Earnings Release • Aug 28, 2014
Earnings Release
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PARIS, August 28, 2014 – Mauna Kea Technologies (Euronext: MKEA, FR0010609263, PEA-SME eligible), a leader in the optical biopsy market, today reported its full financial results for the first half of the current financial year, ended June 30, 2014.
| In €K - IFRS | H1 2014 | H1 2013 |
|---|---|---|
| (June 30, 2014) | (June 30, 2013) | |
| Operating Revenue | ||
| Sales | 4,569 | 4,320 |
| Other income | 537 | 271 |
| Total revenue | 5,106 | 4,591 |
| Operating Expenses | ||
| Cost of sales | (1,461) | (1,236) |
| Gross margin (%) | 68% | 71% |
| Research and Development | (2,084) | (1,859) |
| Sales & Marketing | (6,113) | (5,854) |
| General & Administrative expenses | (1,911) | (1,955) |
| Share-based payments | (794) | (286) |
| Total Operating Expenses | (12,364) | (11,191) |
| Operating profit / (loss) | (7,257) | (6,600) |
| Net Profit / (loss) | (7,324) | (6,612) |
In the first half of 2014, sales increased by 6% to €4,569K versus €4,320K in H1 2013. Clinical sales increased by 15% to €3,958K and pre-clinical sales decreased by 31% to €610K.
The product mix shifted towards consumables, which saw a 13% increase in sales to €1,252K, whereas the sales of systems remained stable at €2,942K. Sales of services grew 40% to €374K. Systems, consumables and services represented 64%, 27% and 8% of H1 2014 sales, respectively. In the half-year period, 36 Cellvizio systems were sold versus 32 systems in H1 2013 and the number of consumables sold increased by 22% as 355 miniprobes were sold versus 290 miniprobes in H1 2013.
In terms of the geographic mix, sales in the APAC region (Asia Pacific) increased by 14% to €1,492K, boosted by regulatory approval in Japan. The EMEA region (Europe, Middle East and Africa) saw strong growth of 37% to €1,219K. The Americas region fell by 13% to €1,857K, largely due to ongoing uncertainty around
healthcare reform in the United States, which has caused a temporary slow-down in adoption of new technologies. The Americas, APAC and EMEA accounted for 41%, 33% and 27% of first half 2014 sales, respectively.
At June 30, 2014, 392 Cellvizio systems were installed worldwide, with 277 located in hospitals and clinics and 115 in pre-clinical research centers. On a geographic basis, 130 Cellvizio systems were installed in North America, including 120 in the United States, 175 were in the EMEA region, 75 were in the APAC region and 12 were in Latin America.
Other income was €537K in the first half of 2014, up +92% versus H1 2013, and is primarily related to an increase in the Research Tax Credit from €168K in H1 2013 to €490K in H1 2014. This increase is associated with the fact that the company received no repayable advances during the half-year period, and with the increase in R&D expenses.
The gross margin declined to 68% versus 71% in H1 2013, due to discounts granted on the selling price of the systems and consumables in the United States.
Sales and Marketing costs were up 4% to €6,113K in the first half of 2014, reflecting the hire of new members of the sales team worldwide. Research and Development expenses increased 12% to €2,084K due to continued investment in improving the company's optical biopsy technology and the rising development costs of the next-generation Cellvizio technology.
Total operating expenses amounted to €12,364K in the half-year period versus €11,191K in H1 2013. Operating loss was €7,257K in the first half of 2014 versus €6,600K in H1 2013.
Net loss was €7,324K in the first half of 2014 versus a net loss of €6,612K in the same period of 2013.
During the first half-year of 2014, the Company utilized €7.8 million of cash versus €6.1 million in H1 2013. As of June 30, 2014, available cash was €20 million.
At June 30, 2014, Mauna Kea Technologies had 118 employees versus 113 employees a year earlier.
Sacha Loiseau, CEO and founder of Mauna Kea Technologies, commented: « The disappointing sales for the second quarter in the United States adversely impacted our financial results for the first half of 2014. However, we remain dedicated in our efforts to drive the adoption of Cellvizio in this geography as well as throughout the rest of the world. We continue to be optimistic about the opportunity in front of us for the remainder of the 2014 year ».
specialties. Currently, Japan is the world's second largest market for medical devices and is the most innovative country in endoscopy;
510(k) regulatory clearance was granted in the United States for a new Cellvizio system using an infrared wavelength, a significant step forward in the company's "products" roadmap. The Cellvizio 785 nm technology opens new possibilities for microscopic imaging inside the human body.
Mauna Kea Technologies is a global medical device company focused on leading innovation in endomicroscopy and optical biopsy. The company designs, develops and markets innovative tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company's flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues. Largescale, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has 510(k) clearance from the United States Food and Drug Administration and CE Marking in the European Union for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan.
For further information on Mauna Kea Technologies, visit www.maunakeatech.com
Madis Phileo Press Relations Sophie Langlois Tel: +33 (0) 1 56 80 24 94 [email protected] NewCap. Investor Relations Florent Alba / Pierre Laurent Tel: +33 (0)1 44 71 94 94 [email protected]
Westwicke Partners United States – Investor relations Mark Klausner Tel : +(443) 213-0500 [email protected]
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