$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
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.
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
 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.  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.  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.  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).  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
Just out minutes ago - RBC- CFO meeting consistent with our positive outlook and thinking...We think CELG should go higher because of new Crohn's drug GED-0301, front-line myeloma approval, longer than expected duration Revlimid, and buybacks.
September 10, 2014
CFO meeting consistent with our positive outlook and thinking
We think CELG should go higher because of new Crohn's drug GED-0301, front-line myeloma approval, longer than expected duration Revlimid, and buybacks.
We met with newly in-place CFO Peter Kellogg who started August 1st
(prev from Merck and Biogen CFO roles) today and came away with the
message of 1) positive on CELG's rich pipeline particularly in hematology
and I+I (Otezla, GED-0301, etc) and many partnerships that could drive
future growth beyond 2017, 2) high confidence in growth visibility to 2017
and possibly beyond, 3) maintaining focus on capital allocation particularly
share buybacks and later on, continued thoughts on dividend down the
road, 4) keeping up the positive things that have been working for CELG
recently. To be clear, the initial message we take away is that there's not
much likely to change (a good thing...). We think investors do believe
that over time, ex-CFO Jackie Fouse will eventually continue to build
out managerial experience (now running Hemonc biz) and perhaps could
continue to get promoted higher (would think that's at least 2016-17).
We have said we think 2020 guidance will eventually come at some point
for CELG and this will likely surprise the Street to the upside. We appreciate
this is unlikely until at least a settlement with Actavis but we believe
investors should be owning CELG because a settlement is reasonable
(CELG continues to reiterate a sense of "rational" behavior) and that
would be a strong catalyst to the stock; this could lead to high confidence
on visibility to 2020 which then could lead to upside guidance....CFO
Kellogg mentioned that one big difference on guidance between CELG
and pharma was the number of LOE (loss of exclusivity) issues that were
always hampering pharma and lack of ability to have long-term visibility
for pharma and this generally isn't the case for CELG.
1) we think Crohn's data presented in October at UAG will be
positive and show high responses and any concerns on bowel strictures as
a side effect is probably manageable and can be moderated through pulse
2) Company continues to work through discovery phase of patent
case with Actavis and should get more info by end of February and expects
a court date sometime mid-15, but the companies should be rational....,
3) company agrees duration of therapy for Revlimid keeps getting better
with Kyprolis and hopefully confirmed through ABBV elotozumab study
eventually reading out too (on top of Revlimid)
Webcast link to Scott Smith (President, Global Inflammation and Immunology) presenting at Morgan Stanley at 12:55 pm eastern Tuesday....
(see Celgene website Investor Relations section or Investorvillage CELG board for link to the webcast as yahoo won't allow links to be pasted/posted
Morgan Stanley Global Healthcare Conference;
September 8-10, 2014
The Grand Hyatt Hotel
New York City, NY
Tuesday, September 09, 2014 12:55:00 PM ET
Smart shorts are covering - stubborn ones can cover mid 30s.
. ACAD smoking out of the gate this am over 28 up $1.20 +4% % 1st hour over 600.000 shrs Surge on volume good sign. Smart shorts starting to cover after breakthrough designation. EU approval will come also on only 1 Ph 3 not in price
VERY nice close $3.30 up 31 cents a penny from HOD - 1,425,000 shares vs 700k avg last 2 days & 335,300 daily avg last week......Hmmmmm....
Date Open High Low Close Volume Adj Close*
Sep 4, 2014 3.09 3.09 2.98 2.99 770,900 2.99
Sep 3, 2014 3.01 3.10 2.99 3.07 674,200 3.07
Sep 2, 2014 3.23 3.27 2.99 3.00 1,117,800 3.00
Aug 29, 2014 3.16 3.23 3.15 3.23 337,900 3.23
Aug 28, 2014 3.25 3.28 3.14 3.15 463,100 3.15
Aug 27, 2014 3.32 3.35 3.25 3.29 307,300 3.29
Aug 26, 2014 3.27 3.32 3.23 3.28 507,200 3.28
Aug 25, 2014 3.22 3.33 3.21 3.22 365,000 3.22
Summary of MUST READ 65 pg comprehensive Suntrust RH Celgene initiation - "A Hematology Stalwart Looking to Diversify; Initiating with a Buy & $121 Price Target" (Base Case - Bull case target is $163)
See full report on Investorvillage CELG board by tomorrow
A Hematology Stalwart Looking to Diversify; Initiating with a Buy & $121 PT
CELG is the preeminent large-cap biotech in hematologic oncology focused
on diversifying away from Revlimid, its flagship product, through the
emerging inflammation & immunology franchise and a rich pipeline of
• Key value driver for CELG remains Revlimid, with near-term growth
from E.U. 1st-line myeloma (NDMM) approval and longer treatment
duration. Revlimid is the main contributor to CELG's topline ($4.3B, 66%
of revenue in 2013). We expect NDMM approval in 1H15 to enable
reimbursement in the E.U. and spur continuous treatment ($7.3B WW
Revlimid revenue in 2017). We believe that Revlimid will remain the backbone
of myeloma therapy and the duration of therapy will increase with the
addition of proteasome inhibitors (e.g Kyprolis), antibodies (e.g.elotuzumab)
• The Revlimid dispute will likely play out in a 2015 settlement. Following a
Markman hearing in May 2014 regarding Revlimid, which we believe favored
CELG versus generic company Natco/Actavis, we view a settlement in 2015
as likely, given Actavis' history and management's comments.
• Early script trends suggest Otezla could be positioned to meet
guidance. CELG is taking its first commercial steps with its inflammation
& immunology (I&I) franchise with the launch of Otezla in psoriatic arthritis.
Investors have been lukewarm, but IMS weekly Rx trends (early) are
suggestive of steady growth. We note rheumatologists are historically slow
to adopt new therapies in favor of entrenched standard-of-care (e.g. TNFs).
However, we estimate $1.5B in 2017 WW sales (vs $1.1B consens
See investor village CELG board for more of report and all slides
UBS - Outlook into YE14: Still Bullish on Biotech-Upside to numbers, pipeline, and M&A...GED-031 multiple expansion....CELG/GILD favorites....raise CELG target to $112
Outlook into YE14: Still Bullish on Biotech
Biotech outperforming YTD; Why we’re sticking with our call into YE14
Biotech indexes are up 22-34% YTD, outperforming the market (S&P: +8%) and healthcare (XLV: +15%), and in this note, we re-assess our views on the sector and our favorite stocks. Despite recent sector performance, we believe the drivers of biotech outperformance are still relevant into YE2014. **Please join us for a conference call at 11am ET TODAY to discuss sector metrics and best ideas into YE14 The SLIDES for the call start on page-3 of this note.
Three drivers of upside still relevant: Upside to numbers, pipeline, and M&A
 We continue to think numbers are beatable in large cap this year. None of our models look stretched, and in our view there appears to be plenty of room to beat (particularly for GILD), which we think can continue to drive numbers higher.  We also think multiple expansion can be driven by pipeline catalysts this fall, including CELG’s GED-301, initial data for GILD’s simtuzumab in cancer (where expectations are non-existent, in our view), and 7-day data for ACHN’s nuc in HCV.  We are more bullish on M&A given the inflection of cash flows in large cap, coupled with the need for large cap to address toughening growth comps by 2016-17, and because mid-caps have done a good job in value creation through de-risking of valuable assets. We expect PBYI to be top of the list for bolt-on growth.
Favorites into YE14: CELG, GILD in large cap; VRTX, PBYI, ACHN in smids
Amid low expectations, we think both CELG and GILD could see $5-10 upside if pipeline readouts described above are convincing. We see compelling risk-reward in VRTX shares considering upside/downside scenarios, and we surmise it is under-owned in large cap growth portfolios. We
ISI thinks it could be a $5 billion a yr blockbuster...Ph 2 data coming - could be curative
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).
See investorvillage CELG board for link
we would expect that concession to be quite modest and to occur in early to mid 2015.
Among Celgene's patents for Revlimid, the '800 patent offers the strongest and the longest protection. Of the 18 patents at issue in this case, the latest-to expire is the '800 patent which claims the hemihydrated crystalline form (polymorph) of Revlimid (lenalidomide). This patent expires in the US in April 2027, and we have regarded it as the most significant protection beyond the actual composition of matter patents that expire in 2019. The claims of this patent, presuming it is upheld, are likely to prevent Natco from proceeding with a "nearly the same" version of Revlimid, which is almost equivalent to the protection afforded by true composition of matter patents in our view. For example, if Natco proceeds with a version of lenalidomide that is not a hemihydrate, then it is unlikely to be considered truly bioequivalent to Revlimid. If they proceed with a hemihydrated form, however, they are likely to infringe the claims in the '800 patent, particularly after the relatively broad interpretation allowed by the Judge in this trial in the recent Markman hearing.
Natco's original strategy focused on circumventing the '800 patent and invalidating the other less important patents, particularly method of use and distribution patents. Natco's legal strategy has focused on invalidating all the extant patents asserted by Celgene, with the notable exception of the '800 polymorph patent. In both the Markman hearing and the additional pre-trial motions, it is clear that the '800 patent is also of real importance to Natco. From the outset, Natco attempted to propose a narrow interpretation of the term "hemihydrate" to circumvent Celgene's claim without breaking the patent; presumably, the patent could help Natco deter other potential generic entrants until 2027. The Natco strategy appears to be driven more by commercial considerations than by legal considerations, and it may have backfired with the broad interpretation of the "hemihydrate" claims in the Markman ruling. This may explain why Natco appear to be back-tracking in terms of their strategy with respect to the '800 patent.
The Markman ruling in May was a significant setback to Natco's non-infringement arguments against the '800 patent. As we have discussed before, the Judge sided with Celgene's proposed interpretation of the term "hemihydrate", which is considerably broader than Natco's proposed interpretation. We believe the Judge's ruling may have dealt a significant blow to Natco's arguments for non-infringement. With the claim language being as broad as it is, it may have become more difficult for Natco to engineer a version of the drug with similar properties to Revlimid that does not infringe the '800 patent. In addition, Natco may have been caught flat-footed without other arguments against the patent either.
Recent court maneuvers by Natco suggest that Celgene has a strong case in defending the '800 patent. Natco recently petitioned to the Court for permission to now advance invalidity arguments against the '800 patent, suggesting that the company has decided to change strategy in light of the Markman ruling. However, Natco faces an uphill battle to add new invalidity arguments at this point, almost four years into the case. According to our legal advisors, there is at least a 50-50 chance that the Court will deny Natco's petition outright. Even if Natco is allowed to present its invalidity arguments (based on indefiniteness and lack of written description), the arguments they are making do not strike us as particularly convincing.
We expect Celgene to settle the case on favorable terms by Q1 next year. While Celgene appears to have a strong case, going to trial may not be the best option due to additional legal costs, distraction for management, and overhang on the stock due to the small but catastrophic risk of a negative outcome. Based on current timelines, a trial would not start until Q2 or Q3 next year. In our recent conversations with Celgene, the message is clear: "We are open to settlement if it's in our shareholders' interest." Right now, Celgene appears to be applying maximum pressure through legal maneuvers to drive Natco to the settlement table with Celgene holding a strong negotiating position. We think the most likely timing for a settlement is in Q1 2015, after the completion of expert discovery and before the start of the trial. It would not surprise us if initial discussions with Natco have already taken place.
The Cubicin patent settlement provides a template for settlement in the Revlimid case. During our recent investor dinner with Celgene, the Cubicin patent settlement was mentioned as an example for a settlement that favors the branded manufacturer. As part of the settlement, Cubist granted Teva a license to launch a generic Cubicin 15 months before the latest patent expiry; Teva agreed to purchase its generic drug exclusively from Cubist during the license period, and pay COGS plus margin, as well as a share of its profits, thus largely hedging the innovator against the loss of revenue from the earlier entrant. In the case of Revlimid, the market currently prices in the equivalent of 2023/2024 generic entry; therefore, a settlement that bars generic entry until 2025/2026 (or 1-2 yrs before the '800 patent expiry) would be a win for Celgene, particularly if it involved terms similar to the Cubicin arrangement.
We continue to recommend Celgene's stock strongly at these levels. We believe that the Revlimid patent is likely to be upheld through 2025, the company has sustainable revenue and earnings growth through 2017 based on new markets and indications for Revlimid, and the early stage pipeline remains underappreciated by investors. The company does have a "gap" in late stage development candidates, but we expect more visibility about their recent acquisitions and collaborations in the second half of the year that may bolster their portfolio. Our revenue forecast for Celgene remains 1-2% above consensus and our EPS estimates are 6-9% higher based on lower share count and improving margins. We believe the emerging early to mid stage pipeline offers significant and under-appreciated optionality for investors looking beyond the next 3-6 months.
Go to CELG investorvillage board for full report that wont fit on yahoo...
BERNSTEIN * Celgene: Natco's Case Getting Weaker; We See Settlement in Q1'15 Barring Revlimid Generic Entry Until 2025/26. Expect concession to be quite modest. Pressure will mount on Natco...Got unrestricted version of July 22nd report - a MUST READ
- Perhaps one of the most important analyst reports ever written on CELG
BERNSTEIN * Celgene: Natco's Case Getting Weaker; We See Settlement in Q1'15 Barring Revlimid Generic Entry Until 2025/26.
Despite the strength of Celgene's stock recently, the major issue facing the company near term remains the ongoing Natco challenge to the Revlimid patents. In 2010, Natco and its partners filed an Abbreviated NDA for a generic version of Revlimid, claiming the many issued patents protecting the drug are invalid, unenforceable and/or would not be infringed by the generic. We have taken a relatively sanguine view of the outlook for this challenge, and believe that a settlement barring generic entry until 2025/2026 (or 1-2 yrs before last patent expiry) remains the highest probability outcome. We have had counsel retained on this issue since we first initiated coverage of Celgene, and their advice has informed our views and valuation. In this note we summarize the landscape as we see it today, and provide a foundation on which future disclosures, and research, will build. Although there continues to be sparring between the parties during the final stages of pre-trial discovery and expert testimony, it appears to us that Celgene started with the upper hand, has had the better of the exchanges, and remains in a dominant position. A settlement with some concessions seems likely to minimize the small but catastrophic risk of a negative trial outcome, but
RBC - Otezla total scripts up 7% wk/wk (+174% QTD) - Q2 undercaptured rate because of free titration starter packs -We see greater appreciation for Otezla over next couple quarters...
Reporting eighth week of Q3:14 IMS scripts (week ending 8/22/14).
CELG: Otezla TRx 927, +7% wk/wk (+174% QTD), and NRx 544, +4% wk/wk in 21st week of launch
Q2 sales were $5M, which undercaptured because of free titration starter packs that led to commercial drug after reimbursement approval.
We see greater appreciation for Otezla over the next couple quarters, because scripts are tracking much higher than Xeljanz's launch, implying Q3 cons estimates of $29M are achievable. PFE's Xeljanz reported TRx/NRx of 569/335 in its 21st week of launch (ending 04/05/13), and $22M during its second full quarter of launch.
Deustche Banks - We just added GILD, CELG and BIIB and AMGN as BUYs to DB's SOLAR (short term conviction ideas).
We just added GILD, CELG and BIIB and AMGN as BUYs to DB's SOLAR (short term conviction ideas).
In short, our call is that there will be upside earnings revisions from new product launches and each company has pipeline catalysts that read out near term and are not in models.
Rationale for each below...
There is a new SOLAR idea on the Deutsche Bank Research Website.
Stock: Buy Celgene (CELG.OQ)
Analyst: Robyn Karnauskas
Basis for the short-term investment idea:
The company has data read-out from a new pipeline product that uses antisense technology to treat Crohne's disease; the product is GED-031. Data will be released in Vienna at the Gastroenterology meeting. This is NOT in numbers. In addition, we see upside revisions to earnings expectations for Celgene on the back of the Otezla launch.
1) GED-031 read-out in Vienna October 18-22; 2) ASH - additional data; 3) JPM - January - company could give updated guidance; 4) quarterly call color on Otezla sales.
Risks to the short-term investment idea:
1) Disappointing earnings; 2) disappointing clinical trial results; 3) concern about patent cliff.
Long-Term Fundamental Rating: Buy