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Cambrex doesn't manuf biologics which have much higher margins... so you can't compare apples with oranges
Still a good sign the cdmo biz continues to consolidate...
As for bavi being worthless as some have posted... looks like merck stepping up for third trial and second with keytruda.... they must see something they like... wonder what the milestone payment will be...
Listened to the halo cc...
in a nutshell... several other companies looking at combining their drugs to enhanze
Janssen filed bla in us and eu for darzelex sc...
the approved roche product saves about 90 minutes of infusion time and that form is taking 60% of mkt... made comment that darzelex takes 3 plus hrs so mkt should be good for sc version
roche filing bla first part of 2020..
I was very aware of the subgroup and the results. If you look closely at the figure in the original art, it shows the separation on the survival curve and also shows why it was stopped early because the bavi arm took a while to get started. The IP was not stolen... just poorly managed by SK and crew. They had 500 mil shares to print out to keep their personal gravy train going. We might get something out of bavi down the road.
http://m.biospectator.com/view/news_view.php?varAtcId=8193
Good article on CDMO competitor ....
one tidbit worth noting...
Also yesterday, the company announced plans to expand its bioconjugation facility in Visp, Switzerland, to meet increased demand and said it recently received approval for commercial manufacturing of a third antibody-drug conjugate.
The expansion will take two years, and contracts are already in place for the extra capacity, according to Lonza. The facility "will provide current and future customers with launch and commercial manufacturing and will serve the rapidly expanding early clinical phase market for bioconjugates," the company said
https://www.biopharmadive.com/news/lonza-plans-facility-expansion-amid-pharma-focus/559541/
based on today's reaction we get about a $10 mil upgrade in value...
yes ... covering the Research Triangle area in NC...
https://www.linkedin.com/in/brycechaney
Good art on Darzalex SC...
Many other BP's have sc trials going on with Halo...
How much biz avid gets is still a puzzle but things are looking very good.... have not seen the resilience in sp in quite some time... normally when we hit the overbought zone on the RSI we get smacked down right away...
https://bioprocessintl.com/bioprocess-insider/global-markets/multiple-myeloma-mab-helps-drive-q2-as-jj-looks-to-subcu-formulation/
It should be pretty quick.. per Halo cc ... 3 for 3 so far on enhanze approval and dr's want this asap... if I can recall they expect it on the mrkt 2nd half this year and roche product first part 2020...
Thanks for the correction.... still don't know whether Avid gets any of Janssen biz...
I've been expecting this pr. Per the ASM notes, Lias told some attendees they produce for Shire... I believe Janssen bought Shire within the last two years... Also on the CC prior to the last one, I want to say Lias indicated they were doing commercial validation runs for other clients of Halo outside of the Roche relationship. The only one that was close to commercialization was Janssen with a phase 3 wrapping up and the other BP's had phase threes just starting.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145011633
So bottom line it could be Avid's biz or a part of it but need verification. Also, Catalent is the other manuf for Halo(Calalent bought Cook).... so even if Catalent got the biz it would free up capacity at Avid for other Halo biz. I listened to the Catalent cc and they seem to being going full speed and are expanding capacity.
Also note they had a project engineer for facilities job opening at Avid a while back and is no longer on the web page. I don't know if it was filled. Part of the job descrip was facilities expansion.
I think we have a different crew with some hint of ethics... could be wrong... the old crew had the you can't touch me moxy until ronin showed them they could be ousted... the first equity placement by new management with wells fargo was a bloodbath but the company was a huge question mark as to whether it would survive... any capital raise now will be for expansion which would present a better story on future prospects...
and it could be they are getting some of the housekeeping done before a capital raise... and we have possible payments from oncologie for milestones such as clinical trial starts...
if there is a capital raise, the sp should bounce back pretty quickly... the institutional ownership has increased quite a bit which should temper the impact... all imo...
cool graphic...
https://twitter.com/IRIS_EPO
so lucy does show up!
https://twitter.com/dljcss
not too worried and tustin site is not too close to any fault lines...
from what i gather he is a daytrader looking at 15 min or 30 min intervals.... given he shows up at big moves either up or down, i think he looks at whether the trends can continue.... for the most part he seems to be right with the RSI out of whack....
as for different feel... avid has some tangible goods and an analyst group that is tuned in... combine that with a management team aligned with shareholders and a much bigger institutional investor base and then the hidden secrets both good and bad get exposed to the capital markets in search of profit...
It has been a "Horror Story Stock!" eom
halo cfo goes into detail.... enhanze stuff around 8 min mark if i remember..
janssen filing second half this yr.... roche first part of 2020...
enhanze products have 100% fda approval rate so far...
i am sure they are getting commercial ready to hit the ground running... sorry bad metaphor
both drugs should be approved and immediate demand in place pairing w/ successful drugs
http://wsw.com/webcast/jmp39/register.aspx?conf=jmp39&page=halo&url=http://wsw.com/webcast/jmp39/halo/index.aspx
do you think some pretty knowledgeable folks that have brought drugs to market would go through the trouble to open up offices in boston and shanghai and raise close to $100 mil in funding where bavi is the lead drug? and Avid sp reflects prob zero value for the ip right now...
the annual report talks about needing about $5 mil for capital improvements fy 20.... a couple milestone payments from oncologie just might be the source... i also think the cfo will be smart about capital raise and at a decent price if needed....
very good day... prob overbought w rsi but a base to move up from...
yes and expect more activity by invisible hands defying gravity before your own eyes.....but as Avid becomes a bigger bait ball, more predators are ready to grab shares... things could be bumpy as the float tightens up...
We might get a russell bounce given many funds using russell are weighted by market cap so the bigger market cap, the more shares will be bought to adjust portfolios.... so maybe a minor bump...
On the call no mention of the progress of the IP.... Oncologie just raised $80 mil and is expected to start a bavi trial soon. CDMO can get up to $95 mil in milestones... so expect some milestone payments in FY20.
Just reading the AR... Federal operating loss carry forward is $425 mil and $273 mil CA loss carry forwards.... so some pretty low taxes for a while combined with a cash flow machine...
Good call.... halo has good track record on fda approvals.... and the products going for approval are what doctors actually want asap..... that's where the commercial side will take off.... expect rev's to be lumpy for the year and that's prob why they don't want to give qtr guidance...
and i love the Socal location comment...
Pantheon, Catalent... Lonza...
And Samsung has huge facility in Asia... Socal would be a great gateway...
we are on the menu.... just a matter of time..
They also bought a Bristol Myers facility in Italy and raised $500 mil in a private placement at an interest rate of 5%. Right now cdmop preferred is trading above par. At some point in time the preferred could be traded in for cheaper debt.
Yes agree.... they had a job requirement a while back for a construction project engineer. And if they need to expand there could be capital requirements which might require a capital raise. That would be a short term weakness which should recover quickly. The end game max value for the manuf assets is when the expansion capacity revenue projection is real as in backed by signed contracts. The sp seems to be anticipating something... like another charlie brown moment. Once the expansion capacity is real (if ever), the company would be a takeover target imo... assuming CDMO consolidation is still going on. If you look at the top three players like Catalent, Pantheon and Lonza. a socal location would seem to be a good location for all of them. IMO
Agree... the biz is out there ... i don't think they were ready right out of the chute to get some of the biz in that the facilities needed to be upgraded before one could even go after it...
looking forward to the halo update... enhanze is taking off and should really take off by the end of the calendar year for both roche and janssen as they are expected to go into commercialization...
oncologie just raised 80 mil and is planning a trial so we should see some milestones and manuf biz..
One would think that given they are chasing clients and employees, at some time they would want to start showing a winning hand. As to market reaction? How many times have we been charlie browned?
My hope is they want to start improving share price with a decent quarter and explain where we are w/ Halo and other clients followed by a decent cc in August w/ contracts.
The charlie brown side of me says they want to tube the share price for cheap options with a "we still don't know" cc call. Damn Lucy!
As to whether some BP wanted the IP, we don't know the conditions of the deal. We know the BOD had zero incentive to do a deal which would have ended the gravy train. And if the old BOD insisted on control, look wher that got them.... booted out the door.
And imo the old BOD tainted the credibility of the IP. And remember the delay in the ASM? That was sk and crew scrambling to get a deal done and Oncologie stepped up.
And this coment:
How many believe Merck do not advance certain programs properly?
Avid client Acumen (Goure) even agrees and with PS Targeting? I don't trust Merck at all
BP has make capital allocation decisions as well... maybe the drug in question wasn't top on the list.
Where is SK now with all his drug dev expertise? Helping CJ drain the cash out of a company trading at a third of a penny.. think about it, the company would have to triple to get to a penny stock... all imo...
He's now a blockchain expert getting a $150k consulting gig... how much does CJ get out of that? all imo
looks like there is a drug shortage from a halo product due to demand...
hyqvia...
https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=515
https://www.takeda.com/siteassets/system/what-we-do/research-and-development-rd-in-takeda/our-pipeline/pipeline_en_q4.pdf
from cj daddy note from ASM in oct 18. Note that Takeda bought Shire in dec 18
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145011633
..F/U 329005: “After the meeting, Lias came over to Horselover45 and me for a sidebar. I asked about Halozyme. He said: We are still producing for Halozyme. Their main customer Roche ordered a stockpile a while back because they were planning that we were going to use a newer, state-of-the-art, process which would take a while to get all the FDA testing, paperwork, and approvals. We are cautiously optimistic that Roche has worked through that stockpile. Halozyme is supposed to be communicating the latest forecast in a week or so. We are the sole supplier of that product to Roche. That is because we were the only ones who passed all the strict requirements that they had (that is a remarkable achievement). Now, we know that Halozyme has a few more customers for this product and we are presently producing for one of them, Shire. Others may also use us. He did not elaborate on other customers but he restated that they want Halozyme's business to be more like 5% and not 95% of our total.”
good sign... someone wants shares and trying to shake stops...
here's a doc talking up the sc version at European conference ...
sorry but that ship has sailed and don't expect anyone to care about it...
no fbi... no fda... notta ...
there is potential to get some revs short term from the IP and possible manuf biz... nothing needle moving and all gravy if it comes...
Halozyme JMP presentation...
Enhanze discusion starts 9:08
http://wsw.com/webcast/jmp39/halo/index.aspx
tustin should be pretty busy pretty soon...
everybody bp and biotech going to sub q as they call it...
product extension... competitive advantage... lower costs... patient preference 5 minutes vs hours to deliver...
janssen to file second half for darzalex which is already a $3 bil drug and roche has another product almost ready for approval...
commercialization coming and a bunch of trials....
this fog won't last forever..
yes... and i pointed that out to mr white when the boys came rolling into town... he was just a paid mercenary .... he must be good to keep him...
Bavi needed lots of money to continue and avid needed a bunch of money to upgrade... and they had no money which was not a problem with previous mgmt with 500 mil shares to play with... new team cut authorized shares to 150 mil shares... got a real CFO and a stellar BOD... one previous bod member with zero experience made as much as the entire seven member bod
Lias was the last tie to the old crew...
And i would not be surprised if Halo takes up a bunch of capacity... we should know more in mid july... all imo...
Agree and I think the reason they (as in previous mgmt) could not get a deal done was the makeup of the bod... remember the shareholder lawsuit where they agreed to add a bod member once bavi was approved. I contributed to the lawsuit by filing a shareholder response to the court. Luckily ronin came in and booted them out.
And then the conspiracy theories as to the old bod and sk etc getting control... looks like nobody wanted sk...
right now I think he is helping cj with a $150 k consulting gig on blockchain... (basically helping cj drain the cash out of ptsc imo)
agree... and where is Kevin Bacon in all this...
Bottom line is PS targeting was a novel approach and not quite accepted by the bp machine yet ... it needed research and dollars to develop... and a credible team
combine that with a 4 person BOD that had zero credibility and a history of screwing shareholders, the PS targeting team ran out of money and institutional investors...
ronin cleaned house and we have a chance to make some money and bavi has a chance to succeed...
I posted earlier but this is worth a repeat:
"There are few such targets left, so if one comes to market, the bidding is likely to be intense."
dif drug than enhanze .... the wait will be on janssen applying for fda approval on sc version of their drug... approval should be no problem given phase 3 met endpoints...
my guess is he wasn't doing bad enough to get fired for cause so they negotiated a buyout... just glad to have an active knowledgeable bod to steer right now...
i also think halo and others will cover capacity soon and a buyout there after based on what i'm reading in the cdmo consolidation... and my guess is they will get pressure from bp to be under the wing of a big cdmo and pressure from investors to strike the best deal possible..
pantheon or catalent... within 12 months or less...
not gonna rub off for a while... enhanze sales should heat up w/ roche approvals but big jump will be for darzalex sc which should be approved 3rd qtr or 4th... the demand will be high imo..
and all the other trials starting with all the other partners...
so until avid revs are publicly linked to halo enhanze sales and forecasts, we will drift and mgmt has no incentive to drive share price... for the time being...
remember they have the options to dole out and they get to play with sk and crew options that went back into the pool (lots of them and karma strikes again)... so hopefully the entire avid crew partakes in the reward plan vs just the top dogs...
patience for now... when the table is all set, things should start to happen...
tappan crew is well aware of value... i'm not worried...