SINGAPORE, Nov. 7, 2012 /PRNewswire/ -- Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG:SP; Reuters: BIOS.SI; SGX: B20), a developer, manufacturer and marketer of innovative medical devices, today announced financial results for the second quarter of fiscal year 2013 (Q2 FY13) and the fiscal six months ended 30 September 2012 (H1 FY13).
Q2 FY13 and Recent Highlights:
- Total revenue of US$79.8 million, representing 28% year-on-year growth
- Interventional Cardiology Products (IVP) sales, largely comprising drug-eluting stent (DES) sales, increased substantially by 61% year-on-year to US$61.9 million
- Gross margin on total product sales was 80%, a significant improvement of 9% year-on-year
- Operating profit reached US$33.9 million, a 71% year-on-year increase, while net profit excluding exceptional items grew 36% year-on-year to US$29.2 million
- A study published in August in the Journal of the American Medical Association (JAMA) confirms BioMatrix reduces cardiac events in acute myocardial infarction (AMI) patients more effectively than a bare-metal stent
- In October, Biosensors extended its licensing agreement with Terumo for territories outside the United States and Japan and positions itself for more strategic cooperation with Terumo in all sales territories, including Japan
- At the Transcatheter Cardiovascular Therapeutics (TCT) conference in October, the Company released the final 5-year results for its ground-breaking LEADERS trial, demonstrating improved long-term clinical outcomes for BioMatrix Flex as compared to Cypher® Select
"Despite a challenging macro-environment in the second quarter, Biosensors continued to deliver excellent operational performance. We reported 28% year-on-year growth in total revenue, underpinned by the continued robust sales growth of our DES product lines in several of our key markets, as well as the consolidation of the operating results of JW Medical System Ltd. (JWMS)," said Biosensors' CEO Dr. Jack Wang. "During the first half of this financial year, we made substantial improvements to gross margin, operating profit and net profit excluding exceptional items, all of which grew significantly on a year-on-year basis. Finally, we extended a key licensing agreement with Terumo, enhancing our strategic cooperation both in and outside of Japan."
Performance Summary for Q2 FY13
For Q2 FY13, Biosensors reported total revenue, including licensing and royalties, of US$79.8 million, a 28% increase over US$62.2 million in the second quarter of fiscal year 2012 (Q2 FY12). Correspondingly, IVP sales rose to US$61.9 million, up 61% from US$38.4 million in Q2 FY12, driven largely by the full-quarter consolidation of JWMS' results and continued growth in the sales of the Company's BioMatrix family of DES. Sales revenue of critical care products (CCP) was US$3.6 million, compared to US$3.5 million in the same period last year.
Licensing and royalties revenue was at US$14.3 million, a 29% reduction from the US$20.3 million in Q2 FY12. The reduction in royalty income was largely due to various major DES producers introducing newer products into the Japanese market in the last quarter which created a potential over stocking effect in the market.
Overall operating expense as a percentage of total revenue for the quarter was 41%, compared to 49% in Q2 FY12.
In detail, the quarter's sales and marketing (S&M) expense was US$18.3 million; general and administrative (G&A) expense was US$9.2 million; research and development (R&D) expense, which included costs for new product development and testing, clinical trials, patent registration and regulatory approval, was US$5.5 million.
For the quarter, the Group's operating profit was US$33.9 million, representing a 71% year-on-year increase compared to the same period last year.
Excluding exceptional items, which comprise fair value adjustments for warrants, net profit for Q2 FY13 would have been US$29.2 million or basic earnings per share (basic EPS) of 1.69 US cents and diluted earnings per share (diluted EPS) of 1.67 US cents. This compares to a net profit of US$21.5 million or basic EPS of 1.60 US cents and diluted EPS of 1.56 US cents, for Q2 FY12 after excluding the fair value adjustments for warrants.
Including exceptional and non-operating items, net profit for Q2 FY13 was US$28.2 million, or basic EPS of 1.63 US cents and diluted EPS of 1.61 US cents, compared to a net profit of US$22.9 million, or basic EPS of 1.71 US cents and diluted EPS of 1.66 US cents, for Q2 FY12.
Performance Summary for the First Half of FY13
Total revenue for H1 FY13 was US$166.1 million, a 39% year-on-year increase from US$119.2 million in the first half of FY12 (H1 FY12). Total product revenue in H1 FY13 was US$134.5 million, up 61% from US$83.3 million in H1 FY12. IVP revenue rose 68% to US$127.6 million, compared to US$76.1 million for H1 FY12, primarily driven by the Company's DES sales and the consolidation of JWMS' financial results starting from the third quarter of FY12 (Q3 FY12). CCP revenue was US$6.9 million.
Licensing and royalties revenue in H1 FY13 was at US$31.6 million, a 12% decrease from the US$35.9 million in H1 FY12.
Gross margin on total revenue was 84% for H1 FY13, compared to 81% in the same period last year. Gross margin on total product sales was 81% for H1 FY13, compared to 73% in H1 FY12. Product mix, geographical mix coupled with currency fluctuations, as well as overall market conditions contributed to this improvement.
Overall total operating expenses accounted for 44% of total revenue in H1 FY13, compared to 45% in H1 FY12. S&M expense was US$40.6 million, G&A expense was US$19.4 million, while R&D expense was US$11.8 million.
In H1 FY13, the Group's operating profit was US$67.6 million, representing a 56% year-on-year increase from the same period last year.
Financial Guidance for FY13
The Company maintains its full-year financial guidance. For the fiscal year ending 31 March 2013 (FY13), management anticipates total revenue to grow by 20% to 30% over the fiscal year ended 31 March 2012 (FY12), driven by continued strong DES revenue growth.
"This is our thirteenth consecutive quarter of year-on-year revenue growth all the more impressive in light of challenging global market conditions and intense competition. Our ability to continue growing and to take share from larger competitors speaks to the strengths of both our technology and our team," said Dr. Wang. "On the clinical front, the recent JAMA publication demonstrating BioMatrix's benefit in emergency cardiac interventions should help drive increased use of our DES in this complex patient group. Together with the final five-year results of our LEADERS trial, we have a strong and growing base of clinical evidence to support further growth in the use of our products to treat coronary artery disease. We will continue to pursue world-class clinical research and publications on our products. Finally, we continue to evaluate strategic opportunities to further enhance shareholder value, and we remain confident about executing our long-term growth strategies."
 Räber L et al. Effect of biolimus-eluting stents with biodegradable polymer vs bare-metal stents on cardiovascular events among patients with acute myocardial infarction. The COMFORTABLE AMI randomized trial. JAMA 2012; 308:777-787
 For more details, refer to " BioMatrix Flex Improves Clinical Outcomes Compared to Cypher® Select For Up To Five Years" Press Release dated 23 October 2012 < http://biosensors.listedcompany.com/news.html/id/321805>
About Biosensors International Group, Ltd
Biosensors International develops, manufactures and markets innovative medical devices for interventional cardiology and critical care procedures. We aim to improve patients' lives through pioneering medical technology that pushes forward the boundaries of innovation.
With the increasing use of the BioMatrix family of drug-eluting stents and the recent launch of our Axxess self-expanding bifurcation drug-eluting stent, we are rapidly emerging as a leader in the global coronary stent market. The development of the BioFreedom drug-coated stent will further reinforce our market position.
All three stents incorporate Biolimus A9 (BA9), an anti-restenotic drug developed and patented by Biosensors specifically for use with stents. Both the BioMatrix stent family and the Axxess stent feature a unique abluminal biodegradable polymer coating, which fully degrades into carbon dioxide and water after six to nine months as it releases BA9. The BioMatrix stent family features workhorse stent platforms for a broad range of lesions, and the Axxess stent employs a self-expanding stent platform specifically designed for treating bifurcation lesions. BioFreedom, a completely polymerfree stent abluminally coated with BA9, is currently undergoing clinical evaluation.
For more information, please visit www.biosensors.com.
Certain statements herein include forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the use of forward-looking terminology, such as "may," "will," "expect," "intend," "estimate," "anticipate," "believe," "project" or "continue" or the negative thereof or other similar words. All forward looking statements involve risks and uncertainties, including, but not limited to, customer acceptance and market share gains, competition from companies that have greater financial resources; introduction of new products into the marketplace by competitors; successful product development; dependence on significant customers; the ability to recruit and retain quality employees as Biosensors grows; and economic and political conditions globally. Actual results may differ materially from those discussed in, or implied by, the forward-looking statements. The forward-looking statements speak only as of the date of this release and Biosensors assumes no duty to update them to reflect new, changing or unanticipated events or circumstances.
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SOURCE Biosensors International Group, Ltd.