Annual Report • Apr 16, 2019
Annual Report
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| Year in brief 3 | |
|---|---|
| Statement by the CEO4 | |
| About Bactiguard6 | |
| Healthcare associated infections8 | |
| The technology10 | |
| BIP products 12 | |
| Market overview14 | |
| License business16 | |
| Clinical studies and research 18 | |
| The patient in focus19 | |
| Our employees20 | |
| Sustainability 23 |
| Board of Directors' report 25 | |
|---|---|
| Corporate Governance report31 | |
| Group management34 | |
| Board of Directors36 | |
| Financial information 38 | |
| Notes45 | |
| Auditor's report 64 | |
| Glossary and references67 |
| 163.2 MSEK | ||
|---|---|---|
| 22.2 MSEK | ||
| 14% | ||
| 587.5 MSEK | ||
| 63% | ||
| -0.45 MSEK | ||
Orthopaedic trauma implants with Bactiguard's coating have been CE marked and can now be sold. It is a major breakthrough that opens up for new license business. Page 17
Bactiguard accelerates its ambitions in China through a combined distribution and license agreement with Well Lead Medical at an initial value of more than SEK 30 million. Page 15

Bactiguard received Sweden's most important labour market award, which is awarded to companies who lead the way by creating opportunities for people with disabilities. Page 21
With its 50 percent women in the management team and two female board members, Bactiguard advanced during 2018 on Allbright's list of the most equal listed Swedish companies on Nasdaq Stockholm. Page 22
Bactiguard has initiated a collaboration with Mediplast in the Nordics and the Benelux countries aiming to adress more markets more efficiently. Page 15
Bactiguard has entered a new partnership with Asid Bonz GmbH through an exclusive distribution agreement for Germany, including all products in Bactiguard's portfolio. Page 15
Bactiguard's Foley catheters have been approved for sale in Egypt This opens new opportunities in the most populous country in the region. Page 15

Bactiguard won its first Swedish tender for central venous catheters (CVC), covering the Skåne region. Our urinary catheters are today procured through tenders covering approx. 70 % of the Swedish population. Page 4
Statement by the CEO
2018 was an exciting and eventful year for Bactiguard as we reached several important milestones. I particularly want to highlight the strong growth in sales of our own product portfolio for infection control (BIP portfolio), the distribution and license agreement with Well Lead for China and the CE mark for orthopaedic trauma implants, which broadens the applications for Bactiguard's technology.
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Our primary focus in 2018 was to generate growth through increased sales of the BIP portfolio and by new license agreements, which we succeeded in.
Healthcare associated infections is one of the most common causes of death in the Western world and leads to four deaths every day in Sweden alone. This is serious as increasing antibiotic resistance makes the infections more difficult to treat. In Agenda 2030 for Sustainable Development, preventing antibiotic resistance is an important part of the work against global health threats. Therefore, it is encouraging that sales of the BIP portfolio almost doubled. It reflects that the need for infection prevention is increasing in healthcare and that our technology is gaining ground across the world, not least in China. In addition to increased sales of our catheters for infection control, the agreement with Well Lead (one of the world's largest catheter manufacturers) means that we have established a new
license business. In a few years' time, we will thereby broaden the product range in the Chinese market to include our entire product portfolio, which will generate new license revenues.
The CE mark for orthopaedic trauma implants, which was secured in December 2018, is a breakthrough for Bactiguard. We already have a product portfolio that prevents infections in the urinary tract, the respiratory tract and in the blood stream. Now we take another big step. This is the first time our technology has been approved for use on metal implants intended to stay in the patient's body for many months, up to several years and sometimes lifelong.
This clearly shows that the technology is safe for patients. At the same time, it opens the door to the global market for trauma implants, with an annual turnover exceeding USD 5 billion and therefore an important growth area for us. Our current

license agreement with Vigilenz is limited to Southeast Asia. Our highest
priority is therefore to establish new license deals in this application area, covering the major global markets.
BIP sales were strongest in China and we delivered products at a value of just over SEK 20 million in 2018. This is more than a doubling compared to the year before. India and Europe, primarily Germany and Sweden, also generated growth. Through our partnership with Mediplast, we expect to gain greater leverage from the Swedish tenders we have won and faster growth in the other Nordic and Benelux countries. The Middle East experienced an interim year, mainly due to delayed product registrations which are now in place.
The license business with our largest customer BD is stable and the agreement with Well Lead generated new license revenues, although not in line with the new license revenues in 2017.
Earnings and margins were lower than the year before despite the strong growth in BIP sales. This is primarly because we took considerable costs to terminate the previous distribution agreement for China and made write-downs of accounts
receivable in Iraq. The decision to change partner
in China is strategically right and will strengthen our long-term profitability.
The disposal of accounts receivable also affected earnings but provides a positive cash flow in early 2019. If we adjust for one-off costs, the EBITDA margin was at par with 2017.
Finally, I want to share how proud and happy I am that Bactiguard was acknowledged as one of the most equal listed Swedish companies and received the "Visa vägen" award as Employer of the Year 2018. It is evident that our work with sustainability and an inclusive leadership contribute to us as a company, our employees and the society at large.
In 2018 we reached several important milestones. We now look forward to an equally exciting and eventful 2019, with even greater leverage from our technology and the investments that lie behind us. As we develop our business we increase patient safety, prevent suffering and save more lives and thereby contribute to a more sustainable development.
Bactiguard is a Swedish medical device company with a mission to increase patient safety and save lives. To achieve this mission, we develop and supply infection preventive solutions which reduce the risk of healthcare associated infections and the use of antibiotics. This, in turn, contributes to a more sustainable development through reduced spread of antibiotic resistance.
With Bactiguard's infection prevention solutions we increase patient safety and reduce suffering. At the same time hospital stays are shortened which save significant resources and costs for the healthcare systems and society at large.
The Bactiguard technology prevents bacterial adhesion and biofilm formation on medical devices. The technology is offered through license agreements with other medical device manufacturers and our proprietary BIP (Bactiguard Infection Protection) portfolio of products. Through our license partner BD (following their acquisition of C.R. Bard), urinary catheters with Bactiguard's coating are market leading in the USA and Japan. Bactiguard's own product portfolio of urinary catheters, central venous catheters and endotracheal tubes prevent some of the most common infections, which appear in the urinary tract, the blood stream and the respiratory tract.
Bactiguard is in a strong expansion phase in Europe, China, India and the Middle East as well as by establishing license agreements in new therapeutic areas. The company has some 70 employees around the world. The headquarters and one of two production sites are located in Stockholm, the other one in Malaysia. Bactiguard is listed on Nasdaq Stockholm since 2014.



We do this by developing and providing infection prevention solutions that reduce the risk of healthcare associated infections.

Our vision is to eliminate healthcare associated infections to:

Everything we do in our daily operations is permeated by:
…and is embraced by empathy, respect and communication.
Healthcare associated infections, HAIs, are a major global problem and a threat to public health. According to the World Health Organization, WHO, on average every tenth patient seeking care is afflicted by a HAI, and HAI is today the third most common cause of death in developed countries.1
Healthcare associated infections, also known as nosocomial infections, are acquired by patients seeking healthcare. In addition to unnecessary suffering and longer hospital stays these infections also entail higher costs and resource allocation for healthcare, and many patients die.2
The OECD published a report in 2017 which emphasised that the costs for infection prevention are much lower than the costs associated with the occurrence of a HAI.3
Over half of all healthcare associated infections are caused by bacterial growth on medical devices. The urinary tract, respiratory tract and bloodstream are three of the most common areas where HAIs arise. Many HAIs require treatment with antibiotics, which means they also contribute to increased antibiotic resistance.4
In Sweden almost 65,000 patients are afflicted every year, which results in approximately 750,000 extra days for care at a cost of SEK 6.5 billion. Approximately 1500 patients die every year in conjunction with HAI, meaning four patients a day.2
Preventing HAIs has never been more important. Every infection prevented, is an antibiotic treatment avoided.
WORLD HEALTH ORGANIZATION (WHO)1
1 in every 10 patients is affected by healthcare associated infections worldwide1
According to WHO, if the current development continues, by 2050, 10 million lives are at risk every year due to antibiotic resistance. This can be compared to about 8 million people dying of cancer every year.5
To reduce the problem of antibiotic resistance, it is important that antibiotics are only prescribed when necessary, as the use itself leads to increased resistance. The resistance makes common infections such as tonsillitis and ear infections very hard to treat, even resulting in death.6 The same applies to common surgical procedures and cancer treatments that rely on antibiotics to complement the patient's own immune system.

Mutations that change bacteria arise all the time. Some of the changes lead to the bacteria becoming resistant to antibiotics.
Antibiotics kill both harmful bacteria that cause diseases and bacteria that protect the body — but not resistant bacteria. The strongest bacteria survive due to natural selection.
The new generation consists entirely of resistant bacteria. The conditions are ideal for antibiotic-resistant bacteria to take over and grow.
Sepsis, former known as blood poisoning, is the life-threatening condition that arises when the body's response to infection results in organ dysfunction or failure.7 Late diagnosis and antibiotic resistance make it increasingly difficult to treat bacterial infections and to prevent them from developing into sepsis.
An estimated 50% of all cases of sepsis can be attributed to healthcare associated infections.8 Consequently, preventing HAIs is imperative in reducing the occurrence of sepsis.

Bactiguard is a proud sponsor of World Sepsis Day
Bacteria and other microbes easily attach to the surface of medical devices, for example catheters, and this often leads to the development of biofilm. When they disperse, the risk for infection increases. Microbes that form biofilm are also more resistant to antibiotics and the patient's immune system, than those that do not produce biofilm.

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The galvanic effect creates a micro current that reduces microbial adhesion to the catheter material, which decreases the risk for biofilm formation leading to infections. A few hoursA few hoursA few seconds
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To date approx.170 million catheters have been used without any reported side effects related to the coating. The technology has been shown to be both tissue-friendly and safe for the patient, and effective in reducing microbial adhesion and subsequent infections.
Bactiguard's patented technology is protected by a trinity.
Patent – The current patent is in force in the U.S. until 2029 and until 2027 in other countries. It comprises a combination of noble metals deposited on the surface of a product, the application process and most of the medical devices on which the technology can be applied.
Know-how – Both process know-how and pre-treatment tailored to the base material are called for to ensure that the coating attaches to the underlying material and has the desired effect.
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Trade secrets – Trade secrets supplement both the patent and process know-how, and the formula is a valuable and well-safeguarded asset.
The BIP portfolio, Bactiguard Infection Protection, consists of urinary catheters, endotracheal tubes and central venous catheters with Bactiguard's coating, which reduce the risk of infections in the urinary tract, respiratory tract and bloodstream. Most of all healthcare associated infections affect these three areas, and medical devices are often the cause.
BIP Foley Catheters are suitable for patients who need a catheter for more than 2 days, for example intensive care or surgery patients, or for patients who require a permanent catheter. Catheters with Bactiguard's coating have shown a significant reduction in catheter associated urinary tract infections (CAUTI) and antibiotic treatments.
Bactiguard is the market leader in coated urinary catheters through the company's own sales and its license partner BD (C.R. Bard). Since the product was launched in 1995, more than 170 million catheters have been used for patients all over the world.

BIP Foley Catheter – Silicone BIP ETT Evac BIP Foley Catheter
infections (CAUTI) constitute the most frequently occurring type of infection, estimated to represent 30% of all HAIs.4 They are often caused by indwelling urinary catheters and can lead to serious complications that cause suffering for the patient, higher mortality rate and increased healthcare costs.
BIP ETT reduces the risk of VAP since fewer bacteria colonize the in- and outside of the tube. BIP ETT Evac offers twice the protection, in part through subglottic secretion drainage (SSD) and in part through the coating's effect. A clinical study with 100 patients concluded that BIP ETT reduced the occurrence of VAP by 67%.9
Usage of endotracheal tubes with SSD has become increasingly common since they significantly reduce the risk of VAP. Bactiguard is the only company that can offer twice the protection through this feature and in addition, the coating.

(VAP) is a very serious respiratory tract infection that can afflict patients treated with endotracheal tubes. It is most common in intensive care, and it is estimated to afflict up to 25% of patients.4,12,13 VAP prolongs hospital stay by up to 25 days, and the mortality rate that can be directly linked to VAP is as high as 30–50%.14,15
– Infection prevention central venous catheter BIP CVC has been shown to reduce CRBSI by up to 52%.10 Another common complication is thrombosis, where Bactiguards coating can be favourable for outcome. Compared to central venous catheters that are uncoated as well as with competitive coatings, BIP CVCs have better blood compatibility and entail lower risk of thrombosis.11
Central venous catheters with infection prevention properties are an established treatment method in many parts of the world, and several different coatings are available on the market. BIP CVC is both effective against infections, while having a very good blood and tissue compatibility.

infections (CRBSI) constitute one of the most common, expensive and most fatal complications associated with central venous catheters. According to WHO, treatment can cost up to USD 56,000. The Centre for Disease Control estimates that 12–25 % all patients who are afflicted by CRBSI die from the condition.16
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All BIP products are associated with lower total healthcare costs thanks to fewer complications and thus shorter hospital stays, lower treatment costs and improved quality of life for patients.17,18

| standard product |
BIP Foley Catheter |
||
|---|---|---|---|
| Number of patients | 200 000 | 200 000 | |
| Number of patients with infection | 21 000 | 13 650 | 35% less |
| Costs | |||
| Product costs (SEK) | 5 000 000 | 20 000 000 +15 MSEK | |
| Treatment costs (SEK) | 200 000 000 | 130 000 000 -70 MSEK | |
| Cost savings (SEK) | 55 MSEK |
Assumptions:
• Incidence infection: 10 %
• Incidence sepsis: 0.5 %
• 35% less infections with BIP Foley Catheter
• Treatment costs per infection19: 5 000 SEK
• Treatment costs per case of sepsis19: 100 000 SEK
Market overview
In 2018, sales of BIP products increased by almost 90 percent, mainly due to the development in China where we more than doubled sales and India where it tripled. Also, Europe and South America generated growth, while the Middle East had a decline after a strong year in 2017.
2018 was a very strong year for Bactiguard in China. We more than doubled sales compared to 2017, and also signed a strategically important agreement with Well Lead for both distribution and license. The Chinese market for healthcare products and medical devices has undergone major changes in recent years. Among other things, locally produced products are favoured more than before and the authorities have introduced new regulations to reduce the number of intermediaries in the distribution chain. Against this background, Bactiguard decided to take steps towards a more locally anchored product portfolio by entering into a deeper and broader collaboration with a Chinese company that has both distribution and manufacturing capacity. The agreement with Well Lead, one of the world's leading manufacturers of medical devices, covers all Bactiguard's products.
Also, Europe showed growth in 2018, where focus lies on establishing ourselves in the larger countries in the region. Our new partner in Germany is preparing a major launch in 2019, and we are working intensively to expand our presence with strong partners in other strategically important markets. For the Nordic and Benelux countries, we have initiated a collaboration with Mediplast with the aim of more efficiently addressing tender regions in Sweden and gaining access to completely new markets such as Denmark and Norway.
Greece is often referred to as a terrifying example of antibiotic resistance. One focus for the authorities is to reduce blood stream infections, and our BIP CVC is used in
several hospitals. In Poland and Austria, patients themselves buy our urinary catheters for long-term use to avoid common problems related to bacterial colonization.
Sales in India picked up during 2018, thanks to the collaboration with our new partner, whose overall focus on intensive care and critically ill patients gives us good access to the hospitals. Since all our products are now approved for use in the country, we have a leverage effect on sales, as a broader concept of infection prevention can be presented. A large, randomized multi-center study with BIP Foley Catheter was completed during the year, and the results will be published in 2019.
After a strong 2017 with doubled growth, the Middle East generated somewhat weaker overall sales in 2018. Large markets such as Saudi Arabia and Pakistan showed growth but political challenges as well as the registration process in Egypt where timelines extended, brought down the results for the region. We see positive developments in 2019 when a recovery is expected.
Brazil is the largest market in South America and one of the most populous countries in the world with over 200 million inhabitants. Unfortunately, the launch that took place during the second half of 2017 did not meet our expectations because of long lead times and regulatory processes. In 2018, an agreement was signed with a distributor for Mexico and the market introduction has begun.
The Bactiguard technology is suitable within many different application areas where there is a need for infection prevention and tissue-friendly properties. We therefore continuously explore new collaborations where our technology can increase patient benefits and hence the value of the underlying products. Two significant news during 2018 was that Bactiguard-coated trauma implants received CE mark, and an extensive license collaboration with Well Lead was initiated for China.

The CE mark for orthopedic trauma implants that was completed in December 2018 is a major breakthrough for Bactiguard. We already have a product portfolio that prevents infections in the urinary tract, the respiratory tract and in the bloodstream. The new partnership with Well Lead covers the entire portfolio and was another important milestone.
Since 1995, Bactiguard has a successful licensing agreement with the global medical device company C.R. Bard. BD acquired C.R. Bard in 2017 partly to be stronger within infection prevention. BD is now the market leader in USA and Japan with Bactiguard coated Foley catheters under the brands Bardex IC and Lubrisil IC.
Since 2015 Bactiguard collaborates with Vigilenz Medical Devices within orthopaedic trauma implants for Southeast Asia. The implants with Bactiguard's coating received CE mark at the end of 2018 and can now be sold and used in markets
that accept EU's CE mark. Healthcare associated infections are frequent and severe for complicated bone fractures, and clinical studies are ongoing.
With the new CE mark as a precedent, Bactiguard intends to establish new partnerships and enter new agreements with one or more major trauma implant manufacturers covering the rest of the world.
The collaboration with Swedish Smartwise began in 2017. Advanced injection systems allow medication and other types of treatment to be delivered directly to damaged tissue in vital organs, for example after a stroke or a heart attack.
Bactiguard's coating can reduce the risk of infections and thrombosis for these seriously ill patients.
During spring 2018, Smartwise entered a collaboration agreement with AstraZeneca, a major breakthrough. The catheters are currently in preclinical development.
Well Lead is today China's largest and at the same time one of the world's leading manufacturer of medical devices, such as urinary catheters and endotracheal tubes. Since 2018 Well Lead has the exclusive right to sell and distribute Bactiguard's urinary catheters (BIP Foley) in China. At the same time, the process of obtaining product approval for locally-produced urinary catheters, central venous catheters and endotracheal tubes with Bactiguard's coating has been initiated. This means that, in a few years' time, Well Lead will manufacture and sell all products in Bactiguard's portfolio on the Chinese market.
The Bactiguard technology can be applied to most materials used for medical devices. The coating is very thin and therefore not visible to the naked eye. This also means that other properties of the medical device, such as thickness, shape and size are not affected.
The production process is adaptable for new applications and can easily be scaled up. New materials are always tested since
every material has a unique surface composition. Bactiguard has successfully applied the coating to several types of titanium, stainless steel, latex,
silicone, polymers, ceramics and non-woven materials. Process validation is based on welldefined steps to enable repetition and reproducibility.
There are no specific packaging requirements for Bactiguard coated products, which can be sterilised using standardised methods. Nor are there any specific requirements for handling procedures or waste management.
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Clinical studies and research
Bactiguard's products have a substantial impact on the lives and health of human beings, therefore we conduct clinical studies on an ongoing basis in both Sweden and abroad, and in cooperation with physicians, nurses and other healthcare professionals. All studies are designed according to international and local laws, regulations and ethical principles. They are reviewed and approved by ethical committees and relevant authorities. The purpose of the clinical studies is primarily to assess the technology efficacy of preventing infections, and its safety profile.
Bactiguard collaborates with academia, healthcare institutions, organisations and companies to promote the development of new and improved products which will help reduce the number of healthcare associated infections. At the same time, collaboration is a way to partially fund research and product development. Bactiguard belongs to several scientific networks which have received funding from the EU and Sweden, primarily through Vinnova and Medtech4Health.
In this project, which has received funding from Vinnova/Eurostars (Horizon 2020), Bactiguard is developing a new generation of venous catheters which reduce the risk of both infections and thrombosis – two of the most serious complications associated with using venous catheters. The project began by developing a new generation of central venous catheters and is now focusing on haemodialysis catheters and vascular transplants/grafts. The project was launched in 2015 and will be concluded during 2019.
Together with Professor Dan Andersson's research team at Uppsala University, Bactiguard received a grant from MedTech4Health/Vinnova for a six-month project during 2017–2018. The purpose was to survey bacteria and determine which characteristics are most and least significant in terms of their ability to attach to and multiply on products with Bactiguard's coating. The collaboration at Uppsala Antibiotic Center has received further funding.
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Life changed dramatically that day in January, when Elisabeth* suffered a stroke that left her in a wheelchair. Being confined to a wheelchair meant Elisabeth needed a urinary catheter permanently. This led to repeated urinary tract infections and constant rounds of antibiotics.
– Every time I got a new catheter, I fell ill within the space of a week. The chronic urinary tract infections made me feel ill and generally down, she says with a sigh.
The recurrent urinary tract infections and the large consumption of antibiotics resulted in Elisabeth developing antimicrobial resistance, which is when bacteria no longer respond to treatment. This meant that the countless urinary tract infections could no longer be treated with antibiotics. Around two years ago,
Elisabeth's urotherapist at the Central Hospital in Karlstad, Sweden, told her about Bactiguard's BIP Foley Catheters.
The results exceeded all expectations for Elisabeth. She didn't have any urinary tract infections for two years. Elisabeth feels that everyone should be offered a Bactiguard catheter from the very start and stresses that the healthcare sector should give greater consideration to patient wellbeing when deciding which catheter to procure.
Since the risk of infection increases with duration of catheterization, CAUTI is a large health burden for patients with neurogenic bladder dysfunction who use indwelling catheters permanently. These patients suffer from voiding dysfunction due to a brain-, spinal cord-, or other nerve conditions, caused by e.g. stroke, spinal cord injury, multiple sclerosis or birth defects.
We met Elisabeth a few years ago through her nurse and have documented her case in a clinical study that will be published during 2019.
While Elisabeth was using her previous catheters, she experienced urinary tract infections that requiried antibiotics almost every month for four years. After one month with BIP Foley Catheter, the symptoms disappeared, and she remained free of infections and subsequent antibiotic treatment for 2.5 years.
If it is as good for others as it has been for me, more patients should be offered the opportunity to use this catheter to avoid pain and discomfort. It would be a win/win situation, both for patients who would avoid unnecessary suffering and the healthcare sector that can reduce its costs for difficult to treat, chronic infections. ELISABETH
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Our employees are Bactiguard's most important asset. Thanks to them the company is innovative, entrepreneurial and diverse.
Bactiguard currently has some 70 employees, most of whom work at our headquarters in Sweden and at the production facility in Malaysia, but we also have employees closer to the market, in other European countries, China, India, the Middle East and Latin America.
We work together to achieve our objectives and thus create a work environment where employees experience job satisfaction and commitment. We strive to utilize our employees' individual competencies, which span several different areas such as product and business development, production, clinical studies, marketing and sales.
Together we work to prevent healthcare associated infections and save lives.

Bactiguard was during 2018 awarded "Employer of the Year" by the collaboration partner Samhall. The prize, referred to as Sweden's most important labour market prize, is awarded to companies and individuals who lead the way in the labour market by opening opportunities for people with disabilities.
The winner of Samhall's "Visa vägen" prize was announced at a prize ceremony in Stockholm in the presence of H.R.H Princess Sofia. Bactiguard was awarded Employer of the Year for its efforts in creating opportunities and breaking the exclusion in the labour market for people with disabilities.

Hanna Stjärne, CEO SVT, Joanna Halvardsson, H.R.H Princess Sofia, Christian Kinch, CEO Bactiguard.
Winning the prize as Employer of the Year in Sweden is fantastic. The diversity and competencies of Samhall's employees help us grow and become stronger in the fight against healthcare associated infections. CHRISTIAN KINCH, CEO
"This year's Employer sees diversity as a cornerstone of its business concept. There is an uncompromising belief in the individual's ability to provide the company with a skill boost through his or her competencies. This year's Employer creates a team of different talents and succeeds in running a spearhead company in its industry, capable of competing internationally and at the same time securing jobs in Sweden. A striking evidence that diversity gives multiplicity in reward."
AllBright is a non-political and non-profit foundation that works in favour of gender equality and diversification in leading positions in business. The Foundation continuously reviews business leaders and boards to highlight the issue of representation.
Bactiguard climbs on Allbright's green list, listing the most equal public companies in Sweden. With 50 percent women in the management team and two female board members, Bactiguard advanced from position 29 (2017) to 21 among the 329 listed companies.
AllBright annually ranks the companies on the Stockholm Stock Exchange, from an equality perspective. The most equal companies are found on their "green list", while the less equal are placed on the "yellow list" and the male-dominated companies on the "red list". Bactiguard advanced several positions this year to place 21 (29) on the list which includes all listed companies. In Bactiguard there is a wide variety of
different nationalities and languages, with employees from 17 different countries, of which 60 percent are women and 40 percent men. In the executive management team, there are as many women as men and two out of five board members are female. Since October 2018, the chairman of the Nomination Committee is also a woman.
Bactiguard values good health by preventing infections and promoting a healthy lifestyle. Since 2012, Bactiguard has sponsored Team Bactiguard through the Good to Great Tennis Academy, which was founded by former elite players Magnus

Norman, Nicklas Kulti and Mikael Tillström. The opportunity to support some of the world's best tennis players from an early age while inspiring other young people to focus on health and sport is Bactiguard's goal for this unique venture on Swedish tennis.
Bactiguard supports its own team of promising young players and Team Bactiguard, currently consists of: Måns Dahlberg, Isac Strömberg, Arslan Temirhanov, Tsegai Gebremeskel and Henrik Bladelius. Team Bactiguard enables the players to practise tennis full time in parallel with their studies, and to play and compete in a worldclass environment both in Sweden and internationally.
Sweden's highest ranked tennis players, the Ymer brothers Elias and Mikael, were both part of the very first Team Bactiguard, which strongly has contributed to their success.
Bactiguard's mission is to prevent healthcare associated infections and antibiotic resistance, one of the greatest health threats and challenges of our time. This is our primary contribution to a sustainable future, in line with the goals of Agenda 2030.
Bactiguard aims to be a reliable, long term partner which inspires confidence and delivers high-quality and safe products. The purpose of our sustainability work is primarily to contribute to a positive social development by preventing infections and limiting the spread of multi-resistant bacteria - while minimizing the business burden on society and increasing the value for patients, customers and shareholders.
Our code of conduct comprises the entire value chain, including our internal work and cooperation with external partners and includes guidelines for how our employees are to conduct day-to-day operations in a manner that is ethically, socially and environmentally sustainable. Together with compliance to laws and regulations, it ensures that the company behaves in a responsible manner towards patients, employees, customers, suppliers, shareholders and other stakeholders.
Assuring patient benefit, including safety and quality aspects, is an integral part of our product development and product
supply processes. Our quality management system and its processes comprise all the phases of the products' life cycles and also supports ongoing improvements of our products and business. Bactiguard's quality management system is certified in accordance with the standard for medical devices, ISO 13485.
Within the framework of our overall sustainability work, we involve secure management and handling of chemicals and waste within product development and production. Bactiguard aims to continue reducing the impact that our operations and products have on the environment by increasing efficiency, reducing consumption of materials and improving waste management.
Bactiguard's coating contains very small amounts of noble metals and requires no special procedures for disposal. The metals in the coating are not destroyed during waste incineration but are collected in the combustion plant's filters.
The company encourages meetings to be conducted with tele or web conferencing to reduce the amount of business travel.
Bactiguard's environmental management system is based on ISO 14001 to ensure that the company adheres to existing environmental laws and requirements and that satisfactory performance reviews are performed.
Financial reporting
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The Board of Directors and Chief Executive Officer of Bactiguard Holding AB (publ) hereby present their annual report and consolidated financial statements for the 2018 financial year.
Bactiguard is a Swedish medtech company with a global presence. The company offers an infection prevention solution that prevents healthcare associated infections caused by medical devices. By preventing infections, the company contributes to reduced usage of antibiotics and consequently the spread of multi-resistant bacteria, which is a growing problem for society worldwide. Bactiguard saves lives, shortens the duration of treatment, increases patient safety and thereby results in significant cost savings for healthcare and society.
Operations are primarily in Sweden and Malaysia and include research and development, production, marketing, and sales.
Bactiguard's product portfolio, Bactiguard Infection Protection (BIP) covers medical devices within three application areas; the urinary tract, the blood stream and the respiratory tract.
Bactiguard has ISO 13485 certification, and EC certification for the BIP Foley Catheter (indwelling urinary catheters), BIP ETT (endotracheal tube) and BIP CVC (central venous catheters) product portfolios.
The Group includes Bactiguard Holding AB and its whollyowned subsidiary Bactiguard AB which in turn owns subsidiaries. All operative activities were conducted in the Group of Bactiguard AB in the year.
Bactiguard has the following revenue streams:
• License revenues are revenues from sales of products through licensing agreements. In 2018 these revenues came from: the Group's licensing agreement with Becton Dickinson and Company ('BD', previously C.R. Bard) for Foley Catheters for the USA, Japan, the UK, Ireland, Canada and Australia; the licensing agreement with Vigilenz Medical Devices for orthopaedic trauma implants for the South East Asian ASEAN region; a global licensing agreement with Smartwise Sweden AB ('Smartwise') for vascular injection catheters; and a licensing agreement with Well Lead Medical ('Well Lead') for all products in Bactiguard's product portfolio for the Chinese market, all with the Bactiguard coating.
• The sale of BIP products relates to BIP Foley Catheters, BIP ETT and BIP CVC, under their own brand.
• Other revenues mostly comprise exchange rate differences and other operating revenues, for example, grants for development projects.
Group revenues for the full-year were MSEK 163.2 (153.6). License revenues from BD accounted for the highest proportion of revenues at around MSEK 101.2 (104.3). The reduction is due to slightly lower volumes at the beginning of the year. Although the underlying business is stable, the volumes vary across the quarters and do not follow any clear seasonal pattern.
In June 2018 a new licensing deal was signed with Well Lead for China, which is one of the world's largest manufacturers of urinary catheters. This deal generated license revenues of MSEK 8.3 during the year. This can be compared with new license revenues of MSEK 21.4 that were generated from the licensing agreement with Smartwise.
The increase in total revenues is mostly due to the sale of BIP products. In 2018 BIP products were sold at a value of MSEK 40.6 (21.8). China accounted for a significant proportion of this sales increase. Sales in the other regions also increased in 2018, except for the Middle East. This growth combined with the increase in value for the product mix resulted in revenues from BIP sales increasing by 86%.
Other revenues increased during the year, mostly as a result of positive currency effects.
For the full-year, EBITDA, operating profit before depreciation, totalled MSEK 22.2 (34.4), with an EBITDA margin of 14% (22%). This change from the previous year is mostly due to new license revenues being MSEK 13.1 higher in 2017, while other external costs increased, partly as a result of non-recurrent costs in 2018.
The significant increase in BIP revenues in 2018 had a positive impact on the profit. Investments were also made in marketing and staff within the sales team to help fuel the expansion, which increased other external costs and personnel costs by approximately MSEK 5 compared with the previous year.
A new agreement was signed with Well Lead for China, which meant that the contract with the previous distributor (Jian AN) had to be terminated early. There were non-recurrent costs associated with the early termination of this agreement, which included remuneration for the investments Jian AN had made in marketing, the product approval process in China and the re-purchase of products. In total these nonrecurrent cost negatively impacted EBITDA by MSEK 11.5.
At the start of 2019 Bactiguard transferred its distribution in Iraq and accounts receivable to a European distributor. The difference between the sale proceeds and the book value amounted to MSEK 4.3, resulting in impairment that affected the profit for 2018. The sale proceeds will generate a positive cash flow in the beginning of 2019.
Operating profit totalled MSEK -12.0 (-0.6). Depreciation, which is a non-cash item, affected operating profit by MSEK -34.2 (-35.0).
Profit from financial items amounted to MSEK -8.7 (-7.7). Interest on bank loans and changes in the value of forward contracts had a negative impact on financial items during the year.
Consolidated net profit for the full-year 2018 was MSEK -14.9 (-3.3).
The equity ratio for the Group was 63% (62%) and shareholders' equity totalled MSEK 370.8 (387.1).
Cash and cash equivalents for the Group totalled MSEK 1.9, which was a decrease of MSEK 9.7 compared to the previous year. Net debt totalled MSEK 155.8 (152.4).
Total assets for the Group were MSEK 587.5 (625.4). The largest asset items in the balance sheet refer to goodwill of MSEK 226.3 (226.3) and technology relating to Bactiguard's product portfolio, which amounted to MSEK 189.0 (212.8).
Interest-bearing liabilities comprise a financial lease liability of MSEK 10.9 and a bank loan of MSEK 142.5 with a duration of three years to December 2020. The facility is subject to the customary covenants. The loan runs at an interest base of Stibor 90, but with a minimum of 0% and an interest surcharge of 3.0%.
— 25 —
| An overview of the Group's financial performance MSEK |
1/1/2018 –31/12/2018 |
1/1/2017 –31/12/2017 |
1/1/2016 –31/12/2016 |
1/1/2015 –31/12/2015 |
1/1/2014 –31/12/2014 |
|---|---|---|---|---|---|
| Group | |||||
| Revenues | 163.2 | 153.6 | 128.3 | 138.5 | 98.3 |
| Net sales | 150.1 | 147.5 | 118.7 | 131.4 | 93.6 |
| EBITDA1 | 22.2 | 34.4 | 15.1 | 20.2 | -5.4 |
| EBITDA margin 2 , % |
14 | 22 | 12 | 15 | -5 |
| Operating profit/loss | -12.0 | -0.6 | -18.3 | -12.7 | -35.5 |
| Profit before tax | -20.7 | -8.3 | -31.3 | -31.0 | -115.8 |
| Profit after tax | -14.9 | -3.3 | -26.9 | -26.5 | -110.7 |
| Total assets | 587.5 | 625.4 | 632.1 | 676.2 | 811.1 |
| Operating cash flow3 | -4.9 | -0.1 | -19.8 | -32.5 | -54.0 |
| Earnings per share4 , SEK |
-0.45 | -0.10 | -0.81 | -0.80 | -4.43 |
| Operating cash flow per share5 , SEK |
-0.15 | 0.00 | -0.60 | -0.97 | -2.16 |
| Number of shares at period-end6 | 33,302,373 | 33,302,373 | 33,302,373 | 33,302,373 | 33,302,373 |
| Weighted average number of shares6 | 33,302,373 | 33,302,373 | 33,302,373 | 33,302,373 | 25,007,242 |
| Equity ratio, % | 63 | 62 | 62 | 62 | 55 |
| Net debt | 155.8 | 152.4 | 134.4 | 120.0 | 90.4 |
| Average number of employees | 66 | 66 | 57 | 65 | 58 |
The consolidated figures are stated in accordance with accounting policies stated in note 2.
1 Earnings before interest, taxes, depreciation and amortisation.
2 EBITDA/Revenues
3 Cash flow from operating activities after investments and changes in working capital
4 Earnings for the period/weighted average number of shares during the period, issue-adjusted
5 Operating cash flow/weighted average number of shares during the period, issue-adjusted 6 Adjusted for split
Investments in property, plant and equipment for the year totalled MSEK 0.7 (2.6) and are related to investments in ERP systems and improvement expenses for rented premises.
Investments in intangible assets totalled MSEK 5.0 (3.7) for the year and are primarily related to capitalised development expenditure.
No investments in financial assets took place during the year.
Operating cash flow (cash flow from operating activities after investments and changes in working capital) totalled MSEK -4.9 (-0.1). The cash flow from operating activities before changes in working capital was positive at MSEK 17.6 (28.5), but was impacted by a negative cash flow from working capital of MSEK -16.7 (-22.4). Working capital improved slightly compared with the previous year, which was partly due to measures to convert outstanding accounts receivable into cash flow. During the year the bank loan was amortised by a total of MSEK -7.5, which negatively impacted cash flow.
Total cash flow for 2018 was negative at MSEK -9.9 (-3.3).
The company presents certain financial measures in its annual report that have not been defined in line with IFRS (referred to as alternative key ratios as set forth in the ESMA guidelines). The company believes that these measures will provide valuable additional information to investors and the company's management as they facilitate the evaluation of the company's performance. As not all of the companies calculate financial measurements in the same way, these are
not always comparable with measurements used by other companies. These financial measures must therefore not be seen as a replacement for the measures that are defined in line with IFRS.
The definitions and tables below describe how the company's key ratios are calculated. Key ratios are alternative in line with ESMA guidelines unless otherwise stated.
Demonstrates the earnings capacity of the business from ongoing operations without any regard to capital structure and the tax situation. The key ratios are used to facilitate a comparison with other companies operating in the same industry. The company considers this key ratio as the most relevant performance measure as the company has a major asset item in Technology that generates a lot of depreciation while it is judged to be of significant value even after it has been fully depreciated. Bactiguard's patented and unique technology can be applied to an extensive range of products, both in the BIP portfolio and through license agreements.
The company defines EBITDA as operating income excluding depreciation and impairment of tangible and intangible assets.
| Group | ||||
|---|---|---|---|---|
| MSEK | 2018 | 2017 | ||
| Operating profit/loss | -12.0 | -0.6 | ||
| Depreciation | 34.2 | 35.0 | ||
| EBITDA | 22.2 | 34.4 |
Demonstrates the earning capability of the business from ongoing operations without any regard to capital structure and the tax situation, in relation to the company's revenue. Key ratios are used to facilitate performance monitoring and comparisons with comparable companies.
| MSEK | Group | ||
|---|---|---|---|
| 2018 | 2017 | ||
| EBITDA | 22,2 | 34,4 | |
| Revenues | 163,2 | 153,6 | |
| EBITDA margin | 14% | 22% |
Net debt is a measure used to describe the Group's indebtedness and its ability to repay liabilities with liquid funds generated from the Group's ongoing operations if the liabilities were due today. The company considers this key ratio to be of interest for creditors who are looking to understand the group's debt situation.
The company defines net indebtedness as interest-bearing liabilities less cash and cash equivalents at the end of the period.
Interest-bearing liabilities consist of liabilities to credit institutions, as well as the interest-bearing portion of other non-current and current liabilities.
| Group | |||
|---|---|---|---|
| MSEK | 2018 | 2017 | |
| Interest-bearing portion of other long-term liabilities | 10.9 | 12.5 | |
| Non-interest-bearing portion of other long-term liabilities |
- | - | |
| Other long-term liabilities | 10.9 | 12.5 | |
| Group | |||
| 2018 | 2017 | ||
| Interest-bearing portion of other short-term liabilities | 1.5 | 1.5 | |
| Non-interest-bearing portion of other short-term liabilities |
14.2 | 5.4 | |
| Other short-term liabilities | 15.7 | 6.9 | |
| Group | |||
| 2018 | 2017 | ||
| Liabilities to credit institutions | 145.2 | 150.0 | |
| Interest-bearing portion of other long-term liabilities | 10.9 | 12.5 | |
| Interest-bearing portion of other short-term liabilities | 1.5 | 1.5 | |
| Interest-bearing liabilities | 157.7 | 163.9 | |
| Cash and cash equivalents | -1.9 | -11.6 | |
| Net debt | 155.8 | 152.4 |
Equity is a measure that the company regards as important for creditors who are looking to understand the company's long-term ability to pay. The company defines equity ratio as equity and untaxed reserves (less deferred tax) in relation to the balance sheet total.
| Group | ||
|---|---|---|
| MSEK | 2018 | 2017 |
| Equity | 370.8 | 387.1 |
| Total assets | 587.5 | 625.4 |
| Equity ratio | 63% | 62% |
Cash flow from operating activities after investments and changes in working capital. Directly adjustable in relation to the financial statements.
Operating cash flow per share is operating cash flow in relation to the average number of shares outstanding. Key ratios regarding operating cash flow is presented as they are used by analysts and other stakeholders to evaluate the company.
Financial income minus financial expense. Directly adjustable in relation to the financial statements.
• During the year Bactiguard extended its product range. In Central Venous Catheters, BIP CVC sets with the popular Raulserson syringe for easier handling and insertion were launched. Within BIP Foley urinary catheters, Female was launched, which is adapted to a woman's anatomy, along with Tiemann, which facilitates the catheterisation of men.
• In June Bactiguard signed a combined distribution and licensing agreement with Well Lead Medical (Well Lead) for China, comprising all products in Bactiguard's portfolio. This agreement generated revenues of approximately MSEK 28 during the year, comprising around MSEK 20 from product deliveries and MSEK 8 from license revenues. At the same time, the partnership with the distributor Jian AN was terminated early, which meant that Bactiguard had to pay a compensation of MSEK 11.5 for the significant investments Jian AN had made in marketing, the product approval process and the re-purchase of inventories. Well Lead is currently China's biggest manufacturer of medical devices and one of the biggest in the world. This agreement gives Well Lead the exclusive right to sell and distribute Bactiguard's urinary catheters in China. A process was also started to secure approval for locally manufactured central venous catheters and endotracheal tubes, all featuring Bactiguard's infection prevention technology. In a few years' time Well Lead is expected to manufacture and sell all products on the Chinese market and generate license revenues for Bactiguard.
• During the year Bactiguard started partnerships with new distributors in Mexico and Germany.
• In May Bactiguard's licensing partner Smartwise Sweden AB signed a strategic partnership agreement with Astra-Zeneca for the development of advanced vascular injection catheters featuring Bactiguard's coating for new, innovative treatment methods for heart failure and cancer. Although this agreement will not generate any new license revenues for Bactiguard initially, it will generate royalty revenues when the catheters reach the market, which is expected in two to three years' time.
• At the Annual General Meeting in May 2018 Jan Ståhlberg was elected as a Board member and Chairman of Bactiguard Holding AB (publ). At the end of the financial year Jan Ståhlberg had a shareholding corresponding to 8.9% of the capital and 4.3% of the votes, making him the fourth largest shareholder in the company.
• Jonas Östregård was recruited to the new position of Vice President Sales; he has extensive sales experience from various positions within AstraZeneca.
• During the year Bactiguard won its first Swedish procurement of central venous catheters (CVC) in Region Skåne. Bactiguard also won a procurement for urinary catheters in Östergötland during the year and secured a one-year extension of the framework agreement for urinary catheters with Region Skåne.
• In September the shareholder base in Bactiguard was broadened, following a transaction comprising 6.6 million shares. This transaction involved the two main owners Christian Kinch and Thomas von Koch each selling
3,315,000 B shares at a rate of SEK 39 per share. The total value of this transaction amounted to MSEK 258.6. The total number of shares in the company amounts to 33,302,373 and the total number of votes stands at 69,302,373. Following this transaction, the two main owners each have shares corresponding to 18.4% of the capital and 34.8% of the votes in the company. Together they still control the majority of the votes.
• In December titanium orthopaedic trauma implants that feature Bactiguard's infection prevention technology were CE marked, which means that they can be sold and used in healthcare on markets that apply EU quality standards. Bactiguard intends to use this new CE mark to establish new partnerships and sign agreements with one or more major suppliers of trauma implants for other parts of the world. The global market for trauma implants is forecast to exceed MUSD 5 billion in 2019.20
• During the year Bactiguard set up an exclusive partnership with Mediplast for sales and distribution in Sweden, Norway and Denmark. Mediplast is a medical device company and supplier to healthcare throughout the Nordic Region. At the end of the year this partnership was expanded to cover Belgium, the Netherlands and Luxembourg, and Finland was also included from January 2019. This means that the partnership now comprises seven European countries.
• The product approval process for Bactiguard's urinary catheters for infection prevention in Egypt was completed in October.
• Bactiguard was awarded the 'Visa vägen' (Showing the Way) prize as Employer of the Year. This is considered to be the most important labour market prize in Sweden and is given to companies and pioneers that are showing the way on the labour market by creating opportunities for people with accessibility issues.
Preventative measures are high up on the agenda of the World Health Organization (WHO), World Economic Forum, health ministers in the G7 nations and governments worldwide. Increased awareness of the consequences of antibiotic resistance has resulted in greater demand for infection prevention solutions for healthcare, which also paves the way for Bactiguard's infection prevention
products and coating. Growth within this segment is managed by both a desire to reduce the number of healthcare associated infections and reduce the costs which can be related to these. This means that Bactiguard has good conditions to strengthen its position in existing markets and at the same time establish itself in new markets.
Company research and development activities are focused on developing new products, and increasing knowledge of the problem of healthcare associated infections. The main focus for product development during 2018 was to broaden the range of BIP Foley catheters, Female adapted to a woman's anatomy and Tiemann, which facilitates the catheterisation of men. In terms of knowledge about healthcare-related infections, the company has focused on completing a major clinical study with BIP Foley catheter in India during the year and to start a clinical study on BIP ETT Evac in Belgium. Work on a third-generation patent has also taken considerable resources during the year. Today 11 people are working within R&D in the company.
The Group engages in notifiable activities under the Swedish Environmental Code (environmentally hazardous activities and health protection) and to the Swedish Work Environment Authority (use of contagions in risk group 2).
The notifiable activities concern portions of the production process and the research and development the company conducts
The average number of employees in the Group for the year was 66 (66) employees.
The Board of Directors proposes that the 2019 AGM decides on the following guidelines for remuneration and other employment terms for senior management (unchanged compared to the decision of the 2018 AGM).
Senior management includes the CEO and other executives within Bactiguard, and the Board of Directors, to the extent they retain remuneration for assignments other than as directors.
Bactiguard shall have levels of remu-
neration and terms that are necessary in order to recruit and retain senior managers with the skills, competencies and experience required to achieve the company's operational targets. The total remuneration paid to senior managers shall be competitive, reasonable, and designed for this purpose.
Senior managers shall be offered a fixed salary that is competitive in market conditions and which shall be determined based on the individual's responsibilities and experience. Review of the fixed salary shall be made annually for each calendar year.
Senior managers may, from time to time, be offered variable remuneration that is adjusted to market conditions. Such variable remuneration shall be designed for the purpose of promoting long-term value creation in Bactiguard and be related to predetermined and measurable criteria. Any variable remuneration shall be limited to 50% of the fixed annual salary. In designing variable remuneration for senior managers that is paid in cash, the Board of Directors shall consider imposing reservations that (i) make payment of a portion of such remuneration conditional to that the performance to which earning such remuneration is based shall be sustainable over time (ii) provide the company the opportunity to recall any such remuneration that has been paid based on information that is later found to be obviously false.
Senior managers are entitled to retirement solutions that are adjusted to market conditions. Defined contribution retirement plans shall be preferred.
Other benefits may include access to company car, healthcare contribution and other common benefits. Other benefits may not constitute a significant portion of the total remuneration.
On termination of senior managers by the company, the notice period for such termination may not exceed 6 months. Any severance pay may not exceed the amount of a single year's fixed salary.
When the Board of Directors finds it appropriate, company senior managers shall also be offered participation in long-term share or share price-related incentive programmes that shall ensure long-term commitment to the development of the company. Determination of any such share or share price-related
| Total series A | Total series B | ||||
|---|---|---|---|---|---|
| Shareholders | shares | shares | Total shares | % of capital | % of votes |
| Christian Kinch with family and company | 2,000,000 | 4,125,977 | 6,125,977 | 18.4 | 34.8 |
| Thomas von Koch and company | 2,000,000 | 4,125,878 | 6,125,878 | 18.4 | 34.8 |
| Nordea Fonder | 3,158,095 | 3,158,095 | 9.5 | 4.6 | |
| Ståhlberg, Jan | 2,956,831 | 2,956,831 | 8.9 | 4.3 | |
| Fjärde AP Fonden | 2,853,000 | 2,853,000 | 8.6 | 4.1 | |
| Handelsbanken Fonder | 1,599,619 | 1,599,619 | 4.8 | 2.3 | |
| Försäkringsaktiebolaget, Avanza Pension | 1,040,213 | 1,040,213 | 3.1 | 1.5 | |
| Lancelot Asset Management AB | 600,000 | 600,000 | 1.8 | 0.9 | |
| Swedbank Försäkring | 542,790 | 542,790 | 1.6 | 0.8 | |
| Fröafall Invest AB | 502,000 | 502,000 | 1.5 | 0.7 | |
| Total, largest shareholders | 4,000,000 | 21,504,403 | 25,504,403 | 76.6 | 88.7 |
| Total, other | 7,797,970 | 7,797,970 | 23.4 | 11.3 | |
| Total number of shares | 4,000,000 | 29,302,373 | 33,302,373 | 100.0 | 100.0 |
incentive programme shall be made by the Board of Directors.
The Board of Directors will evaluate on an annual basis whether a long-term incentive programme should be proposed at the AGM or not, and if this is the case, whether the proposed longterm incentive programme should comprise transfer of shares in the company. These guidelines shall apply to agreements that are entered subsequent to the AGM, and to all changes made to existing agreements after that time. The Board of Directors shall be entitled to depart from the above guidelines when, in the assessment of the Board of Directors in a specific case, there are special reasons therefore.
Trade in the Bactiguard share was started at Nasdaq Stockholm with the ticker symbol "BACTI."
The closing price for listed B shares as per 31 December 2018 was SEK 40.20 with a market capitalisation of MSEK 1,339.
Share capital in Bactiguard as per 31 December 2018 was MSEK 0.8 allocated to 29,302,373 series B shares each carrying a single vote (29,302,373 votes) and 4,000,000 series A shares, each with ten votes (40,000,000 votes). The total number of shares and votes in Bactiguard as per 31 December 2018 was 33,302,373 shares and 69,302,373 votes.
For the company's series A shares the duty to give prior option of purchase applies in accordance with Section 15 of the articles of association, but for the rest there are no restrictions on transferability for these shares.
Bactiguard Holding's operations and profits are affected by several external factors. The company continually engages in a process of identifying all risks that may arise and assessing how each of these risks shall be managed. The company is primarily exposed to market related risks, operational related risks and financial risks. The risks Bactiguard is thus exposed to are addressed separately below.
Through its activities, the Group is exposed to various types of risk. Therefore the Group has a comprehensive risk management programme that concentrates on minimising potential unfavourable effects on financial results. The company's Board of Directors is ultimately responsible for the exposures, management and follow-up of the Group's risks. The frameworks that apply to the exposures, management, and follow-up of financial risks are set by the Board of Directors and revised annually. The Board of Directors has delegated responsibility for daily risk management to the company's CEO, who in turn has delegated this to the company's CFO. The Board of Directors is able to decide on temporary departures from these established frameworks.
Financial risks are described in note 4.
Weak economic performance and high national debt may cause both public and private customers to experience difficulty in obtaining financing. As well, this may have a negative impact on some countries' ability and political willingness to invest in and allocate public resources to healthcare. Bactiguard maintains market presence in many geographic markets for the purpose of minimising any country-specific portion of the combined macroeconomic risk.
As manufacturer of medical devices, Bactiguard's operations are subject to requirements and standards that are determined by regulatory authorities for each of the markets where Bactiguard is represented. Regulatory processes in various countries may cause a risk of delays in the launching process of products in these countries. Bactiguard works with its local distributors and regulatory advisors to minimise these risks.
There are technological advances in medical technology, which result in new products and improved treatment methods being launched continuously. Bactiguard has obtained patents in many of the countries in which the company operates in order to protect its technology, and has applied for patents in additional countries. Bactiguard has also taken several other measures to ensure that company-unique knowledge (such as application and manufacture of the Bactiguard coating) is not disclosed to any competitor.
Liquidity risk is defined as the risk of not having access to cash assets or credit available to cover payment commitments, including interest payments and amortisation. Liquidity risk is especially significant in the event large unanticipated payment commitments arise. Lack of liquidity to cover large payment commitments can have a negative impact on Bactiguard's operations and its financial position. As per 31 December 2018, the Group has liquidity amounting to MSEK 28, including approved bank overdraft facilities of MSEK 30. The liquidity risk is monitored on a monthly basis through rolling forecasts of 3 months
— 29 —
which evaluate the liquidity situation and is the base of taking relevant measures (financial or operational).
The management deems that current liquidity levels will be sufficient to manage the company's commitments for the coming year.
Revenues consist of invoiced group-wide costs (management fees). The parent company has received interest on its receivables from group companies during 2018. The company's financial expenses relate to interest on bank loans. No investments have been made during 2018.
The following retained earnings are at the disposal of the Annual General Meeting (SEK)
| Retained earnings | -11,040,550 |
|---|---|
| Share premium reserve | 473,016,706 |
| Profit/loss for the year | -5,523,186 |
| 456,452,970 | |
| The Board of Directors | |
| proposes that the profits be | 456,452,970 |
| carried forward | |
| 456,452,970 |
In regard to the Group's and parent company's profit and financial position in general, further reference is made to the following financial statements. All amounts are expressed in thousands of Swedish krona (TSEK), unless otherwise specified.
The Corporate Governance Report for the 2018 financial year is available on page 31.
Bactiguard Holding AB (publ) ("Bactiguard" or "the company") has prepared this Corporate Governance Report in compliance with Chap 6, Section 6 of the Swedish Annual Accounts Act and Chap10 of the Swedish Code of Corporate Governance ("the Code").
In addition to the principles for corporate governance required by law or other applicable legislation, at Bactiguard corporate governance is based on internal documents such as the articles of association, the Board of Directors' work plan and CEO instruction, and policies and guidelines, as well as external rules such as the Nasdaq Stockholm Rules and regulations for Issuers and the Code. In 2018, the company has not made any deviations from the Code.
Bactiguard must observe the provisions of the EU's Market Abuse Regulation No 596/2014 (MAR), which imposes strict requirements on how the company handles insider information. MAR regulates, for example: the way in which insider information is released on the market; conditions under which this publication may be postponed; and the register that must be kept of the people who work for the company and who have access to insider information (this is known as a 'log book').
Since September 2018 Bactiguard has been using the digital tool Insider-Log to ensure that the way it handles inside information complies with the requirements in MAR and the company's insider policy; this includes everything from the decision to postpone the publication of insider information all the way through to the notification that must be sent to the Swedish Financial Supervisory Authority when the insider event is over and the information has been published. Only authorised people in Bactiguard have access to InsiderLog.
The Bactiguard series B share is listed on Nasdaq Stockholm. At the end of 2018, the total number of shares was 33,302,373 (of which 4,000,000 non-listed series A shares) and the number of shareholders was 2,834. Page 29 contains a list of the company's ten biggest shareholders as per 31 December 2018.
The shareholders' right to decide on matters affecting Bactiguard is exercised at the general meeting in accordance
with the Swedish Companies Act and is the company's highest decision making organ. The rules that govern general meetings of shareholders are found in the Swedish Companies Act, the Code, and the company articles of association Sections 10–12.
All shareholders registered in the share registry as of the record date and who have provided timely notice of their intention to participate in the general meeting are entitled to participate at the meeting and vote proportionally to the total number of shares they have. There are no limitations as to the number of votes shareholders may exercise at the general meeting. Notice for convening the general meeting is published for shareholders on the company's website and announced in Post- och Inrikes Tidningar. Simultaneously with publication of the notice, the company advertises this information in the newspaper Dagens Industri. Shareholders wanting to have a matter considered at the general meeting shall request so in writing to the Board of Directors. Such matters shall be brought for consideration at the general meeting if the request was submitted to the Board of Directors no later than seven weeks prior to the meeting. All shareholders are entitled to ask questions to the company regarding matters on the agenda for the general meeting, and in relation to the company and the Group's financial position.
The annual general meeting ('AGM') shall be held in Stockholm, Huddinge or Botkyrka within six months of the closing date for the financial year. The company's financial year begins on 1 January and closes 31 December. The AGM determines issues including adopting the company's annual report, appropriation of the company's profit or loss, and discharging the board members and the CEO from liability. The AGM also appoints board members and auditors, and determines the establishment of a nomination committee, fees for the Board of Directors and auditors, and guidelines for determining salaries and other remuneration to the CEO and other senior managers. Resolutions by the general meeting are normally passed by simple majority vote, except where the Swedish Companies Act imposes requirements for a higher portion of the shares and assigned votes represented at the general meeting, for example, resolutions regarding amendment of the company's articles of association. The general
meeting has not authorised the Board of Directors to repurchase company shares.
Bactiguard's articles of association are published in full on the Bactiguard website, www.bactiguard.se. Changes to Bactiguard's articles of association are made in accordance with the provisions of the Swedish Companies Act. Bactiguard's articles of association stipulate that the Board of Directors shall consist of not less than three and no more than seven members. The board members are elected by the AGM for one year at a time. The company articles of association do not contain any special provisions on appointment or dismissal of board members.
At the 2018 AGM, rules were adopted for appointment of members to the Nomination Committee for the 2019 AGM. These rules, as adopted, provide that the Nomination Committee is to consist of five members and shall be formed by the Chairman of the Board of Directors contacting the four largest shareholders (by votes) as per ownership statistics as of 31 August, who each shall be entitled to appoint one member to serve together with the Chairman of the Board of Directors on the Nomination Committee. For the 2019 AGM, the Nomination Committee consists of Helena Borglund, Chair, (appointed by KK Invest AB, a company controlled by Christian Kinch), Thomas von Koch (appointed by Bactiguard B.V., a company controlled by Thomas von Koch), Mats J Andersson (appointed by Nordea Fonder), Per Colleen (appointed by Fjärde AP-Fonden) and Jan Ståhlberg (Chairman of the Board of Directors).
The Board of Directors is the highest management organ of the company, standing under the authority of the general meeting. The Board of Directors is, inter alia, responsible for the company's organisation and management of the company's affairs, ensuring that the company's organisation is designed to adequately control the company's accounts, financial management and other economic conditions. The Board of Directors shall continually assess the company's financial position. The Board of Directors shall primarily address comprehensive
and long-term issues, and other issues of unusual character or great significance to the Group and the company.
The Board of Directors' work shall follow a written work plan that shall ensure that the Board of Directors is fully informed and that all control related aspects of the company's operations are addressed. Pursuant to the work plan, the Chairman of the Board of Directors is responsible for monitoring and discussing the developments of Bactiguard in regular contacts with the CEO. The Chairman of the Board of Directors shall also perform duties such as ensuring that the Board of Directors receive continual information from the CEO as necessary to monitor the company's financial position, financial planning and development, and that an annual assessment of the work of the Board of Directors is conducted. In addition to the specific responsibility of the Chairman of the Board of Directors, the Board of Directors has not allocated its areas of responsibility in any way, other than that stipulated in the instructions for the audit and remuneration committees.
The work plan of the Board of Directors stipulates that the Board of Directors shall, in a 12 month cycle, address at least the following areas of importance for the company; accounting and auditing issues; market and market analyses; risk identification; strategy; organisation; assessment of the Board of Directors and the CEO and the system for internal control; and the company's capital structure. The Chairman of the Board of Directors is responsible for the annual evaluation of the work of the Board of Directors. In 2018 a survey was conducted that covered 18 different aspects of the Board's work and its efforts to promote value creation. The results of this survey were presented to both the Board and the Nomination Committee.
During 2018 the Board of Directors held a total of 8 meetings where minutes were recorded. All Board members were present at all Board meetings, except for one meeting when one Board member could not participate. In 2018, the Board's work, in addition to the regular board work, focused on the long-term strategy of reaching the company's financial targets of an average growth of 20% and an EBITDA margin of 30% over a five-year period.
Before the Annual General Meeting of 2018 Stanley Brodén declined re-election and Jan Ståhlberg was elected as the new Chairman at the AGM.
Since the 2018 AGM, the Board has therefore consisted of Jan Ståhlberg (Chairman), Mia Arnhult, Marie Wickman-Chantereau, Svante Östblom and Christian Kinch (CEO). Additional information on the board members is available on pages 36–37.
The Audit Committee is tasked with monitoring the company's financial reporting and the effectiveness of internal controls and risk management in the company, and internal audits as necessary. The committee shall also monitor and review the auditor's independence and impartiality, and especially follow whether the auditor provides other services than purely auditing services to the company. The committee also contributes proposals to the general meeting for adoption regarding the appointment of auditors. Up until the 2018 Annual General Meeting, the committee consisted of Mia Arnhult (Chair), Stanley Brodén, Marie Wickman-Chantereau and Svante Östblom. Since the 2018 AGM, Jan Ståhlberg has replaced Stanley Brodén as a member of the committee. All members were present at Audit Committee meetings during 2018.
The Remuneration Committee shall support the Board of Directors with proposals, advice, and preparation in regard to issues of remuneration principles for the CEO and other senior managers, and individual remuneration to the CEO in accordance with remuneration principles. These principles include the relationship between fixed and any variable remuneration, and the relationship between performance and remuneration, the general terms for any bonus and incentive programme, and the general terms for non-monetary benefits, pension, notice of termination and severance pay. The Board of Directors is also responsible as a whole for establishing remuneration levels and other employment terms for the CEO. Share-related incentive programmes for group management are, however, adopted only by the AGM. The committee shall also; support the Board of Directors in monitoring the system through which the company complies with publication requirements stipulated by legislation, market regulations and the Code in regard to information related to remuneration of the CEO and other senior managers. Monitor and assess any ongoing or concluded incentive programs for variable remunerations to the CEO and/or other senior managers; evaluate compliance
with the guidelines for remuneration to the CEO and other senior managers adopted by the AGM as well as the current structure and levels of remuneration. Up until the 2018 AGM, the Remuneration Committee comprised the Board members Stanley Brodén (Chairman) and Marie Wickman-Chantereau. Since the 2018 AGM Jan Ståhlberg has replaced Stanley Brodén as the Chairman of the committee. All members comply with the Code's independence requirements for members of the committee. All members were present at Remuneration Committee meetings during 2018.
The CEO is appointed by the Board of Directors and is responsible for the daily administration of the company's operations in accordance with the instructions and regulations of the Board of Directors. The CEO also functions as the Chairman of the management making all decisions in consultation with other managers. Christian Kinch was the company's CEO in 2018. Additional information on the CEO is available on pages 34 and 36.
As the company's financial system is designed to ensure that entering agreements and payment of invoices, and similar, must follow the decision processes, and the signatory and authorisation procedures provided in internal steering documents, the company has a basic control structure to counteract and prevent the risks identified by the company. In addition to these control structures, a series of additional control activities are conducted to further discover and correct any errors and deviations. Such control activities consist of follow-up at various levels in the organisation, for example, follow-up and review by the Board of Directors regarding their formal decisions; review and comparison of income items and account settlement; and approval of the accounting of business transactions with the finance department. In accordance with its work plan, the Board of Directors conducts an annual review of these internal controls and also, annually, performs risk identification and establishes risk mitigation measures. The auditor is invited to a board meeting to present its auditing measures in regard to internal control.
The division and delegation of responsibility have been documented and communicated in internal steering documents established for the Board of Directors and the company, such as; the work plan of the Board of Directors, the CEO instruction, and the delegation of authority, authorisation procedure and other internal steering documents, such as the financial handbook. All internal steering documents are maintained up-to-date on a regular basis, to reflect legislative changes or revision of reporting standards. Bactiguard has established an organisation for the purpose of ensuring that all financial reporting is correct and efficient.
The internal steering documents define responsibilities and daily interactions between the positions involved so that all necessary information and communication reach all persons as necessary. The group management receives monthly financial information regarding the company and its subsidiaries in regard to developments of upcoming investments and liquidity planning. The company's communication policy is designed to ensure that publication of all information, both internal and external is made correctly and at the appropriate time for all occasions.
Monitoring is conducted continuously at all levels of the organisation. The Board of Directors regularly assesses the information which the company's senior management and auditors submit. In addition, the Board of Directors conduct annual follow-up of previous risk assessments and any measures implemented therefore. The Board of Directors' monitoring of developments in internal controls and ensuring that measures are taken in regard to any shortcomings or suggestions that arise are particularly important.
Considering the scope of the company's operations and the organisational structure at large, the Board of Directors has not found any reason to implement an internal auditing unit. The Board of Directors has assessed that the monitoring and review programme described above are sufficient, in combination with the external audits, to maintain effective internal controls in regard to the financial reporting.

Employed: 2005 (founder)
Born: 1966
Education: Studies at the Stockholm School of Economics.
Other assignments: Board member of Swecare Aktiebolag. Chairman of the Board of SWIB Holding AB (holding company for Smartwise Sweden AB and Procella Therapeutics AB). Owner and Board member of KK Invest AB, KK Consult AB and KK Technology AB.
Background: Founder and CEO of Kinchard AB and Netpharma AB.
Shareholding in the Company: 2,000,000 shares series A (legal entity) and 4,125,977 shares series B (family and legal entity), whereof 100 shares series B (children).

Employed: 2014
Born: 1966
Education: BSc Business and Economics, Stockholm School of Economics.
Other assignments: Board member of Nordic Public Affairs AB.
Background: Various positions at SEB, as well as in Group Management for Scania AB and TeliaSonera AB
Shareholding in the Company: 216,948 shares of series B (own).

Employed: 2014
Born: 1977
Education: Diploma in Marketing from IHM Business School. Studies in medical education, Karolinska Institutet
Other assignments: –
Background: Several assignments within international marketing and sales for Johnson & Johnson, programme coordinator at the Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU).
Shareholding in the Company: 84,632 shares of series B (own).

Employed: 2018
Born: 1975
Education: BSc Business and Economics, Stockholm University Other assignments: –
Background: Various sales positions at AstraZeneca, reserve officer Shareholding in the Company: 21,175 shares of series B (own).

Elected: 2018
Born: 1962
Education: BSc Business and Economics, Stockholm School of Economics. MBA programme at New York University, student at Stern School of Business.
Other assignments: Board member of Trelleborg AB and ITB-Med AB. Owner and CEO of Trill AB.
Shareholding in the Company: 2,956,831 shares of series B (own).
Independent of the company and company management: Yes


Elected: 2014
Born: 1969
Education: Degree in Business finance and trade law, Lund University.
Other assignments: CEO and Board member of M2 Asset Management AB, M2 Gruppen AB and M2 Gruppen 1 AB. CEO for Locellus AB and Arnhult Invest AB. Board member of Odd Molly International AB, Devyser Holding AB, Lidingöloppet, Suburban Properties Stockholm AB with its subsidiaries, and M2 Capital Management AB.
Shareholding in the Company: 50,000 shares series B (own) and 502,000 shares series B (legal entity)
Independent of the company and company management: Yes
Elected: CEO of the Group since June 2015 and during the period June 2005 to March 2014. Chairman of the board from March 2014 to June 2015.
Born: 1966
Education: Studies at the Stockholm School of Economics.
Other assignments: Board member of Swecare Aktiebolag. Chairman of the Board of SWIB Holding AB (holding company for Smartwise Sweden AB and Procella Therapeutics AB). Owner and Board member of KK Invest AB, KK Consult AB and KK Technology AB.
Shareholding in the Company: 2,000,000 shares series A (legal entity) and 4,125,977 shares series B (family and legal entity), whereof 100 shares series B (children).
Independent of the company and company management: No

Elected: 2016
Born: 1955
Education: M.D and Med. DR., Associate Professor of Plastic Surgery, Karolinska Institutet Stockholm.
Other assignments: Chief Medical Officer, Sophiahemmet, and Professor in Medical Science at Sophiahemmets Högskola.
Shareholding in the Company: 20,000 shares of series B (legal entity).
Independent of the company and company management: Yes

Elected: 2017
Born: 1960
Education: BSc Business and Economics, Uppsala University.
Other assignments: Board member of Adamo Telecom Iberia S.A, Origo Group AB (Chairman), Bredbandsgruppen AB, Arremon AB and Candidator AB.
Shareholding in the Company: 50,000 shares of series B (legal entity).
Independent of the company and company management: Yes
| Amounts in TSEK | Note | 2018 | 2017 |
|---|---|---|---|
| Net sales | 5, 6 | 150,097 | 147,458 |
| Other operating revenues | 5, 7 | 13,063 | 6,181 |
| Total | 163,160 | 153,639 | |
| Raw material and consumables | -25,717 | -20,262 | |
| Other external expenses | 8, 9 | -56,429 | -42,329 |
| Personnel costs | 10 | -53,838 | -51,475 |
| Depreciation | 15, 17-22 | -34,194 | -35,015 |
| Other operating expenses | 7 | -5,022 | -5,141 |
| Total | -175,201 | -154,221 | |
| Operating profit/loss | -12,040 | -582 | |
| Profit/loss from financial items | |||
| Financial revenues | 11 | 3,698 | 1,378 |
| Financial expenses | 12 | -12,353 | -9,088 |
| Total | -8,655 | -7,710 | |
| Profit before tax | -20,695 | -8,292 | |
| Taxes for the period | 13 | 5,764 | 5,042 |
| Profit/loss for the year | -14,931 | -3,251 | |
| Attributable to: | |||
| The parent company's shareholders | -14,931 | -3,251 | |
| Earnings per share in SEK* | -0.45 | -0.10 |
*no dilution is applicable
| Amounts in TSEK | 2018 | 2017 |
|---|---|---|
| Profit/loss for the year | -14,931 | -3,251 |
| Other comprehensive income: | ||
| Items that will be reclassified to profit or loss for the year | ||
| Translation differences | -421 | 28 |
| Other comprehensive income, after tax | -421 | 28 |
| Total comprehensive income for the year | -15,352 | -3,223 |
| Attributable to: | ||
| The parent company's shareholders | - 15,352 | -3,223 |
| Total earnings per share, SEK | -0.46 | -0.10 |
| ASSETS Non-current assets Intangible assets Goodwill 14 226,292 226,292 Technology 15 188,998 212,805 Brands 16 25,572 25,572 Customer relationships 17 9,368 10,548 Capitalised development costs 18 21,494 18,568 Patent 19 414 571 Total 472,138 494,355 Property, plant and equipment Improvements, leasehold 20 10,896 13,031 Machinery and other technical plant 21 16,761 19,580 Equipment, tools and installations 22 2,133 3,107 Total 29,790 35,717 Financial assets Non-current accounts receivable 26 - 17,263 Other non-current receivables 477 - Participations in associates and joint ventures 24 - - Total 477 17,398 Total non-current assets 502,405 547,336 Current assets Inventories 25 14,266 13,608 Accounts receivable 26 54,492 39,596 Other current receivables 3,224 2,046 Prepaid expenses and accrued income 27 11,197 11,254 Cash and cash equivalents 28 1,893 11,550 Total 85,072 78,054 TOTAL ASSETS 587,477 625,390 EQUITY AND LIABILITIES Equity attributable to shareholders of the parent Share capital 29 833 833 Translation reserve -305 116 Other capital contribution 675,690 675,690 Retained earnings including net profit for the year -305,396 -289,533 Total 370,821 387,105 Total equity 370,821 387,105 Non-current liabilities Advance payments from customers - 17,263 Deferred tax liabilities 13 19,471 25,243 Liabilities to credit institutions 30, 31 130,805 142,500 Other long-term liabilities 21 10,938 12,476 Total 161,214 197,482 Short-term liabilities Liabilities to credit institutions 30 14,400 7,500 Accounts payable 7,051 4,832 Other short-term liabilities 21 15,721 6,855 Accrued expenses and prepaid income 32 18,270 21,616 Total 55,442 40,803 Total liabilities 216,655 238,285 |
Amounts in TSEK | Note | 31/12/2018 | 31/12/2017 |
|---|---|---|---|---|
| TOTAL EQUITY AND LIABILITIES | 587,477 | 625,390 |
| Equity attributable to shareholders of the parent | |||||
|---|---|---|---|---|---|
| Amounts in TSEK | Share capital |
Other capital contribution |
Translation reserve |
Retained earnings including net profit for the year |
Total equity attributable to shareholders of the parent company |
| Opening balance 1 January 2017 | 833 | 675,690 | 88 | -286,283 | 390,328 |
| Comprehensive income | |||||
| Profit/loss for the year | – | – | – | -3,251 | -3,251 |
| Other comprehensive income: | |||||
| Translation differences | – | – | 28 | 28 | |
| Total other comprehensive income, after tax | – | – | 28 | – | 28 |
| Total comprehensive income | – | – | 28 | -3,251 | -3,223 |
| Transactions with shareholders | |||||
| Total transactions with shareholders | – | – | – | – | – |
| Closing balance 31 December 2017 | 833 | 675,690 | 116 | -289,533 | 387,105 |
| Adjustment of opening balance on 1 January | |||||
| 2018, changed accounting policy, IFRS 9 | – | – | – | -932 | -932 |
| Opening balance 1 January 2018 | 833 | 675,690 | 116 | -290,465 | 386,173 |
| Comprehensive income | |||||
| Profit/loss for the year | – | – | – | -14,931 | -14,931 |
| Other comprehensive income: | |||||
| Translation differences | – | – | -421 | – | -421 |
| Total other comprehensive income, after tax | – | – | -421 | - | -421 |
| Total comprehensive income | – | – | -421 | -14,931 | -15,352 |
| Transactions with shareholders | |||||
| Total transactions with shareholders | – | – | – | – | – |
| Closing balance 31 December 2018 | 833 | 675,690 | -305 | -305,396 | 370,821 |
| Amounts in TSEK | Note | 2018 | 2017 |
|---|---|---|---|
| Cash flow from operating activities | |||
| Net profit/loss for the year | -14,931 | -3,251 | |
| Adjustment for non-cash flow items: | |||
| Depreciation | 34,194 | 35,015 | |
| Other non-cash items | -1,708 | -3,224 | |
| 17,555 | 28,540 | ||
| Increase/decrease inventory | -427 | 1,565 | |
| Increase/decrease accounts receivable | -1,162 | -12,476 | |
| Increase/decrease other current receivables | -2,884 | 1,231 | |
| Increase/decrease accounts payable | 2,213 | -56 | |
| Increase/decrease other current liabilities | -14,431 | -12,687 | |
| Cash flow from operating activities | -16,691 | -22,424 | |
| Investing activities | |||
| Investments in intangible assets | -5,020 | -3,661 | |
| Investments in property, plant and equipment | -725 | -2,571 | |
| Cash flow from investing activities | -5,745 | -6,232 | |
| Operating cash flow | -4,881 | -117 | |
| Financing activities | |||
| Amortisation of financial leasing debt | -1,466 | - 1,398 | |
| Amortisation of loan | -7,500 | -150,000 | |
| Debt incurred | - | 150,000 | |
| Up-front fee for loan | - | -1,800 | |
| Change to bank overdraft | 3,905 | - | |
| Cash flow from financing activities | 34 | -5,061 | -3,198 |
| Cash flow for the year | -9,942 | -3,315 | |
| Cash and cash equivalents at start of year | 11,550 | 15,645 | |
| Exchange difference in cash and cash equivalents | 285 | -780 | |
| Cash and cash equivalents at end of year | 1,893 | 11,550 |
| Amounts in TSEK | Note | 2018 | 2017 |
|---|---|---|---|
| Net sales | – | – | |
| Other operating revenues | 5, 7 | 6,967 | 6,464 |
| Total | 6,967 | 6,646 | |
| Other external expenses | 8, 9 | -1,740 | -2,474 |
| Personnel costs | 10 | -8,700 | -7,467 |
| Total | -10,440 | -9,941 | |
| Operating profit/loss | -3,474 | -3,477 | |
| Profit/loss from financial items | |||
| Interest income and similar items | 11 | 3,073 | 3,076 |
| Interest expenses and similar items | 12 | -5,122 | -5,321 |
| Total | -2,049 | -2,245 | |
| Profit/loss after financial items | -5,523 | -5,722 | |
| Taxes for the period | 13 | – | – |
| Profit/loss for the year | -5,523 | -5,722 |
| Amounts in TSEK | 2018 | 2017 |
|---|---|---|
| Profit/loss for the year | -5,523 | -5,722 |
| Other comprehensive income | – | – |
| Total comprehensive income | -5,523 | -5,722 |
| Amounts in TSEK | Note | 2018 | 2017 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Financial assets | |||
| Shares in subsidiaries | 23 | 414,574 | 414,574 |
| Receivables from group companies | 192,915 | 208,415 | |
| Total | 607,489 | 622,989 | |
| Current assets | |||
| Current receivables | |||
| Other current receivables | 146 | 4 | |
| Prepaid expenses and accrued income | 27 | 201 | 1,962 |
| Total | 347 | 1,966 | |
| Cash and bank balances | 28 | 648 | 374 |
| Total current assets | 995 | 2,340 | |
| TOTAL ASSETS | 608,484 | 625,329 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 29 | 833 | 833 |
| Total | 833 | 833 | |
| Non-restricted equity | |||
| Retained earnings | 461,976 | 467,698 | |
| Profit/loss for the year | -5,523 | -5,722 | |
| Total | 456,453 | 461,976 | |
| Total equity | 457,286 | 462,809 | |
| Non-current liabilities | |||
| Liabilities to credit institutions | 30 | 126,900 | 142,500 |
| Total | 126,900 | 142,500 | |
| Short-term liabilities | |||
| Liabilities to group companies | 7,656 | 9,775 | |
| Liabilities to credit institutions | 30 | 14,400 | 7,500 |
| Accounts payable | 181 | 296 | |
| Other short-term liabilities | 343 | 369 | |
| Accrued expenses and prepaid income | 32 | 1,718 | 2,080 |
| Total | 24,298 | 20,020 | |
| Total liabilities | 151,198 | 162,520 | |
| TOTAL EQUITY AND LIABILITIES | 608,484 | 625,329 |
| Amounts in TSEK | Share capital | Restricted equity |
Non-restricted equity |
Total equity |
|---|---|---|---|---|
| Opening balance 1 January 2017 | 833 | – | 467,698 | 468,531 |
| Comprehensive income | ||||
| Profit/loss for the year | – | – | -5,722 | -5,722 |
| Total comprehensive income | – | – | -5,722 | -5,722 |
| Total transactions with shareholders | – | – | – | – |
| Closing balance 31 December 2017 | 833 | – | 461,976 | 462,809 |
| Opening balance 1 January 2018 | 833 | – | 461,976 | 462,809 |
| Comprehensive income | ||||
| Profit/loss for the year | – | – | -5,523 | -5,523 |
| Total comprehensive income | – | – | -5,523 | -5,523 |
| Total transactions with shareholders | – | – | – | – |
| Closing balance 31 December 2018 | 833 | – | 456,453 | 457,286 |
| Amounts in TSEK | Note | 2018 | 2017 |
|---|---|---|---|
| Cash flow from operating activities | |||
| Net profit/loss for the year | -5,523 | -5,722 | |
| Adjustment for non-cash flow items: | -2,487 | -3,314 | |
| -8,010 | -9,036 | ||
| Increase/decrease other current receivables | 682 | 5,323 | |
| Increase/decrease accounts payable | -114 | 210 | |
| Increase/decrease other current liabilities | -284 | 29,459 | |
| Cash flow from operating activities | -7,726 | 25,956 | |
| Investing activities | |||
| Shareholder contributions subsidiaries | - | -30,000 | |
| Cash flow from investing activities | – | -30,000 | |
| Financing activities | |||
| Amortisation of loan | -7,500 | -150,000 | |
| Debt incurred | 150,000 | ||
| Up-front fee for loan | -1,800 | ||
| Amortisation loan group companies | 15,500 | 5,100 | |
| Cash flow from financing activities | 34 | 8,000 | 3,300 |
| Cash flow for the year | 274 | -744 | |
| Cash and cash equivalents at start of year | 374 | 1,118 | |
| Cash and cash equivalents at end of year | 648 | 374 |
Bactiguard Holding AB, corporate identity number 556822-1187, is a limited company registered in Sweden and domiciled in Stockholm The address of the headquarters is Box 15, 146 21 Tullinge. The operations of the company and its subsidiaries ('the Group') are conducted in south Stockholm (headquarters and production facilities) and in Malaysia (production facilities). The operations cover research and development, production, marketing and sales of the company's products and technical solutions.
The consolidated financial statements for Bactiguard Holding AB have been prepared in accordance with International Financial Reporting Standards (IFRS) as approved by the EU and the interpretations of the IFRS Interpretations Committee (IFRIC) as per 31 December 2018.
In addition, the Group applies the Swedish Annual Accounts Act and the Swedish Financial Reporting Board's recommendation RFR 1 "Supplementary rules for Group accounting".
Items in the consolidated financial statements have been prepared on a cost basis, except for certain financial instruments which are stated at fair value.
The accounting currency of the parent company is the Swedish krona, which is also the presentation currency of the Group. All amounts are specified in thousands unless otherwise stated. The significant accounting policies which have been applied are described below.
| Changes | Shall be applied for the financial year starting: |
|---|---|
| IFRS 9 Financial Instruments | 1 January 2018 |
| IFRS 15 Revenue from Contracts with Customers 1 January 2018 | |
| IFRIC 22 Foreign Currency Transactions and Advance Consideration |
1 January 2018 |
IFRS 9 Financial Instruments replaces IAS 39 Financial Instruments: Recognition and Measurement. IFRS 9 contains rules for accounting, classification and measurement, impairment, derecognition and general rules for hedge accounting. The major changes are in the areas of classification and measurement, impairment and hedge accounting. The Group does not apply hedge accounting.
Classification and measurement: In the first report that complies with IFRS 9, the financial assets are classified as fair value via the income statement, amortised cost or as fair value via other comprehensive income.
Impairments: removes the requirement of identifying an eventual loss event and introduces a model for expected credit losses. The model calculates expected credit losses , which means all financial assets valued at amortised cost must have a reserve already at the time the asset is booked into the balance sheet. The model establishes a three-digit classification based on whether there has been a significant increase in credit risk or not. For financial assets where there has been no significant increase in credit risk since initial recognition, the provision corresponds to the credit loss that is expected to occur as a result of the default event within a period of 12 months. For financial assets where there has been a significant increase in credit risk since initial recognition and for those that are doubtful, the provision corresponds to the expected credit losses for the remaining maturity period of the asset.
The Group has applied this standard for the first time during the 2018 financial year. Bactiguard has elected to apply the forward-looking method for transitioning to IFRS 9 and has therefore not remeasured prior periods. Classification of financial assets has changed due to new model but the transition has not meant differences in the valuation of the assets. However the Group is affected by the new impairment model for calculating the expected credit loss provision for all accounts receivable, with the opening balance for equity in January 2018 being adjusted by MSEK -0.9 as a result of this new standard. For other financial assets valued at amortised cost no reserve for credit losses has been considered necessary, as these have a duration of less than 12 months and the credit
risk is considered low. Thus, the transition to IFRS 9 did not have any significant effects for the Group with respect to impairment of these assets. Further information about the Group's impairment model is presented in note 4.
IFRS 15 replaces IAS 18 Revenue, IAS 11 Construction Contracts and Related Interpretations. The new standard means a new model of revenue recognition (five-step model) based on when the control of a product or service is transferred to the customer. The basic principle is that a company reports revenue to illustrate the transfer of promised goods and services to customers at an amount that reflects the remuneration that the company is expected to be entitled to in return for these goods or services. IFRS 15 introduces a five-step model:
Step 1 Identify the agreement
Step 2 Identify the performance obligations
Step 3 Determining the transaction price
Step 4 Allocation of the transaction price for performance obligations Step 5 Report revenue when (or as) the company fulfilles its performance obligations
IFRS 15 contains more guidance and comprehensive disclosure requirements.
The Group has applied this standard for the first time during the current financial year. A detailed analysis in line with the five-step model has been conducted regarding the company's significant customer agreements. The analysis shows the Group's revenue streams, how the transaction price is determined, and how revenue recognition for each revenue stream illustrates the transfer of promised goods and services to the Group's customers. Following this analysis of the company's revenue recognition, the transition to IFRS 15 did not have any quantifiable impact on revenue flows. This means that this new standard has not resulted in any changes to the recognised amounts in the financial statements.
Bactiguard has elected to apply the forward-looking method and has therefore not remeasured prior periods. Further information about the Group's allocation of revenue is presented in note 5.
IFRIC 22 clarifies how transactions in foreign currency arising from the payment or receipt of advance consideration are to be recognised (for example an advance paid when purchasing property, plant and equipment or inventories). IFRIC 22 states that the payment and receipt of the advance consideration are to be recognised at the exchange rate on the transaction date. If there are multiple payments or receipts in advance, the company must determine a transaction date for each payment or receipt of advance consideration.
The Group has applied IFRIC 22 for the first time during the current financial year. This application has not resulted in any changes to the recognised amounts in the financial statements as the Group's accounting already complied with the content in IFRIC 22.
The management assesses that other new or amended standards and new interpretations, which have entered into force in 2018, have not had any material impact on the Group's financial statements.
The new or amended standards and new interpretations issued by the International Accounting Standards Board (IASB) and the IFRS Interpretations Committee (IFRIC) but that entered into force for the financial year beginning after 1 January 2019 are yet to be applied by the Group. The standard described below is the standard that is judged to have an impact on the consolidated financial statements as it is being applied for the first time.
| Changes | Shall be applied for the financial year starting: |
|---|---|
| IFRS 16 Leases | 1 January 2019 |
This standard has a leasing model for lessees, which means that virtually all leases must be recognised in the statement of financial position in order to provide a fairer picture of the company's financial position and to improve the disclosures on indebtedness and the use of capital.
The right of use (leasing asset) and the liability are measured at the present value of future lease payments. The right of use also includes direct costs attributable to the signing of the leasing agreement. In the income statement depreciation on the right of use and interest expenses are recognised. The right of use is recognised separately from other assets in the statement of financial position, or is included in the item in which the corresponding assets would be recognised if they were owned. If it is included among other assets, the company has to state this along with the items that include rights of use. In subsequent periods, the right of use is recognised at acquisition value less depreciation and impairments, if any, and is adjusted for any remeasurement of the leasing liability.
— 45 —
The leasing liability is recognised separately from other liabilities. If the leasing liability is not recognised separately, the company has indicate the items that cover these liabilities. In subsequent periods, the liability is recognised at the amortised cost and is reduced by the leasing payments that have been made. The leasing liability is revalued following changes to the leasing period, residual value guarantees and changes to lease payments, if any.
Short leasing contracts (12 months or shorter) and leasing agreements where the underlying assets amount to at low value (a maximum of TSEK 45) do not need to be recognised in the statement of financial position. These will be recognised in operating income in the same way as previous operating leases.
There are virtually no changes in rules for lessors in IFRS 16.
This new standard contains more extensive disclosures compared to the current standard.
The Group will start to apply IFRS 16 from 1 January 2019. In 2018 Bactiguard compiled and analysed all of the Group's leases and service agreements to determine which must be classified as leases in accordance with IFRS 16. As a result, 12 operating leases were identified for offices, company cars and office equipment, which will be reclassified as financial leases in accordance with IFRS 16. Bactiguard has a financial leasing agreement for a production plant, which used to be recognised in accordance with IAS 17 Leases, but which will be reclassified in accordance with IFRS 16 at the amounts that were reported on the day immediately before the application of this new standard.
The Group will apply the forward-looking method for transitioning to this new standard, which means that the comparison figures will not be recalculated. The effect of applying IFRS 16 is recognised as per 1 January 2019. Bactiguard will recognise a right of use at an amount corresponding to the lease liability, adjusted for the amount of any prepaid or accrued expenses that are attributable to the leasing agreement, as recognised as per 31 December 2018. The transition to IFRS 16 will therefore not have any impact on the Group's equity.
When establishing the right of use and lease liability for current agreements, the most important judgements are whether an agreement is, or contains a leasing agreement, establishing the leasing periods and discount rates. Leases with a term less than 12 months are classified as short-term agreements, and leases where the underlying asset has a replacement value less than TSEK 45 are classified as low-value agreements. None of these types of agreement are included in the rights of use or lease liabilities that have been recognised. The right of use period has been established based on how the termination and extension clauses are expected to be used, taking into account the company's strategic future plans, and historic information about how the extension options have previously been used. If it is not reasonably certain that there will be an extension, the extension will not be included in the calculation of the lease liability. The company's marginal loan rate at the transition date is used as the discount rate. This has been established per country based on the ten-year government bond rate, the company's credit risk and the currency risk.
Following calculations, the opening balances as per 1 January 2019 for the leasing asset and interest-bearing lease liability items have been adjusted by MSEK 74. When applying IFRS 16 EBITDA will increases as leasing fees decrease
and is replaced by depreciation of the leased assets. and interest attributable to the lease amortization. Also the cash flow from operating activities will increase and cash flow from the financing activities will decrease compared to earlier, since amortization of the leasing liabilities will be classified as cash flows from financing activitites. IFRS 16 will also affect some of the key figures presented in the external reporting,such as EBITDA, Equity ratio and Net debt.
The consolidated financial statements cover the parent company Bactiguard Holding AB and those companies over which the parent company has direct or indirect control (subsidiaries). Control involves the entitlement to directly or indirectly design strategies of a company in order to obtain economic benefits. In determining whether control exists, any shareholder agreements or potential voting shares that may be utilised or converted without delay shall be considered. Control normally exists when the parent company directly or indirectly holds shares representing more than 50% of the votes.
Subsidiaries are consolidated in the financial statements as of the acquisition date, and are excluded from consolidation as of the date when such control ceases.
The accounting policies for subsidiaries have been amended, when necessary, to ensure consistent application of the Group's accounting policies. All intra-group transactions, dealings and unrealised gains and losses attributable to intra-group transactions have been eliminated when preparing the consolidated financial statements.
If the parent company loses control over a subsidiary, the gain or loss is measured at the time of disposal as the difference between: i) the total of the fair value for the consideration
Business combinations are recognised using the acquisition method. The cost of business combinations is carried at fair value on the acquisition date, and is measured as the sum of the fair value on the acquisition date for the assets paid, any incurred or assumed liabilities, and the equity interest issued in exchange for control of the acquired business. Acquisitionrelated costs are recognised in the income statement when they are incurred.
The identifiable acquired assets and assumed liabilities, and contingent assets are recognised at fair value on the acquisition date with the following exceptions:
• Non-current assets (or disposal groups) classified as held for sale according to IFRS 5. Non-current assets held for sale and discontinued operations are measured according to the standard.
Contingent liabilities assumed in a business combination are recognised as though they are existing liabilities that are the result of past events, and whose fair value can be measured reliably.
For business combinations where the total purchase price, any holding without control, and fair value on the acquisition date of previous shareholding, exceeds the fair value of identifiable acquired net assets on the acquisition date, the difference is recognised as goodwill in the statement of financial position. If the difference is negative, this is recognised as a profit on an acquisition at a low price immediately in the income statement after testing the difference.
In every business combination, the previous holding without control in the acquired business is carried either at fair value or at the value of the proportional share of the holding without control in the identifiable net assets in the acquired business.
Goodwill arising from acquisition of subsidiaries is measured as the amount where the total purchase price, any holding without control and fair value on the acquisition date of previous shareholding exceeds the fair value on the acquisition date of the identifiable acquired net assets. Goodwill that arises during the acquisition of subsidiaries is recognised at cost less any accumulated impairments.
For impairment testing, goodwill is allocated to the cash generating units that are expected to benefit from synergies expected from combining operations. Goodwill shall be tested for impairment annually, or more often whenever events indicate that the carrying amount may not be recoverable. If the recovery value of a cash generating unit is determined to be lower than the carrying amount, the amount of write-down is allocated, first by reducing the carrying amount for goodwill attributable to the cash generating unit and then by the carrying amount for goodwill attributable to the other assets attributable to the cash-generating unit proportionally based on the carrying amount of each asset in the unit. A recognised impairment of goodwill can not be reversed in a later period.
During the sale of a subsidiary, the remaining carrying amount for goodwill is included in the calculation of the capital gain or loss.
Operating segments are components of a company that engages in business activities from which it may earn revenues and incur expenses, whose operating profit/loss is audited regularly by the company's chief operating decision maker, and for which independent financial information is available. The company's reporting of operating segments matches the internal reporting to the chief operating decision maker. The chief operating decision maker is the function that assesses the operating segment's results and makes decisions on the allocation of resources. The company's assessment is that the group management is the chief operating decision maker.
The company is deemed to operate entirely within a single operating segment.
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Before 1 January 2018 the Group applied IAS 18 Revenue for recognising revenue. From 1 January 2018 the Group applies IFRS 15 Revenue from Contracts with Customers, where the basic principle for revenue recognition is that a company should recognise revenue to illustrate the transfer of promised goods or services to the customer at an amount that reflects the remuneration to which the company expects to be entitled in exchange for these goods or services. Revenue is recognised when the customer obtains control over goods or services. The transition to IFRS 15 had no effect on the Group's revenue recognition.
The Group's revenues are mostly from license revenues and product sales. Revenues are recognised at the transaction price of the consideration that has been received or will be received, less VAT, discounts and similar deductions.
License revenues are attributable to sales of products under license, which currently includes the Group's licensing agreement with Becton Dickinson and Company regarding Foley catheters for the USA, Japan, the UK, Ireland, Canada and Australia, a license agreement with Vigilenz Medical Devices for orthopaedic trauma implants, covering the ASEAN region, a global license agreement with Smartwise Sweden AB for vascular injection catheters as well as a license agreement with Well Lead Medical covering all products in Bactiguard's portfolio for the Chinese market, all with the Bactiguard technology
The licensing rights refer to the right to use Bactiguard's technology to provide coating for products. The Group's revenues from existing licensing agreements are recognised at a certain point of time, which is corresponding to the period to which the license entitlement refers. License revenues also include royalties. Royalties are a variable consideration from license customers, which are based on various factors in the agreement. Revenues for royalties are recognised continuously based on the expected value. The expected value is calculated based on current, historical and projected data.
When a new license agreement is signed, it is analysed based on the five-step model in IFRS 15; i.e. i) identify the agreement, ii) identify the performance obligations, iii) determining the transaction price, iiii) allocation of the transaction price for performance obligations, iiiii) report revenue when (or as) the company fulfilles its performance obligations. A new license agreement is normally divided into two phases; the collaboration phase and the commercial phase. Various performance obligations are identified in the different phases of the license agreement and a transaction price per obligation is stipulated in the agreement. The revenue from the new license agreement is recognised as the performance obligations are fulfilled.
Thus, only part of revenues from the new license agreements are recognized over time, other license revenues are recognized at a certain point of time. For detailed and quantified information, see note 5.
Bactiguard's BIP (Bactiguard Infection Protection) product portfolio currently includes sales of the BIP Foley, BIP ETT and BIP CVC products. Revenues from the sale of products are recognised at the time the control passes to the customer, i.e. when the ownership of the
product has been transferred to the customer which normally coincides with delivery to customer.
Previously entered distribution agreements regarding the rights to geographical markets are recognised as accounts receivable and prepaid income. The distributor is entitled to call off products at a value corresponding to the prepaid revenue. Revenue is recognised once settlement against prepaid income occurs, that is once the products are delivered.
Since 2015, no new agreements have been concluded with the right to call off products. As of 31 December 2018 the company only has a limited number of these kinds of agreements. For information about prepaid income in these agreements, see note 32.
A financial leasing agreement is an agreement that essentially transfers all the financial risks and rewards associated with ownership of an object from the lessee to the lessor. Other leases are classified as operating leasing agreements. As of 31 December 2018, the Group has a financial lease for part of a production plant, which is recognised in the balance sheet, while other agreements are classified as operating leasing agreements.
Assets held under financial leasing agreements are recognised as non-current assets in the consolidated balance sheet at fair value at the beginning of the lease period, or at the present value of the minimum lease payments whichever is lower. Corresponding liabilities to the lessor are recognised in the balance sheet as financial leasing debt. Leasing payments are divided between interest rates and amortisation of the debt. The interest is allocated over the leasing period to ensure that each accounting period is charged with an amount corresponding to a fixed interest rate on the liability recognised during each reported period. The interest expense is recognised directly in the income statement. If the interest expense is directly attributable to the acquisition of an asset that necessitates taking considerable time to complete the intended use or sale, the interest expense is instead to be included in the asset's acquisition value in line with the Group's borrowing costs principles (see below). Fixed assets are depreciated over the shorter period of the useful life of the asset and the leasing period. Leasing fees from operating leasing
agreements are charged on a straight-line basis over the lease term unless other systematic methods better reflect the economic utility of users over time.
Items in the individual financial statements of each Group entity are presented in the currency of the primary economic environment in which each entity mainly operates. All amounts in the consolidated financial statements are translated to Swedish krona (SEK), which is the parent company's accounting and reporting currency.
Foreign currency transactions in each entity are translated into the entity's functional currency according to prevailing exchange rates on the transaction date. On each balance sheet date, monetary items in foreign currency are translated at the exchange rate on the balance sheet date. Non-monetary items, carried at fair value in a foreign currency, are translated at the rate that existed when the fair value was determined. Non-monetary items, carried at historical cost in a foreign currency are not translated.
Exchange rate differences are recognised in the income statement for the period in which they arise, except for transactions that are hedges that fulfil the conditions for hedge accounting of cash flows or for net investments, where the gain or loss is recognised in other comprehensive income.
In preparing these consolidated financial statements, foreign subsidiaries' assets and liabilities are translated to Swedish krona using the exchange rate on the balance sheet date. Revenue and cost items are translated to the average exchange rate for the period, unless the exchange rate has fluctuated significantly during the period, whereby the exchange rate on the transaction date is used instead. Any translation differences that arise are recognised in other comprehensive income and transferred to the Group's translation reserve. On disposal of a foreign subsidiary, such translation differences are recognised in the income statement as a part of the capital gain or loss.
Goodwill and changes to fair value that arise in the acquisition of a foreign business are treated as assets and liabilities of the operations and translated at the exchange rate on the balance sheet date.
Borrowing costs that are directly attributable to the acquisition, construction or production of an asset that necessarily takes a substantial period of time to complete for its intended use or sale are included in the cost of the asset up to the time the asset is completed for its intended use or sale. Interest income from the temporary investment of such borrowings is deducted from the borrowing costs that are recognised in the asset's cost.
Other borrowing costs are recognised in the income statement in the period they arise.
Employee benefits in the form of salaries, bonus, paid vacation, paid sick leave, and similar, as well as pensions are recognised as they are incurred. Pensions and other benefits after terminated employment are classified as defined contribution or defined benefit pension plans. The Group only has defined contribution pension plans.
The company pays fixed fees to a separate independent legal entity for defined contribution plans and has no liability to pay additional fees. Group earnings are charged for costs as the benefits are earned, which normally coincides with the date when the premiums are paid.
Tax expense is the sum of current and deferred tax.
Current tax is measured as the taxable earnings for the period. Taxable earnings differ from the profit shown in the income statement, which includes non-taxable revenue and non-deductible expenses, and revenues and costs that were taxable or deductible in other periods. The Group's current tax liabilities are calculated applying the tax rates that have been decided or advised as of the balance sheet date.
Deferred tax is recognised for all temporary differences that arise between the carrying amount of the assets and liabilities in the financial statements and the taxable amounts used when calculating taxable income. Deferred tax is recognised, using the balance sheet liability method. In principle deferred tax liabilities are recognised for all taxable temporary differences, and in principle deferred tax assets are recognised for all deductible temporary differences to the extent it is probable that the amounts can be utilised against future taxable profit. Deferred tax liabilities and tax assets are not recognised if the temporary difference is attributable to goodwill or if it arises from a transaction that is the first reporting of an asset or liability (that is not a business combination) and which, on the transaction date, does not affect recognised or taxable income.
Deferred tax liabilities are recognised for taxable temporary differences attributable to investments in subsidiaries, except when the date for reversing the temporary differences can be controlled by the Group and it is probable that such a reversal will not take place in the foreseeable future. The deferred tax assets that are attributable to deductible temporary differences related to such investments shall only be recognised to the extent it is probable that the amounts can be utilised against future taxable profit and it is probable that these will be utilised in the foreseeable future.
The carrying amount for deferred tax assets is reviewed at the end of each reporting period and reduced to the extent it is no longer probable that sufficient taxable profit will be available to be utilised, wholly or partially, against the deferred tax assets.
Deferred tax is measured at the tax rates that are expected to apply for the period when the asset is realised or the liability is settled, based on tax rates (and tax laws) that have been decided or notified on the balance sheet date.
Deferred tax assets and tax liabilities are offset when they are attributable to income tax levied by the same authority and when the Group intends to settle the tax with a net amount.
Current and deferred tax is recognised as an expense or revenue in the income statement, except when the tax arises from transactions that are recognised as other comprehensive income or directly against equity. In such cases, the tax is also recognised in other comprehensive income or directly against equity. For current and deferred tax that arises during reporting of business combinations, the tax effect should be recognised in the acquisition calculation.
Property, plant and equipment is recognised at cost less accumulated depreciation and any accumulated impairments.
The cost consists of the purchase price, costs directly attributable to bringing the asset to the site and working condition for its intended use, and the estimated cost of dismantling and removing the asset, and restoring the site where it is located. Additional costs are included only if the asset is recognised as a separate asset, when it is probable that the future economic benefits that can be attributed to the item will flow to the Group and the cost for the same can be measured reliably. All other costs for repairs, maintenance and additional fees are recognised in the income statement for the period they arise.
Depreciation of property, plant and equipment is written off so that the asset's value less the estimated residual value at the end of the useful life, is depreciated on a straight-line basis over the estimated useful life, which is assessed as:
Improvements, leasehold 5–15 years Machinery and other technical plant 5 years Equipment, tools and installations 5 years
Estimated useful life, residual values, and depreciation methods are retested at least at the end of each financial period, the effect of any changes to assessments is recognised prospectively.
The carrying amount for property, plant and equipment is derecognised in the statement of financial position when it is retired or disposed, or when no future economic benefits are expected from the use or retirement/disposal of the asset. The gain or loss that arises when the asset is retired or disposed, is the difference between any net revenue during disposal and the carrying amounts recognised in profit for the period when the asset is derecognised in the statement of financial position.
Separately acquired intangible assets Intangible assets with a determinable useful life that are acquired separately are recognised at cost less accumulated depreciation and any accumulated impairments. Depreciation takes place on a straight-line basis over the asset's estimated useful life. Estimated useful life and depreciation methods are retested at least at the end of each financial year, the effect of any changes to assessments is recognised prospectively.
The Group's product development expenses are recognised as internally generated intangible assets in cases where the following conditions have been met:
If these conditions are not met, the cost of development is recognised instead as an expense in the period in which they arise.
Depreciation of the asset begins once product development for each internally generated intangible asset is considered complete. The asset is then recognised at cost of acquisition less accumulated depreciation and any accumulated impairments.
Intangible assets acquired through a business combination are identified and recognised separately from goodwill when they meet the definition of an intangible asset and their fair value can be measured reliably. The cost of such intangible assets comprises their fair value on the acquisition date.
After initial recognition, intangible assets acquired in a business combination are carried at cost less accumulated depreciation and any accumulated impairments in the same way as with separately acquired intangible assets.
| Technology | 15 years | |
|---|---|---|
| Customer relationships | 15 years | |
| Patents | 20 years | |
| Capitalised expenses for | ||
| product development | 5 years | |
| Brands | Indeterminable useful life |
An intangible asset is derecognised in the statement of financial position when it is retired or disposed, or when no future economic benefits are expected from the use or retirement/ disposal of the asset. The gain or loss that arises when an intangible asset is derecognised in the statement of financial position, comprises of the difference between the payment received during the disposal and the asset's carrying amount, and is recognised in the income statement when the asset is derecognised from the statement of financial position.
intangible assets excluding goodwill On each balance sheet date, the Group analyses tangible and intangible assets to determine whether there is evidence that these assets have decreased in value. If so, the asset's recovery value is measured to determine the value of any impairment. If it is not possible to determine the recovery value of an individual asset, the Group measures the recovery value of the cash generating unit to which the asset belongs.
Intangible assets with indeterminable useful life and intangible assets that are not yet finished for use shall be tested for impairment annually, or when there is evidence of loss in value.
The recoverable amount is the higher of the fair value less selling cost and its value in use. When measuring value in use, an estimate of the future cash flows is discounted to present value using the pre-tax discount rate that reflects current market assessments of the time value of money and the risks specific to the asset.
If the recovery value of an asset (or a cash generating unit) is determined to be below the carrying amount, an impairment loss is recognised for the carrying amount of the asset (or the cash generating unit) to reflect the recovery value. The impairment loss is immediately recognised as an expense in the income statement.
When an impairment loss is reversed, the carrying value of the asset (or the cash generating unit) is revalued to reflect the increase in recovery value, but this increased recovery value may not exceed what the depreciated historical cost would have been if the impairment of the asset had not been recognised (or cash generating unit). Reversal of an impairment loss is recognised directly in the income statement.
Financial assets or liabilities are recognised in the balance sheet when the company becomes a party pursuant to the contractual terms of the instrument. A receivable is recognised when the company has performed its contractual obligations, and there is a contractual obligation for the counterparty to pay, even if no invoice has been sent. Accounts receivable are recognised in the balance sheet when an invoice has been sent. A liability is recognised when the counterparty has performed its contractual obligations, and there is a contractual obligation to pay, even if no invoice has been received. Accounts payable are recognised when an invoice has been received.
A financial asset is derecognised in the balance sheet when the entitlements in the contract are realised, when the risks and rewards are transferred to another party, when the right to the cash flows ends or the company loses control of the asset. The same applies to part of a financial asset. A financial liability is derecognised in the balance sheet when the agreed obligation is discharged or otherwise extinguished. The same applies to part of a financial liability. The acquisition and sale of financial assets are recognised on the trade date, which is the day when the company commits itself to acquire or sell the asset.
From 1 January 2018 the Group applies IFRS 9 Financial Instruments. Before 1 January 2018 the Group applied IAS 39 Financial Instruments: Recognition and Measurement. When applying IFRS 9, financial assets and financial liabilities have a new classification as described below.
Financial liabilities
amortised cost
Cash and cash equivalents include cash assets and bank balances, and other short-term securities that are readily convertible to cash and are subject to an insignificant risk of changes in value. Classification as cash or cash equivalents requires that the maturity does not exceed three months from the date of the acquisition. Cash assets and bank balances are classified as 'Hold to collect' and these are measured at amortised cost. Since bank deposits are payable on demand, amortised cost equals the nominal amount.
Accounts receivable are classified as 'Hold to collect' and these are measured at amortised cost.
The Group does not apply hedge accounting, and all derivative instruments are therefore categorised as 'Fair value via the income statement' in the subcategory 'Other'. Derivative instruments with a positive fair value are recognised as assets in the 'Other current receivables' item. Derivative instruments with a negative fair value are recognised as liabilities in the 'Other current liabilities' item. Changes in value from derivative instruments are recognised either in net financial items or in operating income depending on the purpose of the instrument.
Currency forwards are used to hedge foreign currency flows. The Group used currency futures to hedge the USD flow in the year. The results for these are recognised under financial items.
Accounts payable are measured at their amortised cost. However, the expected maturity of accounts payable is short, so the liability is recognised at the nominal amount and is not discounted.
Interest-bearing bank loans, bank overdrafts and other loans are measured at their amortised cost using the effective interest rate method. Any differences between the loan received (net after transaction costs) and the repayment amount or the amortisation of the loan are recognised over the maturity period of the loan.
The fair value of financial assets and financial liabilities is measured as follows:
The fair value of financial assets and liabilities that have standard conditions that are traded on an active market is measured in relation to the quoted market price.
The fair value of other financial assets and liabilities is determined according to generally accepted valuation models that are based on information obtained from observable current market transactions.
The carrying amounts of all financial assets and liabilities are deemed to be a reasonable approximation of their fair value, unless otherwise stated.
Amortised cost is the amount at which the asset or liability is measured at initial recognition, less principal repayments and plus or minus any accumulated accruals using the effective interest method of the initial difference between the amounts received or paid and amounts to be received or paid on the due date and less depreciation. The effective rate is the interest rate at which, when discounting all estimated future cash flows over the expected maturity, results in the initial carrying amount of the financial asset or the financial liability.
Financial assets and financial liabilities are offset and recognised as a net amount in the balance sheet when there is a legal right to offset and when the intention is to settle the items on a net basis or to simultaneously realise the asset and settle the liability.
One new feature of IFRS 9 is that a credit loss provision must be made based on expected losses. The Group recognises a provision for expected credit losses from financial assets measured at amortised cost or fair value via other comprehensive income, for lease receivables and contract assets. The impairment rules do not extend to equity instruments. On each balance sheet date, the change in expected credit losses since initial recognition is recognised in profit or loss.
The purpose of the impairment requirements is to recognise the expected credit losses for 12 months for all financial assets and the remaining term for all financial assets for which significant increases have occurred in the credit risk since initial recognition, either assessed individually or collectively, in view of all reasonable and verifiable data, including forward-looking data. The Group measures expected credit losses from a financial instrument in a way that reflects an objective and probability-weighted amount that
is determined by evaluating a range of possible outcomes, the time value of money and reasonable verifiable data about current conditions and forecasts regarding future economic conditions.
Cash and cash equivalents and other operating receivables with a maturity of less than 12 months are covered by the general model, with the exception of low credit risk. Based on this no credit loss provision has been deemed necessary for the Group's cash and cash equivalents and other operating assets.
For accounts receivable, contract assets and lease receivables there is a simplified model, which means that the Group directly recognises expected credit losses for the remaining term of the asset. The Group applies the simplified model for accounts receivable using a matrix, where a historic credit loss is an indicator that is adjusted for current and future factors.
The Group's exposure to credit risk is primarily attributable to accounts receivable. The simplified model is used to calculate credit losses on the Group's accounts receivable. When calculating the expected credit losses, accounts receivable have been grouped based on the customers' credit rating. The expected credit losses for accounts receivable are calculated using a provision matrix based on previous events, current conditions and forecasts regarding future financial conditions. For quantified information, see note 4.
Impairment of accounts receivable and other receivables is recognised in operating expenses. Impairment of cash and cash equivalents and Other non-current securities holdings are recognised as a financial expense.
Before 1 January 2018, when IAS 39 was applied, the Group made reservations for doubtful account receivables, which consisted of the overdue account receivable for which payment appeared to be less likely.
IAS 39 Financial Instruments: Recognition and Measurement, had another classification of financial assets and financial liabilities:
Regarding transitional effects on financial assets in terms of classification and valutaion, see note 4.
Inventories are carried at the lowest of cost or net realisable value. Cost is measured by first applying, the FIFO (First in, first out) method. Net realisable value is the expected sales price less expected costs necessary for completion and expected costs necessary for a sale.
Provisions are recognised when the Group has a legal or informal obligation based on past events, it is probable that an outflow of resources will be required to settle the obligation, and the amount can be reliably measured.
The amount reserved is the best estimate of the amount required to settle the existing obligation on the balance sheet date, considering the risks and uncertainties associated with the obligation. When a provision is measured by
estimating the payments expected to be required to settle the obligation, the carrying amount shall correspond to the present value of these payments.
When a part or all of the amount required to settled a provision is expected to be repaid by a third party, the reimbursement shall be separately recognised as an asset in the statement of financial position when the realisation of income is virtually certain if the company settles the obligation and the amount can be reliably measured.
The parent company applies the Swedish Annual Accounts Act and the Swedish Financial Reporting Board's Recommendation (RFR 2) Accounting for legal entities. The application of RFR 2 means that the parent company, to the extent possible, follows all the EU approved IFRS within the framework of the Swedish Annual Accounts Act and the Swedish Pension Obligations Vesting Act and considers the relationship between accounting and taxation.
The new standard IFRS 9 Financial instrumentsdeals with classification, valuation and accounting of financial assets and liabilities. For a description of IFRS 9 see corresponding section above for the Group. The changes in the RFR2 regarding IFRS 9 shall be applied for fiscal years starting January 1, 2018 or later.
Taking into account the connection between accounting and taxation companies do not have to apply IFRS 9 to a legal entity. The parent company has chosen not to apply IFRS 9 in legal person. The changes that came into force January 1, 2018 regarding write-down requirements according to IFRS 9, must be applied even if the company is applying the exception. The above did not have any effect on the reported amounts in the parent company's financial statments, but the changes have led to expanded information.
The changes in RFR 2 regarding IFRS 15 Revenue from Agreements with customers, shall be applied for fiscal years starting January 1, 2018 or later. For a description of IFRS 15 see corresponding section above for the Group. The transition to IFRS 15 did not have any effect on the reported amounts in the parent company's financial statements, but the changes have led to expanded information.
The differences between the accounting policies of the parent company and the Group are described below:
The parent company's income statement and balance sheet follow the format specified in the Swedish Annual Accounts Act. The differences from IAS 1 Presentation of Financial Statements that were used in preparing the Group's financial statements are primarily recognising revenues and costs,
The most significant assumptions concerning the future, and other important sources of uncertainty in estimations on the balance sheet date, which cause a significant risk for substantial adjustment to carrying amounts for assets and liabilities in the coming financial year are described below.
One condition for revenue recognition is that revenue from sales must illustrate the transfer of promised goods and services to customers at an amount that reflects the consideration that the company is expected to be entitled to in return for these goods or services. The assessment of when these risks and rewards are transferred requires review of each contract and circumstance under which each transaction is conducted.
Bactiguard's new licensing agreements involve a certain level of complexity, as the value of the licensing business needs to be distributed over time based on the assessment of phases, obligations and the distribution of the transaction price. These estimates and judgements for new licensing agreements may have a significant impact on recognised revenues. The quantified amounts which are assessed as revenues are recognised in note 5.
The Group conducts impairment testing annually for goodwill and brand or whenever there is an indication they may be impaired. In order to determine whether the value of these assets has decreased, the cash-generating unit to which goodwill and trademark are attributed must be measured by discounting the unit's cash flows. By applying this method, the company is relying on a number of factors, including achieved results, business plans, economic forecasts and market data. This is described in more detail in Note 14. As can be deduced from the description, changes in the conditions for these assumptions and estimates could have a significant effect on the value of goodwill and brand.
non-current assets, equity, and the introduction of provisions as a separate item.
Shares in subsidiaries are recognised at cost in the parent company's financial statements. Acquisition-related costs for subsidiaries that are charged in the consolidated financial statements are included as a part of the cost for shares in subsidiaries.
A group contribution received by the parent company from a subsidiary is recognised using the same policies as regular dividends from that subsidiary, which entails that the group contribution is recognised as financial income.
Group contributions from the parent company to a subsidiary are recognised in the income statement as an appropriation.
The parent company's pension commitments have been calculated and recognised based on the Swedish Pension Obligations Vesting Act. Applying the Swedish Pension Obligations Vesting Act is a prerequisite for tax deductibility.
As the parent company has elected not to apply IFRS 9 to legal entities, a method has been applied that is based on cost of financial instruments in accordance with the Swedish Annual Accounts Act.
Due to the relationship between accounting and taxation, the rules in IFRS 16 Leases do not need to be applied to legal entities. The companies that elect to apply the exemption instead introduce rules that include the principles that apply to the reporting of leasing agreements by lessees and lessors, the recognition of sale-and-lease back transactions, and disclosure requirements. The amendments to RFR 2 regarding IFRS 16 will start to be applied for the financial year beginning 1 January 2019 or later.
The parent company will not apply IFRS 16 to legal entities, which means that the transition to IFRS 16 will not have any impact on the parent company's financial statements, but may lead to increased disclosures.
The management assesses that other amendments to RFR 2, which have not entered into force, are not expected to have any material impact on the parent company's financial reports when they are applied the first time.
Group management determines the estimated useful life and consequent depreciation for the Group's intangible and tangible fixed assets. Estimates of the useful lives of intangible assets are based on expectations of how long the asset is expected to yield financial benefits. The useful lives of the tangible assets are based on the history of the useful lives of the corresponding assets. The useful life and assessed residual values are evaluated at the end of each financial year, and the estimated useful life could change the outcome whereby the results and financial position of the period may be affected.
Accounts receivable are one of the most substantial items in the balance sheet and are recognised at their nominal amount, net after deductions for expected credit losses.
The expected credit losses for accounts receivable are subject to estimates and judgements. In line with IFRS 9 the Group uses a model for provisioning based on the credit risk of all accounts receivable. The model contains several parameters which are subject to judgments, for example how different risk classes are defined and how expected default for each risk class is assessed on the basis of history and expected development. These estimates and assessments affect the size of the credit loss reserve and thus also the reported results of the Group.
Through its activities, the Group is exposed to various types of risk. The Group's objective is to create a comprehensive risk management programme that concentrates on minimising potential unfavourable effects on financial results. The company's Board of Directors is ultimately responsible for the exposures, management and follow-up of the Group's risks. The frameworks that apply to the exposures, management, and follow-up of financial risks are set by the Board of Directors and revised annually. The Board of Directors has delegated responsibility for daily risk management to the company's CEO, who in turn has delegated this to the company's CFO. The Board of Directors is able to decide on temporary departures from these established frameworks. The financial risks Bactiguard is thus exposed to are addressed separately below.
Liquidity and financing risks involve the risk of not being able to meet payment obligations due to having insufficient liquidity or difficulties in obtaining external loans. The table below illustrates the Group's liquidity risks using a maturity analysis of financial liabilities. The amounts in these tables are not discounted values and they also contain, where applicable, interest payments and amortisation, whereby these amounts can not be reconciled against the amounts recognised in the balance sheets. Interest payments are determined based on conditions which apply on the balance sheet date. Amounts in foreign currencies are translated to Swedish krona on the balance sheet date exchange rates.
The company manages liquidity and financing risks through continual monitoring of liquidity forecasts and assessment of alternative financing solutions.
| Within 3 months | 3–12 months | 2–5 years Later than 5 years | Total | ||
|---|---|---|---|---|---|
| Group 31/12/2017 | |||||
| Liabilities to credit institutions | 1,188 | 10,899 | 150,406 | – | 162,493 |
| Leasing debt | 360 | 1,106 | 6,616 | 5,860 | 13,942 |
| Accounts payable | 4,832 | – | – | – | 4,832 |
| Total | 6,380 | 12,005 | 157,022 | 5,860 | 181,267 |
| Group 31/12/2018 | |||||
| Liabilities to credit institutions | 1,081 | 18,151 | 131,168 | – | 150,400 |
| Leasing debt | 378 | 1,160 | 8,891 | 2,047 | 12,476 |
| Accounts payable | 7,051 | – | – | – | 7,051 |
| Bank overdraft | – | – | 3,905 | – | 3,905 |
| Total | 8,510 | 19,311 | 143,964 | 2,047 | 173,832 |
| The parent company 31/12/2017 | |||||
| Liabilities to credit institutions | 1,188 | 10,899 | 150,406 | – | 162,493 |
| Accounts payable | 296 | – | – | – | 296 |
| Total | 1,484 | 10,899 | 150,406 | – | 162,789 |
| The parent company 31/12/2018 | |||||
| Liabilities to credit institutions | 1,081 | 18,151 | 131,168 | – | 150,400 |
| Accounts payable | 181 | – | – | – | 181 |
| Total | 1,262 | 18,151 | 131,168 | – | 150,581 |
Credit risk refers to the risk that a counterparty in a transaction causes a loss to the Group by not fulfilling its contractual obligations. The Group's exposure to credit risk is primarily attributable to accounts receivable. To limit the Group's credit risk, every new customer is subjected to a credit analysis. The financial situation for existing customers is also continually monitored to identify warning signals at an early stage.
Accounts receivable are spread to a large number of customers where, however, a few of these represent a substantial amount of total accounts receivable. The company's largest customer is BD whose payment history is excellent, and payment terms with 50% advance invoicing are applied. Advance invoicing is also applied to larger transactions and to new distributors in order to minimise credit risk.
There is no significant concentration of credit risks. Sales of goods are only made to customers for which the credit risk is assessed as small. Bactiguard uses the Swedish Export Credits Guarantee Board's assessment of credit worthiness in each country. The greatest exposure to credit risk corresponds to the carrying amount in the balance sheet for each financial asset.
From 1 January 2018 the Group applies IFRS 9 Financial Instruments, which involves a new way of classifying and measuring financial instruments. The table below shows the transition effects on financial assets from classification and measurement, and how the Group's financial assets are classified as per 31 December 2018.
Accounts receivable are not concentrated to any single geographic area.
| Financial assets | IAS 39 Recognised as of 31/12/2017 |
Effect transition IFRS 9 |
IFRS 9 1/1/2018 |
Recognised as of 31/12/2018 | ||
|---|---|---|---|---|---|---|
| Category | Loans and | Hold to collect | Hold to collect | Other | Hold to collect | |
| accounts receivable | and sell | |||||
| Fair value | Fair value through | |||||
| through the | other compre | |||||
| Measurement | Amortised cost | Amortised cost | Amortised cost | income statement | hensive income | |
| Assets | ||||||
| Accounts receivable | 56,859 | -932 | 55,927 | 54,492 | ||
| Other current receivables | 2,046 | 0 | 2,046 | 3,204 | 20 | |
| Accrued expenses and | 11,254 | 0 | 11,254 | 11,197 | ||
| prepaid income | ||||||
| Cash and cash equivalents | 11,550 | 0 | 11,550 | 1,893 | ||
| Total | 81,709 | -932 | 80,777 | 70,786 | 20 |
| Financial liabilities | IAS 39 Recognised as of 31/12/2017 |
Recalculated as a result of IFRS 9 |
IFRS 9 Recalculated on 1/1/2018 |
Recognised as of 31/12/2018 |
|---|---|---|---|---|
| Category | Financial liabilities | Financial liabilities | Financial liabilities | |
| Measurement | Amortised cost | Amortised cost | Amortised cost | |
| Liabilities | ||||
| Long-term interest-bearing liabilities | 142,500 | 0 | 142,500 | 130,805 |
| Short-term interest-bearing liabilities | 7,500 | 0 | 7,500 | 14,400 |
| Accounts payable | 4,832 | 0 | 4,832 | 7,051 |
| Other liabilities | 40,947 | 0 | 40,947 | 44,930 |
| Total | 195,779 | 0 | 195,779 | 197,186 |
Accounts receivable with a maturity longer than 12 months are discounted. As of 31 December 2018 there were no non-current accounts receivable.
A credit loss provision has been calculated in accordance with IFRS 9 and is set out in the table below. The credit loss provision for the transition to IFRS 9 on 1 January 2018 was calculated at TSEK -932 and was booked via the opening balance in Equity. The Group's impairment model is based on four different risk classes. Customers are classified into these risk classes based on their credit worthiness and payment history. Each risk class has an expected loss level, which is assessed based on previous events, current conditions and forecasts regarding future financial conditions. The classification of customers is reviewed on each quarterly closing and the customers may then be reclassified to a different risk class. Changes in the provision for expected credit losses are booked quarterly.
In addition to expected credit losses for all accounts receivable there is also a provision for credit losses from individual assessment. For example in cases when there is an assessment that the full amount of the receivable needs to be written down. For mor more information regarding the Group's provision for credit losses, see Note 26.
| Risk class 1 | Risk class 2 | Risk class 3 | Risk class 4 | Credit loss pro vision, individual |
Total outstanding receivables SEK |
|
|---|---|---|---|---|---|---|
| assessment | ||||||
| 31/12/2017 | ||||||
| Accounts receivable, gross | 54,063 | |||||
| Bad debts | -688 | |||||
| Exchange rate adjustment | 3,484 | |||||
| Total accounts receivable, net 31/12/2017 | 56,859 | |||||
| 01/01/2018 | ||||||
| Accounts receivable, gross per risk class | 30,173 | 4,936 | 4,181 | 14,772 | 54,063 | |
| Exchange rate adjustment | 3,484 | |||||
| Expected loss level % | 0.2% | 1% | 2% | 5% | ||
| Credit loss provision | -60 | -49 | -84 | -739 | -688 | -1,620 |
| Total accounts receivable, net 01/01/2018 | 55,927 | |||||
| 31/12/2018 | ||||||
| Accounts receivable, gross per risk class | 6,290 | 29,947 | 3,651 | 16,344 | 56,232 | |
| Exchange rate adjustment | 4,664 | |||||
| Expected loss level % | 0.2% | 1% | 2% | 5% | ||
| Credit loss provision | -13 | -299 | -73 | -817 | -5,202 | -6,404 |
| Total accounts receivable, net 31/01/2018 | 54,492 |
The Group's objective of managing capital is to ensure the Group's capability to continue its operations, in order to generate reasonable returns to the shareholders and benefit other stakeholders.
Currency risk relates to the risk that the fair value or future cash flows fluctuate due to changes in exchange rates. The exposure for currency risk primarily derives from payment flows in foreign currencies, referred to as 'transaction exposure,' and from translating balance sheet items in foreign currency and during translation of foreign subsidiaries' income statements and balance sheets to the Group's presentation currency which is Swedish krona, referred to as 'currency exposure.'
The Group's outflows primarily consist of SEK and USD while the
primary inflows are USD and EUR. The Group is thereby highly affected by changes in these currency exchange rates.
Under the Group's currency policy such transaction exposure can be reduced through the use of derivative instruments. Pursuant to the currency policy, the Group may use forward contracts, swaps and currency options. If such instruments are used, hedging should take place by 40–80% of the forecasted cash flows in the relevant currency for the next twelve months. As of 31 December 2018 there was MEUR 0.3 (-) in outstanding currency contracts.
The Group's consolidated profit is primarily affected by exchange rates which are mostly attributable to USD and EUR. Under the Group's finance policy, currency exposure shall not be hedged.
Based on the year's revenues, cost, and currency structures, a general one percent point change in the exchange rate between SEK and USD would impact the Group's operating profit by approximately MSEK +/– 0.5 (0.6). A similar change to the rate of SEK in relation to the EUR (one percentage point) would impact the Group's operating profit by approximately MSEK +/- 0 (0.1).
Interest rate risk relates to the risk that the fair value or future cash flows fluctuate due to changes in market rates of interest. The Group is primarily exposed to interest rate risk through its loan financing.
As the loan runs at an interest base of Stibor 90, however minimum 0%, and an interest surcharge of 3.0%, the company's foremost interest risk to possible changes is represented by the underlying Stibor rate.
— 52 —
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | ||
| License revenues | 109,536 | 125,609 | – | – | |
| Sales of BIP products | 40,561 | 21,849 | – | – | |
| Change in inventory of finished goods and products in progress | 1,405 | 1,238 | |||
| Other operating revenues | 11,658 | 4,943 | 6,967 | 6,464 | |
| Total | 163,160 | 153,639 | 6,967 | 6,464 |
From 1 January 2018 the Group applies IFRS 15. The transition to IFRS 15 did not have any impact on the Group's profit or financial position. The table above includes items from the income statement that are not defined as revenue in accordance with IFRS 15; the table has only been produced to illustrate the items in net sales and other operating revenues from the income statement. Below he Group's revenues are defined in accordance with IFRS 15.
The Group's revenues come from sale of BIP products and license revenues.
Revenues from the sale of products are recognised at the time the control passes to the customer, i.e. when the ownership of the product has been transferred to the customer which normally coincides with delivery to customer.
The licensing rights refer to the right to use Bactiguard's technology to provide coating for products. When a new license agreement is signed, it is analysed based on the five-step model in IFRS 15. A new license agreement is normally divided into two phases; the collaboration phase and the commercial phase. Various performance obligations are identified in the different phases of the license agreement and a transaction price per obligation is stipulated in the agreement. The first obligation in the collaboration phase is normally when the contractual party obtains the license entitlement to immediately use Bactiguard's technology. A signing fee is payable for this right and the performance obligation in this part of the agreement is completed when the contract has been signed and is
therefore recognised as revenue directly, at a certain point in time. The collaboration phase then continues with several different
performance obligations, such as development and testing. The time frames for satisfying each performance obligation is set based on definitions and expectations in agreements and project schedules. When the performance obligation has been fulfilled, the part of the transaction price that has been allocated to this performance obligation is recognised as revenue. These revenues are therefore recognised over time. Production methods are used to determine whether a performance obligation has been fulfilled. These methods include analysing the performance that has been achieved, test results and the amount of time that has passed. Continual assessments are made in consultation with the license party to determine how far the collaboration has progressed, what the next step is, etc. This is considered to be a suitable basis for assessing which performance obligations have been met and which transaction price can be recognised as revenue in the period.
When the collaboration phase is finished the license agreements turns into the commercial phase. Most of the Group's existing license agreements are in the commercial phase. In this phase the revenues are recognised at a certain point in time, relating to the period to which the licensing right relates.
The table below shows the division of the Group's revenues for 2018 in terms of the type of product/service, the time of revenue recognition, and the part of the transaction price that has been allocated to the remaining performance obligations in the future.
| 2018 | |
|---|---|
| License revenues | 109,536 |
| Sales of BIP products | 40,561 |
| Total | 150,097 |
| Time of revenue recognition | Group |
|---|---|
| 2018 | |
| Performance obligations fulfilled at a certain point in time | 141 781 |
| Performance obligations fulfilled over time | 8,317 |
| Total | 150,097 |
Revenues for remaining performance obligations as per 31 December 2018 amount to TSEK 2,072. These revenues come from the new licensing deal with Well Lead in China, which was signed in 2018 for the right to use Bactiguard's technology. The remaining performance obligations in this licensing deal and how these are expected to be recognised are set out in the table below.
Transaction price that is allocated to the remaining performance obligations Group
| 2019 | 2020 | 2021 | |
|---|---|---|---|
| Services for technical support and quality assurance | 1,036 | - | - |
| Services for consultation on regulatory product approval | 1,036 | - | - |
| Total | 2,072 | - | - |
Bactiguard does not apply a general right of return for products to its distributors.
The Group applies a variety of different payment terms, depending on, for example, the market where the distributor operates and complexity in the agreement. Payment terms with 50% advance invoicing is applied to the Group's largest customer, BD. Advance invoicing is also applied to new distributors. The former business model involved the distributor paying a
fee for the right to a geographic market, with the right to call off products at a value corresponding to the prepaid income. Since 2015 no new agreements have been concluded with the right to call off products, but a few remain where prepaid income is considered to be an advance paid by a customer, with a contractual liability recognised in the balance sheet. The table below shows the agreement balance of advances from customers and prepaid territorial fees.These agreement liabilities is shown in the item accrued expenses and prepaid income (see Note 32).
| Agreement liabilities | Prepaid income |
|---|---|
| Opening balance 1 January 2018 | 29,299 |
| Gross increase during the year | 9,309 |
| Revenues recognised during the year | -6,535 |
| Other changes to contract balances* | -22,668 |
| Closing balance 31 December 2018 | 9,406 |
* This change relates to prepaid territorial fees that were adjusted during the year due to contracts being terminated. The territorial fees are mirrored by an account receivable of the same amount, which is also cleared from the balance sheet when contracts are terminated.
Intra-group purchasing in the parent company for 2018 was TSEK 6,967 (6,464) and purchases were TSEK 0 (-).
The information recognised to the chief operating decision makers as bases for distribution of resources and assessing segment profit, is not separated into different operating segments. The Group is therefore seen as a single operating segment.
Net sales totalled TSEK 150,097 (147,458) allocated to the following geographic markets: America 68% (71%), MEA 3% (4%), Asia (19%) (7%), Europe 11% (18%) of which Sweden 2% (15%).
Of the Group's total intangible and tangible assets of TSEK 501,927 (530,072), less than 1% (1%) were attributable to foreign subsidiaries.
No sales of goods were made in the parent company for the period.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Operating profit includes exchange rate differences relating to operating receivables and operating liabilities as follows: |
||||
| Other operating revenues | 5,691 | 2,208 | – | – |
| Other operating expenses | -5,022 | -5,141 | – | – |
| Total | 669 | -2,939 | – | – |
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Deloitte | ||||
| audit assignment | 530 | 510 | 530 | 510 |
| additional audit assignments | 57 | 124 | 33 | 124 |
| tax consultancy | – | 2 | – | 2 |
| other services | 37 | – | 22 | – |
| Total | 624 | 636 | 585 | 636 |
| Other auditors | ||||
| audit assignment | 56 | 48 | – | – |
| audit-related | – | – | – | – |
| services | ||||
| tax consultancy | – | – | – | – |
| other services | – | – | – | – |
| Total | 56 | 48 | – | – |
The audit assignment refers to fees charged for the statutorily required audit. The assignment includes auditing the annual accounts and financial statements, reviewing the administration of the Board of Directors and Chief Executive Officer, and the fees for audit advice provided to the company during the audit engagement. Other audit assignments refer to quality assurance services and include, for example, an in-depth audit of new IFRS rules and audits of projects with grants.
On the balance sheet date, the parent company and the Group had outstanding commitments in the form of minimum lease fees for non-cancellable operating leasing agreements, with due dates as below:
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Within 1 year | 10,584 | 9,178 | – | – |
| Between 1 year and 5 years | 37,136 | 35,839 | – | – |
| After more than 5 years | 49,379 | 57,018 | – | – |
| Total | 97,099 | 102,035 | – | – |
The rental commitment is the largest portion of the amounts above. Expenses for operating leasing agreements for the year totalled TSEK 10,529 (10,391) for the Group and TSEK 0 (0) for the parent company.
| Employees | 2018 | 2017 | |||
|---|---|---|---|---|---|
| Number of | Of which | Number of | Of which | ||
| Average number of employees | employees | women | employees | women | |
| Parent company | 3 | 1 | 3 | 1 | |
| Swedish subsidiaries | 43 | 24 | 36 | 22 | |
| Foreign subsidiaries | 20 | 15 | 27 | 17 | |
| Group total | 66 | 40 | 66 | 40 |
| 2018 | 2017 | ||||||
|---|---|---|---|---|---|---|---|
| Salaries and | Salaries and | ||||||
| Total salaries and other remuneration to | other remu | Social secu | other remu | Social security | |||
| employees | neration | rity costs | Total | neration | costs | Total | |
| Parent company | 4,966 | 3,101 | 8,066 | 4,467 | 2,634 | 7,100 | |
| – of which pension costs | 1,320 | 1,320 | 1,231 | 1,231 | |||
| Swedish subsidiaries | 29,444 | 12,237 | 41,681 | 28,665 | 12,284 | 40,949 | |
| – of which pension costs | 5,107 | 5,107 | 4,995 | 4,995 | |||
| Foreign subsidiaries | 3,298 | 565 | 3,862 | 3,253 | 542 | 3,795 | |
| – of which pension costs | 318 | 318 | – | – | |||
| Group total | 37,708 | 15,902 | 53,610 | 36,385 | 15,459 | 51,844 | |
| – of which total pension costs | 6,745 | 6,745 | 6,226 | 6,226 |
Salaries and remuneration to employees excludes consultant fees, i.e. not employees. The above figures do not include other personnel costs, which amount to TSEK -2,392 (-1,474). Personnel costs relating to the time spent on ongoing product development projects of TSEK 2,497 (1,843) have been capitalized during 2018 and has positively affected the item Personnel costs in the Income Statement.
| Board of Directors and senior managers in the Group | 2018 | 2017 | |||
|---|---|---|---|---|---|
| Board of | Senior | Board of | Senior | ||
| Gender distribution in Board of Directors and senior managers | Directors | managers | Directors | managers | |
| Men | 3 | 2 | 3 | 5 | |
| Women | 2 | 2 | 2 | 5 | |
| Total | 5 | 4 | 5 | 10 |
The CEO, also board member, is included in the Board in the above table.
| 2018 | 2017 | |||||||
|---|---|---|---|---|---|---|---|---|
| Remuneration and other ben efits to senior managers in the |
Other | Other | ||||||
| Group | Salary/Fee | benefits | Pension | Total | Salary/Fee | benefits | Pension | Total |
| Chief Executive Officer | 1,946 | – | 522 | 2,468 | 2,113 | – | 522 | 2,635 |
| Other senior management | 6,456 | – | 1,463 | 7,919 | 12,362 | 62 | 2,182 | 14,606 |
| Total | 8,402 | – | 1,985 | 10,387 | 14,475 | 62 | 2,704 | 17,242 |
The CEO of the parent company Bactiguard Holding AB was employed for the year. No agreements regarding severance pay are in effect between the company and the current CEO or other senior management. The definition of other senior managers has changed for the year 2018 and now only includes Group management, which comprised four people at the end of the year. However, more people were in Group management during the full-year 2018, so salaries to other senior executives are equivalent to salaries for 5.5 senior managers. In previous years, the CFO, three regional sales managers, the head of product development and market access, the clinical research manager, and a manager for production and purchasing were also included in the definition of senior managers. Guidelines for remuneration to senior executives are described in the Directors' Report on Page 28.
| 2018 | 2017 | |||||||
|---|---|---|---|---|---|---|---|---|
| Other | Other | |||||||
| Salary/ | remunera | Salary/ | remunera | |||||
| Board of Directors | Board fee | tion | Pension | Total | Board fee | tion | Pension | Total |
| Jan Ståhlberg, Chairman of the | 292 | 58 | 350 | |||||
| Board from AGM May 2018 | ||||||||
| Stanley Brodén, Chairman of the | 208 | 42 | – | 250 | 500 | 100 | – | 600 |
| Board up to AGM May 2018 | ||||||||
| Christian Kinch, member of the | – | – | – | – | – | – | – | – |
| board | ||||||||
| Mia Arnhult, member of the board | 200 | 100 | – | 300 | 200 | 100 | – | 300 |
| Marie Wickman-Chantereau, Board | 200 | – | – | 200 | 200 | – | – | 200 |
| member | ||||||||
| Svante Östblom, member of the | 200 | _ | – | 200 | 117 | – | – | 117 |
| board from AGM May 2017 | ||||||||
| Peter Hentschel, Board member, | – | – | – | – | 83 | – | – | 83 |
| up to AGM May 2017 | ||||||||
| Total | 1,100 | 200 | – | 1,300 | 1,100 | 200 | – | 1,300 |
Board fees are paid from the parent company. Variable remunerations, , included in the afore-mentioned salaries and remuneration to the Board of Directors and CEO totalled TSEK - (-). Defined benefit plans do not form any portion of the total pension costs of the Group parent company. Other remuneration comprises fees for the chair of the audit and remuneration committees.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Interest income | 38 | – | – | – |
| Interest income, group company | – | – | 3,073 | 3,076 |
| Exchange rate gains | 1,246 | – | – | – |
| Other financial income | 2,414 | 1,378 | – | – |
| Total financial income | 3,698 | 1,378 | 3,073 | 30,076 |
All interest income is attributable to financial assets that are measured at their amortised cost. Other financial income for 2018 refers in its entirety to the reversal of the discounting of non-current receivables. The discounting of receivables was reversed following the early termination of the agreement with the former distributor in China. There was also a non-current liability with the same distributor, which has been discounted. The reversal of a discounted liability impacts other financial expenses by a corresponding amount (see note 12), which means that the early termination has not had any net effect on financial items.
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | ||
| Interest expenses | 5,927 | 6,438 | 5,122 | 5,321 | |
| Exchange rate loss | – | 796 | – | – | |
| Other financial expenses | 6,426 | 1,854 | – | – | |
| Total financial expenses | 12,353 | 9,088 | 5,122 | 5,321 |
Interest expenses in the Group are attributable to interest on bank loans and interest on financial leasing liabilities. The bank overdraft facility has been measured at amortised cost. Other financial expenses comprise losses in currency contracts and the discounting of non-current liabilities.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Nominal tax (22%) | 4,553 | 1,824 | 1,215 | 1,259 |
| Tax effect non-deductible expenses | -899 | -470 | 0 | -1 |
| Tax effect non-deductible income | 34 | 537 | – | – |
| Utilized loss carry-forwards for which no deferred tax assets are recog | 3,299 | 4,410 | – | – |
| nised | ||||
| Tax effect for which no deferred tax loss carry-forwards are recognised | - 1,223 | -1,259 | -1,215 | -1,258 |
| Total | 5,764 | 5,042 | – | – |
The Group has tax loss carry-forwards on 31 December 2018 of TSEK -340,233 (-347,599) that can be used against future profits. The tax loss carry-forwards have no maturity date.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Current taxes | -8 | – | – | – |
| Deferred taxes | 5,772 | 5,042 | – | – |
| Total | 5,764 | 5,042 | – | – |
Temporary differences occur whenever the carrying amounts and taxable values of assets and liabilities differ. The temporary differences of the Group and parent company have resulted in deferred tax liabilities and deferred tax assets in regard to the following items:
| Group | ||||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | |||
| Deferred tax assets | - | |||
| Opening value loss carry-forwards | 33,606 | 33,606 | ||
| Change of the year | - | - | ||
| Change due to new tax rate | -2,139 | - | ||
| Closing value deferred tax assets | 31,467 | 33,606 | ||
| Deferred tax liabilities | - | - | ||
| Intangible assets | 58,848 | 63,891 | ||
| Change of the year | -4,853 | -5,043 | ||
| Change due to new tax rate | -3,058 | - | ||
| Closing value deferred tax liabilities | 50,938 | 58,848 | ||
| Total net deferred tax liabilities | 19,471 | 25,242 |
The deferred tax asset of TSEK 31,467 (33,606) arose when Bactiguard Holding acquired Bactiguard AB. In 2018 the deferred tax asset was remeasured at 20.6% which is a new tax rate that will come into force from 2021. This tax claim is not expected to be utilized until after 2021 because additional loss carry-forwards have arised after the acquisition.
The deferred tax assets have reduced the deferred tax liabilities on intangible assets in conjunction with this acquisition. The year's change to deferred tax liabilities is attributable to temporary differences related to the depreciation of intangible assets. The deferred tax liabilities were remeasured in 2018 and the new tax rates will apply from 2019.
The net is recognised as deferred tax liability in the balance sheet. The remeasurement based on these new tax rates affected deferred tax by TSEK 918 in 2018.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 226,292 | 226,292 | – | – |
| Closing accumulated acquisition value | 226,292 | 226,292 | – | – |
| Net carrying amount | 226,292 | 226,292 | – | – |
The carrying amount of goodwill is attributable to Bactiguard Holding's acquisition of Bactiguard AB.
Impairment testing of goodwill and brands with indeterminable useful life is conducted annually in the Group and, when indications arise of the necessity for impairment testing. Goodwill that arose in connection with a business combination was allocated on the transfer date to the cash generating units in the Group that were expected to obtain benefits of the combination. Bactiguard Holding has a single cash generating unit.
The recoverable amount for a cash generating unit is established based on estimations of value in use. These estimations are based on expected future cash flows identified in financial forecasts that were approved by the company management that cover a five-year period. The assessment of future cash flows includes assumptions regarding primarily sales growth and discount rates. The management expects stable growth and a good rate of development for both sales of BIP products and license revenues, for a five-year period. The discount rate of 13.7% (13.2%) before taxes reflects specific risks tied to the asset. The forecasted operating margin was based on previous performance and the management's expectations of the market. Growth beyond the forecasted five-year period is expected to be 1.5% (1.5%) per year, which matches the Group's long-term assumptions for inflation. These assumptions are in line with the previous year's impairment testing.
The assumptions of impairment testing follow the company's growth strategy which is divided into the following four phases;
Bactiguard is in a growth and build-up phase, with market expansion. Investments have been made in the sales and marketing function, the product portfolio has been developed, and opportunities for new licensing business have been investigated. The rewards of these investments are now expected to have greater impact. In the impairment test, this means an assumption of rising operating margins during the five-year period due to higher sales volumes and license revenues.
Based on the assumptions presented above, the value in use exceeds the carried goodwill and the conclustion is that there is no impairment requirement for goodwill and brand. Sensitivity analysis has been carried out, where the discount rate has been increased by 4 percentage points and expected future cash flow has increased by 30%without this resulting in a change of the conclusion. The impairment testing does not include any effects of potential future restructuring or future improvements to the bulk of assets. The forecast revenue is based on the present and existing condition of the assets.
— 57 —
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 357,100 | 357,100 | – | – |
| Closing accumulated acquisition value | 357,100 | 357,100 | – | – |
| Opening depreciation | -144,295 | -120,488 | – | – |
| Depreciation for the year | -23,807 | -23,807 | – | – |
| Closing accumulated depreciation | -168,102 | -144,295 | – | – |
| Net carrying amount | 188,998 | 212,805 | – | – |
The item technology includes Bactiguard's patented and unique coating technology which can be applied to a broad spectrum of products.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 25,572 | 25,572 | – | – |
| Closing accumulated acquisition value | 25,572 | 25,572 | – | – |
| Net carrying amount | 25,572 | 25,572 | – | – |
The carrying amount for brands is attributable to Bactiguard Holding's acquisition of Bactiguard AB as Bactiguard was identified as an intangible asset. The brand is known, established and enjoys trademark protection for an indeterminate period in relevant markets where the company operates. The Group conducts impairment testing annually for the brand or whenever there is an indication that it may be impaired, see note 14.
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | ||
| Opening acquisition value | 17,700 | 17,700 | – | – | |
| Closing accumulated acquisition value | 17,700 | 17,700 | – | – | |
| Opening depreciation | -7,152 | -5,972 | – | – | |
| Depreciation for the year | -1,180 | -1,180 | – | – | |
| Closing accumulated depreciation | -8,332 | -7,152 | – | – | |
| Net carrying amount | 9,368 | 10,548 | – | – |
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 24,245 | 20,586 | – | – |
| Capitalisation for the year | 4,867 | 3,658 | – | – |
| Closing accumulated acquisition value | 29,112 | 24,245 | – | – |
| Opening depreciation | -5,677 | -4,024 | – | – |
| Depreciation for the year | -1,941 | -1,652 | – | – |
| Closing accumulated depreciation | -5,678 | -5,677 | – | – |
| Net carrying amount | 21,494 | 18,568 | – | – |
Capitalised development expenditure refers to ongoing development projects. Impairment is initiated when the project is completed.
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | ||
| Opening acquisition value | 2,859 | 2,856 | – | – | |
| Capitalisation for the year | 153 | 3 | – | – | |
| Closing accumulated acquisition value | 3,012 | 2,859 | – | – | |
| Opening depreciation | -2,288 | -1,835 | – | – | |
| Depreciation for the year | -310 | -453 | – | – | |
| Closing accumulated depreciation | -2,598 | -2,288 | – | – | |
| Net carrying amount | 414 | 571 | – | – |
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 21,058 | 21,058 | – | – |
| Purchases | 209 | – | – | – |
| Closing accumulated acquisition value | 21,267 | 21,058 | – | – |
| Opening depreciation | -8,027 | -4,925 | – | – |
| Depreciation for the year | -2,344 | -3,102 | – | – |
| Closing accumulated depreciation | -10,371 | -8,027 | – | – |
| Net carrying amount | 10,896 | 13,031 | – | – |
Improvements to the property of a third party primarily concerns installations at headquarters/ production facilities in Tullinge.
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | ||
| Opening acquisition value | 28,207 | 10,777 | – | – | |
| Purchases | 174 | 17,431 | – | – | |
| Exchange rate differences | 776 | -1 | – | – | |
| Closing accumulated acquisition value | 29,157 | 28,207 | – | – | |
| Opening depreciation | -8,627 | -5,118 | – | – | |
| Depreciation for the year | -3,297 | -3,510 | – | – | |
| Exchange rate differences | -475 | 1 | – | – | |
| Closing accumulated depreciation | -12,396 | -8,627 | – | – | |
| Net carrying amount | 16,761 | 19,580 | – | – |
This item includes a finance leasing agreement for production equipment in Tullinge with a current value of a minimum lease fee of TSEK 13,636. During the year, lease assets were depreciated by TSEK -1,704, whereby the closing value in the balance sheet as at 31 December 2018 is TSEK 11,931. The remaining lease commitments are given in the table below, these are also recognised as leasing liabilities in the balance sheet under other long and other short-term liabilities. Once the lease is completed, Bactiguard is entitled to acquire ownership of the production equipment for SEK 1.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Within 1 year | 1,538 | 1,466 | – | – |
| Between 1 year and 5 years | 6,939 | 6,616 | – | – |
| After more than 5 years | 3,999 | 5,860 | – | – |
| Total | 12,476 | 13,942 | – | – |
| Group | Parent company | ||||
|---|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | ||
| Opening acquisition value | 7,776 | 7,707 | – | – | |
| Purchases | 341 | 480 | – | – | |
| Sales/scrapping | – | -441 | – | – | |
| Closing accumulated acquisition value | 8,117 | 7,776 | – | – | |
| Opening depreciation | -4,669 | -3,770 | – | – | |
| Depreciation for the year | -1,315 | -1,310 | – | – | |
| Sales/scrapping | – | 411 | |||
| Closing accumulated depreciation | -5,984 | -4,669 | – | – | |
| Net carrying amount | 2,133 | 3,107 | – | – |
| Parent company | ||
|---|---|---|
| 31/12/2018 | 31/12/2017 | |
| Opening acquisition value | 414,574 | 384,574 |
| Shareholder contributions subsidiaries | – | 30,000 |
| Closing acquisition value | 414,574 | 414,574 |
| Share of voting | |||||
|---|---|---|---|---|---|
| Subsidiaries | Corp.ID. no. | Domicile | Share of equity % | power % | Book value |
| Bactiguard AB | 556668-6621 | Stockholm | 100 | 100 | 414,574 |
| Bactiguard International AB | 556754-7731 | Stockholm | 100 | 100 | – |
| Bactiguard China Limited | 1403452 | Hong Kong | 100 | 100 | – |
| Bactiguard Malaysia SDN. BHD. | 970618-V | Malaysia | 100 | 100 | – |
| Bactiguard Singapore Pte. Ltd. | 201135972E | Singapore | 100 | 100 | – |
| Bactiguard Israel Ltd. | 514794247 | Israel | 100 | 100 | – |
| Total | 414,574 |
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Opening balance | - | 1,228 | – | – |
| Investments | – | – | – | – |
| Sales/scrapping | - 1,228 | |||
| Participations in result of associates | – | – | – | – |
| Closing balance | – | – | – | – |
The participations in previous years relate to a 50% ownership in Casil BG Medical Ltd (Joint venture in Cadila Pharmaceuticals in India) which were phased out, with the participations being written down in their entirety in 2017.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Raw material | 3,134 | 2,750 | – | – |
| Products in progress | 2,103 | 1,716 | – | – |
| Finished goods | 9,029 | 9,142 | – | – |
| Total inventory | 14,266 | 13,608 | – | – |
The Inventories item includes an impairment of TSEK 5,176 (5,261) and for the parent company by TSEK - (-). This refers to earlier generations products where the technical life span exceeds the commercial. Goods are scrapped after the end of the technical life, which is an unchanged principle. No significant reversals of previous impairments have been made in 2018 or 2017.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Accounts receivable, gross | 60,895 | 57,547 | – | – |
| Provision for expected credit losses | -6,404 | -688 | – | – |
| Total accounts receivable, net after loss provision | 54,492 | 56,859 | – | – |
Non-current accounts receivable amount to TSEK - (17,263). 0.2% (30%) of accounts receivable refer to territorial fees and correspond to deferred income and advance payments from customers of the same amount and have thereby not impacted the income statement.
The management has assessed that the carrying amount for accounts receivable, net after loss provision, is the fair value.
| Group | |||
|---|---|---|---|
| Age analysis of accounts receivable | 2018 | 2017 | |
| Not due | 32,432 | 19,712 | |
| Overdue 1–30 days | 2,122 | 6,660 | |
| Overdue 31–90 days | 1,377 | 1,553 | |
| Overdue > 90 days | 24,963 | 29,682 | |
| Provision for expected credit losses | -6,404 | -688 | |
| Total | 54,492 | 56,859 |
| Group | Parent company | |||
|---|---|---|---|---|
| Provision credit losses | 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 |
| Opening balance | -688 | -58,191 | – | – |
| Provision for expected credit losses | -6,404 | -476 | – | – |
| Realised loss | 688 | 57,978 | – | – |
| Closing balance | -6,404 | - 688 | – | – |
At the beginning of 2019 Bactiguard transferred its distribution in Iraq and accounts receivable to a European distributor with a book value of TSEK 17,062. The difference between the sale proceeds and the book value amounted to TSEK 4,265, which is included in the provision for expected credit losses in the figure for 2018. As this receivable was not sold as of 31 December 2018, the receivable is still included in total accounts receivable above, and in Overdue > 90 days.
The figures for 2017 have not been remeasured in accordance with IFRS 9, but are based on IAS 39 and bad debt.
The previous provision of accounts receivable between 2013 and 2017 that was linked to previous business models was cleared from the balance sheet in the previous year (2017), resulting in a loss of TSEK 57,978, which had no effect on earnings or cash flow.
The company's assessment is that payment will be received for accounts receivable that are past due but not impaired.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Prepaid rent | 2,525 | 2,403 | – | – |
| Other items | 8,672 | 8,851 | 201 | 1,962 |
| Total | 11,197 | 11,254 | 201 | 1,962 |
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Cash and bank balances | 1,893 | 11,550 | 648 | 374 |
| Total | 1,893 | 11,550 | 648 | 374 |
Provision for expected credit losses for cash and cash equivalents are not considered necessary as the Group's cash and cash equivalents are invested in reputable banks with low credit risk.
Share capital in Bactiguard as per 31 December 2018 was TSEK 833 allocated to 29,302,373 series B shares each carrying a single vote (29,302,373 votes) and 4,000,000 series A shares, each with ten votes (40,000,000 votes). The total number of shares and votes in Bactiguard as per 31 December 2018 was 33,302,373 shares and 69,302,373 votes. The shares have a quotient value of SEK 0.025.
The disclosures are unchanged compared to 31 December of the previous year.
| Group | Parent company | |||
|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | |
| Long-term liabilities to credit institutions | 126,900 | 142,500 | 126,900 | 142,500 |
| Short-term liabilities to credit institutions | 14,400 | 7,500 | 14,400 | 7,500 |
| Total | 141,300 | 150,000 | 141,300 | 150,000 |
At the end of December 2017, the Company signed an agreement with the Skandinaviska Enskilda Banken (SEB) for a three year credit facility totalling TSEK180,000 in the form of a bank overdraft of TSEK 30,000 and a bank loan of TSEK 150,000. The loan runs at an interest base of STIBOR 90, however minimum 0%, and an interest surcharge of 3.0%. The bank loan of TSEK 150,000 is amortised by a total of TSEK 35,000 over the maturity period. The facility is subject to the customary covenants.
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Bank overdraft facilities granted | 30,000 | 30,000 | – | – |
| Unutilised bank overdrafts | 26,095 | 30,000 | – | – |
| Utilised bank overdrafts | 3,905 | – | – | – |
| Group | Parent company | |||
|---|---|---|---|---|
| 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 | |
| Accrued interest expenses | 48 | 63 | 48 | 63 |
| Accrued holiday pay | 6,295 | 5,806 | 1,319 | 1,053 |
| Prepaid income* | 9,406 | 12,036 | – | – |
| Other items | 2,522 | 3,712 | 351 | 965 |
| Total | 18,270 | 21,616 | 1,718 | 2,080 |
Disclosures regarding contract liabilities included in this row can be found in Note 5.
| Group | Parent company | |||
|---|---|---|---|---|
| Pledged assets | 31/12/2018 | 31/12/2017 | 31/12/2018 | 31/12/2017 |
| Shares in subsidiaries | 162,226 | 169,328 | 414,574 | 414,574 |
| Floating charge | 150,000 | 150,000 | – | – |
| Total | 312,226 | 319,328 | 414,574 | 414,574 |
There are no contingent liabilities in effect.
| Group | 31/12/2017 | Cash flow from financing activities |
Change to short-term loans |
Other changes* |
31/12/2018 | |
|---|---|---|---|---|---|---|
| Non-current liabilities | ||||||
| Leasing debt | 12,476 | -1,538 | 10,938 | |||
| Liabilities to credit institutions | 142,500 | 3,905 | -15,000 | -600 | 130,805 | |
| Short-term liabilities | ||||||
| Leasing debt | 1,466 | -1,466 | 1,538 | 1,538 | ||
| Liabilities to credit institutions | 7,500 | -7,500 | 15,000 | -600 | 14,400 | |
| Reconciliation of liabilities attributable to financing activities |
163,942 | -5,061 | -1,200 | 157,681 | ||
| Cash flow | Effect of | |||||
| from | Change to | changes to | ||||
| financing | short-term | exchange | Other | |||
| Parent company | 31/12/2017 | activities | loans | rate | changes | 31/12/2018 |
| Non-current liabilities | ||||||
| Liabilities to credit institutions | 142,500 | -15,000 | -600 | 126,900 | ||
| Short-term liabilities | ||||||
| Liabilities to credit institutions | 7,500 | -7,500 | 15,000 | -600 | 14,400 | |
| Reconciliation of liabilities attributable | 150,000 | -7,500 | - | - | -1,200 | 141,300 |
to financing activities
* Liabilities to credit institutions relates to the net of loans and prepaid up-front fee regarding the loan. TSEK 600 of the up-front fee refers to year 2019 and TSEK 600 to year 2020, whereby they affected short-term and long-term liabilities to credit institutions.
Transactions between the company and its subsidiaries, which are related to the company, have been eliminated in the consolidation, and disclosures regarding these transactions are therefore not provided in this note. Disclosures regarding transactions between the Group and other related parties are presented below.
Services and other transactions between companies within the Group are charged based on commercial principles.
Since 2017 the company has had a licensing agreement with Smartwise Sweden AB, a company owned by a group of private investors, including Bactiguard's CEO and main owner Christian Kinch and main shareholder Thomas von Koch.
Besides that stated above, neither Bactiguard nor its subsidiaries have provided loans, guarantees or guarantee commitments to or for the benefit of any board members or senior management in the Group. None of these people have had any direct or indirect participation in another business transaction with any company within the Group which is or was uncustomary in its nature or with respect to the conditions.
Details of remuneration and benefits for key individuals in a managerial position are provided in note 10.
Bactiguard is focusing its operations in the Middle East. It has transferred its distribution for Iraq to a European distributor, which also took over accounts receivable at a book value of MSEK 17.1. The proceeds amounts to MSEK 12,8 and, therefore, a write-down of accounts receivable corresponding to the balance of MSEK 4.3 is made in the accounts for 2018.
No dividends were issued during 2018 and no dividends are proposed to the 2019 AGM.
The following retained earnings are at the disposal of the Annual General Meeting (SEK)
| Retained earnings | -11,040,550 |
|---|---|
| Share premium reserve | 473,016,706 |
| Profit/loss for the year | -5,523,186 |
| 456,452,970 | |
| The Board of Directors proposes that the profits be | 456,452,970 |
| carried forward |
456,452,970
The Board of Directors and Chief Executive Officer hereby certify that these consolidated financial statements were prepared in accordance with the international financial reporting standards, as referenced in the European Parliament and of the Council regulation (EC) No 1606/2002 of 19 July 2002 on the
application of international accounting standards and provide a fair representation of the parent company's and the Group's operations, financial position and performance and describe the material risks and uncertainties facing the parent company and group companies.
Stockholm 11 April 2019
Christian Kinch CEO and Board member
Jan Ståhlberg Chairman of the Board
Svante Östblom Board member
Marie Wickman-Chantereau Board member
Mia Arnhult Board member
Our auditor's report was submitted on 12 April 2019. Deloitte AB
Kent Åkerlund Authorised Public Accountant
We have audited the annual accounts and consolidated accounts of Bactiguard Holding AB (publ) for the financial year January 1, 2018 – December 31, 2018 except for the corporate governance statement on pages 31–37. The annual accounts and consolidated accounts of the company are included on pages 25–63 in this document.
In our opinion, the annual accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of parent company as of 31 December 2018 and its financial performance and cash flow for the year then ended in accordance with the Annual Accounts Act. The consolidated accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the group as of 31 December 2018 and their financial performance and cash flow for the year then ended in accordance with International Financial Reporting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act. Our opinions do not cover the corporate governance statement on pages 31–37. The statutory administration report is consistent with the other parts of the annual accounts and consolidated accounts.
We therefore recommend that the general meeting of shareholders adopts the statement of comprehensive income for the parent company and the group, the balance sheet for the parent company and the statement of financial position for the group.
Our opinions in this report on the annual accounts and consolidated accounts are consistent with the content of the additional report that has been submitted to the parent company's audit committee in accordance with the Audit Regulation (537/2014) Article 11.
We conducted our audit in accordance with International Standards on Auditing (ISA) and generally accepted auditing standards in Sweden. Our responsibilities under those standards are further described in the Auditor's Responsibilities section. We are independent of the parent company and the group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements. This includes that, based on our best knowledge and belief, no prohibited services referred to in the Auditors Regulation (537/2014) Article 5.1 has been provided to the audited company or, where applicable, its parent company or its controlled companies in the EU.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions.
Key audit matters of the audit are those matters that, in our professional judgment, were of most significance in our audit of the annual accounts and consolidated accounts of the current period. These matters were addressed in the context of our audit of, and in forming our opinion thereon, the annual accounts and consolidated accounts as a whole, but we do not provide a separate opinion on these matters.
The Group revenue amounts to 163 MSEK for the financial year 2018 and mainly consists of license revenues and revenues from product sales.
License revenues are received and recognised based on the volume that the company's clients have sold to the end-customers and is recognised in the period of the sale. The license contracts can contain various components and revenue streams that must be evaluated under the recognition criteria of IFRS 15. For example revenue that is recognised directly upon signing of an agreement.
Revenues from product sales are recognised when control have been transferred to the buyer. In the instances where deliveries are made close to a period-end an estimate needs to be made to determine when the control have been transferred to the buyer and in what period to recognise the revenue.
Estimates related to various components in the license contracts and the cut off related to revenues from the sale of products make revenue recognition a key audit matter in the audit.
For further information refer to accounting principles on page 45 and 47, Note 3 and Note 5 in the annual report.
Our work included the following pro-
cedures, but were not limited to these:
The Group has goodwill amounting to 226 MSEK and other intangible assets, foremost technology, amounting to 246 MSEK accounted for in the balance sheet. These assets are tested annually, or as soon there are events indicating that there is a need, for impairment. Since the total value of these assets represent a significant part of the total assets and is sensitive to changes in assumptions such as growth rate and discount factor we consider it to be a key audit matter in our audit.
For further information refer to accounting principles on page 46 and 48, Note 3 and Notes 14 to 19 in the annual report.
Our work included the following procedures, but were not limited to these:
— 64 —
• We have reviewed that appropriate disclosures have been presented in the relevant notes to the financial statements.
The Group has accounts receivable amounting to 54 MSEK. The receivables have in some instances long payment terms and are to a great extent related to foreign clients. For a portion of the receivables there is a risk for customers not paying due to that regulatory approvals are delayed or due to country and client specific risks. Accounts receivable represent a significant asset in the Group's statement of financial position and is associated with difficult judgments related to the customer's ability to pay and as a consequence it is key audit matter in our audit.
For further information refer to accounting principles on page 49 and Note 3 as well as 26 in the annual report.
Our work included the following procedures, but were not limited to these:
This document also contains other information than the annual accounts and consolidated accounts and is found on pages 1–24 and 67. The Board of Directors and the Managing Director are responsible for this other information. Our opinion on the annual accounts and consolidated accounts does not cover this other information and we do not express any form of assurance conclusion regarding this other information.
In connection with our audit of the annual accounts and consolidated accounts, our responsibility is to read the information identified above and consider whether the information is materially inconsistent with the annual accounts and consolidated accounts. In this procedure we also take into account our knowledge otherwise obtained in the audit and assess whether the information otherwise appears to be materially misstated.
If we, based on the work performed concerning this information, conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.
The Board of Directors and the Managing Director are responsible for the preparation of the annual accounts and consolidated accounts and that they give a fair presentation in accordance with the Annual Accounts Act and, concerning the consolidated accounts, in accordance with IFRS as adopted by the EU. The Board of Directors and the Managing Director are also responsible for such internal control as they determine is necessary to enable the preparation of annual accounts and consolidated accounts that are free from material misstatement, whether due to fraud or error.
In preparing the annual accounts and consolidated accounts, The Board of Directors and the Managing Director are responsible for the assessment of the company's and the group's ability to continue as a going concern. They disclose, as applicable, matters related to going concern and using the going concern basis of accounting. The going concern basis of accounting is however not applied if the Board of Directors and the Managing Director intends to liquidate the company, to cease operations, or has no realistic alternative but to do so.
The Audit Committee shall, without prejudice to the Board of Director's responsibilities and tasks in general, among other things oversee the company's financial reporting process.
Our objectives are to obtain reasonable assurance about whether the annual accounts and consolidated accounts
as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinions. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and generally accepted auditing standards in Sweden will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these annual accounts and consolidated accounts.
A further description of our responsibilities for the audit of the annual accounts and consolidated accounts is located at the Swedish Inspectorate of Auditors website: www.revisorsinspektionen.se/revisornsansvar. This description forms part of the auditor's report.
In addition to our audit of the annual accounts and consolidated accounts, we have also audited the administration of the Board of Directors and the Managing Director of Bactiguard Holding AB (publ) for the financial year January 1, 2017 – December 31, 2017 and the proposed appropriations of the company's profit or loss.
We recommend to the general meeting of shareholders that the profit to be appropriated in accordance with the proposal in the statutory administration report and that the members of the Board of Directors and the Managing Director be discharged from liability for the financial year.
We conducted the audit in accordance with generally accepted auditing standards in Sweden. Our responsibilities under those standards are further described in the Auditor's Responsibilities section. We are independent of the parent company and the group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions.
The Board of Directors is responsible for the proposal for appropriations of the company's profit or loss. At the proposal of a dividend, this includes an assessment of whether the dividend is justifiable considering the requirements which the company's and the group's type of operations, size and risks place on the size of the parent company's and the group's equity, consolidation requirements, liquidity and position in general.
The Board of Directors is responsible for the company's organization and the administration of the company's affairs. This includes among other things continuous assessment of the company's and the group's financial situation and ensuring that the company's organization is designed so that the accounting, management of assets and the company's financial affairs otherwise are controlled in a reassuring manner. The Managing Director shall manage the ongoing administration according to the Board of Directors' guidelines and instructions and among other matters take measures that are necessary to fulfill the company's accounting in accordance with law and handle the management of assets in a reassuring manner.
Our objective concerning the audit of the administration, and thereby our opinion about discharge from liability, is to obtain audit evidence to assess with a reasonable degree of assurance whether any member of the Board of Directors or the Managing Director in any material respect:
• has undertaken any action or been guilty of any omission which can give rise to liability to the company, or
• in any other way has acted in contravention of the Companies Act, the Annual Accounts Act or the Articles of Association.
Our objective concerning the audit of the proposed appropriations of the company's profit or loss, and thereby our opinion about this, is to assess with reasonable degree of assurance whether the proposal is in accordance with the Companies Act.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with generally accepted auditing standards in Sweden will always detect actions or omissions that can give rise to liability to the company, or that the proposed appropriations of the company's profit or loss are not in accordance with the Companies Act.
A further description of our responsibilities for the audit of the management's administration is located at the Swedish Inspectorate of Auditors website: www.revisorsinspektionen. se/rn/showdocument/documents/rev_dok/revisors_ansvar.pdf. This description forms part of the auditor's report.
The Board of Directors is responsible for that the corporate governance statement on pages 31–37 has been prepared in accordance with the Annual Accounts Act.
Our examination of the corporate governance statement is conducted in accordance with FAR's auditing standard RevU 16 The auditor's examination of the corporate governance statement. This means that our examination of the corporate governance statement is different and substantially less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden. We believe that the examination has provided us with sufficient basis for our opinions.
A corporate governance statement has been prepared. Disclosures in accordance with chapter 6 section 6 the second paragraph points 2–6 of the Annual Accounts Act and chapter 7 section 31 the second paragraph the same law are consistent with the other parts of the annual accounts and consolidated accounts and are in accordance with the Annual Accounts Act.
Deloitte AB, was appointed auditor of Bactiguard Holding AB (publ) by the annual general meeting of the shareholders on May 16, 2018 and has been the company's auditors' since May 18, 2012.
Stockholm April 12, 2019 Deloitte AB
Kent Åkerlund Authorised Public Accountant
Microorganisms, such as bacteria, that have developed a resistance to antibiotics, which makes infections and diseases caused by these bacteria to no longer be treated as effectively with antibiotics.
Bactiguard Infection Protection (BIP) central venous catheter.
Bactiguard Infection Protection (BIP) endotracheal tube.
Bactiguard Infection Protection (BIP) urinary catheter.
Causes the red blood cells to burst
A study designed to determine the effects that medical technical devices have on patients.
Bacteria that are resistant to several antibiotic treatments, so that established antibiotic alternatives can no longer be used for treatment or preventive purposes.
Infections that occur while treated at hospital, at other healthcare unit or at home.
Phone: +46 8-440 58 80 | Fax +46 (0)8 440 58 90 | www.bactiguard.se | [email protected]
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Street address Alfred Nobels Allé 150, Tullinge, Sweden Postal address: Box 15, 146 21 Tullinge, Sweden
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