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Mauna Kea Applied sciences stories its monetary outcomes for the primary half of 2022

Gross margin improvement due to a more favorable revenue mix and a reduction in operating loss

Good business after strategic repositioning and reallocation of resources

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

PARIS & BOSTON–(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 on Investors section.

Mauna Kea Technologies (FR0010609263 : MKEA) Inventor of Cellvizio®the multidisciplinary miniprobe 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 demonstrate the implementation of our strategic repositioning. This transition, which began in late 2021, is yielding its first tangible results, notably through the recent establishment of a joint venture in China with Tasly Pharmaceutical.” said Sacha Loiseau, Chairman and CEO of Mauna Kea Technologies. “At the same time, we have continued to strengthen the Company’s core technology assets, with favorable clinical trial results in new therapeutic areas, continued improvement of our imaging platform and the receipt of new regulatory approvals in the United States. If 2022 ultimately remains a year of transition, I have growing confidence in Mauna Kea’s ability to better leverage Cellvizio’s significant commercial potential in early 2023.”

Financial overview for the first half of 2022

  • Gross margin up to 73% versus 71% in H1 2021

  • The ongoing operating loss was reduced by 19% to €4,957,000 compared to €6,099,000 in H1 2021

  • Net loss of €6,212,000 compared to €6,691,000 in H1 2021

  • Total sales for the first half of 2022 at €3,391,000, up slightly by €77,000 i.e. +2% compared to the previous period in 2021

  • Total sales for the first half of 2022 decreased slightly by €154,000 (-4%) to €3,708,000 compared to the first half of 2021

  • Cash on hand of €5.3m at the end of June 2022 and total 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 upon completion of highlights

  • Formation of a joint venture and licensing agreements between Mauna Kea Technologies and Tasly Pharmaceutical

On July 11, Mauna Kea Technologies announced it had signed a strategic agreement to form a joint venture (JV) with a Chinese pharmaceutical company, Tasly Pharmaceutical. On November 7th, the joint venture was legally formed under the name Tasly Mauna Kea Medical Engineering Technology Co.Ltdbased in Zhejiang Province, China, with a registered capital of RMB 250 million (EUR 35 million).1).

Under the terms of their agreement, this partnership includes:

– Commercialization of most Cellvizio indications in China,

– The development and global 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.

  • Appointment of Sacha Loiseau as CEO

On October 4th, Sacha Loiseau, co-founder and chairman of Mauna Kea Technologies, was named chief executive officer. Mr. Sacha Loiseau now combines the roles of Chairman and Chief Executive Officer of Mauna Kea Technologies.

  • Success of a clinical study predicting severe side effects in patients with inflammatory bowel disease (IBD) with Cellvizio

Mauna Kea Technologies announced the success of a long-term prospective clinical study to predict remission or relapse in patients with inflammatory bowel disease (IBD) using Cellvizio confocal laser endomicroscopy. The results were published in gastroenterology, the flagship journal of the American Gastroenterological Association. The study prospectively showed that the predictive value of gut barrier healing, assessed 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

S1 2022

S1 2021

Var. €

Var. %

Sales volume

3,391

3.314

77

+2%

other income

318

548

(230)

(42%)

Entire products

3,708

3,862

(154)

(4%)

cost of goods sold

(911)

(971)

(60)

(6%)

Gross Margin (%)

73%

71%

research

(1990)

(1,584)

406

+26%

Sales & Marketing

(2,841)

(3,605)

(764)

(21%)

overhead

(2,767)

(3,442)

(675)

(20%)

Share-based Compensation

(155)

(359)

(204)

(57%)

business expenses

(8,665)

(9,961)

(1,296)

(13%)

ongoing operating income

(4,957)

(6,099)

(1,142)

(19%)

Long-term operating income

(85)

operating result

(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%)

*For rounded numbers, totals do not necessarily equal the sum of the items.

Total revenues for the first half of 2022 amounted to €3,391,000, a slight increase of +2% compared to the previous period.

First-half revenue benefited in particular from good momentum in systems and service sales, which grew 11% and 22%, respectively.

Geographically, sales in the United States for the first half of the year recorded an increase of +35% compared to the previous year, despite a reduced sales force. The decline in consumables sales was due in part to the nationwide shortage of fluorescein in the United States.

In the EMEA & ROW region, generated revenue increased by +6%, while sales in the Asia-Pacific market fell by -61%, the latter continuing to be impacted by restrictions due to the pandemic.

Gross margin rate for H1 2022 was 73%, up 2 points from 71% in the previous period, thanks to a more favorable revenue mix in H1 2022.

The operating expenses without the production costs contained therein fell from period to period by € 1,237 thousand to € 7,753 thousand. This variance is explained by lower expenses in Sales & Marketing (-21%), Administrative expenses (-20%) and Share-based Compensation (-57%), while R&D expenses increased slightly by €405,000.

As such, the operating loss improved to -€5,042,000 compared to -€6,099,000 in H1 2021. The restructuring of Mauna Kea Technologies and the reallocation of resources to the R&D department enabled this improvement.

After taking all these elements into account, the net loss for the first half of 2022 amounts to -€6,212,000, an increase of €479,000 compared to the previous period.

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

  • €6.2 million cash used from operating activities,

  • €0.1 million cash outflow from investing activities,

  • €0.3 million in cash related to financing activities.

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

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

The 2022 Half Year Financial Report will be available on the Company’s website in the Investors section until November 30, 2022.

***

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical technology company that manufactures and markets Cellvizio®, the in vivo real-time cellular imaging platform. This technology provides a unique in vivo cellular visualization that enables physicians to monitor disease progression over time, assess emerging responses, classify areas of uncertainty, and guide surgical procedures. Used in many countries around the world and across multiple medical specialties, the Cellvizio platform is transforming the way doctors diagnose and treat patients. Visit www.maunakeatech.com for more information.

warning

This press release contains forward-looking statements regarding Mauna Kea Technologies and its business. All statements other than statements of historical fact contained in this press release, including but not limited to the financial condition, business, strategies, plans and objectives of management of Mauna Kea Technologies for future transactions are forward-looking statements. Mauna Kea Technologies believes these forward-looking statements are based on reasonable assumptions. However, there can be no assurance that the projections expressed in these forward-looking statements will be achieved, which are subject to numerous risks and uncertainties, including those described in Chapter 3 of 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 economic conditions, financial markets and markets in Mauna Kea Technologies operates. The forward-looking statements contained in this press release also involve risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not believe are material at this time. The materialization of all or a portion of these risks could cause Mauna Kea Technologies’ actual results, financial condition, performance or achievements to differ materially from the results, financial condition, performance or achievements expressed in these forward-looking statements. This press release and the information contained herein does not constitute an offer to sell or subscribe for, or a solicitation of an order to purchase or subscribe for, shares in Mauna Kea Technologies in any jurisdiction where such offer, solicitation or Sale previously would have been unlawful registration or qualification under the securities laws of that jurisdiction. The distribution of this press release in some jurisdictions may be restricted by local law. Persons into whose possession this document comes are responsible for compliance with any local regulation governing this document.

1 From 11/06/2022.

contacts

Investor Relations
newcap – financial communication

Thomas Grojean

+33 (0)1 44 71 94 94

[email protected]

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