Mauna Kea Technologies Reports Second Quarter and First Half 2023 Revenue

Regulatory News:

Mauna Kea Technologies (Euronext: MKEA) inventor of Cellvizio, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today reported its revenue for the second quarter and half year ended June 30, 2023.

Highlights:

• Revenue up 77% in Q2 2023 driven by U.S. sales growth and licensing fee income from the J.V. with Tasly Pharmaceutical
• PPU growth accelerates to 50%, benefitting from increased utilization and new users
• Clinical development activity remains high, including a new dual-center peripheral lung cancer study at the Mayo Clinic in Jacksonville and Rochester in the United States
• Growing strategic partnership pipeline reflects increasing role of Cellvizio interventional oncology advanced imaging in new procedures

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: “Building on strong Q1 results, we are very pleased with our Q2 commercial performance, led by notable U.S. sales momentum in systems and consumables, as well as our PPU (pay-per-use) program, despite ongoing fluorescein supply issues. Strategically, the Mauna Kea team has done an excellent job advancing the implementation of our previously announced Joint Venture with Tasly Pharmaceutical, a collaboration that is core to capturing the large and growing Chinese domestic market. Finally, we are exploring an expanding number of strategic partnership opportunities, where we see the potential to accelerate the adoption of Cellvizio in novel indications, a strategy we believe creates capital efficient growth potential and value for our shareholders.”

Second Quarter Sales:

(in €k) - IFRS	Q2 2023	Q2 2022	Change %
Systems	699	363	+93%
Consumables	1,100	786	+40%
Services	381	362	+5%
Total sales	2,180	1,511	+44%
Licensing and Technology fees	499	-	-
Total revenue*	2,679	1,511	+77%
* Totals may not add due to rounding

Second Quarter & First Half 2023 Sales by Category:

(in €k) – IFRS	Q2 2023	Q2 2022	Change		H1 2023	H1 2022	Change
			€k	%			€k	%
Systems	699	363	336	+93%	1,086	1,294	(208)	-16%
Consumables	1,100	786	314	+40%	1,761	1,419	342	+24%
Services	381	362	19	+5%	699	684	15	+2%
Total sales	2,180	1,511	669	+44%	3,547	3,397	149	+4%
Licensing and Technology fees	499	-	499	-	3,301	-	3,301	-
Total revenue*	2,679	1,511	1,168	+77%	6,848	3,397	3,450	+102%
* Totals may not add due to rounding

In the second quarter of 2023, total sales amounted to €2,679k including direct sales of €2,180k, up +44%, and licensing and technology fees of €499k corresponding to the quarterly recurring revenue from the JV with Tasly Pharmaceutical. Sales of systems posted a strong 93% growth in Q2 2023 benefiting in particular from new sales in the United States. Consumables sales were up +40% in the quarter driven mainly by the PPU program.

In the first half of 2023, total sales reached €6,848k, up +102% versus prior year, positively impacted by the recognition of €3,301k in licensing and technology fees from the JV with Tasly Pharmaceutical.

Second Quarter & First Half 2023 Sales by Geography:

(in €k) – IFRS	Q2 2023	Q2 2022	Change		H1 2023	H1 2022	Change
			€k	%			€k	%
United States	1,669	833	836	+100%	2,520	2,228	292	+13%
EMEA & ROW	481	358	123	+34%	949	819	130	+16%
Asia-Pacific	30	320	(290)	-91%	77	349	(272)	-78%
Total sales	2,180	1,511	669	+44%	3,547	3,397	149	+4%
Licensing and Technology fees	499	-	499	-	3,301	-	3,301	-
Total revenue*	2,679	1,511	1,168	+77%	6,848	3,397	3,450	+102%
* Totals may not add due to rounding

In the second quarter of 2023, sales were mostly driven by the United States and to a lesser extent by Europe. The United States benefited from additional sales of systems and probes, and from the acceleration of PPU revenue, even though impacted by an ongoing shortage of fluorescein. In Asia-Pacific, as expected, there were no sales in China due to the transfer of Mauna Kea activities to the JV, but the Company still recorded sales of services outside China.

Second Quarter 2023 Sales in Units:

Units (#)	Q2 2023	Q2 2022	Change
New systems sold*	4	4	-
New systems placed**	2	3	(1)
Total systems	6	7	(1)
Total consumables delivered	152	139	13
* The change in the number of new systems sold over the period may differ from that in reported sales, due to inventory adjustments and product mix variation
** The reference date is the contract signature date, which may differ from the system installation date

Next financial release:

Financial results for the first half of 2023, on September 28, 2023 after market close.

***

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 about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Techonologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 3 of Mauna Kea Technologies' 2022 Universal Registration Document filed with the Autorité des marchés financiers (AMF) on June 28, 2023 under number D-23-0545, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.

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The MAUNA KEA TECHNOLOGIES (O) Stock at the time of publication of the news with a fall of -0,15 % to 0,646EUR on Lang & Schwarz stock exchange (20. Juli 2023, 17:44 Uhr).