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Halozyme -- I think the revenue estimates are too low for 2015 and for the rest of 2014. My prediction is that they will be profitable in 2015
http://finance.yahoo.com/q/ae?s=HALO+Analyst+Estimates
Why do I think the revenue estimates are low?
1. Roche provided some details on their conference call. Sweden, Denmark, UK have already switched 50% over to the Sub cutaneous versions.
https://d3j5vwomefv46c.cloudfront.net/photos/large/861292128.jpg?1406183721
2. Roche's patent expired on July 28th for IV Herceptin and there will be generic competition. So, they are eager to switch over 100% of the users to the SC versions to get premium pricing.
http://www.medscape.com/viewarticle/817812
3. Funding / Insurance issues behind SC Mabthera in the UK has been resolved. So that should help with acceleration of the switch.
http://www.pharmatimes.com/Article/14-08-05/Roche_s_MabThera_SC_to_be_funded_on_NHS.aspx
http://www.news-medical.net/news/20140806/Blood-cancer-patients-in-the-UK-can-now-benefit-from-Roches-MabThera-SC.aspx
4. Hyqvia US revenues were not included in these estimates. Now it is a possibility with a most likely approval in Sep 2014.
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So with 3 drugs in Europe, 1 in the US (most likely) and more to follow in the US (Roche will try to get their Sub Cutaneous versions of Herceptin and Mabthera approved here now after the likely approval of Baxter's Hyqvia) and other drugs in partnerships with Roche and Pfizer, the royalty stream is likely to keep getting bigger.
Also, their Diabetes and Pancreatic cancer programs seem interesting
Institutions own a very high percentage of HALO stock and they are increasing their positions.
http://www.nasdaq.com/symbol/halo/institutional-holdings/new#ixzz39l9mRwbB
http://finance.yahoo.com/q/mh?s=HALO+Major+Holders
The short interest is at the highest levels ever at 17 million.
http://www.nasdaq.com/symbol/halo/short-interest
If Halozyme does a beat and raise then the shorts should cover here. If not, they won't give up easily.
Frankly I don't know why they are still here with Baxter's Hyqvia likely approval coming and the clinical hold being lifted on their pancreatic cancer drug and with Roche indicating good numbers in the switch to SC Herceptin. Maybe some of them have covered in the last week. It is unlikely as the stock has gone nowhere with all the good news.
PS: Thanks to Fezziwig2008 for some of the links. She seems to only follow HALO, so she knows a lot about HALO.
http://www.forbes.com/sites/davidkroll/2014/08/07/fda-moves-on-tekmiras-ebola-drug-while-sareptas-sits-unused/
FDA Moves On Tekmira's Ebola Drug While Sarepta's Sits Unused
Sarepta's Ebola program getting more coverage. I don't think this would have happened if Sarepta hadn't spoken about it.
Maybe Ebola is what it takes for Sarepta's shorts to start covering?
Maybe there will be pressure on the DOD to restart the Sarepta Ebola and Marburg programs.
In the congressional hearing on Ebola yesterday there was repeated mention of Marburg too. There seems to be a sense of urgency now to make sure that we are protected for all viral hemorrhagic fevers.
http://www.theflyonthewall.com/permalinks/entry.php/CLVSid2053695/CLVS-Clovis-price-target-raised-to--from--at-Piper-Jaffray
Clovis price target raised to $100 from $87 at Piper Jaffray
Piper Jaffray raised its price target for Clovis shares to $100 saying the company's clinical development programs are progressing well, with strong enrollment indicated for rociletinib and rucaparib trials. Piper reiterates an Overweight rating on the stock.
The stock has sold of from 90+ to 36 yesterday. Looks like it might be a good time to get into it?
Adam made a complete ass of himself this week (so what else is new?) -- he seems to have no clue how bad this Ebola situation is worldwide.
He first put down TKMR causing it to crash from around 17 back to 13 on Monday after this article. I was upset since I had a lot of shares and lot of Aug/Sep calls. I used that drop to 13 to load up on more calls. So, I guess I have to thank him for that
http://www.thestreet.com/story/12831845/1/the-tekmira-ebola-trade-may-already-be-over.html?puc=yahoo&cm_ven=YAHOO
His tweets yesterday after the hold was changed to a partial hold were downright idiotic. I guess he was trying to defend his earlier idiotic call.
https://twitter.com/adamfeuerstein
Now he is giving the Sarepta shorts more ammunition with another idiotic article. I think Sarepta did the right thing in announcing that they have some Ebola treatments. So what if he announced it on TV? People all over West Africa are asking for treatments. The more people are aware of it, the better. So, CG is putting pressure on the DOD to restart their Ebola / Marburg program. Any smart CEO should do that.
http://www.thestreet.com/story/12835746/1/sarepta-should-shut-up-about-ebola-focus-on-job-no-1.html?puc=yahoo&cm_ven=YAHOO
Tekmira halted. Hope it is the lifting of the clinical hold or an Alnylam buy-out for $40
https://twitter.com/search?f=realtime&q=%24TKMR&src=ctag
Sarepta Ready to Provide Ebola Drug if Needed
Wow! CG stepping up. Nice article in Barrons (published at 7:05 pm -- sending the stock up to 22.5 after hours). So, first Mapp and now Sarepta being aggressive while TKMR is in hiding (or at least it appears that way for now). Only this time I am not complaining if SRPT does benefit from this
http://online.barrons.com/news/articles/SB50001424053111904329504580072041992787302
U.S. FDA says 'stands ready' to work with companies developing Ebola drugs
http://www.reuters.com/article/2014/08/02/us-health-ebola-fda-idUSKBN0G201I20140802
U.S. FDA says 'stands ready' to work with companies developing Ebola drugs
http://www.reuters.com/article/2014/08/02/us-health-ebola-fda-idUSKBN0G201I20140802
Wow! From 9 to 14.6 in a week. I will take it
I got lucky as I had bought some Aug $12.5 calls for 0.25 and some Sept $12.5 calls for 0.65 cents last week (and a whole bunch of the Aug/Sep $7.5 and $10 calls when it was at 9 last week)
jq1234, Thanks again for your feedback. I always appreciate it!
Now let us see if I can get something to rescue my underwater calls in MNTA soon
It is mind boggling that HALO finished lower today than it was before the approval.
Roche's earnings call seemed to indicate that SC Herceptin was doing great with many European countries already switching over in more than 50% of the cases.
I bought more today on the drop. Seems to be de-risked more here. I am guessing that is quite unlikely that the FDA will go against a 15-1 vote.
Can't wait for the HALO earnings call. HALO went to 18 before the Adcom vote and before the Mabthera approval. Now post Hyqvia AdCom and post Mabthera launch it is trading at 9? I just don't get it.
Maybe I should just buy TWTR. It jumped what 40% because of a 1 cent beat?
This can't be good. Should they be in quarantine for 21 days before allowing them to get back to the US?
http://www.news-record.com/news/local_news/article_6f6074c4-1786-11e4-974b-0017a43b2370.html
Two North Carolina-based missionary groups have ordered the evacuation of their non-essential personnel from Liberia after a doctor and a missionary contracted Ebola.
..
Spokesman Palmer Holt said approximately 60 employees will be evacuated. A statement from SIM says none of the evacuees is displaying any symptoms of Ebola, but all are being monitored continually.
A Texas-trained doctor and a missionary from Charlotte have contracted the disease
This can't be good. Should they be in quarantine for 21 days before allowing them to get back to the US?
http://www.news-record.com/news/local_news/article_6f6074c4-1786-11e4-974b-0017a43b2370.html
Two North Carolina-based missionary groups have ordered the evacuation of their non-essential personnel from Liberia after a doctor and a missionary contracted Ebola.
..
Spokesman Palmer Holt said approximately 60 employees will be evacuated. A statement from SIM says none of the evacuees is displaying any symptoms of Ebola, but all are being monitored continually.
A Texas-trained doctor and a missionary from Charlotte have contracted the disease
Why Ebola reaching Nigeria’s largest city is a whole new level of scary
http://qz.com/241241/why-ebola-reaching-the-nigerian-capital-is-a-whole-new-level-of-scary/
Nigeria’s health minister says authorities are currently trying to track down an unspecified number of the 100 or so other passengers on the flight.
This might be tricky. The 35 Nigerian co-passengers took flight once word got out that the health ministry was supposed to have quarantined them, prompting the federal government to launch a manhunt to track them down, reports Sunday Newswatch, a Nigerian newspaper, citing a federal security agent.
....
Given that deadly efficiency, the fact that at least 35 people who might have been exposed are at large in Lagos—to say nothing of the other passengers arriving from infected areas of West Africa—is disquieting as well. Confined by geography, the built-up areas of metropolitan Lagos now have more than 20,000 people per square kilometer (53,000 per square mile)—about the same urban density as Dhaka or Mumbai. It has among the highest prevalence rates of open defecation of all major African cities, as well as some of Africa’s lousiest healthcare infrastructure.
Why Ebola reaching Nigeria’s largest city is a whole new level of scary
http://qz.com/241241/why-ebola-reaching-the-nigerian-capital-is-a-whole-new-level-of-scary/
Nigeria’s health minister says authorities are currently trying to track down an unspecified number of the 100 or so other passengers on the flight.
This might be tricky. The 35 Nigerian co-passengers took flight once word got out that the health ministry was supposed to have quarantined them, prompting the federal government to launch a manhunt to track them down, reports Sunday Newswatch, a Nigerian newspaper, citing a federal security agent.
....
Given that deadly efficiency, the fact that at least 35 people who might have been exposed are at large in Lagos—to say nothing of the other passengers arriving from infected areas of West Africa—is disquieting as well. Confined by geography, the built-up areas of metropolitan Lagos now have more than 20,000 people per square kilometer (53,000 per square mile)—about the same urban density as Dhaka or Mumbai. It has among the highest prevalence rates of open defecation of all major African cities, as well as some of Africa’s lousiest healthcare infrastructure.
HALO Briefing Docs
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM407013.pdf
Any opinion on this? What are the chances of a positive ADCOM vote?
Thanks.
Ebola outbreak: Is it time to test experimental vaccines?
http://www.cnn.com/2014/07/25/health/ebola-outbreak-experimental-vaccines/index.html
(CNN) -- Ebola virus disease is sweeping across West Africa in the largest outbreak of the virus to date. Mortality rates are currently at 60% in a disease where up to 90% of infected people can die. But despite this lethality there remain no licensed treatments or vaccines available, nearly 40 years after the disease was first discovered.
...
It is too late in this outbreak for vaccines to have enough of a preventative impact, but Ebola will emerge again in the future. If safety can be proven, the stockpiling of vaccines could improve the outcome of future outbreaks.
"Vaccines enable a preparative framework to be established rather than a reactive one," explains Heymann. "But firstly it must be shown to be safe in humans."
The ability to control future epidemics may depend on it.
----------------------------------
This current outbreak seems to be getting out of control pretty quickly. Does anybody think that
-- The FDA may/will be forced to remove the clinical hold on the TKM_Ebola trials sooner than later?
-- TKMR's chances of getting recurring revenues every year for the stockpiling of the Ebola vaccine just went up significantly?
Wow! News from Ohad. Hope he stays safe. What an incredible Biotech resource he is.
http://www.orf-blog.com/clovis-oncology-still-a-long-term-core-holding/
AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for New Drug Application for Zalviso
http://ih.advfn.com/p.php?pid=nmona&article=63039797&xref=newsalerttweet&adw=1126416
I guess that kills any possible run-up in HALO for the 7/31 ADCOM.
Nigeria confirms Liberian man died of Ebola in Lagos
http://news.yahoo.com/liberian-ebola-symptoms-dies-nigeria-official-132822550.html
--------------
Now Africa's most populous city (Lagos) might have a suspected Ebola patient
http://www.voanews.com/content/lagos-awaits-lab-results-for-suspected-ebola-patient/1965065.html
Lagos Awaits Lab Results for Suspected Ebola Patient
Ebola outbreak -- Could the WHO approach the FDA / TKMR?
Things are getting out of control if Tyler Durden (Zero Hedge) has to start talking about it
http://www.zerohedge.com/news/2014-07-25/ebola-victim-run-west-africa-capital
Ebola Victim On The Run In West Africa Capital (Sierra Leone's capital Freetown)
http://www.zerohedge.com/news/2014-07-23/head-doctor-fighting-africas-out-control-ebola-epidemic-contracts-virus
Head Doctor Fighting Africa's "Out Of Control" Ebola Epidemic Contracts The Virus
Now Africa's most populous city (Lagos) might have a suspected Ebola patient
http://www.voanews.com/content/lagos-awaits-lab-results-for-suspected-ebola-patient/1965065.html
Lagos Awaits Lab Results for Suspected Ebola Patient
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I grabbed a lot of shares / calls in the 9-9.50 range last week (after picking up my first batch of shares in the 15-18 range).
What is the likelihood that something can be worked out between the WHO / FDA and TKMR to provide some kind of treatment.
So far, the WHO has had their head in the sand and the FDA is working at a glacial pace, totally oblivious of what is going on in Africa with the current outbreak.
Ebola outbreak -- Could the WHO approach the FDA / TKMR?
Things are getting out of control if Tyler Durden (Zero Hedge) has to start talking about it
http://www.zerohedge.com/news/2014-07-25/ebola-victim-run-west-africa-capital
Ebola Victim On The Run In West Africa Capital (Sierra Leone's capital Freetown)
http://www.zerohedge.com/news/2014-07-23/head-doctor-fighting-africas-out-control-ebola-epidemic-contracts-virus
Head Doctor Fighting Africa's "Out Of Control" Ebola Epidemic Contracts The Virus
Now Africa's most populous city (Lagos) might have a suspected Ebola patient
http://www.voanews.com/content/lagos-awaits-lab-results-for-suspected-ebola-patient/1965065.html
Lagos Awaits Lab Results for Suspected Ebola Patient
-------
I grabbed a lot of shares / calls in the 9-9.50 range last week (after picking up my first batch of shares in the 15-18 range).
What is the likelihood that something can be worked out between the WHO / FDA and TKMR to provide some kind of treatment.
So far, the WHO has had their head in the sand and the FDA is working at a glacial pace, totally oblivious of what is going on in Africa with the current outbreak.
http://www.nasdaq.com/symbol/mnta/after-hours
472k block after hours at 10.99;
Damn! It is not easy being a SRPT investor!
http://www.sec.gov/Archives/edgar/data/873303/000119312514277845/d763233d8k.htm
HALO / Roche Herceptin update: From Roche's earnings call
Herceptin Subcutaneous deliveries: Fast adoption in vast majority of countries
Herceptin SC OVER 50% of the Market in UK, Denmark, and Sweden
Herceptin SC between 40-50% of the Market in Chile, Finland, Austria, Norway
https://d3j5vwomefv46c.cloudfront.net/photos/large/861292128.jpg?1406183721
Looks like some nice royalties will start coming in. Maybe Manthera's adoption will be equally good?
Credit Suisse on Clovis
http://online.barrons.com/news/articles/SB50001424053111904255004580037790574691662
Renaissance Avoided More Than $6 Billion Tax, Report Says
http://www.bloomberg.com/news/2014-07-21/renaissance-avoided-more-than-6-billion-tax-report-says.html
FDA Commissioner Hamburg's husband works for these crooks at Renaissance.
ARWR data
Anybody here long ahead of this? (I guess mcBio). Anybody just playing this with Calls? What strike price / expiration month?
Thanks
Every Day Counts: Teva Responds to Formal FDA Request for Citizen Petition On Copaxone
http://www.pharmamedtechbi.com/publications/rpm-report/first-take/2014/5/every-day-counts-teva-responds-to-formal-fda-request-for-citizen-petition-on-copaxone
Every Day Counts: Teva Responds to Formal FDA Request for Citizen Petition On Copaxone
http://www.pharmamedtechbi.com/publications/rpm-report/first-take/2014/5/every-day-counts-teva-responds-to-formal-fda-request-for-citizen-petition-on-copaxone
ENTA downgraded; $50 price target removed
http://www.theflyonthewall.com/permalinks/entry.php/ENTAid2033809/ENTA-Enanta-downgraded-to-Market-Perform-from-Outperform-at-JMP-Securities
Enanta downgraded to Market Perform from Outperform at JMP Securities
JMP Securities downgraded Entana (ENTA) given the unlikelihood of an acquisition by AbbVie (ABBV), now that its pursing Shire (SHPG), and increased competition in the HCV space.
http://www.streetinsider.com/Downgrades/JMP+Securities+Downgrades+Enanta+Pharmaceuticals+%28ENTA%29+to+Market+Perform/9640459.html
JMP Securities downgraded Enanta Pharmaceuticals (NASDAQ: ENTA) from Market Outperform to Market Perform and removed its price target (prior $50).
ENTA downgraded; $50 price target removed
http://www.theflyonthewall.com/permalinks/entry.php/ENTAid2033809/ENTA-Enanta-downgraded-to-Market-Perform-from-Outperform-at-JMP-Securities
Enanta downgraded to Market Perform from Outperform at JMP Securities
JMP Securities downgraded Entana (ENTA) given the unlikelihood of an acquisition by AbbVie (ABBV), now that its pursing Shire (SHPG), and increased competition in the HCV space.
http://www.streetinsider.com/Downgrades/JMP+Securities+Downgrades+Enanta+Pharmaceuticals+%28ENTA%29+to+Market+Perform/9640459.html
JMP Securities downgraded Enanta Pharmaceuticals (NASDAQ: ENTA) from Market Outperform to Market Perform and removed its price target (prior $50).
IMGN sell of on Morgan Stanley's bearish call. Sold off from 13.7 to 11.60 today. Anybody interested in IMGN at these levels?
https://finance.yahoo.com/news/shares-immunogen-down-morgan-stanleys-122612608.html
Citing “no upside driver beyond Kadcyla,” Morgan Stanley initiated coverage on ImmunoGen (NASDAQ: IMGN) with an Underweight rating and $10 price target
In the best case scenario, Morgan Stanley analyst Matthew Harrison sees Kadcyla capturing 50 percent of the market. Further, “We model Kadcyla with $6B in peak sales and $8/share in value (NOLs offset Kadcyla taxes until 2023).
...
Harrison is more bearish on ImmunoGen’s pipeline. He puts a $0 value on the proprietary pipeline and $2 per share value on the partnered pipeline.
Hmm! $6B in peak sales and price target of $10?. This doesn't make any sense!
IMGN was one of the six in Ohad's watch list.
http://www.orf-blog.com/6-stocks-on-my-watch-list/
http://seekingalpha.com/news/1829395-teva-files-a-citizen-petition-regarding-approvability-of-generic-versions-of-copaxone?uprof=45
Teva files a citizen petition regarding approvability of generic versions of Copaxone
In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
Teva is doing everything it can to hold on. Looks like Citi's call that Copaxone approval won't happen until the end of the year is looking more and more reasonable.