bioMérieux – First-Half 2024 Results

bioMérieux – First-Half 2024 Results

{  +9.9% organic sales growth in H1 at €1,902m driven by the strong performance of the GO•28 strategic plan’s four growth engines, together with BIOFIRE^®1 respiratory panels: 

•            BIOFIRE^®* non-respiratory panels up +19%, a strong and balanced performance with each region and each panel growing at least double digit 

•            Microbiology: +8.7%, with reagents growing +13% driven by volumes and price increases 

•            SPOTFIRE^®1: €33m of sales (€13m in Q2) in line with the €80m 2024 sales guidance, offering now the most comprehensive suite of respiratory assays in the segment.

•            Industrial Applications: +11% on reagents (+7% total), with a strong bounce back of the food segment and a positive dynamic on prices

•            BIOFIRE^® respiratory panels up +14%, demonstrating the competitiveness of the solution and the strong leverage of the existing installed base.

{  €937 million of sales in Q2 2024, up +10.1% like-for-like 

{  GO•28 deployment kicked-off in Q2 on all 4 dimensions

{  Contributive operating income before non-recurring items (CEBIT)² reached €306 million for the first half of the year, representing a +155bps CEBIT margin improvement at constant exchange rate vs H1 2023 and a steady +20% like-forlike evolution versus H1 2023, perfectly on track to increase the 2024 CEBIT by at least +10% as per the GO•28 commitment. The reported evolution stands at +5%, negatively impacted by a -€44m currency effect². 

{  Net income (group share) of €215m, increased by +33% versus the H1 2023 performance which was negatively impacted by the Hybiome (Chinese immunoassays entity) goodwill impairment. 

{  2024 full year guidance revised upward: sales expected to grow organically by +8% to +10% (6% to 8% initially) and CEBIT to grow by +12% to +17% organically (at least +10% initially). The full year exchange rates impact is expected to be negative in the range of -€70m (-€50m initially).

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

²  As defined in Appendix #3

*  

Marcy l’Etoile (France), September 5^th, 2024 – The Board of Directors of bioMérieux, a world leader in the field of in vitro diagnostics, met on September 4^th under the chairmanship of Alexandre Mérieux and approved the consolidated financial statements for the six months ended June 30, 2024.

SALES

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

Consolidated sales amounted to €1,902 million in first-half 2024 from €1,770 million in the prior year period. Reported growth stood at +7.4% impacted by a -€50 million negative currency effect, primarily due to the devaluation of the Argentinian peso, some Asian currencies and the Turkish Lira.

ANALYSIS OF 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.

{  CLINICAL APPLICATION sales (84% of the consolidated total), rose by more than 10% year-on-year to €788 million in the second quarter of 2024:

▪  In molecular biology: 

o  BIOFIRE^® non-respiratory panels sales were up +19% in Q2 despite a high basis of comparison, with double-digit sales growth in each region and for each panel, illustrating the high medical value of these assays and the efficient execution of the cross selling strategy. 

o  In parallel, BIOFIRE^® respiratory panels sales were up +17% in the second quarter of 2024 driven by the competitiveness of the solution and the leverage of the existing installed base. 

o  The BIOFIRE^® installed base expanded by 400 instruments over the second quarter, reaching more than 26,100 units at June 30, 2024. 

o  SPOTFIRE^® sales reached close to €13 million in Q2 2024 resulting in half year sales of €33 million, fully in line with the 2024 sales guidance of €80 million. SPOTFIRE^® installed base reached 1,450 instruments at June 30, 2024.

▪  The microbiology business delivered a robust 8% growth led by double digit sales growth in the key ranges of the reagents (especially VITEK^® cards and BACT/ALERT^® bottles) thanks to both volumes growth and price increases.

{  In immunoassays, sales of VIDAS^® routine and emergency assays were up 4% in the second quarter, offset by the downward trend in procalcitonin test sales, as expected.  

{  INDUSTRIAL APPLICATION sales, (16% of the consolidated total), increased by 9% year-on-year to €149 million in the second quarter, with the food safety & quality segment growing double digit for the third quarter in a row driven by a very strong performance of the molecular business. Overall, price increases contributed to around 50% of the reagents’ growth of the franchise.

ANALYSIS OF SALES BY REGION

(1) Including Europe, the Middle East and Africa.

{  Sales in the Americas (50% of the consolidated total) reached €469 million in second quarter 2024, a strong organic growth of nearly 12% versus the same period in 2023:

•      In North America (43% of the consolidated total), the quarterly performance of +8% has been led by the strong demand in BIOFIRE^® non respiratory and respiratory panels and by industrial applications.

•      Latin America (7% of the consolidated total) recorded an excellent performance in the second quarter of +36% driven notably by strong price increases in Argentina to compensate for hyperinflation and the local currency depreciation. Excluding Argentina, the quarterly sales growth for the region is close to 10% driven primarily by BIOFIRE^® and industrial applications.

{  Sales in the Europe – Middle East – Africa region (33% of the consolidated total) came to €312 million for the second quarter with a solid growth like-for-like of more than 10% fueled by a very strong growth in BIOFIRE^® respiratory and non-respiratory panels sales, alongside a robust performance in microbiology key ranges and industrial applications.

{  Sales in the Asia-Pacific region (17% of the consolidated total) came to €155 million in the second quarter of 2024, up nearly 5% compared with the same period in 2023. Reagent sales were up +11% across the region, mainly supported by China and ASEAN.

CONSOLIDATED INCOME STATEMENT

{  Contributive operating income before non-recurring items (CEBIT)

For the six months to June 30, 2024, CEBIT increased by +5.0% year-on-year to €306 million, representing 16.1% of sales. The reported CEBIT includes an unfavorable currency effect of -€44 million. At constant exchange rate and scope of consolidation, CEBIT increased by +19.9% compared with first half 2023, a 155bps like-for-like margin improvement.

▪  Gross profit stood at €1,063 million, or 55.9% of sales, as compared to 56.4% in the half-year 2023. At constant exchange rates and scope of consolidation, the gross profit rate improved by 100 bps mainly thanks to a contained increase in manufacturing costs, a dynamic price evolution and a favorable mix effect, with an increased share of reagents in total sales versus last year.

▪  Selling, general and administrative expenses amounted to €536 million, or 28.2% of sales, compared with 28.4% in first-half 2023. On a like-for-like basis, they rose by 9.4%, mainly driven by a continuous investment in selling and marketing capabilities with both salary increases and new hires. 

▪  R&D expenses amounted to €241 million, or 12.7% of sales, compared with €227 million and 12.8% one year earlier, a 6.4% increase on a like-for-like basis primarily driven by investments in the molecular franchise.

▪  Other operating income amounted to €20 million in line with the amount as of June 30, 2023.

{  Operating income before non-recurring items

The amortization and impairment of acquisition-related intangible assets and acquisition costs amounted to €18 million, down from €84 million in first-half 2023, which was mainly impacted by the impairment recognized on the Hybiome (Chinese immunoassays entity) acquisition goodwill. 

As a result, the Group ended first-half 2024 with operating income before non-recurring items of €288 million, up 38.7% on the €208 million reported during the same period one year earlier. 

{  Net income of consolidated companies

▪  Net financial expense amounted to -€4.8 million over the period versus +€0.5 million recorded in

2023 mainly driven by reduced financial income from FX hedging and the impact of hyperinflation  ▪                   The Company's effective tax rate stood at 24.2 % at June 30, 2024. 

▪  Net income, Group share amounted to €215 million in first-half 2024, up 33.2% year on year.

CASH MANAGEMENT AND FINANCING

{  Free cash flow^[3]

EBITDA⁵ came to €424 million in first-half 2024, or 22.3% of sales, up 8% from the €394 million reported for the same period one year earlier in line with the positive evolution of contributive operating income before non-recurring items.

Income tax paid represented €129 million, an increase from the €119 million paid in the first six months of 2023, primarily due to a larger tax base in the US.

Operating working capital rose by €107 million in first-half 2024. The change was primarily a result of the following items:

▪  inventories rose by €84 million during the period, driven by the inventory build-up for the new instruments launches, mainly SPOTFIRE^®, and the increase in BIOFIRE^® reagents inventories to support the steady demand and the coming winter season.

▪  trade receivables fell by €35 million mainly thanks to good cash collection in the US, and trade payables came down €45 million. 

▪  other working capital requirement items increased by €13 million at June 30, 2024, primarily due to annual bonuses payments.

Capital expenditures represented around 8% of sales or €150 million in first-half 2024 similar to the H1 2023 amount. The majority of these expenditures was invested in the US manufacturing sites, to increase capacity and automation, and in the new placements of instruments, mainly SPOTFIRE^®. 

In light of the above, free cash flow came in at €50 million in first-half 2024, compared to €1 million in first-half 2023.

{  Change in net debt

A dividend of €100 million was paid in first-half 2024, a constant level versus 2023.

As a result, consolidated net debt⁵ came to €286 million as of June 30, 2024, versus a net debt of €167 million as of December 31, 2023. This net debt includes the discounted liability related to leases amounting to €165 million (IFRS16).

2024 OBJECTIVES 

▪  In response to its first-half 2024 performance, bioMérieux revises upward the 2024 full year guidance released in March for both sales and CEBIT. 

▪  Sales growth for 2024 is now expected to reach +8% to +10% at constant exchange rates and scope of consolidation (previously +6% to +8%). 

▪  CEBIT should grow between +12% and +17% at constant exchange rates (previously at least +10%)  

▪  The full year currency effect on the contributive operating income is now expected to reach approximately -€70 million (previously -€50 million) 

SIGNIFICANT EVENTS OF THE SECOND QUARTER OF 2024

{  bioMérieux receives U.S. FDA Special 510(k) clearance and CLIA-waiver for its BIOFIRE^® SPOTFIRE^® Respiratory/Sore Throat (R/ST) Panel Mini

On June 26, 2024, bioMérieux announced having received the U.S. Food and Drug Administration (FDA) 510(k) clearance and the U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for the fast and accurate multiplex PCR-based BIOFIRE^® SPOTFIRE^® Respiratory /Sore Throat (R/ST) Panel Mini. It detects five of the most common viral and bacterial causes of respiratory or sore throat in about 15 minutes. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.

{  bioMérieux receives US FDA 510(k) clearance for its AST System VITEK^® REVEAL™

On June 21, 2024, bioMérieux announced having received the U.S. Food and Drug Administration (FDA) 510(k) clearance for the VITEK^® REVEAL™ AST System. The modular VITEK^® REVEAL™ AST System can deliver actionable results for gram-negative bacteria directly from positive blood cultures in an average of 5.5-6 hours enabling same-day treatment decision-making for patients suffering from bacteremic sepsis. The instrument seamlessly integrates into bioMérieux’s unique and comprehensive portfolio of diagnostic solutions to address bloodstream infections and sepsis.

{  bioMérieux receives FDA 510(k) clearance of VIDAS^® TBI (GFAP, UCH-L1), an innovative test to improve the assessment of patients with mild traumatic brain injury

On May 28, 2024, bioMérieux announced having received the U.S. FDA 510(k) clearance of VIDAS^® TBI (GFAP, UCH-L1), a serum-based test to support the assessment of patients with mild traumatic brain injury (mTBI), including concussion. The test can help reduce the number of unnecessary head Computed Tomography (CT) scans performed for mTBI patients by predicting the absence of accute intracranial lesions (ICL).

SUBSEQUENT EVENTS 

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

On July 26^th, 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.

{  M-Pox: bioMérieux provides a real-time PCR detection kit called MONKEYPOX R-GENE^®. On August 14^th, 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.

{  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. 

INVESTOR PRESENTATION

bioMérieux will hold an investor presentation on Thursday, September 5^th, 2024 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=1679601&tp_key=d3f0e72633

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

Conference call:

INVESTOR CALENDAR

        2024 third-quarter sales                                                                         October 30, 2024

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 agrifood, 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. Investors section: www.biomerieux.com/en/finance

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 48      Tel.: (919) 521-0507 media@biomerieux.com    lheilbronn@image7.fr             lizad@seeztoday.com

APPENDIX 1: QUARTERLY SALES BY APPLICATION AND REGION

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

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

(1)Including mainly BioFire Defense, 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.

Sales equipments, reagents & services in € millions (IFRS15)

APPENDIX 2: SUMMARY CONSOLIDATED FINANCIAL STATEMENTS AT JUNE 30, 2024

             .                                                                 

ASSETS

LIABILITIES AND SHAREHOLDERS' EQUITY

^(a) Including allocations (reversals) of short term provisions. 

^(b) Free cash flow is defined as the sum of flows related to the activity and those related to investments excluding the net cash of the impact of changes in the scope of consolidation.

APPENDIX 3: 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.

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.

Contributive operating income before non-recurring items (CEBIT): operating income before non-recurring items, excluding items relating to the amortization and impairment of intangible assets related to acquisitions and acquisitionrelated costs. The Company considers that this indicator provides the best possible representation of the operational performance of the Company. The reconciliation between the operating income before non-recurring items and the contributive operating income before non-recurring items is presented in note #24 of the June 30^th 2024 financial report.

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 comparison period. In practice, those rates are either average rates communicated by the ECB, or hedged rates if hedging instruments have been set up.

Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA): sum of the contributive operating income before non-recurring items, depreciation and amortization. The reconciliation between the Contributive operating income and EBITDA is presented in note #12 of the June 30^th 2024 financial report.

Free Cash Flow Generation: cash flow from operations plus cash flow from capital expenditure excluding net cash from acquisitions and disposal of subsidiaries. This indicator is presented in the consolidated cash flow statement in the June 30^th 2024 financial report.

Net debt: sum of cash and cash equivalents less committed debt and bank overdrafts and other uncommitted borrowings. This indicator is presented in the note #12 of the June 30^th 2024 financial report.

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.