 31, 1997
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  • Just hit all time high regular session $105.48...as I said near 100, $110 is possible after NEJM GED-031 publication, Cramer says $120 coming.

  • ISI doc says if Ph 3 similar to Ph 2 - 50% of Chrohns patients would likely use the drug. WOW.

  • RBC out after the bell - More incremental positive developments on patent case, part of our "5-point thesis".... CELG won three notable motions today

    Impact:

    CELG won three notable motions today and expert discovery will still keep going, and finish in early 2015.

    First impression

    Today, a Judge in the Celgene vs NatCo case ruled on three motions with essentially CELG winning on all three (email us for the documents). Basically NatCo had filed a motion and tried to limit the number of asserted patent claims (denied without prejudice), and also dismiss CELG's claim of "unclean hands" (denied), which was a potential positive "wild-card" argument we previously wrote about in prior notes on how NatCo got access to Revlimid drug inappropriately/illicitly. Also, CELG had a motion to bifurcate and stay the "REMS" patents (granted).

    All three motions were ruled in favor of CELG generally help bolster the ongoing litigation for CELG and against the defendant NatCo. Recall we've written ultimately the Markman hearing was net positive in favor of CELG and that we think both parties will eventually be logical and rational in considering options to eventually settle at some point. We don't necessarily assume it would be before court around mid-15 and it's certainly possible the parties do go to Court but still eventually settle thereafter.

    Separately NatCo did file to try to amend some of the claims for their "invalidity" argument on the "hemihydrate" patent. Both parties this week filed responses for/against allowing NatCo to "amend" their defense (CELG argued to deny saying it's far too late, been years, and can't after Markman finished, will cause case and discovery to delay and drag on...).

    Our "5-point" thesis on CELG is: 1) GED031 is a Phase III asset that could drive $1B in growth towards 2020, 2) 23 partnerships in pipeline, 3) potential to settle with NatCo/ACT, 4) capital allocation/earnings growth, 5) eventual guidance of $10 earnings power in 2020...

  • (WFR) CELG: Positive Developments In Revlimid Patent Proceedings


    (WFR) CELG: Positive Developments In Revlimid Patent Proceedings

    +------------------------------------------------------------------------------+

    CELG: Positive Developments In Revlimid Patent Proceedings

    2014-10-24 22:08:19.61 GMT

    **Late this afternoon, the U.S. District Court issued rulings on several pending motions related to the ongoing Revlimid patent litigation case between Celgene and Natco/Actavis.

    **There are four separate motions the Court was considering-three were ruled in favor of CELG, and the decision on one motion is still pending.

    Explanations were not provided.

    **Motion 1 by Natco: Denied. Natco filed a motion to limit the number of contested claims to a more manageable number, arguing that 246 claims asserted by CELG are duplicative and would make it unwieldy for the Court to efficiently and effectively conduct the case within a reasonable timeframe. We see this as the most important of the four, as with the burden on Natco to invalidate and/or show non-infringement, a more complex/lengthy litigation should theoretically favor CELG.

    **Motion 2 by Natco: Denied. Complicated, but implication is that Court appears to be open to CELG's ''unclean hands'' defense, which would likely mean extensive discovery into how Natco acquired Revlimid for their bioequivalence testing would be needed.

    **Motion 3 by CELG: Granted. In response to Natco's attempts to limit the number of asserted claims, CELG filed a motion to ''bifurcate'' the REMS patents (see our prior note 9/4/14)-essentially removing REMS patents from consideration given other patent families like polymorphs expire later anyway.

    Court ruled in CELG's favor.

    **Motion 4 by CELG: Pending. CELG filed a motion to deny Natco's request to amend the '800 (polymorph) patent, arguing that Natco should not be able to change their strategy after the fact based on the Markman outcome. Two sides filed a brief on the topic on 10/23 and 10/24.

    **BOTTOM LINE: Today's decisions on several motions in favor of CELG likely helps to prolong the case, maintain a high barrier for Natco to overcome, and preserve one of CELG's potential defense strategies (''unclean hands'').

    Reiterate Outperform.

  • rob_cos rob_cos Oct 24, 2014 1:58 PM Flag

    Won't do it - might sell it to Big Pharma but never take it over - his model is to have cubs with most of expense on their pooks that are not consolidated in his income stmt...Right now the power of that model is tough to see but lets say he has 5 cancer drugs on mkt in 7 yrs plus a genetically modified grass seed and a special way to make LNG......50% of the cancer drug profits and other profits will come to intrexon with no capital to speak up the cash flow and ROE down the road will be enormous...Now a partnership in brain cancer with a big pharma or biotech would triple this and then up from there then at some point he could sell ziop (and all the rights and 50% of the profits of all cancer drugs XON will ever make_ to Big Pharma/Bio....but imo he won't do that until ZIOP is at $20/$30+ on its own.

  • See what people are missing is there is INSANE short interest in a tightly held company and Kirk's history.

    His deals take time but he gets them done and they don't leak usually so the shorts are often caught by suprise...Happened at Scios, New River, Clinical data - these stocks were down hard weeks before announcement.

    Also Kirk followers are loyal....If Kirk and his fund friends move their shares to non-borrowable on deal announcement (I have people with over 3 million shares who will do that btw and others should call their broker and see if they can do it - you may have to open a separate account to do it) ....I see a deal causing a 3 tier runup.... the deal depending on when announced and price could cause a triple....then the short squeeze could cause a ridiculous temporary run up - then and most importantly will be the next few weeks wall st and institutional analysis will suddenly realize what ZIOP owns - if a big name partner does a deal for one indication at xxx then what oh what is owning the rights to EVERY cancer Drug XON will ever make worth - well if a big pharma validates XON technology after a yr of due diligence with a deal - that eventual number could be staggering.

  • A high volume multiple day breakout on 2000, 2000, 9000, 4000+ call volume breaking through 50 DMA/EMA like hot knife through butter is VERY important.



    Especially with company confirming discussions with multiple potential partners this yr and after the Greenberg note and Bill Miller and Einhorn comments on XON cancer technology.

  • 2000+ calls traded Tues&Wed & 9000+ yesterday (vs 50/day avg) & $ZIOP just blew through both 50 DMA & EMA.Kirk/ $XON will get deal done soon

  • Insane to be short $ZIOP over any weekend. HUGE short interest & Kirk & fund friends will move shrs to non-borrowable on deal PR. #SQUEEZE

  • Respected $300/mo pay service cites high $ZIOP option vol &BMY big immunology announcement coming this month. $XON RJ Kirk deal coming? $IBB

  • DB - CELG- *Doc color on GED-301, sees promise in potential Crohn's game changer - Our doc thinks the data is “stellar” for a ph 2

    Deutsche Bank - Equity Research - North America

    Celgene Alert - Doc color on GED-301, sees promise in potential Crohn's game changer
    22 October 2014 (1 page/ 117 kb)

    Celgene {Ticker: CELG.OQ, Closing Price: 94.97 USD, Target Price: 115.00 USD, Recommendation: Buy}

    We did a doc call w/ Stefan Schreiber, MD discussing new data in Crohn’s disease with a focus on CELG’s GED-301. He is a professor of Medicine and Gastroenterology and head of the Institute for Clinical Molecular Biology at a University in Germany. We highlight that this is one of the many CELG pipeline readouts in the coming years, for which the Street has assigned minimal value.

    Our doc thinks the data is “stellar” for a ph 2

    He is extremely encouraged by the statistically significant, durable response rates in the active treatment arms. However, there are a few questions about the integrity of the data and action of the drug. Some docs are skeptical of the very low placebo rate which was much lower that would be expected for this population. Even our doc thought that it would be closer to 30-40% vs. 9.5%; however, he does not see this to be an issue. .

    He firmly believes that there were no data integrity issues

    Our doc noted that there were many centers involved in the trial and does not think that pts were “handpicked” by the investigators. He would have been concerned if only 1 or 2 centers were used in the trial, but there were over 17. He also noted that CELG would not have made such an investment ( $700M) if there were data issues during their diligence.

    Exact mechanism of action is unknown, our doc believes the drug is active

    Many docs in Vienna and our KOL were unsure of the exact mechanism of the drug. He thinks it could be a non-specific oligonucleotide effect on the TLR-7. He also indicated that complete understanding of mechanism is not essential, bu

  • Credit Suisse - GED301 Domain Dominates – Increasing Peak Sales Estimate to $3B and TP to $125

    22 October 2014

    Americas/United States

    Equity Research

    Biotechnology Celgene Corp. (CELG)

    INCREASE TARGET PRICE

    GED301 Domain Dominates – Increasing Peak Sales Estimate to $3B and TP to $125

    ■ Summary: Post this week's PII data for Mongersen (aka GED-0301), we are increasing our peak sales estimates to $3B (from $2B) and concomitantly increasing CELG TP to $125 (from $113).

    ■ Don’t miss the forest for the trees – Mongersen likely to be a paradigm shift in the Crohn's disease. We are not dismissing the need for scientific/clinical analysis or rigor – indeed, within the note we include our recently published updates which include detailed "apples-to-watermelons" comparison of GED301 and the anti-TNF's, the "validity" of the data given baseline considerations and left vs. right CD. But standing back from the minutia – GED301 looks like a significantly more efficacious drug vs. anti- TNF's (PS. PIII does not have to show a 2x vs. anti-TNF's in PIII for this to still be valid), which is oral and has significantly lower AE burden. These sorts of drug profiles, dare we say it, tend to cause a revolution vs. evolution within a given therapeutic area (and, yes, there are analogies with Tecfidera in our view!).

    ■ Moving peak GED301 sales to $3B (from $2B) and launch to 2018 (from 2019). We expect the recruitment for Phase III study to begin by the end of the 2014 and now expect a 1-year maintenance duration study – thus potential launch in 2018. We assume only 70% of CD addressable (right hand CD only) and a ~35% penetration rate (previously ~25%) into this population or ~30% penetration rate (previously ~20%) into the entire population (including left hand CD).

    ■ Valuation: Our new TP of $125 places CELG at 15.7x 2017 EPS of $7.98 vs the 4 large cap average multiple of 15.8x. We note CELG has '13-'17 EPS CAGR of 28% vs. 25% for the gro

  • ISI remission rates per the CONVENTIONAL definition were just reported - 72% remission at high dose 70% middle dose at 4 wks...these are what should be compared to biologics (Remicade 48%, Humira 28.5%, Cimizia 22%, Entyvio 14.5%)....


    We now understand that remission rates per the CONVENTIONAL definition were just reported at the medical meeting.

    At 4 weeks, the remission rates (defined as only a CDAI score below 150 at week 4) were:

    72% high dose

    70% middle dose

    29% low dose

    14% placebo


    The numbers above (not the numbers in the abstract which we wrote about yesterday) should be used to compare to historical data for biologics.

    The historical data is below:
    (See investor village CELG board for slide doesn't print on yahoo -but it shows Remicade 48%, Humira 28.5%, Cimizia 22%, Entyvio 14.5% vs 72% GED-031 at high dose and 70% at medium dose. WOW WOW WOW

  • $CELG partenr $AGIO R&D day webcast live NOW go to agios investor relations section as yahoo does not allow links… $CELG has found a real gem with differentiated mechanism in AML/Leukemia

  • rob_cos rob_cos Sep 25, 2014 5:54 PM Flag

    ASH not ASCO - American Society of Hematology meeting will be huge for AGIO and its a buy into it

  • Can't post links here but I posted them on the investorvillage AGIO board....go there and watch the video and read this MUST read article.

  • My favorite CELG partner - agree CELG will own this company at some point and it may be sooner than most think...feels like ASH data will be spectacular...after the New Yorker article and actually very well research Cramer piece on AGIO mentioning that article - more and more are taking time to do real due diligence and like CELG - love what they see when they do it. AGIO is going to be a BIG BIG BIG winner....do not sell too early

  • UBS - CFO/IR Lunch- Otezla in Methotrexate failures & some plans REQUIRING patients fail Otezla prior to getting biologics (earlier than expected) Rob:"HUGE" -- UBS REAL UPSIDE TO 2015-18 sales ests....
    Rob: This is the holy grail for Otezla as I said upon approval - eventually insurers will REQUIRE cheaper/safer/oral Otezla to more expensive/infection/leukemia/lymphoma risking biologics....of course they will but its "HUGE" that its starting already earlier than expected.


    First Read
    Celgene Corporation
    Datapoints from CFO/IR Lunch

    Buy side questions mainly on Otezla and GED-0301
    We maintain our Buy rating on CELG shares after attending the sell side lunch with new CFO Peter Kellogg along with the IR team. Most investor interest in recent 1x1's was on Otezla's commercial trends and launch metrics, as well as the near-term ph2 data for GED-0301 in Crohn's disease. Here we provide the key points of discussion.

    Key points on Otezla, Revlimid, and GED-0301
    [1] Celgene is seeing a growing proportion of Otezla use in methotrexate failures and is also seeing some plans require patients fail Otezla prior to getting a biologic, sooner than expected. These points suggest Otezla is slotting in to the pre-biologic treatment paradigm, which we think supports our thesis that there is real upside to consensus 2015-18 sales. [2] Consistent with prior comments, CELG expects discovery in the Revlimid patent case to conclude 1Q15e, with trial scheduling thereafter; we expect the entire process could be resolved mid-2015e latest. [3] In the EU, 6/7 claims were upheld vs. opposition to the 2023 Revlimid method of use patent. The claims will be narrowed, but the lost claim is irrelevant to commercial sales. Hence the 2023 patent is on solid ground, and we continue to assume 2023 Revlimid loss in EU. [4] Duration of therapy in myeloma is still an investor debate despite data showing longer progression times with combination therapies (e.g., ASPIRE; elotuzumab up next). [5] For GED-301, there were several layers of diligence prior to investment. The key focus now is to properly design the ph3 program to find optimal re-treatment schedules following successful induction therapy since the 14d dosing appears to drive durable responses in Crohn's.

    Key points on tax and partnership accounting practices
    Celgene isn’t pursuing inversion transactions per se, and expects tax reform to be implemented that could have short term consequences to CELG tax rate but longer term benefit in the ability to fully leverage the capital structure. It does believe that the accounting treatment on partnership deals is appropriate and consistent with industry.

    Valuation: Buy, $112 PT based on 21x 2015e EPS
    We see upside on the patent challenge resolution, pipeline, and upward revisions

AMGN
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