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A study of elite athletes shows that ColdZyme provides protection as evidenced by fewer sick days and lost training days, as well as improved quality of life

News   •   Jun 21, 2017 06:30 GMT

Enzymatica is now publishing the results of a study1 in which Swedish elite athletes used ColdZyme® Mouth Spray to protect against and reduce the symptoms of colds. The results of the study show that ColdZyme reduced the number of sick days by more than 50 percent in the two groups of hockey players and biathlon skiers compared with previous control periods. The study also shows that the elite athletes who came down with colds and who used ColdZyme experienced milder symptoms and improved quality of life compared with untreated common colds.

Enzymatica conducted a study of elite athletes who used ColdZyme for 3-12 months during the winter seasons 2012-2014 in Sweden. In all, 11 biathlon skiers, 29 hockey players and 20 handball players participated and submitted information on number of days absent from training and competition. In addition, those who came down with colds responded to questions about their symptoms and quality of life.

The study results show that the average number of sick days per athlete and month when using ColdZyme significantly declined, by 51 percent for the biathlon skiers and 67 percent for the hockey players, compared with the control periods when ColdZyme was not used. The athletes in the study who became infected reported milder symptoms and significant improvement in quality of life (for example, improved sleep and performance) compared with common cold sufferers not treated with ColdZyme. Nine of 11 biathlon skiers reported that they felt better or much better when using ColdZyme and that they had milder or much milder cold symptoms. The handball players reported similar results, where 76 percent responded that when using ColdZyme the cold was so mild that it had little or no effect on quality of life.

  • “Using ColdZyme has been very important for my training as a biathlon skier. Before I began using ColdZyme I could have 30 to 40 days of sick leave per season, compared with 3-5 days when using ColdZyme,” says Torstein Stenersen, who belongs to the Swedish biathlon team.
  • “The results of this study confirm the results of our first clinical study (COLDPREV I), which among other things showed a 50-percent reduction in number of sick days. This study of elite athletes shows that use of ColdZyme can be a simple and practical way to protect against colds, as evidenced by a reduction in the number of sick days and the quantity of cold symptoms,” says Fredrik Lindberg, CEO of Enzymatica.

1 Clarsund, M. Evaluation of ColdZyme Mouth Spray for the Protection against Common Cold in Elite Athletes to Reduce Unwanted Absence from Training and Competition. Open Journal of Respiratory Diseases, 2017, 7, 103-109. https://doi.org/10.4236/ojrd.2017.73010

For more information please contact:
__________________________________________________________________________________

Fredrik Lindberg, CEO, Enzymatica AB Tel: +46 (0)708-86 53 70 | Email: fredrik.lindberg@enzymatica.com

About Enzymatica AB
Enzymatica AB is a life sciences company that develops and sells medical devices for fighting infectious diseases. In a short period of time, the company developed ColdZyme®, a unique mouth spray for fighting colds, launched the product in eight markets and established it as one of the best-selling cold products in Swedish pharmacies measured in SEK. Our strategy is to continue growing by strengthening our position on existing markets and expanding to more geographic markets via established partners. The company’s head office is in Lund and it is listed on the Nasdaq First North. For more information, please go to: www.enzymatica.se.

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Enzymatica receives record order from STADA Arzneimittel AG

Press Releases   •   Jun 14, 2017 09:45 GMT

Enzymatica has received its largest order to date for a total of about SEK 12 million. The global pharmaceutical company STADA Arzneimittel AG (“STADA”), headquartered in Germany, has ordered Enzymatica’s cold product ColdZyme® Mouth spray for the German, Belgian and Austrian markets for the common cold season after the summer.

The order is a result of the cooperation agreement that Enzymatica and STADA reached in February 2017. The agreement grants STADA exclusive rights to sell, market and distribute ColdZyme in Germany, the largest market for OTC products in Europe, as well as in Belgium and Austria.

  • “We are now beginning to see the results of our efforts to sign agreements with international distributors for the major OTC markets. The order is the largest in Enzymatica’s history and is worth much more than the entire sales of SEK 9.6 million for the first quarter this year. The order confirms the commercial potential of ColdZyme and our technology platform,” says Fredrik Lindberg, CEO of Enzymatica.

Enzymatica expects to deliver the order at the end of the summer and the revenue will have an impact on the company’s third quarter sales.

STADA is a publicly-listed German company with a traditionally strong presence in Europe, especially in Germany. STADA is an international company and its five largest markets are Germany, Russia, the UK, Italy and Spain. In 2016 the STADA Group generated sales of EUR 2,139 million and had 10,839 employees all over the world.

The information in this press release is information that Enzymatica is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, on June 14, 2017 at 08.00.

For more information please contact:
_______________________________________________________________________

Fredrik Lindberg, CEO, Enzymatica ABTel: +46 (0)708-86 53 70 | Email: fredrik.lindberg@enzymatica.com

About Enzymatica AB

Enzymatica AB is a medical device company that develops and sells medical devices for infection-related diseases. In just a short period of time, the company developed ColdZyme®, a unique mouth spray for colds, launched the product in eight countries and became established among the top-selling cold products (denominated in SEK) at Swedish pharmacies. The strategy is to continue to grow by strengthening the Company’s position in existing markets and expanding into new geographic markets through established partners. The company is headquartered in Lund and is listed on Nasdaq First North. For more information please visit:www.enzymatica.se.

Enzymatica’s Certified Adviser is Erik Penser Bank.

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Enzymatica enters into partnership agreement with STADA Arzneimittel AG

Press Releases   •   Feb 13, 2017 12:15 GMT

The agreement grants STADA exclusive rights to sell, market and distribute Enzymatica’s common cold product ColdZyme® in Germany. STADA is a global pharmaceutical company, headquartered in Germany, with a strong presence in Europe and leading positions in the cough and cold category in Germany, UK, and Russia.

We are very pleased to have signed the agreement with STADA as our marketing, sales, and distribution partner for Germany, particularly since Germany is the single largest market for over-the-counter products in Europe. This agreement confirms the commercial potential for ColdZyme outside of Scandinavia, and endorses the interest in Enzymatica’s technology platform”,says Fredrik Lindberg, CEO of Enzymatica.

"We are very excited about our agreement with Enzymatica to help maximize the ColdZyme opportunity in Germany. ColdZyme’s unique product offering is different to traditional cold therapies and is a perfect fit to our existing portfolio as well as to our strategy of growing our brandedbusiness on the back of launching innovative, new products”, says Wolfram Gollin, Head of Marketing STADA GmbH.

The company’s first product, ColdZyme, is a unique mouth spray for use against the common cold.

In Europe, ColdZyme is directly marketed and sold by Enzymatica in Sweden, Norway and Denmark and sold through marketing and sales partners in Spain, Finland, Iceland and Greece. In the UK, the ColdZyme business is handled by a sales agent.

For more information, please contact:

Fredrik Lindberg, CEO Enzymatica AB Tel: +46 708-86 53 70 | E-post: fredrik.lindberg@enzymatica.com

This information is information that Enzymatica AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 0830 CET on February 13, 2017.

Enzymatica

Enzymatica is a life science company who develops and sells medical device products against infectious-related diseases. Over a short period the company has developed a unique oral spray for colds, ColdZyme®, and launched it on eight markets. The product has become one of the leading articles for colds in Swedish pharmacies. Enzymatica’s strategy is to continue growing by strengthening its position in existing markets and to expand to more geographical markets through well-established partners. The company is headquartered in Lund, Sweden and is listed on Nasdaq First North. For more information, please visit www.enzymatica.com.

Enzymaticas Certified Adviser is Erik Penser Bank.

STADA Arzneimittel AG

STADA Arzneimittel AG is a publicly-listed globally leading generics producer with a traditionally strong presence in Europe and especially Germany. STADA is internationally-oriented and the Top 5 markets are Germany, Russia, UK, Italy and Spain. STADA generated Group sales of € 2.115,1 million in 2015 and had 10,532 employees worldwide. STADA has its headquarters in Bad Vilbel, Germany.

For more information visit www.stada.com

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ColdZyme demonstrates reduced sick leave during cold season

News   •   Dec 22, 2016 07:45 GMT

Enzymatica presents results recently published in Open Journal of Respiratory Diseases (OJRD)[1], Enzy-003, an open label evaluation by elderly care personnelatEksjö Municipality, investigating the impact of ColdZyme on sick leave during the cold season. ENZY-003 demonstrated a substantial reduction in individual average sick leave days, reduced from 5.2 to 3.7 days among 74 employees at an elderly care residence using ColdZyme during the cold season, compared to the previous year. In addition, 63 percent of those who caught colds reported that their symptoms were milder while using ColdZyme in comparison to previous colds. This result is encouraging and shows the potential to reduce sick-leave days by using ColdZyme in the workplace.

The Enzy-003 study, carried out at a Swedish elderly care housing at Eksjö Municipality, compared the sick leave frequency among 111 employees during a five-month period of ColdZyme treatment, with that registered during the same period the previous year. 24 subjects were excluded in the analysis due to having long-term sickness, not attributed to the common cold (>29 days’ sick leave in 5 months). A substantial reduction of number of sick-leave days was observed among the remaining 74 subjects, with individual average sick leave days reduced from 5.2 to 3.7 days, (p=0.05)[2] and total sick leave days decreasing from 392 without, to 279 with ColdZyme.According to the study results, 63 percent of the staff reported that their symptoms were milder while using ColdZyme in comparison to previous infections.

“Although upper respiratory tract infections can hardly be considered a severe illness, colds pose a major economic burden for both society and the individual. The health economic consequences are considerable for sickness absences both in elderly care and in other public services,” says Christina Bråkenhielm Persson, Healthcare Director at Eksjö Municipality.

Fredrik Lindberg, CEO of Enzymatica commented:” We are satisfied with the positive outcome of ENZY-003, which is a study that reflects a real life situation during winter season”.

The current study supports the results of a previous cold study – COLDPREV – indicating that ColdZyme can reduce the number of sick days.

ColdZyme, being one of the few treatments that addresses the source of common cold by protecting the throat from virus attachment, has in a few years established itself as one of the best-selling common cold products in Swedish pharmacies.

Today the product is marketed and sold in Sweden, Denmark, Norway, Finland, Iceland, UK and Spain. The company is in negotiations with a number of potential distributor for the launch of ColdZyme in other markets. In the beginning of November Enzymatica signed an exclusive distribution agreement with Endeavour Consumer Health for Australia and New Zealand for marketing and sales of ColdZyme.

[1] Clarsund et al, Evaluation of ColdZyme Mouth Spray against Common Cold in Elderly Care Personnel, Open Journal of Respiratory Diseases, 2017, 7, 12-1

[2] p-value, statistical significance value

For more information, contact

Fredrik Lindberg, CEO, Enzymatica AB Tel: +46 708-86 53 70 | Email: fredrik.lindberg@enzymatica.com

About Enzymatica AB

Enzymatica AB is a life sciences company that develops and sells medical devices for fighting infectious diseases. In a short period of time, the company developed ColdZyme®, a unique mouth spray for fighting colds, launched the product in seven markets and established it as one of the best-selling cold products in Swedish pharmacies measured in SEK. Our strategy is to continue growing by strengthening our position on existing markets and expanding to more geographic markets via established partners. The company’s head office is in Lund and it is listed on the Nasdaq First North. For more information, please go to: www.enzymatica.se.

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Medical case report on promising treatment with ColdZyme® of patients with primary immunodeficiency

News   •   Nov 09, 2016 14:00 GMT

Promising results after using ColdZyme in a patient with primary immunodeficiency has recently been published in the October issue of the Journal of Medical Case Reports. The publication describes Enzymaticas product ColdZyme Mouth spray that was used over a period of 15 months, reducing the incidence of upper respiratory tract infections with a twelve year old patient with primary immunodeficiency. During the treatment with ColdZyme, the patient and parents registered a reduction of cold symptoms and therefore an improved quality of life. Persistent infections of the oral cavity healed for the first time in several years, and the patient’s schooling was almost normalized.


A 12-year-old boy diagnosed with Variable Immunodeficiency (common variable immunodeficiency, CVID) began using ColdZyme three years ago, hoping to prevent contracting the common cold virus. The boy had since the age of two years been treated with weekly infusions of adequate doses of IgG (Immunoglobulin G) at a dose of 100-150 mg/kg/week according to the international and national guidelines. Before treatment with ColdZyme, the patient had recurrent infections of the ears, sinuses, nose, bronchi and lungs - which led to frequent absences from school, hospital stays and reduced quality of life. The boy was in addition to the IgG treatment also treated with antibiotics for bacterial infections, and had on one occasion been on prophylactic antibiotic therapy for several months. In an attempt, hoping to reduce the number of cold episodes, the parents let the boy spray ColdZyme twice daily, morning and evening, while treatment with IgG and antibiotics, if necessary, proceeded as usual. The parents and the boy kept a detailed infection-diary both before and during treatment with ColdZyme.

The result of treatment with ColdZyme showed a substantial reduction both in the number of infections and the symptoms of infection, and reduced absenteeism in school, from 1.4 days per week to 0.3 days per week, during the 15-month treatment period, compared to a 21 months period before without treatment.

  • Patients with primary immunodeficiency suffer from many infections before they get treatment with IgG.This treatment is to the vast majority of patients very effective, but there is a smaller group of patients, that despite adequate IgG treatment continues to have an increased frequency of infections in the respiratory tract. The effect of ColdZyme with this patient is very interesting and follow-up studies in a larger group of people with primary immunodeficiency will be very interesting to take part of, says Ann Gardulf, R.N., PhD, Associate Professor at Karolinska Institutet in Stockholm.
  • When ColdZyme was used in order to reduce the number of common cold episodes, it seems that the spray also had effect on other secondary upper respiratory infections in the oral cavity and pharynx. We now proceed to evaluate the possibility of larger studies. The unexpectedly positive results have also prompted us to apply for a patent for the use of ColdZyme at immunodeficiency, says Mats Clarsund, Research Director at Enzymatica.

In Sweden, The National Board of Health and Welfare and the Healthcare anticipate that there are approximately 600 patients diagnosed with variable immunodeficiency. In total there are thousands of children and adults with some form of primary immunodeficiency. Children and adults with primary immune deficiency usually need life-long treatment with IgG. Preparations of concentrate of IgG are extracted from the plasma of healthy donors. Despite adequate IgG therapy, some patients continue to have upper respiratory infections, which make it interesting to find complementary treatments.

For more information, contact:

Fredrik Lindberg, CEO Enzymatica AB Tel: 0708-86 53 70 | E-mail:fredrik.lindberg@enzymatica.com

About ColdZyme

Colds are caused by viruses. ColdZyme is unique because it fights the cause of the cold, the cold virus, instead of treating the symptoms once the patient has already gotten sick like many other products. ColdZyme can thus both prevent and shorten colds.

About Enzymatica AB

Enzymatica AB is a life sciences company that develops and sells medical devices for fighting infectious diseases. In a short period of time, the company developed ColdZyme®, a unique mouth spray for fighting colds, launched the product in six markets and established it as one of the best-selling cold products in Swedish pharmacies measured in SEK. Our strategy is to continue growing by strengthening our position on existing markets and expanding to more geographic markets via established partners. The company’s head office is in Lund and it is listed on the Nasdaq First North. For more information, please go to:www.enzymatica.se.

Enzymaticas Certified Advisor is Erik Penser Bank.

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Customer studies: ColdZyme users fight colds early and actively

News   •   Apr 27, 2016 12:15 GMT

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Information about Enzymatica’s new rights issue

News   •   Apr 20, 2016 13:05 GMT

Today Enzymatica has published the prospectus for the new rights issue with pre-emptive rights for the company’s shareholders. To read more about the subscription of shares – see under “Investors” and “New rights issue April 2016” at the company’s web site. Here you will find a brief description of the rights issue (short version of the prospectus) and how one subscribes for shares and application form. The entire prospectus in Swedish is also available.

For more information, please contact:

Carl-Johan Wachtmeister, deputy communication officer Enzymatica

Tel: 0701-88 50 21 | E-post: carl-johan.wachtmeister@enzymatica.com

Important information

The information in this News does not contain or constitute an offer to acquire, subscribe or otherwise trade in shares, subscription rights or other securities in Enzymatica AB (publ). Any invitation to the persons concerned to subscribe for shares in Enzymatica AB (publ) will only be made through the prospectus that Enzymatica AB (publ) estimates to publish on or about 20 April 2016.

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Frequently asked questions and answers about Enzymatica's acquisition of Zymetech

News   •   Jan 28, 2016 07:24 GMT

Why is Enzymatica purchasing Icelandic company Zymetech?

The acquisition of Zymetech aims to accelerate our expansion and reduce the company’s risks of competition. It makes Enzymatica a stronger and more attractive partner in the context of businessand on the capital market.

How does Enzymatica benefit from the acquisition of Zymetech?

The acquisition will give Enzymatica control over the entire production chain, we will own patent protection for our products on several key markets and we will substantially reduce the risk of competition by acquiring global exclusive rights to the deep-sea enzyme. In addition, Zymetech brings expertise in enzyme and formulation technology to the table, which is conducive to the development of new products. When combined with the other improvements we have made to the company over the past year, such as in terms of quality and regulations, this gives us the solid foundation required to make our planned geographic expansion a reality.

What are the details of the transaction?

Enzymatica AB (publ) (”Enzymatica”) has signed an agreement to acquire the shares of Zymetech ehf. The purchase price consists of 20,9 million new shares and 4 million new warrants in Enzymatica, and the acquisition is thus planned to be completed via a non-cash issue of shares in Enzymatica offered to Zymetech’s shareholders. The transaction is subject to approval at an extraordinary general meeting Enzymatica will give notice of.

What does the transaction entail with respect to your patent protection for ColdZyme?

The patent prevents others from developing or selling products based on the enzyme from cod and expires at the end of 2020, i.e. in five years. The patent covers Europe and certain key markets outside of the EU, including the largest markets for OTC products – Oceania, Canada, Russia, Poland, China, India and Mexico.

What is your opinion on the fact that the patent does not cover the US and Japan, the largest markets for medical equipment/OTC products?

Given that Zymetech is the only producer of the relevant deep-sea enzymes, the merger also gives Enzymatica global control over the raw material, which substantially slows down competition in important countries where Enzymatica does not have full patent protection, such as the US. Enzymatica has a technological lead of several years across the globe. In October 2015, a new patent application was published for a recombinant trypsin, which we expect will supplement the patent for the natural trypsin when it expires. This patent will cover the US as well. We have also filed several patent applications to protect our technology.

What role will Zymetech have in Enzymatica?

Researchers and product developers from Zymetech will be added to the research and development department while continuing to work in Iceland. All production and refinement of the enzyme raw material will also remain in Iceland, as well as several other functions. Zymetech's founder will become the largest single shareholder of Enzymatica and will initially be offered two board posts and a position on the nominations committee.

Does Zymetech have any agreements with distributors on the international market for sales of trypsin and for their own spray?

Zymetech mainly has agreements for dermatology products in Germany, the UK and an Asian market.

How much sales do these agreements generate for Zymetech?

SEK 3-5 million per year.

Why does Enzymatica want to conduct a preemptive rights issue of SEK 60 million?

The capital contributed from the issue will bolster the company’s financial position and we believe that this will enable faster geographic expansion. The purpose is to enable us to pursue commercial opportunities more aggressively and thus foster a long-term increase in the sales of cold product ColdZyme.

The capital contribution will facilitate preparation for the regulatory approval in the US, Asia, Australia and other regions outside of Europe, continuing diversification of the product portfolio and solid sales support for distribution partners in the form of a small internal marketing structure, including key personnel such as international product managers.

What does it mean that the new share issue has preemptive rights for existing shareholders?

It means that those who are registered as shareholders on the record date will receive warrants in proportion to their shareholdings. These shareholders are then given the opportunity to subscribe for new shares before others. The preemptive rights are represented by the warrants allotted.

Why is Enzymatica requesting a mandate to be able to conduct a private placement of SEK 40 million?

The reason for the extended mandate for a private placement is to take advantage of future opportunities to bring in strong long-term owners and provide additional financing for the company's growth strategy.

You raised SEK 80 million just over two years ago, how have these funds been used?

We launched ColdZyme on five new markets: Norway, Denmark, the UK, Finland and Spain in January 2016. As part of these product launch efforts, we ensured that the product is in compliance with each country's legal and regulatory requirements, e.g. by supplementing the documentation forming the basis for the product’s registration and making adaptations to advertising and marketing materials. Intensified quality efforts within the company have been underway since one year ago. These efforts are necessary to reach more geographic markets. We have also expanded our organizational structure so it can cope with the expansion, doubling our workforce to 15 one year ago. In addition, we have continued to invest in production and development projects related to ColdZyme.

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Questions and Answers – regarding the ASA decision, for marketing- and web material of ColdZyme in the UK

News   •   Jan 27, 2016 15:51 GMT

1.Why has the ASA ruled on the content of your ColdZyme ads and Boots’ website? 

ASA is acting on two complaints about claims we have made in a poster and that were made about the product on Boots’ website back in 2014, we have already taken the appropriate corrective action, changing the claims. ASA has the responsibility to see that advertising rules in the CAP code (The UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing) in UK are followed and therefore looked into these complaints.

2.What scientific data do you have to support the claims in the ads?

We have one placebo-controlled study and a few open label studies. These studies support the following claims; ColdZyme can reduce the viral load and can help reduce the number of sick-days suffered with a common cold, when used prophylactically.We feel that these are reasonable claims, and these have been adjusted to comply with the ASA decision.

3.You state in the ads “could prevent or shorten the common cold at the first signs” – what data do you have to support this statement?

Following the ASA decision we have already adjusted our claim in web and marketing material to adhere to the decision. ColdZyme is unique since it acts on the cold virus itself, as opposed to addressing symptoms when already ill. ColdZyme can reduce the viral load in the throat and can help reduce the number of sick-days of a common cold, when used prophylactically.

4.Do you intend to follow and comply with the ASA decision? And if yes, in what way?

We have considered the ASA decision, and have already taken the appropriate corrective action. The poster is not in use, and the website has been amended accordingly.

5.Don’t you think that this type of marketing and information will be harmful to the trust of your product and company?

We strongly believe that our current marketing is supported by reliable and relevant clinical data. Bear in mind that we also have an obligation to our customers to guide them in how to use ColdZyme in the best way. According to good clinical and marketing practice, we are constantly increasing our knowledge around the product by collecting more clinical data as well as post-marketing information for the benefit of the user.

6.How have you communicated with Boots and Lloyds?

The ASA decision has been shared with Boots and Lloyds and corrective action has been taken to adhere to ASA’s decision.

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Fredrik Lindberg appointed CEO of Enzymatica

Press Releases   •   Nov 17, 2014 10:00 GMT

Contacts 3 contacts

  • Press Contact
  • Senior Communication Officer
  • Corporate Communications
  • jgsmjorgen.rexjklorzlnkvsvddo@judrenapzymaticakhqb.com
  • +46(0) 708 19 22 82
  • +46 46 286 31 00

  • Press Contact
  • EVP Marketing & Operations
  • ulf.blom@enzymatica.se
  • 0703777328
  • 0462863100

About Enzymatica AB (publ)

Welcome to Enzymatica AB

Enzymatica is a publicly traded medical device company focused on research, development and sales of innovative enzyme-based products. Enzymaticas products is based primarily on a barrier technology, utlizing a cold adapted enzyme that can be used to create active protective barrier against pathogens. In close collaboration with clinical researchers, the company develops new products for upper respiratory infections, oral infections and inflammations, in dermatology and vetrinary applications.Enzymatica develops products in different market segments to create better customer value , broad recognition and market presence. The sales goes via our own organisation in Scandinavia and through strategic distribution and cooperation agreements for selected geographic markets and countries.