DiaSorin S p A : Strong revenues growth in the First Half of 2022 - Full Year 2022 Guidance on both Revenues and Profitability revised upwards

STRONG REVENUES GROWTH IN THE FIRST HALF OF 2022

FULL YEAR 2022 GUIDANCE ON BOTH REVENUES AND PROFITABILITY REVISED UPWARDS

H1 2022 RESULTS

• REVENUES: € 685 million, +33.0% (+25.1% at CER) compared to H1'21. The change is due to the Luminex inclusion in the scope of consolidation and the strong performance of the immunodiagnostic and molecular diagnostic business, partly offset by the expected decline of COVID sales.
  In particular, ex-COVIDimmunodiagnostic revenues grew by 10.0% (+5.4% at CER), mainly driven by the solid performance of Latent Tuberculosis, Infectious Diseases and Gastrointestinal panel tests.
  Ex-COVIDmolecular diagnostics revenues grew by 170.9% (+147.8% at CER), mainly as a result of the upward trend of DiaSorin tests and the Luminex contribution.
  Licensed technologies revenues were € 106 million on the back of the strong sales performance of xMAP® instruments and consumables.
  COVID serology and molecular diagnostic tests sales, equal to € 150 million, even though exceeding the previous guidance, decreased by 15.5% (-20.6%at CER) compared to H1'21, reflecting both the success of pandemic containment measures implemented by government authorities and the effective vaccination campaigns carried out on large scale. Luminex overall contribution to Group revenues was equal to € 185 million in H1'22, in line with expectations.
• ADJUSTED1 EBITDA2: € 269 million, +10.2% (+4.1% at CER) compared to H1'21, equal to 39.3% of Group revenues (39.4% at CER). The result mainly reflects the growth in revenues, while the decrease in profitability is largely due to the Luminex inclusion in the scope of consolidation and the resulting dilution of Gross Profit and reduction of operating leverage. The profitability was however above the expectations included both in the budget and in the plan prepared at the time of the Luminex acquisition.
  EBITDA2: € 264 million, +13.9% (+7.7% at CER) compared to H1'21, equal to 38.5% of Group revenues.
• ADJUSTED1 EBIT: € 221 million, +3.1% compared to H1'21, equal to 32.3% of Group revenues.
  EBIT: € 197 million, -2.6% compared to H1'21, equal to 28.7% of Group revenues.
• ADJUSTED1 NET PROFIT: € 169 million, +3.7% compared to H1'21, equal to 24.6% of Group revenues.
  NET PROFIT: € 141 million, -6.1% compared to H1'21, equal to 20.5% of Group revenues.
• NET FINANCIAL DEBT: -€1,003 million (-€ 986 million at December 31, 2021). The change, equal to -€ 17 million, is related to the robust operating cash flow generation that was more than offset by the dividend payment for € 56 million, the net cash outlay for treasury shares buy-back plan for € 65 million and by a negative currency effect on U.S. dollar- denominated positions.
• FREE CASH FLOW3: € 139 million at June 30, 2022 (€ 126 million in H1'21). The change reflects H1'22 operating result and the positive contribution deriving from the Luminex positive contribution.
• NEW FULL YEAR 2022 GUIDANCE AT 2021 CONSTANT EXCHANGE RATES: upwards revision of guidance on both revenues and profitability, mainly due to an upturn in sales of COVID tests.
• • REVENUES: growth of approx. +2% compared to 2021, of which COVID-related revenues amounting to approx. € 200 million and ex-COVID revenues increasing by approx. 24%.
  • ADJUSTED 1 EBITDA2 MARGIN4 equal to approx. 38%.
• IMPACT OF THE CURRENT SOCIO-POLITICALSITUATION: The Company does not expect material negative impacts deriving from the conflict between Ukraine and Russia, as it is not significantly exposed in such areas.

1. The adjusted Gross Profit, adjusted EBITDA, adjusted EBIT and adjusted Net Profit indicators are provided in the tables at the end of this Press Release (Tables 4 and 5).
2. EBITDA is defined as the "Operating Result", gross of amortization and depreciation of intangible and tangible assets. EBITDA is a measure used by the Company to monitor and evaluate the Group's operating performance and is not defined as an accounting measure in IFRS and therefore shall not be considered an alternative measure for assessing the Group's operating result performance. Since the composition of EBITDA is not regulated by the reference accounting standards, the criterion of determination applied by the Group may not be homogeneous with that adopted by other operators and/or groups and therefore may not be comparable.
3. The Free cash flow is the cash flow from operating activities, counting utilizations for capital expenditures but before interest payments and acquisitions of companies and business operations.
4. Ratio between EBITDA and Revenues

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H1 2022 HIGHLIGHTS

DEVELOPMENT OF IMMUNODIAGNOSTIC TESTS:

• FDA 510 (k) clearance for LIAISON® MeMed BV® test, developed following the licensing agreement signed with MeMed. The test is the first high throughput blood test to differentiate between viral and bacterial infections. LIAISON® MeMed BV® was CE marked in 2021 and is one of the "special programs" identified as growth driver in the 2022-2025 strategic plan, presented during the Company Investor Day held in December 2021.

DEVELOPMENT OF MOLECULAR DIAGNOSTIC TESTS:

• Launch of the updated version of the Simplexa™ SARS-CoV-2 Variants Direct (Research Use Only) to enable the detection of mutations associated with the new Omicron variant.
• CE marking of the new xMAP® NxTAG® GPP Gastrointestinal panel by Luminex to detect nucleic acids from 16 of the most clinically relevant bacterial, viral, and parasitic pathogens in stool samples on the MAGPIX® System.
• CE marking of ARIES® FLU A/B & RSV+SARS-COV-2Assay for the detection of the four most common respiratory viruses and their underlying respiratory infections.

BUSINESS DEVELOPMENT AND OTHER SIGNIFICANT EVENTS:

• Signing of a partnership with B·R·A·H·M·S, part of Thermo Fisher Scientific, for the development and commercialization of the LIAISON® B·R·A·H·M·S MR-proADM™, an immunodiagnostic test offering a more precise assessment of disease severity and improving patient management.
• Appointment of the new President of Luminex, in the person of Angelo Rago - a senior executive with a 30+ years' experience in top-level positions at global MedTech companies.
• Execution of the project for the redefinition of DiaSorin's corporate structure approved by the Board of Directors on December 16, 2021. The main objective of the project is to align DiaSorin's corporate structure with the Group's organizational development and multinational profile, and its implementation was envisaged thorough the transfer of the branch of business of DiaSorin related to the operating activities carried out in Italy and in the United Kingdom in favor of DiaSorin Italia S.p.A., a wholly-owneddirect subsidiary of DiaSorin S.p.A.

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Saluggia (Italy), August 3, 2022 - The Board of Directors of DiaSorin S.p.A. (FTSE MIB: DIA), a global leader in the research, production and marketing of diagnostic tests and internationally active in the Life Science sector, today examined and approved the Half-Year Financial Report at June 30, 2022.

TABLES OF RESULTS2

			H1						change
Amounts in million of euros
2 0 2 1	2 0 2 2				a mount	%	%
						@ c urre nt		@ CER
Revenues	515.4	685.4	+170.0	+33.0%	+25.1%
Immunodiagnostics ex-COVID	302.4	332.6	+30.2	+10.0%	+5.4%
Molecular Diagnostics ex-COVID	35.7	96.7	+61.0	+170.9%	+147.8%
Licensed Technologies	-	106.4	+106.4	n.m.		n.m.
COVID	177.3	149.8	-27.6	-15.5%	-20.6%
Adjusted EBITDA2	244.2	269.1	+24.9	+10.2%	+4.1%
Adjusted EBITDA 2 margin	47.4%	39.3%				-813 bps
EBITDA2	231.3	263.6	+32.2	+13.9%	+7.7%
EBITDA 2 margin	44.9%	38.5%				-643 bps
Adjusted EBIT	214.7	221.4	+6.6	+3.1%
Adjusted EBIT margin	41.7%	32.3%				-937 bps
EBIT	201.9	196.7	-5.2	-2.6%
EBIT margin	39.2%	28.7%				-1,047 bps
Adjusted net profit	162.5	168.6	+6.1	+3.7%
Adjusted Net profit on Revenues	31.5%	24.6%				-693 bps
Net profit	150.0	140.8	-9.2	-6.1%
Net profit on Revenues	29.1%	20.5%				-856 bps
			Q2						change
Amounts in million of euros
2 0 2 1	2 0 2 2				a mount	%	%
						@ c urre nt		@ CER
Revenues	248.7	327.8	+79.1	+31.8%	+22.0%
Immunodiagnostics ex-COVID	157.4	172.9	+15.5	+9.9%	+4.3%
Molecular Diagnostics ex-COVID	16.1	50.3	+34.2	+212.9%	+178.7%
Licensed Technologies	-	51.6	+51.6	n.m.		n.m.
COVID	75.3	53.0	-22.3	-29.6%	-35.4%
Adjusted EBITDA2	114.6	119.7	+5.1	+4.5%	-2.7%
Adjusted EBITDA 2 margin		46.1%	36.5%				-956 bps
EBITDA2	113.4	117.0	+3.6	+3.2%	-3.9%
EBITDA 2 margin		45.6%	35.7%				-989 bps
Adjusted EBIT	99.8	95.6	-4.2	-4.2%
Adjusted EBIT margin	40.1%	29.2%				-1,095 bps
EBIT	98.5	83.0	-15.5	-15.7%
EBIT margin	39.6%	25.3%				-1,428 bps
Adjusted net profit	75.4	72.3	-3.0	-4.0%
Adjusted Net profit on Revenues	30.3%	22.1%				-824 bps
Net profit	71.8	58.5	-13.3	-18.5%
Net profit on Revenues	28.9%	17.9%				-1,102 bps

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COMMENT ON RESULTS

CONSOLIDATED

REVENUES

Revenues: € 685 million in H1'22, +33.0% (+25.1% at CER) compared to H1'21. The change is due to the Luminex inclusion in the scope of consolidation, the strong performance of DiaSorin immunodiagnostic and molecular diagnostic business, and the expected decline of COVID sales

Ex-COVIDimmunodiagnostics revenues grew by 10.0% (+5.4% at CER), mainly driven by the solid performance of Latent Tuberculosis, Infectious Diseases and Gastrointestinal panel tests, despite the expected decline in Vitamin D and ELISA sales.

Ex-COVIDmolecular diagnostics revenues grew by 170.9% (+147.8% at CER), mainly as a result of the upward trend of DiaSorin tests and the Luminex contribution.

Licensed technologies revenues were € 106 million on the back of the strong sales performance of xMAP® instruments and consumables.

COVID serology and molecular diagnostic tests sales, equal to € 150 million, even though exceeding the previous guidance, decreased by 15.5% (-20.6%at CER) compared to H1'21, reflecting both the success of pandemic containment measures implemented by government authorities and the effective vaccination campaigns carried out on large scale.

Lastly, Luminex overall contribution to Group revenues was equal to € 185 million in H1'22, in line with expectations.

REVENUES BY

GEOGRAPHY

A breakdown of Group revenues by country is shown below.

	H1			Change
Amounts in millions of euros	2021	2022	amount		%
	@ current	@ CER
Europe Direct	154.1	181.5	+27.5	+17.8%	+16.8%
% on total revenues	29.9%	26.5%
North America Direct	102.3	257.1	+154.8	+151.3%	+128.1%
% on total revenues	19.8%	37.5%
Rest of the World	81.7	97.1	+15.3	+18.8%	+11.2%
% on total revenues	15.9%	14.2%
COVID	177.3	149.8	-27.6	-15.5%	-20.6%
% on total revenues	34.4%	21.8%
Total	515.4	685.4	+170.0	+33.0%	+25.1%
	Q2			Change
Amounts in millions of euros	2021	2022	amount		%
	@ current	@ CER
Europe Direct	78.6	92.6	+13.9	+17.7%	+16.4%
% on total revenues	31.6%	28.2%
North America Direct	51.4	131.9	+80.5	+156.5%	+127.0%
% on total revenues	20.7%	40.2%
Rest of the World	43.4	50.3	+6.9	+16.0%	+7.1%
% on total revenues	17.4%	15.4%
COVID	75.3	53.0	-22.3	-29.6%	-35.4%
% on total revenues	30.3%	16.2%
Total	248.7	327.8	+79.1	+31.8%	+22.0%

Revenues by geographical area are provided net of COVID revenues.

Europe Direct

Revenues in H1'22 were € 182 million, +17.8% (+16.8% at CER) compared to H1'21. Growth was mainly driven by the Luminex contribution and the positive immunodiagnostic business performance.

It should be noted that CLIA revenues, net of Vitamin D, grew by approx. 9% at CER, on the back of the Latent Tuberculosis, Infectious Diseases and Gastrointestinal Infections test sales. At CER, Vitamin D sales

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REVENUES BY

TECHNOLOGY

increased slightly compared to H1'21.

The molecular diagnostics business showed a positive trend driven by the Luminex contribution and the good performance of DiaSorin molecular combination test for COVID-Influenza.

North America Direct

Revenues in H1'22, equal to € 257 million, increased by 151.3% (+128.1% at CER) compared to H1'21. The growth was mainly driven by the Luminex contribution and the strong performance of the immunodiagnostic business.

As regards the immunodiagnostic business, CLIA revenues, net of Vitamin D, grew by approx. 30% at CER, mainly on the back of the successful strategy aimed at increasing the penetration in the U.S. hospitals segment and of the specialty testing sales increase (Latent Tuberculosis, Gastro-Intestinal panel, Infectious Diseases panel), despite the expected downward trend of Vitamin D and ELISA sales.

The molecular diagnostic business continued to grow, as a result of the robust reagents sales and the Luminex contribution, partly offset by a decline in revenues from instruments sales that, in 2021, reached a peak as the pandemic spread and hospitals made efforts to provide adequate testing capacity.

Lastly, worthy of note is the solid performance of the Licensed Technologies business, driven by sales of xMAP® instruments and consumables.

Rest of the world

Revenues in H1'22, equal to € 97 million, increased by 18.8% (+11.2% at CER) compared to H1'21. The benefit from the inclusion of Luminex has been partly offset by the decrease in sales recorded in the Chinese market, as a result of the restrictive measures implemented by local authorities to contain the spread of SARS- CoV-2 infections.

The following provides a breakdown of Group revenues by technology.

		H1	Change
%of revenues contributed	2021	2022
Immunodiagnostics ex-COVID	58.7%	48.6%	-1,009 bps
Molecular Diagnostics ex-COVID	6.9%	14.1%	+718 bps
Licensed Technologies	-	15.5%	n.m.
COVID	34.4%	21.8%	-1,256 bps

		Q2	Change
%of revenues contributed	2021	2022
Immunodiagnostics ex-COVID	63.3%	52.7%	-1,053 bps
Molecular Diagnostics ex-COVID	6.4%	15.4%	+902 bps
Licensed Technologies	-	15.7%	n.m.
COVID	30.3%	16.2%	-1,409 bps

The percentage of sales by technology on total revenues was impacted by the Luminex inclusion in the scope of consolidation as from the date of its acquisition. Specifically, H1'22 highlights the following:

• Ex-COVIDImmunodiagnostics on total revenues: 48.6%, down from H1'21. The growth in revenues, mainly on the back of CLIA sales, was diluted by the inclusion of Luminex revenues.
• Ex-COVIDMolecular Diagnostics on total revenues: 14.1%, up from H1'21, as a result of the Luminex contribution and the robust performance of DiaSorin reagents' sales.
• Licensed Technologies on total revenues: 15.5%.
• COVID on total revenues: 21.8%, down from H1'21, as a result of the expected reduction of volumes due to the pandemic containment measures implemented by government authorities along with widespread and effective vaccination campaigns.

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