Devyser intends to list its shares on Nasdaq First North Growth Market in Stockholm

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO, THE UNITED STATES OF AMERICA, JAPAN, CANADA, AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL. OTHER RESTRICTIONS ARE APPLICABLE. PLEASE SEE “IMPORTANT INFORMATION” AT THE END OF THE PRESS RELEASE

Stockholm, 22 November, 2021

Devyser Diagnostics AB (publ) (”Devyser” or the ”Company”), which develops, manufactures and sells kits for genetic testing in routine diagnostics to laboratories in more than 45 countries, today announces its intention to launch an initial public offering of its shares (the “Offering”) and to list its shares on Nasdaq First North Premier Growth Market. The Offering is expected to consist of both new shares issued by Devyser and of existing shares in the Company. Nasdaq has announced that the Company meets the listing requirements.

Devyser develops, manufactures and sells kits for genetic testing in routine diagnostics to laboratories in more than 45 countries. The products are used for complex DNA testing in the areas of hereditary diseases, oncology and post-transplantation monitoring in order to enable diagnosis of a large number of genetic diseases, target cancer treatment, and follow-up transplant patients. Devyser’s products simplify complex genetic test procedures, minimize manual elements and deliver rapid results.

Devyser’s Board of Directors and company management, believe that the Offering and the listing of Devyser is a logical and important step in the Company’s development. The main focus for Devyser’s strategy is to continue to conduct sales of the current products on existing markets, convert selected existing markets from distributor sales to direct sales, expand to new geographic markets, as well as develop and launch new products. A listing will broaden the Company’s shareholder base and provide access to the Swedish and international capital markets, which is believed will promote the Company’s continued growth and development. The Company also believes that a listing of the Company’s shares on Nasdaq First North Premier Growth Market will increase knowledge about the Company and strengthen the Company’s brand.

Nasdaq has announced that the Company meets the listing requirements.

Fredrik Alpsten, CEO of Devyser:

“I am very pleased to announce the intended listing of Devyser on Nasdaq First North Premier Growth Market. The plans have generated a great deal of interest, both from new investors and existing owners. The listing is a milestone for Devyser and a logical next step in our successful and so far profitable growth journey. The Company has historically shown good profitability, but in 2020 took Devyser and active and conscious decision to invest in market and sales efforts to increase the growth rate. The funds provided by the planned share issue will enable continued investments in our international expansion and conversion of existing distributor markets into direct sales markets. The capital will furthermore enable continued successful product development while also providing flexibility for potential acquisitions that can accelerate the company's growth. Increased marketing efforts in selected markets paired with a clear focus on direct sales and a stronger organization makes us well positioned to accelerate the already high sales growth even further. I am really looking forward to gaining new shareholders who will be able to take part in Devyser's exciting growth journey.”

Mia Arnhult, Chairperson of the board of Devyser:

“The listing of Devyser has all the prerequisites to become a stepping stone for the company in several ways. Through the share issue, the company will gain a solid foundation for a focused expansion of its presence in new geographical markets and for building profitable growth, using the successful establishment in Italy as a role model. Being listed, Devyser will gain a stronger identity and can benefit from the increased attention the listing provides. I am glad that the opportunity to take part in Devyser’s continued journey forward as shareholders now is spread to many more.”

The Offering in brief

Should the Company proceed with the IPO, the shares will be offered to:

• the general public in Sweden; and
• to institutional investors in Sweden and abroad.

The Offering is expected to consist of newly issued shares by Devyser corresponding to gross proceeds of approximately SEK 300 million, and existing shares in the Company. Furthermore, the Company is expected to issue an over-allotment option, comprising newly issued shares, corresponding to a maximum of 15 percent of the Offering (the ”Over-allotment Option”).

In connection with the Offering, the Company, members of the Company’s board of directors, the management team and founders, are expected to enter into customary lock-up undertakings of 360 days, and certain other shareholders are expected to enter into customary lock-up undertakings of 180 days.

Subject to receiving relevant approvals from Nasdaq Stockholm AB, as well as prevailing equity capital market conditions, the Offering is expected to be completed during the fourth quarter of 2021.

Full terms, conditions and instructions for the Offering will be included in the prospectus expected to be published by the Company in connection with the Offering and the listing. The prospectus will, if published, be available on the Company’s website at www.devyser.com.

About Devyser

Devyser is specialized in the development, manufacture, and sales of diagnostic kits. The products are sold to routine diagnostic laboratories in more than 45 countries. The products are used for complex DNA testing within hereditary diseases, oncology, and transplantation. The products are used to guide targeted cancer therapies, to enable a wide array of genetic tests, as well as in post-transplant follow-up. Devyser’s product development focuses on simplifying and streamlining complex testing processes to improve throughput, reduce hands-on time and produce accurate and trusted results. Devyser was founded in 2004 and is based in Stockholm, Sweden.

Key strengths and competitive advantages

• Specialized supplier of advanced DNA testing combined with software adapted to market-leading DNA sequencing instruments

Devyser was founded in 2004 with the idea of developing a rapid, noninvasive diagnostic test based on multiplex PCR technology for prenatal diagnostics. Since its inception, Devyser’s product portfolio has been developed and expanded to meet the need for simple and rapid processes for complex DNA testing in the areas of hereditary diseases, oncology, and post-transplantation monitoring to enable diagnoses of a large number of genetic diseases, targeted cancer treatment, and follow-up of transplant patients. Devyser also offers software for data analysis and interpretation of results as a complement to its product portfolio. With this software, the user can analyze and visualize an infinite number of samples and cell types. The Company believes that it has an attractive offer in the routine diagnostics value chain since Devyser's DNA testing kits are device agnostic and adapted to common sequencing devices.

Devyser focuses on developing products for customers within routine diagnostics which differs from developing products for traditional research diagnostics since the Company believes that other qualities are focused on in routine diagnostics. This means, among other things, that the Company's products are developed in a tailored manner for specific indications within the Company's three market segments. Since the Company has developed its products with the routine diagnostics customer in mind, an area which is impacted by extensive legislation, Devyser has developed a history of regulatory knowledge and expertise.

• Devyser addresses large and growing markets

Devyser operates on the markets for genetic diagnostics of hereditary diseases, oncology and post-transplantation monitoring. According to the Market Study ^[1], the total market for the Company’s products, i.e. the total addressable market (TAM) for hereditary diseases, oncology and post-transplantation monitoring amounted to approximately EUR 5.8 billion in 2020 and is expected to grow by approximately 2 percent per year and about to EUR 5.8 billion in 2026. Devyser's serviceable addressable market (SAM) is estimated to have amounted to approximately EUR 1.3 billion in 2020 and is expected to grow by approximately 13 percent per year and amount to approximately EUR 2.6 billion in 2026. The serviceable addressable market is expected to grow as a consequence of increased awareness of the advantages of genetic testing and national investments in compensation systems and screening programs. In the opinion of the Company, Devyser offers testing which is well-adapted for use in routine diagnostics laboratories and within the framework of national screening programs, which means that the Company is well-positioned to take advantage of the growth possibilities which exist.

• Product portfolio with value-add for customers

The Company believes that it offers its customers a simpler process for carrying out diagnostic testing as compared with the traditional processes. The traditional processes can be regarded as complex and involving several stages and a large number of test tubes in order to produce results. Devyser has simplified the process by producing a three-step process which only requires one test tube and which reduces the number of steps in the testing process. The Company believes that a simplified testing process and reduced complexity also reduces the risk of tests being mixed-up which can lead to unreliable results and the need to redo the process.

Since the traditional methods involve several steps, such as pre-processing of DNA, and several test tubes, a large amount of DNA is required in order to be able to produce reliable results. Devyser’s solution, however, does not require any pre-processing and only a small amount of DNA. Since Devyser reduces the number of steps in the process, it also reduces the manual handling time of approximately 1 to 2 days down to approximately 45 minutes. The shortened processing time also means shorter waiting times for the patient for test results. The Company estimates that the total amount of time needed to carry out testing according to traditional methods, including sequencing and data analysis, is between 4 and 14 days which can be compared with Devyser's total processing time of 1 to 2 days.

• Financial profile characterized by high sales growth and underlying profitability

Devyser is a rapidly growing company in the commercial phase with a documented history of organic net sales growth and what the Company considers to be high gross margins. Since 2015, the Company's net sales have had an annual rate of growth of approximately 35 percent, and in 2020 amounted to SEK 65.7 million. As per 30 September 2021, net sales for the preceding 12-month period amounted to SEK 86.8 million. The Company has historically shown good profitability, but in 2020 took and active and conscious decision to invest in market and sales efforts to increase the growth rate.

Devyser has a well-invested and scalable production department where a large portion of the production costs are fixed and which will thus generate sound profitability as the volumes increase. As a result of increased sales volumes, the Company increased its gross margin to 77.5 percent for the nine-month period ending on 30 September 2021.

• Management group with experience in the medical devices industry

Devyser's management group consists of individuals with many years of experience in the medical devices industry. The Company's CEO, Fredrik Alpsten, has over 20 years of experience in the medical devices industry and two of the Company's founders, Ulf Klangby and Anders Hedrum, also serve in the management group. Ulf Klangby has a Fil. Lic. in Tumor Biology from Karolinska Institute, and is the Company's deputy CEO with over 20 years of experience in medical device companies. Anders Hedrum has a PhD in Molecular Biology from the Royal Institute of Technology in Stockholm and is the Company's Chief Technology Officer with responsibility for the Company’s development department, and has 20 years of experience in the medical devices sector.

Financial highlights

*Period on period growth.

**Operating profit (EBIT) adjusted for items affecting comparability.

Comprehensive information of Devyser’s historical financial information will be included in the prospectus expected to be published by the Company in connection with the Offering.

Trading update for the nine months ended 30 September 2021

The Covid-19 pandemic has had a negative impact on revenue during 2020. During 2021, the effects of the Covid-19 pandemic have gradually diminished and Devyser’s sales have been strong, and the third quarter of 2021 became the strongest quarter in the Company's history.

• The first nine months of 2021 showed a strong sales growth of 43.9 percent, 49.5 percent adjusted for exchange rate fluctuations, compared with the corresponding period in 2020. The strong sales growth in the period was primarily driven by strong growth in EMEA and the Company’s direct sales markets.
• Gross profit increased by 58.3 percent to SEK 53.5 million (SEK 33.8 million), which resulted in an improvement in the gross margin by 6.9 percentage points and mounted to 77.5 percent (70.6 percent), as a result of the increased net sales in relation to fixes costs.

Financial targets and dividend policy

Devyser’s board of directors has adopted the following financial targets and dividend policy:

• Growth: Devyser's goal is to achieve an annual organic rate of growth in excess of 30 percent
• Gross margin: Devyser’s goal over the medium range (3 to 5 years) is to achieve a gross margin in excess of 80 percent
• Operating margin (EBIT): Devyser’s goal is to prioritize investments in the organization in order to support growth and, over the medium range (3 to 5 years), to achieve an operating margin (EBIT margin) in excess of 20 percent
• Dividend policy: Devyser is in an expansion phase and therefore will prioritize growth over dividends in the coming years. Taking into consideration the Company’s financial position, the Company’s long-term objective is to distribute between 30 percent and 50 percent of earnings after tax.

 
Advisers

Carnegie Investment Bank AB (publ) (”Carnegie”) acts as Sole Global Coordinator and Sole Bookrunner. Advokatfirman Hammarskiöld & Co AB is the legal adviser to Devyser. Wigge & Partners Advokat KB is the legal adviser to Carnegie. Redeye AB is the Certified Adviser to the Company.
 

For more information, please contact:

Fredrik Alpsten

CEO

Email: fredrik.alpsten@devyser.com

Tel: +46 706 673 106

Sabina Berlin

CFO

Email: sabina.berlin@devyser.com

Tel: +46 739 519 502

Important information

This announcement is not an offer to sell or a solicitation of any offer to buy any securities issued by Devyser Diagnostics AB (publ) (the “Company”) in any jurisdiction where such offer or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of such jurisdiction.

Any offering of the securities referred to in this announcement will be made by means of a prospectus. This announcement is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/ EC (and, with respect to the United Kingdom, such regulation as it forms part of the domestic law of the United Kingdom by virtue of the European Union (Withdrawal) Act 2018) (the “Prospectus Regulation”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

In any EEA member state other than Sweden, and in the United Kingdom, this communication is only addressed to and is only directed at qualified investors in that member state or the United Kingdom within the meaning of the Prospectus Regulation (as applicable), i.e., only to investors who can receive the offer without an approved prospectus in such EEA member state or in the United Kingdom.

This document and the information contained herein are not for distribution in or into the United States. This document does not constitute an offer to sell, or a solicitation of an offer to purchase, any securities in the United States. Any securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States.

In the United Kingdom, this document is only being distributed to and is only directed at (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (ii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons in (i) and (ii) above together being referred to as “relevant persons”). The Shares are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person must not act or rely on this document or any of its contents. Persons distributing this document must satisfy themselves that it is lawful to do so.

Matters discussed in this press release may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “will,” “may,” “continue”, “should”, “could” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond the Company’s control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.