DiaSorin: Revenues and Profitability continue upward momentum in the First Half of 2021, with Guidance raised following the acquisition of Luminex

REVENUES AND PROFITABILITY CONTINUE UPWARD MOMENTUM IN THE FIRST HALF

OF 2021, WITH GUIDANCE RAISED FOLLOWING THE ACQUISITION OF LUMINEX

H1 2021 RESULTS

REVENUES: € 515.4 million, +34.8% (+39.6% at CER) compared to H1'20.

It should be noted that ex-COVID revenues in H1'21 grew by 21.4% at CER compared to H1'20. Sales of SARS-CoV-2 serology and molecular diagnostic tests were € 177.3 million (€ 94.6 million in H1'20; +87.4%).

Lastly, in Q2'21 ex-COVID business was +52.5% at CER compared to Q2'20, while total revenues grew by 23.0% at CER.

ADJUSTED EBITDA1: € 244.2 million, +58.9% (+64.0% at CER), equal to 47.4% of Group revenues (47.2% at CER). The result reflects the sales growth in H1'21, the operating leverage generated by high volumes of tests for SARS-CoV-2and the containment of operating expenses.

EBITDA was € 231.3 million, +50.6% (+55.6% at CER) compared to H1'20, equal to 44.9% of Group revenues (40.2% in H1'20).

EBIT: € 201.9 million, +63.3%, equal to 39.2% of Group revenues (32.3% in H1'20).

NET PROFIT: € 150.0 million, +58.4%, equal to 29.1% of Group revenues (24.8% in H1'20).

NET FINANCIAL POSITION: + € 436.3 million at June 30, 2021 (+ € 305.3 million at 31 December 2020). The increase, equal to € 131.0 million, includes the dividend distribution amounting to € 54.0 million, as resolved by the Shareholders' Meeting on April 22, 2021.

FREE CASH FLOW: € 125.8 million in H1'21 (€ 73.9 million in H1'20).

IMMUNODIAGNOSTIC ANALYZERS INSTALLED: 9,029 units at June 30, 2021. Strong performance of LIAISON® XL placements in H1'21 (+299 units) for a total installed base of around 5,400 units.

NEW FY 2021 GUIDANCE AT CONSTANT EXCHANGE RATES: following the recent acquisition of Luminex, completed on July 14, 2021, DiaSorin provides the following new FY 2021 guidance:

• REVENUES: growth between 35% and 40%, equal to approx. € 1.2 billion
• ADJUSTED EBITDA1 MARGIN: equal to approx. 42%

The expected revenues growth at CER and on a like-for-like basis is between 15% and 20%, of which ex-COVID revenues around +15%.

The COVID-19 pandemic continues to impact both the global economy and, even more deeply, the sector in which DiaSorin operates, leading to uncertainty in anticipating future purchasing behavior trends in laboratories and hospitals. The guidance range for revenues reflects the difficulty in accurately forecasting sales performance of COVID tests due to the unpredictability of viral mutations that may affect vaccine's efficacy and the speed and pervasiveness of vaccine rollout in the different geographies where DiaSorin operates. The guidance reflects DiaSorin's current visibility into market conditions, customer order patterns for Group products and is based on the current assumptions about the effects of the virus spread.

IMPACT OF THE COVID-19 PANDEMIC ON BUSINESS: H1'21 was marked by the ongoing COVID-19 pandemic, without any negative impact on the diagnostic sector. In this context, DiaSorin has not identified any COVID-19-associated risk that may threaten its business continuity and no disruptions in all Group sites have been experienced in research, manufacturing and distribution activities, carried out in compliance with the provisions intended to ensure its employees' safety.

DIASORIN INVESTOR DAY 2021

The Company's Industrial Plan, expected to be approved by the end of September 2021, has been postponed to provide the financial community with a more detailed representation of the strategies of growth deriving from the integration of Luminex in the Group's business perimeter. The new Industrial Plan will therefore be presented the Board of Directors and subsequently to the financial community by mid-December 2021. More information will be made available in the "Investors" section at www.diasoringroup.com.

1Adjusted EBITDA = EBITDA net of "one-off" costs related to the acquisition of Luminex (€ 12.9 million in the first 6 months of 2021)

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H1 2021 HIGHLIGHTS

BUSINESS DEVELOPMENT

• Completion of the acquisition of Luminex Corporation, a company that develops, manufactures and sells proprietary biological testing technologies and products with leading applications throughout the Diagnostics and Life Science industries. The acquisition, completed on July 14, 2021, strengthens DiaSorin's positioning in the molecular diagnostics market and the current value proposition, in line with the Group's strategic priorities.
  Through the acquisition, DiaSorin gained access to Luminex's multiplexing technology and a portfolio that strengthens its existing offering, while expanding the Group presence in the United States. Additionally, this deal provides access to Luminex's applications throughout the Life Science industry, supporting access to academic and scientific research, expanding engagement with biopharma companies, and increasing access to clinical multiplexing assays for future Value Based Care projects.
• Strategic collaboration with Lumos Diagnostics for the development of the LIAISON® IQ, an immunoassay Point-of-Care (POC) platform, and its first two assays for COVID-19 diagnosis - an antibody and an antigen test.

ISSUE OF CONVERTIBLE BOND FOR THE COMPLETION OF THE ACQUISITION OF LUMINEX CORPORATION

• Offer of € 500 million senior unsecured equity-linkedbond due 2028 aimed at completing the acquisition of Luminex Corporation, completed on July 14, 2021.

DEVELOPMENT OF IMMUNODIAGNOSTIC TESTS

• CE marking and Emergency Use Authorization from the U.S. Food and Drug Administration for the LIAISON® SARS-CoV-2TrimericS IgG, a new quantitative serology test (semi-quantitative in the U.S.) for determination of IgG antibodies and developed using the full-lengthSARS-CoV-2 Spike protein in its Trimeric form, which perfectly mimics the native conformation of the protein.
• Approval in the U.S. of 2 serology tests for the diagnosis of the Lyme disease, the LIAISON® Lyme IgM and LIAISON® Lyme IgG, for the determination of respectively IgM and IgG antibodies against Borrelia burgdorferi.
• Emergency Use Authorization from the U.S. Food and Drug Administration for LIAISON® SARS-CoV-2Ag, an antigen test to determine the presence of SARS-CoV-2 in nasal and nasopharyngeal swabs.
• CE marking for the new Point-of-Care (POC) platform LIAISON® IQ and its first test - the LIAISON® Quick Detect COVID TrimericS Ab - for the detection of IgG antibodies in capillary blood samples using lateral flow technology.
• CE marking for the new LIAISON® LymeDetect test developed in partnership with QIAGEN for the early diagnosis of Lyme Borreliosis, based on QuantiFERON technology.
• CE marking for the antigen test LIAISON® Quick Detect COVID Ag, a new Point-of-Care (POC) test on nasal and nasopharyngeal swabs using lateral-flow technology, available on the LIAISON® IQ.
• CE marking for the LIAISON® Murex Anti-HEVIgG & IgM assay for the diagnosis of Hepatitis E for use on the LIAISON® family platforms. It is the first fully automated CLIA high-throughput solution for diagnosing Hepatitis E.

DEVELOPMENT OF MOLECULAR DIAGNOSTIC TESTS:

• Launch of SimplexaTM SARS-CoV-2 Variants Direct (Research Use Only) assay for rapid detection and discrimination of 4 SARS-CoV-2mutations, without requiring upfront RNA extraction.

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Saluggia (Italy), July 30, 2021 - The Board of Directors of DiaSorin S.p.A. (FTSE MIB: DIA), today:

• examined and approved the Half-Year Financial Report at June 30, 2021;
• resolved to call an Extraordinary Shareholders' Meeting on October 4, 2021, at 11 a.m., to pass resolutions concerning the proposal to:
• 1. authorize to convert into DiaSorin ordinary shares the equity-linked bond with a nominal amount of € 500 million directed to qualified investors and denominated "€500 million Zero Coupon Equity Linked Bonds due 2028", issued on May 5, 2021, and maturing on May 5, 2028 ("Bond Loan") and
  2. increase the share capital, for the purposes of the Bond Loan, payable in tranches with the exclusion of pre-emptive rights, pursuant to Article 2441(5) of the Italian Civil Code, for a total amount of € 500 million, including any share premium, issued on one or more times through the issue of ordinary shares with the same characteristics as those in circulation and regular entitlement;
  3. consequently amend art. 5 of the Bylaws by introducing a new and additional paragraph that incorporates the share capital increase to service the conversion of the Bond Loan.

The notice of call and the documentation relating to the proposed share capital increase will be made available to the public in the manner and within the timescales provided for under the applicable legislation.

• resolved to start up the treasury shares buy-back plan pursuant to the resolution of the Shareholders Meeting dated April 22, 2021, for the purposes set forth in Article 5 of the EU Regulation no. 596/2014, and namely for the implementation of the share incentive plan for key executives of DiaSorin S.p.A. and of the companies that it controls directly or indirectly, named "DiaSorin S.p.A. 2021 Stock Options Plan", approved by the Shareholders' Meeting on April 22, 2021. The purchases will be carried out upon terms and conditions set out in the above mentioned Shareholders' resolution, consistently with the conditions for trading set forth in Article 3 of Delegated Regulation (EU) no. 2016/1052, for a maximum amount of no. 300,000 Company's common shares, equal to 0.536% of the Company's share capital, corresponding to an estimated maximum amount2 of € 53,095,500, within the final term of 18 months as of the aforementioned Shareholders' resolution, and therefore within October 22, 2022. The purchases will be executed for a consideration per share that may never be higher than the higher between the price of the last independent trade and the highest current independent purchase bid on the trading venue where the purchase is carried out, without prejudice to the fact that the consideration may never be lower by more than 15% or higher by more than 15% than the official price posted for the DiaSorin shares during the stock market trading session that preceded each buy transaction. In the event of purchases, DiaSorin will communicate the transactions details along with any other information required by the applicable Laws by the end of the seventh trading day following the date of execution of the transaction. Any subsequent changes to the above described buy-back plan will be promptly disclosed by the Company. At the present date the Company holds no. 1,199,823 treasury shares, equal to 2.145% of the share capital. Further details are provided in the authorization resolution approved by the Shareholders' Meeting on April 22, 2021, and in the relevant Explanatory Report of the Board of Directors available on the Company's website www.diasoringroup.com (Section Governance/ Information for shareholders/Shareholders meetings and board/2021).

2Amount calculated on the maximum price per share in accordance with the Shareholders' resolution, based on the DiaSorin ordinary shares reference close registered on April 22, 2021.

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TABLES OF RESULTS

	H1			change
Amounts in million of euros				%	%
	2 0 2 0	2 0 2 1	a mount
	@ c urre nt	@ CER
Revenues	382.3	515.4	+133.1	+34.8%	+39.6%
CLIA tests	230.1	286.4	+56.3	+24.5%	+27.8%
ELISA tests	34.5	27.9	-6.6	-19.0%	-15.6%
Molecular tests	81.1	160.3	+79.2	+97.6%	+108.0%
Instruments sales and other revenues	36.6	40.8	+4.2	+11.6%	+14.8%
EBITDA adjusted	153.6	244.2	+90.6	+58.9%	+64.0%
EBITDA adjusted margin	40.2%	47.4%	+719 bps
EBITDA	153.6	231.3	+77.7	+50.6%	+55.6%
EBITDA margin	40.2%	44.9%	+469 bps
EBIT	123.6	201.9	+78.2	+63.3%
EBIT margin	32.3%	39.2%	+682 bps
Net profit	94.7	150.0	+55.3	+58.4%
	Q2			change
Amounts in million of euros				%	%
	2 0 2 0	2 0 2 1	a mount
	@ c urre nt	@ CER
Revenues	207.7	248.7	+41.0	+19.8%	+23.0%
CLIA tests	117.4	146.3	+28.9	+24.6%	+27.1%
ELISA tests	13.6	14.2	+0.6	+4.3%	+8.7%
Molecular tests	56.6	69.4	+12.9	+22.7%	+27.8%
Instruments sales and other revenues	20.1	18.8	-1.3	-6.5%	-5.1%
EBITDA adjusted	89.2	114.6	+25.5	+28.6%	+30.5%
EBITDA adjusted margin	42.9%	46.1%	+316 bps
EBITDA	89.2	113.4	+24.2	+27.2%	+29.1%
EBITDA margin	42.9%	45.6%	+265 bps
EBIT	74.2	98.5	+24.3	+32.7%
EBIT margin	35.7%	39.6%	+388 bps
Net profit	57.0	71.8	+14.8	+26.0%

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COMMENT ON RESULTS.

CONSOLIDATED REVENUES

Revenues: € 515.4 million in H1'21, +34.8% (+39.6% at CER) compared to H1'20.

Upward trend driven by ex-COVID business recovery, with revenues up compared to H1'20, and by sales of SARS-CoV-2 serology and molecular tests, equal to € 177.3 million (€ 94.6 million in H1'20; +87.4%), particularly in USA, Canada and Europe.

It should be noted that H1'21 ex-COVID revenues recorded a positive trend with figures substantially in line and, in some areas, outperforming 2019 pre-COVID levels, with a growth of 21.4% at CER when compared to H1'20.

Foreign exchange rates had a negative impact of € 18.4 million.

Sales trend by technology as follows:

• CLIA tests, net of Vitamin D: +25.4% (+28.3% at CER)
• Vitamin D (CLIA tests): +19.6% (+25.0% at CER)
• ELISA tests: -19.0%(-15.6 % at CER)
• Molecular tests: +97.6% (+108.0% at CER)
• Instruments sales and other revenues: +11.6% (+14.8% at CER)

The expansion of CLIA platforms installed base continued in H1'21, with a total of 9,029 units, and a strong performance of LIAISON® XL units installed (+299 units), equal to around 60% of the total immunodiagnostic installed base (approximately 5,400 units).

In Q2'21, revenues were € 248.7 million, +19.8% (+23.0% at CER) compared to Q2'20.

The sales trend was marked by a strong ex-COVID business recovery (+52.5% at CER compared to Q2'20), with a positive performance on the back of the contribution from Latent Tuberculosis test, Gastrointestinal panel and Vitamin D test, the latter penalized during 2020 by the reduction in volumes as a result of the restrictive measures adopted to contain the pandemic.

Sales trend by technology as follows:

• CLIA tests, net of Vitamin D: +18.1% (+20.1% at CER)
• Vitamin D (CLIA tests): +78.0% (+85.0% at CER)
• ELISA tests: +4.3% (+8.7% at CER)
• Molecular tests: +22.7% (+27.8% at CER)
• Instruments sales and other revenues: -6.5% (-5.1%at CER)

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