BioMerieux : BioMérieux – First-Quarter 2023 Business Review

bioMérieux - First-Quarter 2023 Business Review

• Solid first-quarter sales performance with an organic growth of +7.5%
• This robust performance has been fueled by BIOFIRE® non-respiratory panels growing a remarkable +32%, while respiratory panels remained positive at +3%
• Very good performance also in microbiology (+12%) and industrial applications (+9%)
• As a result, total non-respiratory sales organic growth reached +8.8%, in line with full-year guidance
• Strong momentum of product launches: key milestones have been achieved especially on
  VITEK® REVEAL™, BIOFIRE® SPOTFIRE® and VIDAS® KUBE™ fronts
• bioMérieux confirms its 2023 outlook for sales and operating profit, as published on March 8th

Alexandre Mérieux, Chairman and Chief Executive Officer, said: "bioMérieux had a good dynamic in this first-quarter,the company delivered a solid sales performance both in clinical and industrial applications. In line with its commitment to innovation for enhanced diagnostic, bioMérieux also had a strong momentum in terms of collaboration and key product launches."

Marcy l'Étoile (France), April 27th, 2023 - bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the three months ended March 31th, 2023.

SALES

Consolidated- sales totaled €906 million in the first quarter of 2023, up 8.2% from €837 million in the year earlier period. Organic growth (at constant exchange rates and scope of consolidation) stood at +7.5%, in line with expectations. Exchange rate movements resulted in a positive currency effect of €6 million, mainly reflecting a stronger euro versus the US dollar.

Analysis of sales

In € millions

SALES - THREE MONTHS ENDED MARCH 31, 2022	837
Currency effect	+6	+0.7%
Changes in scope of consolidation	0
Organic growth (at constant exchange rates and scope of consolidation)	+62	+7.5%
SALES - THREE MONTHS ENDED MARCH 31, 2023	906	+8.2%

Note: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

ANALYSIS OF SALES BY APPLICATION

Sales by Application	Q1		Q1	% change	% change
2023	2022		rates and scope of
				as reported	at constant exchange
In € millions					consolidation
Clinical Applications	760.4		703.8	+8.0%	+7.2%
Molecular biology	352.7	320.1	+10.2%	+7.4%
Microbiology	299.6	269.0	+11.4%	+11.9%
Immunoassays	95.6	104.5	-8.6%	-6.9%
Other lines(1)	12.5	10.2	+23.0%	+18.6%
Industrial Applications(2)	145.4	133.3	+9.0%	+9.0%
TOTAL SALES	905.7	837.1	+8.2%	+7.5%

• 1. Including mainly BioFire Defense, R&D-related revenue arising on clinical applications
  2. Including R&D-related revenue arising on industrial applications.
• Clinical applications sales, which account for approximately 84% of the consolidated total, increased by 7.2% year-on-year to €760 million in the first quarter of 2023.
• • In molecular biology, the sales performance for BIOFIRE® non-respiratory reagents has been remarkable, overall up 32%, with a consistent growth across the portfolio and the regions. Respiratory panels sales grew 3% despite a decrease of demand since February, linked to the early slow-down of the respiratory pathogens season. BIOFIRE® installed base increased by 500 new systems, bringing the total to around 24,000 units.
  • In microbiology, sales performance has been very robust for reagents, led by VITEK® automated ID/AST and BACT/ALERT® blood culture ranges, and including price increases in these ranges. Sales growth for equipment has been strong in key ranges.
  • In immunoassays, the routine assays have pursued their return to positive growth, started in Q3 2022, while procalcitonin assays continued to experience downward trends in the US and in China.
• Industrial applications sales, which represent around 16% of the consolidated total, increased by a robust +9% year-on-year to €145 million, fueled by a high single-digit growth in reagents sales, and notably a remarkable business trend in healthcare segment.
   ANALYSIS OF SALES BY REGION

	Q1	Q1	% change	% change
Sales by Region	2023	2022	as reported	at constant
			and scope of
				exchange rates
In € millions				consolidation
Americas	455.4	413.2	+10.2%	+6.5%
North America	402.7	365.5	+10.2%	+5.6%
Latin America	52.7	47.7	+10.5%	+13.6%
EMEA(1)	287.6	269.8	+6.6%	+8.2%
Asia Pacific	162.7	154.2	+5.6%	+8.7%
TOTAL SALES	905.7	837.1	+8.2%	+7.5%

1. Including Europe, the Middle East and Africa.

Note: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

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• Sales in the Americas (half of the consolidated total) reached €455 million in the first quarter, up 6.5% compared to the same period last year.
• • In North America (44% of the consolidated total), sales performance has been fueled by the growth of BIOFIRE® non-respiratory panels and, to a lesser extent, respiratory panels as well as BACT/ALERT® blood culture assays, slightly offset by the decrease in immunoassay PCT.
  • In Latin America, quarterly organic sales performance has been robust, reflecting a solid momentum in microbiology reagents sales.
• Sales in the Europe - Middle East - Africa region (32% of the consolidated total) came to €288 million in the first three months, up 8% year-on-year. This strong performance has been driven by BIOFIRE® non- respiratory panels sales, as well as microbiology key ranges.
• Sales in the Asia Pacific region (18% of the consolidated total) amounted to €163 million in the first quarter, up nearly 9% organically compared with €154 million in the same period of 2022. Growth has been led by reagents sales in India and equipment sales in China.

FIRST-QUARTER OPERATING HIGHLIGHTS AND SUBSEQUENT EVENTS

• US FDA 510(k) clearance for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

In April 2023, bioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the fast and accurate multiplex PCR*-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. bioMérieux will immediately apply for Clinical Laboratory Improvement Amendments (CLIA) waiver for the test. The new BIOFIRE® SPOTFIRE® R Panel Mini detects five of the most common viral causes of upper respiratory tract infections: SARS-CoV-2 (virus associated with COVID-19), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus, in about 15 minutes.

• Oxford Nanopore and bioMérieux to enter into a strategic partnership agreement

In April 2023, Oxford Nanopore Technologies plc, the company delivering a new generation of nanopore- based molecular sensing technology, and bioMérieux SA announced that they have teamed up to improve health outcomes globally by exploring selected opportunities to bring nanopore sequencing to the infectious disease diagnostics market. Initial areas of collaboration will include a test for determining antibiotic resistance of tuberculosis; an assay to identify pathogens in normally sterile clinical samples; and validating Oxford Nanopore's sequencing platform with BIOMÉRIEUX EPISEQ® CS application for rapid infection outbreak monitoring in patient-care settings.

• bioMérieux submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the VITEK® REVEAL™, formerly known as SPECIFIC REVEAL™ Rapid AST System

This rapid, modular, antimicrobial-susceptibility test platform that can deliver actionable results for Gram- negative bacteria directly from positive blood cultures in an average of five and a half hours enabling same-day treatment decision-making for patients suffering from bacteremic sepsis. The rapid AST system VITEK® REVEAL™ is already available on-market under CE-IVDD (assay panel) and IVDR (instrument) designation across Europe. The FDA 510(k) clearance will allow its commercialization in the U.S. and other countries recognizing this authorization.

• BioFire Defense partners with BARDA to accelerate development of the SPECIFIC REVEALTM Rapid AST System

In March 2023, bioMérieux announced that BioFire Defense, LLC, its affiliate and leader in pathogen detection systems for the U.S Department of Defense, has received a contract from the Biomedical Advanced Research and Development Authority, to accelerate development of the Specific Diagnostics SPECIFIC REVEALTM Rapid AST System, a rapid, modular, antimicrobial-susceptibility test platform that can deliver phenotypic results in an average of five and a half hours from positive blood cultures.

Note: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

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• bioMérieux launches BIOFIRE® FIREWORKSTM a cutting-edge,data-driven software solution that takes BIOFIRE Systems to the next level

In April 2023, bioMérieux announced the launch of this innovative solution, optimizing laboratory services and supporting data-driven decisions. This software is the newest addition to the BIOMERIEUX VISION SUITE, the company's portfolio of Data and IT Solutions supporting increased efficiency and productivity in laboratories worldwide.

• New MyShare 2023 worldwide employee share ownership plan
  As of May 3, 2023, bioMérieux eligible team members will be able to purchase shares of bioMérieux stock (directly or indirectly in the case of French employees) at a discount and with a matching employer contribution. The new plan will once again offer eligible team members an opportunity to take part in the Company's success. The plan was approved by the Board of Directors on December 14, 2022 and is open to any team member in countries where such plans are authorized by local legislation. The subscription period will run from May 3 to May 22, with settlement and delivery in the following weeks, in accordance with applicable laws and regulations.

INVESTOR CALL

bioMérieux will hold an investor presentation on Thursday, April 27th, 2023 at 2:00 pm Paris time (GMT+1). The presentation will be conducted in English and will be accessible via webcast.

Webcast link: https://event.webcasts.com/starthere.jsp?ei=1607571&tp_key=3c410cae13

For people unable to join the webcast URL, the presentation can be attended through below conference numbers

Conference call:	France	Europe	United States
[phone]	[phone]	[phone]
		Access code: 590 8899

INVESTOR CALENDAR

Annual General Meeting	May 23rd, 2023
Second-quarter 2023 sales and first-half 2023 results	September 1st, 2023
Third-quarter 2023 sales	October 26th, 2023

Notes and definitions

The above forward-looking statements are based, entirely or partially, on assessments or judgments that may change or be modified, due to uncertainties and risks related to the Company's economic, financial, regulatory and competitive environment, notably those described in the 2022 Universal Registration Document. Accordingly, the Company cannot give any assurance nor make any representation as to whether the objectives will be met. The Company does not undertake to update or otherwise revise any forecasts or objectives presented herein, except in compliance with the disclosure obligations applicable to companies whose shares are listed on a stock exchange.

Currency effect: this is established by converting actual numbers at the average rates of year y-1. In practice, those rates are either average rates communicated by the ECB, or hedged rates if hedging instruments have been set up. Argentina and Turkey are considered in bioMérieux's accounts since 2022 in a state of hyperinflation. Impacts of hyperinflation in accordance with IAS 29 in the Company's accounts are excluded in the calculation of Like-for-Like growth.

Changes in scope of consolidation: these are determined:

• for acquisitions in the period, by deducting from sales for the period the amount of sales generated during the period by acquired entities as from the date they entered the consolidated reporting scope;
• for acquisitions in the previous period, by deducting from sales for the period the amount of sales generated in the months in the previous period during which the acquired entities were not consolidated;
• for disposals in the period, by adding to sales for the period the amount of sales generated by entities sold during the previous period in the months of the current period during which these entities were no longer consolidated;
• for disposals in the previous period, by adding to sales for the period the amount of sales generated during the previous period by the entities Sold

Note: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

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BIOMÉRIEUX GAME CHANGER FOR 60 YEARS

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for 60 years, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors. In 2022, revenues reached €3.6 billion, with over 90% of sales outside of France.

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

bioMérieux is listed on the Euronext Paris stock market. Symbol: BIM - ISIN Code: FR0013280286

Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com. Investor website:

CONTACTS

Investor Relations

bioMérieux Franck Admant

Tel.: [phone] [e-mail]

Media Relations
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Romain Duchez	Laurence Heilbronn	Claire Doligez
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Note: Unless otherwise stated, growth is expressed year-on-year at constant exchange rates and scope of consolidation (like-for-like).

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