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Safe Group Announces First Half Financial Results and Third Quarter Revenue

  • H1 revenue up 30.4% compared to H1 2021
  • EBITDA up 25% compared to H1 2021
  • Q3 sales up 19%

Eragny-sur-Oise, France, October 6e2022, 8:30 a.m. CET – Safe (FR0013467123 – ALSAF), a company specializing in the design, manufacture and marketing of single-use technologies for spinal surgeries, publishes its financial results for the half-year ended June 30, 2022 as approved by the Board of administration of October 5, 2022 and certified by the auditors, as well as its turnover for the third quarter of 2022.

Financial results for the first half of 2022
Safe’s 2022 half-year financial report will be available on the Company’s website (www.safeorthopaedics.com) by October 30, 2022 in the section Investors > Documentation > Regulated information.

In thousands of euros – IFRS standard* 06/30/2022 06/30/2021
Revenues – Direct Sales 1,114 773
Revenue – Indirect Sales 560 556
Turnover – Production subcontracting 1,071 776
Adjusted total revenue 2,745 2,105 +30.4%
Other income 15 4
Purchases consumed and changes in inventory (994) (1,425)
External costs (987) (973)
Personnel costs (3,490) (3,341)
Other operating expenses (765) (377)
Operating income / (loss) before non-recurring items (3,478) (4,006) +13.2%
Other operating income (expenses) 43 (6)
Operating income / (loss) (3,434) (4,012) +14.4%
Financial income / (losses) (464) (204)
Net income / (loss) (3,897) (4,216) +7.5%
* Verified Accounts

Turnover of €2,760K (including other income of €15K and post IFRS15 impact of €80K), up 31%, driven by double-digit growth: 27% for Safe Orthopedics and 38 % for Safe medical.

Safe Orthopedics’ growth was driven by its direct sales activity in the United States and France, despite the optimization of sales resources for the French sales force, and by stable indirect sales (+26% compared to the first semester 2021).

Safe Medical’s growth is explained by rising orders and strong commercial momentum to which historical customers entrust more and more integrated projects (+38% compared to the first half of 2021);

Purchases are down thanks to a positive change in inventories, due in particular to the increase in inventories to serve US growth, support the clinicpartner contract and the international roll-out of Hickory and Sycamore products.

Staff costs are stable compared to H1 2021, as are external costs, the stability of which is linked to the implementation of internal budget management tools and the drop in consulting fees offset by the increase in fees related to clinical studies.

Other operating expenses increased by €388,000 due to the impact of depreciation allowances (purchase of new production machines and their qualification at Safe Medical at the end of 2021/beginning of 2022) and allowances for provisions related to the current assets (stocks, receivables). As previously communicated, the Group has internalized all of its production and anticipates a relative drop in external costs.

It should be noted that EBITDA for the first half of 2022 is equal to €2,778K, an improvement of 25% compared to the first half of 2021 when it was €3,706K.

Third-quarter 2022 revenue

In thousands of euros Q3 2022
(3 months)
Q3 2021
(3 months)
9M 2022 9M 2021

direct sales 707 +40% 506 1,887 +43% 1,318
Indirect sales 249 +0% 248 808 +1% 804
Contract sales 441 +5% 420 1,543 +26% 1,221
Total sales 1,397 +19% 1,174 4,238 +27% 3,342

*Unaudited. Excluding IFRS 15

In the third quarter, the Group grew by 27% in the Safe Orthopedics scope and by 5% in the Safe Medical scope.

As in the previous three quarters, Safe Orthopedics achieved double-digit growth, driven by direct sales in the United States and France.

Quarterly direct sales are up sharply, driven by US sales at €212,000 and French sales at €380,000, up 23% compared to the previous year. Since the beginning of the year, a strong recovery of 43% has been observed in direct sales areas compared to the previous year.

Indirect quarterly sales were stable compared to last year, reflecting the cautious recovery of distributors in all geographies.

Sales of outsourced production (Safe Medical) rose sharply by 26% over 9 months to €1,543k.

As a reminder, in the first, second and third quarters, Safe Medical announced sales growth of 26%, 48% and 5% respectively. Indeed, at the request of its customers, the company had delivered products before the summer shutdown of the plant, thus explaining the strong growth of the second quarter and the contained growth of the third quarter.

Cleanrooms generated their first sales to third parties in the first half.

“Our first half of 2022 shows double-digit commercial growth in our Safe Orthopedics and Safe Medical entities as well as a 25% improvement in our EBITDA at the consolidated group level. Today, we are announcing a third quarter in line with the previous ones. The latest news from the Group, the fully integrated production and the partnership with Wenzel Spine, are important milestones to continue to improve our financial results over the coming quarters and strengthen our innovation potential in the global market. commented Pierre Dumouchel, President and CEO of the Safe Group. “We are aware that the Group’s financing and the international financial crisis are weighing heavily on the share price. However, we remain focused on our commercial execution and are working on the opportunities to reach the financial balance as quickly as possible, which is essential for the revaluation of our group.


Treasury

As of June 30, 2022, the Group’s audited cash amounted to €0.2 million, compared to €3.9 million at the end of June 2021. As a reminder, the remaining balance of financing to be received amounts to a maximum of 2.4 M€. .

It is recalled that the press release published on December 10, 2021 lists the risks related to financing, including the risk of dilution induced by financing by convertible bonds.

The impact of the capital increases linked to the conversion of the OCEANEs under the said financing program on the investment of a shareholder holding 1% of the Company’s share capital on the launch date of the program, December 9, 2021 ( based on the number of shares making up the Company’s share capital as of December 9, 2021, i.e. 54,113,396 shares) is summarized below:

Shareholder participation
Total number of shares Undiluted basis Diluted basis(1)
Before the show 54,113,396 1.00% 0.99%
Dilution to date (after issuance of 187,632,338 shares resulting from the conversion of OCEANEs) 241.753.024 0.22% 0.22%
Final dilution, after issuance of 240,000,000 new shares resulting from the conversion of the OCEANEs(2) 481.753.024 0.11% 0.11%
  1. The diluted basis takes into account the exercise of all existing dilutive instruments on December 9, 2021, which could lead to the creation of a maximum of 581,599 new shares.
  2. Theoretical calculations made on the basis of a conversion made on the basis of the nominal amount of the share, ie 0.01 euro.

Next financial publication

Notice of convocation of an extraordinary general meeting of October 10, 2022 (after market)

Second-half 2022 revenue, January 10, 2023 (after market)

About Safe Group

Safe Group is a French medical technology group that brings together Safe Orthopedics, a pioneer in ready-to-use technologies for spine pathologies, and Safe Medical (formerly LCI Medical), a subcontractor of medical devices for orthopedic surgery. The group employs around 150 people.

Safe Orthopedics develops and manufactures kits combining sterile implants and single-use instruments, available to the surgeon at any time. These technologies are part of a minimally invasive approach aimed at reducing the risks of contamination and infection, in the interest of the patient and with a positive impact on hospitalization times and costs. Protected by 18 patent families, SteriSpineTM kits are CE marked and FDA approved. Safe Orthopedics is headquartered in the Paris region (95610 Eragny-sur-Oise) and has subsidiaries in the United Kingdom, Germany, the United States and in the Lyon region (Fleurieux-sur-l’Arbresle).

For more information: http://www.safeorthopaedics.com/

Safe Medical produces implantable medical devices and ready-to-use instruments. It has an innovation center and two production sites in France (Fleurieux-sur-l’Arbresle, 69210) and in Tunisia, offering numerous industrial services: design, industrialization, machining, finishing and sterile packaging. Supported by the French recovery plan in 2020, the company is investing in additive printing and will be operational in 2022 on this new technology.

For more information: http://www.safemedical.fr/

contacts

Safe group
Francois-Henri Reynaud
Financial and Administrative Director
Such. : +33 (0)1 34 21 50 00
[email protected]