Biosensors   

Is Biosensors a good buy?

BIG will book US$8m profit for 1QFY2009 and 4 more times of US$8m for the next 4 years. Plus, China JWMS (BIG's subsidiary) will make at least US$25m this year. Im using a net profit CAGR of around 60% only. Net profit CAGR of 2007 vs 2006 is almost 100% for JWMS. Hope that can ease your mind a little. FYI, JWMS made US$8.5m in 2006 and US$16m in 2007. In 2006 and 2007, JWMS enjoy tax free income from the chinese government. In 2008 and 2009, tax rate will be half the usual. With the newly released 2,000 patient CREATE trial showing excellent results for this Made-In-China EXCEL DES, the sales of EXCEL DES should get a tremendous boost. So i think my net profit forecast for JWMS of at least US$25m is conservative. US$8m plus US$25m = US$33m profit liao. I think there will be more to come.     

evercare      ( Date: 29-Apr-2008 21:28) Posted: read through many bengster's good reports, he's great! but can't find a good reason to accumulate when p&l still in the red. i believe the Q4 result will still in the red, guess must wait till Q1 when part of $40m fund comes in to realise profits. sigh! who dares win, but i don't. anyone cares to explain?

 

so did u get any bro?

 

 

strange, large lots dumpings are out again at 69cts. Will monitor again

 

Lelong,Lelong, Buy 1 get 1 free.Offer, offer 999 Gold Bar

 

dcang84 Member

Posted: 30-Apr-2008 00:21

x 0 x 0

Pls compile and send it to www.talkingcock.com . They'd welcome your contribution. bengster68      ( Date: 29-Apr-2008 23:49) Posted: My personal calculation is takeover should happen around end of 2008. If it doesn't happen, i will be a bit disappointed. FDA approval takes a long time more. BIG has to get IDE (investigational device exemption) clearance to kick start STEALTH II RCT against Taxus Express. It will be a 3,000 patient RCT and the FDA will look at 2 years results to determine whether Biomatrix gets the FDA approval. BIG is the first DES to be caught in this new FDA ruling and i suspect this measure is specifically targeted at BIG to protect home ground market share. The big 4 DES rivals have very powerful lobbting mechanism in FDA and BIG cannot go to USA market alone. BIG need to get a medical device partner to is strong in USA to settle this lobbying with FDA. Drugs and medical device industry is a very dirty business but yet present themselves in the name of safety and improving patients quality of life. FYI, Biomatrix's IDE should come out in 2008. It has been delayed for so freaking long already, just like what happended to CE Mark. Ridiculous delays and delays to slow down the commercialisation of Biomatrix.

Takeover at end 2008 is my pesonal opinion and im entitled to have my own opinion. IDE has been delayed for a long time and i believe it should come out soon after LEADERS trial as FDA will have no other reason to delay Biomatrix's IDE any further. My reasoning is simple. IDE is to qualify if Biomatrix is "fit for human clinical trial". LEADERS trial is a massive RCT against Cypher (already a FDA approved DES). If Biomatrix can show "non-inferiority" against Cypher in LEADERS results, that essentially means Biomatrix is "at least on par" with Cypher. If Biomatrix can even show "non-inferiority" under LEADERS, why Biomatrix still cannot get FDA approval even to start human clinical trial? You already passed "O Levels" and yet they still don't want to pass your "PSLE"??? Under traditional FDA approval, by showing "non-inferiority" in such massive scale RCTs like LEADERS trial should be sufficient to warrant an FDA approval for Biomatrix. The purpose of such RCTs is to show the new DES (in this case Biomatrix) is at least on par against Cypher (an FDA approved DES). Since Cypher is approved, Biomatrix should be approved. This is called performance benchmarking. It is not FDA's job to assess whether Biomatrix is "superior" to Cypher or not. But it is FDA's job to assess whether can they approve Biomatrix since their performance is "non inferior" to Cypher. Since Cypher is already commercialised, Biomatrix has won its rights to be commercialised in USA.

Previously, FDA requires RCT of about 1,500 patients for 9 months to show "non-inferiority" against an approved DES. Now they raised the standard very substantially to 3,000 patients at 2 years. This measure was implemented immediately after Endeavor and Xience got FDA approval. Now the late-thrombosis issue has been fiercely debated 2 years ago in 2006 EuroPCR at Barcelona. FDA had a choice to raise the bar 2 years ago but they kept the goal posts the same. But they narrowed the goal posts substantially only very recently just after Endeavor and Xience scored their FDA goals. Biomatrix is the next player to kick the ball into the FDA goal post and will be caught in this new requirement. This new measure is simply targeting at Biomatrix and was delayed to allow Endeavor and Xience a smooth entry into USA market. Plus, EndeavorIII RCT against Cypher failed their primary end-point. Endeavor IV failed secondary end-point, had higher TLR and thrombosis rate but Endeavor had UNANIMOUS vote for FDA approval from the panel of FDA advisors. I would say Medtronic is very skillful in getting FDA approval. This smooth sailing approval will not be possibly if that DES in question was Biomatrix. Xience had 9 out of 10 votes for FDA approval despite cases of late-thrombosis problems keep cropping up. The FDA is targeting this dreaded blood-clot problem and making new measures to scrutinise this new problems for DES approvals and yet they just allow Xience to score the FDA goal easily again. I believe FDA panel of advisors are under the payroll / granted share options of medical device companies classified under "research / sponsorship programs". How can these guys say no to their paymaster's products at FDA approval stage? These guys are under the sponsor's research program and paid handsomely for a reason: To help their sponsors' medical products lobby for FDA approval. China ex-FDA chief was executed for corruption last year, the ex-FDA chief is still under charges for corruption. How clean can regulatory authorites be when multi-billion dollars are at stake?

Now we go back to history at CE approval. Traditionally CE is one of the easiest approval to obtain. Even Costar, the DES that flopped eventually at massive scale RCT also got approved. I remember Costar submitted just 2 months before Biomatrix and was approved about 2 years before Biomatrix. Biomatrix is the best DES this industry has ever seen and still can kena stuck at CE for years. The CE panel wants to see NOBORI RCT before deciding to approve Biomatrix. This sort of ridiculous demands was never seen before in the history of CE approval for DES and only slapped on Biomatrix when it was BIG's turn for CE approval. The traditional CE requirement is a small scale trial (100 to 200 patients) comparing your DES vs your BMS counterpart without drug. In this case, it will be Biomatrix Vs S-stent (without BiolimusA9 drug and PLA biodegradable polymer). Such a trial was done under STEALTH 1 and STEALTH 1 is already sufficient to get CE approval. But why another new pattern to see RCTs against an approved DES (Taxus Liberte)??? Never in the history of CE approval does any DES player need to provide such evidence to obtain CE approval. The regulatory agencies like CE or FDA don't have to reject your approval. They just need to delay and delay for years until competitors (in this case the rival DES big boys) catch up with BIG's technology.

These are my analysis on regulatory approvals and not just mere talking-cock. It is much more easier to accuse me of talking-cock as compared to spending time to really study deeply into the situation, make a conclusion and type out a lengthy post to share with forumers.  

I remember last year there are shortists and doomsday sayer said BIG may not get CE, spread rumours that CE require a new trial and BIG will take many more years to get CE. During that time, I have always comforted disappointed forumers and maintained:

"IT IS NOT A QUESTION ON WHETHER BIOMATRIX WILL GET C.E. MARK APPROVAL BUT A QUESTION OF WHEN."     

I think the same will apply for BIG's takeover possibilities. 31/12/2008 is only 8 months time. I hope im right again this time. Lets just sit back, relax and watch the grand BIG finale together. We can "talk-cock" together and have some fun but don't accuse people of "talking-cock".

 

is easy to say then done.... but one thing for sure.... u dont buy ...u will never loss.... so u r safe.....

 

i'm sold! just bought 15 lots at 0.69, test water for 3-6 months.

 

I fully agree with jack.  Never lost a single in this counter.  Buy low, sell high. Below 70c is a super buy. 

 

Jack, log on. He he.

 

ha ha... that is humorous ...

aiya... whethere it is talking cock or non-talking cock, as long as its a earning cock, it is a good cock. ha ha..

don't expect you put money today and earn money tomorrow... sometimes be patience, I have experieced the full roller coaster process of BIG, can't go wrong  ...  my beloved re-entry is always 69... yeah... here i am .. who cares it will drop later... if can drop to 59 cents la.. then, buy again lo.

 

wa man, dcang? how could you?? bengster is not talking cock over here la... heehee

 

Pls compile and send it to www.talkingcock.com . They'd welcome your contribution.

bengster68      ( Date: 29-Apr-2008 23:49) Posted: My personal calculation is takeover should happen around end of 2008. If it doesn't happen, i will be a bit disappointed. FDA approval takes a long time more. BIG has to get IDE (investigational device exemption) clearance to kick start STEALTH II RCT against Taxus Express. It will be a 3,000 patient RCT and the FDA will look at 2 years results to determine whether Biomatrix gets the FDA approval. BIG is the first DES to be caught in this new FDA ruling and i suspect this measure is specifically targeted at BIG to protect home ground market share. The big 4 DES rivals have very powerful lobbting mechanism in FDA and BIG cannot go to USA market alone. BIG need to get a medical device partner to is strong in USA to settle this lobbying with FDA. Drugs and medical device industry is a very dirty business but yet present themselves in the name of safety and improving patients quality of life. FYI, Biomatrix's IDE should come out in 2008. It has been delayed for so freaking long already, just like what happended to CE Mark. Ridiculous delays and delays to slow down the commercialisation of Biomatrix.

 

thanks bengster for the insight, may all your dreams come true...

 

My personal calculation is takeover should happen around end of 2008. If it doesn't happen, i will be a bit disappointed. FDA approval takes a long time more. BIG has to get IDE (investigational device exemption) clearance to kick start STEALTH II RCT against Taxus Express. It will be a 3,000 patient RCT and the FDA will look at 2 years results to determine whether Biomatrix gets the FDA approval. BIG is the first DES to be caught in this new FDA ruling and i suspect this measure is specifically targeted at BIG to protect home ground market share. The big 4 DES rivals have very powerful lobbting mechanism in FDA and BIG cannot go to USA market alone. BIG need to get a medical device partner to is strong in USA to settle this lobbying with FDA. Drugs and medical device industry is a very dirty business but yet present themselves in the name of safety and improving patients quality of life. FYI, Biomatrix's IDE should come out in 2008. It has been delayed for so freaking long already, just like what happended to CE Mark. Ridiculous delays and delays to slow down the commercialisation of Biomatrix.    

 

FY2008 will confirm report a loss. But this company has "turned around" already with CE approval. Past yearly losses are caused primarily due to CE delay. US$8m profit will be booked in 1QFY2009 so BIG already made US$8m in the very first month of FY2009. Further US$8m will be booked every year for another 4 more years. BIG has already emerged out from their "pre-earnings" stage. Cash level has been improved by US$40m. Fundamentals has improved tremendously compared to a few months ago. Nobori trial result is a testament that BIG's technology is undisputed number one now by wide margins against global number one top selling DES Taxus. China JWMS will be BIG's fully owned subsidiary and just the value of JWMS is worth more than BIG's market cap now. Even if JWMS list next year with a forward PE of 20 times of forecasted 2009 net earnings, JWMS is worth US$800m. I expect JWMS's EXCEL DES to capture even more market share after the recent excellent 2,000 patient CREATE trial results. I have also identified so many DESs in breach of BIG's patent (including next generation DESs from MDT, ABT and JNJ) and this means multi-million settlement and royalty package in the future. The settlement package will come, its just a matter of when. It is BIG's forte to pass all sorts of clinical trials with flying colours. I believe the same will happen for LEADERS trial. I think it is hard to fault me if i quote this sentence now:

"IT IS NOT A QUESTION OF WHETHER BIOSENSORS WILL BE TAKEN OVER BUT A QUESTION OF WHEN". 

 

 

Hi Bengster,

Are you losing confidence in this counter if take over is not happening within this year? Without FDA approval, take over is still likely within this year?

 

bengster68      ( Date: 28-Apr-2008 13:11) Posted: Historically, this stock will only move when the BBs goreng it. It is difficult to tell what the BBs' game plan is. Nobody will know. We also won't know if they are the equity portfolio fund management type of BBs that buy and hold due because they see good value in BIG or the trading type of BBs that pump and dump. As such, we don't know when this stock will be moved up. I have already decided to hold on all the way until 31/12/2008 for takeover to happen. If it doesn't happen, i will re-assess my positions in BIG. Don't want to miss a thing, esp when huge takeover premium will most likely be involved when it happen. 8 months only, very fast one lah.

 

read through many bengster's good reports, he's great! but can't find a good reason to accumulate when p&l still in the red. i believe the Q4 result will still in the red, guess must wait till Q1 when part of $40m fund comes in to realise profits. sigh! who dares win, but i don't. anyone cares to explain?

 

lelong sale

buy...

 

Too many punters this stock. Fundamentally nothing bad has happened. Just that Terumo paid BIG US$40m cash. Is that fundamentally good or bad? Will people just pay you US$40m cash like that? You guys decide.  

 

Dont worry, this counter has been up and down for a while. It will be back to $1 soon.