April 23, 2013 -- Lifeline Scientific, the medical technology company, announces results for the twelve months ended 31 December 2012. Lifeline is focused on developing technologies to help improve clinical outcomes in transplantation. Its lead product, LifePort® Kidney Transporter, is a clinically proven, market leading renal preservation and transport system designed to address the global challenge of human donor organ shortages.
Financial Highlights
• Total Revenue for the period US$30.2 million (2011: US$25.4 million) with Revenue from Transplantation products and services increased by 20% to US$29.1 million (2011: US$24.2 million)
-- Revenue from single-use disposables increased by 20% to US$27.8 million (2011: US$23.1 million)
• Revenue from outside North America increased 140% from US$2.2 million to US$5.3 million, driven by investments targeted at geographic expansion
-- Initial sales of US$1.3 million recorded in Brazil
• Gross Profit increased 12.8% to US$18.3 million (2011: US$16.2 million) demonstrating the underlying growth in the business
• Operating profit decreased to US$0.1 million (2011: US$1.9 million), or US$1.3 million before non-recurring items, reflecting planned strategic investments in product development and geographic expansion
o R&D spending increased to US$3.2 million in 2012 (2011: US$2.4 million), reflecting the progression of the LifePort Liver Transporter development
• Cash of US$5.7 million at the period end (2011: US$9.4 million)
Operational Highlights
• Commenced the sale of LifePort Kidney Transporter 1.1 which includes several important new features including embedded GPS and enhanced data capture of key organ performance measures
• Regulatory approval received from Brazil for the company’s complete line of products and first commercial sales recorded despite ANVISA public strike in June-September 2012
-- First two LifePort clinical programmes in Brazil were established in the states of Ceara and Rio
• Regulatory approval received at year-end in the nation of Colombia, a growing market in renal transplantation, for LifePort Kidney Transporter, disposables and solution product line
• Progressed LifePort’s full portfolio of products through SFDA registration in China in 2012, with approval anticipated for summer 2013, and pre-approval sales recorded
• Commercial prototype of LifePort Liver Transporter presented at the 24th International Congress of The Transplantation Society in Berlin
• Secured a national UK tender for an initial 2400 litre order of Lifeline’s SPS-1, a market leading solution used in organ transplant procedures, and invitation to bid on UK national multi-year tender
David Kravitz, Chief Executive Officer of Lifeline, said:
“2012 has been an important year for Lifeline, during which we have made significant progress towards our twin growth objectives of geographical expansion for our LifePort Kidney Transporter product line and continued efforts to deliver market-driven enhancements to our existing product lines and develop new products.
I have been particularly satisfied with the regulatory and commercial traction we achieved in Brazil, where the attainment of regulatory approval for our full suite of LifePort Kidney Transporter products enabled nation-wide market access and the recording of our first sales in one of the world’s largest national transplant markets. Likewise, our efforts toward obtaining regulatory clearances in China for our full suite of Kidney transplant products have progressed well. I am also pleased to say that the commercial prototype of LifePort Liver Transporter was presented for the first time at the 24th International Congress of The Transplantation Society in Berlin and received a strong positive reception, marking a meaningful step in our commitment to developing additional technologies to improve donor organ availability and transplantation outcomes.
I remain confident that the marked increase in sales recorded outside of North America, along with the progress made on key product development efforts underscores the importance of the strategic investments we have made throughout 2012 and how these investments can accelerate revenue growth, profitability and shareholder value.”
For further information please contact:
Lifeline Scientific, Inc. +1 847-294-0300
David Kravitz, CEO
Panmure Gordon +44 (0)20 7886 2500
Freddy Crossley (Corporate Finance)
Adam Pollock / Victoria Boxall (Corporate Broking)
FTI Consulting
Simon Conway / John Dineen +44 (0)20 7831 3113
About LifePort Kidney Transporter
Created with the challenges of organ recovery and transport in mind, LifePort Kidney Transporter is a proprietary medical device designed to provide improved kidney preservation, evaluation and transport prior to transplantation. Today, it is widely recognised as the world’s leading machine preservation device for kidneys. Employed by surgeons in over 140 leading transplant programmes in 25 countries worldwide, LifePorts have successfully preserved over 40,000 kidneys intended for clinical transplant. The product provides a sealed, sterile, protected environment where a solution is gently pumped through the kidney at cold temperatures to minimise damage while the organ is outside the body. LifePort is lightweight and portable, allowing organs to be perfused from the time of recovery until transplant. It is designed to travel unaccompanied by land or air, safely transporting the kidneys across town or between countries. While the kidney is being perfused, LifePort records data on temperature, flow rate, vascular resistance and pressure every 10 seconds providing surgeons with additional data prior to transplant. LifePort is the only system with clinical outcomes data produced from an independent, prospective, randomised, statistically powered, multi-centre clinical trial. Study results have been widely published in scientific journals, including the New England Journal of Medicine. Data indicates that patients receiving LifePort preserved kidneys experienced significant reduction in the incidence and duration of delayed graft function and increased graft survival at 1-year and 3-years post transplant. LifePort has also been recognised for its design and engineering. It has received prominent awards for design excellence from the medical device industry, has been selected for exhibition at the Smithsonian Cooper-Hewitt, National Design Museum and is part of the permanent Collection of The Museum of Modern Art (MoMA) in New York City.
Upcoming events
Expected mailing date for the annual report: 14th May 2013. It will also be available on the Company website, www.lifeline-scientific.com.
Date of Annual General Meeting: 12th June 2013.
About Lifeline Scientific Inc.
Lifeline Scientific, Inc. is a Chicago-based global medical technology company with regional offices in Brussels and Sao Paulo. The Company’s focus is the development of innovative products that improve transplant outcomes and lower the overall costs of transplantation. Its lead product is the market-leading and clinically validated LifePort Kidney Transporter. Devices for preservation of the liver, pancreas, heart and lung are in late stage pre-clinical development.
Victoria Foster Mitchell
Senior Consultant
Strategic Communications
F T I Consulting
+44 (0)20 3077 0486 direct
+44 (0)7816 944 230 mobile
Victoria.FosterMitchell@fticonsulting.com
Holborn Gate, 26 Southampton Buildings
London, WC2A 1PB
www.fticonsulting.com
