Boule Diagnostics : Annual report 2021

Boule Diagnostics AB (publ)

Boule works to ensure that all people have access to safe diagnoses

Boule Diagnostics AB is a global diagnostics company specialized on decentralized blood diagnostics. The company is one of the few companies in the global diagnostics market that develops, manufactures and markets instruments and consumables for blood diagnostics under its own direction. Boule mainly targets small and medium-sized hospitals, clinics, laboratories, and veterinary clinics, and other diagnostics companies.

Boule Diagnostics AB (publ)

142+

tests per year, millions

Humans and animals

Boule offers complete solutions for hematology in both the human and veterinary markets.

28 600

active instruments

Strong brands

Boule offers several brands to better reach different target groups and meet their needs, and to increase penetration in all markets.

100+

countries

Global presence

Boule has a global network of distributors who market and sell Boule's high-quality instruments and consumables to labs in the near-patient market.

Contents

• 4 The year in brief

• 6 A word from the CEO

• 8 Strategy

• 11 Financial targets

• 12 Market

• 16 Sales

• 18 Offering

• 19 Boule Academy

• 20 Boule around the globe

• 22 Sustainability report

• 27 Value creation

• 28 Environment

• 29 Work environment

• 30 Ethics and governance

• 32 Five-year summary

• 34 The stock

• 36 Risks and opportunities

• 41 Definitions

• 42 Corporate Governance Report

• 46 Board of Directors

• 47 Group management

• 48 Directors' report

• 54 Financial statements

• 60 Notes

• 87 Declaration by the Board

• 88 Audit Report

• 91 Other information

The year in brief / Boule Diagnostics AB (publ)

The year ends with record sales

463 43% 36

Net sales,	Gross margin	Operating profit/loss,	Operating cash flow,
SEK million	SEK million	SEK million
43

The year in brief

Boule Diagnostics AB (publ) / The year in brief

The beginning of 2021 continued to be strongly affected by the Covid-19 pandemic, and due to the many restrictions around the world, this had a negative impact on sales. Over the year we saw a turnaround with growth in both instruments and consumables and continued positive development of our OEM products.

Increasing test volumes with increasing vaccination coverage

Boule has a large installed base worldwide, and sales have been affected by shutdowns as non-emergency medical visits have fallen dramatically. In many countries, vaccination rates increased towards the end of 2021, which has had a positive impact on Boule's sales. In the longer term, we expect test volumes to return to more normal levels, which will contribute to continued sales growth.

Expansion in emerging markets

We are focused on continued expansion in emerging markets where a local presence, combined with our expertise in hematology and robust technology solutions, gives us competitive advantages. In the second half of 2021, we established a local presence in the Middle East and Africa. This is a slightly longer-term investment, but one that has already resulted in new business opportunities in these regions in 2021.

Start of serial production for OEM customer

The OEM business, where we sell consumables to other manufac- turers, has continued to develop well, thanks in part to a ten-year agreement signed in 2020. There are also several promising projects in progress with the potential to increase revenue in the years to come.

Local production in Russia

In September, our factory was completed and the first deliveries of consumables were shipped from the new production facility to cus- tomers in Russia. The decision regarding this investment was made in 2019, when local production meant direct advantages in public procurement, shorter lead times, lower transportation expenses and a reduced environmental impact from transportation. Given the war in Ukraine, the potential is now very uncertain.

Continuing improvement of our digital communication

An important part of strengthening relationships with our distrib- utors is increasing our digital presence. By offering marketing and sales support and attractive digital product training, we can deliver added value that simplifies procedures for distributors and deepens customer relationships. During the year, we increased the offerings of the Boule Academy, our training platform, where we share appli- cation, service and clinical interpretation knowledge that is valuable to both our distributors and end users.

Milestones for IVDR alignment

Updates to comply with the new regulatory requirements in Europe, IVDR, passed an important milestone in November when a second and final external audit of the Boule quality system was complet- ed without remarks. The EU has decided on a deferred and phased introduction of the new regulatory framework for certain risk classes of products, which means May 2027 for Boule's instruments. We will be well prepared, as we have already submitted the first technical file.

Development of a new product platform

The intensive development work that sets the foundation for Boule to be a global leader in the future of decentralized blood diag- nostics has continued during the year. In addition to the develop-ment of new products, the development of our own cloud service is an important part of our strategy. A proof of concept solution was delivered in mid-2021. Initially, we will offer cloud services that are used for service and maintenance. New functionality will be added over time, and through connected services, Boule will increase cus-tomer value and create differentiated solutions.