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The Macedonian pharmaceutical manufacturer Alkaloid, which has recorded an average growth rate of over 12% in the past five years, has opened a subsidiary in Romania to strengthen its position in the local market. The company, which operates in nearly 50 countries, is pursuing global expansion to maintain its growth momentum. The Romanian market is deemed strategic at its Skopje headquarters, with local operations increasing sales by 66% in the first year. Alkaloid currently markets about 20 products in Romania out of a portfolio of nearly 250 products. Our plans for Romania include expanding the team, enlarging the product portfolio, and increasing brand awareness, says Zhivko Mukaetov, CEO and President of the Management Board of Alkaloid AD Skopje.

A History of Almost Nine Decades

Alkaloid's modest beginnings date back to August 1936, when one of the oldest alkaloid processing plants opened on the outskirts of Skopje, part of the former Yugoslav community. With only two plants and 15 workers, today, 88 years later, Alkaloid has around 80.000 m² of manufacturing facilities and nearly 3.000 employees at its Skopje headquarters and the 22 subsidiaries in 15 countries around the world.

“Alkaloid's sustained business success and growth stem primarily from the quality of our products, the dedication of our personnel, the strength of the Alkaloid brand, and the individual brands our employees have tirelessly built over the decades. Investment has been a constant throughout Alkaloid’s history. In the past fifteen years, we have allocated nearly €220 million to building new pharmaceutical facilities, enhancing research and development, and installing cutting-edge equipment, laboratories, technologies, software, and training personnel. Today, Alkaloid sells more than 70% of its products in nearly 50 countries. We embrace global trends in pharmaceuticals, chemicals, phytotherapy, and cosmetology, adhering to the strictest Good Manufacturing Practice standards, as confirmed by renowned authorities,” says CEO Mukaetov.

Sales in the dynamic pharmaceutical industry often reflect our investments, skills, and expertise. We have focused on positioning the Alkaloid brand globally for the past few decades. Romania is a key strategic market for us. After several years of presence there, we registered our own company in Bucharest in 2022. Alkaloid's Romanian portfolio includes various pharmaceutical and hemodialysis products. Our leading product in this market is the cephalosporin antibiotic cefixime, known as Pancef® in Macedonia and XIFIA® in Romania, which ranks among the top 5 antibiotic brands in Romania, according to CEO Zhivko Mukaetov.

People, above all, power all of Alkaloid's products, brands, and ventures. We strive to build a company of satisfied individuals who invest their potential in our collective success. The company's image, values, credibility, and culture are reflected in its people. Alkaloid's goal is to stand out through knowledge and developing value-added products, upholding high ethical standards and professionalism in all our operations. Even in challenging times, we remain committed to the most important thing in life: HEALTH ABOVE ALL!

Zhivko Mukaetov, Alkaloid’s CEO and President of the Management Board 

“Our story is developing very well so far,” says Darko Stoleski in the interview, jokingly mentioning that he is breaking the ice as this is his first conversation with a journalist. It comes during a busy period with meetings involving members of the parent company management. Casual and attentive to details, he listens carefully and explains the company's progress since its founding in June 2022. “Our main goal in the first year on the local market was to build the team. We also exceeded our sales goals by 30%, surpassing €10 million in 2023. In the first quarter of 2024, our consolidated sales were 27% higher year-over-year.” Darko explains that Alkaloid is a generic drug manufacturing company based in Macedonia that has almost 90 years of history. The company's success story began there, evolving through several phases: nationalization, becoming a private company listed on the Macedonian Stock Exchange for more than two decades, and now global expansion, being present in about 50 countries. The group currently has 2,910 employees, with 2,215 in the country and 695 in subsidiaries and representative offices abroad.

Expansion to other markets is now one of the group's priorities and lies at the core of Alkaloid’s business model. “Our story in Romania is not so fresh. Even though we opened the subsidiary less than two years ago, some of our products were already present on the Romanian market through local partners,” says Darko Stoleski. Our first cooperation with the local market dates back to 2004, making our products well-known among Romanian physicians, pharmacists, and consumers. “Since our subsidiary came later than our products, it was important to create a connection between the brands already known to healthcare professionals and Alkaloid as a manufacturer. The Xifia and Forexo brands were well known to most physicians, but we had to build Alkaloid’s brand image from scratch,” adds the company representative.

Alkaloid's representative says that the long-term goal for the Romanian market is the same as in all markets where the company operates – to bring high-quality products at affordable prices to Romanian patients and consumers. The company's current portfolio in Romania includes several antibiotics (Xifia and Forexo), a product for treating benign prostatic hyperplasia, and nutritional supplements for women planning pregnancy, pregnant, or breastfeeding. Additionally, through a partnership with MagnaPharm Marketing & Sales Romania, the company sells several pain, cold, and flu relief products under the Caffetin brand. “This year, we intend to launch two additional food supplement products – an iron supplement and a product that is part of a larger children's portfolio of OTC medicines and nutritional supplements, a unique formula of probiotics, vitamins, and minerals under the name Becutan KidsVits Multiimmuno. By the end of 2024, we plan to launch Alkaloid’s latest innovation – liquid Omeprazole, making this value-added product available to Romanian patients,” says Darko Stoleski.

The current portfolio includes three oral antibiotics: Xifia (cefixime), Forexo (cefpodoxime), and Kimoks (moxifloxacin). Xifia is the most well-known and has been available in the Romanian market since 2014. It is the only cefixime variant available in both adult and pediatric forms. “Thanks to our business partners, Pharmalink SRL, who launched the product, Xifia is a brand already trusted by healthcare professionals in Romania. It is used annually by thousands of children and adult patients needing antibiotic treatment.. Forexo, the second important antibiotic in the portfolio, is the only cefpodoxime available in both pediatric and adult forms on the Romanian market,” says Darko Stoleski

Stoleski adds that the company specializes in manufacturing cephalosporin antibiotics, particularly cefixime (Xifia), for which it is one of the largest producers in Europe. The portfolio for the Romanian market also includes Seldono (tamsulosin) for treating benign prostatic hyperplasia. In 2023, they launched their first nutritional supplement, PreMama Duo, a unique formula designed to meet the needs of women planning pregnancy, pregnant, or breastfeeding. We appreciate the fact that the Romanian Association of Obstetrics and Gynecology recommends PreMama duo as a unique formula on the market.

The Macedonian pharmaceutical company has products in all major therapeutic areas. “We have a large portfolio of cardiological products already launched in other markets and several products for treating central nervous system diseases. We are also among the top three producers of substitution therapy for addictions, specifically liquid methadone. Additionally, Alkaloid offers a rich line of OTC and nutritional supplements, an area we plan to develop further in the coming years due to the growing drug and supplement consumption trend. We intend to expand this segment in Romania as well. In summary, there are many opportunities for us to grow,” states Stoleski.

He emphasizes that his current priority is building a solid base with the existing portfolio and launching new products that will establish themselves as brands in the Romanian market. “We are a generic company, and we want to build brands that will remain on the market for many years and be recognized by consumers, patients, and doctors.”

Extra speed

“Although some of our pharmaceutical products have been on the market for many years, in 2022, we decided to take a step forward with our business model and focus primarily on medical promotion, and our team is now 100% dedicated to promoting Alkaloid's portfolio,” says Darko Stoleski. He emphasizes that opening the subsidiary in Romania is a strategic move, recognizing the country's significant potential as a member of the European Union and considering the behaviour of consumers and health professionals.

“An important goal was to connect the brands already known to Romanian health workers with the Alkaloid brand as a manufacturer. Since the subsidiary appeared after the products, we had to build the Alkaloid brand image from scratch. For most doctors, Xifia and Forexo were well-known, but we needed to establish Alkaloid as a recognizable name,” says Darko Stoleski, CEO of Alkaloid Bucharest

Plans for the near future include developing the local portfolio of products intended for paediatric use, with eight additional people to be employed for this division. “The biggest challenge is recruitment,” admits the manager. He emphasizes that among Alkaloid's central values, people come above all. “The company trusts people, encourages open communication, and values individuals with high integrity. Recruitment is the most difficult part of the business because it is hard to find a perfect match where the company and the employee share the same values and work principles,” he says.

He adds that while skills, experience, and previous successes are important, the most crucial attribute is a high level of integrity. Candidates should be honest and open to communication and learning, as the company is ready to invest in enhancing the knowledge of its team members. In terms of recruitment, things have changed a lot over the years, he acknowledges. Still, it's essential that people feel welcome and valued, that they feel they contribute to the company's success, and that they can develop within it. So far, we have a solid organization, and most colleagues have been part of the Alkaloid team since the first half of 2023.

Regarding market specifics, Darko Stoleski notes that there are many similarities in consumer behaviour and the mentality of doctors compared to other markets in Central and Eastern Europe, particularly Macedonia. Since joining the European Union, Romania's pharmaceutical market has continuously grown in value and volume. The availability of medicines for Romanian patients has also improved in recent years, positioning Romania as one of the leading countries in terms of potential in the entire region. Another important aspect is that the local pharmaceutical market is well-regulated in terms of new product registration and pricing.

“Like all markets, Romania presents both opportunities and challenges. For instance, there are pressures related to reducing pharmaceutical product prices. However, a positive development occurred last year when the Romanian government decided to increase the regulated prices of the positive list of medicines. All pharmaceutical manufacturers certainly appreciate this decision. Every producer is affected by that price increase, and we are among the most affordable generics on the Romanian market. Additionally, I must commend this year's decision by the authorities to freeze drug prices until the end of the year. This helps us maintain an improved degree of predictability, which is essential for creating business plans,” Stoleski acknowledges.

Alkaloid AD Skopje recently completed its most significant investment in the last two decades, worth €19.4 million, to increase manufacturing capacity.

Years in the positive

Alkaloid AD Skopje has been listed on the Macedonian Stock Exchange since 2002, and its shares are among the most traded and liquid on the Exchange. According to company data, the average price of Alkaloid AD Skopje shares was €289 in 2023, and in Q1 of 2024, the average price increased to €318 per share. The company's current market capitalization is approximately €472 million.

In 2023, Alkaloid achieved consolidated sales of €268.3 million globally, marking a 16% increase year-over-year. The pharmaceutical segment accounts for 90% of the total consolidated sales, while the chemical, cosmetic, and botanical segments have grown by 10%. About 70% of total sales come from exports. By region, South-East Europe contributes 29% of sales, Western Europe 22%, Eastern Europe 17%, and other markets take 1% of the total consolidated sales. The company's total consolidated exports increased by 17%, with Romania showing one of the highest sales growth rates in 2023, with a 66% increase in consolidated sales compared to 2022. In 2023, the Romanian subsidiary of Alkaloid contributed almost €10.4 million in consolidated net sales.

In the first quarter of the current year, the group continued its growth trend, achieving consolidated sales of €79.9 million, a 13% increase compared to the same period last year. Sales in Romania are again among those with the highest growth, recording a 27% increase year-over-year, according to Darko Stoleski.

Investments

“In the last five years, the company has invested over €220 million,” says the representative of Alkaloid. He adds that while the group is present in 13 countries in the region, the most significant investments are directed to Macedonia, where almost all of its manufacturing facilities are located.

Alkaloid AD Skopje recently completed its most significant investment in the last two decades, valued at €19.4 million, to increase manufacturing capacity. The project focused on developing a manufacturing unit for solid pharmaceutical forms, named Tablet Department 2.0, along with the corresponding technical infrastructure. This new technical-technological infrastructure, designed to increase production volume and flexibility, covers 6,200 square meters, including manufacturing and technical facilities. “In the last 15 years, we have undertaken various investment projects totalling €220 million, and we intend to continue on this trajectory. In recognition of our investment efforts from 2018 to 2022, amounting to €104.1 million, the Western Balkans Investment Forum (WB6CIF) named Alkaloid the Lead Investor in the Western Balkans in 2023.”

The research and development department in Macedonia is also constantly expanding. Established precisely 15 years ago with the inauguration of the Research and Development Institute, it now comprises 170 people, over 150 of whom hold advanced degrees, master's degrees, or doctorates. Several teams within the institute work on developing different groups of products, utilizing both internal expertise and the knowledge of external consultants. Recently, Alkaloid AD's revolutionary formula, the liquid ready-to-use Omeprazole, a medicine with added value and the first of its kind worldwide, was awarded the Patent of the Year 2023 by the State Industrial Property Office of Macedonia. The company's development labs are currently working on several other innovative formulas.

Two decades of growth



The company increased its consolidated sales from approximately €53 million in 2005 to €268.3 million in 2023, with an average annual growth rate of 12.4% over the past five years.

In recent years, Alkaloid has focused on redesigning existing generic pharmaceutical products for new indications. The goal was to develop value-added drugs that address the needs of individuals or specific patient groups. “Strategic investments aimed at modernizing our product portfolio led to the successful development of the first patented drug with added value from the Alkaloid portfolio.

This medicine is primarily designed to treat reflux esophagitis and gastroesophageal reflux disease (GERD). Proton pump inhibitors, including Omeprazole, are the drugs of choice for treating these conditions, the Alkaloid representative explains Traditionally, these drugs are available in tablets, gastro-resistant capsules, or powder forms for dissolution. “With a revolutionary breakthrough, Alkaloid has developed the first ready-to-use liquid Omeprazole. This innovative product features two separate solutions in a dual-chamber package that automatically mix upon opening to form the liquid Omeprazole. The first marketing authorizations for this drug were granted for the Macedonian and British markets. Registration processes for European countries are underway, and we are currently in the national registration phase in Romania. We aim to make this drug available to Romanian patients by the end of the year,” concludes the representative from Alkaloid.

Four questions for Darko Stoleski, CEO of Alkaloid Bucharest

1.   This is your first position as a CEO abroad. How did you react when it was proposed to you?

I am a doctor by profession, but I entered the pharmaceutical industry immediately after graduating. I have been in this field for 17 years, with my career spanning several positions in two companies. The role in Romania is my first CEO-level position with this company, where I have worked for six years. Previously, I served as the regional marketing and sales manager in the Croatian subsidiary, acting as a direct link between the headquarters and the subsidiary. This experience was excellent preparation.

When I was offered this role, I responded positively. I liked the idea of establishing a new subsidiary and creating an organizational culture. It is a challenging but rewarding experience, and I consider this role a privilege.

2.   What kind of management style do you employ?

I believe in recognizing those who strive to be better versions of themselves. I encourage my team to make decisions to achieve their goals and I am always available for open and direct conversations. If necessary, we work together to identify problems and find solutions.

3.   When did you first have contact with Romania, and how has the country changed since then?

I first got to know Romania during 2012/2013 through my previous position before joining Alkaloid. At that time, there were challenges with financing innovative medicines. Now, I see significant positive changes. Since my arrival almost two years ago, I have noticed a positive mentality and very hospitable people ready to help in various ways. Bucharest is a very safe city, which is important for those who relocate here for their career and life.

4.   What do you miss most from home?

Of course, I miss my family and friends. We visit Skopje as often as we can, usually for Easter, Christmas, and during the summer holidays.