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Diasorin

Earnings Release Nov 5, 2025

4129_rns_2025-11-05_ba9076fe-d9fd-4989-a293-d32eb3db89aa.pdf

Earnings Release

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Data/Ora Ricezione : 5 Novembre 2025 17:43:27

Oggetto : Diasorin's Board of Directors approves results

for the first 9 months of 2025. FY 2025

Guidance revised

Testo del comunicato

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DIASORIN'S BOARD OF DIRECTORS APPROVES RESULTS FOR THE FIRST 9 MONTHS OF 2025. FY 2025 GUIDANCE REVISED

  • REVENUES: € 900 MILLION, +3% COMPARED TO 9M'24 (+5% AT CER, +6% AT CER AND EXCLUDING COVID REVENUES)
  • ADJUSTED1 EBITDA2 : € 302 MILLION, +3% COMPARED TO 9M'24 (+7% AT CER), EQUAL TO 34% OF REVENUES AT CURRENT AND CONSTANT EXCHANGE RATES
  • COMMERCIAL AGREEMENT WITH QUEST DIAGNOSTICS FOR THE USE OF THE INNOVATIVE LIAISON PLEX® MULTIPLEXING MOLECULAR PLATFORM
  • FDA 510(K) CLEARANCE FOR THE SIMPLEXA COVID-19, FLU A/B & RSV DIRECT TEST ON THE LIAISON MDX® PLATFORM

Saluggia (Italy) - November 5, 2025 - The Board of Directors of Diasorin S.p.A. (FTSE MIB: DIA), examined and approved the Group's Consolidated Financial Statements as of September 30, 2025.

TABLES OF RESULTS1

9 months change
Amounts in millions of euros 2024 2025 amount %
@ current
%
@ CER
Revenues 876 900 +23 +3% +5%
ex-COVID Immunodiagnostics 583 616 +33 +6% +7%
ex-COVID Molecular Diagnostics 147 146 -1 -0% +3%
Licensed Technologies 126 128 +2 +2% +4%
COVID 20 10 -11 -53% -51%
Revenues net of Covid 856 890 +34 +4% +6%
Adjusted1
EBITDA2
292 302 +10 +3% +7%
Adjusted 1
EBITDA 2
margin
33% 34% +19 bps
EBITDA2 289 291 +1 +0% +4%
EBITDA 2
margin
33% 32% -73 bps
Adjusted1
EBIT
225 233 +8 +3%
Adjusted 1
EBIT margin
26% 26% +18 bps
EBIT 193 194 +1 +0%
EBIT margin 22% 22% -50 bps
Adjusted1
net profit
176 174 -2 -1%
Adjusted 1
Net profit on Revenues
20% 19% -74 bps
Net profit 141 137 -4 -3%
Net profit on Revenues 16% 15% -82 bps

1 With reference to the indicators Adjusted Gross Margin, Adjusted EBITDA, Adjusted EBIT, and Adjusted Net Income, please refer to the table at the end of this Press Release.

2 EBITDA is defined as the "Operating Result", gross of amortization and depreciation of intangible and tangible asset. 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 therefore shall be considered an alternative measure for assessing the Group's operating result performance.

Q3 change
Amounts in millions of euros 2024 2025 amount %
@ current
%
@ CER
Revenues 287 280 -7 -2% +2%
ex-COVID Immunodiagnostics 193 198 +5 +3% +6%
ex-COVID Molecular Diagnostics 46 43 -3 -7% -1%
Licensed Technologies 42 37 -5 -12% -6%
COVID 6 3 -4 -58% -55%
Revenues net of Covid 281 278 -3 -1% +3%
Adjusted 1
EBITDA 2
94 88 -6 -7% -2%
Adjusted 1
EBITDA 2
margin
33% 31% -141 bps
EBITDA 2 93 87 -6 -7% -2%
EBITDA 2
margin
32% 31% -143 bps
Adjusted 1
EBIT
72 65 -7 -9%
Adjusted 1
EBIT margin
25% 23% -178 bps
EBIT 62 56 -6 -9%
EBIT margin 21% 20% -156 bps
Adjusted 1
net profit
57 50 -7 -13%
Adjusted 1
Net profit on Revenues
20% 18% -208 bps
Net profit 45 38 -7 -15%

COMMENTS ON ECONOMIC RESULTS

REVENUES: € 900 million in 9M'25, +3% (+5% at CER) compared to the same period in 2024. Excluding the COVID business, revenues grew +6% at CER.

Net profit on Revenues 16% 14% -206 bps

In Q3'25, revenue variation was -2% (+2% at CER), driven by the following factors:

  • Significant depreciation of the US Dollar against the Euro, impacting Q3'25 by approximately € 12 million;
  • Contraction of the Chinese market due to Volume-Based Procurement (VBP) regulations, which continue to negatively affect the performance of the entire diagnostics sector;
  • Expected decline in COVID-related sales;
  • Timing of LTG business revenues which, despite confirming growth over the first 9 months, in Q3'25 recorded a 6% decline at CER;
  • Moderate sales volumes of molecular tests for respiratory infections.

At CER and excluding the COVID business, Q3'25 revenues grew by +3%, thanks to the strong performance of the immunodiagnostics business and excellent sales of specialty tests on the lowplex molecular diagnostic platform LIAISON MDX®.

The following is the revenue performance by business line:

  • Immunodiagnostics ex-COVID: € 616 million in 9M'25, up € 33 million, +6% (+7% at CER) compared to the same period in 2024, driven by strong CLIA specialty test sales.
  • Q3'25 registered +3% growth (+6% at CER) supported by the U.S. Hospital Strategy, which is performing in line with the target of achieving 600 hospitals in the U.S. by 2027, as well as by increased sales in the European market. Despite lower-than-expected organic volume growth in some countries and compared to previous quarters, these results offset the unfavorable comparison with 2024 outbreak-driven volumes and the effects from the Chinese market which are impacting the performance of all companies operating in the diagnostic segment.

Excluding these two effects, this business line grew +10% at CER in the first 9M'25.

  • Molecular Diagnostics ex-COVID: € 146 million in 9M'25, flat at current exchange rates (+3% at CER) compared to the same period in 2024, due to:
  • Double-digit growth in specialty test sales on the lowplex LIAISON MDX® platform, as well as in panel sales currently available on the automated multiplexing platforms (Verigene I and LIAISON PLEX®);
  • Decline in respiratory panel sales on lowplex LIAISON MDX® and non-automated multiplexing platforms;

Discontinuation of the Aries platform.

In Q3'25, sales declined -7% (-1% at CER), due to:

  • Strong performance of specialty tests on LIAISON MDX® (ca. +40% at CER), offsetting the overall weakening of the respiratory segment due to the limited test volumes associated with the flu season;
  • Growth of automated multiplexing platforms (Verigene I & LIAISON PLEX®), equal to +3% at CER, driven by modest contributions from seasonal viral infection tests;
  • Unfavorable comparison with Q3'24 due to Aries lowplex platform discontinuation, as well as the absence of outbreak-driven revenue contributions.

Excluding the effects of the Aries platform and of the outbreaks, molecular diagnostics ex-COVID revenues grew +2% at CER in Q3'25 and +7% at CER in 9M'25.

Licensed Technologies: € 128 million in 9M'25, +2% (+4% at CER) compared to the same period in 2024. Strong performance in the Diagnostics segment was partially offset by lower Life Science segment sales, in line with broader market trends.

Q3'25 (-12% at current exchange rates; -6% at CER) was impacted by unfavorable timing of key orders that had boosted revenues earlier in the first months of 2025.

COVID: € 10 million in 9M'25, -53% (-51% at CER), declining as expected compared to 9M'24.

The following is the revenue performance by geography excluding COVID contribution:

  • Direct North America: € 446 million in 9M'25, +6% (+9% at CER). Growth was driven by strong immunodiagnostics performance (+12% at current exchange rates; +15% at CER), confirming the success of the hospital strategy and CLIA specialty test offering. Positive performance also noted in the lowplex LIAISON MDX® molecular segment, especially the specialty test segment.
  • Direct Europe: € 315 million in 9M'25, +4% at both current and constant exchange rates. Growth was led by immunodiagnostics, particularly specialty tests which characterize Diasorin's offering, despite unfavorable comparisons with 9M'24, which benefited from outbreak-driven volume, and reduced organic volume growth in key European countries in Q3'25.

Excluding outbreak impacts, growth was +7%.

Rest of the World: € 129 million in 9M'25, -4% (flat at CER).

Positive performance in countries served directly or via distributors was offset by revenue contraction in China, mainly due to the implementation of VBP regulation, which is affecting the performance of all companies operating in the diagnostic segment.

Excluding China, the "Rest of the World" area grew +7% at CER.

ADJUSTED1GROSS PROFIT: € 587 million (65% of revenues), up € 9 million, +2% vs. 9M'24.

ADJUSTED1 EBITDA2 : € 302 million (34% of revenues at both current and constant exchange rates), up € 10 million (+3% at current; +7% at CER) vs. 9M'24, with a higher incidence on revenues (33% in the previous year).

The reduction in margin in Q3'25 compared to the same period in 2024 (31% at current exchange rates; 32% at CER) is mainly due to tariff impacts and a different technological and geographical sales mix.

ADJUSTED1 EBIT: € 233 million (26% of revenues), up € 8 million (+3%) vs. 9M'24.

Q3'25 EBIT declined -9% vs. 2024 (23% of revenues), due to US Dollar depreciation, slight margin reduction from unfavorable product/technology mix, tariff impacts, and slightly lower operating leverage.

NET FINANCIAL CHARGES: € 12 million, in line with 9M'24.

TAXES: € 45 million, with a tax rate of 24.5%.

ADJUSTED1 NET PROFIT: €174 million (19% of revenues), down € 2 million (-1%) vs. 9M'24.

COMMENT ON FINANCIAL RESULTS

CONSOLIDATED NET FINANCIAL DEBT: -€ 617 million (-€ 618 million as of December 31, 2024). The € 1 million variation is mainly attributable to strong operating cash generation in 9M'25, offset by dividend payments totaling € 63 million and a € 97 million outlay following the exercise of the withdrawal right by certain shareholders due to the enhanced voting mechanism.

FREE CASH FLOW3 : € 161 million as of September 30, 2025 (€ 164 million as of September 30, 2024).

The year-over-year variation is primarily due to higher tax payments in 9M'25, especially in the United States, compared to the same period in 2024, which had benefited from prior-year tax credits. Additionally, following the conversion into law of Legislative Decree No. 95 dated June 30, 2025 (known as the "Economy Decree"), an amount of approximately € 6 million was paid in Italy as a payback related to the years 2015-2018.

BUSINESS HIGHLIGHTS

IMMUNODIAGNOSTICS:

  • New evidence presented at ACEP 2025 on the role of MeMed BV in supporting clinical decision-making in emergency medicine;
  • Launch of LIAISON TSH-R Ab, a test designed to improve the diagnosis of Graves' disease, in all CE-mark accepting countries.

MOLECULAR DIAGNOSTICS:

  • FDA 510(k) clearance for the SIMPLEXA COVID-19, Flu A/B & RSV Direct test on the LIAISON MDX® platform;
  • Commercial agreement with Quest Diagnostics for the use of the innovative LIAISON PLEX® multiplexing molecular platform;
  • Submission of the molecular diagnostic Point-of-Care platform LIAISON NES® and its respiratory 4-plex panel (Flu A, Flu B, COVID, RSV) to the U.S. FDA for 510(k) clearance and CLIA Waiver;
  • Launch of the full panel portfolio to diagnose bloodstream infections on LIAISON PLEX®, the new multiplexing platform of the Group, following the U.S. FDA 510(k) clearance for the LIAISON PLEX® Gram-Positive Blood Culture Assay, LIAISON PLEX® Gram-Negative Blood Culture Assay, and LIAISON PLEX® Blood Culture Yeast Assay;
  • Launch of a new Measles Virus Primer Pair in the U.S., expanding the growing portfolio of Analyte-Specific Reagents (ASRs);
  • Launch of Simplexa™ C. auris direct assay on the LIAISON® MDX platform for all countries accepting the CE Mark.

FY 2025 GUIDANCE AT 2024 CER

The Company revises FY 2025 guidance:

  • EX-COVID REVENUES: approx. +5%, approx. +4% including COVID revenues (equal to approx. € 10 million)
  • ADJUSTED1 EBITDA2 MARGIN: approx. 33%

***

Mr. Piergiorgio Pedron, the Officer in charge of preparing the corporate accounting documents of Diasorin S.p.A. declares that, pursuant to paragraph 2, Art. 154 bis of the Consolidated Law on Finance, to the best of his knowledge, the accounting information contained in this Press Release corresponds to the documental results, accounting books and records.

***

This press release is available to the public at the registered office of the Company and is also published on the Company's website (www.diasorin.com) under the section "Investors - Financial Corner - Press Releases" and on the centralized storage system named eMarket STORAGE at .

***

9M'25 results will be presented to the financial community during a conference call on Wednesday, November 5, 2025, at 6:00 PM CET. To participate in the conference call, dial the following numbers:

  • From Italy + 39 02 8020911
  • From U.K. +44 1212 818004
  • From U.S.A. +1 718 7058796

Presentation slides will be made available under the section "Investors - Financial Corner - Presentations" on the Company's website (www.diasorin.com) and on the centralized storage system named eMarket STORAGE at prior to the beginning of the conference call.

***

Annex: Financial statements not subject to audit by the Group's Independent Auditors.

3 Free Cash Flow equals net cash flow generated from operating activities including uses for investment and before payment of interest and acquisitions of companies and businesses.

ANNEXES

CONSOLIDATED INCOME STATEMENT

9 months Change
Amounts in millions of euros 2024 2025 amount %
Net Revenues 876 900 +23 +3%
Cost of sales (299) (313) -14 +5%
Gross profit 578 587 +9 +2%
66% 65% -69 bps
Sales and marketing expenses (211) (212) - 1 +1%
Research and development costs (65) (70) - 5 +7%
General and administrative expenses (96) (92) +5 -5%
Total operating expenses (372) (373) -1 +0%
42% 42% -97 bps
Other operating income (expense) (12) (19) - 7 +61%
non recurring amount (3) (11) - 8 n.m.
EBIT 193 194 +1 +0%
22% 22% -50 bps
Net financial income (expense) (12) (12) - 1 +5%
Profit before taxes 182 182 +0 +0%
Income taxes (41) (45) - 4 +9%
Net result 141 137 -4 -3%
EBITDA 2 289 291 +1 +0%
33% 32% -73 bps
Q3 Change
Amounts in millions of euros 2024 2025 amount %
Net Revenues 287 280 -7 -2%
Cost of sales (99) (99) - 0 +0%
Gross profit 188 181 -7 -4%
65% 65% -85 bps
Sales and marketing expenses (70) (69) +0 -0%
Research and development costs (22) (23) - 1 +3%
General and administrative expenses (32) (30) +2 -6%
Total operating expenses (124) (122) +1 -1%
43% 44% +57 bps
Other operating income (expense) (2) (3) -0 +13%
non recurring amount (1) (1) -0 +2%
EBIT 62 56 -6 -9%
21% 20% -156 bps
Net financial income (expense) (4) (6) - 2 +38%
Profit before taxes 58 50 -7 -13%
Income taxes (12) (12) +1 -4%
Net result 45 38 -7 -15%
EBITDA2 93 87 -6 -7%
32% 31% -143 bps

REVENUES BY TECHNOLOGY

9 months
% of revenues contributed 2024 2025 Change
Immunodiagnostics ex-COVID 67% 69% +288 bps
Molecular Diagnostics ex-COVID 17% 16% -51 bps
Licensed Technologies 14% 14% -13 bps
COVID 2% 1% -124 bps
Q3
% of revenues contributed 2024 2025 Change
Immunodiagnostics ex-COVID 67% 71% +354 bps
Molecular Diagnostics ex-COVID 16% 15% -85 bps
Licensed Technologies 15% 13% -148 bps
COVID 2% 1% -121 bps

REVENUES BY GEOGRAPHY

9 months Change
Amounts in millions of euros %
2024 2025 amount @ current @ CER
North America Direct 420 446 +26 +6% +9%
% on total revenues 48% 50%
Europe Direct 302 315 +13 +4% +4%
% on total revenues 34% 35%
Rest of the World 134 129 -5 -4% +0%
% on total revenues 15% 14%
COVID 20 10 -11 -53% -51%
% on total revenues 2% 1%
Total 876 900 +23 +3% +5%
Q3 Change
Amounts in millions of euros %
2024 2025 amount @ current @ CER
North America Direct 141 139 -3 -2% +5%
% on total revenues 49% 49%
Europe Direct 95 98 +3 +3% +4%
% on total revenues 33% 35%
Rest of the World 45 41 -4 -8% -4%
% on total revenues 16% 15%
COVID 6 3 -4 -58% -55%
% on total revenues 2% 1%
Total 287 280 -7 -2% +2%

CONSOLIDATED BALANCE SHEET

Amounts in millions of euros 12/31/2024 09/30/2025 Change
Goodwill and intangibles assets 2,028 1,798 -230
Property, plant and equipment 271 261 -11
Other non-current assets 34 39 +5
Net working capital 346 330 -16
Other non-current liabilities (264) (241) +22
Net Invested Capital 2,417 2,187 -230
Net Financial Debt (618) (617) +1
Total shareholders' equity 1,799 1,570 -229

CONSOLIDATED STATEMENT OF CASH FLOWS

Amounts in millions of euros 9 months
2024 2025
Cash and cash equivalents at the beginning of the period 280 344
Cash provided by operating activities 286 260
Cash provided/(used) in investing activities (37) (108)
Cash provided/(used) in financing activities (306) (348)
Net change in cash and cash equivalents before investments in financial assets (57) (196)
Net change in cash and cash equivalents (57) (196)
Cash and cash equivalents at the end of the period 223 148
Q3
Amounts in millions of euros 2024 2025
Cash and cash equivalents at the beginning of the period 170 173
Cash provided by operating activities 131 115
Cash provided/(used) in investing activities (26) (80)
Cash provided/(used) in financing activities (51) (60)
Net change in cash and cash equivalents before investments in financial assets 54 (25)
Net change in cash and cash equivalents 54 (25)
Cash and cash equivalents at the end of the period 223 148

OVERVIEW OF THE GROUP'S OPERATING PERFORMANCE AND FINANCIAL POSITION

This press release presents and comments on certain financial indicators that are not identified in the IFRS. These indicators, which are described below, are used to comment on the Group's business performance, in compliance with the requirements of Consob communication of 28 July 2006 (DEM 6064293), as subsequently amended and supplemented (Consob communication 0092543 of 3 December 2015, which incorporates the ESMA Guidelines ESMA/2015/1415).

The alternative performance indicators listed below should be used to supplement the information required by IFRS to help readers of the press release gain a more comprehensive understanding of the Group's economic, financial and operating position, by excluding the result of one-off elements for the Luminex integration from the amortization deriving from the Purchase Price Allocation, and the financial expenses related to the financing of the transaction, including their tax impact. It should be noted that the calculation of these adjusted indicators could differ from those used by other companies.

9M 2025 ADJUSTED INDICATORS

Amounts in millions of euros Gross Profit EBITDA EBIT Net Result
Financial Statements Measures 587 291 194 137
% on Revenues 65% 32% 22% 15%
Adjustments
"One-off" costs related t o integration and restructuring of non recurring
events
- 11 11 11
Depreciation of Luminex intangibles identified in the Purchase Price
Allocation
- - 28 28
Financial charges relating t o debt instruments and t o the convertible bond
issued to finance the acquisition of Luminex net of hedging effects
- - - 11
Total adjustments before tax effect - 11 39 50
Fiscal effect on adjustments - - - (13)
Total Adjustments - 11 39 37
Adjusted Measures 587 302 233 174

9M 2024 ADJUSTED INDICATORS

Amounts in millions of euros Gross Profit EBITDA EBIT Net Result
Financial Statements Measures 578 289 193 141
% on Revenues 66% 33% 22% 16%
Adjustments
"One-off" costs related to the integration and restructuring of Luminex - 3 3 3
Depreciation of Luminex intangibles identified in the Purchase Price
Allocation
- - 29 29
Financial charges relating t o debt instruments and t o the convertible bond
issued to finance the acquisition of Luminex net of hedging effects
- - - 15
Total adjustments before tax effect - 3 32 46
Fiscal effect on adjustments - - - (11)
Total Adjustments - 3 32 36
Adjusted Measures 578 292 225 176

OPERATING PERFORMANCE IN 9M 2025 AND COMPARISON WITH 9M 2024

Amounts in millions of euros 09/30/2024 % on Revenues 09/30/2025 % on Revenues
Net Revenues 876 100% 900 100%
Cost of Sales (299) 34% (313) 35%
Gross Profit 578 66% 587 65%
Adjusted 1 Gross Profit 578 66% 587 65%
Sales and marketing expenses (211) 24% (212) 24%
Research and development expenses (65) 7% (70) 8%
General and administrative expenses (96) 11% (92) 10%
Total operating expenses (372) 42% (373) 42%
Other operating income (expense) (12) 1% (19) 2%
EBIT 193 22% 194 22%
Adjusted 1
EBIT
225 26% 233 26%
Net financial income (expense) (12) 1% (12) 1%
Profit before taxes 182 21% 182 20%
Income taxes (41) 5% (45) 5%
Net Profit 141 16% 137 15%
Adjusted 1 Net Profit 176 20% 174 19%
EBITDA 2 289 33% 291 32%
Adjusted 1
EBITDA 2
292 33% 302 34%

For additional information, please contact:

INVESTOR RELATIONS

Corporate Vice President Communication, ESG & Investor Relations Corporate Investor Relations & ESG Senior Analyst [email protected] [email protected]

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