Mauna Kea Technologies Reports Full-Year 2012 Results in Line With Expectations

Mauna Kea Technologies Reports Full-Year 2012 Results in Line With Expectations 
2012 Sales Grew 76% to EUR 8.8 Million; Growth of Operating Expenses
Slowed in the Second Half of 2012; Company Ended Year With Strong
Cash Position at EUR 37.6 Million; Gross Margin Reached Record 69% 
PARIS -- (Marketwire) -- 03/26/13 --   Mauna Kea Technologies
(EURONEXT PARIS: MKEA), leader in the optical biopsy market and
developer of Cellvizio(R), the fastest way to see cancer, today
announced its full financial results for the 12 months ended December
31, 2012. 

Thousands of euros (EUR )- IFRS       December 31, 2012   December 31, 2011 
------------------------------------  -----------------   ----------------- 
  Sales                                           8,810               5,016 
  Other Revenue                                   1,472                 960 
  Total Revenue                                  10,282               5,976 
Operating Expenses                                                          
  Cost of Goods Sold                             (2,705)             (1,583)
  Gross Margin                                       69%                 68%
  Research & Development                         (3,262)             (2,291)
  Sales & Marketing                             (12,527)             (6,281)
  Overhead                                       (3,684)             (3,271)
  Share-based Payments                           (1,073)               (654)
  Total Expenses                                (23,251)            (14,079)
  Operating Income (Loss)                       (12,969)             (8,103)
  Net Earnings (Loss)                           (13,056)             (7,909)

Fiscal Year 2012 Sales Up 76%  
Fiscal year 2012 sales grew by 76% to EUR 8.810 million. Sales of
Cellvizio to hospitals and clinics, the company's key target market,
grew by 69% to EUR 7.461 million in 2012, while Cellvizio sales for
pre-clinical research more than doubled to EUR 1.349 million, an
increase of 129%. 
The breakdown of 2012 sales by product type and geography highlights
strong growth in equipment sales (sales of Cellvizio systems) and
consumables (sales of multi-use confocal miniprobes used with
Cellvizio systems), which increased 82% and 96% to EUR 6.172 million
and EUR 2.003 million, respectively.  
Sales in the Americas region accounted for nearly half of the
company's sales (48%), while the EMEA (Europe, Middle East and
Africa) and APAC (Asia-Pacific) regions constituted 36% and 16% of
sales, respectively. 
Other revenues totaled EUR 1.472 million, driven mainly by grants
associated with the company's collaboration under the PERSEE project
and EUR 0,975 million in research tax credit. 
As of December 31st, 2012, Mauna Kea Technologies has an installed
base of 283 Cellvizio systems worldwide with 185 in hospitals and
clinical care facilities and 98 in pre-clinical research facilities. 
At year-end, 102 Cellvizio systems were installed in North America,
including 95 in the United States, while 142 systems have been
installed in EMEA, 38 systems in APAC, and one system in Latin
Gross margin reaches a record high 
The gross margin continued to improve, reaching a record 69% in 2012,
compared to 68% and 65% in 2011 and 2010, respectively. The increase
is largely attributable to an increase in the average selling price
of systems and miniprobes. 
Sales Growth Significantly Outpaces Sequential Increase in Operating

                               H2 2012     H1 2012     H2 2011     H1 2011  
    Sales (EUR  million)         5.3         3.5         3.2         1.8    
      Sequential Growth         50.4%       10.1%       75.6%         -     
     OPEX (EUR  million)        12.1        11.1         8.6         5.4    
      Sequential Growth         9.3%        28.3%       59.7%         -     

The company finished recruiting its direct sales forces for the United
States and France early in the second half of 2012. Consequently,
sequential growth in operating expenses began to slow in comparison
to sequential sales growth in the second half of the year.  
The company ended the year with a net loss of EUR 13.056 million. As
of December 31, 2012, the company reported cash and cash equivalents
of EUR 37.6 million. Mauna Kea Technologies had 121 employees as of
December 31st, 2012 compared to 88 employees at the end of 2011. 
"Optical biopsy is becoming established as a standard of care in
gastroenterology and in other disciplines, paving the way for better
care for patients," Sacha Loiseau, Chief Executive Officer of Mauna
Kea Technologies, stated. "The healthy growth in Cellvizio system and
miniprobe sales -- in spite of the very bleak global business
environment -- reflects the medical community's adoption of the
technology as a vital tool to improve the diagnosis and treatment of
patients with many of the world's most common diseases. The
investments we made in our commercial organization at the beginning
of 2012, coupled with the growing body of clinical data and positive
reimbursement milestones in the U.S. have helped us lay a strong
foundation for success in our key markets. We continue to manage our
substantial cash resources while delivering on our goals to increase
the utilization of optical biopsies across clinical applications and
regions around the globe." 
Recent Developments and Highlights 
Record Number of Cellvizio Studies Published in 2012 

--  Over 66 papers on the benefits of optical biopsies across indications
    were published.
--  Publications during 2012 supported the use of Cellvizio in new
    applications including needle-based procedures in the pancreas and
    stomach cancer.
--  Additionally, gastroenterologists in Japan and Germany used Cellvizio
    to view the enteric nervous system of the digestive tract during an
    endoscopy procedure for the first time. Study findings were published
    in the November 2012 issue of Gastroenterology, the leading medical
    journal in the digestive field.
--  There was also an increase in publications validating the use of
    Cellvizio optical biopsies for irritable bowel disease (IBD) and
    syndrome (IBS), Barrett's Esophagus (BE), colorectal diseases, and
    cancers of the bile and pancreatic ducts.

U.S. Reimbursement Highlights 

--  On January 1st, 2013, new Category I CPT codes for the use of
    Cellvizio in the digestive tract were implemented. Payment from
    Medicare/Medicaid for these codes had been established at 
$927 per
    procedure. The company recently launched an information and support
    initiative to help its customers obtain coverage from private

Cellvizio Optical Biopsy Probe CE Marked For Urological Applications 

--  In December 2012, the company's Cellvizio optical biopsy probe for
    urological applications received CE mark approval for use during
    cystoscopy procedures in Europe. First indication will be bladder
    cancer surveillance.

Regulatory Clearance in Brazil, Canada, Turkey, Russia, and China 

--  In December 2012, Mauna Kea Technologies received regulatory approval
    for Cellvizio from the State Food and Drug Administration (SFDA) in
    China. The company has a strategic partnership with FUJIFILM (China),
    for the expansion of Cellvizio optical biopsy distribution throughout
--  The company received regulatory clearance in Brazil in June 2012 to
    sell its Cellvizio 100 Series optical biopsy system throughout the
    country, which is the largest medical device market in South America.
--  In 2012, the company also received regulatory clearance from Health
    Canada, the Canadian Federal department responsible for medical device
    approval, the Turkish Ministry of Health, and the Russian Ministry of
    Health to sell both the Cellvizio 100 optical biopsy system and the AQ
    Flex 19 miniprobe throughout Canada, Turkey, and Russia. These
    countries are among the most dynamic medical device markets in the

Company Reports First Cellvizio System Sales in Japan, World's Second
Largest Healthcare Market  

--  At the beginning of 2013, physicians at Japanese medical schools,
    including the Hirosaki University Graduate School of Medicine in
    Aomori, have acquired two Cellvizio systems to better understand
    stomach, pancreatic and esophageal cancers, as well as common
    functional gastrointestinal and motility disorders such as irritable
    bowel syndrome (IBS), gastro esophageal reflux disease (GERD) and
    chronic constipation.

Revolutionary Cellvizio Dual Band Color Lab Imaging System Launched 

--  Cellvizio Dual Band, launched September 2012, incorporates color into
    the state-of-the-art molecular imaging system that allows researchers
    to visualize both structural and functional information of tissue
    inside animals' bodies in real time.

Next Quarterly Financial Press Release: 2013 First Quarter Sales, April
16, 2013 (post-market)  
About Mauna Kea Technologies 
Mauna Kea Technologies is a global medical device company dedicated
to the advent of optical biopsy. The company researches, develops and
markets innovative tools to visualize and detect cellular
abnormalities during endoscopic procedures. Its flagship product,
Cellvizio(R), a probe-based Confocal Laser Endomicroscopy (pCLE)
system, provides physicians and researchers high-resolution cellular
views of tissue inside the body. Large, international, multicenter
clinical trials have demonstrated Cellvizio's ability to help
physicians more accurately detect early forms of disease and make
treatment decisions immediately. Designed to improve patient outcomes
and reduce costs within a hospital, Cellvizio can be used with almost
any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and
Drug Administration and the European CE-Mark for use in the GI tract,
biliary and pancreatic ducts and lungs. 
For more information on Mauna Kea Technologies, visit  
This press release and the information contained herein do not
constitute an offer to sell or subscribe to, or a solicitation of an
offer to buy or subscribe to, shares in Mauna Kea Technologies ("the
Company") in any country. This press release contains forward-looking
statements that relate to the Company's objectives. Such
forward-looking statements are based solely on the current
expectations and assumptions of the Company's management and involve
risk and uncertainties. Potential risks and uncertainties include,
without limitation, whether the Company will be successful in
implementing its strategies, whether there will be continued growth
in the relevant market and demand for the Company's products, new
products or technological developments introduced by competitors, and
risks associated with managing growth. Unfavorable developments in
connection with these and other risks and uncertainties described, in
particular, in the Company's prospectus prepared in connection with
its IPO and on which the French Autorite des marches financiers
("AMF") granted its visa number 11-236 on June 20, 2011, could cause
the Company to fail to achieve the objectives expressed by the
forward-looking statements above. 
United States
Erich Sandoval
Tel: +1 917 497 2867 
France and Europe
Investor Relations and Financial Communication 
Pierre Laurent / Florent Alba
Tel: +33(0)1 44 71 94 94 
Mauna Kea Technologies
Eric Cohen
Vice President, Finance
Tel: + 33 1 70 08 09 86 
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