Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced fourth quarter and full year 2021 sales.

Total Sales for the Full Year 2021 increased €1.17 million, +18% year-over-year, to €7.70 million

  • Systems sales at €3.19 million, +24% year-over-year
  • Consumables sales at €3.20 million, +13% year-over-year
  • Services sales at €1.30 million, +17% year-over-year

Total Sales for the Fourth Quarter of 2021 increased €0.23 million, +10% year-over-year, to €2.61 million

  • Systems sales at €1.23 million, +8% year-over-year
  • Consumables sales at €0.92 million, -5% year-over-year
  • Services sales at €0.46 million, +70% year-over-year

“For the full year, global sales increased +18% year-over-year despite the unpredictable effects of the COVID-19 pandemic on the healthcare industry. Our strong installed base of users in the U.S. has enabled us to achieve +17% sales growth in this region even with pandemic-associated delays in elective procedures and capital sales. In Asia, which has operated in full isolation, we saw a modest decline of -11% in sales. In Europe, our focus on pancreatic cysts and food allergy applications has yielded a +66% growth in sales year-over-year, nearly returning to pre-pandemic levels,” said Nicolas Bouvier, interim Chief Executive Officer of Mauna Kea Technologies. “The efforts to establish a core base of committed U.S. users over the past three years, combined with our strategic repositioning and associated operating plan with optimized resources, are giving us much better visibility. We’re looking forward to executing our new strategic plan and regularly updating our investors on our progress.”

Fourth Quarter and Full year 2021 Sales by Category:

(in € million) – IFRS

Q4 2021

Q4

2020

€ Chg. Y/Y

% Chg. Y/Y

Full yr 2021

Full yr

2020

€ Chg. Y/Y

% Chg. Y/Y

Systems

1.23

1.14

0.09

8%

3.19

2.58

0.61

24%

Consumables

0.92

0.97

(0.05)

(5%)

3.20

2.83

0.38

13%

Services*

0.46

0.27

0.19

70%

1.30

1.11

0.19

17%

Total Sales

€ 2.61

€ 2.38

€ 0.23

10%

€ 7.70

€ 6.53

€ 1.17

18%

*Numbers may not foot due to rounding. Note: 2021 Q4 service revenue included €148K of collaboration service fees from clinical research partners.

Fourth Quarter and Full Year 2021 by Geographic Region:

(in € million) – IFRS

Q4 2021

Q4 2020

€ Chg. Y/Y

% Chg. Y/Y

Full yr 2021

Full yr 2020

€ Chg. Y/Y

% Chg. Y/Y

United States

1.70

1.28

0.43

34%

4.18

3.59

0.60

17%

Asia-Pacific

0.52

0.66

(0.14)

(21%)

1.56

1.76

(0.20)

(11%)

EMEA & ROW

0.39

0.45

(0.06)

(13%)

1.96

1.18

0.78

66%

Total Sales

€ 2.61

€ 2.38

€ 0.23

10%

€ 7.70

€ 6.53

€ 1.17

18%

*Numbers may not foot due to rounding

Fourth Quarter and Full Year 2021 Units Sales by Type

Units (#)

Q4 2021

Q4 2020

% Chg.

Y/Y

Full yr 2021

Full yr 2020

% Chg.

Y/Y

 

New Systems Sold

11

11

-

31

26

19%

New System Placements

2

2

-

15

10

50%

Total Systems

13

13

-

46

36

28%

Consumable Probe Shipments

143

196

(27%)

547

507

8%

 

Total shipments of Cellvizio systems increased 28% year-over-year for the full year, with growth in both sales and placements of systems.

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Financial calendar: Annual results 2021 and First Quarter Sales 2022, April 21, 2022 (post-market).

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

Disclaimer

This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding Mauna Kea Technologies’ financial condition, business, strategies, plans and objectives of management for future operations are forward-looking statements. 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 Chapter 3 of the 2020 Universal Registration Document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on June 17, 2021 under number D-21-0566 and the amendment to the 2020 Universal Registration Document filed with the AMF on September 17, 2021, which are both available on the Company's website (www.maunakeatech.com), and risks relating the 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 jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. The distribution of this document may, in certain jurisdictions, be restricted by local regulations. Persons who come into possession of this document are required to observe all applicable local regulations relating to this document.