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2861-2880 of 10899
Axxess™ Self-Expanding Bifurcation Drug-Eluting Stent
San Francisco, USA, 8 November 2011
AXXESS PLUS is a prospective, single-arm multi-center study involving 139 patients at 13 clinical sites in Europe, South America and New Zealand. 117 patients were followed-up through five years. In addition to Axxess implantation in the proximal parent vessel, conventional stents could be implanted in the distal parent vessel and/or the side branch at the discretion of the operator. In over 76% of cases, the additional stent implanted was sirolimus-eluting. 23% were non-sirolimus DES, and less than 1% were BMS.
Axxess implantations in the parent vessel achieved high levels of procedural and angiographic success (94.9% and 100% respectively). At five years post-procedure, the cumulative rate of MACE (a composite of cardiac death, MI, emergent cardiac artery bypass graft (CABG) and clinically-driven target lesion revascularization) was 19.7%. The occurrences of the individual components were 3.4% for cardiac death, 9.4% for MI, and 12.8% for clinically-driven TLR (there were no incidences of emergent CABG). There were no cases of definite and/or probable VLST (Very Late Stent Thrombosis) observed, as defined by ARC.
" These results confirm that this new dedicated bifurcation DES is both safe and effective in the long term for the treatment of bifurcation lesions," commented Professor Grube. " This is particularly impressive considering that these types of lesion are associated with higher complication and restenosis rates than conventional lesions."
" We have already conclusively demonstrated the patient benefits of a stent which releases Biolimus A9 from a biodegradable polymer coating with our increasingly popular BioMatrix stent family" , added Jeffrey B. Jump, Co-CEO of Biosensors. " Now with Axxess, physicians have the option of using the same proven technology with a stent platform specifically designed for bifurcation lesions." - Biosensors International Group, Ltd. (" Biosensors" , " Company" , Bloomberg: BIG SP) has announced final results of the AXXESS PLUS trial, which demonstrated the long-term efficacy and safety of the Axxess™ stent in the treatment of patients with coronary bifurcation lesions. Axxess is a self-expanding bifurcation stent which releases Biolimus A9™ from an abluminal biodegradable polymer coating. Results will be presented today by Professor Eberhard Grube, University Hospital Bonn, Germany, at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
The Axxess bifurcation DES consists of a self-expanding, nitinol (nickel/titanium) stent platform specifically designed to conform to the shape of the bifurcation anatomy. It has been tailored to reconstruct the bifurcation without creating a false carina, lowering the risk of uncovered struts at the flow divider. The Axxess stent is abluminally coated with a biodegradable poly-lactic acid (PLA) polymer that releases Biolimus A9™ (BA9™), an anti-restenotic drug developed and patented by Biosensors specifically for use with drug-eluting stents. BA9 is a vital component of the BioMatrix Flex™ DES system, which has been proven safe and efficacious in the landmark " all-comers" LEADERS study.
Biosensors received CE Mark approval for Axxess in April 2011, supported by the positive nine-month results from the DIVERGE trial, which were published in the Journal of the American College of Cardiology (JACC) in March 2009. These demonstrated low overall rates of MACE (7.7%), restenosis (0.7%) and late stent thrombosis (0.3%) in patients treated with Axxess. Three-year data from the DIVERGE trial, presented at EuroPCR in May 2011, confirmed that low overall rates of MACE (16%) and VLST (1%) were maintained over the long term.
Axxess is now available in certain markets in Europe and Asia.
Shown To Be Safe and Effective Up To Five Years
Buy Biosensors
Entry: $1.42
Stop-Loss: $1.37
Target: $1.52
More on my Blog at Alex Trades.
Good luck.
Lau Lan we are talking about sale growth form 50-60% guidance to move up 70-80%.
Do do not get your point of price drop of 50%. at this junction of company growth and sales
gain of market share.
RESEARCH ALERT-Nomura ups Biosensors target to S$1.70
SINGAPORE | Thu Nov 3, 2011 12:55am EDT
SINGAPORE Nov 3 (Reuters) - Nomura has raised its target price for Singapore-listed medical technology firm Biosensors International Group Ltd to S$1.70 from S$1.65 and kept its buy rating.
STATEMENT:
Nomura has raised its earnings estimates for Biosensors in fiscal 2012-2014 by 2-5 percent, after it reported second quarter earnings that were ahead of the brokerage's expectations.
Biosensors said on Wednesday its second quarter net profit more than doubled to $22.9 million, up from $8.5 million a year ago.
The brokerage also noted that Biosensors' management has raised its guidance for sales to grow by 70-80 percent in fiscal 2012, up from 50-60 percent previously.
Further market share penetration by Biosensors international
(ocbc)
Biosensors International Group (BIG) reported its 2QFY12 results with revenue rising 70.5% YoY and 9.0% QoQ to US$62.2m. Its net profit saw a surge of 171.0% YoY but a decline of 10.8% QoQ to US$22.9m. 1HFY12 revenue and net profit (excluding exceptional items) of US$119.2m and US$45.7m met 42.0% and 43.4% of our full-year forecasts, respectively. This was largely within expectations as 2H is seasonally stronger for BIG and the group would also be fully-consolidating JW Medical Systems (JWMS) into its financials from 3QFY12.
BIG’s earnings momentum was underpinned by its BioMatrix DES sales, which saw further market share penetration, as well as strong licensing revenue. Management also revised upwards its guidance for FY12 revenue growth to the range of 70%-80% (previously 50%-60%). As we incorporate the latest figures in our assumptions, our DCF-derived fair value inches up marginally to S$1.87 (previously S$1.86). Maintain BUY.
BIOSENSORS REPORTS CONTINUED STRONG SALES AND EARNINGS GROWTH
Singapore 2 November 2011 - Biosensors International Group, Ltd. (" Biosensors" or the " Company" , Bloomberg: BIG SP), a developer, manufacturer and marketer of innovative medical devices for interventional cardiology and critical care procedures, today announced financial results for the second quarter of fiscal year 2012 (" Q2 FY12" ) and the fiscal six months ended 30 September 2011 (" H1 FY12" ).
Q2 FY12 Performance Highlights: Consecutive 12 quarters of high revenue growth with total revenue reaching US$62.2M (71% year-on-year growth) IVP" ) recorded robust year-on-year increase of 31% at US$38.4M, driven primarily by the strong sales of the Company’s flagship BioMatrix™family of drug-eluting stents (" DES" ) JWMS" ) on 3 October 2011 2 of 4
Licensing and royalties revenues in Q2 FY12 grew to US$20.3 million, a year-on-year increase of 404% from US$4.0 million.
Gross margins on total product sales were 71% for the quarter, compared to 76% in Q2 FY11. Currency fluctuations, overall industry market conditions and changes in geographical product mix contributed to this difference.
Our overall operating expenses as a percentage of total revenue for Q2 FY12 was 49% compared to Q2 FY11’s 53%.
In detail, for Q2 FY12, sales and marketing (" S& M" ) expenses were US$12.2 million compared to US$11.4 million in Q2 FY11. General and administrative (" G& A" ) expenses were US$6.3 million compared to US$4.5 million in Q2 FY11. Research and development (" R& D" ) expenses, which include costs for new product development and testing, clinical trials, patent registration and regulatory approval, were US$4.3 million compared to US$3.3 million in Q2 FY11.
The equity method of accounting for the Company’s 50% ownership interest in JWMS resulted in a net income of US$4.0 million in Q2 FY12, compared to US$4.6 million for Q2 FY11.
For the quarter, the Group reported a net profit of US$22.9 million or 1.71 US cents basic earnings per share (" basic EPS" ) and 1.66 US cents diluted earnings per share (" diluted EPS" ), compared to a net profit of US$8.5 million or basic EPS of 0.79 US cents and diluted EPS of 0.76 US cents for Q2 FY11.
Excluding the fair value adjustments for warrants, net profit for Q2 FY12 would have been US$21.5 million or basic EPS of 1.60 US cents and diluted EPS of 1.56 US cents. This is compared to a net profit of US$11.2 million or basic EPS of 1.04 US cents and diluted EPS of 1.00 US cents for Q2 FY11 after excluding the fair value adjustments for warrants.
H1 FY12 Performance Summary
Total product revenues in H1 FY12 were US$83.3 million, up 35% from the US$61.8 million reported in the fiscal six months ended 30 September 2010 (" H1 FY11" ). IVP revenues rose 37% to US$76.1 million compared to US$55.7 million for H1 FY11, primarily driven by the Company’s DES sales. CCP sales were US$7.2 million, an 18% increase from US$6.1 million in H1 FY11.
For H1 FY12, S& M expenses were US$28.3 million compared to US$20.8 million in H1 FY11. The increases were mainly due to expenses associated with product revenue growth including payroll, warehousing and trade shows. G& A expenses were US$12.4 million compared to US$9.0 million in the previous year’s corresponding period. The increases were mainly due to higher patent renewal fees and payroll expenses. R& D expenses were US$8.7 million compared to US$6.5 million in H1 FY11. The increases were mainly due to increased R& D activities and clinical trial expenses.
H1 FY12’s overall total operating expenses over total revenue was 45% compared to H1 FY11’s 53%. Page 3 of 4
The equity method of accounting for the Company’s 50% ownership interest in JWMS resulted in a net income of US$8.0 million in H1 FY12 compared to US$9.8 million in H1 FY11. The Company successfully completed its acquisition of the remaining 50% equity interest in JWMS on 3 October 2011, and will consolidate JWMS’ operating results from the second half of its fiscal year 2012 (" H2 FY12" ).
For H1 FY12, the Group reported a net profit of US$45.5 million or basic EPS of 3.39 US cents and diluted EPS of 3.30 US cents, compared to a net profit of US$11.7 million or basic EPS of 1.09 US cents and diluted EPS of 1.05 US cents for H1 FY11. Excluding the fair value adjustments for warrants, net profit for H1 FY12 would have been US$45.7 million or basic EPS of 3.40 US cents and diluted EPS of 3.32 US cents. For H1 FY11, excluding the fair value adjustments for warrants and the restructuring charges recorded, net profit would have been US$21.1 million or basic EPS of 1.96 US cents and diluted EPS of 1.90 US cents.
As a result of the robust performance for H1 FY12, the Company expects its full year FY12 total revenue, which will include the consolidation of JWMS’ operations from H2 FY12, to be 70% – 80% higher than its full year FY11 total revenue. This is an upward revision from the previous guidance of 50% – 60% growth in total revenue over FY11.
" We see a strong momentum, evidenced by our continued growth in worldwide market sales quarter after quarter and leading technology development, to carry Biosensors to a higher level of success. Hence, we revised our total revenue guidance to 70% – 80% for this fiscal year," concluded Co-CEO Dr. Jack Wang. " The completion of our acquisition of JWMS, and having Shandong Weigao become one of our key shareholders as a result, will strengthen the Company’s long-term position in China, the world's fastest-growing DES market."
The Biosensors board has today established a strategic corporate development, corporate governance and investor relations sub-committee, which will be chaired by Mr. Jiang Qiang, our non-executive board member. The objective of this committee is to enhance the strategic positioning of Biosensors as a growing medical technology company.
Sales of Interventional Cardiology Products ("
Net profit increased 171% year-on-year to US$22.9M
Completed acquisition of the remaining 50% equity in JW Medical Systems Limited ("
Terumo Corporation, the Company’s licensing partner, continues to record strong revenue growth after it commenced sales of the Nobori DES in Japan in May. This led to a five-fold increase in licensing revenue, year-on-year, for the Company
" This past quarter is the first to fully include Japanese revenues from our licensing partner Terumo. We are delighted to see this significant year-on-year increase resulting from their successful penetration of the Japanese market," commented Co-CEO Mr. Jeffrey B. Jump. " At the same time, our own product sales have continued their strong growth, led by increased sales of interventional products, particularly our BioMatrix™DES family. We continue to expand our market share in all the territories where BioMatrix is currently available, and are confident that this growth will continue."
For Q2 FY12, Biosensors reported total revenue, including licensing and royalties, of US$62.2 million, a 71% increase over the US$36.5 million reported in the second quarter of fiscal year 2011 (" Q2 FY11" ). IVP sales rose to US$38.4 million, up 31% from US$29.4 million in Q2 FY11, largely due to the continued growth in sales of the Company’s BioMatrix™family of DES. Sales of critical care products (" CCP" ) reached US$3.5 million, an increase of 13% from US$3.1 million in Q2 FY11. Page
IN THE SECOND QUARTER OF FISCAL YEAR 2012
Q2 result is definitely good but the most stunning i think they might lift their forecast from 50-60% to 100% for the FY 2012. In Q1 result presentation slide, they mention the following guidance on 27/07/2011
FY2012 total revenue is 50-60% higher than FY2011(ended in March 2011). OCBC has a recent tgt price of 1.86 and reason for that is Japan mkt sale beyond expectation. This is very possible due to Terumo influence in Japan and heard that terumo capture 50% of the mkt. Morever J& J in Japan is no more in stent buisness.
selling stent is like selling humburger... hahaha
This stock is definitely for long haul.
junction ( Date: 27-Oct-2011 21:39) Posted:
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cwwan1 ( Date: 27-Oct-2011 17:32) Posted:
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Result will be stunning!
Better get back in as good result on 2 nov
Date of Release of Second Quarter and First Half Financial Results for the Fiscal Year Ending 31 March 2012
Biosensors International Group, Ltd (" Biosensors" or the " Company" ) will announce its results for the second quarter and first half of its financial year 2012 ended 30 September 2011 on 02 November 2011, after trading hours.
Co-CEOs Dr. Jack Wang and Mr. Jeffrey B. Jump, and CFO Mr. Ronald H. Ede will host an analyst conference call on that day at 5.30 pm (Singapore Time) to discuss the financial results and provide an update on the Company’s progress.
A live webcast of the audio conference will be available through the corporate website
bishan22 ( Date: 11-Oct-2011 10:08) Posted:
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Wow I would buy at below 1.20, depending on general market of course.
It has good long term potential.
JesseTyler ( Date: 16-Oct-2011 17:21) Posted:
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OCBC Research
Biosensors International Group: On a growth trajectory
Summary: We believe that Biosensors International Group (BIG) is set to make further headways in China’s growing DES market, following the recent completion of its acquisition of JWMS (remaining 50% stake). Furthermore, there is also the possibility of an upside surprise on its licensing revenue front, underpinned by the strong initial penetration made by Terumo Corp’s Nobori DES (incorporates BIG’s DES technology in exchange for a royalty fee) after its launch in Japan in May 2011. We raise our core earnings estimates for FY12 and FY13 by 11.1% and 9.6% respectively, largely on the back of higher market share gains assumption by the Nobori DES in Japan. Coupled with the recent appreciation of the USD against the SGD, we derive a higher FCFE-based fair value estimate of S$1.86 (previously S$1.68). Maintain BUY.
Jessee:
Thank you for your opinion. On what do you base your " feelings" ?
When compared with other stocks in the " interventional" space with such a high growth rate, especially focused on high growth A/P market, it appears greatly undervalued. Other exchanges (Hong Kong, United States, Europe) would give it a much higher value.
Tell me Jessee, do you play this counter?