SINGAPORE, Feb. 7, 2013 /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 its third fiscal quarter ("Q3 FY13") and nine months ended 31 December 2012 ("FY13 nine-month period").
Financial Performance and Recent Highlights:
- In January, Biosensors received CE Mark approval for its polymer-free drug-coated stent (DCS), BioFreedom™; the Company has also commenced global patient enrollment for LEADERS FREE clinical study during the quarter
- Biosensors has signed an OEM agreement for both coronary and peripheral drug-eluting balloons which will be marketed under Biosensors' brand name. These products have obtained several regulatory approvals including CE mark and will be available to Biosensors for worldwide distribution
- Recently, the Company successfully raised S$300 million (approximately US$240 million) from the issuance of 4.875% fixed rate notes due 2017 under its S$800 million Multicurrency Medium Term Note Programme
- In Q3 FY13, Interventional Cardiology Products (IVP) sales, largely comprising drug-eluting stent (DES) sales, increased by 9% year-on-year. For the FY13 nine-month period, IVP sales grew 42% compared to the same period last year
- Total revenue for the FY13 nine-month period increased 21% over the same period last year; in Q3 FY13, total revenue declined by 4% year-on-year due to lower royalty and licensing revenue
- In Q3 FY13, gross margin on total product sales was 82%, improved from previous quarter's 80% and 70% in the same quarter last year
"We have a number of important and exciting developments recently, including the CE Mark approval of our next-generation product, BioFreedom, as well as the completion of our note offering. These are significant accomplishments as we continue to grow our company," said Biosensors' CEO Dr. Jack Wang. "In spite of a weaker pricing environment and other policy adjustments in the third quarter, we were able to outgrow several of our key markets, both for the quarter and year-to-date, due to our differentiated product combined with the execution of our sales strategy. We are also pleased to see that our gross margin has further improved. We will continue to focus on our R&D efforts to further strengthen our DES and related product offerings."
For Q3 FY13, Biosensors reported total product revenue of US$67.6 million, an 8% increase over US$62.7 million in the third quarter of fiscal year 2012 ("Q3 FY12"). Correspondingly, IVP sales rose to US$64.0 million, up 9% from US$58.7 million in Q3 FY12, driven by increased DES sales. Sales revenue of critical care products (CCP) was US$3.6 million, compared to US$4.0 million in the same period last year.
Licensing and royalties revenue was US$13.7 million, down 38% from US$22.0 million in Q3 FY12.
Gross margin on total product sales was 82% for the quarter, up from 70% in Q3 FY12 contributed mainly by geographical, product mix and economy of scale.
Overall operating expense as a percentage of total revenue for the quarter was 51%, compared to 45% in Q3 FY12.
In detail, the quarter's sales and marketing (S&M) expense was US$25.6 million; general and administrative (G&A) expense was US$9.8 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$5.6 million.
For the quarter, the Group's operating profit was US$27.2 million, comparable to the same period last year.
Excluding exceptional items, which comprise fair value adjustments for warrants, net profit for Q3 FY13 would have been US$24.3 million or basic earnings per share ("basic EPS") of 1.41 US cents and diluted earnings per share ("diluted EPS") of 1.39 US cents. This compares to a net profit of US$26.8 million or basic EPS of 1.63 US cents and diluted EPS of 1.60 US cents, for Q3 FY12 after excluding the one-off non-operating gain of $279.6 million on re-measurement of the Group's interest in JWMS, goodwill impairment and the fair value adjustments for warrants.
Including exceptional items, net profit for Q3 FY13 was US$24.9 million, or basic EPS of 1.45 US cents and diluted EPS of 1.43 US cents, compared to a net profit of US$291.5 million, or basic EPS of 17.78 US cents and diluted EPS of 17.42 US cents, for Q3 FY12.
Performance Summary for FY13 Nine-month Period
Total product revenue in the FY13 nine-month period was US$202.1 million, a 38% year-on-year increase from US$146.0 million reported for the fiscal nine months ended 31 December 2011 ("FY12 nine-month period"). IVP revenue rose 42% to US$191.6 million, compared to US$134.9 million for the FY12 nine-month period, primarily driven by the Company's DES sales and the consolidation of JWMS' financial results starting from Q3 FY12. CCP revenue was US$10.5 million, a 6% decrease from the US$11.2 million for the FY12 nine-month period.
Overall total operating expenses accounted for 46% of total revenue in the nine months of FY13, compared to 45% for the FY12 nine-month period. S&M expense was US$66.2 million, G&A expense was US$29.2 million, while R&D expense was US$17.5 million.
For the FY13 nine-month period, the Group's operating profit was US$94.7 million, representing a 34% year-on-year increase from the same period last year.
Financial Guidance for FY13
Year-to-date, the Company has achieved healthy growth in its product sales, in line with the original target. However, due to changes in the dynamics of the Japanese market, including regulatory imposition and new products from competitors, licensing revenue from Terumo Corporation (Terumo) for the sales of the Nobori DES was adversely affected in the first nine months of the fiscal year. As such, management is adjusting its guidance for total revenue for the fiscal year ending 31 March 2013 (FY13) to a 15% to 20% growth over FY12, driven by continued strong DES revenue growth in the key markets managed by the Company, but offset by a decrease in licensing revenue.
"We will leverage our experience in the international markets, along with the positive clinical results we achieved, to work closely with Terumo to strengthen Nobori's competitive position in Japan, aiming at increasing the product's market share and our royalty revenue. In China, we have seen that the tendering process has accelerated, which will inevitably create some short-term disruptions. However, this will remove the overhanging uncertainty on the future of this important market. At the same time, we will also introduce new products to improve our overall sales revenue in China. For the rest of the world, we continued to perform well in Europe and Asia Pacific, with strong year-on-year growth outpacing the market," said Dr. Wang. "During the quarter, we successfully raised approximately US$240 million from the bond offering. Coupled with our existing financial resources, we accumulated more than US$570 million of cash and cash equivalents. We are in various stages of discussions with several potential M&A targets, some of these discussions being near completion. We believe these possible transactions, once concluded, can further expand our product offering. Such efforts can substantially increase our shareholder value and take Biosensors to the next level."
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 polymer‐free 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.