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Corporate resources focused on highest value clinical applications
Significant reduction in operating expenses implemented
Cash runway now extended to Q4 2023
PARIS & BOSTON, January 13, 2022--(BUSINESS WIRE)--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 announces a board-approved plan designed to reduce operating expenses and maximize capital resources in order to support the Company's strategic focus on the use of Cellvizio as an aid for real-time characterization of lung cancer and for molecular imaging guided surgical interventions.
"The opportunities to leverage Cellvizio as a key technology platform in the lung cancer market represent the most material driver of potential shareholder value creation for the Company. In addition, there is significant promise over time for the use of Cellvizio to enable molecular imaging guided surgical interventions," said Sacha Loiseau, Ph.D., Founder and Chairman of Mauna Kea Technologies. "The Company’s extended cash runway will allow us to achieve meaningful milestones on our product and clinical roadmaps as we seek to identify additional strategic partners with the engineering expertise and commercial scale to integrate Cellvizio’s clinical insights and improve patient care. While the Company is reducing its activity in direct sales efforts in the U.S., it will continue to support its significant installed base and target high volume users. The Mauna Kea Board strongly believes that this more capital-efficient strategy will enable the Company to best meet the needs of our shareholders, employees, and clinicians."
As of December 31, 2021, the Company had a cash balance of €11.8M. Annualizing the impact of the cost reductions implemented, the Company expects to reduce operating expense by about 40% (in 2020, the Company had cash-based operating expenses of €17.1M and total revenue of €7.9M including €6.5M from sales). These expense reductions reflect a combination of reduced administrative costs, reduced sales and marketing expenditures, reduced board fees, the elimination of several non-core external advisors, and a more focused and disciplined product development roadmap, among other sources. In this new configuration, the Company now expects its cash runway to be extended to Q4 2023, giving it time to meet its planned strategic milestones1.
Shu-i Gautheron, Finance and Administrative Director since June 2021, has been promoted to Chief Financial Officer following the departure of Christophe Lamboeuf. Mr. Lamboeuf elected to leave the Company at the end of 2021 to pursue a new opportunity, and his contributions during his tenure are greatly appreciated. Ms. Gautheron brings 25 years of international experience as a senior finance executive, including China. She was previously Managing Director of Finance at EnTrust Global and Permal Group.
In addition, Daryl Donatelli, currently Senior Director, Global Marketing, will become Vice President, Global Marketing. Finally, Fred Banegas, who joined the Company in March 2021 as Director of R&D has been promoted to Chief Technology Officer.
"We are lucky to have such a strong collection of talents supporting our important medical technology platform," commented Nicolas Bouvier, interim Chief Executive Officer. "I am convinced that our strategic repositioning combined with a more streamlined organization will yield significant improvements in operational effectiveness."
Next Financial Communication: Mauna Kea will announce Q4 and year-end 2021 sales results on January 20, 2022.
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.
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.
1 This estimate includes all capital expenditures, interest, and principal repayments, as well as the use of the existing equity line with Kepler Chevreux (3.6 million outstanding warrants). On December 31, 2021, the company had a gross financial indebtedness of approximately €29M, of which €27M are long term.
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