PARIS, January 26,2016 /PRNewswire/ --
Mauna Kea Technologies (Euronext: MKEA, FR0010609263, PME/PMI eligible), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced its sales for the fourth quarter and financial year ended December 31, 2015.
Sacha Loiseau, Founder and Chief Executive Officer of Mauna Kea Technologies, stated: "Following our announcement on October 8 of the Company's intent to modify its commercialization strategy, we anticipated a dilution of sales productivity as the global leadership team and regional sales leaders worked to implement our new strategy. With Cook Medical as an early and visible illustration of the larger market opportunity to integrate Cellvizio with leading clinical platforms, we are encouraged by the current pipeline of strategic partnership opportunities. While maintaining our focus on delivering new clinical approvals while making long-term product development investments, we made considerable efforts in 2015 to reduce the rate of cash burn cash in order to maintain financial flexibility and protect shareholder value. In the second half of 2015 our cash consumption was €1.6 million vs. €5.0 million in 2H'14."
EUR thousands - IFRS 2015 2014 Change Q1 (ended March 31) 1,855 2,164 -14% Q2 (ended June 30) 2,170 2,405 -10% Q3 (ended September 30) 1,867 3,229 -42% Q4 (ended December 31) 2,655 3,218 -17% Total sales 8,547 11,016 -22%
Q4 2015: introduction of the strategy of commercial partnerships by indication
Mauna Kea Technologies' Q4 2015 sales came to €2,655 thousand, down 17% on the Q4 2014 level (€3,218 thousand).
Sales in the Americas declined 37% to €557 thousand (vs. €883 thousand), with sales in North America dropping 32% to €519 thousand (vs. €761 thousand).
APAC (Asia-Pacific) sales recorded an increase of 7% to €1,193 thousand (vs. €1,118 thousand), but EMEA (Europe, Middle East and Africa) sales decreased 26% to €906 thousand (vs. €1,217 thousand).
Over the quarter, sales in the Americas, APAC and EMEA accounted for 21%, 45% and 34% of total sales respectively (vs. 27%, 35% and 38% in Q4 2014).
Clinical sales (use of Cellvizio in hospitals and clinics) fell by 22% to €1,562 thousand (vs. €2,011 thousand), and pre-clinical sales (use of Cellvizio in pre-clinical research) were down 9% to €1,094 thousand (vs. €1,207 thousand). Over the quarter, sales to hospitals and clinics accounted for 59% of total sales, compared with 41% for pre-clinical sales (vs. 62% and 38% respectively in Q4 2014).
Sales of equipment and consumables declined by 19% to €1,751 thousand (vs. €2,160 thousand) and by 25% to €648 thousand (vs. €862 thousand) respectively.
Services generated an increase of 31% in sales to €256 thousand (vs. €196 thousand).
By volume, the company recorded sales of 14 systems and 176 probes (vs. 25 and 288 respectively in Q4 2014).
2015, a challenging year on the commercial front, but plenty of major milestones reached
Mauna Kea Technologies recorded a 22% decline in its full-year 2015 sales to €8,547 thousand (vs. €11,016 thousand in 2014). Sales in the Americas region declined by 10% over the period to €3,603 thousand (vs. €4,012 thousand in 2014), mostly due to a complete absence of sales in Brazil, where a sluggish economy and a general slowdown of public funding brought sales to a complete halt in 2015.
North American sales rose by 14% to €3,490 thousand (vs. €3,060 thousand) thanks to the United States, reflecting a recovery in this market and backing the Group's strategic decisions there.
Sales in APAC declined by 35% to €2,491 thousand (vs. €3,806 thousand in 2014) as a result of the delay in obtaining regulatory approval for the Cellvizio 100s in China, which was finally granted in December.
Amid tough economic conditions, EMEA sales dropped 23% to €2,453 thousand (vs. €3,197 thousand) over the full year.
The 29% decline in clinical sales to €6,082 thousand (vs. €8,591 thousand) was not offset by the small growth of 2% in pre-clinical sales to €2,465 thousand (vs. €2,425 thousand in 2014).
Over the period, system sales dropped back 28% to €5,190 thousand (vs. €7,175 thousand), sales of consumables were down 16% to €2,473 thousand (vs. €2,958 thousand) and sales of services remained stable at €884 thousand (vs. €882 thousand).
In total, the company sold 51 systems and 669 consumables (vs. 88 and 896 respectively in 2014). Despite this decrease in sales of consumables, the company confirms the continued strong adoption of technology, with 492 new probes orders by existing customers ("reorder"), against 420 in 2014, an increase of 17%.
During the second half of 2015, the company's net cash burn was €1.6 million (vs €5 million in the second half of 2014), leading to a cash position of €10.6 million at the end of the year.
Summary of the highlights of 2015
· October 2015: redefinition of strategy around a global indication-driven commercialization plan with strategic partners, a reduction in operating expenses and strengthening of the leadership team;
· December 2015: global multi-year commercialization partnership entered into with Cook Medical covering endomicroscopy in urology. Cook Medical will commercialize a private-labeled version of Cellvizio for urological applications with a launch date in North America, Western Europe and China scheduled for the first half of H1 2016.
Regulatory approvals and reimbursement codes
· March 2015: the American Medical Association (AMA) awarded a new CPT code related to the use of endomicroscopy during endoscopic retrograde cholangiopancreatography (ERCP) procedures, which enable physicians to diagnose health problems in the biliary tract, including biliary strictures and biliary cancer. More than 500,000 ECRPs are conducted annually in the United States.
· April 2015: regulatory approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), the Mexican health authority, for the commercialization of Cellvizio;
· April 2015: CE mark for use of Cellvizio in minimally invasive laparoscopic surgery;
· June 2015: CE mark for use of Cellvizio® during interventional radiology procedures;
· July 2015: approval from Japan's ministry of health, labor and welfare for AQ-Flex 19™, its confocal endomicroscopy solution;
· July 2015: CE mark for its Cellvizio 800 intra-operative platform, which provides infra-red endomicroscopic imaging during minimally invasive surgical procedures;
· October 2015: US FDA clearance for use of Cellvizio in Minimally Invasive Surgery (MIS) during a range of surgical procedures to treat many different types of cancer;
· December 2015: regulatory approval in China for commercialization of Cellvizio 100s for expanded use of Cellvizio in pancreatic and urological applications, with the clearance of all the associated miniprobes.
Clinical results and conferences - the medical value of optical biopsy
· April 2015: record attendance at ICCU 2015 and at the associated course on endomicroscopy;
· May 2015: presentation of the confocal endomicroscopy applications at the congress of the Japan Gastroenterological Endoscopy Society (JGES), the largest in the world dedicated to endoscopy;
· August 2015: publication of the results of a new trial into the use of endomicroscopy with Cellvizio in the peer-reviewed journal Neurosurgery, partly financed by Siemens Corporate Technology. The data compiled indicate that use of Cellvizio provides real-time histomorphological diagnosis of pathology with results similar to use of traditional surgical biopsy;
· September 2015: publication of the results of a trial involving the use of CLE with Cellvizio in the Breast Cancer Research and Treatment journal. The results show that endomicroscopy can be used to identify cancerous and healthy tissue in real time during breast conserving surgery;
· September 2015: surgeons from the University of Florida investigated for the first time the use of Cellvizio in radical or partial nephrectomies using endomicroscopy to distinguish in real time between cancerous and normal tissue in small renal masses;
· October 2015: new publication confirming the importance of needle-based endomicroscopy for the characterization of different types of pancreatic cysts. Retrospective analysis of CONTACT-1 population establishes robust imaging criteria to classify pancreatic cystic lesions;
· December 2015: world premiere in interventional radiology with tissue ablation monitored in real time at cellular level and presentation of the first series of microscopic image-guided tumor biopsies and ablations.
Next press release: 2015 financial results March 24, 2016 (after market close)
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on eliminating diagnostic and treatment uncertainties thanks to direct visualization at the cellular level. The Company's flagship product, Cellvizio, has received clearance to sell for a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit www.maunakeatech.com.
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