bioMérieux – Third-Quarter 2024 Business Review

bioMérieux – Third-Quarter 2024 Business Review

{  +10.3% sales organic growth in the first nine months of the year with sales reaching €2,871m. A strong momentum fueled by the four growth drivers of the GO•28 strategic plan, growing +12%, together with a strong contribution from BIOFIRE^®1 respiratory panels:

o    BIOFIRE^® non-respiratory panels sales are up +18% with all panels contributing strongly;

o    Continued expansion of the SPOTFIRE^®2 solution, reaching sales of €53m and a total installed base close to 2,100 instruments (+600 in Q3);

o    Solid dynamic in microbiology, with sales increase of +9%, driven by a 13% growth in reagent sales thanks to volume uptake and prices increases;

o    Industrial Applications sales are up +9%, with double digit growth in reagents sales in both food and pharma segments;

o    BIOFIRE^® respiratory panels sales increased +14%, illustrating the competitiveness and the high medical value of the solution, and benefiting from a sustained respiratory epidemiology. 

{  +11% organic sales growth in Q3 2024 at €969m. 

{  Confirmation of the 2024 full year revised guidance with a slight update on the expected impact of the currency effect:

▪  Organic sales growth between +8% and +10% at constant exchange rates;

▪  Contributive operating income before non-recurring items (CEBIT)³ is expected to grow between +12% and +17% at constant exchange rate ;

▪  The currency effect³ is expected to have a negative impact in the range of around - €60m on the 2024 annual CEBIT versus around -€70m previously. 

¹  In this document, BIOFIRE^® refers to BIOFIRE^® FILMARRAY^® TORCH system and panels.

²  In this document, SPOTFIRE^® refers to BIOFIRE^® SPOTFIRE^® system and panels.

³  See definition in Appendix #2

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Marcy l’Étoile, France, October 30, 2024 – bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the nine months ended September 30, 2024.

SALES

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

Consolidated sales amounted to €2,871 million for the first nine months of 2024 versus €2,668 million for the prior-year period, representing a growth of +7.6% as reported. Organic growth (at constant exchange rates and scope of consolidation) reached +10.3% for the first nine months of the year. Changes in exchange rates had a negative €76 million impact on sales over 9 months, due to the appreciation of the euro especially against the Argentinian peso, the Turkish lira, Asian currencies and the American dollar.

ANALYSIS OF SALES BY APPLICATION  

Sales by Application

In € millions

Clinical Applications

Molecular biology 

Microbiology

Immunoassays 

Other lines⁽¹⁾

Industrial Applications⁽²⁾

TOTAL SALES

(1) Including BioFire Defense, R&D-related revenue arising on clinical applications (2) Including R&D-related revenue arising on industrial applications.

{  Clinical Applications sales (85% of total sales), increased by 11% over the quarter compared to 2023:

▪  In molecular biology:

o  the non-respiratory BIOFIRE^® panels sales growth was very dynamic, up +16% versus prior year leveraging the existing installed base with each panel growing double digit;

o  the BIOFIRE^® respiratory panels delivered another solid quarterly sales growth with a +14% increase versus the third quarter of 2023 driven by double digit growth in North America, Europe –

Middle East – Africa and Latin America; o the BIOFIRE^® installed base has continued to expand to 26,250 units at September 30, 2024, versus 26,100 at June 30, 2024;

o  the SPOTFIRE^® sales amounted to €20m in the quarter and the installed base reached close to 2,100 instruments at the end of September 2024, with more than 600 instruments installed over the third quarter, a significant acceleration compared to second quarter (250 installations).

▪  In microbiology, the strong momentum continued, with a 12% growth in reagents’ sales primarily driven by volumes increases in VITEK^® automated ID/AST and blood culture BACT/ALERT^® reagents as well as price increases. Instruments sales were back to growth, largely driven by the dynamic BACT/ALERT^® equipment sales in the US and in China, and the continuous uptake of the VITEK^® MS PRIME.

▪  In immunoassays, VIDAS^® instruments and routine reagents sales were flat over the quarter, while the continuous decrease in VIDAS^® procalcitonin tests (PCT) sales negatively impacted the performance of the entire franchise.

{  Industrial Applications sales (15% of total sales), delivered close to 12% organic increase, with a balanced growth between the food and pharma segments. Growth was driven by reagents’ sales, up +14% thanks to both prices and volumes increases, and a positive uptake in equipment sales.

ANALYSIS OF SALES BY REGION

{  Sales in the Americas (51% of the consolidated total) reached €491 million in third-quarter 2024, an increase of 16% compared to third-quarter 2023. 

▪  North America (44% of the consolidated total), delivered a strong and balanced sales growth (+13%), with double digit increases in BIOFIRE^® respiratory and non-respiratory panels, microbiology reagents and Industrial Applications reagents combined with the acceleration of SPOTFIRE^® sales.

▪  In Latin America, excluding Argentina (hyperinflation), the quarterly growth was close to 12%, thanks to solid performance in BIOFIRE^®, VITEK^®, BACT/ALERT^® and Industrial Applications franchises.

{  Sales in the Europe – Middle East – Africa region (32% of the consolidated total) came to €310 million for the quarter, up +7% year-on-year driven by a +21% growth in BIOFIRE^® non-respiratory panels sales, a double digit growth in BIOFIRE^® respiratory panels and microbiology reagents and a high single digit growth in Industrial Applications.

{  Sales in the Asia Pacific region (17% of the consolidated total) amounted to €169 million for the third quarter of 2024, up +3% from the prior-year period. The performance was mainly driven by the growth in BIOFIRE^® non-respiratory panels, the successful uptake of SPOTFIRE^® in Japan and the double digit growth of Industrial Applications reagents’ sales, partially offset by the decrease in immunoassays sales in China and in ASEAN.

EVENTS OF THIRD-QUARTER 2024 

{  The USP Microbiology Expert Committee approves endotoxin testing using non-animal derived reagents 

On July 26th, 2024, the Microbiology Expert Committee of the USP (US Pharmacopeia) has approved the inclusion of Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, which permits the use of non-animal-derived reagents for endotoxin testing. Endotoxin testing is a critical step in ensuring the quality and safety of many sterile pharmaceutical products. 

Based on recombinant Factor C (rFC), bioMérieux ENDONEXT™ technology eliminates the need to harvest horseshoe crab blood and provides reliable results everywhere from in-process controls to final product testing on the most complex matrices. 

{  Internal verifications in the US 

After 30 June 2024, in the framework of the Group’s internal procedures, some internal control and compliance shortcomings have been identified within the Group's US operations. The Group has run additional verifications resulting in non-material financial impacts. These impacts have been integrated in the reported half-year statements. The Group continues to pursue its internal investigations and in parallel has started working on the implementation of actions to reinforce its internal control in the United States.

{  M-Pox: bioMérieux provides a real-time PCR detection kit called MONKEYPOX R-GENE®. 

On August 14th, 2024, the World Health Organization (WHO) declared Mpox, a Public Health Emergency of International Concern which implies the highest level of epidemiological monitoring. To respond to this public health emergency, bioMérieux proposes a MONKEYPOX R-GENE® PCR kit. Available for Research Use Only (RUO), this kit can easily be used by laboratories around the world. 

SUBSEQUENT EVENTS

{  bioMérieux receives CE-marking for VIDAS^® VITAMIN B12 TOTAL, a blood test to measure total Vitamin B₁₂ concentration

On October 15^th, 2024, bioMérieux announced the CE-marking of VIDAS^® VITAMIN B₁₂ TOTAL, an automated quantitative test for use on the VIDAS^® immunoassay instruments, for the measurement of total Vitamin B12 concentration in human serum or plasma. Vitamin B₁₂, also known as cobalamin, is essential for well-being and cellular metabolism. This micronutrient, mainly present in food products from animal origin – particularly meat, fish, eggs and dairy – is required for normal functioning of the central nervous system, DNA synthesis and healthy red blood cell formation. 

The commercial launch of VIDAS^® VITAMIN B₁₂ TOTAL is planned in selected countries at the end of 2024, with an extended rollout in Q1 2025.

{  bioMérieux and Oxford Nanopore Technologies signed an exclusive worldwide distribution agreement, for the AmPORE TB^®, Research Use Only (RUO) assay, a molecular sequencing solution delivering a fast answer in the treatment of Mycobacterium Tuberculosis. 

The AmPORE TB^® RUO test based on targeted nanopore sequencing can detect Mycobacterium tuberculosis complex (MTBC) genetic variants associated with antimicrobial resistance in DNA extracted from sputum samples. bioMérieux will leverage its worldwide presence to distribute the solution, initially through a few trusted partner sites with a strong expertise in the diagnosis of tuberculosis and, then starting mid 2025 with a worldwide launch as a Research Use Only product.

INVESTOR PRESENTATION

bioMérieux will hold an investor presentation on Wednesday, October 30, 2024 at 3:00 pm Paris time (GMT+1). The presentation will be given in English and will be accessible via webcast under following link:

https://event.webcasts.com/starthere.jsp?ei=1693228&tp_key=ddabb09226 

If you are unable to join the webcast URL, please join audio conference with:.

INVESTOR CALENDAR

Fourth-quarter 2024 sales and 2024 financial results                                 March, 7^th 2025

ABOUT BIOMÉRIEUX

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 2023, revenues reached €3.7 billion, with over 93% 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

CONTACTS

Investor Relations                           bioMérieux                  

     Aymeric Fichet                                                                                        

Tel.: +33 (0)4 78 87 20 00                  investor.relations@biomerieux.com                    

     Media Relations                                                                                                                         

      bioMérieux                                          France                                    United States

Romain Duchez       Laurence Heilbronn (Image 7)    Liza Deckelbaum Tel.: +33 (0)4 78 87 20 00        Tel.: +33 (0)1 53 70 74 64           Tel.: (919) 521-0507

    media@biomerieux.com                        lheilbronn@image7.fr                 lizad@seeztoday.com

APPENDIX 1: QUARTERLY SALES DETAILS

Sales by Application in € millions and % Change in Sales by Application

(1)Including mainly BioFire Defense and R&D-related revenue arising on clinical applications

(2)Including R&D-related revenue arising on industrial applications.

(1)Including mainly BioFire Defense and R&D-related revenue arising on clinical applications

(2)Including R&D-related revenue arising on industrial applications. (3) At constant exchange rates and scope of consolidation.

Sales by Region in € millions and % Change in Sales by Region

(1) Including the Middle East and Africa.

(1) Including the Middle East and Africa. (2) At constant exchange rates and scope of consolidation.                                             

APPENDIX 2: GLOSSARY & DISCLAIMER 

DEFINITIONS  

Changes in the scope of consolidation:  

The effects of changes in the scope of consolidation are determined: 

o  for acquisitions for the period, by deducting from sales and operating expenses for the period the amount of sales and operating expenses made during the period by the entities acquired from their entry into the scope of consolidation; 

o  for acquisitions of the previous period, by deducting from sales and operating expenses for the period the amount of sales and operating expenses made during the months in which the acquired entities were not consolidated during the previous period; 

o  for disposals for the period by adding to sales and operating expenses for the period the amount of sales and operating expenses made by the entities sold the previous period, during the months in which these entities are no longer consolidated over the current period; 

o  for disposals for the previous period, by adding to the sales and operating expenses of the period the sales and operating expenses made during the preceding period by the entities sold. 

Contributive operating income before non-recurring items (CEBIT): operating income before nonrecurring items, excluding items relating to the amortization and impairment of intangible assets related to acquisitions and acquisition-related costs. The Company considers that this indicator provides the best possible representation of the operational performance of the Company. 

Currency effect: established by comparing the actual numbers converted at the average exchange rates of the current year to the actual numbers converted at the average exchange rates of the comparative period. In practice, those rates are either average rates communicated by the ECB, or hedged rates if hedging instruments have been set up. 

Operating income before non-recurring items: recurring income less recurring expenses and amortization and impairment of intangible assets related to acquisitions and acquisition-related costs. Non-recurring expenses and income are not included. 

DISCLAIMER 

The forward-looking statements contained in this document 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 2023 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.