Vitrolife AB (publ) Annual Report 2021 1 Annual Report 2021
Creating a global leader in reproductive health, page 10 Vitrolife’s sustainability approach strengthen long-term competitiveness and value creation, page 19 Contents The year in summary 3 CEO’s comments 4 Market and sales 6 IVF treatment and Vitrolife’s offering 8 Acquisition of Igenomix 10 The value chain for the Consumables and Technologies business areas 14 Business concept, goals and strategies 16 Sustainable organisation and business 19 Auditor’s report 31 The Vitrolife share 32 FINANCIAL STATEMENTS* 5-year summary 35 Key ratios 36 Management report 37 Board of Directors 46 Executive management 47 Income statements 49 Statements of financial position 51 Changes in equity 53 Cash flow statements 54 Notes 55 Auditor’s report 70 Definitions of alternative performance measures 73 Glossary 75 Shareholder information 75 Addresses 76 Our history Vitrolife is committed to delivering successful treatment outcomes through a focus on IVF and the needs of clinics and testing labs. We have been dedicated to IVF since 1994, when the field was still young. Vitrolife was one of the first companies to provide IVF laboratories with high-quality, ready-touse culture media. Through well-executed product development, consistent quality controls and the acquisition of other innovative IVF companies, Vitrolife has grown with the global market. As a result, our portfolio includes product solutions ranging from oocyte retrieval all the way to embryo transfer and cryopreservation, together with services that provide personalised genetic information. We support customers worldwide and always keep sustainability in mind. Our aim is to deliver outstanding products for the entire IVF journey, providing consistent performance and guaranteed quality. Vitrolife’s vision is to fulfil the dream of having a baby. We achieve this by supporting our customers by improving their clinical practice and the outcome of the patient’s fertility treatment. This is a translation of the Swedish version of the Annual Report. When in doubt, the Swedish wording prevails. A new Vitrolife, page 4 *The Vitrolife Group's formal financial statements can be found on pages 37–69 and have been audited by the Group's auditors.
Vitrolife AB (publ) Annual Report 2021 3 The year in summary • During 2021, the IVF market recovered from the decline caused by the pandemic in 2020. The pace of the recovery differs regionally, but the number of IVF treatments globally are back on levels before the pandemic outbreak. The pandemic continued to impact Vitrolife’s operations, although we were able to obtain our production capacity, supply chain of raw materials and customer distribution without major disruption. • The acquisition of Igenomix was completed at the end of November and was included as the Genetic Services division as of December 2021. In connection with the acquisition, a new management team was established with competence from Vitrolife and Igenomix. Initially, the focus is to develop the customer offering. • Sales amounted to SEK 1,681 million (1,246), corresponding to an increase of 35 percent in SEK. In local currencies, Consumables increased by 25 percent, Genomics by 49 percent and Technology by 34 percent. Sales from the acquired business Igenomix corresponded to a growth of 9 percent. • Operating profit before amortisation, depreciation and impairment (EBITDA) amounted to SEK 645 million (454), adjusted for acquisition-related costs of SEK 101 million, corresponding to a margin of 38 percent (36). Currencies negatively impacted EBITDA with SEK 24 million. • Net profit for the year amounted to SEK 244 million (288), giving earnings per share of SEK 2.97 (2.64). After the end of the period • Russia’s invasion of Ukraine has created uncertainty in the geo- and security political environment, whose consequences are not possible to judge. • The Board’s proposed dividend amounts to SEK 108 million (87), corresponding to SEK 0.80 (0.80) per share. Normalisation and acquisition of Igenomix Throughout the annual report, the corresponding value for the previous year is stated in parentheses, unless otherwise stated. *Adjusted for acquisition-related nonrecurring costs. **For definitions, justifications and reconciliations of key figures, see pages 73–74. ***Excluding amortisation of acquisitionrelated intangible assets. ****Before and after dilution. 2021 2020 Net sales, SEK m 1,681 1,246 Sales growth in local currency, % 39 -13 Gross margin, % 62 62 Adjusted gross margin, %*** 63 64 Operating profit before depreciation, amortisation and impairment (EBITDA), SEK m 544 454 Operation margin before depreciation, amortisation and impairment, % 32 36 Net income, SEK m 344 288 Net debt/EBITDA 3.2 -2.1 Earnings per share, SEK**** 2.97 2.64 Share price on closing date, SEK 560,00 215.80 Market capitalisation on closing date, SEK m 75,850 23,425 Equity per share, SEK 113.12 18.54 Average number of employees (FTE) 478 405 1,681 SEK M 35% 38% Sales Sales growth in SEK EBITDA adjusted* Sales by region Sales by division Asia 21% (22) Japan & Pacific 15% (17) Technologies 28% (30) North and South America 21% (18) Genomics 9% (9) Genetic services 7% (–) Consumables 54% (61) EMEA 43% (43) Sales and EBITDA, SEK m 408 1,046 479 1,151 587 1,480 454 1,246 1,681 544 2017 2018 2019 2020 2021 Sales Operating profit before depreciation, amortisation and impairment (EBITDA) Key ratios**
4 Vitrolife AB (publ) Annual Report 2021 Recovering market We are continuing to see a strong recovery in the market following the pandemic, although this varies between regions. More treatments are being carried out in the US market compared with previous years, while we have seen some weakening in the Chinese market. IVF tourism continues to be impacted by travel restrictions, which has an impact on several markets. All-in-all, approximately the same number of IVF treatments are done globally as before the pandemic. Global leader in reproductive health We are continuing to develop Vitrolife and are now – through the acquisition of Igenomix – a company offering both products and services. The acquisition was completed at the end of November, and as Genetic Services division during December. The acquisition was financed through a combination of a non-cash issue of shares, directed new issue of shares, bank loans and cash and is expected to have a positive contribution to EBITDA per share from 2022. With 27 laboratories globally, Genetic Services offers clinically validated genetic tests and services, covering a wide range of genetic diagnostics in reproductive medicine, with preimplantation tests mainly driving sales. From the beginning of this year, we have a new management team and structure in place with the business areas Consumables (including Genomics), Technologies and Genetic Services, with global marketing and sales organisations as well as Group functions. Initially, the focus will be on developing our customer offering. Profitable growth We increased our sales in SEK by 35 percent during the year, of which 30 percent was organic growth in local currencies, 9 percent was acquired growth and a negative currency impact of 4 percent. Our divisions are growing strongly and in local currencies Consumables grew by 25 percent, Technology by 34 percent and Genomics by 49 percent. During the year, we successfully launched iDAScore and EmbryoMap, which will continue to contribute to our positive development. Our strongest growth is in the North and South America region, where we are growing by 64 percent, of which 38 percent is organic, followed by EMEA of 41 percent, of which 33 percent is organic, the Asia region with 28 percent, of which 25 percent is organic and Japan and Pacific with 20 percent, of which 16 percent is organic. Operating profit before amortisation, depreciation and impairment (EBITDA) amounted to SEK 645 million, adjusted for non-recurring acquisition related costs of SEK 101 million, corresponding to a margin of 38 (36) percent. The increase in profit is mainly due to increased sales and economies of scale. The cost of customer-related activities were significantly lower during most of the year compared to before the pandemic, but increased slightly during the latter part of year. At the end of the year, operating income was negatively impacted by increased raw material prices, shipping costs, personnel-related costs and non-recurring costs for product certifications. In order to compensate for the cost increases during 2021, we implemented a general price increase in the beginning of 2022. CEO’s comments A new vitrolife “We are continuing to develop Vitrolife and are now– Through the acquisition of Igenomix – a company offering both products and services”
Vitrolife AB (publ) Annual Report 2021 5 Consolidation increase opportunities As IVF clinics recover from the pandemic, we can note that the trends seen in the market before the pandemic are continuing. The consolidation and new ownership structure of IVF clinics is driven by Private Equity companies. The number of IVF clinics that have been acquired in Europe is higher compared with other regions. We expect this trend to continue over the coming years. The management of the acquired clinics will focus on improving the patient experience and enhancing efficiency in their own operational activities. The IVF clinics who are not a part of a IVF-chain will be competitive based on their ability to attract customers locally and/or by serving as a professional fertility clinic. Vitrolife's product and service offering for genetic testing will help those customers to improve the patient experience through clinic results, by offering the clinics an opportunity to do the genetic testing themselves or by offering external analysis with genetic advice from us. With the software development in time-lapse, we can offer solutions to facilitate work in clinics and contribute to improved treatment results. Thanks to product development and launch of our own PGT-A test (EmbryoMap) and the acquisition of Igenomix, we can offer several alternative methods for genetic testing of embryos. Overall, the ambition is to be the preferred partner for IVF clinics and IVF chains in their ambition to assist hopeful couples and individuals have children. Sustainable development As a strategic prioritisation, Vitrolife worked actively during 2021 to enhance its sustainability approach and further integrate it into the strategic management of the company's organisation and business development. This means direct measures, combined with a more long-term strategic approach with the intention of developing the business in line with the UN's sustainable development goals. One important activity during the year was the signing of the UN’s Women Empowerment Principles. These seven principles are based on the fact that global business has a major responsibility to contribute to the development of gender equality and women's rights. Not only is this an important position for Vitrolife, it also has a clear connection to Vitrolife's operations and will be beneficial from a broader perspective in the long term. The results of Vitrolife’s dedicated sustainability work and strong focus on work environment and good culture is also reflected in employee well-being. Despite two years of pandemic and challenges, we saw that the Employee Net Promoter Score in 2021 continued to increase. Outlook Increased vaccination rates are supporting the recovery of the IVF market and enabling a return to more normal customer operations. Russia’s invasion of Ukraine has created uncertainty in the geo- and security political environment, whose consequences are not possible to judge. Our total sales to Russia, including the Igenomix laboratory with 14 employees and sales of medical devices, represented approximately 2 percent of our consolidated sales (pro-forma). In terms of risks, the spread of Covid-19 is still strong in some regions, creating uncertainty about the market recovery. We are working actively with customer deliveries by securing our levels of stock and alternative subcontractors where necessary. A gradual cost increase is expected with new recruitments and a normalisation of operations, for example, trade fairs and customer visits and also development costs within the Genetic Services business area. Vitrolife estimates that the long-term market outlook is largely unchanged, meaning a continuously growing market which, in financial terms, is expected to grow by 5-10 percent per year for the foreseeable future. We will continue to focus on expanding sales by expanding and improving the product and service offering. Thanks I would like to take this opportunity to thank all our customers, committed employees and business partners for their efforts that have resulted in another successful year for Vitrolife. I would also like to welcome our new colleagues. Gothenburg March 2022 Thomas Axelsson CEO Revenues, rolling 12 months, SEK m. Cumulative annual growth 2011–2021: 17%
6 Vitrolife AB (publ) Annual Report 2021 Market size and growth excluding Genetic Services Vitrolife’s customers comprise private and public clinics, hospitals and laboratories. From the perspective of IVF clinics, the global market for assisted conception is estimated to be worth around SEK 100–150 billion. The cost of the disposable products used in an IVF treatment in which Vitrolife currently offers products amounts to approximately SEK 2,000 per treatment cycle for the clinic (excluding the cost of genetics kits). The total price for the clinic for a fertility treatment amounts on average to around SEK 50,000. Prices vary greatly between different countries. Vitrolife estimates that some 2 million IVF treatments are carried out each year. Reliable data on the number of treatments worldwide is limited, which is why the figures are an estimate by Vitrolife based on local market data and official statistics. The clinics’ total purchases of disposable products and equipment are estimated to be approximately SEK 10–15 billion, corresponding to around 10 percent of the clinics' sales. Based on this market definition, Vitrolife has a global market share of around 10 percent. During 2021, the IVF market recovered from the decline caused by the pandemic in 2020. Over the long term, market growth in terms of value is estimated to be 5–10 percent per year, with considerably stronger growth in Asia than in western Europe. This growth is primarily being driven by a growing middle class, along with prospective parents opting to try for children later in life, increased social acceptance of IVF and increased use of technology in IVF treatments. Vitrolife’s sales in 2021 including Genetic Services Sales amounted to SEK 1,681 million (1,246), corresponding to an increase of 35 percent in SEK, 30 percent organic growth in local currency and 9 percent in acquired growth. Foreign exchange rates had a negative effect of 4 percent. Market and sales The market recovered during the year and is expected to return to long-term growth of 5–10 percent per year During the year, the IVF market recovered from the decline caused by the pandemic. Recovery in the IVF market
Vitrolife AB (publ) Annual Report 2021 7 Sales for the EMEA region (Europe, Middle East and Africa) amounted to SEK 735 million (533). Sales increased by 41 percent in local currencies, of which organic growth amounted to 33 percent. In the North and South America region, sales amounted to SEK 354 million (226). Sales increased in local currencies by 64 percent, of which organic growth came to 38 percent. Sales in the Japan and Pacific region amounted to SEK 245 million (214). Sales increased by 20 percent in local currencies, of which organic was 16 percent. Sales in the Asia region increased by 28 percent in local currencies, of which organic growth was 25 percent, amounting to SEK 347 million (273). Growth in all regions was positively affected following the negative effect of the pandemic during the previous year. Sales in the Consumables division increased by 25 percent in local currency and amounted to SEK 913 million (752). Sales in the Technology division increased by 34 percent in local currency and amounted to SEK 474 million (363). Sales in the Genomics division increased by 49 percent in local currency and amounted to SEK 153 million (107). Freight revenue amounted to SEK 27 million (24). Sales for the new Genetic Services division amounted to SEK 116 million, of which SEK 2 million is reported as freight revenue. Growth in all divisions was positively affected following the negative effect of the pandemic during the previous year. Competitors Vitrolife’s main competitors are global companies with a wide range of IVF-related products. Prominent examples are Cooper Companies, Cook Medical, Kitazato and Irvine Scientific. There are also global competitors who have specialised in niche product groups. Fast facts Customers Private and public clinics, hospitals and laboratories No. of clinics >5,000 Payment for treatments Partially subsidised in most European countries, mainly private in the US and Asia No. of treatments per year >2 million Global average price per treatment Approx. SEK 50,000 Market size Approx. SEK 10–15 billion* Market share Around 10%* Largest markets in terms of no. of treatments 1: China, 2: Japan, 3: USA *Market defined as the IVF clinics' total purchases of disposable products and equipment, including products that Vitrolife does not offer. *Refers to the Consumables and Technologies business areas Vitrolife’s sales and growth by region Percent of sales 21% 43% 21% 15% Growth in local currency Total 39% 41% 28% 64% 20%
8 Vitrolife AB (publ) Annual Report 2021 IVF treatment and Vitrolife’s offering Competitive offering in a growing market Involuntary childlessness The World Health Organization (WHO) estimates that approximately 48 million couples and 186 million individuals of reproductive age have difficulties with infertility. There are several methods to treat involuntary childlessness. Intrauterine semination is often the first treatment option offered, but in vitro fertilisation (IVF), commonly called a test-tube baby procedure, is considered the most effective method. The IVF process The laboratory procedure of an IVF treatment consists of several steps; collection and preparation of eggs and sperm cells, fertilisation, embryo culture and transfer of the embryo(s) into the uterus. Viable eggs, sperm cells and embryos not utilized can be cryopreserved for future use. The assessment of embryo development and subsequent selection of which will be transferred, is based on a microscopic analysis. Whereby the embryos are taken out of the incubator (the culture cabinet) and are analysed on several occasions during the culture process. Alternatively, the embryos can be left undisturbed by using a technology that allows almost constant visual monitoring of the embryos within the incubator (time-lapse technology). Such visual data have allowed the development of software for selecting embryos based on events observed during this period. Another method for embryo selection is to determine the chromosomal normality of cells (removed from the embryo) through DNA analysis. This technique is called preimplantation genetic testing (PGT) and its availability is generally regulated by the legislation in each country. Treatment results Some good news for patients is that clinical outcomes are improving. In the middle of the 1980s, approximately 15 percent of IVF treatments, on average, resulted in a successful pregnancy. Towards the end of the 1990s, the corresponding numbers were about 25–35 percent. Now certain clinics can achieve 50 percent or higher. The frequency of pregnancies depends on which groups are treated and how the treatment is conducted. Age, diagnosis, embryo culture factors and the number of embryos transferred are also important factors for the treatment outcome, but this increase is explained, mainly, by improved technique. Today, products specifically designed and tested for IVF are available, which are based on research and years of clinical experience. Competitive offer Vitrolife’s product portfolio includes needles for oocyte retrievals, pipettes for micromanipulation and disposable products. The range also includes media for supporting, handling and culturing of oocytes, sperm and embryos, as well as products used to cryopreserve them – all of the same high quality that ensures a good clinical outcome. Time-lapse technology is used by IVF clinics around the world to monitor embryo development, to make accurate assessments, and select embryos for transfer. Vitrolife is a market leader in this area with the time-lapse systems EmbryoScope+, EmbryoScope 8 and EmbryoScope Flex. Vitrolife also offers a microlaser system that is mainly used for embryo biopsy, which allows removal of cells from the Vitrolife’s product offer covers all steps in the IVF process For more information about Vitrolife’s products, visit the Group’s home page www.vitrolife.com. CULTURE EVALUATION EMBRYO TRANSFER CRYOPRESERVATION OOCYTE RETRIEVAL SPERM PREPARATION FERTILISATION Guided Annotation KIDScore iDAScore
Vitrolife AB (publ) Annual Report 2021 9 embryo, for subsequent genetic analysis. Since 2019, Vitrolife has also offered products for labs assessing preimplantation embryo biopsy samples through a global partnership with Illumina. At the end of the year, Vitrolife acquired Igenomix, which offers genetic tests of the embryo. For more information about Genetic Services, see pages 10–13. 2021 – a year when we increased our product offering in several markets The big news during 2021, besides the acquisition of Igenomix, was the launch of iDAScore (intelligent data analysis), which is a software that can be used by customers who have a Vitrolife time-lapse machine. With the help of iDAScore, clinics can automate certain processes and get objective ranking based on the likelihood of implantation of the patient’s embryos. The study that was started during 2020 has continued and, parallel to the study, a series of clinics have already purchased and begun to use the software. iDAScore was developed by Vitrolife’s competent AI team in Aarhus, Denmark, and is unique because the AI technology builds on algorithms through deep learning. One of the biggest advantages of the new technology is that it removes all subjectivity, but also, to a significant degree, improves workflow efficiency in the lab because the end user does not need to spend time manually looking at images and entering data. Another mark of progress was the launch of OVOIL HEAVY at the beginning of the year, a more viscous oil that offers a number of advantages when handling the oil and can provide a better culture environment. OVOIL HEAVY is now sold in the USA, EMEA and Japan. Another innovation within media is the Gx Media system, which has recently been launched in the USA. Gx Media contains antioxidants which protect the embryo from oxidative stress, creating optimal conditions for the embryo to develop. Another significant development from Vitrolife, which has been introduced globally during the year, is EmbryoMap, a kit containing reagents and associated software that can be used for labs assessing preimplantation embryo biopsy samples. EmbryoMap is initially only available for research purposes and enables a more efficient workflow and increased capacity. Quality, efficiency, service and support Important factors for a successful treatment are quality, settings and the correct handling of the technical equipment. All materials that the egg, sperm cells and embryos come into contact with during the procedure can affect the results negatively. Therefore, besides a quality assured product line, Vitrolife has a team of experienced embryologists who help customers set up their processes and flow in an optimal way. Vitrolife’s ambition has been to create long-term and close collaborations with engaged customers, which has resulted in progress and good treatment results. Collaboration is Vitrolife’s brand promise: “Together. All the way”. For Vitrolife, the brand promise describes a feeling that the Group wants all those who come into contact with Vitrolife to experience.
10 Vitrolife AB (publ) Annual Report 2021 Acquisition of Igenomix Creating a global leader in reproductive health A global leader in reproductive genetic testing services One of Vitrolife’s five strategic focus areas is the exploration of external growth opportunities through partnerships and acquisitions. The acquisition of Igenomix was completed in late November 2021 and it now forms part of the Genetic Services business area. Together, Vitrolife and Igenomix create a global leader in reproductive healthcare, expanding what is available to customers during the entire IVF treatment. A leading IVF platform has been created through the combination of Igenomix’s portfolio of reproductive genetic testing services with Vitrolife’s best-in-class product portfolio within IVF. The ambition is to generate long-term, profitable growth. Through the enhanced scale and synergies between products and services, Vitrolife can better serve clinics, professional staff and patients around the world. Specifically, acquiring Igenomix allows Vitrolife to leverage the respective commercial network of each entity, allowing the cross-selling of products and offering enhanced solutions to its customers, as well as sharing knowledge in order to drive innovation. Igenomix was founded in 2011. The company is a global leader in the field of molecular genetics focused on providing personalised genetic information to improve clinical practice in reproductive medicine and rare diseases. Excellence, innovation, passion and humility are the core values of Igenomix. Together with clinics, fertility doctors and physicians worldwide, Igenomix investigates human reproduction and genetic testing to change the lives of couples who are trying to conceive and families that are affected by a genetic disorder. Igenomix has 27¹ laboratories across the globe and a head office in Valencia, Spain. The company collaborates with more than 4,000 clinics (of which more than 3,000 are IVF clinics) in 80 countries. Igenomix’s affiliates applies the same business model as at the Group level, but with adjustments to take into account the local market’s special circumstances. The respective country managers are responsible for implementing strategies that are in line with the programme Think global, Act local. This international presence is a strength that drives and motivates Igenomix 271 Laboratories +80 Countries 1,252 Sales SEK m 492 Scientific publications Igenomix laboratories New laboratories 2021 1. Including Colombia which is a commercial office. 6 Patent 744 Employees 66% women 34% men Employee Distribution by gender 12% No. employees with PhD qualifications
Vitrolife AB (publ) Annual Report 2021 11 Igenomix is a global leader in reproductive genetic testing at IVF clinics. The product portfolio consists of clinically validated genetic tests and services which cover a wide range of genetic diagnoses in reproductive and personalised medicine. A global leader in reproductive genetic testing services to develop global practices and procedures that are applicable to all the countries in which the company is present. In this way, the business grows globally in a sustainable manner. Globally, the revenue is divided in the following way: EMEA 36 percent, North and South America 50 percent, Japan and Pacific 7 percent and Asia 6 percent. Igenomix’s main competitor is Cooper Companies. Differentiated testing portfolio Genetics have become a foundation within modern medicine. Personalised and appropriate care can be provided within all medical specialities, through identifying genes and applying knowledge about them. Reproductive medicine and rare disease medicine, in particular, have dramatically benefitted and continue to benefit from the development of genetic testing. The complete service portfolio from Igenomix spans preconception, preimplantation, prenatal and postnatal stages of the reproductive cycle, as well as neonatal and child-adulthood. Of the global revenue, sales of ERA and PGT-A tests contribute 70%. These two services have many competitive advantages. PGT-A test quantifies the number of chromosomes in each embryo biopsy to differentiate between chromosomally normal embryos (euploid) and chromosomally abnormal (aneuploid). The PGT-A test is performed using NGS technology and allows the analysis of all 24 chromosomes. Igenomix is the only lab that has published the validation of its PGT-A algorithm. The ERA test is performed using NGS technology coupled to a computational predictor that is much more accurate. ERA test establishes the time when the endometrium is receptive and reports the optimal time for embryo transfer, the predictive genetic analysis model analyses 248 genes, providing a much more complete view of all the processes which are involved in the endometrial receptivity. Its powerful AI-based algorithm provides decision support for the diagnosis of repeated implantation failure patients worldwide. Several publications, not only by Igenomix but also by a number of external clinics, show the clinical outcomes of personalised embryo transfer guided by ERA. The company works with the largest IVF networks, which helps make it a more accessible service. Additionally, the company offers full support and counselling by phone/e-mail to any location worldwide. “Genetics have become a foundation within modern medicine”
12 Vitrolife AB (publ) Annual Report 2021 Portfolio backed by science Igenomix focuses on scientific research and the company’s research and development division is a leader in the field. The team at Igenomix have well-established collaborations with well-respected institutions. From the start of 2011, the focus has been on supporting patients seeking reproductive medical treatment with one desire: a healthy baby at home. Igenomix’s research and development approach is focused on the following areas: 1. Basic studies used as a baseline for the acquisition of new knowledge and to open the way for new lines of related research. 2. Translational projects such as clinical trials, based on the progress of basic studies. 3. Clinical protocols for immediate application both in the reproductive sector and in common clinical practice. With research as a cornerstone, the company’s growth has been based on a solid track record of entering new strategic markets and new product development. Sustainability Igenomix is fully appraised of the current local and global challenges, from the reduction of poverty and inequalities, to the fight against climate change and the promotion of diversity. Socially responsible behaviour is especially important for Igenomix including respect for employees' rights, free mutual negotiation, equal opportunities for men and women, non-discrimination and the protection of employee access to health care. In line with this, Igenomix believes in its people, their talent and in continuous personal growth. Igenomix affects and is affected by several of the UN Sustainable Development Goals, which is an important compass for the company’s long-term business priorities. Direct examples of how Igenomix contributes to these goals are: Igenomix promotes a healthy life and wellness for all its employees, patients and stakeholders, which is essential for sustainable development. Igenomix promotes fair and dignified working conditions, offering adequate and competitive remuneration in line with market conditions. Igenomix works together with fertility clinics and doctors around the world, researching human reproduction to change people's lives. This collaboration plays an important role in introducing and marketing new technologies. The company has undertaken significant work to become even more effective, productive and competitive through continual development. This work, in combination with the consolidation with Vitrolife, will form an important part of our future success. For more information about Igenomix, visit the web site www.igenomix.com
Vitrolife AB (publ) Annual Report 2021 13 Complete offer of services within testing through all stages of the reproduction cycle + Preconception Preimplantation Prenatal and postnatal Neonatal/ child-adulthood The Right Embryo The Right Endometrium GPDx (genomic precision diagnostics): Genetic testing and sequencing for diagnosis and screening of medical conditions and rare diseases that derive from genetic mutations. CGT (carrier genetic test): This is an important genetic test when planning a family because it helps to determine whether a couple carry genetic mutations that could be transmitted to their offspring. WES (whole exome sequencing): This is a complete DNA test to analyse the entire coding sequence of a gene to identify mutations in over 24,000 genes related to complex genetic conditions. SAT (sperm aneuploidy test): This is a test to study the genetic factors of male infertility. It evaluates the presence of sperm chromosomal abnormalities. PGT-A (preimplantation genetic testing for aneuploidies): This test is a genetic screening of the embryo produced during IVF treatment to identify numerical chromosomal abnormalities (aneuploidies). PGT-SR (preimplantation genetic testing for structural rearrangements): This test is a genetic screening of the embryo produced during IVF treatment to identify numerical and/or structural rearrangements of the chromosomes. PGT-M (preimplantation genetic testing for monogenic disorders): This is a genetic test that helps significantly decrease the chance of having a child with an inherited genetic disorder by analysing embryos before transfer and identifying those that do not carry the altered disease-causing gene. EMBRACE (niPGT-A) (embryo analysis of culture environment): This is a non-invasive test for prioritising embryo transfer that avoids invasive embryo biopsy. ERA (endometrial receptivity analysis): A transcriptomic test that determines each woman’s unique personalised embryo transfer timing, therefore, synchronising the embryo transfer with the individualised window of implantation. EMMA (endometrial microbiome metagenomic analysis): This is a test that analyses the endometrial microbiome to help identify abnormalities associated with a poor reproductive prognosis. ALICE (analysis of infectious chronic endometritis): This is a test that detects pathogenic bacteria, which cause chronic endometritis linked to implantation failure and recurrent miscarriage and recommends appropriate antibiotic treatment. A suitable antibiotic treatment is recommended. EndomeTRIO is a complete endometrial analysis that bundles the ERA, EMMA and ALICE tests together with only one biopsy. NACE (non-invasive prenatal test): This is a non-invasive prenatal screening test for the most frequent chromosomal abnormalities (chromosomes 13,18, 21, X,Y). NACE24 (non-invasive prenatal test): This is a non-invasive prenatal screening test for all 24 chromosomes. POC (products of conception) Analyses fetal tissues from a miscarriage to determine if the lost pregnancy was the result of an aneuploidy.
14 Vitrolife AB (publ) Annual Report 2021 The value chain for the Consumables and Technologies business areas High and consistent quality is one of Vitrolife’s competitive advantages Innovative product development based on customer benefit and science Vitrolife’s Consumables and Technologies business areas cover the entire product’s value chain, from research, development and production to sales and distribution. For information about Genetic Services, see pages 10–13. The research function together with the business areas evaluate new product opportunities with a focus on customer needs, medical needs and economics. The development work includes comprehensive testing and collaboration with opinion leaders to ensure the best functionality and safety, which leads to faster market acceptance of new products. Vitrolife develops innovative products with solid scientific basis and it is of particular importance that they are protected through product or method patents. The application for a patent occurs at an early research stage, with applications submitted in the most important markets. Vitrolife also has a number of registered trademarks, for example, EmbryoGlue®, EmbryoScope® and OVOIL®. The development work covers both pre-clinical and clinical studies to document the products efficacy and safety. The studies are often presented at scientific congresses and published in scientific journals. When delivering a product, these studies create a good basis for communicating the product’s value. Product approval Most of Vitrolife’s products are classified as medical devices. The requirements for documentation for medical devices are different from the requirements for medicinal products. Product approval is required in each individual market in which the products will be sold. For example, in the USA approval by the Food and Drug Administration (FDA) is required, and in China approval is required from the National Medical Products Administration (NMPA). Within the EU, the product must be CE-marked (Conformité Européenne). The requirements for approvals for medical devices is increasing in the majority of markets. In May 2021, the EU Medical Device Regulation (MDR) came into force, which means that there are now more stringent standards. Purchase of raw materials, production and quality control Vitrolife has their own manufacturing capability, supplemented with the outsourced production of disposable products in plastic, packaging and sterilisation. A large part of Vitrolife’s competitiveness is based on a well-developed manufacturing technology. Since raw material suppliers lack methods for testing whether raw materials are appropriate for IVF treatment, many resources are dedicated to finding and testing acceptable raw materials. Continuous evaluation of raw material suppliers Stringent testing of all raw material Highly controlled manufacturing Extensive testing of final products Controlled distribution process Products that make a difference for the clinic Extensive quality control from raw material to delivered product
Vitrolife AB (publ) Annual Report 2021 15 A large part of the production is performed in clean rooms and all businesses are governed by a quality system, which fulfils the standards and regulations for medical devices. Advanced tests of raw materials, semi-finished and finished products ensure a high and consistent quality and is a strategic means of competition. Sales and distribution Vitrolife has sales in more than 110 markets. To support all markets, the group has developed a customer support function where customers can quickly gain access to qualified, scientific support. Along with the development of more advanced products, the need for qualified customer support also increases. Customer support for both direct and distributor markets ensures that the products are used in the right way, ensuring that clinics can access the improved results that the products provide. Even the distribution of medical devices requires high standards, for example, the transportation of refrigerated media to all parts of the world. Vitrolife has a long experience of this type of transport and our global cold chain balances quality requirements, environmental aspects and economy. Vitrolife offers world-leading products with the highest quality control and efficacy Vitrolife’s quality and environmental management system* ISO 14001:2015 ISO 13485:2016 MDSAP US Quality System Regulation Canadian Medical Device Regulations EU Good Distribution Practice etc. Auditors for Vitrolife 2021 DNV, BSI, Presafe, TÜV Rheinland and TÜV SÜD. *Refers to the Consumables and Technologies business areas.
16 Vitrolife AB (publ) Annual Report 2021 Business concept Vitrolife’s business concept is to develop, produce and market advanced, effective and safe products and systems for assisted reproduction. Business goal Vitrolife’s goal is to be the leading provider of solutions that reduce the time to achieve a healthy baby and improve workflow efficiency and control for IVF clinics. Strategy Vitrolife has identified five strategic focus areas to achieve that goal: • Scalable global organisation and way of working focusing on attractive culture and sustainable capabilities. • Strong sales and support channels that can offer customised solutions. • Competitive and complete portfolio with leading support and service offering. • Innovative research and development as well as efficient manufacturing and efficient processes. • Take advantage of external growth opportunities such as collaborations and acquisitions. Business concept, goals and strategies Vitrolife’s goal supports patient’s desire to have A healthy baby and the IVF clinic’s efficiency requirements *Includes Media and Disposable Devices business units **Includes Time-lapse and ART Equipment business units Vitrolife’s growth strategy ”To fulfil the dream of having a baby” ”Leading provider of solutions that reduce the time to achieve a healthy baby and improve workflow efficiency and control for IVF clinics” vision with a purpose divisions focused business strategy values market regions EMEA QUALITY THAT MAKES A DIFFERENCE ALWAYS FORWARD YOU CONTRIBUTE TO OUR SUCCESS TOGETHER Americas Asia Japan & Pacific distinct business goal delivering financial value 20% Annual growth average 3 years EBITDA margin Net debt/ EBITDA 30% 3 Strategic acquisitions, alliances and collaborations Integration and executional support EXTENDED CAPABILITIES 5 Innovative research and product development Efficient manufacturing and processes OPERATIONAL EXCELLENCE 4 Strong sales & support channels Customised solutions SALES DEVELOPMENT 2 Scalable global organisation and procedures Attractive culture and sustainable capabilities SUSTAINABLE STRUCTURE AND OPERATIONS 1 Competitive and complete product portfolio Leading support and service offering CUSTOMER OFFERING 3 Consumables* Technology** genetic services genomics
Vitrolife AB (publ) Annual Report 2021 17 Financial objectives The Board of Directors intends that Vitrolife will have a strong capital base to enable continued high growth, both organically and through acquisitions. Vitrolife aims to achieve growth through profitability. The objective for Vitrolife’s growth over a three year period is a sales increase with an average of 20 percent per year in local currencies for an operating margin before depreciation, amortisation and impairment (EBITDA) of more than 30 percent. The Group’s net debt should normally not exceed a multiple of three times EBITDA. Fulfilment of objectives Financial goals Sales growth During the last three year period, Vitrolife’s sales have grown both organically and through acquisition by an average of 14 percent per year in local currencies. The pandemic affected the IVF market negatively. The acquisition of Igenomix in 2021 contributed to Vitrolife’s sales for one month. The objective of 20 percent growth per year is defined as growth measured in local currencies organically, and through acquisition, as an average over three years. Growth in 2021 exceeded the target, while annual growth during the last three-year period is below the objective. EBITDA margin In 2021, the operating margin before depreciation, amortisation and impairment (EBITDA) was 32 percent. EBITDA adjusted for acquisition-related non-recurring costs came to 38 percent. Vitrolife’s objective is to have EBITDAmargin higher than 30 percent. The Group, thereby, reported a operating margin for 2021 that exceeded the objective. Net debt/EBITDA Net debt in relation to EBITDA grew in 2021 to 3.2 times (-2.1). The net debt increased as a result of the acquisition of Igenomix. Net debt in relation to EBITDA adjusted for non-recurring acquisition-related costs is calculated as approx. 2.7 times. Vitrolife’s strong financial position enable financing of future acquisitions. Financial objectives -1.0 2017 2018 2019 2020 2021 -2.1 -1.2 -1.0 3.2 Net debt/EBITDA Sales growth objectives Local currencies (3-year average) Before depreciation, amortisation and impairment (EBITDA) Outcome 2021 Outcome 2017–2021 EBITDA margin Net debt/EBITDA 20% 30% 3 39% 32% 3.2 EBITDA, SEK m EBITDA, percent 2017 2018 2019 2020 2021 408 479 587 454 654 32% 39% 42% 46% 40% Sales, SEK m Cumulative annual growth (CAGR) 2017 2018 2019 2020 2021 1,046 1,151 1,480 1,246 1,681 CAGR: 14%
18 Vitrolife AB (publ) Annual Report 2021 Integrated sustainability approach that strengthen the business By taking long-term and responsible action in line with the UN's global sustainability goals, Vitrolife's sustainability approach can strengthen the company’s long-term competitiveness and profitability. In this way, the company takes responsibility for reducing its negative impact and enhancing the positive impact from a broader perspective. Vitrolife's management and Board of Directors have resolved that sustainability must be integrated into everything the company does. Based on a thorough analysis of the value chain, four long-term sustainability themes have been identified on which the company will focus its efforts. These themes enable effective integration of sustainability into the core business through long-term strategic commitments and direct measures in line with the company's material sustainability issues. Monitoring Measuring and reporting the company's development is an important part of monitoring progress and providing transparency for relevant stakeholders. To ensure consistent and transparent reporting related to sustainability issues Vitrolife complies with current legislation and relevant reporting frameworks to ensure quality and comparability. In 2022, Vitrolife will continue to develop and concretises its longterm focus areas, through objectives and additional metrics. Theme Long-term focus areas Prioritised issues in 2022 Sustainable growth and global partnerships Creating inclusive growth that strengthens Vitrolife's operations while simultaneously having a positive impact on society and the environment throughout the company's value chain Innovation, development and product accessibility Ethical, safe and accessible products Acting responsibly in all respects and ensuring consciously ethical decision-making Product quality, performance and ethics Ecological footprint and net-zero emissions Minimising the company's ecological footprint, ensuring circular resource flows and taking measures to combat climate change Climate impact and packaging materials Gender equality, health and rights of all workers Working continuously to ensure employees' rights and equality by striving for a company structure and culture in which everyone has equal rights and opportunities Diversity and employee opportunities Strategic sustainability framework SÄKERSTÄLL TRANSPARENS MITIGATE RISK AND CAPTURE OPPORTUNITIES MINIMIZE NEGATIVE IMPACT PROVIDE TRANSPARENCY MAXIMIZE POSITIVE IMPACT Sustainable growth and global partnerships for impact Ethical conduct and accessible & safe products Ecological footprint and zero emissions Equality, rights and health of all workers SUSTAINABLE BUSINESS Sustainability themes In 2021, Vitrolife defined four key sustainability themes that describe the strategic sustainability direction up until 2030 and beyond. These four cornerstones govern what is required for Vitrolife to ensure sustainable business development across its entire value chain. This is done by managing risks, capturing opportunities, ensuring transparency and increasing the company's positive impact while minimising its negative impact.
Vitrolife AB (publ) Annual Report 2021 19 Systematic value-creating sustainability approach For Vitrolife, running a responsible business is about managing risks, reducing negative impacts and acting responsibly and ethically. At the same time, the company addresses social and environmental challenges in a way that favor the business. The sustainability approach is managed and followed up by Vitrolife's executive management team, through relevant goals and metrics for the business. The functionally responsible for Vitrolife's sustainability approach is a member of the executive management team, and reporting on the commitments is conducted regularly at executive management meetings. The sustainability report for 2021 excludes Igenomix, as the company was acquired at the end of the financial year. Enhanced sustainability commitments In 2021, Vitrolife has worked actively to strengthen its approach to sustainability and further integrate it into the strategic management of the company's organisation and business development. This means direct measures here and now, while the company is also working on long-term strategic commitments up to 2030 and beyond. The approach is to ensure that Vitrolife's business and operations develop in line with the UN’s sustainable development goals and contribute to sustainable development. The company's strategic approach to this is based on its prioritised sustainability themes. The Sustainable Development Goals Vitrolife is committed to making a real difference in creating a sustainable future. For this reason, the UN’s Sustainable Development Goals (SDGs) have been an integral part of the analysis carried out in 2021, in defining how Vitrolife's operations affect and will be affected by the global agenda. This creates a basis for the company to capture opportunities, handle the risks and adapt the business to the adjustments that the SDGs entail. Vitrolife's in-depth materiality analysis has identified that 10 of the 17 SDGs are of high importance for the company's operations. Sustainable organisation and business Vitrolife’s sustainability approach strengthen long-term competitiveness and value creation The Sustainable Development Goals The 2030 Agenda and 17 SDGs show the way to a better future for all. They also provide the private sector with a lens which it can use to translate global needs and ambitions into business solutions throughout the value chain.
20 Vitrolife AB (publ) Annual Report 2021 Step-by-step process Vitrolife works on the basis of a systematic step-by-step process which provides a solid foundation and enables the entire organisation to contribute and jointly identify and prioritise the sustainability challenges that are most important to its stakeholders and operations. This enables Vitrolife to conduct proactive long-term strategic discussions together with specific, direct measures in the company's current material sustainability issues integrated into its core business. Value chain analysis To ensure understanding of, and communication regarding, Vitrolife's current impact, be it positive or negative, as well as the company's contribution and opportunities, a comprehensive analysis of the value chain has been carried out. This is an effective way of analysing the company's business operations and helps to identify social and environmental issues that are outside the scope of the assets the company directly owns or controls. It also helps to highlight potential risks and business opportunities upstream and downstream in the value chain. The approach is based on participation and through involvement from the organisation on an ongoing basis, diversity is strengthened and perspectives are broadened. At the same time, the efforts have contributed in producing a shared picture and greater understanding of how the business's actions and impact are connected. The results of the work carried out in 2021 generated 35 sustainability issues and 27 different stakeholder groups present throughout Vitrolife's value chain. In order to gain a consistent and shared understanding of Vitrolife's value chain, the method has been based on SDG Compass Guide and GRI Standards. As part of establishing the impact throughout the value chain, relevant legislation and frameworks such as the EU taxonomy, CSRD, GRI Standards and SASB have also been used to ensure transparency and comparability in sustainability issues. The value chain, the company's impact and stakeholders will all be evaluated annually. Significant sustainability issues and stakeholders Of the 35 sustainability issues identified, the materiality analysis identifies which sustainability issues are most important in the value chain. It also assist to ensure that the Moderate impact Reported annually in our sustainability report • Anti-corruption • Gender equality • Supplier management and traceability • Evidence-based methods • Waste from production and recycling • Use of material • Energy consumption • Health and safety • Transparent corporate communication • Transportation, travel and logistics • Legal compliance • Corporate governance • Collaborations, training and knowledge-sharing • Employee development • Sustainable growth • Diversity and equal opportunities • Packaging materials • Product quality and performance • Innovation, research and development • Ethical and responsible business • Product accessibility Significant impact Reported annually with associated metrics Major impact Reported annually with associated metrics and acts as a guide for the company's direct sustainability initiatives Results of the materiality analysis Overview of the 21 most significant sustainability issues for Vitrolife Vitrolife is certified as a ‘Nasdaq ESG Transparency Partner’ – a certification awarded to Nasdaq-listed companies that actively work with sustainability issues and related reporting. This is a confirmation of Vitrolife's desire to be transparent with the market regarding the company’s sustainability status, with respect to current and future investors, employees, customers and other stakeholders.