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2018 Report

Letter to shareholders

"Dear Shareholders,
the year 2018 confirmed DiaSorin’s excellent financial results, with increased revenues and profitability along with record net profit and cash generation.

We undertook several projects as evidence of our ongoing quest for cutting-edge, reliable products, in order to provide our customers - the diagnostic laboratories - with more effective solutions capable of delivering high-quality and swift answers.

Our customers have always been at the hearth of every single initiative and decision related to investment and development, as regards both the consolidated immunodiagnostics framework and the recent molecular diagnostics segment.

The year 2018 continued to confirm DiaSorin as the immunodiagnostic Company with the broadest specialty menu available on the global market with over 115 products, including 30 high-specialty tests. We kept on expanding the number of molecular diagnostic tests by launching 4 new kits and 11 new ASRs, increasing our already extensive menu available on LIAISON MDX and laying the foundation for further business growth.

It is noteworthy to mention the launch of latent tuberculosis test, following the agreement with QIAGEN on the use of QuantiFERON technology. This diagnostic specialty offers strong growth prospects for both companies, given the spread of Tuberculosis around the world. Furthermore, the successful development of this test opened the way for new diagnostic applications generated by synergy among technologies.

The success of LIAISON analyzers placements continued with an overall installed base exceeding 7,800 units, with LIAISON XL representing more than 50% of analyzers. During the year, we continue to focus on the development of the new LIAISON XS: the analyzer will be launched on the European market in first month of 2019 to serve small-medium sized laboratories.

In 2018, we worked on business development, through an important agreement signed with MERIDIAN BIOSCIENCE, a major U.S. diagnostics company, to sell DiaSorin’s FDA-cleared H. Pylori stool antigen test to detect Helicobacter Pylori for use on its automated LIAISON platform.

In light of the above, I believe that DiaSorin, once again, represents the excellence standard in the diagnostic sector at global level, laying the foundation for further success to be achieved in the forthcoming years. This success stems from our vision, strategy, passion, ability to adapt to changing market conditions, as well as a corporate talent-oriented culture, which is a necessary and essential condition for an innovative and fast-growing company like DiaSorin.

I would like to thank our Top Management, all employees and Shareholders for confirming their trust in the Group’s important objectives that are intended to drive our Company towards important results. And, I would also like to mention our commitment to corporate sustainability initiatives that, again this year, have been at the basis of our conduct, especially with respect to local communities where we operate.

Our projects range from those to support talent and love for science, like Mad for Science, to those to help athletes facing difficult situations, like Talent Project with FISIP or DiaSorin Sitting Volley Cup, or those to ease hospitalized children’s anxieties, like Pinocchio Project…small acts demonstrating how focus on Individuals has become increasingly important to build up a better future for our Society.

Chairman
Gustavo Denegri

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LIAISON XL

Thanks to its flexible configuration, provides both highly automated solutions, through the connection to the Laboratory Automation Systems used by the main market players, and stand-alone solutions.

483

UNITS
INSTALLED
IN 2018

4,001

TOTAL INSTALLED
BASE

LIAISON XS

2018 set new targets in the LIAISON XS development; in addition to the validation phase of the assays that will be part of the analyzers' menu, DiaSorin added Serveability and Usability tests for a complete check of its functionality. As of today, more then 30 units have been installed at the Group's main manufacturing and R&D facilities, with the aim of completing the test's validation phase, up to the final stages of the analyzer's development, in view of its commercial launch in the European market in the first months of 2019.


IMMUNODIAGNOSTICS
MOLECULAR DIAGNOSTICS

Products development on LIAISON/LIAISON XL

LIAISON QUANTIFERON-TB GOLD PLUS

Launched in Europe, in partnership with Qiagen, to detect latent tuberculosis infections.

LIAISON BRAHMS PCT II GEN

Clearance to market in the U.S. the assay for Sepsi’s diagnosis through the quantitative determination of procalcitonin.

LIAISON XL MUREX ANTI-HDV

Clearance to market in Europe the specialty assay for the diagnosis of Hepatitis D virus (HDV), completing the CLIA menu for Hepatitis and Retrovirus available.

LIAISON CALPROTECTIN

Clearance to market in the U.S. the test for the quantitative determination of Calprotectin in stool samples.

Launch of new kits and ASRs on LIAISON MDX ANALYZER

KITS

HSV 1 & 2

Certification to extend the analyzable claims of Simplexa HSV 1 & 2 molecular kit on the “Direct Amplification Disc” in the U.S.

vzv direct

CE marking for Simplexa VZV Direct test in Europe.

GROUP B Streptococcus

CE marking for Simplexa Group B Strep Direct in Europa and the U.S.

Bordetella Direct

FDA clearance to launch in the U.S. the Simplexa Bordetella Direct molecular test for qualitative detection and differentation of Bordetella pertussis and Bordetella parapertussis.

ASRs - Analyte Specific Reagents

Anaplasma phagocytophilum, Ehrlichia And Babesia

For the identification of infections caused by these pathogens, commonly carried by ticks.

Legionella species, Clhamydophila pneumoniae and Mycoplasma pneumoniae

For the identification of infections caused by bacteria that may affect lungs.

PEOPLE AT THE HEARTH
1,971
TOTAL EMPLOYEES
99%
PERMANENT CONTRACTS
67%
BACHELOR DEGREES
60,463
TRAINING HOURS

2018 was an important year in the management of our people. We focused on organizational, management and project aspects that impacted different business areas.

Internal growth

Involving a significant number of high-impact resources within our business.

Key resources

Identification of key resources for business development from the market.

New positions

Definition of new positions and recruitment of the Head of Innovation, as a result of the implementation process started over the past years.

TRUST project

Implementation of the TRUST project, based on the SAP Success Factor platform, which aggregates different management processes, including leadership evaluation for 900 resources, and the management of the rewarding process, reporting and recruiting.

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2018

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Income statement

Income statement (€ thousands)20182017
Net revenues669,197637,487
Gross profit455,769431,896
EBITDA (1)255,351237,922
Operating result (EBIT)204,525184,420
Net profit for the year158,130139,878
Adjusted EBITDA (2)n.a.241,185
Adjusted EBIT (2)n.a.192,085

(1) Looking at the data on the Table, the Board of Directors defines EBITDA as the “operating result (EBIT)” before amortization of intangibles and depreciation of property, plant and equipment.
(2) In order to better understand the operating and financial results, the Board of Directors defined, for the current financial year only, Adjusted EBITDA and Adjusted Ebit indicators; Adjusted EBITDA is defined as EBITDA, net of the contribution of the Siemens’ ELISA business and economic impact of the project to close the Irish facility; Adjusted EBIT is defined as the Operating Result, net of the contribution of the Siemens’ ELISA business and economic impact of the project to close the Irish facility.

Financial position

Statement of financial position (€ thousands)20182017
Capital invested in non-current assets491,080460,482
Net invested capital629,424592,653
Net financial position75,311149,302
Shareholders’ equity704,735741,955

Cash flow statement

Statement of financial position (€ thousands)20182017
Capital invested in non-current assets491,080460,482
Net invested capital629,424592,653
Net financial position75,311149,302
Shareholders’ equity704,735741,955