QT VASCULAR REPORTS 9M2015 REVENUE OF US$9.1M
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1 MEDIA RELEASE QT VASCULAR REPORTS 9M2015 REVENUE OF US$9.1M Highlights: Gross profit margin improved to 35.4% in 9M2015, up from 12.6% in 9M2014 Working capital position will strengthen with conversion of convertible bonds into ordinary shares Chocolate Touch expected to be launched in new markets later this year following CE mark clearance SINGAPORE, 9 November 2015 QT Vascular Ltd., together with its subsidiaries ( QT Vascular or the Group ), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today revenue and net loss attributable to shareholders of US$9.1 million and US$45.3 million respectively, for the nine months ended 30 September 2015 ( 9M2015 ). The results were impacted by the one-off recognition of the entire sum of the AngioScore litigation judgement expenses of US$20.4 million being damages awarded against QT Vascular, TriReme Medical, LLC, Quattro Vascular Pte. Ltd., and the Group s CEO, Dr Eitan Konstantino, following a court decision in relation to the State Law Claims in July The final sum to be borne by the Group in relation to the State Law Claims will be determined at the conclusion of the appeal which the Group intends to file. With regard to the Patent lawsuit, the Group announced on 30 September 2015, that following a positive outcome in the Spectranetics/Angioscore Patent trial, the Group can continue to make and sell Chocolate PTA without impediment under its own independent intellectual property and does not expect to incur any liability on the Patent Claim. Dr. Eitan Konstantino, Ph.D., Chief Executive Officer of QT Vascular added, Operationally, the Group has continued to make progress in efficiency and commercialising our range of products. At this stage of the Company s development, we are grateful to have secured funding via the issue of the first tranche of convertible bonds in July With certain Page 1 of 5
2 bond holders exercising their rights to convert their bonds to ordinary shares in October 2015, our working capital position will strengthen. For the three months ended 30 September 2015 ( 3Q2015 ), the Group recorded revenue and net loss attributable to shareholders of US$2.5 million and US$33.3 million respectively. Geographically, 91.9% of sales came from the United States ( US ), 6.6% from Asia and 1.5% from Europe. Revenue was 26.7% lower in 3Q2015 mainly due to a decrease in sales of Chocolate PTA Balloon Catheter ( Chocolate PTA ) to Cordis Inc. ( Cordis ) as the Group only finalized renegotiating the terms of the distribution agreement with Cordis on 18 September Under the revised agreement with Cordis, the Group is allowed to sell the Chocolate PTA to a select group of 88 healthcare providers in the US effective immediately. Previously, Cordis was the sole distributor of the Group s Chocolate PTA in the US. Sales of Chocolate PTCA Balloon Catheter ( Chocolate PTCA ) and Glider PTCA by our direct sales team continued to improve, delivering a 289.2% increase in average sales per sales representative of US$56,120 in 3Q2015 as compared to US$14,418 in 3Q2014. Gross profit rose 60.8% to US$1.1 million in 3Q2015, compared with US$669,000 in 3Q2014. This was mainly due to improvements in overall production efficiency, with gross profit margin higher at 43.4% in 3Q2015, up from 19.8% in 3Q2014. Net loss attributable to shareholders reached US$33.3 million in 3Q2015, compared with US$3.7 million in 3Q2014. This was mainly due to an increase in sales and marketing expenses, administrative expenses, research and development expenses and derivatives in relation to the convertible bonds as well as the judgement liability expenses in relation to the State Law Claims. Corporate Developments Recent appointments to the Board are as follows: a) Mr Toe Teow Heng was appointed as Non-Independent Non-Executive Chairman of the Company with effect from 19 October 2015, replacing Mr Mark Allen Wan, who has been redesignated as a Non-Independent Non-Executive Director of the Company. b) Mr Sho Kian Hin was appointed as an Independent Director of the Company with effect from 25 September c) Mr Gary Ng Sin Tong was appointed as an Executive Director of the Company with effect from 6 August Page 2 of 5
3 On 7 September 2015, the Group announced that it received the CE mark clearance for its unique peripheral drug-coated balloon, Chocolate Touch. Interim clinical trial results from ENDURE, the first study of Chocolate Touch, revealed positive outcomes, including low rate of bail out stenting, lumen loss and re-intervention at six months, as announced on 5 October This is expected to bode well for long-term growth prospects and continued strong interest for the product. Commercial launch of Chocolate Touch in countries that are accepting CE mark is expected to commence later this year. In August 2015, final results from below-the-knee ( BTK ) cohort in the Chocolate Balloon Angioplasty Registry presented at the 5 th Annual Amputation Prevention Conference show that BTK patients treated with Chocolate PTA in this study showed a lower rate of unplanned stenting, a lower rate of repeat interventions, a lower incidence of amputation and lower overall mortality. Business Outlook In the world s largest medical device market, the US, the adoption of drug-coated balloons ( DCBs ) continues to increase at a strong pace. With two products approved in the US (Medtronic s In.Pact Admiral and CR Bard s Lutonix) and continued strong clinical data (which now covers up to two years in some studies), Management expects this continued growth in the use of DCBs to continue for some time. Some analysts estimate that the use of DCBs may reach 20% of procedures in the femoralpopliteal arteries. The impact on other technologies such as stents, atherectomy, conventional balloons, and specialty is still unclear, but these categories may be expected to experience some weakening of their previous sales growth. In fact, the Group has experienced some flattening of its shipments to its US distributor, Cordis (which was the result of Cordis s recent acquisition by Cardinal Health, Inc. as well as our renegotiation of the distribution agreement). An additional short-term challenge is a possible delay in the approval of Chocolate PTA in Japan from late 2015 until 1H2016. Despite these near-term headwinds, the Group expects FY2016 growth to be driven by continued adoption of its Chocolate PTCA device in the US, the launch of Chocolate Touch (drug-coated Chocolate PTA) in Europe and the launch of Chocolate PTA in Japan. ~~ End ~~ This press release is to be read in conjunction with the Company s announcement posted on the SGX website on 6 November Page 3 of 5
4 ABOUT QT VASCULAR LTD. (SGX Stock code: 5I0) QT Vascular Ltd. together with its subsidiaries ( QT Vascular or the Group ), is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. QT Vascular works closely with leading physicians and scientists from around the world to create differentiated devices that improve procedural and clinical outcomes. QT Vascular is based in Singapore with a US subsidiary, TriReme Medical LLC ( TriReme Medical ), based in Pleasanton, California. TriReme Medical s range of percutaneous transluminal angioplasty ( PTA ) and percutaneous transluminal coronary angioplasty ( PTCA ) products include (i) Chocolate PTA Balloon Catheter, (ii) Chocolate PTCA Balloon Catheter, (iii) GliderXtremeTM PTA Balloon Catheter, (iv) GliderfleX PTA Balloon Catheter and (v) Glider PTCA Balloon Catheter, all of which have the CE Mark that allows them to be sold in Europe, and FDA clearance to be sold in the United States. Additionally, the GliderXtreme PTA Balloon Catheter has the regulatory clearance in China and Japan, while the Glider PTCA Balloon Catheter has the regulatory clearance in Japan. These products are mainly sold through its main distributors: (i) Cordis Corporation (a wholly-owned subsidiary of Cardinal Health, Inc.), (ii) Shandong Weigao Group Medical Polymer Co Ltd and (iii) Century Medical, Inc. For more information, please visit the company website at Issued on behalf of QT VASCULAR LTD. by: WATERBROOKS CONSULTANTS PTE LTD Tel: For media and analysts, please contact: Mr Wayne Koo (M): wayne.koo@waterbrooks.com.sg Ms Lynette Tan (M): lynette@waterbrooks.com.sg Ms Angeline Cheong (M): angeline@waterbrooks.com.sg Page 4 of 5
5 Cautionary Note on Forward-Looking Statements All statements other than statements of historical facts included in this announcement are or may be forward-looking statements. Forward-looking statements include but are not limited to those using words such as expect, anticipate, believe, estimate, intend, project, plan, strategy, forecast and similar expressions or future or conditional verbs such as if, will, would, should, could, may and might. These statements reflect the Company s current expectations, beliefs, hopes, intentions or strategies regarding the future and assumptions in light of currently available information. Such forward-looking statements are not guarantees of future performance or events and involve known and unknown risks and uncertainties. Accordingly, actual results may differ materially from those described in such forward-looking statements. Shareholders should not place undue reliance on such forward-looking statements, and the Company undertakes any obligation to update publicly or revise any forward-looking statements, subject to compliance with all applicable laws and regulations and/or the rules of the SGX-ST and/or any other regulatory or supervisory body or agency. QT Vascular Ltd. (the Company ) was listed on Catalist board of the Singapore Exchange Securities Trading Limited (the "SGX-ST") on 29 April The initial public offering of the Company was sponsored by PrimePartners Corporate Finance Pte. Ltd. (the "Sponsor"). This press release has been prepared by the Company and its contents have been reviewed by the Sponsor for compliance with the SGX-ST Listing Manual Section B: Rules of Catalist. The Sponsor has not verified the contents of this press release. This press release has not been examined or approved by the SGX-ST. The Sponsor and the SGX-ST assume no responsibility for the contents of this press release including the accuracy, completeness or correctness of any of the information, statements or opinions made or reports contained in this press release. The contact person for the Sponsor is Ms Gillian Goh, Director, Head of Continuing Sponsorship, at 16 Collyer Quay, #10-00 Income at Raffles, Singapore , telephone Page 5 of 5
Page 1 of 7. 1 Based on an exchange rate of US$1 = S$1.272
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