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Amgen, Inc. (AMGN) Message Board

rob_cos 93 posts  |  Last Activity: Dec 12, 2014 9:31 AM Member since: Dec 31, 1997
  • CS ■ Management reiterated that GED0301 data is coming out "very, very soon" in prestigious medical journal. -- Perhaps its Lancet or something...feels like this week? (ISI says it will cause "crescendo" in stock price)

    Dr Fouse told CS VERY VERY SOON - Remember ISI said this publication will cause a "crescendo" in CELG stock price

  • Strong Buy
    Dr Fouse presents TODAY at 3 PM eastern at Credit Suisse 2014 Healthcare Conference in AZ - her first HC conference presentation since becoming President, Global Hematology and Oncology - Link to webcast.....

    November 11 - Celgene presents at Credit Suisse 2014 Healthcare Conference in Arizona. Dr Fouse will present, her first HC conference presentation since becoming President, Global Hematology and Oncology. Should be interesting to hear her perspective from this position for the first time.

    WEBCAST LINK:

    (Can't post - link is on Celgene message board on investorvillage or you can go to Celgene website under Investor Relations)

    Credit Suisse 2014 Healthcare Conference
    November 10-13, 2014
    Phoenix, Arizona

    Celgene Corporation
    Tuesday, November 11, 2014 1:00:00 PM MT

  • rob_cos rob_cos Nov 10, 2014 7:25 PM Flag

    XLRN Celgene partner...check out that company - have posted some reports on CELG investorvillage board

  • Great data - ACR Otezla (Apremilast) abstracts posted on IV Celgene board

    Too much to post here won't fit - go to investorvillage Celgene message board

  • I believe this gives more insurers the ammo to REQUIRE safer oral cheaper Otezla to failure BEFORE agreeing to reimburse for injectable biologics with adverse side effects and leukemia, lymphoma, tuberculosis and infection risk

  • Leerink today on AGIO - 3 Major Data Updates by YE:14. Accelerated approval possible for AG-120 & AG-221. Expect rapid devel'pt. $90 Target Outperform..





    Leerink

    November 10, 2014
    OUTPERFORM

    Price Target: $90
    Reason for report: COMPANY UPDATE

    AGIOS PHARMACEUTICALS, INC.

    3Q:14 Highlights

    • Bottom Line: On its 3Q:14 earnings call, AGIO highlighted its recent R&D day and three upcoming data presentations at both EORTC-NCIAACR (11/18-21) and ASH (12/6-9)meetings this year. ASH abstracts
    (LINK) suggested durable response and no new safety concerns for
    AG-221 (IDH2 inhibitor), as well as initial biochemical efficacy for wholly owned AG-348 (pyruvate kinase deficiency). While there appears to positive expectations in the stock for the upcoming data that also include AG-120 (IDH1 inhibitor, LBA [late breaker abstract] presentation on Nov 19) to which AGIO owns full US rights, we expect read-through from the current to 2015 catalysts including continued maturation of AG-221 duration of treatment data if it suggests chronic treatment in responders, solid tumor data for AG-120, and patient efficacy data for AG-348 to drive the stock. We reiterate OP rating and $90 price target for AGIO.

    • Pipeline advances rapidly, potential for accelerated regulatory
    pathways. Following initial positive data, AG-221 expansion cohorts at 100mg QD will address all lines of acute myeloid leukemia (AML) patients
    as well as other IDH2+ hematologic malignancies (total ~100 pts). We also expect rapid development for AG-120 and AG-348 programs with Phase II initiation expected in 2015. Robust response rates for both AG-221 and AG-120 may be sufficient to gain accelerated US regulatory approval while for AG-348, clinical and regulatory development pathway could be similar to Soliris in PNH.

    • Upcoming key catalysts in 2014.



    1) AG-120 initial Phase I data as LBA at EORTC-NCI-AACR meeting;


    2) AG-221 Phase I update as oral presentation at ASH;


    3) AG-348 initial data from healthy volunteer at ASH.

    • Model update. AGIO reported $33.9M in revenue vs. our estimate
    of $8.4M, mainly due to change of accounting guidance to reflect
    the amendment of CELG (OP)collaboration agreement. R&D and
    SG&A expenses were $25.5/5.2M, slightly higher than our estimate of
    $22.0/4.2M. GAAP EPS was $0.10 vs. our estimate of ($0.53). AGIO
    ended the quarter with $238M cash, which, in our view, is sufficient to
    support operation through mid-2017

  • Could be an important week for CELG ..- Dr Fouse first H/C presentation in new roll tomorrow, then XLRN data, Otezla 2 yr data & good shot GED-031 in NEJM....

    RECENT POSITIVE EVENTS:
    October 21, 2014 – Oral Presentation at the United European Gastroenterology Week (UEGW) meeting on in Vienna of Data from the 166-patient Phase II induction trial of GED-0301 in Crohn’s Disease (Celgene clearly excited about this data & says people will understand why they bought this when they see it…ISI says this could be a $5 billion drug). --- Abstract available online October 20, 2014. -- (DONE-DATA STELLAR AMAZING REMISSION RATE MUCH HIGHER THAN BIOLOGICS AND MUCH SAFER)
    October 23, 2014 - Q3 earnings release and conference call - likely another beat and raise with many important operational disclosures. (DONE-ANOTHER BEAT AND RAISE CAUSED MANY ANALYSTS TO RAISE TARGETS)
    October 28, 2014 - Bank of America/Merrill Lynch adds CELG to its US 1 top picks list. Cites CELG as one of the highest growth companies in biotech.(Top list at firm)
    November 3 - Bank of America/Merrill Lynch conference call discussed CELG GED-031 results with Dr Vincent Lorenzo-Zunigia Garcia MD PhD who attended the UEGW Vienna presentation. (POSITIVE)
    November 4 - Celgene management (Mark Alles and others) met with Leerink at Group Investor Luncheon in Boston. VERY positive report with BASE GED-031 $2-$3 billion a yr with mgt confident of upside. See report at this link: (see investor village CELG board can’t post links here)
    November 4 - Celgene CEO Hugin adds another incremental $15 million of stock to his pile.
    November 5-7 - Morgan Stanley Celgene Partners Bus Tour - AGIO, BLUE, BMRN, CELG, EPZM, OMED, XLRN in San Diego, San Francisco, and Boston.
    November 6 – Abstracts from the biggest hematology meeting of the yr – the American Society of Hematology (“ASH” - Moscone Center, San Francisco) released. Celgene said on earnings call that they will have 160 ASH related presentations/abstracts at this yrs ASH plus important partner data from some of their 25 biotech partners including XLRN, AGIO and EPZM. See Celgene PR for highlights of most important abstracts on IV:
    COMING SOON:

    November 11 - 3 PM eastern- Celgene presents at Credit Suisse 2014 Healthcare Conference in Phoenix, Arizona. Dr Fouse will present, her first HC conference presentation since becoming President, Global Hematology and Oncology. Should be interesting to hear her perspective from this position for the first time at an investor healthcare conference.
    November 11 – 17, 2014 - American Society of Nephrology (ASN) - CELG will present several abstracts abstracts detailing the clinical and pre-clinical development of sotatercept (partnered with XLRN). These studies include assessments of bone mineral density and hemoglobin levels in hemodialysis patients and studies in rodents that support the prevention of vascular calcification. JMP reviewed the abstracts and said they represent"compelling evidence of clinical benefit in dialysis patients treated with sotatercept".
    November 11 & 12 - NEJM comes out online Weds Nov 12 but some people get the hard copy on Tuesday Nov 11. CELG mgt said publicly they expect detailed GED-031 publication shortly on Oct 23 earnings call. Company and analysts expect positive details to clear up some uncertainties. ISI said the NEJM publication of GED-031 data could cause a “crescendo” in Celgene stock price. (Could be any week this month)
    November 14 – 19, 2014 – American Academy of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts. 19 Otezla abstracts have been submitted including the very Important 2 yr Phase 3 Otezla Palace-1 data. Celgene was outwardly excited about this data on Q2 call – efficacy improves with time vs biologics where it declines (safety should be fine vs increased infection/lymphoma/leukemia risk with time on biologics). This data could be powerful ammunition for more insurers to REQUIRE safer, cheaper, Otezla pill until failure BEFORE approving reimbursement for dangerous, injectable biologics for non-life threatening diseases.
    November 19, 2014 (2:50 p.m. CET) - Phase 1 study of Celgene partner AGIO's compound, AG-120, an orally available, selective, potent inhibitor of the mutated IDH1 protein, will be highlighted in a late breaking oral presentation at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place November 18 - 21, 2014, in Barcelona, Spain.Celgene has all the Outside of US rights for Agios' AG-120.
    Q4:14 - Phase II Sotatercept (ACE-011, soluble activin receptor Type IIA fusion protein) data in MDS – Accelron (XLRN) drug
    Q4:14 - Phase II Sotatercept (ACE-011) data in Renal Anemia - Accelron (XLRN) drug
    Q4:14 - Phase II data on Luspatercept (ACE-536, modified type II activin receptor fusion protein) in MDS and beta thalassemia - Accelron (XLRN) drug
    Q4:14 - Complete enrollment in Revlimid’s CONTINUUM trial in CLL maintenance
    Q4:14 – Ph 1 / 2 read-out in ovarian cancer (TBD) and Ph 2 pancreatic cancer trial initiation for OncoMed/Celgene partner drug Demcizumab
    Q4:14 - CC-292 (BTK inhibitor) data release in RA
    Q4:14 - CHMP opinion on Otezla for PsA and psoriasis in EU
    Q4:14 Abraxane Phase II trials in CRC and ovarian cancer
    Q4:14 Abraxane Phase I/II combo with anti-PD1/PD-L1
    Q4:14 Oral Vidaza (CC-486) Phase I data from AZA-ST-001
    December 2 - 3:25 PM eastern- Celgene presents at the Deutsche Bank 2014 BioFEST in Boston...First presentation with new Celgene Executive Vice President, Chief Financial Officer Peter Kellogg as lead presenter.
    December 7 – 11 PM eastern - Celgene analyst/investor meeting at the American Society of Hematology at in San Francisco 11:00 p.m. ET. First ASH meeting with Dr Fouse in charge of Hematology Business I would expect her to run the presentation and ensure a successful ASH.
    December 6-9 - Expect over 160 ASH related presentations/abstracts at this yrs ASH (Moscone Center, San Francisco) plus important partner data - Including:
    December 6-9 - Full Phase III Revlimid data in non-del 5q MDS (MDS-005) at ASH
    December 6-9 - Full Phase II Revlimid data from MCL-002 study in r/r mantle cell lymphoma
    December 6-9 – Additional information on dose escalation study data in solid tumor and hematologic malignancies with IDH2 mutations in AML for Celgene partner AGIO on their partnered AG-221 drug that Celgene mgt was publicly very excited about on Q2 earnings call in July - Celgene opted in Q2 to take AG-221 over and have the global rights to this compound - (Maximum tolerated dose has not been reached & not all mutations have been identified, Leerink believes there is a $1Billion+ blockbuster opportunity here). This data should provide positive clarity on durability of response which will be a positive for AGIO and CELG investors.
    Hugin & Alles commented on AGIO last earnings call:
    Robert Hugin - Chairman, Chief Executive Office
    Capturing the full value of our franchises is the highest order of corporate priority. We’re making exceptional progress in building for the future. During the quarter, we strengthened our hematology product portfolio with important new clinical data in MDS, AML, and mantle cell lymphoma. The future of our hematology franchise was further enhanced through meaningful progress on strategic collaborations, including ACE-011 and ACE-536 in beta thalassemia, and exciting data in targeted relapse refractory AML with AG-221. We’re aggressively moving these programs forward with our partners, Acceleron and Agios
    Mark Alles - Global Head, Hematology and Oncology
    We are excited about the data from the ongoing Phase I study of AG-221, a small molecule oral inhibitor of the mutant form of IDH-2 discovered by our partner, Agios Pharmaceuticals, that was presented at EHA. These results summarized the activity and safety of AG-221 in 35 patients homogenously defined with the IDH-2 mutation positive relapsed and refractory AML. Treatment with AG-221 demonstrated a very high objective response rate with a very manageable safety profile. Given these early but promising Phase I data, we exercised our option to an exclusive worldwide license to AG-221 in June. This is now a high priority program and we are rapidly advancing plans to conduct global registration trials
    December 6-9 - Celgene partner AGIO initial AG-348 data at ASH in Dec (potential proof of concept in PK deficiency in 2015). -- Not yet a Celgene drug but halo effect and important if Celgene takes over AGIO or partners this drug later.
    December 6-9 - Detailed oral data presentation of AMGN’s ASPIRE trial which analysts believe will increase Revlimid duration significantly over time (Deutsche Bank says this alone will be worth $24 to $32 incremental to Celgene stock price over time).
    December 9 - 13 - Updated Abraxane data in Breast Cancer at the San Antonio Breast Cancer Symposium. Dr Fouse - President of Hematology and Oncology said there will be compelling new data at this conference on the earnings call
    By year end 2014 - P3 initiation of GED-031 trial – potential blockbuster multi-billion Crohn’s drug acquired from Nogra
    By year end 2014 - Select one of 2 XLRN drugs P3 start in beta thal by YE14
    By year end 2014 - Complete enrollment in Revlimid’s RELEVANCE trial in untreated follicular lymphoma
    YE 2014/ early 2015 - XLRN/CELG Phase 3 initiation in MDS likely by YE 2014/early 2015
    H2:14/H1:15 - IFM 2005-02 post-transplant maintenance mature OS data
    H2:14/H1:15 - CALBG 100104 post-transplant maintenance mature OS data
    January 11, 2015 – Updated guidance for Celgene at JP Morgan Healthcare Conference in San Fran – On Q2 call Celgene Chairman/CEO Bob Hugin indicated Post-2017 guidance (perhaps 2020) could be coming…
    "...clarity over the next couple of quarters will give you and us the ability to really articulate more clearly what is the incredible opportunity for us that we see, say, in 2020...".
    Early 2015 - EMA decision on Otezla for PsA and psoriasis
    Early 2015 – Initiate Ph 1/Ph 2 trial - Revlimid + CC-292 (BTK Inhibitor) in CLL
    Q1:2015 – Phase 1 / 2 top-line data in Multiple Myeloma of Celgene/MorphoSys partnered drug MOR202 (antibody against CD38) at ASH – Phase 2 / 3 starts in H1:2015 – analysts and CELG very excited about this.
    February 22, 2015 - Revlimid PDUFA date for label expansion in NDMM in the US
    Q1 or Q2 2015 – EU (EMA) front line Revlimid approval
    2015 – Celgene/AGIO partnered drug AG-120 Ph 1 data in solid and heme tumors (Recently moved up to late breaker November 19th at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain)
    TBD 2014-2015 – Readout of VentiRx / CELG partnered heme/onc drug VTX-2337 (motolimod - VentiRx's lead investigational agent)
    TBD 2014-2015 - BLUE/CELG Ph 1 initiation CAR t cells in Heme/Onc
    TBD 2014-2015 - Forma drug TBD Ph 1 initiation
    TBD 2014-2015 - GlobeImmune Ph 2 readout - GI-6300 program- GI-6301
    TBD 2014-2015 - Acetylon/Celgene drug ACY-1215 Hem/Onc Ph 1 / 2 readout
    Ongoing – Continuing launches and international expansion of Pomalyst, Abraxane pancreatic and Otezla psoriatic arthritis (plus psoriasis starting Sept 23rd or sooner)
    Ongoing – Updates on the Revlimid patent case, update on the unclean hands defense, scheduling of the trial and other dates, possible disclosure of settlement talks, possible settlement out of nowhere (Bernstein thinks limited concessions with likely outcome generic barred until 2025/2026 adding $30 billion to $40 billion in sales to current analyst models at 90%+ margins). CELG just won three motions 3 weeks ago in court over Natco. Company feels everything in this case is headed in the right direction.

  • rob_cos rob_cos Nov 7, 2014 4:25 PM Flag

    Hilarious - I have been posting about CELG on tihs board and on investor village since 1998.
    I do about 6 to 10 hours of due diligence a day on a select group of stocks and post real time when I buy or sell/cover. I am in most stocks for yrs - this stock CELG I originally bought in 1998 at about 35 cents (8 3/8 adjusted for 24 for 1 splits) and was the author of post number 4 and post number 100,000 on this yahoo CELG message board and have been on the CELG Investor Village board since its inception and have over 100,000 recommendations on this board (ticker stopped counting in the 99,000s for some reason - might have broken it) - by far the most in the history of Investor Village. There are at least 50 Celgene Millionaires (and hundreds of more who would tell you my work on CELG changed their lives) who thank me annually for helping them become that . If you can't make money after I post about CELG you ought to think about having someone else invest your money

  • ISI bio video said ASH could be important as CELG lays out R2 CR approval FL strategy which would cause MATERIAL UPSIDE to approval time line in NHL- adding $billion/yr+ to Revlimid annual sales then settle with Natco with longer IP to RLI could be big


    "ASH is gonna be potentially important as they are probably going to tell us all about how the FDA might be amenable to approval Revlimid + Rituxan in first line Follicular Lymphoma based on 30 month Follow up to Complete Response Rates which would accelerate getting Revlimid to market in NHL which is a big market not clearly in numbers - If they can couple that with an Actavis settlement next yr where they extend the IP and then add a billion dollar sales a yr to Revlimid - that's important and I think that's what they are trying to do.

    There's a flash meta analysis pathologic complete response is highly correlated in to Survival and PFS in Follicular Lymphoma - and of course OS and PFS in FL and NHL take a long time to generate so this would be MATERIAL UPSIDE TO THE TIMING EXPECTATION OF APPROVAL OF REVLIMID IN NHL"

  • Just out Leerink - Mgt sees GED-031 as $2-$3 Bill/yr product BASE case - perhaps MUCH better. Confident F/L MM approvals. Positive on Otexla/Abrax. Excited about OMED, AGIO & XLRN. $123 target


    November 6, 2014

    OUTPERFORM

    Reason for report:

    COMPANY UPDATE

    Price Target: $123.

    CELGENE, INC.

    Takeaways from Management Meeting

    • Bottom Line: We hosted an investor luncheon with CELG management

    this week and our takeaways include: 1) confidence in front-line

    approvals for Revlimid in multiple myeloma, 2) bullish outlook for

    GED-301 as a multi-billion dollar product and interesting color on its

    extensive due diligence, 3) positive expectations for Abraxane to reverse

    recent weakness and accelerated growth of Otezla, 4) excitement about

    partnered programs with OMED, AGIO & XLRN (all OP) and continued

    interest in new opportunities especially in solid tumors. Our PT is $123.

    • Confident in multiple myeloma front-line approval in US and EU;

    REMARC data as early as early 2015. For the filing in newly diagnosed

    multiple myeloma (NDMM, 2/22/15 PDUFA in US, decision expected

    in EU in 1H:15), management stated that it fully expects approvals.

    There are 3 scenarios for the label: best case with full approval and no

    limitation on treatment duration and patient age; base case with approval

    in transplant ineligible patients (assumed for 2017 guidance); and worst

    case with cap on treatment duration (18-24 months). Duration is a strong

    driver for revenue growth and is estimated currently at over 1.5 years

    in the US and over 1 year Ex-US. Although RELEVANCE (Revlimid/

    Rituxan in first-line follicular lymphoma) readout will require at least a 30-

    month follow-up even for the complete response endpoint (likely in 2017),

    REMARC (Revlimid as maintenance in diffuse large B-cell lymphoma)

    could have an interim look with 50% of the events in early 2015. The

    analysis is event-driven and has a high statistical hurdle. Regarding

    upcoming ASH data on MDS-005 (Revlimid in lower risk myelodysplastic

    syndrome), management noted that the outlook for further expansion into

    MDS will depend on ongoing discussions with the FDA. Management

    continues to express confidence in its IP position on Revlimid, and its

    intention is to first litigate then consider settlement.

    • Management sees GED-301 (Crohn's) as a $2-3B product in the

    base case and hopes to do much better. Management provided color

    on its due diligence and noted that it has strong internal expertise in the

    area in addition to external advice it received and due diligence including

    reviewing each case report. Its Chief Medical Officer, Dr. Jerome Zeldis,

    has extensive experience in inflammatory bowel diseases, and Zelnorm

    (approved for irritable bowel syndrome) was named after him. Regarding

    whether the blind in the Phase II could have been compromised,

    management noted that the placebo has a similar appearance and taste

    compared to drug treatment. Management noted that Phase II data

    have been accepted by a prestigious medical journal and a publication

    is expected before YE:14. Regarding Phase III design, management

    stated that it has clarity on endpoints. It appears likely that CDAI (Crohn's

    disease activity index) will be one of the endpoints, although by itself

    it is likely not sufficient. Management stated that it intends to include

    endoscopy as one of the endpoints in the Phase III. There are sufficient

    supplies for Phase III, and the company plans to use one formulation for

    all indications including ulcerative colitis.

    Please refer to pages 9 - 13 for Important Disclosures, Price Charts and Analyst Certification.

    INVESTMENT THESIS

    We believe that Celgene's Revlimid is emerging as a dominant franchise in cancer and biotech. Revlimid has shown strong efficacy in multiple myeloma (MM) and myelodysplastic syndrome (MDS) and we see continued growth opportunities from expanded maintenance use, combination use with Velcade and other agents, as well as geographical expansion in international markets. In addition, we anticipate potential applications of Revlimid outside the currently approved indications in non-

    Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In particular, we are intrigued by emerging data of Revlimid in combination with Rituxan in follicular lymphoma and other settings and with elotuzumab in MM that, in our opinion, are suggestive of the enhancement of antibody-dependent cellular cytotoxicity (ADCC) by Revlimid. We believe this, in turn, could have important implications for the long-term outlook of Revlimid and expand its use. We expect growth for Revlimid to be complemented by continued expansion of use of Vidaza, and Abraxane, as well as newly launched Pomalyst) and Otezla. Our patent analyses lead us to believe that Revlimid is likely protected beyond 2019 to the 2023-27 timeframe.

    · Challenges for Abraxane (breast, pancreatic and lung cancers) in 3Q expected to reverse themselves and management remains comfortable with long-term guidance of $1.5-2B. Abraxane weakness in 3Q was contributed by new approval of Eisai's Halaven in breast cancer and the availability of generic Xeloda. Although the nature of the study is not clear, management noted potential to have a late-breaking abstract presentation at the San Antonio Breast Cancer Symposium that could be very important for CELG.

    · Inflection point for Otezla since Labor Day -- comfortable with consensus 2014 estimate of ~$70M. This would imply substantial growth in 4Q to ~$48M (from $18M in 3Q and $5M in 2Q), following US approval in psoriasis in Sept. and continued expansion in psoriatic arthritis. Although Otezla is in the launch phase and is not currently profitable, management stated that it is implementing tiered build-out for the infrastructure to support Otezla in order to reduce impact on earnings and expects the franchise will contribute nicely to the bottom line in the 2016-17 time frame.

    · Partner programs with OMED, AGIO and XLRN highlighted. Data from AGIO and XLRN programs will be highlighted at upcoming conferences (EORTC and ASH). Management was enthusiastic about assets from OMED and noted that it is sitting on a decision on whether to

    move demcizumab to Phase II or directly to Phase III.

    · Remains opportunistic on outside opportunities -- hungry to add to solid tumors.

    Regarding business development opportunities, management stated that it is as excited about the opportunities as 2 years ago. It noted that the example of GED-301 shows that it does not need a profitable franchise to bring in an asset. Management seems particularly interested in expanding the solid tumor franchise.

    Celgene Expected Upcoming Events

    Source: Company Reports and Leerink Partners

    Program Timing Event

    Revlimid

    4Q:14 Phase III MD-005 non-del 5q MDS data

    Feb 22, '15 PDUFA in NDMM

    2015 Approval for NDMM in EU

    MOR202 (antibody against CD38) 2015 Phase I data in RRMM

    Sotatercept (ACE-011, soluble activin receptor Type IIA fusion protein)

    4Q:14 Phase II data in renal anemia

    4Q:14 Phase II data in MDS

    Luspatercept (ACE-536, modified type II activin receptor fusion protein)

    4Q:14 Phase II data in MDS and beta-thalassemia

    CC-292 (BTK inhibitor)

    4Q:14 Data in RA

    2015 Initiate Phase I/II CC-292+Revelimid in CLL

    Abraxane

    4Q:14 Phase II trials in CRC and ovarian cancer

    4Q:14 Phase I/II combo with anti-PD1/PD-L1

    Oral Viadaza (CC-486)

    4Q:14 Phase I data from AZA-ST-001

    Otezla (apremilast, Oral anti-TNF/PDE4 inhibitor)

    4Q:14 CHMP opinion for PsA and PSOR

    1Q:15 EU approval in PsA/psoriasis

  • ACT CEO on Mad Money when Cramer brought up Revlimid patent case-looked really nervous and tried to change subject and Cramer said "so far Bob's (Hugin) doing better "(in the case)....

    Cramer had a decent segment with ACT CEO Brent Saunders and eventually got to Celgene/Revlimid case

    CRAMER: "Now you know Celgene's a favorite we're both Jerseyites - you know Bob Hugin's my neighbor - but your still going after Revlimid and the patent - you're still doing it"

    Saunders looked very nervous - and tried to spin it a bit and imo change subject (my interpretation - of course I am VERY biased - is that he knows he is not doing so well in this case and really did not want this to be part of the interview):...

    Cramer closed that very small part of the interview with :

    CRAMER: "So far Bob's (Hugin) doing better" (meaning in the Revlimid case) - yeah he actually said this to the ACT CEO who had no response.

    Was nice to see this guy squirming and to me (again biased) he looked anything but confident....he looked (to me at least) like he knows its not going as well as they hoped and CELG is not caving at all - of course that's my biased interpretation. Go get him Summit.

  • Big 225,000 buy block into close plus .very near term call vol spiked into close too...Nice close bouncing from $106.05 low to close near high of day at $107.41 green for day (with down mkt & IBB/BTK) into multiple catalysts this week
    October 28, 2014 - Bank of America/Merrill Lynch adds CELG to its US 1 top picks list. Cites CELG as one of the highest growth companies in biotech.

    November 3 (TODAY) 2 PM - Bank of America/Merrill Lynch is having a conference call today at 2 PM to discuss CELG GED-031 results with Dr Vincent Lorenzo-Zunigia Garcia MD PhD who attended the UEGW Vienna presentation.

    November 4 & 5 - NEJM comes out online Weds Nov 5 but some people get the hard copy on Tuesday Nov 4. CELG mgt said publicly they expect detailed GED-031 publication shortly on Oct 23 earnings call. Company and analysts expect positive details to clear up some uncertainties. ISI said the NEJM publication of GED-031 data could cause a “crescendo” in Celgene stock price.

    November 4 - 12 noon - Celgene management (Mark Alles and others) to meet with Leerink at Group Investor Luncheon in Boston.

    November 6 – Abstracts from the biggest hematology meeting of the yr – the American Society of Hematology (“ASH” - Moscone Center, San Francisco) released at 9 am. Celgene said on earnings call that they will have over 150 ASH related presentations/abstracts at this yrs ASH plus important partner data from some of their 25 biotech partners including XLRN, AGIO and EPZM. (See December list below for some of the abstracts expected).

    November 11 - 3 PM eastern- Celgene presents at Credit Suisse 2014 Healthcare Conference in Phoenix, Arizona. Dr Fouse will present, her first HC conference presentation since becoming President, Global Hematology and Oncology. Should be interesting to hear her perspective from this position for the first time at an investor healthcare conference.

    November 11 – 17, 2014 - American Society of Nephrology (ASN) - CELG will present several abstracts abstra

  • Significant updates(as of today) to my CELG catalyst list....much is STILL coming through yr end and into 2015....

    MUCH easier to read version on Investor Village CELG board with links and highlights not allowed on yahoo – HIGHLY recommend viewing this amazing list on that board for much more info.

    October 21, 2014 – Oral Presentation at the United European Gastroenterology Week (UEGW) meeting on in Vienna of Data from the 166-patient Phase II induction trial of GED-0301 in Crohn’s Disease (Celgene clearly excited about this data & says people will understand why they bought this when they see it…ISI says this could be a $5 billion drug). --- Abstract available online October 20, 2014. -- (DONE-DATA STELLAR AMAZING REMISSION RATE MUCH HIGHER THAN BIOLOGICS AND MUCH SAFER)
    October 23, 2014 - Q3 earnings release and conference call - likely another beat and raise with many important operational disclosures. (DONE-ANOTHER BEAT AND RAISE CAUSED MANY ANALYSTS TO RAISE TARGETS)
    October 28, 2014 - Bank of America/Merrill Lynch adds CELG to its US 1 top picks list. Cites CELG as one of the highest growth companies in biotech.
    November 3 (TODAY) 2 PM - Bank of America/Merrill Lynch is having a conference call today at 2 PM to discuss CELG GED-031 results with Dr Vincent Lorenzo-Zunigia Garcia MD PhD who attended the UEGW Vienna presentation.

    November 4 & 5 - NEJM comes out online Weds Nov 5 but some people get the hard copy on Tuesday Nov 4. CELG mgt said publicly they expect detailed GED-031 publication shortly on Oct 23 earnings call. Company and analysts expect positive details to clear up some uncertainties. ISI said the NEJM publication of GED-031 data could cause a “crescendo” in Celgene stock price.
    November 4 - 12 noon - Celgene management to meet with Leerink at Group Investor Luncheon in Boston.

    November 6 – Abstracts from the biggest hematology meeting of the yr – the American Society of Hematology (“ASH” - Moscone Center, San Francisco) released at 9 am. Celgene said on earnings call that they will have over 150 ASH related presentations/abstracts at this yrs ASH plus important partner data from some of their 25 biotech partners including XLRN, AGIO and EPZM. (See December list below for some of the abstracts expected).
    November 11 - 3 PM eastern- Celgene presents at Credit Suisse 2014 Healthcare Conference in Phoenix, Arizona. Dr Fouse will present, her first HC conference presentation since becoming President, Global Hematology and Oncology. Should be interesting to hear her perspective from this position for the first time at an investor healthcare conference.
    November 11 – 17, 2014 - American Society of Nephrology (ASN) - CELG will present several abstracts abstracts detailing the clinical and pre-clinical development of sotatercept (partnered with XLRN). These studies include assessments of bone mineral density and hemoglobin levels in hemodialysis patients and studies in rodents that support the prevention of vascular calcification. JMP reviewed the abstracts and said they represent"compelling evidence of clinical benefit in dialysis patients treated with sotatercept".
    November 14 – 19, 2014 – American Academy of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts. 19 Otezla abstracts have been submitted including the very Important 2 yr Phase 3 Otezla Palace-1 data. Celgene was outwardly excited about this data on Q2 call – efficacy improves with time vs biologics where it declines (safety should be fine vs increased infection/lymphoma/leukemia risk with time on biologics). This data could be powerful ammunition for more insurers to REQUIRE safer, cheaper, Otezla pill until failure BEFORE approving reimbursement for dangerous, injectable biologics for non-life threatening diseases.
    http://www.acrannualmeeting.org/
    November 19, 2014 (2:50 p.m. CET) - Phase 1 study of Celgene partner AGIO's compound, AG-120, an orally available, selective, potent inhibitor of the mutated IDH1 protein, will be highlighted in a late breaking oral presentation at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place November 18 - 21, 2014, in Barcelona, Spain. Celgene has all the Outside of US rights for Agios' AG-120.
    H2:14 – Initial Ph 1/Ph 2 trial - Revlimid + CC-292 in CLL
    H2:14 - Phase II Sotatercept (ACE-011) data in MDS – Accelron (XLRN) drug
    H2:14 - Phase II Sotatercept (ACE-011) data in Renal Anemia - Accelron (XLRN) drug
    H2:14 - Phase II data on ACE-536 in MDS and beta thalassemia - Accelron (XLRN) drug
    H2:14 - Phase 2 trial initiation using Celgene/Epizyme partnered drug EPZ-5676 in MLL-r and MLL-PTD
    H2:14 - Complete enrollment in Revlimid’s CONTINUUM trial in CLL maintenance
    H2:14 – Ph 1 / 2 read-out in ovarian cancer (TBD) and Ph 2 pancreatic cancer trial initiation for OncoMed/Celgene partner drug Demcizumab
    Q4:14 - CHMP opinion on Otezla for PsA and psoriasis in EU
    December 2 - 3:25 PM eastern- Celgene presents at the Deutsche Bank 2014 BioFEST in Boston...First presentation with new Celgene Executive Vice President, Chief Financial Officer Peter Kellogg as lead presenter.
    December 7 – 11 PM eastern - Celgene analyst/investor meeting at the American Society of Hematology at in San Francisco 11:00 p.m. ET. First ASH meeting with Dr Fouse in charge of Hematology Business I would expect her to run the presentation and ensure a successful ASH.
    December 6-9 - Expect over 150 ASH related presentations/abstracts at this yrs ASH (Moscone Center, San Francisco) plus important partner data - Including:
    December 6-9 - Full Phase III Revlimid data in non-del 5q MDS (MDS-005) at ASH
    December 6-9 - Full Phase II Revlimid data from MCL-002 study in r/r mantle cell lymphoma
    December 6-9 – Additional information on dose escalation study data in solid tumor and hematologic malignancies with IDH2 mutations in AML for Celgene partner AGIO on their partnered AG-221 drug that Celgene mgt was publicly very excited about on Q2 earnings call in July - Celgene opted in Q2 to take AG-221 over and have the global rights to this compound - (Maximum tolerated dose has not been reached & not all mutations have been identified, Leerink believes there is a $1Billion+ blockbuster opportunity here). This data should provide positive clarity on durability of response which will be a positive for AGIO and CELG investors.
    Hugin & Alles commented on AGIO last earnings call:
    Robert Hugin - Chairman, Chief Executive Office
    Capturing the full value of our franchises is the highest order of corporate priority. We’re making exceptional progress in building for the future. During the quarter, we strengthened our hematology product portfolio with important new clinical data in MDS, AML, and mantle cell lymphoma. The future of our hematology franchise was further enhanced through meaningful progress on strategic collaborations, including ACE-011 and ACE-536 in beta thalassemia, and exciting data in targeted relapse refractory AML with AG-221. We’re aggressively moving these programs forward with our partners, Acceleron and Agios
    Mark Alles - Global Head, Hematology and Oncology
    We are excited about the data from the ongoing Phase I study of AG-221, a small molecule oral inhibitor of the mutant form of IDH-2 discovered by our partner, Agios Pharmaceuticals, that was presented at EHA. These results summarized the activity and safety of AG-221 in 35 patients homogenously defined with the IDH-2 mutation positive relapsed and refractory AML. Treatment with AG-221 demonstrated a very high objective response rate with a very manageable safety profile. Given these early but promising Phase I data, we exercised our option to an exclusive worldwide license to AG-221 in June. This is now a high priority program and we are rapidly advancing plans to conduct global registration trials
    December 6-9 - Celgene partner AGIO initial AG-348 data at ASH in Dec (potential proof of concept in PK deficiency in 2015). -- Not yet a Celgene drug but halo effect and important if Celgene takes over AGIO or partners this drug later.
    December 6-9 – Phase 1 / 2 top-line data in Multiple Myeloma of Celgene/MorphoSys partnered drug MOR202 at ASH – Phase 2 / 3 starts in late 2014/early 2015 – analysts and CELG very excited about this
    December 6-9 - Detailed oral data presentation of AMGN’s ASPIRE trial which analysts believe will increase Revlimid duration significantly over time (Deutsche Bank says this alone will be worth $24 to $32 incremental to Celgene stock price over time).
    December 9 - 13 - Updated Abraxane data in Breast Cancer at the San Antonio Breast Cancer Symposium. Dr Fouse - President of Hematology and Oncology said there will be compelling new data at this conference on the earnings call
    By year end 2014 - P3 initiation of GED-031 trial – potential blockbuster multi-billion Crohn’s drug acquired from Nogra
    By year end 2014 - Select one of 2 XLRN drugs P3 start in beta thal by YE14
    By year end 2014 - Complete enrollment in Revlimid’s RELEVANCE trial in untreated follicular lymphoma
    YE 2014/ early 2015 - XLRN/CELG Phase 3 initiation in MDS likely by YE 2014/early 2015
    H2:14/H1:15 - IFM 2005-02 post-transplant maintenance mature OS data
    H2:14/H1:15 - CALBG 100104 post-transplant maintenance mature OS data
    January 11, 2015 – Updated guidance for Celgene at JP Morgan Healthcare Conference in San Fran – On Q2 call Celgene Chairman/CEO Bob Hugin indicated Post-2017 guidance (perhaps 2020) could be coming…
    "...clarity over the next couple of quarters will give you and us the ability to really articulate more clearly what is the incredible opportunity for us that we see, say, in 2020...".
    Early 2015 - EMA decision on Otezla for PsA and psoriasis
    February 22, 2015 - Revlimid PDUFA date for label expansion in NDMM in the US
    Q1 or Q2 2015 – EU (EMA) front line Revlimid approval
    2015 – Celgene/AGIO partnered drug AG-120 Ph 1 data in solid and heme tumors (Recently moved up to late breaker November 19th at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain)
    TBD 2014-2015 – Readout of VentiRx / CELG partnered heme/onc drug VTX-2337 (motolimod - VentiRx's lead investigational agent)
    TBD 2014-2015 - BLUE/CELG Ph 1 initiation CAR t cells in Heme/Onc
    TBD 2014-2015 - Forma drug TBD Ph 1 initiation
    TBD 2014-2015 - GlobeImmune Ph 2 readout - GI-6300 program- GI-6301
    TBD 2014-2015 - Acetylon/Celgene drug ACY-1215 Hem/Onc Ph 1 / 2 readout
    Ongoing – Continuing launches and international expansion of Pomalyst, Abraxane pancreatic and Otezla psoriatic arthritis (plus psoriasis starting Sept 23rd or sooner)
    Ongoing – Updates on the Revlimid patent case, update on the unclean hands defense, scheduling of the trial and other dates, possible disclosure of settlement talks, possible settlement out of nowhere (Bernstein thinks limited concessions with likely outcome generic barred until 2025/2026 adding $30 billion to $40 billion in sales to current analyst models at 90%+ margins). CELG just won three motions

  • RBC #1 call for Nov - (1) Buy CELG because it's the large cap with earnings potentially doubling from ~$5 in '15 to $10 in '20 and GED-301 could be $1B+ that has to go into consensus and we expect they'll settle with ACT,

    Reading the Yee-Leaves for November
    Sentiment, our conviction stock calls, top investor discussions, events...

    November 2, 2014
    RBC Capital Markets, LLCMichael J. Yee (Analyst)

    What matters for November? See inside for more events, catalysts, top 30 reports read by buyside
    After a summer pullback when biotech 2015-16E P/E ratios got near pharma P/E ratios (a buying signal...) biotech continues to work higher and AMGN, CELG, GILD have hit new all-time highs from: 1) generally solid earnings and mostly raising guidance, 2) generalists tell us this is attractive particularly against a backdrop of what they describe as very mixed results across other go-go growth sectors so biotech looks even better. We think AMGN and CELG are getting the most "moneyflow" because 2015 stories are setting up to look better than expected. GILD reached highs too but we sense debate is turning up on Harvoni launch dynamics. BIIB short-term no catalysts but agreement 2015 should be defined by how the LINGO and Tysabri SPMS data look....

    To finish the year, the big-cap biotech names we think want to be owned with good stories at reasonable valuations - i.e. they are "only" trading at 15x on 2016E....what's working is working - particularly if there is a "performance chase" into year-end. Smid cap is more mixed and hit-or-miss: RCPT had great Phase II UC data and BMRN is beating and raising, and VRTX optimism higher into '661 data. But smids that miss earnings like AEGR or ARWR which disappointed on HBV data experienced a formidable selloff. We predict investors will be playing long/short volatility into two big conferences AASLD and ASH.

    5 stock calls: (1) Buy CELG because it's the large cap with earnings potentially doubling from ~$5 in '15 to $10 in '20 and GED-301 could be $1B+ that has to go into consensus and we expect they'll settle with ACT, (2) AMGN should keep grinding higher as a re-rating because they're buying back stock and managing EPS for '15 and we're high-end of guidance; we expect PCSK-9 and new Phase II CGRP migraine antibody will have positive data at YE:14 and this matters over time, (3) Buy BMRN as a top mid-cap for '15 because they have 5 major data readouts in '15 vs zero in '14 and it should go up into Q2:15 achondroplasia data that can't really fail per se, in our view, (4) Buy VRTX for '661 data in January and high pricing on '809 combo (5) Buy DYAX for LINGO data in Jan and Phase Ib HAE data early '15 should be fine.

    Top 5 Q+A discussions: (1) what do GILD Harvoni scripts need to do to and by when to reach Q4:14 consensus $3.7B (US $3B) - are sell-side analysts over-modeling Q4 and any risk to 2015 consensus? (2) what are the positive and negative drivers to the GILD Harvoni launch in next 3-6 mos versus consensus? (3) Is AMGN truly undergoing a re-rating now and can it go higher and why? (3) What should we expect from CELG at ASH and JPM conf and are there any big catalysts if GED-301 data finished now? (4) What's going on with PCYC launch now and outlook for Q4 and anything at ASH that could impact PCYC? If they in-license something, is that good or bad? (5) Why is ICPT sentiment so controversial and with recent pullback what could get it higher from here?

    Mgmt roadshows in Nov/Dec: XNPT, ICPT, GILD, ASMB

    12/4 Denver HC day: ABT, ACRX, ACOR, AERI, AGRX, ASMB, INFI, ICPT, PRTA, SGNT, SGEN, XNPT

    All values in USD unless otherwise noted.

    Priced as of prior trading day's market close, EST (unless otherwise stated).

  • 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.

AMGN
168.48+5.00(+3.06%)Dec 18 4:00 PMEST

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