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Is Biosensors a good buy?
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cwwan1
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26-May-2008 19:18
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Biosensors' Q4 net loss deepens Biosensors Int'l Group on Monday reported net loss for the fourth quarter ended March 31, 2008 deepened to US$19.15 million from US$9.99 million a year ago. The company said this was primarily due to the one-time impairment and fair value adjustments recorded. For the full year to end March, net loss was at US$30 million, compared to US$36.29 million. 'The lower net loss was primarily due to the settlement of a legal action and the receipt of licensing milestone from a licensee, offset by the one-time Occam impairment, fair value adjustments to the warrants to purchase shares from a licensee and increased operating expenses,' Biosensors said in a statement to the Singapore Exchange. Revenue for the fourth quarter rose 23 per cent to US$11.93 million, as growth in sales of interventional cardiology products offset a drop in sales of drug-eluting stents. For the full year, sales grew 29 per cent to US$44.32 million, also attributed to a non-recurring milestone payment received from a licensee in the first quarter of the current fiscal year. The company believes that on an overall basis, annual operating expense reductions will range from US$7.0 million to US$9.0 million as a result of restructuring efforts. While the restructuring should have a positive effect on future operating results, the company is planning to continue its expansion efforts in the international markets and expects future operating expense increases to offset the savings related to the restructuring. -- BT newsroom |
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PensionAlterEgo
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26-May-2008 18:55
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bengster, since you are the accounting expert, what is this entry for..
"fair value adjustment of derivatives" so much losses ... amounting to 3.14 mill compared to gains of 4.83 mill in 074Q. |
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AK_Francis
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26-May-2008 18:04
Yells: "Happy go lucky, cheers." |
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Its steady today, may see bright light 2morow. Cheers. | ||
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bengster68
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26-May-2008 15:46
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BIG depends on patents and IPs to make money. I hope they do their patent fencing strategy with a global top class patent legal advisor / counsel. I think BIG will try to cover as much fencing as possible under the "central claim" method via BIG's own invention of BiolimusA9 drug and usage of PLA biodegradable polymer for DES use. In that case, BIG has to be more specific details written in their claim statement to show more "original inventor" of this DES technology formula. Nothing is 100% certain in court case disputes. However if done the patent fencing correctly, BIG can increase the chance of successfully defending their patents when the need arises. Angiotech couldn't win their patent infringement case against Conor in U.K court. But in most of the other Europe countries, Angiotech successfully defended their patent rights. Maybe its because in UK, the courts uses "peripheral method" to judge the validity of patents? |
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PensionAlterEgo
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26-May-2008 14:25
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Okay, maybe there is some respite for BIG supporters on this whole biodegradable polymer issue....but still needs some extra confirmation from the IR dept. Thanks bengster for the number.. maybe I might check with them... Here's what I discovered.. If we look at the claim process in patents.. (taken from Wiki) The claims may contain one or more hierarchical sets of claims, each having one or more main, independent claim setting out the broadest protection, and a number of dependent claims which narrow that protection by defining more specific features of the invention. In the U.S., claims can be amended after a patent is granted, but their scope cannot be broadened beyond what was originally disclosed in the specification. No claim broadening is allowed more than two years after the patent issues." The "specification part" is where BIG has a very broad scope covering all sorts of Polymers.. Taken from their orig granted patent.."The polymer for use in the invention includes, but is not limited to, poly(d, l-lactic acid), poly(l-lactic acid), poly(d-lactic acid), ethylene vinyl alcohol (EVOH), ?-caprolactone, ethylvinyl hydroxylated acetate (EVA), polyvinyl alcohol (PVA), polyethylene oxides (PEO), and co-polymers thereof and mixtures thereof, dissolved in chloroform, or acetone, or other suitable solvents. These polymers all have a history of safe and low inflammatory use in the systemic circulation. " So based on the specifcation part, even PLGA should be covered...because co glycolic is combination with poly lactic. But this is not in the claim! And from the claim shown below (taken from orig patent doc), you can see that BIG made a narrower claim! 
Thanks to bearbey for pointing out the EPO forms, I now see ammendments to the claims (should be within 2 years) to include a slightly broader claim to the polymers. I noticed a 2006 patent application doc (not granted yet but have to keep our fingers crossed) with the same title and I include the newer claims here.. 
Notice that the claim now says poly-lactide polymers .... and Phew! this is much broader. What we need to probably check is whether PLGA is a form of poly lactic polymer.. Something else about claims. I checked the wiki on claims and there are two types of claiming system exist:
No patent system today is a purely either central or peripheral, but the system used in Germany and most of the other countries of continental Europe is considered more central than the system currently used in the United Kingdom, the United States, and especially Japan, which are more peripheral. In recent years, Japan's system has become more peripheral, while the system used in the United States has become less peripheral. So basically, based on the system used, one could also use the "specification part" of the patent doc and not just the claims part to argue the case. In BIG's case, there have broader claims in the specification part.. |
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Maxximo
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26-May-2008 13:44
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Is there a call-in Q&A session after tonite result annoucement ??? If yes, maybe PAE or bengster can call in and ka-qiao ka-qiao ... and pose all this question to them. This is better right ??? Cheers. |
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bengster68
Master |
26-May-2008 12:10
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Walau got 7 types of biodegradable polymer ah? This patent thing is very chieem. Need to ask some Chemistry expert and specialist IP legal expert. Alternatively, we should just call BIG's IR for an answer: Does your patent covers all types of limus drugs on all types of biodegradable polymer (including PLA, PGA, PGLA, etc) as suggested by some research house analysts? What drug and biodegradable polymer is specifically covered? Is JNJ's NEVO DES technically in breach? Is MDT's Zotarolimus drug on Biodegradable polymer in breach? ABSORB DES is clearly in breach so no need to ask liao. Don't bother to email, they will never reply. P-A-E, you seem to have the most in-depth knowledge about this patent thing here. Can we nominate you as the representative from SJ forum to call BIG's Senior Vice President Mr Low Chee Mun, Eric (also in charge of the IR dept) at 62135777. I think this guy can provide us all the info we need about BIG's patent. P/S: Also, ask him whether he got any employee share option or not har, how come the IR dept don't generate enuf investor awareness to make the share price chiong? 
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investor
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26-May-2008 12:02
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Conors is using the polymer call PLGA, whereas, the one that Renu mentioned is PGLA. According to one report that I read on the Conors technology, The PLGA polymer has the following characteritics : 1) Fully biodegradable in 6 mths (current formulation) 2) Degrades into naturally occuring products, lactate and glycolate 3) Different co-monomer ratios permit variable resorption times (few weeks to many months). For info only. Readers should do their own research before comitting to buy/sell. | ||
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PensionAlterEgo
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26-May-2008 11:10
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Sorry that the pictures in my earlier postings did not appear.. so I got it removed and I am resending it..... this time linking the pictures from a online free image upload website. Hope it works.. I think Sirolimus, which is Rapamycin is covered in the patent. I checked claim no 4 in the patent and found the following statement.. 
Note the red circle above states R is H.. which is same as the structure of Sirolimus at the Rxlist.com as shown below. Both R primes at 28th position O are H in the two diagrams. 
After reading the patent carefully, it appears that BIG might only be covering limus on PLA and not PLGA. Not sure why BIG did not do a more comprehensive blanket claim to include most of these common Polymer like PLGA, which was claimed (together with PLA) to be invented/used in the last 20 years. |
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PensionAlterEgo
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26-May-2008 10:10
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I found this US web site rather intriguing... http://www.stent-injury-lawyer.com/ some extract from the site.... If you or a loved one have been injured during surgical placement of a stent or have been injured as a result of an implanted drug eluting stent (drug coated stent) such as the Boston Scientific Taxus stent or the Johnson & Johnson Cypher stent you may be entitled to compensation. To learn more about the stent recalls, for information regarding your legal rights, or the possibility of a class action lawsuit contact our stent lawyers for a free, confidential, case evaluation today. Fill out our online case evaluation form or call us toll free at 1-800-856-6405. Don't play play.. can get sued u know! Maybe good for BIG to stay away from US first.. :-)
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bengster68
Master |
26-May-2008 01:44
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I think Mr Investor is right. Excel uses PLA biodegradable polymer. That means EXCEL is using BIG's S-stent metal backbone and BIG's PLA biodegradable polymer technology. Only the drug is different. BIG stated at Biomatrix DES's biodegradable polymer "biodegrades at 6 months". I think the PLA biodegradable polymer that Biomatrix uses only start to biodegrade at 6 months (if we are to rephrase the 6 months info that BIG vaguely gave) after implant and biodegrades at more than 90% at 9 months (as according to Dr Renu). BIG could have configured the PLA polymer matrix composition to set a biodegration time beginning at 6 months onwards for optimal drug release timing and duration. Optimal drug elusion quantity at the first 24hrs after implant, first one week after implant, first one month after implant and over the next few months is very crucial for the making of a good DES. Each DES manufacturer has their own set of believe in optimal drug elusion quantity and timing and configure the polymer matrix accordingly to achieve their optimal drug elusion formula. The polymer technology must be able to follow the optimal drug elusion quantity and timing that the particular DES manufacturer believe in. The 6 months after implant reminds me of a late thrombosis definition using something called "ARC definition". Blood clots within the first 6 months can happen to DES and even BMS and are considered more "normal" type of occurance. However, the late thrombosis / blood-clot scare that is plaguing DES industry now is specifically refering to those blood-clot cases after 6 months. Those post 6 months blood clots cases are often fatal. PLA, PLGA or PGLA, etc. Does BIG's patent really cover all these biodegradable polymers? Does BIG's limus drug covers only Everolimus drug and BiolimusA9 or any kind of limus family drugs? That OCBC report seems to suggest the patent covers "any limus drug on any biodegradable polymer". We got to get to the bottom of this key patent issue. If the patent fencing is narrowed significantly, this will affect the valuation of BIG significantly. If my "wide patent fencing" assumption of this patent is wrong , then i have to reassess this company's valuation liao. |
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AK_Francis
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26-May-2008 00:24
Yells: "Happy go lucky, cheers." |
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Tks for all the invaluable postinngs. The ultimate aim is to hold. If AK didn't misinterpreted. Comments pse. | ||
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investor
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25-May-2008 23:26
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I gather from one of Renu Virmani's talk or slides (in the case of Xtent symposium), that PLA degrades by more than 90 % in 9 mths, while Biolimus is gone within 6 mths, which as far as the cardiologist is concerned, is as good as 'gone'. My understanding is that the PLGA is gone within 6 mths - But I do not know whether, how is its safety in terms of inflammation, thromgenecity, etc. Biosensor's patent definitely covers Everolimus, as well as biodegradable stents using the PLA polymer (the Abbot clinical trial called ABSORB), and I think that the JWMS Excel DES definitely use the PLA polymer and is therefore are under the patent. In any case, Biosensors supply the bare metal stent, and therefore it is impossible for them to do without Biosensors' help. Our technical (or chemical )knowledge is not sufficient to know what the whole range of polymers that is mentioned in the patent is applicable to PLGA or not. For info only. |
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bengster68
Master |
25-May-2008 22:41
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I read somewhere that there are about 4 types of biodegradable polymer currently being used on DES and among all the biodegradable polymer, PLA is the safest and best for DES use. Biomatrix's PLA biodegrades after 6 months. Not sure if the 6 months means start of biodegration or end of biodegration though. If BIG's patent covers only strictly PLA biodegradable polymer, then the patent fencing is narrow and the value of this patent is lower. However, if Angiotech can successfully sue Conor for Paclitaxel even on PLGA biodegradable polymer, that means their patent fencing for the polymer is very wide to include both durable and biodegradable. However, Angiotech failed to win their court case against Axxion DES which uses Paclitaxel but without polymer use. I think BIG will definitely try to widen their patent fencing when they applied for it and i believe their patent should cover all types of limus drug on any biodegradable polymer. BIG must have their patent specialist lawyer to cover it as wide as possible on a global basis. Sirolimus is also known as rapamycin. BiolimusA9 is a derivative of sirolimus/rapamycin. I think BIG's patent also covers sirolimus on any biodegradable polymer because China JWMS's EXCEL DES also uses siolimus on a biodegradable polymer (not PLA). I heard from an expert in the DES industry that BIG technically can sue China JWMS for patent breach and perhaps this is one of the reasons why WeiGao and Dr Jack Wang agreed to let BIG buy over their shares. People may think that China has poor IP protection but i think the country is improving on this aspect, esp if the company in breach is a well respected China company like WeiGao. Of course to enforce IP and patent breach in China's 3rd or 4th tier city's backyard factories may be a problem. Maybe BIG really can legally bring China JWMS down on their knees if the JWMS shareholders refuse to sell? BIG is also not stupid to let Medtronic (which owns 15% of WeiGao and a key DES rival) to have a free ride on breaching BIG's patent. |
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investor
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25-May-2008 14:57
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Biosensors' patent no 6939376 covers 'the use of anti-restenotic, immuno-suppressive drugs, including Everolimus, in combination with a biodegradable drug-release polymer coating on an endovascular stent' as stated in their press release dated 19 sept 2005. I am not sure if this patent includes the Sirolimus drug, although an OCBC report dated 19th Jan 2007 stipulates that the patent covers 'the use of all limus derivatives for use on a biodegradable polymer in stents. It could be possible that as J & J will be using the conors' own biodegradable polmer PLGA, they may not be infringing on this patent. In other words, this patent may only apply specifically, to Everolimus, Biolimus and only in conjunction with the PLA polymer. I hope that I am wrong in this interpretation. As Renu Virmani has said in her presentation in EUROPCR, not all biodegradable polymers are created equal, and she has shown that some of the biodegradable polymers actually cause inflammation, etc, but in the case of Biosensors' polmyer PLA, it seems to be OK. Could that be the reason why Conors did not use Sirolimus in their original clinical trials, instead of using Paclitaxel ? and risk the chance of being sued by Boston Scientific ? That is, their PLGA polymer may not be suited for the Sirolimus drug. So it will be interesting to see the results of the J & J Nevo DES clinical trial. Whatever the outcome of the trial - It can only be positive for Biosensors, as it draws the attn of the public to biodegradable technology. There may not even be the need for Biosensors to to sue any party, as long their technology (using the PLA polymer and the Biolimus drug) is superior in efficacy (lower mace rates, TLR ,etc) and safety (less inflammation, better endothelial function,etc). Also, Biosensors has a headstart as they have the CE mark, while it will take J & J at least 2 yrs to get it. Above scenarios are conjectures and meant for discussions. Not an inducement to buy/see. |
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bengster68
Master |
24-May-2008 23:07
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Yes it looks like they could be shifting R&D to Singapore for tax rebates under this year's budget announcement. I think they wouldn't be tackling USA market alone and would probably look for a licensing/JV partner after Biomatrix's FDA IDE. Everything now hinges on LEADERS trial as potential licensing / JV partner to bring Biomatrix into USA market will definitely want to see the results of LEADERS trial before making a decision. If BIG announce a JV or licensing for Biomatrix in USA, that is a good news for BIG (as an independent company) but the chances of takeover will be greatly diminished. I think BIG will choose takeover as first priority but if no one can give the $3 per share offer, BIG will remain independent of go ahead with plans on the USA market. Fight with the big DES boys all the way to become a global DES powerhouse in its own capacity. There are a few key points to look in BIG for this year: 1. Better than expected Biomatrix sales. This is an evidence that people in DES industry is accepting biodegradable polymer technology and outlook for this technology looks bright commercially. BIG and licensee has very strong potential to capture a significant slice of the global market share. I would love to see Biomatrix sales of at least twice the forecasted projections (for sales before LEADERS results) and Biomatrix sales of at least 4 times the forecasted projections (for sales after LEADERS results). BIG must show that they are already doing very well in Europe and Asia markets and win over market share from DES rivals. 2. BIG must be holding at least US$250m cash. This is to show that BIG has the ability to take on global markets independently and has the financial means to do it. 3. Show first class LEADERS trial results. Most DES players do RCTs against Taxus as Taxus is obviously a weaker performance DES. If Biomatrix can even show statistical primary or secondary end-point superiority against Cypher (a better DES compared to Taxus) in massive scale clinical trial, the whole industry will know Biomatrix is really a first class product. Endeavor DES failed to meet end-point measurements when compared against Cypher. 4. USA FDA's IDE approval. This is a clear threat to existing DES players that BIG can invade into their USA homeground within the next couple of years and take away their market share. USA/Canada market is close to 40% of global DES sales. This huge North America market cannot be ignored if BIG wants to become global DES powerhouse. 5. Continue to maintain the zero case of late-thrombosis track record even after years of clinical trials. Biodegradable polymer could be the solution DES industry is desperately looking for to solve the blood-clot problems that causes decline in DES sales. Take away this blood-clot problem, the demand for DES will increase a lot more. Watch out for the above key points. If everything is happening smoothly for BIG, the $3 takeover price looks very achieveable. |
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PensionAlterEgo
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24-May-2008 22:07
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May 24th news .. what should we make out of this.. good or bad.. or perhaps moving to Singapore for cheaper tax rebates for research..?
BioSensors Downsizing Newport Beach Office HEALTHCARE: Co. focusing on other operations; pushing stent line Orange County Business Journal Staff
The company plans to cut or transfer about 80 Southern California workers with the bulk of the affected jobs at its U.S. headquarters in Newport Beach. Biosensors employs about 65 people in Newport Beach. The company also has operations in La Jolla, which could see a gain of jobs from Orange County as well as some cuts or transfers. In all, Biosensors plans to cut 40 to 50 workers. The company is likely to keep a downsized office in Newport Beach, where Chief Execu-tive Mike Kleine and Chief Financial Of-ficer Kevin Sayer work. Biosensors makes blood pressure kits, drug-eluting stents and catheters that are used during heart and other surgeries. It counts about 300 workers companywide. The company is “currently focused on Asia and Europe,” Sayer said in an e-mail. Neither Sayer nor Kleine were available for further comment last week as both were in Singapore. The company’s Newport Beach office houses administrative and engineering jobs. La Jolla has the company’s advanced engineering operations. Biosensors has offered Newport Beach and other workers a chance to transfer to La Jolla and other locations in Europe and Asia, Sayer said. Biosensors expects some workers won’t choose to stay with the company at its other offices, according to Sayer. The company has been in Newport Beach for more than four years. Stent Push Biosensors is making a big push for its drug-eluting stents, which are placed into a patient’s narrowed and diseased arteries and release drugs that help prevent blockage. Its Web site says the company is “well positioned to emerge as a leader in drug-eluting stents, an evolving therapy that is rapidly gaining market share from traditional cardiovascular therapies.” Its drug eluting-stent products include BioMatrix, Axxion and BioFreedom. Biosensors began selling BioMatrix in Europe in April. U.S. clinical trials haven’t started yet, according to the company. In 2006, the company was tapped as one of 50 to be watched by Medical Device and Diagnostic Industry magazine, according to its Web site. The magazine mentioned Biosensors’ stent, which is made of a biodegradable polymer. Domestic sales of drug-eluting stents totaled some $1.8 billion last year, according to the Wall Street Journal. Of that, Boston Scientific Corp.’s Taxus stent accounted for $1 billion in sales, while Johnson & Johnson’s Cypher accounted for $825 million in U.S. sales. But the drug-eluting stent market has hit some turbulence in recent years due to safety concerns raised by doctors. Other companies that are involved in drug-eluting stents include Medtronic Inc., whose Endeavor stent line was approved in February, and Abbott Laboratories Inc., which is testing its Xience drug-eluting stent. Biosensors works with other companies, such as Japan’s Terumo Medical Corp., a maker and marketer of more than 1,500 medical products. Terumo uses BioSensors’ BioMatrix technology in its Nobori drug-eluting stent system. Biosensors recently said it amended terms of its license agreement with Terumo. Under the deal, Terumo will pay $40 million to Biosensors’ European unit in exchange for a reduction in revenue-sharing provisions that apply to sales of the Nobori stent outside Japan. Biosensors was founded in 1990. Besides Newport Beach, La Jolla and Singapore, it has offices in India, Switzerland, the Netherlands, Germany and Japan. OC Tie Kleine assumed the chief executive role in January. He succeeded founder Yoh Chie Lu as part of a transition the company planned for once its stents were brought to market. Kleine has some history in OC. He had served as chief executive of MicroVention Inc., a maker of catheter-based devices for treating ballooning blood vessels in the brain that was based in Aliso Viejo. Terumo bought MicroVention, which had raised some $53 million in venture funding in its history, in 2006 for undisclosed terms. Kleine’s history also includes serving as chief executive of Sorin Biomedical Inc., which closed a 250-person plant in Irvine in the late 1990s. Sorin Biomedical, part of Italy’s Sorin Biomedical SPA, now has North American operations in Vancouver, British Columbia. |
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AK_Francis
Supreme |
24-May-2008 18:33
Yells: "Happy go lucky, cheers." |
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No retreat, support all the way. | ||
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bengster68
Master |
24-May-2008 16:27
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Angiotech also tried to sue BIG for patent breach on BIG's Axxion DES that uses Paclitaxel drug but without any polymer use. BIG won the suit as Axxion DES does not use any polymer so there is no breach of Angiotech's patent "Paclitaxel drug with polymer for use in DES". Patents are very powerful weapons and can be used to make DES rivals go down on their knees and beg for mercy. This is why BIG is a very attractive takeover target with "any limus drug on biodegradable polymer" patent. Limus drug is the best drug for DES use and this industry is clearly going towards biodegradable polymer usage due to its very strong potential to address late-thrombosis blood-clot problems. | ||
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bengster68
Master |
24-May-2008 16:17
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NEVO DES uses Sirolimus drug on biodegradable polymer. So this DES confirm is breaching BIG's "any limus drug on biodegradable polymer" patent. This means potential lump sum payment plus royalty from sales. BIG will only sue JNJ if NEVO DES can CE approval. No point wasting legal fees now as maybe NEVO DES will be another failure just like Costar DES. Why BIG did not sue Conor's Costar is because Costar uses Paclitaxel drug on biodegradable polymer, not a limus family drug. However, Canada's Angiotech is holding the patent of Paclitaxel drug on polymer use on DES so they instituted patent breach law suits against Conor and won sales injunction of Costar in many countries except in UK. | ||
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