Just out - ISI new PEG #'s - CELG PEG ratio is still ridiculously low despite the triple..earnings growth at deep discount the cheapest of the group...
CELG trading at HALF its earnings growth rate in 2016/17 CRAZY CHEAP and those EPS numbers are WAY low imo
Company 2014-2015-2016-2017 (FROM ISI)
GILD 1.3x 1.1x 1.0x 0.9x
AMGN 1.8x 1.7x 1.6x 1.4x
CELG 1.0x 0.7x 0.6x 0.4x (Based on EPS that is likely $1.00+ low imo)
BIIB 1.3x 1.0x 0.8x 0.7x
REGN 1.6x 1.3x 1.2x 1.0x
ALXN 1.9x 1.7x 1.3x 1.1x
AMGN/CELG: ASPIRE Data Positive for Both
ASPIRE data helps both AMGN and CELG (and more importantly, patients)
Amgen's impressive ph3 ASPIRE trial of KRd regimen (Kyprolis+ Revlimid + low-dose dex) in relapsed/refractory multiple myeloma (RRMM) is a positive for AMGN, in our view, as it should establish KRd as a standard of care in RRMM, and sets the bar for the upcoming interim analysis of Rd with BMY/ABBV's elotuzumab. The data are also positive for CELG, in our view, as it should meaningfully increase the Revlimid duration of therapy in this large setting, considering the 8.7 improvement in PFS (26.3mo of KRd vs. 17.6mo of Rd, HR=0.690, p
DB - Celgene - AMGN Aspire could add $24-$32/share to our CELG NPV longer Revlimid use** Reiterate Buy and $115 target - Celgene also has 1 of most transformational pipelines...
Today, Amgen reported their top-line data from the Aspire study. As a reminder, Aspire is Kyprolis+Revlimid+dex vs. Revlimid+dex. There was a 8.7 mos benefit in progression free events from adding Kyprolis (26.3 mos vs. 17.9 mos). Here is our take on what it specifically means for Celgene’s valuation.
As we have noted before, we expect Revlimid duration to increase based on Aspire data. Revlimid remains the key value driver for Celgene, and we think that this Revlimid duration nuance is ignored by the street.
Therefore 8-9 mos of longer Revlimid use could add $24-$32/share to our Celgene NPV alone in the US. Sensitivities are below
*From our model, every 1 month of US Revlimid duration is worth ~$3-4/sh to our CELG NPV. We currently in our model only assume ~2mos additional Rev duration increased in the US. We do not assume any duration increase for Revlimid in our EU model.
*Every 1 month of EU Revlimid duration is worth ~$1-2/sh. We currently assume no EU Revlimid duration increase in our model.
Our Celgene model includes an APP for Revlimid duration increase and builds for every pipeline product for Celgene
One of the key questions for investors around Celgene remains how to think about their pipeline and potential duration expansion for Revlimid. Please ask us for our model.
*From our model with duration increases similar to Aspire in the US ONLY AND pipeline, we think that the co could potentially be worth $128-$174/share.
Reiterate Buy and $115 TP. We believe that Celgene has one of the most transformational internal & external pipelines in biotech
.....playing catch up - petitioning the court to NOW now advance invalidity arguments against the'800 patent, suggesting that the company has decided to change strategy in light of the Markman ruling. Legal advisors suggest Natco faces "an uphill battle" to add new invalidity arguments at this point, almost four years into the case. Its about 50/50 right now that the Court will deny Natco's petition outright and even if somehow the judge allows them to present the invalidity arguments - the do not appear convincing in Bernstein and their counsels opinion.
The case between Cubist and Teval was pointed to as a template for settlement brought at a recent investor dinner - Celgene management viewed this as a reasonable comparison...(Celgene clearly has been preparing for this for yrs and are steps ahead of Natco IMO)..... 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."
The report goes on in a lot more detail with 12 solid pages of rationale as to why Bernstein thinks Celgene should be able to leverage its strong position in the case into favorable settlement terms - During that investor meeting Dr Fouse message was clear: "We are rational people and open to settlement if it's in our shareholders' interest." Porges states that it would not surprise them if the initial settlement discussions with Natco have already taken place. Bernstein expects settlement with modest concessions (barring generic entry to 2025/2026 - 1-2 yrs before patent expiry as the most likely outcome) ... - its clear now that it will be in Natco's interests to settle as well per Bernstein : If Natco loses the case, it will realize zero value for the significant investment it has made in filing the ANDA and challenging the patents. On the other hand, a settlement would likely lead to a period of exclusivity for the Natco generic prior to the '800 patent expiry, leading to significant value for Natco. Indeed, a large majority of patent cases are settled before trial.
Celgene currently appears to be applying maximum pressure through legal maneuvers to drive Natco to the settlement table and strengthen its own negotiating position. According to Bernstein's advisors, if the Court sides with Celgene in denying Natco's petition to advance invalidity arguments, and/or in not reducing the number of claims, pressure will mount on Natco to settle earlier.
Sorry I cannot post the report - but again I consider this a watershed report on probably the biggest inflection point in Celgene's recent history - once this case is settled focus will immediately go on to more important things, the 23+ partnership with the worlds leading early stage biotechs - some that will change medicine, the undervalued earnings growth trading at deep discounts (less than half the growth rate on CONSERVATIVE out yr #'s), Otezla with the September psoriasis approval on deck, the GED-031 data that may first come out in a medical publication and then be presented in October in detail, then ASH abstracts and perhaps a market moving ASH, data from those partners, more NHL updates, EU front line approval, etc...I feel strongly that Celgene's stock will move up into this settlement and once the settlement is announce and the Chrohn's data is seen - well we get our second BIIB-like move (or do we now call it a Celgene-like move after our recent triple - hmmm). I suspect post settlement (which if Natco was smart they would push for sooner not later) - that because of the huge Revlimid sales upside and also the removal of the overhang - Celgene's stock could spring $20 to $25 in the month following settlement...
Use last week's ridiculous market weakness to round out your Celgene position at bargain basement before settlement and before Dr Fouse puts the Hematology and Oncology business into overdrive - I suspect Celgene may start 3 or 4 Phase 3 trials by yr end. As Dr Fouse said loud and clear at the end of her segment of the earnings call a few weeks ago - "The best is yet to come"
Got a chance to read this Bernstein report on the Revlimid patent case in detail over the weekend and while I am not at liberty to post the report - I would like to give you my thoughts on what I read.
I have been reading CELG analyst reports for over 15 yrs, and quite simply I consider this one perhaps one of the most important every written as far as laying out a case for why the settlement of this case "with modest concessions" since Celgene clearly has the upper hand makes this the time to buy more Celgene - with Bernstein continuing to "Recommend Celgene's stock STRONGLY at these levels"
As was reported by the flyonthewall - the report was titled " Celgene: Natco's Case Getting Weaker; We See Settlement in Q1'15 Barring Revlimid Generic Entry Until 2025/26.
Bernstein's Geoff Porges - who I view as one of the best biotech analysts that currently covers Celgene - has always had a very positive view of Celgene winning this battle - but they have had expert counsel retained on this issue since they first covered Celgene and that counsels opinion as well as Porges' - which was very very much in the Celgene camp - clearly has strengthened significantly over recent months given the Markman hearing results and Celgene legal maneuvering before, during and after.
The report goes into some detail on how Natco's original strategy focused on circumventing the '800 patent and invalidating the other less
important patents, particularly method of use and distribution patents. The problem Natco has is that "The Markman ruling in May was a significant setback to Natco's non-infringement arguments against the '800 patent". Porges argues that the judges interpretation of the term "hemihydrate" - which is considerably broader than Natco's proposed interpretation- had dealt Natco a "significant blow" re: their arguments for non-infringement. Bernstein feels Natco may have been caught flat-footed without other arguments against the patent.
Now it appears Natco is playi
i recommend this to everyone....this is so cool', just get half of my profits' and its getting better and better, Thank You!
Personally, I think this is a 3X bagger, so I am not a fan of getting a 50% premium now, when I know if I just wait 2-3 years I'll get a heck of a lot more.
4 OUTRAGEOUSLY BOGUS STATEMENTS BY NVLX CONMAN KENNETH L. WAGGONER ON 7/14/14 PR:
1. If Nuvilex has completed the necessary preliminary steps to commence a Phase 2b clinical trial of its pancreatic cancer treatment that it expects to begin in Q1 2015, then why hasn't the FDA Centers for
Biological Evaluation & Research at 800-835-4709 ever heard of NVLX or its subsidiary Austrianova?
2. If NVLX was virtually debt free, then explain an accumulated deficit of (52,229,316) according to the last NVLX 10-Q dated 03/17/14???
3. If Nuvilex has secured a traditional investment banking relationship with Chardan Capital Markets, then why no funding from Chardan itself? It's just an agreement for Chardan to peddle NVLX stock for a fee according to the 05/29/14 8-K!!!
4. If Nuvilex has established credibility with accredited and institutional investors, why not mention any names? No proof of this whatsoever!!!
PR ON 7/17/14 A REHASH OF OLF AUSTRIANOVA TRIAL DATA FROM 2002:
"J Mol Med (Berl). 2002 Sep;80(9):610-4. Epub 2002 Jun 28.
A clinical protocol for treatment of canine mammary tumors using encapsulated, cytochrome P450 synthesizing cells activating cyclophosphamide: a phase I/II study.
Winiarczyk S1, Gradski Z, Kosztolich B, Gabler C, König G, Renner M, Saller RM, Prosl H, Salmons B, Günzburg WH, Hain J.
1Department of Epizootiology and Clinic of Infectious Diseases, Faculty of Veterinary Medicine, Agriculture University, Gleboka Street 30, 20612 Lublin, Poland."
OMG...SELL EVERYTHING YOU OWN TO SHORT THE NVLX CRIMINAL ENTERPRISE!!!!!!!!!!!!!
Sentiment: Strong Sell
Finally someone gets it..I've been trying to tell this board about the impact of this new drug and no one gets it......it's a huge game changer and this board has no clue..thanks for this great post