Safe group announces its 2021 results and reiterates its

Safe group announces its 2021 results and reiterates its 2022 objectives

  • 2021 revenue of €4.6 million, up +24%.
  • +18% improvement in gross margin
  • Operating profit at pre-health crisis level
  • +19% improvement in net income
  • 4 strategic axes recalled for 2022

Eragny-sur-Oise, France, May 2n/a2022 08:45 CET – Safe (FR0013467123 – ALSAF), a company specializing in the design, manufacture and marketing of single-use technologies for spine surgeries, delivering the safest treatment for spine fractures treated in emergency, today announces its 2021 results and reiterates its 2022 strategic objectives.

The Safe group’s 2021 annual financial report will be available on the Company’s website (www.SafeOrthopaedics.com) in the section Investors > Documentation > Regulated information from April 30, 2022.

Consolidated financial statements – In thousands of euros – IFRS 31/12/2021 31/12/2020 21/20 31/12/2019 21/19
Turnover – Direct Sales 1,775 1,647 +8% 2,109 -16%
Revenue – Indirect Sales 990 1,623 -39% 2,683 -63%
Turnover – Sales of production subcontracting 1,791 415 +332%
Total revenue 4,556 3,685 +24% 4,792 -5%
Cost of goods sold and change in inventory (1,985) (2,259) +12% (3,420) +42%
% Gross margin 56% 39% +18% 29% +28%
External charges (2,561) (2,081) -23% (3,257) +21%
Human resources expenditure (6,693) (5,443) -23% (4,633) -44%
Other operating expenses (966) (569) -70% (939) -3%
current operating income (7,650) (6,667) -15% (7,456) -3%
Other operating income and expenses 85 1 8
Operating result (7,566) (6,666) -13% (7,449) -1%
bottom line 875 -1,640 -521
Net revenue (6,691) (8,306) +19% (7,970) +16%

In 2021, revenue reached €4,556,000 (after the impact of IFRS 15, which deducts marketing costs directly from revenue), up 23.6%, driven by an increase in direct sales from Safe Orthopedics and Safe Medical, even as the Covid-19 pandemic continues to limit surgeries and sales approaches.
The annual direct sales of Safe Orthopedics increased by 8% thanks to the performance in Germany (+263 K€) and the start of marketing in the USA (+122 K€). To enable investments in these last two territories and improve European operating profit, a pooling of sales and marketing teams and a reduction in the number of French sales teams (5 in 2021 compared to 9 in 2020) have been put in place without reducing the national network.

Indirect sales of Safe Orthopedics reached €990K, strongly impacted by covid over the last two fiscal years 2020 and 2021. In Japan, the Otsuka Group sold the distribution of Safe Orthopedics products to Teijin Medical, creating a temporary slowdown.
The turnover of Safe Medical fully integrated into the Group in 2021 amounts to €1.8 million, up 106% between the second half of 2021 and 2020 (the company was acquired in July 2020). In parallel with this commercial acceleration, the construction of an Integrated Center for Innovation and Production (CIPI) in Fleurieux-sur-l’Arbresle has been completed, and will supply all industrial equipment from September 2021 (microbiological cleaning and clean rooms ) necessary for the in-house production of ready-to-use medical devices: the transfer of production of the Safe Orthopedics kits has started and all the SteriSpineTM ranges will be produced there in the first half of 2022.

The first financial synergies of the group begin to significantly increase the gross margin of the Safe group by 18%. After the transfer of SteriSpineTM technologies in the first half of 2022, the gross margin will be maximized, production times will be halved and working capital requirements optimized.

External expenses increased by 23% directly linked to the Group’s return to growth, the launch of new technologies such as Hickory, Sycamore or SORA and investments in Safe Medical, but down €700k compared to 2019 for a level of similar turnover. Safe Orthopedics has also accelerated its clinical investments by strengthening its clinical, quality and regulatory affairs workforce in order to meet new European MDR (Medical Device Regulation) requirements and to demonstrate the clinical benefits of Sycamore (the 3-month clinical performance was published on December 20, 2021).

The 23% increase in human resources expenditure is explained by the reintegration of Safe Medical staff over a full year (compared to 5 months in 2020), the end of financial aid from the State during the confinement period in 2020 and by the recruitment of new operator cleanroom staff allowing integrated production and a reduction in external expenses in the last quarter of 2021. As previously explained, an optimization of the workforce of Safe Orthopedics has been initiated and correlated with commercial expectations in direct markets ( FR, UK, GER and USA) in order to improve the commercial contribution and to respect the objective of financial equilibrium within 24 to 36 months.

The review of the 2019 accounts shows that while the health crisis was still in full swing in 2021, the operating result has caught up with the pre-crisis level.

After a positive financial result of €0.87 million made up of foreign exchange variations in the current accounts of the subsidiaries, the net result amounts to 6.69 million euros, an improvement of 19.4% compared to the previous year.

2021 was a year rich in value creation: the launch of new differentiating technologies such as Sycamore and SORA, the acceleration of sales in Germany, the marketing of our technologies in the United States, the industrial and commercial development of Safe Medical. Even though the COVID-19 pandemic is still disrupting execution, our sales increased by 24% in 2021, our current operating income recovered to the level of 2019 even though significant investments were made to build our Safe group, support our innovation and the conversion of the global market to our ready-to-use technologies” comments Pierre Dumouchel, CEO of the Safe group “Our 2022 roadmap was communicated at the start of the year and can be summed up in 4 main areas: Deploy quality global distribution delivering accelerated double-digit growth, innovate and digitize the surgical act, reduce our ecological impact and improve our financial performance to reach financial balance in 3 years, 2022 starts in accordance with our plan: 31% growth driven by the USA and Germany, several dozen SORA and Sycamore surgeries, 80% of our technologies produced in-house.”

Safe reaffirms its strategic objectives for 2022:

  • Deploy high-quality global distribution that delivers accelerated double-digit growth. Our experienced sales and marketing teams focus on the adoption of our off-the-shelf products and promoting their health-economic benefits to hospitals, purchasing organizations and national health systems.

Sales in the United States were €120K in Q1 2022 compared to €129K for the whole of 2021 (as a reminder, a sales representative was recruited in February 2021). Sales outside the US reached €1.3m in Q1 2022 compared to €1.07k in Q1 2021. New Sycamore and Hickory technologies have already boosted sales by €30k while new customers have been acquired at the end of the first quarter. The signing of an agreement with Clinicpartner was also published during the quarter.

  • Continue to innovate and digitize the surgical act. Initiated by SORA (Safe Operating Room Assistant), our teams support surgeons and hospitals around the world to deploy the 2.0 surgical act, offering digital support from the patient’s first consultation in the operating room to post-operative clinical follow-up. This data is extremely interesting for the design and production of our technologies.

Several dozen surgeries assisted by SORA have already been performed in the first French assessment center. The close collaboration with its team of surgeons has made it possible to make the technology more reliable, to initiate new functionalities and to accelerate sales by an average of 84% over two quarters. Safe Orthopedics plans to deploy additional units in France in the second quarter and internationally in the second half of 2022.

  • Reduce our environmental impact. In connection with the SORA program and the modernization of its factories, the Group is working on the validation of “green-kits”. Safe Orthopedics is committed to reducing the waste generated in the operating room by 30%, and more generally the consumption of water, energy and CO2 emissions thanks to its CIPI.

Since the qualification of clean rooms in the summer of 2021, the French site of Safe Medical has been certified IS013485 by AFAQ on this new industrial perimeter and 80% of Safe Orthopedics technologies are produced there.

  • Aim for financial equilibrium in the medium term. Despite the economic and commercial consequences of COVID-19, which has limited the number of spinal surgeries performed in healthcare institutions around the world, Safe Group continues to show double-digit growth and aims to break even three years here.

Safe hosted an investor meeting on April 14 to present its progress and financial strategy. The Group will publish its financial results for the first half of 2022 on September 29, 2022 and has already announced a new investor meeting on September 22, 2022 in Fleurieux sur l’Arbresle.

Cash flow

With a major refinancing of €8.0 million at the level of Safe SA at the end of the year, and the receipt of a subsidy of €0.8 million from the recovery plan, the balance of which was received in March 2022, the Group cash position amounted to €912,000 as of December 31, 2021.

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: www.safeorthopedics.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: www.safemedical.fr

contacts

Safe group

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

Press relations
Ulysses Communication
Pierre-Louis Germain / +33 (0)6 64 79 97 51 / [email protected]
Bruno Arabe / +33 (0)6 87 88 47 26 / [email protected]

  • 20220429 – PR_results 2021 vDef

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