Market is due for a pullback especially the bio stocks. You will get another chance to buy CELG cheaper. Just have some patience. My guess is we pull back to $88 or so before we head over $100.
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
Just curious to see if anyone follows a smaller early stage company called Senesco? I am a shareholder and hope celg eventually buys us (think they will have to at some point in the future, likely sooner)
FDA orphan drug status, fast track. Might help someone? Hopefully.
9 products or applications in different phases along with R J Kirk and Intrexon and an experienced staff and no debt show some promise!
Sentiment: Strong Buy
IF it works out to be a multibillion dollar drug then the investment will have been worth it, but it's all a crap shoot until the FDA approves it and you have to hope that there's not some other drug about to do it better. I've got a large position in CELG, so I'm hoping it works out. We'll see. GLTAL
SGX203? So you think Beconase (the nasal spray that's been around for 50 years) put into a pill form will be the magic cure all for Crohn's disease?
Maybe, but I'll trust CELG over some repackager of old meds with my dollars.
$60MM market cap, and GILD also announced that they just went forward with another GBIM product for Hep B into a second phase 2 study.
Sentiment: Strong Buy
$710 million up front to Nogra Pharma and up to $1 billion in milestone payments if the drug gets to $4 billion in sales. So they sold the cow, hopefully the magic beans take them to the golden goose.
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.
JMP - Rx Launch Tracker – Week 8 into 3Q14: Another Strong Week for Otezla, Imbruvica Continues Growth Trend
Weekly prescription data for Imbruvica (PCYC, MO, $200 PT) and Otezla (CELG, MO, $102 PT) were released by Symphony Health Solutions for the week ending August 22. Regarding Imbruvica, total prescriptions (TRx) increased 9% over the prior week (1,250 vs. 1,143), while four-week average TRx grew 3% (1,171 vs. 1,137). Assuming zero growth from the current four-week moving average, our launch model now forecasts 3Q14 sales of $137.9MM, tracking slightly ahead of both our formal estimate ($125.9MM) and consensus ($120.5MM). Regarding Otezla, TRx continues its recovery, increasing 7% (740 vs. 693), pushing the four-week moving average further up 5%. Our launch model currently forecasts 3Q14 sales of $13.3MM, tracking behind consensus ($32MM).
Continued Rx growth reflects promising trends for Otezla. As we’ve noted previously, extrapolating
from reported Otezla sales implies both a high capture rate in the Symphony Rx data along with a steep
discounting of the product from the use of "starter" and "bridging" packs. This week’s continued growth
in average TRx represents a strong positive performance indicator. We believe with the expected label
expansion to include to psoriasis toward the end of 3Q14 (psoriasis PDUFA date of Sept. 23) that Rx
trends will improve more dramatically. Our Otezla launch model reflects an 80% capture rate and 35%
gross-to-net adjustment, conservatively forecasting 3Q14 sales of $13.3MM (vs. $32MM consensus).
Imbruvica TRx imply 3Q14 sales tracking ahead of our estimate assuming a high rate of capture.
Our quarterly launch tracker is based on cumulative 90-count and 120-count Imbruvica TRx, plus projected
weekly TRx (equal to current four-week moving averages),
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.
Right now I really want to see what GED-301 phase II data that they are presenting in October. I think this new drug could be even bigger then Revlimid. If it truly as good as I expect for Chron's disease, it could be huge growth potential.