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NKTR / BMY:
PIVOT-02 Slides
http://www.nektar.com/application/files/8115/1042/7902/SITC2017_-Oral_Session_207_-_PIVOT-02_-_Adi_Diab-preso.pdf
Oral Session Ongoing
(Investor) Webcast 6:15 (ET):
https://edge.media-server.com/m6/p/cn2rdud9
Seeking Alpha Article https://seekingalpha.com/article/4123549-clinuvel-high-cash-returns-catalysts-growth-lined
I posted there and referenced this board
NKTR
A couple of the posters are out.
http://www.nektar.com/application/files/1315/1033/7352/NKTR-214__2017SITC_Poster-P77.pdf
Here is a very interesting one NKTR-262 (TLR agonist) + NKTR-214
The mouse model they injected just 1 tumor with one dose of 262 and then NKTR-214. They've said they intend to file IND in 2017 still.
http://www.nektar.com/application/files/8015/1033/6150/NKTR-262-NKTR-214__2017SITC_Poster-P275.pdf.pdf
For those interested again the presentation is 6:15pm (ET) tomorrow webcast is (Not sure if all of it will be on the PIVOT-02 full data or they'll talk about the preclinical stuff too):
https://edge.media-server.com/m6/p/cn2rdud9
OMER:
A lot of people follow/know more than I, especially Biotech Jim! I don't have a position in the company though I've been interested in it for some time (at preferably much lower stock price).
With those caveats... I was surprised Omidria revenue growth held up! I was expecting a weak quarter. I realize everyone values 721 more (I don't disagree) however I thought a weak quarter would spook people even more then the reimbursement change coming in 2018.
On FGEN drop
I was as surprised as many with it. I thought the call had a couple (minor) negatives but not to justify this magnitude of drop.
1-Reimbursement in China could take 5+ years to go nationally even regionally takes couple years. Peter has posted he thinks it could go faster
http://www.siliconinvestor.com/readmsg.aspx?msgid=31343635
2-For IPF Phase 3 they'll only give out P3 design in 1H '18 which I'd suspect trial won't start till 2H '18 which is a lot later then I thought.
Again I don't think either of these points justified such a big drop.
I posted some notes on twitter here
https://twitter.com/MauriceOnTW/status/928404960852762625
I haven't used it much so can't vouche for accuracy but the content is certainly very robust!
https://www.biopharmcatalyst.com/calendars/fda-calendar
NKTR:
With the caveat that its a very small n still (16 total). The RCC data seems most encouraging. At the presentation saturday (I linked it in prior post if interested) they said they will present data from all 38 patients with spider graph (showing when measurements taken). I think they'll also show by PD-L1 level. Initial 214 (single agent) was a bit disappointing so it wasn't clear how combo therapy would do. I was actually disappointed they couldn't dose beyond the .006/.009 level, I know IL2 is toxic but thought they could go a lot higher. Its actually quite impressive that the dose is so low.
They also have a deeper IO pipeline (though its preclinical) one molecule is specifically designed to work with 214 and should soon enter the clinic. The preclinical data are pretty impressive. They had an IDO compound (preclinical) a couple years back but have since removed it from presentations not sure if ran into tox issues or gave up on MOA.
On 181 heard the call again and to clarify a few things.
- The type C meeting was in October, don't have minutes yet.
- FDA indicated safety and abuse data sufficient
- The review issue will be what I suspected the fact that they had just the 1 trial.
- Agency indicated likely would have an Adcom
- Discussion with agency was that data supports DISCUSSION of whether label could allow for BETTER than C2
- participation in MULTIPLE government private and public meetings on Opiods
- Still intend to partner 181 (Globally)
BMY / CTMX:
Don't know if this is news but apparently there is a second CTLA-4 program in the collaboration
http://ir.cytomx.com/phoenix.zhtml?c=254195&p=irol-newsArticle&ID=2315188
$NKTR in the quarterly Call/PR said after meeting with FDA they plan to file with current data package for approval. Didn't catch exactly what but something will be a review issue (they only had 1 P3 instead of traditional 2) but said agency was open to consider as schedule 2 or better. Howard Robin and others met with White House too. So this may be getting higher ups involved at the time of heightened emphasis on Opioids. This is a pretty big news item IMO.
Additionally more info on NKTR-214 on analyst event saturday 6:15pm ET
https://edge.media-server.com/m6/p/cn2rdud9
PW = CEO Philippe Wolgen
Yes only approved in Europe not US. Concern is they apply the "uniform pricing" policy should they gain US approval. There are no trials ongoing in the US and according to the company FDA has said they are willing to accept the filing with current data. They still have not completed the NDA yet so we are still potential a ways off but they should be talking to payers now (actually some companies have preliminary discussions to get a sense much earlier) to get a feel for pricing/reimbursement.
On Uniform pricing
PW has shown it does NOT work (at least implemented by OUR company) amd is NOT in shareholders best interest!
1. The reimbursement process has taken too long, too many restrictions and still a lot of countries not on board!
2. No other company I am aware is so stringent on pricing. Generally capitalist want to maximize revenue not adhere to a "fair pricing" principle (that doesn't work). Look at ITMN when Esbriet was approved they attempted to get yes a similar price but in a big (20-30%) price band. In general countries that could pay more or had few patients were higher priced.
3. The US market has generally supported a much higher price. Again Esbriet (since I'm well familiar with) had a price over 2x that of the highest initial European price and in some cases > 3x! Not only that but the launch was much more rapid (and most the current sales) are from the US!
On reimbursement
Yes it is very complex often dealing with government bodies and time consuming negotiations which furthers my point about (lack of) competent management. Who do they have do it someone with experience? Someone who understands the process? How about someone doing IR!
Its ridiculous what happened in Germany! ITMN started there and had minimal restrictions. The price is renegotiated at set times what does OUR company do? Wait 2 years to launch get extreme restrictions on number of patients and doses and then what will happen if they need to renegotiate according to German Law!
On Chess
I like to play chess. Clinuvel is an investment for me not a game of chess, when investing I seek to maximize returns. Maximizing Revenue/Net Income is one facet of OUR companies valuation and management has not done a good job here! Q over Q sales decline early in a drug launch is not a good sign (here we have the fallback of bad management to blame so there is hope for recovery and much more EU sales growth). Also there is an issue of future competition (whether through other products or while unlikely generics when Orphan Exclusivity expires) not to mention the time value of money so there should be a sense of urgency!
On Sharescene
Yes I am well aware of the board. It has some good posting/content and a LOT of noise.
Clinuvel is not my first biotech investment. PW would rank on the lower end of CEO's of Bio's I've owned. Yes he did get Scenesse approved to his credit. However management doesn't seem capable to run proper trials, negotiate reimbursement/treatment duration, hire capable people, prepare BEFORE hand for launch/REMS/reimbursement... I especially dislike his lack of transparency to shareholders in the ruse of competitive advantage! Other companies are much more transparent with much greater competition! And some astute Sharescene posters find things our company should disclose and doesn't!
Considering the shares outstanding the volume while much higher then normal is still relatively modest. I know a large number of shares are closely held but they're obviously not selling in an significant amounts the past few days.
I don't doubt he (or something else) is causing a share price increase after frankly a very bad quarterly result. Still if the company manages to submit (and get the file accepted) the stock could be in line for a major move on potential FDA approval. To me its more riskier the company properly completes the file and is accepted. They should get priority review and then we're looking at a Q3 potential approval. Even if they aren't ready to launch (which unfortunately I think mangement likely won't be) the stock should be significantly higher. Lets just hope they stop the uniform pricing nonsense for the US.
I really wish they would have some experienced/competent people moving it forward if not its probably more value creation if someone comes and buys us out who knows what they're doing in rare diseases.
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed entries > ~1 month old, Updated November events, Added December/January Events
Jefferies GT Summit
10/12
http://wsw.com/webcast/jeff110/
Annual BIO Investor Forum
10/17-18
https://www.bio.org/events/bio-investor-forum
BMRN R&D Day
10/18
Credit Suisse Healthcare Conference
11/6-8
https://cc.talkpoint.com/cred001/110717a_as/
Canaccord Genuity's Medical Technology & Diagnostics Forum
11/9
Stifel Nicolaus Healthcare Conference
11/14-15
http://wsw.com/webcast/stifel10/
Jefferies Global Healthcare Conference
11/15-16
http://wsw.com/webcast/jeff108/
Voyager R&D Day in NY
11/16 2:00pm ET
http://ir.voyagertherapeutics.com/phoenix.zhtml?c=254026&p=irol-EventDetails&EventId=5263488
Piper Jaffray Healthcare Conference
11/28-29
Evercore ISI Biopharma Catalyst/Deep Dive Conference
11/29-30
Citi Global Healthcare Conference
12/6-7
Sunesis ASH Update
12/9
Biotech Showcase
1/8-10/18
Annual OneMedForum
1/8-10/18
JP Morgan Annual Healthcare Conference
1/8-11/18
Needham Annual Stock Growth Conference
1/17-18/18
Noble Financial Annual Emerging Growth Investor Conference
1/29-30/18
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical or chronological order as the case may be.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added JPMorgan conference”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
PRV (or PVR )
Was curious how many are floating around since Gilead is hoarding them it seems. Here is a nice article with a lot of info on it and if you page half down there is a list of the granted ones (14):
http://www.raps.org/Regulatory-Focus/News/2015/07/02/21722/Regulatory-Explainer-Everything-You-Need-to-Know-About-FDA%E2%80%99s-Priority-Review-Vouchers/
Thanks for posting. Do you know if the CVR will trade or not?
PBD.AS / PRBGF / PB9.F (Novel AD approach)
Has anyone here heard of Probiodrug AG? I just came across them seeing this press release
http://globenewswire.com/news-release/2017/10/26/1153732/0/en/Probiodrug-to-Present-Data-from-its-Phase-2a-SAPHIR-Study-at-International-Alzheimer-s-Disease-Conference.html
Which led me to their website and their 2A (short 12 week) results released in June of this year
http://www.probiodrug.de/probiodrug-announces-encouraging-results-of-the-phase-2a-saphir-study/
I don't have a science background and haven't dug into PubMed yet to know if their approach has a sound basis. This is from their website:
mdxg "short sellers":
Wow you weren't kidding!
They have a PR out
https://www.prnewswire.com/news-releases/mimedx-adds-new-materials-to-its-website-exposing-misinformation-disseminated-through-short-seller-attacks-300542207.html
which directs you to a rather robust section on their site:
https://www.mimedx.com/content/short-selling-commentary
Retail Roadshow has a couple interesting Bio Presentations
http://www.retailroadshow.com/wp/roadshows.asp
One (I don't know much about)
Spero Therapeutics is an antibiotic company that seems to have appeared a lot on my twitter stream.
The other (I know some about their lead drug)
Allena Pharmaceuticals is taking the old Altus Drug for Hyperoxaluria and after what appears to be some post hoc analysis is moving it forward. The founder was the same founder of the technology at Altus Alexey Margolin who successfully took another failed Altus drug (for Pancreatic Insufficiency) started a company and sold it (forget to who) they were approved 2 years ago according to the presentation (but took more than 1 review).
Edit: I think their second drug (for Gout) is also from Altus! I am not sure about Allena now I liked Alexey and the Altus tech. Seemed they got some new IP which would have been a concern.
Citron Research @CitronResearch Going after MiMedex (MDXG)
Entertaining Video
Management Selling:
When I owned UTHR management was selling all the way up and the stock did extremely well for a number of years. So I don't generalize management selling to be always a negative. They were well rewarded in options though. If anyone is curious I had vaguely recalled them publishing their 10b5 plans (at one point don't believe they've done so for a number of years) I went through the effort to look it up and here is the 8k with some:
https://www.sec.gov/Archives/edgar/data/1082554/000110465907058775/a07-20906_18k.htm
ABEO:
At the R&D Day the MPS presenter said they would be enrolling the MPS IIIB study next week I believe and today there is a clinicaltrials entry.
https://clinicaltrials.gov/ct2/show/NCT03315182
BMRN's MPS IIIB program has initial very impressive biomarker data and initial signs of neurocognitive benefit. Still the route/frequency of administration is not without its challenges. I know payers wouldn't like it but hopefully the two could work synergistically one day and give these kids a better life!
QURE:
IMO No! It likely explains the rise 2 days ago though! The positive potential in going to the Padua modification (which is what ONCE did with a different vector though) is much better news then the Q3 start (if one paid attention closely and read between the lines they said about bleeds as an end point and one could postulate this would be prospective and of significant duration).
I think the stock should be up on today's news (perhaps significantly). Management has done a poor job and made many poor decisions and not explained themselves well there are risks with this but this is probably the best decision they've done since I've owned them. The program was going to be dead IMO otherwise (more because of timeline then limited efficacy).
QURE:
Speaking of which... This is an interesting development
uniQure Announces Hemophilia B Gene Therapy Program To Enter Pivotal Study With FIX-Padua Variant in 2018
https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=3388861&lang=en-GB&companycode=nl-qure&v=
CC at 8:30am ET:
https://edge.media-server.com/m6/p/xoa7ar3j
QURE:
Don't know if it was the poster or not. I just got in haven't looked at it in the depth to analyze (since I am not a science guy it takes me a while to research and compare and my ownership in QURE is pretty low right now to have a high priority). To me the amount of reduction of the protein were not as much as I thought. From notes I have them claiming to get 80% knock down and 40% in cortical areas. The p value's for what they're worth aren't impressive either.
QURE / BMRN:
The poster is here
http://uniqure.com/ESGCT%20Huntington%20mouse%20model%20poster%20FINAL.pdf
I've been selling my position for a while (mostly at prices BELOW today's close). I should post an update as to my thinking sometime but in a couple weeks I should be completely out and it may be better to bash management then .
I was out during the BMRN hemophilia talk and only caught bits and pieces by cell phone but the part I heard talked about trial design and they said 4 year safety follow up I didn't hear if they clarified it in the Q&A or not. SO I am not sure if the agency(ies) are requiring that to file or if they could file on 1 year end point alone.... If the former I'd say that is a good reason for QURE to be down on its own.
http://investors.biomarin.com/download/FINAL_BioMarin_R%26DDay2017.pdf (Slide 118 is trial design)
Also on R&D Day doc seemed to downplay interest in 5-10% factor expression. BTW BMRN guided down revenue for Q3 because of delays in ordering in Brazil related to economic instability there. They said were informally told they'd receive order in Q4 if so revenue would be in middle of guidance if not would be lower.
It looks like they took it down. I think once a company prices they take them down. I follow @RetailRoadshow on twitter to see the notices.
KIDS:
I watched the IPO retailroadshow presentation and was impressed with how management came across. They seemed very focused on their niche and came across quite credible and very ethical. Its an area I've not invested in though so I didn't look at their filings nor their competitors. In a general market weakness I may decide it may be worth a deeper look.
Thanks for sharing your list Jim!
Don't know if anyone cares but in the hopes of others sharing here are my top Bio's
BMRN (curr holdings ~9 years but sold some bought 15 years ago)
FGEN (held avg ~2.5 years)
GLPG (held avg ~3 years)
CLVLY/F (held avg ~2.5 years)
ABEO (held avg ~11 months, Was small orig position grew faster than exp.)
CTMX, NKTR, SRPT (shares + options) are also significant holdings
Spark's AdComm Free Webcast link
https://collaboration.fda.gov/ctgtac101217
Meeting Materials (scroll down)
https://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm
$ABEO R&D Day 10/11 8:30am Webcast Link Now Up
http://investors.abeonatherapeutics.com/phoenix.zhtml?c=63510&p=irol-EventDetails&EventId=5263380
Direct Link:
http://cdn.digitalservices.online/AbeonaTherapeutics/
Reminder also Summit Therapeutics has competing (same time) R&D Day Event follow thread up to see link.
LGND:
One of the things I found interesting was Mr. Higgins background, more specifically him having an economics degree... Could explain his liking of Royalties
Chardan Inaugural GT Conference 10/10
http://wsw.com/webcast/chard/
Bi/Tri/..Specifics:
Ctmx:
They've done great job at getting big name partners in oncology! Looking to branch beyond too.
One bit of caution AMGN did not see any clinical data from other programs.
Couple data calls today at 8:30am
CATB:
https://edge.media-server.com/m6/p/w8dq2398
FOLD:
https://edge.media-server.com/m6/p/b65zu3cf
CTMX / AMGN:
I tweeted some notes for the call and 8-k if anyone is interested
https://twitter.com/MauriceOnTW/status/915334416909635585
CTMX:
Here is the 8k with more details. The shares are ~1.1M @ 17.30 (20 day volume weighted avg. price).
https://www.sec.gov/Archives/edgar/data/1501989/000119312517302235/0001193125-17-302235-index.htm
CC at 5pm
https://edge.media-server.com/m6/p/m7c5vdiy/dmediaset/audio
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added SMMT R&D Day, Jefferies GT Summit
2017 Wells Fargo Healthcare Conference
9/6-7
https://cc.talkpoint.com/well001/090617a_as/
Citi's Annual Biotech Conference
9/6-7
RW Baird Healthcare Conference
9/6-7
http://wsw.com/webcast/baird49/
NewsMakers In The BioTech Industry Conference
9/8
http://www.wsw.com/webcast/biocentury4/
Rodman & Renshaw Healthcare Conference
9/10-12
http://wsw.com/webcast/rrshq27/
Morgan Stanley Global Healthcare Conference
9/11-13
https://cc.talkpoint.com/morg007/091117a_as/
Bank of America Merrill Lynch (BAML) Global Healthcare Conference
9/13-15
Cantor Fitzgerald Healthcare Conference
9/25-27
http://wsw.com/webcast/cantor6/
Ladenburg Annual Healthcare Conference
9/26
Annual Sachs Biotech in Europe Forum
9/26-27
LEERINK Partners Roundtable
9/27-28
http://wsw.com/webcast/leerink29/
Cowen Annual Therapeutics Conference
10/2-3
ACRS R&D Event
10/4 8:00am
http://www.aclaristx.com/events-and-webcasts
Summit R&D Day
10/11 8:30am ET
http://edge.media-server.com/m/p/vqx8zw8i
ABEO R&D Day in NY
10/11 9:00am
Jefferies GT Summit
10/12
http://wsw.com/webcast/jeff110/
Annual BIO Investor Forum
10/17-18
https://www.bio.org/events/bio-investor-forum
BMRN R&D Day
10/18
Credit Suisse Healthcare Conference
11/6-8
Canaccord Genuity's Medical Technology & Diagnostics Forum
11/9
Stifel Nicolaus Healthcare Conference
11/14-15
http://wsw.com/webcast/stifel10/
Jefferies Global Healthcare Conference
11/15-16
Citi Global Healthcare Conference
12/6-7
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical or chronological order as the case may be.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added JPMorgan conference”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
ADHD / Arcturus:
I looked at their website and pubmed and decided to take a pass for now (and likely a long time). They are just too early. Their website lacked any scientific substance which gives the impression they don't have much progress. The top management team consists of two people who also comprise half the board not a good thing to see and again gives the impression of being small/early (at the very least). On pubmed I did find things that were mostly technique or interesting findings (above my level to comprehend the significance) I may have missed something but unless so only one sign of a program anywhere near entering the clinic and not sure on how good it is (outside my area). Here are a couple of the more substantive things I came across via PubMed.
https://www.ncbi.nlm.nih.gov/pubmed/27765835
http://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(16)33586-9?_returnURL=http%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525001616335869%3Fshowall%3Dtrue
ADHD / Arcturus:
Yes I did listen. I was intrigued by the low valuation of the company given they have a few partnerships with reputable companies. They are basically a preclinical company (thus the reverse merger) other than the ABUS HBV program. I got the impression they are in need of funds to get to meaningful data. They were light on details as far as their royalty interests (I didn't look to see if they are anywhere) and if one googles the company there website doesn't even show up on the first couple pages anyway (They do have a website but I wonder if it was just put together http://arcturusrx.com/).
Here is the slide deck used:
https://www.sec.gov/Archives/edgar/data/1566049/000114420417050441/v476068_ex99-3.htm
The transcript is here:
https://seekingalpha.com/article/4110377-alcobra-adhd-ceo-david-baker-arcturus-merger-alcobra-conference-call-transcript?part=single
I am tempted to look closer as buying via ADHD may be a cheap entry because I think they are getting a nice chunk of equity. I wonder if the people in ADHD were looking for something better (I believe there is an activist involved) with the sell off so perhaps it won't go through?
Edit:
Here is the Ultragenyx PR on terms (royalties, milestones, additional targets)
http://ir.ultragenyx.com/releasedetail.cfm?releaseid=939100