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Results presentation
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Financial Highlights
Revenue up 23% at £2.49 million (2008: £2.02 million); underlying income (excluding Med One revenue) up 38%
Recurring revenue increased 41% to £1.63 million (2008:£1.16 million)
Gross profit up 12% to £1.51 million; gross margin 61% (2008: 68%)
Operating loss (based on 2008 foreign currency rates) down 11% to £964,000; actual operating loss £1.19 million (2008: £1.09 million)
£3.02 million (net) of equity raised in the period
Cash balance of £2.54 million. Borrowings reduced to £400,000
Loss per share 0.74p (2008: 0.71p)
USA sales up by 233% at £1.16 million (2008: £348,000), with a rise of 157% in recurring disposables income
Product margins remain healthy: 50% on monitors and 89% on disposables
Operational Highlights
Substantial progress with distributor arrangements in world’s three biggest markets:
US: Aspect Medical appointed for whole of the USA in July; reduces direct sales costs by £0.65 million per annum,
Japan: Grant of Japanese sales and marketing license for the LiDCOrapid to Becton, Dickinson and Company in April
Germany – Absolute Medical appointed as a distribution partner in March<
Combined up-front license fees of US$1.5 million
Sensors, Smartcard and fees-per-use volumes up 53% to 21,083 units (2008: 13,788 units)
Monitors sold or placed in the period were up by 78% to 280 units (2008: 157 units)
The installed monitor base is up by 19% in the period to 1,790 units
Significant increase in level of recurring revenue - up in all territories - now represents 69% of product income
Selected as sole technology for OPTIMISE - UK Government sponsored multi-centre surgical outcomes study
Second generation LiDCOrapid v1.02 software launched
Post period highlight
Covidien (NYSE: COV), a leading global healthcare products company, has entered into a definitive agreement to acquire Aspect Medical Systems, Inc.
Commenting on the results Terry O’Brien, Chief Executive, said:
“In the last six months LiDCO has entered into three significant partnershipsgiving us fuller access to the three largest markets in the world - United States, Japan and Germany. There is a growing demand worldwide for minimally invasive monitoring technology and the clinical community is showing an increasing recognition for the LiDCO brand. The Company is in a very strong position to take full advantage of this opportunity, we now have the right products and distribution partners to achieve significant growth. We continue to make progress on many fronts and LiDCO remains on track to deliver a maiden profit in the coming full year."
The Company presentation will be available from today on the LiDCO website (www.lidco.com).
The first six months of this year have been highly productive for LiDCO, despite challenging global economic conditions. The Company is making excellent progress and has seen significant growth in revenues, distribution reach and a substantial growth of the monitor installed base.
Financials
We are pleased to report sales are up 23% to £2.49 million (2008: £2.02 million) despite a worldwide background of reduced capital spend by hospitals. Recurring disposable revenue sales are encouragingly up in all major territories and we have seen an overall increase of 53% to 21,083 units (2008: 13,788). These results reflect the mounting acceptance and use of our new surgery product the LiDCOrapid monitor that, coupled with our growing sales presence, is resulting in an increasing share of the hemodynamic monitoring market. In a little over one year this product has grown to represent almost one third of our installed base. Between the LiDCOrapid’s launch in April 2008 and July 2009, 546 monitors have been sold or placed with distributors and hospital customers. As expected, the surgery market is proving to be an excellent growth opportunity for the Company.
The LiDCOplus monitor installed base continues to grow, but at a slower rate, mainly due to the resources spent launching and promoting the new LiDCOrapid monitor. The combined effects of a lower number of direct capital sales in the UK (but not placements), price differential between the LiDCOrapid monitor and the more expensive LiDCOplus monitor and a reduced transfer price to Aspect Medical Systems (“Aspect”) has resulted in lower monitor revenue in the period (£745,000 compared with £866,000). However, the lower overall capital revenue concealed a 78% increase in monitors to 280 (2008: 157 units) sold and placed in the period. Disposables revenues were up in all territories. Sales advanced most in the USA, where overall revenues were up by 233% at £1.16 million (2008: £348,000) with a rise of 157% in recurring disposables income. During the period the USA was our biggest territory by both size of installed base (760 monitors) and overall income. Sales were predominantly (67%) to export markets, with the domestic UK market now representing 33% of sales revenue. This broader geographic spread of business represents an important transition and one that makes us less vulnerable to slowdowns in sales in any one territory.
Successful Fundraising
In order to strengthen the Company’s balance sheet and reduce our exposure to potentially uncertain banking facilities we were successful in raising £3.02m (net) in the period from existing investors including management and a group of new institutional funds. The placing was over subscribed and together with the license fees received has significantly reduced our reliance on our existing banking facilities.
Channels to market
To avoid incurring the ever increasing costs of a direct sales force, our strategy since inception has been to increase sales by using third party specialist distributors outside of the UK and, more recently in the USA. Selling our technology is an attractive option for distributors due to the growth and size of the hemodynamic monitoring market and the significant product margins available to them. Last year we added 13 new distributors, covering 18 countries.
Over the last months we have put in place substantial distribution arrangements for the three biggest markets in the world namely the USA, Japan and Germany. Three highly significant additions to our distribution network were made - Becton Dickinson (“BD”) in Japan, Aspect Medical Systems (“Aspect”) in the USA and Absolute Medical in Germany. These appointments are a result of the strength of our technology and increasing body of data showing the benefits of advanced hemodynamic monitoring. We have seen the benefit of these arrangements starting to emerge in the first half’s results, where we have increased revenues and taken an increased market share.
BD and Aspect are major global medical technology corporations, which have paid LiDCO upfront license fees totalling £940,000 for sales and license rights. Aspect has also taken over the majority of our direct sales people in the USA, reducing our direct costs while indirectly providing a sales force of sufficient scale to access the world’s biggest market for the LiDCOrapid.
In July we signed an exclusive distribution agreement for the LiDCOrapid monitor with Aspect, which has one of the biggest anesthesia medical product sales teams in the US and sells into over 80% of operating rooms in major hospitals. Aspect has a proven ability to build market share with new technology and has considerable experience of developing a recurring revenue stream from the placement of monitors in surgery accounts. Equally important is that Aspect has the finances necessary to compete and participate in this growing market opportunity. This agreement gives Aspect an additional product line while significantly improving LiDCO’s level of US sales coverage. We are immediately benefiting from Aspect’s existing sales, sales management and clinical educator force of over 90 staff and with Aspect on board we no longer have the issues and attendant costs of running a sub-scale sales team in the US market. An excellent partnership is already beginning to develop between our two companies. The Aspect team is now fully trained and re-launched the LiDCOrapid product in October, showcasing the product to 15,000 anesthetists at the American Society of Anesthesia meeting in New Orleans. On 28 September 2009 Covidien (NYSE: COV), a leading global healthcare products company, entered into a definitive agreement to acquire Aspect for approximately US$210 million. This is exciting news for LiDCO, the terms of the agreement with Aspect remain unaltered and the acquisition should give our products an even greater exposure in the US market.
Looking ahead, there are significant technical synergies that exist between Aspect’s Bispectral Index (BIS) product, which ensures the correct depth of anesthesia is achieved, and the use of the LiDCOrapid monitor to optimize blood flow and oxygen delivery. By monitoring the brain and simultaneously the hemodynamic response to the stresses of surgery, we can together provide a more complete view of the patient. It is becoming increasingly clear that better management of anesthesia should achieve better patient outcomes. Accordingly we have agreed to collaborate to develop a new unique monitoring product that will integrate both LiDCO’s and Aspect’s technologies. We believe that this product will represent the most evolved surgical monitor available.
BD is one of the world’s biggest global suppliers of medical disposables to the surgery and critical care market and is an important and influential corporate partner for LiDCO. After the US, the Japanese market is the world’s second biggest by value. Minimally invasive hemodynamic monitoring is becoming well established in Japan and its use is generously reimbursed by the Ministry of Health. Since signing the contract BD has received confirmation that LiDCOrapid use will be eligible for reimbursement and the registration/reimbursement processes have now begun. We expect launch to occur late 2010 to early 2011 - when a second license payment will be paid and product sales will start.
In April, LiDCO signed an agreement with Absolute Medical for the German market. With a population of 82 million people, Germany ranks as the third largest medical device market in the world (behind the USA and Japan) and represents 36% by value of the European medical device market. Thus, together with our partners we now can significantly address the global surgical market opportunity, which we estimate to be worth US$800m per annum.
Market trends and prospects for sales
Although the world’s economy has experienced a significant downturn this year, healthcare is expected to remain one of the most defended expenditures made. We expect the worldwide market for minimally invasive hemodynamic monitoring products will continue to grow as hospitals are put under increased pressure to improve profitability through adopting treatments proven to reduce surgical complications. We believe this shift in approach is irreversible and reflects a change in practice in hospitals supported by new payment arrangements made by insurers and reimbursement payments. Not only can our technology be used to reduce the requirement to insert an invasive catheter for fluid management - we have also demonstrated that targeting oxygen delivery using LiDCOplus technology on high-risk surgery patients can reduce hospital stay by an average of 12 days1 and reduce associated hospital costs by £4,800 per patient.
While anticipating continued market growth both we and our distribution partners have already seen a significant shift in how hospitals propose to pay for new technology. Reduced capital equipment purchase budgets have resulted in there being significantly more requests for product placements (where the monitor is installed in a hospital at no cost but the disposables incur a higher charge). To be successful, vendors will need to offer more flexible purchasing terms to hospitals. To do so will require a strong capital base in order to finance the cash flow implications of a predominantly placement approach. In the US market, Aspect already has considerable experience in the development of a recurring revenue stream through monitor placements. Last year it placed 2,500 of its own BIS monitors into the US market and sold 4 million disposables into this installed base. Aspect expects to make further progress in the placement of the LiDCOrapid monitors and thus a further increase in market share. Whilst the placement model is not as profitable as capital sales, revenue sharing arrangements exist if monitors are sold as opposed to placed by Aspect.
Outlook
The first six months have been very productive during which the Company has maintained growth, reduced its borrowings and future costs while significantly expanding its route to market, particularly in the world’s top three territories. Whilst healthcare expenditure is highly defended in developed countries, hospitals are increasingly requiring suppliers to offer less capital intensive and more flexible ways of acquiring new technologies. With a stronger cash position and having partners with strong balance sheets we have the capital structure to, if necessary, address the market through placing of monitors and deriving income from recurring disposables sales. It is a testament to the strength of the Company’s products, partners and the growing acceptance of our technology that these results have been achieved despite the backdrop of a worldwide recession.
The worldwide clinical community is showing an increasing acceptance and recognition for the LiDCO brand for providing safe, minimally invasive monitoring technology that is accurate and very easy to use. This is evidenced by the choice of our technology for use in key multi-centre outcome studies. The Company is in a strong position, it has the right products, funding, cost structure and sales resources in all of the major markets to achieve significant growth in the coming years and we look forward to the future with confidence.
1 Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial, Critical Care 2005, 9:R687-R693 doi:10.1186/cc3887
Business Review - Summary Table
6 months
to 31 July
2009
6 months to
31 July
2008
Increase/
(decrease)
Increase/
(decrease)
%
Sales by type (£’000)
- Monitors
745
866
(121)
(14%)
- Sensors/Smartcards/Fee per Use
1,627
1,156
471
41%
- Licence Fees
122
0
122
100%
Total
2,494
2,022
472
23%
Sales by Units
Monitors sold/placed
280
157
123
78%
Sensor, Smartcard and Fee per Use Sales
21,083
13,788
7,295
53%
Installed Base (end period)
1,790
1,329
461
35%
Regional sales performance summary
USA
•
Strong progress - growth in units sold/placed, overall revenue and disposable sales growth
•
Increased revenue up 233% to £1,159,000 (2008: £348,000)
•
Monitor revenue up to £449,000 (2008:£96,000)
•
Sensor, Smartcard & fee for use sales up 157% to £650,000 (2008: £252,000)
•
Licence fee income of £60,000 (2008: £Nil)
UK
•
Installed base of monitors up by 7% but monitor capital revenue affected by the capital freeze and move to LiDCOrapid & placement model
•
Total sales (excluding MedOne) revenue steady at £822,000k (2008: £852,000; with MedOne £1,063,000)
•
Capital revenue (excluding MedOne) down to £95,000 (2008: £159,000)
•
Sensor, Smartcard and, fee for use sales of £727,000 up 5% (2008: £694,000)
Continental Europe
•
Overall sales revenue down by 21% to £381,000 (2008: £484,000)
•
Capital revenues affected by phasing of monitor sales to distributors
•
Monitor sales revenue of £166,000 down 45% (2008: £300,000)
•
Sensor/Smartcard sales up 17% £215,000 (2008: £184,000)
Rest of World & Licence Fee Income
•
Overall revenue steady at £132,000 (2008:£127,000)
•
Monitor revenue down 64% to £35,000 (2008: £98,000)
•
Sensor/Smartcard sales up by 21% to £35,000 (2008: £29,000)
The net effect of movement in foreign exchange rates both during the period and in comparison with the first half of last year has been to increase the Company’s operating loss. If exchange rates had remained the same as the first six months of last year, the operating loss would have been £964,000 representing an 11% improvement on the interim results for last year.
The result of changes in exchange rates when compared with last year has been to increase sales by £101,000, to increase cost of sales by £175,000 and to increase overheads by £154,000. The largest single element of the adverse fluctuations in exchange rates was the cost of the sales and marketing presence in the USA, which has now been substantially reduced as a result of the agreement with Aspect.
Margins
The average product margin across all products against external procurement costs fell during the period from 81% to 75%, partly as a result of higher costs due to exchange rate movements and partly due to the reduced margins achieved on the sales of LiDCOrapid monitors to Aspect. Margins achieved on LiDCOplus sensors fell 1% to 86% and on Smartcards by 1% to 94%. The overall gross margin on sales after allowing for Med One costs was 61%, down from 68% for this period last year. Med One payments in the period amounted to £400,000 (2008: £253,000) with approximately half the increase arising from adverse exchange rate movements. However, Med One payments have now peaked and should reduce to zero over the next 2 years.
Overheads
Excluding the effect of exchange rate movements, overheads increased by 6% compared with the same period last year, largely the result of increased sales and marketing costs. Total overheads increased by £267,000 of which £154,000 is the effect of adverse exchange rate movements. Going forward, the transfer of most of the US sales force to Aspect will reduce costs by about £650,000 in a full year commencing from the start of the second half this year.
Cash, financing and working capital
The net cash outflow before financing activities was £743,000 compared with an operating loss of £1.192 million. Historically the Company has used bank loans, overdrafts and invoice discount financing facilities as a means of providing working capital. In order to reduce our dependence on such facilities going forward, the Company issued 31,916,000 new ordinary shares at 10p to existing investors, including management and to new institutional investors raising £3.02 million net of costs. During the period the Company was also in receipt of up-front license fees from Aspect and Becton Dickinson totalling £940,000. In addition to generally strengthening the balance sheet, these funds will more readily allow the Company to adopt a placing model for its monitors with its UK customer base.
Cash balances at 31 July amounted to £2.54 million. The Company continues to monitor overheads and cash carefully and is expecting to achieve break even from both a profit and cash perspective on a monthly basis some time during the first half of next year.
PRODUCT DEVELOPMENT
Product development in 2008 centred around existing product support and enhancements, along with the market expansion to surgery with the launch of the LiDCOrapid. The aims for 2009 are to further refine and differentiate the LiDCOrapid user interfaces and also to improve and simplify customer use/connectivity of our products.
LiDCOrapid user interface enhancements
I am pleased to say that a follow-on software release v1.02 has now been launched, and can be implemented simply on all existing monitors with the use of a USB key.
Important new features include:
•
User adjustable timescales for displayed parameters including trending of stroke volume and pulse pressure variations (used for guiding the volume of fluid administered to patients) - now up to 60 minutes of data can be trended.
•
User selected event response window with continuous trending.
•
History Screen added - with up to 24 hours of graphical trends of key parameters available for review.
•
Chart Screen for display and recording of numerical data up to 24 hours - assists the user in the recording of readings to the patient record during or post surgery.
The new features fit in seamlessly with the current user interface, further enhancing usability without changing the core algorithms for determination of stroke volume and cardiac output.
Universal pressure waveform module
The universal waveform acquisition module, under development, will allow wider market adoption of our products by making it easier to access arterial blood pressure data in situations where access to the blood pressure waveform is difficult, or involves additional expensive cabling, or where the primary patient monitor does not provide the necessary analogue arterial pressure output. The new module is planned for release in late 2009/early 2010.
LiDCO language localisation
The aim of this project is to convert LiDCOrapid and LiDCOplus monitors software from English into all the local languages in territories where we are or will be selling the product. It is anticipated that LiDCOrapid language localisation will be concluded in the early months of 2010.
Development of supportive clinical & business cases
Our ambition is to be able to present customers with a compelling clinical and business case linked to the use of our products. To that end improved outcomes have already been demonstrated in two different intensive care populations:
•
in a post-operative surgical intensive care setting, where treated patients’ hospital stay was reduced by 12 days and complications by more than one third;
•
in severely ill patients with shock and sepsis, where the use of LiDCO technology substantially reduced mortality to 12% of patients treated, compared with 32% in the invasive catheter treated group.
We have previously announced that the LiDCOplus was selected as the technology for use in two further significant multi-centre outcome trials in the USA (for details see April 2009 preliminary announcement: Prospective trial improving outcomes in high-risk surgery and USA “Monitor” multi-centre randomised transplantation donor optimization study).Both studies are ongoing and being run by doctors working at the University of Pittsburgh.
More recently in September we were pleased to announce that the LiDCOrapid, the Company's monitor for acute care fluid and drug management, has been chosen as the sole cardiac output monitoring system to be used in OPTIMISE, a government-supported multi-centre trial in the UK, which aims to improve surgical outcomes by optimising cardiovascular management. This trial is believed to be the largest of its type in the world to date and is therefore a significant validation of the choice of LiDCO's technology. The LiDCOrapid will be used to monitor the administration of fluids and drugs in the treatment arm of the OPTIMISE trial. Twelve UK centres and 726 adult high-risk patients undergoing major abdominal surgery will be involved in the study which is scheduled to start this autumn. Co-ordinated by Dr Rupert Pearse, consultant and senior lecturer in intensive care medicine at Barts and The London NHS Trust, the study is supported by an £850,000 grant from the National Institute for Health Research. LiDCO will supply the twelve participating hospitals with up to 24 monitors for the study, which is expected to take 12-18 months to complete.
Terry O’Brien Chief Executive Officer 29 October 2009
LiDCO Ltd. Sales and Marketing, Unit M South Cambridge Business Park, Babraham Road, Sawston, Cambridge CB22 3JH, UK Telephone: +44 (0) 1223 830666 Fax: +44 (0) 1223 837241 VAT number 672 4757 08
