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ACAD from jpm on AD trial
While the pathology of PD and AD are very different, psychosis symptoms are similar. ACAD noted that Nuplazid aims to treat symptoms of the diseases (hallucinations) not the disease itself, Thus given similarity in hallucinations (primarily visual) between PDP and ADP pts, it believes the ADP trial has a high probability of success. Management also pointed to publications/animal models of PDP and ADP that indicate the visual hallucinations in both indications are driven by over activity of the 5HT2A receptor.
The single center, Phase 2 ADP trial is powered for a 3 point reduction in the primary endpoint (NPI-NH). The trial is being run at a single center (with multiple sub-sites) in London, and the geographic concentration allowed for fewer raters, which should help reduce the amount inter-rater variability in the data. The primary endpoint of the trial is change from baseline in the hallucinations/delusions subscale of the (fully validated) Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) scale. Unlike in the PDP trial where patients were interviewed about their symptoms as part of the efficacy measurement, the ADP trial endpoints rely on caregivers only as AD patients suffer from dementia and are unable to talk about their ADP burden. The primary endpoint will be evaluated at 6 wks, and the trial will continue on through week 12 to 1) show maintenance of effect, and 2) evaluate pimavanserin’s effect on cognition. Management has guided to ~2 years between trial start and top- line data (the trial initiated in Nov 2013).
Credit Suisse - GED-0301 Domain Domination Coming Soon -- This is a Sleeping Blockbuster – It Could be a Category Killer
GED-0301 Domain Domination Coming Soon
?We have updated our GED-0301 deep dive (that was originally published as our Ideas’ Engine note “Pipeline Appreciation Catalyzes Domain Domination Premium” – LINK) ahead of the presentation of the PII (n=166, 12 week primary endpoint, GED-0301 dosed for 2 weeks) data for GED-0301 in Crohn's Disease most probably first due at the UEG Conference in Vienna on 21st October 2014. We note that there is the possibility that the PII data could be published in a major peer review journal (most probably NEJM) prior to the UEG Conference.
The key data points in PII:
?GED-031 clinical induction and remission responses. In our view, the over/under hurdle rates for GED301 on clinical induction (4W) and maintenance (12W) are >80% and >50% (which would confer a “retention” rate of 40%). With the caveat of cross trial comparison, PIII anti-TNFs showed induction (4-8W) of ca50% and maintenance (on induction responder patients) of ca50%, conferring a “retention” rate of 25%. The 15 patient single-center GED-0301 PI trial showed induction and 6 month remission rates of 100% and 47% respectively.
? Safety is just as important. In particular, we will be focused on any effects that GED-0301 could have on triglycerides and/or cholesterol, which had been flagged as a potential drug-related adverse event in the PI trial. In addition, we will be looking for any commentary related to fibrosis. In theory, up-regulating TGF-Beta appears to be profibrotic.
? Details on the PIII trial design will be closely watched. The design of the PIII trial will be important, given that CELG will likely have to work out the dosing regimen (i.e. we expect periodic dosing in the maintenance phase, given the strong efficacy of the drug and the concerns around potential safety), primary endpoint (Cimzia was approved on Week 26 endpoint), and study duration (to ensure that FDA is comfortable with long enough patient exposure levels for safety reasons). CELG has previously guided to a PIII program starting in 2014. We understand the end phase II meeting with the FDA has not yet taken place. We also understand that CELG will apply for breakthrough designation.
GED-0301 Overview
? We have updated our deep dive on “GED-0301” - PII data due October 21 at UEG – As we stated previously, this is a sleeping blockbuster – it could be a category killer - We are assuming a 2019 launch and peak sales of $2.0B - >$3B blue sky potential
? GED-0301 is being developed for Crohn’s Disease (CD) and was acquired by CELG in April 2014 from a little known private Italian biotech company. The acquisition price was the highest price every paid for a mid development stage asset.
? The moderate-to-severe Crohn’s Disease (CD) is a ~$4B WW market currently served by (injectable) biologics. GED- 0301 is a totally novel approach to CD. It’s a “1st gen” antisense oligonucleotide vs. novel target “Smad7” – it is orally administered.
? Only early PI data (15 patients) is publically available. Nevertheless, the data was stunning – 100% response rate, 47% 6 month remission after only 7 days treatment . Importantly CELG signed the deal (in a very competitive process) after PII data that we will see in October 2014. If this data shows what PI showed we think the street will have to at least “place- card” holding revenue estimates of peak >$1b.
? We assume a 2019 launch and peak sales of $2.0B which correlates to a conservative ca25% of patients currently treated on biologics.
? There is significant >$3B blue sky potential for GED-0301. We provide a scenario analysis illustrating that “longer duration of treatment/average patient = revenue upside” is a significant sensitivity. There is also notable operating leverage potential in CELG’s emerging I&I infrastructure.
? Our view on CELG is not just an unappreciated pipeline asset call – it’s as much about “Domain Domination” and “Return To Growth” themes
? Our view is a “Perfect Storm” of 3 major themes (1) Pipeline appreciation (2) “Domain Domination” (3) “Return To Growth” themes.
? “Domain Domination” is a concept we have been talking about in in the biotech sector beginning in 2014. Domain domination describes a strategy being employed by select companies to achieve greater company R&D and commercial productivity. The key (stock price sensitive) take home is that it can result in multiple expansion (e.g. BIIB being the best example).
? Return To Growth” in early June the Global Biotechnology and Equity Strategy teams published Notes on “Market Inconsistencies” which outlined a positive stance on large cap biotech due to the magnitude, upside potential and longevity (vs. other sectors) of growth in the sector combined with relatively inexpensive valuations.
Sources: Company data, Credit Suisse research
One Page Take-home on GED-0301 – This is a Sleeping Blockbuster – It Could be a Category Killer
? Obtained via deal with Nogra on April 25, 2014 for “Biggest BioWorld $” deal ever $710M as an upfront payment, $815M in potential aggregate regulatory and development milestones for multiple indications, $1,050M in aggregate tiered sales milestones if annual net sales reach $4,000M, and standard non-double-digit, tiered royalties.
? In development for moderate-to-severe Crohn’s Disease (CD) a ~$4B WW market currently served by biologics. GED-0301 is a totally novel approach to CD. It’s a “1st gen” antisense oligonucleotide vs. novel target “Smad7”.
? Only PI and PC data available...but PI (n=15) data is stunning – 100% response rate, 47% 6 month remission after only 7 days treatment. CELG signed deal after seeing PII data, N=166 14 days treatment.
? Key Phase II catalyst likely October 21, 2014: We expect CELG to present granularity of PII data on 21st October 2014, at the United European Gastroenterology (UEG) Meeting 2014 in Vienna, Austria. We believe the strength of this data will result in at least “place-card” holding revenue estimates (peak >$1b) in sell side models. PIII to start in 2014 as announced in April by CELG – we assume more granularity after UEG.
? We are assuming a 2019 launch and peak sales of $2.0B. Notable operating leverage potential in CELG’s emerging I&I infrastructure
– Amarketshareofca25%ofpatientscurrentlytreatedonbiologics=$2.0B
? There is significant >$3B blue sky potential – Multiple upside revenue opportunities – IfPI“clinicalprofilehint”playstroughitcouldtakethemajorityofbiologicmarketshare.
– Better efficacy = higher patient retention rate = longer duration of treatment/average patient = revenue upside is a significant sensitivity! (we estimate biologics only used for average of 6 month/patient/year).
– Could be used further down the disease paradigm.
Why Are We So Excited By GED-0301 When We Have Only Seen PI Data?
Results for 15 Patient PI Study
? Very little data is available for GED0301...which was only licensed in April 2014 from little known private Italian biotech company. The acquisition price was the highest price every paid for a mid development stage asset – potentially up to $2.6B.
? What does the publically available data on GED-0301 tell us? The phase I trial was only in 15 patients and the drug was only administered for 7 days. However, the results were phenomenal: 100% response rate, 47% 6 month remission. GED-0301’s unique mechanism of action (“antisense” against Smad 7) may explain its high and prolonged activity.
? Key Phase II catalyst likely October 2014: We expect CELG to present granularity of PII data 18-22nd October 2014, at the United European Gastroenterology (UEG) Meeting 2014 in Vienna, Austria. This was a 166 patient trial with 14 days of treatment. We believe the strength of this data will result in at least “place-card” holding revenue estimates (peak >$1b) in sell side models. PIII to start in 2014 as announced in April by CELG (granularity likely on Q2 conference call). at end July. CELG bought CED-0301 in a highly competitive process (multiple bidders) AFTER they had seen this PII data.
? What are we looking for in the PII data/PIII protocol? (1) Efficacy – Can the 100% “induction” response rate be repeated? – Will longer term dosing results in even better 12 week remission rates? (2) Side effects – the only notable signal in PI was raised triglyceride and/or cholesterol levels (3) If the PII data is strong could CELG get regulatory authorities to a novel(shorter) PIII pivotal program?
Clinical
Response (>70 point decrease in CDAI score)
Clinical
Remission (<150 points in CDAI score
15/1512/15 15/1513/15
PII (n=166) Trial Setup – Data Due October
GED-0301* GED-0301* GED-0301* Placebo
Primary Endpoint
9/15 7/15
Days
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
N=166
* Evaluated GED-0301 doses up to 160mg
Day 28
Sources: GED-0301 PI Data, Company data, Credit Suisse research
GED-0301 vs. Standard of Care Biologics Which Have a Low Patient Retention Rate due to Ineffective Maintenance of Responses
? Biologic’s – good but not that good. The $3.8B moderate-to-severe Crohn’s disease market is currently served by injectable biological agents. Whilst these agents have massively improved the treatment of CD they have efficacy limitations with only about half the initially patients responding and half of those in remission by 1 year. In the real world more than 25% patients stay on treatment as they cycle through the different biological agents. These agent also have the obvious limitations of being injectable and serious infection risks.
? Why do we think GED-0301 could be a category killer? Could have the “Goldilocks” profile of oral (vs. injectable) higher efficacy, and better side effect profile. There are analogies with Tecfidera in the multiple sclerosis market.
? Duration of use is a massive revenue sensitivity. A better clinical profile not only means higher market share but also drives higher revenues – see our scenario analysis on next page...
35%
35 Patients
63%
22 Patients
58%
58 Patients
54%
31 Patients
81%
81%
81 Patients
58%
47 Patients
77%
56%
56 Patients
61%
34 Patients
88%
31%
31 Patients
50%
15 Patients
80%
Cimzia
100 Patients
Humira
100 Patients
Remicade
100 Patients
Tysabri
100 Patients
Entyvio
100 Patients
25 Patients
36 Patients
30 Patients
12 Patients
Retention Rate <22%
Retention Rate 25%
Retention Rate 36%
Retention Rate 30%
Retention Rate 12%
BMO MRK
• Incrementally positive. Omarigliptin's similar efficacy to Januvia was clearly demonstrated in this study, in our view, as the HbA1c reduction curves of both drugs seem nearly identical through week 24. We urge caution in comparing A1c reductions across different trials given patient heterogeneity. Importantly, a higher proportion of patients reached treatment targets (HbA1c <7% or 6.5%) with Omarigliptin versus placebo, and the difference for the 7% goal advocated by the American Diabetes Association (ADA) for Omarigliptin versus Januvia is notable (47% vs. 38%). Overall, we believe Omarigliptin should help protect, or at least mitigate the impact of increased competition for Merck's Januvia franchise as its convenience advantage of once-weekly dosing versus once-daily dosing for the newer SGLT-2s helps offset some of the advantages of the SGLT-2s, particularly their 2-3 Kg weight lowering effect. The reason once-weekly dosing is important in diabetes is that many patients are often taking multiple medications, and lack of compliance could have serious consequences.
• We estimate that Japan accounts for roughly 50% of Januvia's ex-US sales, or approximately $950 million in 2013. Merck plans to file for approval by the end of 2014, suggesting that Omarigliptin could reach the Japanese market by early 2016. We forecast an early 2016 launch in Japan, followed by 2017 launches in other key ex-US markets, and expect that Omarigliptin will essentially allow the combined Januvia franchise to grow by roughly 5-7% operationally (ex-Fx) between 2016 and 2020 (7% in 2016, declining to ~5% by 2019). However, we acknowledge that the type 2 diabetes market is becoming increasingly crowded, with new oral agents including SGLT-2/DPP-IV combos, and there may be some downside risk to our estimates in the event of aggressive pricing/rebating tactics (some of which we've already seen in the DPP-IV market). Overall, we are not changing our Januvia franchise forecasts at this tim
TGTX up 15% imho investors digesting CS report from other day.
Strategic rationale for PCYC / TGTX combination
PCYC currently has a single product (Imbruvica) for the treatment of lymphoma and
leukemia. Although it has become the standard of care in its approved indications, the
long-term success of PCYC is likely dependent on it acquiring, in-licensing, or developing
drugs well suited for combination use with Imbruvica. This is important because its
competitors including Roche and Gilead are pursuing multi-drug strategies that combine
multiple proprietary drugs.
TGTX has two drugs in development that are likely to be complementary to PCYC's
Imbruvica.
¦ TG-1101 (ublituximab) is a glyco-engineered anti-CD20 antibody. Currently
Roche's CD20 antibody (Rituxan) is the backbone of treatment for all of the indications
that Imbruvica is targeting. Recently, Roche introduced a next-generation CD20
antibody Gazyva that is more potent than Rituxan. Ublituximab is more similar to
Gazyva, and will likely have its first approval in relapsed CLL in combination with
Imbruvica. TGTX previously reported positive interim Phase I data for the combination
of TG-1101 and Imbruvica at EHA (Exhibit 1). The next clinical data for TG-1101 plus
Imbruvca is expected at ASH in December 2014, where TGTX expects to report
efficacy and safety on 30 CLL patients (previously reported on 7 CLL patients). Prior
data demonstrated a 86% response rate (6/7) in combination with Imbruvica.
¦ TGR-1202 is a PI3K delta inhibitor in Phase I development. TGR-1202 is similar to
GILD's Idelalisib and INFI's duvelisib. TGTX believes it is a best-in-class PI3K delta
inhibitor, though this needs to be demonstrated. Like Idelalisib, TGR-1202 is highly
selective for delta (duvelisib also hits gamma). TGTX reports similar preclinical
efficacy with once-daily dosing, no liver toxicity and no GI toxicity. The safety claims
need to be verified in larger clinical trials.
Merck Presents First Phase 3 Data in Japanese Patients for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes
Omarigliptin significantly reduced HbA1c levels compared to placebo
Business Wire Merck & Co., Inc. 9 minutes ago
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--
Merck (MRK), known as MSD outside the United States and Canada, today announced the presentation of the first data from the Phase 3 clinical development program for omarigliptin, Merck’s investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes. In a study in Japanese patients, omarigliptin provided comparable efficacy and tolerability to Merck’s once-daily DPP-4 inhibitor JANUVIA® (sitagliptin) 50 mg, which is the standard starting dose for sitagliptin in Japan. Merck presented these data on omarigliptin, which has been shown to produce sustained DPP-4 inhibition, at an oral session at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.
“Despite advances in diabetes care in recent years, many people living with type 2 diabetes are not at recommended blood sugar goals,” said Peter Stein, M.D., vice president, Clinical Research, Diabetes and Endocrinology, Merck Research Laboratories. “Merck is committed to helping patients reduce the complexities of managing diabetes. If approved, omarigliptin, as a once-weekly medication, could provide an important new treatment option to help patients attain their blood sugar goals.”
Merck is supporting omarigliptin with a global clinical development program that includes 10 Phase 3 clinical trials involving approximately 8,000 patients with type 2 diabetes. These are the first Phase 3 data presented for omarigliptin and are the pivotal data for filing in Japan. As previously announced, Merck plans to file for approval in Japan by the end of 2014.
About the study
The Phase 3 double-blind, non-inferiority trial assessed the efficacy, safety and tolerability of omarigliptin 25 mg once-weekly compared to sitagliptin 50 mg once-daily (standard starting dose in Japan), and to placebo. The primary efficacy endpoint was the change in HbA1c1 levels from baseline at week 24.
At baseline, randomized patients (n=414) had a mean HbA1c concentration of 7.9, 8.0 and 8.1 percent in the omarigliptin, sitagliptin and placebo groups, respectively. Mean fasting plasma glucose (FPG) levels were also similar between treatment groups.
The primary objectives of the study were met, demonstrating at 24 weeks a significant change from baseline in lowering HbA1c levels versus placebo, while demonstrating similar efficacy to sitagliptin.
At week 24, omarigliptin significantly reduced HbA1c levels by -0.80 percent from baseline relative to placebo. The change relative to sitagliptin was -0.02 percent and met the prespecified non-inferiority criterion. The pre-specified criterion was based on the upper bound of the 95 percent confidence interval (CI) being less than 0.3 percent. Fasting and two-hour post-meal blood sugar levels also were significantly reduced from baseline with omarigliptin and sitagliptin compared to placebo.
There were no meaningful differences in the incidences of adverse events with omarigliptin compared to placebo and sitagliptin. The most common adverse event that occurred with an incidence of greater than 3 percent in the omarigliptin group was nasopharyngitis, which occurred in 12.7 percent of those treated, compared to 30.5 percent of patients receiving placebo and 11.0 percent of those receiving sitagliptin. Symptomatic hypoglycemia was uncommon across all treatment groups in this study [omarigliptin (0), sitagliptin (1), and placebo (0)]. Omarigliptin was generally weight neutral, with a 0.04 kg mean change from baseline at week 24.
RBC on ARWR. From twitter.
$ARWR complete RBC reseacr note 9/17
Arrowhead Research Corp.
On the road with big idea…we predict Street
interest in Hep B just getting started
Our view: We like ARWR long-term because we believe interest is going
to pick up in 2015 with HBV co's, and upside should be quite significant if
Phase IIB shows “cures”.
Key points:
Big picture: Investors are looking for the next big market after Hep C and
that could be NASH (ICPT, GILD, GenFit) or Hep B. On the road w/ mgmt
we learned 1) Phase I now through high-dose 4mg is safe in healthy pts, 2)
Phase II in HBV now dosing 3mg clearly shows knockdown including “long
duration” effects after just one dose….could be "bi-phasic" reduction and
immune system already starting to work (no ALT flair expected), 3) higher
doses could get even better, 4) multiple doses could have more effect, 5)
ARC-520 could be complementary to peg-interferon, or other approaches
(KOLs say this will be a long-term combination just like Hep C….).
So ARWR has many ways to win: They could have “cures” and/or ARC-520
could play a role in a future combination. We will continue to follow
other very early-stage companies with a different approach that could be
“complementary”: OnCore Biopharma (entering Phase I in 2015 – email
us for poster), Novira (Phase I), Assembly Pharma (entering clinic 2015),
Replicor (Canadian biotech). We like ARWR into AASLD and long-term not
only because we believe Street interest is going to pick up in 2015 with
these companies seeking the next big thing but also because we believe
upside for ARWR should be quite significant if Phase IIB shows “cures”, and
adding combos means many shots on goal. It’s not yet confirmed we'll get
the key placebo-controlled Phase IIB data in ’15 (keep it blinded for a year),
but many Phase II open-label studies will be going on with possible data.
What's next? ARWR will submit AASLD abstract by Sep 22nd with updated
data from 1-2mg/kg and will be notified of potential late-breaking slot
by October 8th. Base case is selection and presentation of unblinded data
from 1-2mg including data out past 2 months. If ARWR is not selected (may
be surprising headline risk), they will still report data around then; e.g.,
analyst event around Nov 10th in Boston as a venue. IND to begin Phase
IIB filing in Q4 and enrolling large (hundreds of pts) begins in 2015.
What’s our prediction? We think 1mg will show modest knockdown
(eg 0.1-0.3log), 2mg will show medium knockdown (such as 0.4-0.8log).
Placebo should have minimal effect. We are confident 2mg will be
more clear and tightly dispersed data. The higher 3mg dose is not fully
enrolled and remains ongoing but should be even better. 3mg may not
be “finished” by AASLD but company may “describe” some of the general
blinded data in its update.
Reply · Report Post
Roth Capital affirms TG Therapeutics (Nasdaq: TGTX) at Buy with a price target of $25 following recent discussions with management.
Analyst Joseph Pantginis said TGTX comments indicate significant and impressive cost efficiencies for the upcoming Phase III combination study (under SPA) with TG-1101 and Imbruvica in CLL patients.
Pantginis elaborated, We believe the projected cost for the Phase III study is impressive and believe that TG should have no problems enrolling the study on a timely basis. With patients on both arms slated to receive Imbruvica, we believe this is a compelling hook to enroll as well as the focused and premium physician care patients will receive during the course of the study. We believe TG continues to solidify its place in oncology with what we believe to be differentiated "hot target" drug candidates in TG-1101 and TGR-1202. We also look forward to the disclosure of additional Phase III studies by year end. We believe that TGTX is in control of whether the company wants to partner its products or not. It has already shown the ability to form fruitful alliances such as with Pharmacyclics' (Nasdaq: PCYC) Imbruvica and the ongoing combo study with TG-1101. Management has commented previously that the company would like to hold onto the drugs for as long as possible, and possibly not partner at all. However, given the favorable terms that Infinity (Nasdaq: INFI) secured in the deal with AbbVie (NYSE: ABBV) for its PI3K inhibitor and given TGTX's clinical data to date, we believe TGTX would have significant leverage if it chose to pursue a partnership
http://www.streetinsider.com/Analyst+Comments/Roth+Sees+Significant+and+Impressive+Cost+Efficiencies+in+TG+Therapeutics+(TGTX)+CLL+Combo+Phase+3/9836311.html
CS on TGTX and PCYC tonight
TGTX Pivotal Trial Uses Imbruvica as the
Backbone Therapy in CLL
PCYC's Imbruvica has become the standard of care in its approved indications including relapsed CLL. The TGTX trial would be the first pivotal trial testing the combo of Imbruvica with a "next-generation" CD20 antibody, and could be the second antibody combination with Imbruvica approved in relapsed CLL. We believe this trial is positive for PCYC, and TGTX could be viable strategic combination with PCYC.
¦ TG-1101 (ublituximab) is a next generation CD20 antibody: TG-1101, like Roche's Gazyva, targets CD20 (similar to Rituxan) but has been engineered for added efficacy. Roche has previously reported superiority of a Gazyva based regimen vs. Rituxan in CLL.
¦ SPA offers clear path to approval: FDA has agreed that superiority in overall response for TG-1101 + Imbruvica vs. Imbruvica alone is sufficient for accelerated approval. We believe this should be an easy win and expect data in 2016. Phase I data for this combo is expected at ASH in Dec 2014.
¦ Multiple trials test combos with CD20 antibodies: Imbruvica is being combined with Rituxan-based regimens in pivotal trials for r/r CLL (HELIOS), 1st line CLL (ALLIANCE and ECOG1912), 1st line MCL (SHINE), 1st line DLBCL (PHOENIX), r/r indolent NHL (SELENE), and Waldenstrom's macroglobulinemia (PCYC-1127)
¦ Recent CS publications on Imbruvica publications: (1) Proprietary doc survey predicts robust near-term growth (LINK); (2) Clinical trials of oral lymphoma drugs (LINK).
Mark Schoenebaum, an analyst at ISI who follows Merck closely, says the fracture data Merck reported is in line with the standard of care. But even while there was no statistically significant worsening in cardiovascular events, the placebo arm's ability to do better on atrial fibrillation, stroke, MACE events and deaths would mark this drug for careful scrutiny at the FDA. And even if it is approved with this data, sales could be restricted, as detaling the drug would be made more difficult. Schoenebaum put potential sales at $300 million, well below the bar for success for a company like Merck.
Merck had said earlier that it would file for an approval in the second half of 2014, but that schedule has been delayed again, with a submission planned for some time in 2015. Nevertheless, Merck is maintaining its optimistic outlook on this drug.
"Merck believes the currently available data support a favorable benefit/risk profile for odanacatib," said Dr. Keith Kaufman, vice president of clinical research, diabetes and endocrinology for Merck.
"Despite the important and serious consequences of fractures related to osteoporosis and our ability to identify patients who would benefit from therapy, many patients with osteoporosis are not being treated. There is a need for additional treatment options. The effects of odanacatib on fracture risk from the LOFT study are very encouraging," said Michael McClung, founding director of the Oregon Osteoporosis Center.
Initially Merck had been reluctant to discuss the safety profile for odanacatib when CEO Ken Frazier announced a big delay in the development and regulatory plans for the therapy. A fresh change in the schedule along with hard numbers on stroke will likely only raise fresh questions about the market prospects for this drug, once tapped as a much-needed blockbuster for Merck. But with pembrolizumab gaining a recent breakthrough approval and a closely watched hep C program in late-stage development, Merck doesn't need this one as badly as it once did.
Odanacatib works by inhibiting cathepsin K, an enzyme that plays a key role in bone resorption. Merck investigators detailed the data in Houston on Monday at the annual meeting of the American Society for Bone and Mineral Research.
Ladenberg increases target to 22 from 18 on tgtx
tgtx still one of my favorites LONGTERM Plays
We expect TG
to update the data from the TG-1101 + Ibrutinib study at ASH in December 2014 and
we expect ORR to remain high (at 90%+). We believe TG-1101 will differentiate itself
from other anti-CD20 mAbs (including Ofatumumab, with its superior safety profile and
ease of use, and from Rituximab, with its enhanced ADCC activity) as it could be the
only anti-CD20 mAb approved for use with Ibrutinib in this patient population. When
TG-1101 + Ibrunitib combo is potentially approved for R/R CLL, it would also facilitate
a number of other potential registration combo studies TG is planning for TG-1101 to
gain approval in other indications
We reiterate Buy and increase our price target to $22 from $18. We are impressed
by TG’s ability to reach agreement with the FDA for an SPA with ORR as the primary
endpoint for its pivotal trial of TG-1101 + Ibrutinib vs. Ibrutinib alone and we view this as
a big win. Given our belief there is a relatively high probability for TG-1101 + Ibrutinib
combo (based on the already announced Phase 1/2 data) to meet the ORR primary
endpoint in the SPA agreement with FDA and the expected relatively fast timeline to
top-line data, we have increased our price target to $22 from $18.
Ladenberg increases target to 22 from 18 on tgtx
We expect TG
to update the data from the TG-1101 + Ibrutinib study at ASH in December 2014 and
we expect ORR to remain high (at 90%+). We believe TG-1101 will differentiate itself
from other anti-CD20 mAbs (including Ofatumumab, with its superior safety profile and
ease of use, and from Rituximab, with its enhanced ADCC activity) as it could be the
only anti-CD20 mAb approved for use with Ibrutinib in this patient population. When
TG-1101 + Ibrunitib combo is potentially approved for R/R CLL, it would also facilitate
a number of other potential registration combo studies TG is planning for TG-1101 to
gain approval in other indications
We reiterate Buy and increase our price target to $22 from $18. We are impressed
by TG’s ability to reach agreement with the FDA for an SPA with ORR as the primary
endpoint for its pivotal trial of TG-1101 + Ibrutinib vs. Ibrutinib alone and we view this as
a big win. Given our belief there is a relatively high probability for TG-1101 + Ibrutinib
combo (based on the already announced Phase 1/2 data) to meet the ORR primary
endpoint in the SPA agreement with FDA and the expected relatively fast timeline to
top-line data, we have increased our price target to $22 from $18.
Dew what chances do you give it to be approved??
On twitter @Sphere3D: John Morelli shows how simple it is to containerize Windows apps using Glassware. http://t.co/CyugWKx8DR
CCI
i am thinking one of the best ways for this to happen is soon ANY may do a another small funding with some bigger brokerage names.
all it would take is ONE major upgrade from one of these sale-side analysts to really help with investor awareness??
dough
streaming
have you ever contacted scottrade and asked them why ANY has a extra 45% margin requirment???
curious
dough
I still can't get there. Tell me one more time
Thanks
@pbookman: RT @ForsytheTech: Simplify VDI http://t.co/wx516uguNV >Imagine simple #VDI + simple Application virtualization? What a solution!! @Sphere3D
@dougheuringaria: $gild Sovaldi TRx -1%, NRX -2% w/w
August 29 with total scripts of 6,767, down 1% from last week. New Rx were 2,401, down 2% w/w.
Update on Otezla prescription data: TRx +23%, NRx +21% w/w
Scripts for Celgene's Otezla indicate TRx of 1,139 (up 23% w/w) and NRx of 656 (up
21% w/w) during the week ending August 29. Below, we include a plot of the launch
thus far for Otezla compared to the same period of the launch for Xeljanz. Launch-todate,
Otezla TRx is tracking 80% higher than Xeljanz’s launch, despite the fact that the
Otezla Rx trends exclude titration packs offered to patients to initiate therapy.
TGTX. Ladenberg comments. Target 25
We see this deal as positive for TGTX in terms of the untapped value of its differentiated PI3K inhibitor TGR-1202. The drug is currently in a broad development program, and we believe the drug will enter pivotal studies by the end of the year. TGR-1202 appears to be differentiated from other PI3K inhibitors in that it appears to have a more benign safety profile than others, including no liver toxicity seen to date. Early '1202 data also supports once per day dosing, compared to twice per day for INFI's drug. Recall that at June 2014 medical conferences, investor feedback to '1202 clinical data to date was overwhelmingly positive, by our observation. We believe that TGTX is in control of whether the company wants to partner its products or not. It has already shown the ability to form fruitful alliances such as with Pharmacyclics' (PCYC- Buy) Imbruvica and the ongoing combo study with TG-1101. Management has
1commented previously that the company would like to hold onto the drugs for as long as possible, and possibly not partner at all. However, given the 8.00 favorable terms that INFI secured in the deal with ABBV and given TGTX's clinical data to date, we believe TGTX would have significant leverage if it chose to pursue a partnership.
Action
We reiterate our Buy rating, Focus Pick and $25 price target. We believe that TG is positioning itself strongly with its lead candidate drugs, with the potential to be integrated in the evolving standard of care for B-cell malignancies.
ACAD. Great post by biobetter on IV. He has been right on
BTD
Only 30% of breakthrough drugs applicants get the designation.
Only 3% of the breakthrough drugs fall into the CNS drug category.
FDA must respond within 60 days of the application.
A few months ago ACAD met twice with FDA and imo requested a rolling review submission that was denied.
My wag is the FDA then said submit a BTD application and then we will talk about a rolling NDA submission.
BTD allows for a rolling NDA submittal and we may now see Pima get approved as early as 2Q of 2015.
ACAD. Ladenberg comments.
Pimavanserin Gains Breakthrough Status. In a very rare occurrence for a CNS therapy, Acadia announced yesterday that Pimavanserin (now brand name Nuplazid) achieved breakthrough status from FDA for use in psychosis related to Parkinson's disease. To gain Breakthrough Status, a molecule must demonstrate a substantial and clinically meaningful effect on an important outcome when compared with placebo - Pimavanserin's clinical work has demonstrated such an effect. With this overt endorsement from FDA also likely leading to priority review, we increase our ACAD price target to $28.50 and reiterate our Buy rating.
$354.5 Pimavanserin's US Filing On Track for Late 2014. Only one Phase 3 study appears
necessary for filing in the US for Parkinson's psychosis. This positive and rare occurrence is based on the strength of the 020 study that demonstrated strong, consistent data across a number of metrics. Stability and drug interaction studies are the rate limiting work remaining for the NDA, which the company stated remains on track for year end 2014. With a Priority Review now estimated, we now estimate Pimavanserin's US approval in mid-2015.
EU Filing Seen In 2015. Acadia management recently provided guidance for its EU plans for pimavanserin for the first time, stating that after considerable consultation with EU experts, it will move straight to the filing of a commercial application during 2015. The EU application content is to be similar to the US NDA, with the rate-limiting item being the company's US application. Though this EU strategy carries some risks, we believe the strength of the pimavanserin data can win the discussion in the EU as well; we continue to model international pimavanserin revenue starting in 2017.
Rbc top ideas. Celg gild icpt arwr
Our recent calls: 1) Buy CELG for October Phase II GED-031 Crohn's disease data; we think this data will look better than Humira. Generalists and analysts should start to risk-adjust this into models and think about expected 2018-2020 EPS, and CELG might give impressive 2020 guidance next year...; this is the stock that we think can still "double" theoretically with only $10B in revs now, which could go to $20B over time and GED-031 could be one of the big drugs that gets it there (eg it's hard to see GILD doubling from here...); 2) buy GILD because it trades at 10x '15E EPS and all-oral price should be ~$95k (8wks = $63k); 3) we see BIIB as more range-bound without major events, but buy for 2015 because of potential upside from LINGO in Jan '15 and Tysabri SPMS Phase III in mid-15 (we don't think Street has done enough work yet on Tysabri SPMS); 4) ICPT and ARWR are our top smid-cap long ideas into AASLD and year-end.
Nice post today on TGTX by
Maxim Kreditor, MD (@cancerdocNYC)
9/2/14, 1:53 PM
Responses to anti-CD20 abs in Rituxan/ chemo pre-treated iNHL. TG-1101, Obinatuzumab look best. $TGTX pic.twitter.com/oOXpTAOxXA
grthzgd
sorry to hear about your first hand experience. i also have experienced this first hand in the hospital setting.
its a great day for all PD patients has the lead investigator has already said this is the biggest advancment in PD in 25 years.
from a investment imho acad has still plenty of room on the upside. i like PIMA chances very much in AD which is clearly a lotto call option going forward.
goodluck to us and patients
dough
Jmp on ACAD target 31
Breakthrough designation increases likelihood of priority review status, in our view; reiterate Market Outperform rating and increase price target on ACADIA Pharmaceuticals from $27 to $31. This morning, Acadia announced that the FDA has granted Breakthrough Therapy designation to NUPLAZID (pimavanserin) for the treatment of Parkinson’s disease psychosis. We view this as positive for multiple reasons. First, it reinforces our conviction in the unmet medical need in this indication. Additionally, in our view, this increases the likelihood that the FDA will also grant priority review status for the drug, providing an expedited review timeline of eight months (vs. 12 months for standard review). We continue to expect the company to file the NUPLAZID NDA late in 2014 and, therefore, a PDUFA date could be as early as late August 2015 (putting timelines roughly in line with our model which currently assumes U.S. launch in early 2016). Our $31 price target now reflects YE2015, vs. YE2014 previously, and includes sales of pimavanserin in PDP, as well as in additional indications, and the company's earlier-stage pipeline.
Ims numbers. ARIA: Iclusig TRx/NRx are 108/41, -11%/-2% wk/wk, in week 32 since the January re-launch.
Also from now on if I do see them I will only
Be posting on twitter. Someone else can copy
Here
Goodluck my friends
Dough
@OverlandStorage: Check out our latest @TandbergData RDX Removable #Storage Solutions! New #AccuGuard Enterprise http://t.co/9KJQIQibxR
Impressive. Nice find noogins
Location: Home » Cloud Computing » Sphere 3D Launches Glassware 2.0 — An Appliance for Windows Apps
CLOUD COMPUTING, DESKTOP VIRTUALIZATION, SMB VIRTUALIZATION
Sphere 3D Launches Glassware 2.0 — An Appliance for Windows Apps
Simon Bramfitt Simon Bramfitt on Google+ • August 28, 2014 • 0 Comments
In its first appearance at VMworld, the Mississauga, Ontario–based company Sphere 3D looks poised to create a whole new technology classification with Glassware 2.0, a hyperconverged cloud client app hosting appliance.
When describing something fundamentally new, analogies can be your friend, so think of Glassware as “XenApp, in a box, for dummies!”: “XenApp,” because it’s a Windows client application delivery platform, although with aspirations for more than just Windows applications. “In a box” because it truly is in a box, offered only as a dedicated converged infrastructure appliance. “For dummies!” because, taking a lesson in user-experience management from current-generation cloud platforms, it has done much to hide the power and complexity of the platform behind an easy-to-use web-based management console that, according to Peter Bookman, founder of V3 Systems and now head of global strategy for Sphere 3D, distills the application installation and publishing process down to just six clicks.
Although the parallels with XenApp are obvious, Glassware is not just another Windows Server RDS management and presentation overlay in the same vein as VMware Horizon 6 RDS Hosted Apps, Quest vWorkspace, or even Azure RemoteApp. Sphere 3D founder John Morelli has taken a fresh approach that appears to bear at least a passing resemblance to Bromium’s microvisor-based approach to security that allows a process access to only those resources it needs to run. Glassware was not designed for security; instead, it was designed for performance, with its microvisor controlling access to the underlying Windows Server OS. Exactly how this works, Morelli isn’t saying, although his description of Glassware sitting between the base OS and the application would suggest a Type-II microvisor, if such a taxonomy exists.
In the run-up to VMworld last week, Sphere 3D gave me access to a sandbox environment in which I was able to put Glassware through its paces. The six-clicks-to-publish claim might need revision, depending on when you start counting. I counted three clicks to select the application to install, one click to start the installation process, one to confirm that the installation was done, and two to finally publish the application. Regardless of the number of actual clicks involved, the process was simple: choose the app, run the installer, identify the executable you wish to associate with the published application, and you are done.
Installing a Glassware appliance is, if anything, even easier. Take it out of the box, put it in the rack, plug it in, assign an IP address, optionally authenticate against Active Directory, and take the rest of the day off. You can even configure it to use a DHCP-assigned IP address, if you are looking for bleeding-edge simplicity.
Sphere 3D claims that a single 2U Glassware server can deliver as many as 500 concurrent sessions. This is higher than I would expect for a similarly configured server running raw RDSH sessions. However, I was unable to do any scalability testing on the sandbox. Glassware’s microvisor-based segmentation of user processes and application installation mechanism meant that I was unable to use Login VSI, the de facto standard for benchmarking hosted apps and desktops, to compare Glassware’s performance with that of other, more conventional RDSH solutions. And without independent performance testing, all numbers are open to challenge. That being said, Glassware is fast. When I connected via cable modem from home to a Glassware server over 2,000 miles away in Mississauga, new sessions launched nearly instantaneously. Moreover, Sphere 3D’s RDP-based remoting protocol performed well enough not to draw attention to itself as something significantly lacking in comparison to Citrix’s HDX, at least when accessing a range of office applications.
Glassware didn’t offer the same snappy user experience that Citrix HDX achieves for viewing fullscreen HD video. It wasn’t clear how much of this was a limitation of the platform, display protocol, or network connection, although the display protocol appears to be tuned for fidelity over throughput, with playback speed suffering at the expense of maintaining lossless quality. One of Sphere 3D’s first customers has been Novarad, which is using Glassware to power its NovaGlass radiology image-viewing system, for which lossless image display is essential.
Hyperconverged infrastructure appliance as a VDI delivery platform is nothing new, and indeed, it is an area in which Sphere 3D has acquired some expertise. Sphere 3D last year acquired V3 Systems, one of the first to recognize that the VDI IOPS challenge is perhaps best addressed through a well-balanced hardware appliance that eliminates the need for complex hypervisor or Flash SAN-based IOPS accelerators. Taking the converged infrastructure approach to old-school application hosting, however, is new, and it brings with it both opportunities and challenges, not least of which is the question,
“Is there a market?”
Dedicated-function plug-and-play appliances are invading data centers everywhere. You can’t swing a cat at VMworld this week without taking the risk of maiming someone touting the benefits of hyperconverged somethings. From this perspective alone, there should be some degree of opportunity for Sphere 3D. However, that’s by no means all of the story. When Kaviza launched VDI-in-a-Box, its simple scale-out architecture was immediately hailed by many as “VDI done right,”—so much so that Citrix was compelled to step in and acquire Kaviza, if only to keep the genie in the bottle. Glassware shares this simple scale-out architecture. Start with one server (two and a load balancer if you need high availability). Then to increase capacity, just add more servers wherever you need them. Each server can perform management and connection-brokering services as well as being a session host. At the same time, Glassware supports siloing of apps into groups of appliances, if warranted to improve manageability in larger, more complex environments.
Aside from its being a hardware appliance, it is its inherent simplicity that is Glassware’s first key differentiator. Provided you know how to plug in a network cable and assign an IP address, you can install a Glassware appliance. If you know how to install a Windows app, then installing and publishing an application on Glassware shouldn’t present any problems. In short, with Glassware, anyone can manage their own enterprise-class application hosting environment.
Glassware’s other big differentiator is its flexibility in distributed and hybrid cloud deployments. Building a multi–data center application hosting service requires advanced knowledge of both the core RDSH platform and external load balancing services to ensure connection requests are routed to the most appropriate server. Morelli’s approach with Glassware is to allow the customer to place servers wherever they are needed—be that in the cloud, a data center, or a branch office—and have the software take care of the rest.
Glassware looks to be a good fit for almost any organization that recognizes it needs an RDSH-style application hosting solution but is unwilling to take on the complexity of current-generation solutions. ISVs looking to take their shrink-wrapped software and deliver it as SaaS may also find Glassware attractive, especially in environments where the customer is looking for SaaS pricing and management, but with the performance and availability assurances that an on-premises deployment can bring. Glassware can’t challenge XenApp in terms of its ability to address the edge cases of enterprise application delivery, which is where XenApp excels, and there’s no VDI component to Glassware, which could be a big mark against it with some potential customers. Sphere 3D has chosen VMworld as the venue at which to relaunch the V3 developed VDI appliance and Desktop Cloud Orchestrator software, which, if memory serves, was a contender for Best of VMworld a couple of years back However, as yet, neither product appears to integrate with the other.
As attractive as it is, Sphere 3D has some major challenges to overcome before its success is assured. Twenty years after Citrix was founded, software vendors still push back when it comes to supporting their desktop apps on a server OS. This problem will be doubly acute for Sphere 3D with its unique approach to application hosting, and it is one that will require careful management to address. However, while Sphere 3D’s approach to application hosting may be new, the challenges it faces are not. Sphere 3D is readying a vendor certification program to allow ISVs to self-certify their applications for use on Glassware—something that took Citrix many years to address. With this in place, the tight control that Sphere 3D has over the Glassware platform should help facilitate identification and resolution of any compatibility issues as they are uncovered.
Amongst the many thousands of products on display at VMworld 2014, all but three were no more than incremental updates to established products. CloudVolumes, while not strictly debuting this year, will create major opportunities, especially when it grows out of its EUC launch platform and takes over in the data center and cloud. The NVDIMM technology that SANdisk demoed will launch a new generation of hyperconverged platforms an order of magnitude faster than current SSD on PCI implementations. And Glassware, a hyperconverged app hosting appliance, makes enterprise-class web-scale application hosting available to everyone.
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Simon Bramfitt (123 Posts)
Simon is an independent industry analyst covering enterprise desktop, mobile and application virtualization, delivery and management technologies.
He is an experienced solutions architect with unmatched insight into the challenges of designing large (200,000 seat plus) high availability presentation and desktop virtualization systems.
Simon was invited to join the Citrix Technology Professionals (CTP) group in May 2010 and joined the Virtualization Practice in September 2010
Connect with Simon Bramfitt:
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Budget VDI Leader NComputing Joins DaaS Party
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Boogins link please I don't see it
Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle
Posted 27 August 2014
By Alexander Gaffney, RAC
The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug.
Background
Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA).
In February 2014, DEA released a rule which proposed classifying suvorexant as a Schedule IV drug based on an eight-factor analysis conducted by FDA. That analysis had determined that the drug, which works by reducing wakefulness, could be abused in a manner similar to other sedatives such as Ambien (zolpidem), which is also a Schedule IV drug.
Under the CSA's rating system, Schedule IV drugs are those with a low but present potential for abuse, a clear medical use and minimal health effects associated with abuse of the drug. The classification means that refills on the drug will be limited so as to limit abuse, and the drug will be subject to tighter labeling, registration, packaging and other requirements.
As Focus explained at the time, the timing of DEA's scheduling decision could actually be construed as positive for Merck. Other companies, such as Arena Pharmaceuticals, have described the DEA scheduling process as a regulatory "black hole" after their FDA-approved drugs were put on hold pending a final DEA scheduling decision.
Without receiving final approval from DEA, a drug isn't allowed to be marketed—something some legislators are now attempting to fix.
Final Scheduling
Now DEA has given its final and widely expected approval to Merck to market its drug under the Schedule IV controls of the CSA.
In a 27 August 2014 final rule, DEA said it had placed suvorexant, "including its salts, isomers and salts of isomers" into Schedule IV of the CSA.
"This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle suvorexant," DEA said.
The final rule will go into effect in 30 days, at which time Merck will be allowed to market the drug. FDA's approval notice for Belsomra had already described the drug as a Schedule IV substance.
In a 13 August 2014 statement, Merck said it expects the drug to be available in "late 2014 or early 2015."
DEA Notice
- See more at: http://www.raps.org/Regulatory-Focus/News/2014/08/27/20134/Mercks-Insomnia-Drug-Belsomra-Clears-Final-DEA-Hurdle/#sthash.o7fwNUYw.dpuf
Interesting. Blueblizzy?? Comments
http://blogs.vmware.com/euc/2014/08/vmware-nvidia-google-working-together-deliver-graphics-rich-applications-enterprise-cloud-desktops.html
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VMware, NVIDIA and Google Collaborate To Deliver Graphics Rich Apps To Enterprise Cloud Desktops
Posted on August 26, 2014 by Louis Cheng
Leave a reply
By Pat Lee, Sr. Director, Remote Experience
Today, I am very excited to share how VMware, NVIDIA and Google are working together to deliver graphics rich applications to enterprise cloud desktops.
The result of our collaboration to date is two key technology previews that we are showing at VMworld 2014.
First, we are showing a technology preview of NVIDIA GRID™ vGPU™ on the VMware platform which will bring rich 3D applications to VMware Horizon and Horizon DaaS.
Second, I am excited to announce a technology preview with Google and NVIDIA to deliver rich workstation level graphics and user experience to Chromebook users.
NVIDIA GRID vGPU: Sharing the Power of Rich 3D to Horizon Desktops
Earlier this year at the GPU Technology Conference, VMware announced our intention to collaborate with NVIDIA to bring GRID vGPU to VMware products and today we are showing off our joint collaboration efforts with a technology preview of GRID vGPU running on VMware products.
NVIDIA GRID vGPU is exciting technology that allows multiple virtual machines to share the power of a single GPU to deliver rich 3D graphics and high performance video. Combined with VMware Horizon, together NVIDIA and VMware will be able to deliver the highest end 3D applications to the most demanding users in design, manufacturing, and engineering.
If you need to deliver high-end 3D graphics with secure remote desktops, you will want to try NVIDIA GRID vGPU with VMware Horizon.
Today, we are also announcing a early access program that be available for select NVIDIA and VMware customers in Q4 2014. Sign up today to be considered for trying out NVIDIA GRID vGPU with VMware products at www.nvidia.com/grid-vmware-vgpu.
Now Deliver Rich Graphics Applications to Chromebooks
Building on the foundation of NVIDIA GRID vGPU in the datacenter to enable rich graphics applications to VMware Horizon desktops, we have partnered with Google and NVIDIA to deliver those rich graphics applications to Chromebook users.
Enterprise customers are using Chromebooks for an affordable, mobile device to access the applications they need. With the new generation of Chromebooks like the Tegra K1 powered Chromebooks, rich graphics is now available to more devices than ever.
We are excited to show off a technology preview of the next generation of VMware Blast Performance to deliver high-performance virtual desktops with workstation-class graphics applications on the latest Chromebooks. Checkout the video below.
We are excited to about the possibilities for the future of the Enterprise Cloud Desktop with our collaboration with NVIDIA and Google.
Seeing is believing, so come by the VMware and NVIDIA booths at VMworld 2014 to see the future of rich graphics applications delivered from the cloud to the devices you want to use.
This entry was posted in VMware Horizon, VMware Horizon DaaS on August 26, 2014 by Louis Cheng.
Whoaaaa. Did you all see this tweet. Now were talking
@michael_keen: #VMWorld2014 how about moving those "traditional apps" off of vSphere all together? Virtualize them differently w/ Glassware from @Sphere3D
More from RBC
VMware, Inc.
Highlights From VMware Analyst Day
Our view: In addition to several new product announcements, the key take-away from VMware's analyst day is that FY/15 revenue is expected to grow in the mid-teens with operating margin expansion of up to 100bps. While this is in-line with our expectations and likely represents a base- case scenario, sentiment had been that revenue guidance could come in below 15%, thus we view the guide as a positive. Maintain Outperform, $120 price target.
Key points:
VMware hosted an analyst day in conjunction with its user conference with over 22,000 attendees. The long-term strategy remains focused on hybrid cloud, end-user computing and SDDC, fortified by new partnerships and products. Overall we feel management did a good job outlining the opportunity which has advanced significantly over the past 12 months and now addresses a TAM at over $60B by 2017. We think the company has made significant progress with NSX, and were encouraged by the vSAN 2.0 beta and vSphere 6, scheduled to be released next year. Maintain Outperform and $120 price target.
Initial thoughts on FY/15:
FY/15 revenue growth was guided to mid-teens vs. RBC at 15.8% and consensus of 15.6%, while operating margins are expected to expand up to 100bps vs. RBC at 100bps. Going into the analyst day, sentiment had been that guidance could come in to reflect revenue growth below 15%. Thus, we view guidance as better-than-expected, essentially in-line with our expectations. Our sense is that this reflects more of a base-case scenario vs a stretch goal as we view upside as likely. A more detailed look into FY/15 is expected to be provided on the Q4/14 conference call in late January.
No longer talking to long-term guidance:
The company is no longer talking to its previously discussed longer- term growth targets. We believe these targets were provided at a time when few thought the company could grow at such a pace. Since then, the company has met or exceeded expectations. To us, the targets had become an overhang that bears rallied around. Importantly, the company still feels good about the longer-term growth outlook, which is easier to see at this point.
Non-standalone vSphere really starting to drive growth:
The company did a good job of outlining non-standalone vSphere products, which are really starting to drive growth. These products accounted for >50% of license bookings in Q2/14, up from ~20% in Q2/11. The two to three year goal is for this percentage to move to the 80%+ mark. Drilling down into license bookings, hybrid cloud grew ~80%, EUC grew >50% and SDDC grew >40% in Q2/14. Essentially, >50% of license bookings are now growing >50% while the balance is still growing at a reasonable level.
@michael_keen: #VMWorld2014 how abt the user who maxes out the resources & needs more? Dynamic movement 2 new desktop & then back again w/ @Sphere3D
Are competition. August 26, 2014
12:32 EDT VMW, EMC VMware slips after updating 2015 guidance at analyst day
Following VMware's (VMW) analyst day meeting, held yesterday afternoon, two research firms issued differing takes on the company's updated fiscal 2015 guidance. BULLISH TAKE: VMware's guidance for revenue growth in the mid teens percentage level and margin expansion of up to one percentage point is positive, RBC Capital analyst Matthew Hedberg wrote today. Although Hedberg said the guidance was in-line with his expectations, investors felt that the company's revenue growth guidance could come in below 15%, the analyst stated. He maintained a $120 price target and Outperform rating on the shares. BEARISH TAKE: Gregg Moskowitz, an analyst at research firm Cowen, wrote today that VMware's FY15 revenue guidance would "likely weigh modestly" on the stock, even though he was not surprised by the outlook. However, VMware continues to be well-positioned for growth, as it is benefiting from several trends, including accelerating infrastructure expansion and the adoption of virtualization by small and medium businesses, Moskowitz believes. Additionally, VMware estimated that its total available market would reach more than $60B in 2017, versus its estimate last year of a $50B+ total addressable market by 2016, Moskowitz noted. He kept an Outperform rating on the shares. WHAT'S NOTABLE: On August 8, research firm Pacific Crest said a survey it conducted indicated that VMware could have an increasing role in both core virtualization and cloud services. The firm said that it had an upward bias to its second half estimates for VMware and kept an Outperform rating on the shares. PRICE ACTION: In early afternoon trading, VMware fell 3% to $97.70. EMC (EMC), which holds an 80% stake in VMware, lost 0.5% to $29.52.
In a couple of years this may be us???
News Breaks
August 26, 2014
07:54 EDT VMW VMware guidance positive, says RBC Capital
After VMware said that it expected its FY15 revenue to grow by mid-teen percentage levels, RBC Capital says that sentiment expected revenue growth guidance to come in below 15%. As a result, the firm views the guidance positively. It keeps a $120 price target and Outperform rating on the shares.
News For VMW From The Last 14 Days
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August 26, 2014
08:03 EDT VMW VMware guidance cut will weigh on stock, says Cowen
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07:54 EDT VMW VMware guidance positive, says RBC Capital
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August 25, 2014
12:04 EDT VMW VMware, VCE expand cloud strategic partnership
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08:06 EDT VMW Gigamon collaborates with VMware
Gigamon (GIMO) announced a collaboration with VMware (VMW) to extend Gigamon's visibility and monitoring solutions to support the software-defined data center. Gigamon will work with VMware to enable mutual customers to maximize previous investments in network, application and security monitoring tools as they virtualize their networks with the VMware NSX network virtualization platform.
RBC ups target on gild
Gilead Sciences
Next-gen HIV pill data coming, should look good; increase confidence in HIV "tail"
Our view: Extended TAF (son-of-Viread) Phase II data coming up at ICAAC in Sept and Phase III data on track to read-out in next month. We predict TAF results to be solid and increase investor comfort in the sustainability of GILD's HIV tail. Thus, we increase our price target to $115/share based on 13.5x (from 12x) on our 2015E EPS.
Key points:
Investors have been highly focused on Hep C but we remind investors that GILD's HIV franchise is also a $10B+ giant and we think the tail is longer than investors are currently modeling. We believe Phase III data for its next-gen HIV pill TAF should look good and further increase long- term visibility.
Aria. IMS. Hi all. Dough
ARIA: Iclusig TRx/NRx are 121/42 in week 31 since the January re-launch.
FDA asked ARIA to suspend marketing/sales of Iclusig late last year, and it was re-launched during the 3rd week of January. Previously restricted volume for Iclusig was just released this week.
Week 31 of the initial launch (ending on 8/2/13) saw comparable TRx/NRx of 118/53.
DB gild. IMS
Gilead Sciences {Ticker: GILD.OQ, Closing Price: 102.27 USD, Target Price: 142.00 USD, Recommendation: Buy}
IMS recently released Sovaldi scripts for the week ended 8/15 and our calculations, adjusted for capture rate, indicate US 3Q’14 sales at $2.11-2.17B (demand only). Gilead noted on their quarterly call that they are beginning to see some warehousing for the all oral regimen (approval expected early Oct). This represents ~19-22% decline over 2Q’14 US sales of $2.7B (US). Consensus for 3Q is $2.4B. This week’s reported NRx down 3% at 2509 this 2582 last. Total scripts were down 2% at 6751 this wk vs. 6898. This figure does not include wholesale inventory. These Sovaldi trends are still early in the launch, as we just have 36 wks of scripts. Please ask for our Sovaldi calculator. (Please see below for key assumptions for our analysis.)