Mauna Kea Technologies publishes its financial results for the first half of 2022

Improvement in the gross margin rate driven by a more favorable sales mix and reduction in the operating loss

Good commercial activity following the strategic repositioning and the reallocation of resources

Cash position as of June 30, 2022 at €5.3m

PARIS & BOSTON, November 16, 2022–(BUSINESS WIRE)–Regulatory News:

Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY):

Webinar | November 16, 2022, at 6 p.m.

https://app.livestorm.co/p/2bd2a372-04cb-4a29-b097-2b16b116f064

The replay will be made available on the Mauna Kea Technologies website in the investors section.

Mauna Kea Technologies (FR0010609263 : MKEA) inventor of Cellvizio®the multidisciplinary mini-probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announces its financial results for the first half of 2022 ended June 30, 2022.

“The financial results for the first half of 2022 are in line with our expectations and materialize the implementation of our strategic repositioning. This transition, which began at the end of 2021, is producing its first tangible results with, in particular, the recent creation of a joint venture in China with Tasly Pharmaceutical.” said Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies. “At the same time, we continued to strengthen the company’s core technology assets, with favorable clinical study results in new therapeutic areas, continuous improvement of our imaging platform and obtaining new regulatory approvals in the United States. In the end, if 2022 remains a year of transition, I have growing confidence in Mauna Kea’s ability to better capitalize on the significant commercial potential of Cellvizio at the dawn of 2023.”

Financial summary for the first half of 2022

  • Gross margin rate up to 73% vs. 71% in H1 2021

  • Current operating loss, reduced by 19%, to €4,957K compared to €6,099K in H1 2021

  • Net loss of €6,212K compared to €6,691K in the first half of 2021

  • Total revenue for H1 2022 at €3,391K, up slightly by €77K, i.e. +2% compared to the previous period in 2021

  • Total revenue for the first half of 2022 down slightly by €154K (-4%) compared to the first half of 2021, to reach €3,708K

  • Cash position of €5.3m at the end of June 2022 and total amount of long-term debt of €26.4m, compared to €11.9m in cash and €26.9m in long-term debt at December 31 2021

H1 2022 post-closing highlights

On July 11, Mauna Kea Technologies announced the signing of a strategic agreement to create a Joint Venture (JV) with a Chinese pharmaceutical company, Tasly Pharmaceutical. On November 7, the Joint Venture was legally incorporated under the name of Tasly Mauna Kea Medical Engineering Technology Co. Ltdbased in the Chinese province of Zheijang, with a capital of 250 million RMB (35 million euros1).

Under the terms of their agreement, this partnership includes:

– The marketing of most Cellvizio indications in China,
– The development and worldwide marketing of a dedicated version of Cellvizio in the fields of neurology and neurosurgery, and
– The eventual manufacture of specific Cellvizio units for the Chinese market.

On October 4, Sacha Loiseau, co-founder and Chairman of the Board of Directors of Mauna Kea Technologies, was appointed as Chief Executive Officer. Mr. Sacha Loiseau now combines the functions of Chairman and Chief Executive Officer of Mauna Kea Technologies.

Mauna Kea Technologies announced the success of a long-term prospective clinical study on the prediction of remission or relapse in patients with inflammatory bowel disease (IBD) using confocal laser endomicroscopy with Cellvizio . The results were published in Gastroenterology, the flagship journal of the American Gastroenterological Association. The study prospectively showed that the predictive value of intestinal barrier healing evaluated dynamically and functionally by confocal laser endomicroscopy (Cellvizio®) was much higher than that of endoscopic and histological remission in predicting remission or long-term relapse in a large cohort of patients with IBD in clinical remission.

Consolidated financial results for the first half of 2022*

(In thousands of €) – IFRS standard

H1 2022

H1 2021

Var. €

Var. %

Turnover

3,391

3,314

77

+2%

Other income

318

548

(230)

(42%)

Total products

3,708

3,862

(154)

(4%)

Cost of goods sold

(911)

(971)

(60)

(6%)

Gross margin rate (%)

73%

71%

Research

(1990)

(1,584)

406

+26%

Sales & Marketing

(2,841)

(3,605)

(764)

(21%)

Overheads

(2,767)

(3,442)

(675)

(20%)

Share-based payment

(155)

(359)

(204)

(57%)

Total operating expenses

(8,665)

(9,961)

(1,296)

(13%)

current operating income

(4,957)

(6,099)

(1,142)

(19%)

Non-current operating income

(85)

Operating income

(5,042)

(6,099)

(1,057)

(17%)

Financial result & other expenses, net

(1,170)

(592)

(578)

(98%)

Net profit

(6,212)

(6,691)

(479)

(7%)

*The figures being rounded, the totals do not necessarily correspond to the sum of the elements.

Total revenue for the first half of 2022 amounted to €3,391,000, up slightly by +2% compared to the previous period.
First-half sales benefited in particular from the good momentum of Systems and Services sales, up 11% and 22% respectively.
Geographically, sales in the United States during the first half recorded an increase of +35% compared to last year, despite a reduced sales force. The drop in consumables sales is partly due to the national shortage of fluorescein in the United States.
Within the EMEA & ROW region, sales generated were up +6%, while sales in the Asia-Pacific market were down -61%, the latter remaining impacted by restrictions due to the pandemic.

The gross margin rate for the first half of 2022 was 73%, up 2 points compared to 71% during the previous period, thanks to a more favorable sales mix during the first half of 2022.

Operating expenses, excluding the cost of goods sold included, fell by €1,237 thousand from one period to the next, to reach €7,753 thousand. This variation is explained by lower expenses in Sales & Marketing (-21%), administrative expenses (-20%) and share-based payments (-57%), while expenses in research and development slightly increased by €405k.

Thus, the operating loss improved to -€5,042k, compared to -€6,099k in the first half of 2021. The restructuring of Mauna Kea Technologies and the reallocation of resources to the R&D department enabled this improvement.

After taking into account all of these elements, the net loss for the first half of 2022 amounts to -€6,212K, up €479K compared to the previous period.

As of June 30, 2022, the Company had a cash balance of €5.3 million and total debt of €26.4 million, compared to €11.9 million in cash and €26.9 million in debt total, as of December 31, 2021. The change in cash during the period breaks down as follows:

  • €6.2 million of cash consumed by operating activities,

  • €0.1 million of cash used in investing activities,

  • €0.3 million in cash related to financing activities.

As of June 30, 2022 Mauna Kea Technologies employed 71 people compared to 87 as of December 31, 2021.

The consolidated accounts for the first half of 2022 have been audited and the audit reports are now published.

The 2022 half-year financial report will be available before November 30, 2022 on the company’s website, in the Investors section.

***

About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and markets Cellvizio®, the real-time in vivo cellular imaging platform. This technology provides unique in vivo cellular visualization that allows physicians to monitor disease progression over time, assess reactions as they occur, classify areas of uncertainty, and guide surgical interventions. The Cellvizio platform is used in many countries around the world and in several medical specialties and is transforming the way doctors diagnose and treat patients. For more information, visit www.maunakeatech.com.

Warning
This press release contains forward-looking statements regarding Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, without limitation, those regarding the financial condition, business, strategies, plans and objectives of the management of Mauna Kea Technologies for future transactions are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no guarantee can be given as to the achievement of the forecasts expressed in these forward-looking statements, which are subject to numerous risks and uncertainties, including those described in Chapter 3 of the Mauna Kea Technologies 2021 Universal Registration Document filed with the Autorité des marchés financiers (AMF) on October 18, 2022 under number D-22-0773, available on the Company’s website (www.maunakeatech.fr), as well as the risks related to changes in the economic conditions, financial markets and markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this date. The realization of all or part of these risks could lead to the actual results, financial conditions, performances or achievements of Mauna Kea Technologies differing significantly from the results, financial conditions, performances or achievements expressed in these forward-looking statements. This press release and the information it contains do not constitute an offer to sell or subscribe, nor the solicitation of an order to buy or subscribe to Mauna Kea Technologies shares in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The distribution of this press release may, in some jurisdictions, be restricted by local law. Persons into whose possession this document comes are responsible for complying with all local regulations applicable to this document.

1 Dated November 06, 2022.

View the source version on businesswire.com: https://www.businesswire.com/news/home/20221116005804/en/

contacts

Investor Relations
NewCap – Financial communication
Thomas Grojean
+33 (0)1 44 71 94 94
maunakea@newcap.eu

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