You can't look at GAAP numbers including acquisition one time costs - ISI is # 1 biotech analyst for institutional investor 5 yrs running and he calculates every month - of course using the #s buy side and sell side look at adjusted EPS taking out non cash items and one time costs....CELG is cheaper using the correct #'s
CELG PEG ratio is still ridiculously low despite the triple..(added this table under the SA comment that lied about the CELG PEG)....GILD and BIIB have climbed but still low - biotech is not expensive its cheap - see Street article today
Company 2014-2015-2016-2017 (FROM ISI recently)
GILD 1.4x 1.3x 1.2x 1.0x
AMGN 2.0x 1.8x 1.7x 1.5x
CELG 1.0x 0.7x 0.6x 0.4x (Based on EPS that is likely $1.00+ low in 2016 and 2017 imo)
BIIB 1.3x 1.1x 0.9x 0.7x
REGN 1.6x 1.3x 1.3x 1.1x
ALXN 2.0x 1.8x 1.4x 1.2x
$CELG PEG ratio cheapest in bio
Piper - Lots of opportunity ahead:$85 to $115/share. CELG is one of our top large-cap picks in biotech with a reasonable multiple and potential to deliver sustainable 25%+ EPS CAGR through the end of decade & we'd take advantage of today's weakness.
Celgene Corporation (CELG) Overweight
Fine Quarter, Growth Prospects Intact With Pipeline Kickers. PT to $115
Changes Previous Current
Rating — Overweight
RaisePrice Tgt US$85.00 to US$115.00
C O N C L U S I O N
This morning CELG reported 2Q results and raised guidance. Total revenue and EPS were a bit ahead of expectations and we're impressed with the pace of adoption for Otezla. CELG appears well-positioned to deliver sustainable mid-20% EPS growth for the foreseeable future which should help maintain the multiple while new pipeline programs emerge to potentially drive additional expansion. We are adjusting our estimates so our PT moves from $85 to $115/share. CELG is one of our top large-cap picks in biotech with a reasonable multiple and potential to deliver sustainable 25%+ EPS CAGR through the end of the decade and we'd take advantage of today's weakness.
• A fine quarter; don't see why shares should be soft: US Revlimid kept the Revlimid franchise ($$1.214B) in line despite weakness from OUS due to distributor purchasing patterns. Pomalyst was strong at $161M, ahead of the Street by $11M. EPS of $0.90 came in just ahead of the consensus $0.89. Upward revision to product sales ( $7.5bn vs prior $7.3-7.4bn) and EPS ($3.60-3.65 vs prior $3.50-3.60) were driven by non- Revlimid performance. We're impressed with the uptake of Otezla and patient access to date; Otezla's opportunity has been a source of debate amongst investors so this performance helps further establish the company's credibility. While the quarter (and Revlimid in particular) wasn't a blow-out, overall we're comfortable that the long-term prospects for CELG remain strong.
• Lots of opportunity ahead: Revlimid in frontline myeloma (EU) will deliver a new leg of growth while Revlimid in MCL, MDS are incremental while Revlimid in NHL could be transformative. Other imids are being developed for solid tumors and combination with cancer immunotherapy. MOR-202 could add a new leg of growth in myeloma, Sotatercept could drive new growth for anemia, and epigenetic priming could deliver long-term sustainable growth in the oncology franchise. Otezla launch is going well and should accelerate with new territories and new indications (psoriasis and potentially ulcerative colitis, Behcet's or others). GED-0301 could emerge as a transformative therapy for Crohn's disease.
• Revisions: Our estimates adjust to reflect CELG's commitment to smooth earnings growth through the end of the decade likely targeting the mid-20% EPS range. This will allow the company to invest more heavily in R&D programs that will deliver growth beyond 2017. As such, a slight decrease in near-term EPS estimates are more than offset by the 2017-20 and beyond opportunity, driving our upward valuation revision. Our valuation methodology is otherwise unchanged
CELG often bottoms on earnings day right after the earnings call hang up when call is over. Will rebound today and then tomorrow Dr Fouse CFO can buyback stock again under normal buyback no restriction. She has been restricted since July 1 because of earnings blackout - great area to add imo
ISI - no reason for CELG to be down so much this morning.....
I honestly don't have a great explanation as to why CELG has traded down so much this morning. Nothing THAT negative was revealed on the call, in my opinion. Please see below for a few key tidbits we picked up as well our detailed "raw" notes:
1 Accelerating duration of Revlimid over last 6 months that CELG expects to continue
2 Otezla - revenues in July meet and exceed sales in Q2'14. Q2'14 affected by delays in adjudication, titration, etc.
3 DMM front line in EU - base case for CELG is initial label for elderly non-transplant patients (~70% of NDMM patients) with revenue in broader (including transplant) population delayed 18-24 mos
4 Clinical data for development programs in MDS and AML indicate potential for revenue growth faster than built into CELG's base case
=== Prepared remarks
Early pipeline moving forward including CD47, CD122, JNK in fibrotic disease, CC-220 scleroderma
AG-221 - early but promising ph1 data in AML, exercised option for WW license
Sotatercept or ACE-536 - choose one for beta-thal study begin YE'14
MDS-005 trial met primary endpt - tfn independence, lower risk MDS
MCL-002 - plan review with regulators - ph2 with R/R MCL vs control arm (investigator selected) SS PFS
Revlimid + R in FL
Rev +R in newly dx'ed ABC DLBCL to start in next few mos
Pomalyst - 3rd line ~30%. Early access in Germany and UK and other markets France and Spain
Abraxane - market share pancreatic 14%, expect peak share 55%. Continue to receive global marketing approvals
Beyond 2017, key drivers toward end of decade
Revlimid in NHL and other indications beyond MM - all growth beyond 2017. As have more visibility will discuss, will have more clarity over next few quarters
Payments for GED-301, etc - how accounted for and ROIC?
AG-221 - nothing specific for opt in. Development costs will shift to us as typical. For GED-301, upfront payment cash, purchase accounting, acquisition amounts IPR&D and some contingent liabilities from milestones. ROIC based on GAAP, most conservative.
Revlimid duration trends?
ITT to progression, about half in US and EU. In last 6 mos, sharp increase in drs, treating to progression (change after stable period). Accelerating duration recently, think will continue. At ASH and 1H'15 - combos with Rev such as elotuzumab and others.
Collaborative across landscape
So many subsets of MM being defined/redefined, will look to close gaps
Moving along, in model for 2015 (US), in EU Q2 approval and normal country by country reimbursement so kicks in more 2016/7
Non-del 5q MDS
Data encouraging, growth in MDS and AML than base case scenario. Data vs active controls.
Event driven, data at ASH
Discussions, coverage of 70-80% of lives
MDS, Revlimid and '536?
Revlimid ~10% of MDS with non-del 5q. Vast majority of MDS patients cycle through tfn and EPO. Role for '536 in tfn-dependent MDS
GED-301, size and scope of ph3?
Need to have regulatory discussions 2H'14
No change in strategy
Otezla adoption PsA?
No one factor driving adoption - access, data, safety, etc. Data for wk 52 to wk 104 at ACR
GED-301, how comfortable with data?
Pbo rates low, dose response, striking and compelling
Clarify expectation for frontline MM in EU?
Pushing for broadest, elderly non-transplant eligible as base case. 70% of NDMM patients would be candidates for Rd. Nothing in model in transplants until 18-24 mos later.
Otezla revenues in July meet and exceed all in 1st quarter of launch
Otezla persistency - early to say but anecdotally c/w clinical program
Participating in market as is and change over time. Over time combo with R, expect value in subsets of DLBCL including ABC as plan
Very, very little Revlimid used off-label in MDS (beyond non-del 5q MDS)
CAR-T and CD47 - accelerate both assets in clinic in 2015
On CELG call new President Marke Alles - "Very excited about Agios AG-221 - top priority to accelerate as quickly as possible- Man does he seem excited about this Agios drug."
Celgene seems pumped up about AGIO drug....
Raymond James - Great timing of 1st ever IOC buyback....Given that the stock is trading 30% below our base case NAV estimate, we think the timing of this announcement is excellent from the standpoint of stabilizing the share price and creating accretion.
InterOil Corp. (IOC/$54.45/Outperform) announces $50 million buyback. After recent weakness in the stock price - giving back essentially all of its year-to-date gains over the past month, largely due to a longer-than-expected timeframe for the exploration program - InterOil has announced a $50 million share buyback authorization. This equates to 2% of shares outstanding. The authorization is valid over the next 12 months. We are big fans of this decision - which marks the first-ever buyback in InterOil's history. Following the resource selldown in March and last month's sale of the refinery and retail marketing assets, there is close to $800 million in cash on the balance sheet, or one-third of market cap.
Given that the stock is trading 30% below our base case NAV estimate, we think the timing of this announcement is excellent from the standpoint of stabilizing the share price and creating accretion. Once the additional Elk/Antelope resource payments are received in 2015, there is room to materially upsize the buyback as well.
TGTX Novel Combination of TG-1101 (Ublituximab) and TGR-1202 Demonstrates Compelling Early Activity and Safety Profile in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) and Aggressive Lymphomas
TG Therapeutics' Novel Combination of TG-1101 (Ublituximab) and TGR-1202 Demonstrates Compelling Early Activity and Safety Profile in Patients With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL) and Aggressive Lymphoma
o100% of CLL/SLL patients had significant nodal reduction with either a normalization of or =80% reduction in Blood Lymphocyte Count
o 4 of 5 CLL/SLL patients achieved a partial response at first assessment, including a patient relapsed from a prior BTK-inhibitor, and the 5th patient with stable disease achieved a 44% nodal reduction pending next assessment
o 2 of 5 heavily pretreated DLBCL patients achieved a PR, including one patient with GCB subtype refractory to prior therapy
o Combination appears well tolerated with no dose-related increases in toxicity observed among patients treated to date
NEW YORK, July 21, 2014 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX), an innovative, clinical-stage biopharmaceutical company, today announced preliminary clinical results from its ongoing Phase I study of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody in combination with TGR-1202, the Company's novel, once-daily PI3K delta inhibitor in patients with advanced CLL and non-Hodgkin's lymphoma. Data from the Phase 1 study is being presented by Dr. Matthew Lunning from the University of Nebraska Medical Center in Omaha, Nebraska during the 2014 Pan Pacific Lymphoma conference being held in Hawaii.
The poster presentation includes data from patients with advanced CLL, including 17p/11q del and a patient with Richter's Transformation, as well as heavily pre-treated, relapsed and/or refractory patients with Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL). I
Almost no volume in in the money CELG calls expiring today - they want the shares called into acct - over 25,000 calls (36,000 if over 85) about 2.5 million (3.6 mill) shares will be taken from people who wrote them....
might be positive for today's action and and especially next week.
Can't post link - posted letter on CELG board
An Open Letter To Janet Yellen: Is There A Biotech Bubble?
7/18/2014 @ 8:24AM
Mark Schoenebaum, the lead health care analyst at International Strategy & Investment Group, sent the following open letter to his clients this morning, in response to comments by Fed chair Janet Yellen that have left both the iShares Nasdaq Biotechnology Index and bellwethers like Celgene, Gilead, and Biogen Idec all down 5% for the week.
I think it’s worth reprinting — I’ve added the headers and changed some punctuation.
The Honorable Janet Yellen, Ph.D.
Board of Governors of the Federal Reserve System
Constitution Ave NW, Washington, DC 20551
Dear Dr. Yellen:
Thank you for sharing your thoughts recently on the biotech sector. Given your stature, I paid very close attention to your comments, as did most biotech observers.
You stated that biotechnology valuations are “stretched, with ratios of prices to forward earnings remaining high relative to historical norms.”
I just gathered biotech price to earnings ratios back to 1993 using Russell 1000 data, and my data show that the current ratio is roughly in-line with the historical median and is approximately 80% below the peak.
Please tell me what I’m missing, Dr. Yellen.
Senior Managing Director
Head of Healthcare Research
International Strategy And Investing Group
Journal Clinical Oncology - The transplantation program with RVD induction and consolidation followed by lenalidomide maintenance produced high-quality responses and showed favorable tolerability in patients with newly diagnosed MM.
Front-Line Transplantation Program With Lenalidomide, Bortezomib, and Dexamethasone Combination As Induction and Consolidation Followed by Lenalidomide Maintenance in Patients With Multiple Myeloma: A Phase II Study by the Intergroupe Francophone du Myélome
Purpose The three-drug combination of lenalidomide, bortezomib, and dexamethasone (RVD) has shown significant efficacy in multiple myeloma (MM). The Intergroupe Francophone du Myélome (IFM) decided to evaluate RVD induction and consolidation therapies in a sequential intensive strategy for previously untreated transplantation-eligible patients with MM.
Patients and Methods In this phase II study, 31 symptomatic patients age
JMP- Read-through to Celgene from JNJ 2Q14 Earnings - "We continue to view CELG as our top large-cap pick and reaffirm our estimates and Market Outperform rating"
JMP today - Read-through to Celgene from JNJ 2Q14 Earnings
MARKET OUTPERFORM | Price: $88.11 | Target Price: $102.00
Johnson and Johnson (JNJ, NC) reported 2Q14 earnings today, disclosing ex-U.S. Velcade sales of $403MM; maintaining Market Outperform rating on Celgene and $102 YE14 price target, derived through DCF and P/E multiple valuation methodologies. Ex-U.S. Velcade sales were $403MM for the quarter - a 1.2% sequential decline from 1Q14 sales ($408MM) and 6.4% gain year over year (from $379MM). For Celgene, we reaffirm our projected 2Q14 ex-U.S. ($516.5MM) and worldwide ($1.2bn) Revlimid estimates, and non-GAAP EPS estimate of $0.88. CELG reports its 2Q14 earnings results on July 24, before market open.
Sequentially flat quarter for Velcade reflects product maturation in the RRMM setting, with limited read-through to overall market growth. As noted above, Velcade growth year over year was modest at 6.4% (6.2% constant currency), and likely primarily a result of price rather than volume. In our view, this trend reflects a leveling in penetration typical of a mature product, and as an IV product, one particularly susceptible to oral agents (Revlimid, Pomalyst). While Q2 results may imply Velcade losing ground to the Celgene myeloma franchise near term, we maintain the view that the primary driver for Revlimid growth longer term will be uptake in the newly diagnosed maintenance setting.
We remain bullish on Celgene and forecast total revenues to rise to $17bn+ by 2020. We expect Celgene’s four blockbuster drugs (Revlimid, Abraxane, Otezla, and Pomalyst) to drive revenues in excess of $13.4bn by 2017, and $17bn by 2020, while investments in collaborators like Acceleron, Epizyme, Oncomed, Agios and others ensure growth from 2017 and beyond. We continue to view CELG as our t
Go to Investor Village CELG board for a better color version of this Celgene Truck....
LOOK OUT SHORTS!!!!! THE CELGENE TRUCK IS NOW BURSTING AT THE SEAMS WITH NEAR TERM CATALYSTS, BARRELING THROUGH ALL TIME HIGHS!!!
|Positive Markman/ 90%+ margin!! |
|20+ early bio partners/ Dr Fouse! ! |
|Split/2015 dividend/ Cash Flow $$ |
|Pending EU Front line approval___
|NHL data/Best Bio Pipeline_||||____\,___
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Someone asked to bring back the Celgene Truck...this one's for long term holders....this truck is 10 yrs old but adding cargo everyday.
Sentiment: Strong Buy
Accelerant for the coming move much higher....this could get interesting. Kindling for the fire. I love high short interest. So does Baker Bros.
TG THERAPEUTICS, INC.
Positive TG-1101 Plus Ibrutinib Combination Phase II Data Presented at EHA 2014
Company & Market Data
Closing Price (as of June 13, 2014): $9.61
Price Target: $18.00
Prior Price Target: $12.00
52 Week Range: $2.97 - $10.15
Shares Outstanding (MM): 38
Market Capitalization (MM): $362
Cash (MM): $54.5
Fiscal Year End: Dec
*Cash (MM): As of March 31, 2014
Chart data: Bloomberg
Positive initial TG-1101 plus ibrutinib combination Phase II trial data presented
at the European Hematology Association (EHA) Conference. The TG-1101 plus
ibrutinib combo study is a Phase II single arm study in relapsed or refractory MCL
and CLL (as per the ibrutinib label). Patients enrolled in the trial had a median of 2
prior therapies (range of 1 to 6) with 43% 3 prior therapies and 96% with prior anti-
CD20 therapy. The study currently has 28 patients (21 CLL and 7 MCL) evaluable
for safety and 10 (7 CLL and 3 MCL) evaluable for efficacy. The initial results for the
first efficacy assessment show an overall response rate (ORR) of 90% with one CR
and 8 PRs. Six of seven (86%) CLL patients showed a PR on the first assessment
with the seventh patient showing 40% nodal response. We believe this patient could
convert to a PR in the future. The data show the addition of TG-1101 controls the
ibrutinib-related lymphocytosis (reduces the severity and the duration thereby creating
earlier clinical responses), with a 79% reduction in ALC. Additionally, it is important to
realize the efficacy data is early as the study is ongoing and this is only the first efficacy
assessment. We are impressed with the initial data as they show the combo treatment
is well tolerated and highly active resulting in a more rapid and more pronounced
response rate (ORR) in this patient population. We believe the preliminary response
rate results are compelling (initial ORR of 90% versus ibrutinib alone which showed an
ORR of 71% in this patient population).
TG presented a positive update for the ongoing TGR-1202 Phase I/II dose
escalation study. The ongoing Phase I/II study TGR-1202 single agent dose
escalation study is in patients with relapsed or refractory hematologic malignancies.
Forty patients are evaluable for safety and 35 patients are evaluable for efficacy. The
clinical activity data from the study show clear, robust nodal responses of greater than
50% in 8 out of 9 (89%) CLL patients treated at 800mg or higher (at ASCO TG reported
7 out of 9 or 78%). The one remaining patient achieved 40% nodal reductions on the
first assessment scan and remains on study awaiting the next scan. We are impressed
with the clinical activity data observed in relapsed/refractory CLL patients as it clearly
indicates TGR-1202 is a highly active agent upon achieving clinically relevant doses.
The data also show TGR-1202 has been well tolerated with no evidence of liver toxicity
and no colitis events. Importantly, with 38% of the evaluable patients treated at 800mg
on study for over 6 months (with some for 1 year) TGR-1202 has an AE profile which
supports combination therapy. No patient has discontinued due to a drug-related AE
and the MTD has not been reached.
We reiterate our BUY rating and increase our price target to $18 from $12.
Our price target increase is based on the positive initial TG-1101 plus ibrutinib data
combined with the maturation of the mono-therapy studies which continue to show solid
safety and efficacy profiles for both TGR-1202 and TG-1101 to date. We look forward
to additional data presentation at upcoming medical conferences with a focus on initial
top-line data from the ongoing TGR-1202 plus TG-1101 combination study and the
definition of a regulatory path with the initiation of a pivotal program in 2014.
Company & Market Data
Closing Price (as of June 13, 2014): $9.61
Price Target: $18.00
Prior Price Target: $12.00