Mauna Kea Technologies Reports Third Quarter 2017 Sales

Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced its sales for the third quarter ended September 30, 2017. The Company will host a conference call today to review the sales results.

Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies declared, "In the third quarter we continued to build momentum in the U.S. around our new Cellvizio pay-per-use business model. We also made progress in hiring additional sales representatives in the U.S. and strengthened our execution capabilities. Other key initiatives moved forward as highlighted by our partner Cook Medical initiating its launch of Cellvizio in the urology market and important regulatory approvals around the compatibility of Cellvizio with surgical robotics.”

Nine Months 2017 Sales

Third Quarter 2017 Sales by Category

In the third quarter of 2017, the Company sold 8 Cellvizio systems and secured contracts for 4 new systems under consignment in the U.S., compared to 10 systems sold and no consignment systems shipped in the third quarter of 2016.

Shipped consumable probes unit volume was 175 units, up 16% compared to 151 probes sold in the third quarter of 2016. The number of probe reorders (probes shipped to existing customers or pay-per-use customers) was 108 in the third quarter of 2017, compared to 110 in the third quarter of 2016. This reflects a significant increase in reorder volumes in the U.S. (+95% in the third quarter and +30% over the first nine months), offset by a decrease in reorder volumes in other markets (-62% in the third quarter and -50% over the first nine months) due to the Company’s focus on the implementation of its new pay-per-use business model in the U.S.

Third Quarter 2017 Sales by Geography with Split by Activity (Clinical / Pre-clinical)

Clinical sales

Clinical sales in the Americas region increased 37% in the third quarter of 2017. The main focus of the Company is the roll-out of its new pay-per-use business model for Cellvizio’s core GI applications in the U.S., which represents a significant market opportunity and is supported by positive reimbursement coverage (cf. press release dated 4 November 2016).

Clinical sales decreased 21% in the Asia-Pacific region (-45% over the first nine months of 2017) and 88% in the EMEA (-57% over the first nine months of 2017) as the company continued to focus its resources on the growth of its core clinical business in the U.S.

Pre-clinical sales

Pre-clinical sales are by nature less recurring compared to clinical ones. Therefore comparison from one period to another is difficult. Pre-clinical sales declined 22% in the third quarter of 2017, with growth in the Asia-Pacific region offset by declines in the Americas and EMEA regions, reflecting the inherent lumpiness in this business and the Company’s focus on its U.S. clinical business.

Nine Months 2017 Quarterly Data

2017 Quarterly Sales by Geography with Split by Activity (Clinical / Pre-clinical)

2017 Quarterly Unit Sales by Type

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell 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

Disclaimer
This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on May 31, 2017 under number D.17-0574 and available on the Company's website (www.maunakeatech.com), and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.

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