Warsaw, 29 April 2026
Dear Sir or Madam,
On behalf of BIOTON S.A., we are pleased to present you with the Annual Report, which sets out the financial results
and key information regarding the operations of the Company and its Group in 2025.
2025 was a period of intense work for the BIOTON Group, which – on balance – proved to be fruitful. Despite a
challenging market and macroeconomic environment, we achieved significant growth in our financial results. The
Group’s consolidated revenue increased by 36% in 2025 to PLN 282.5 million, mainly due to higher export sales of
insulin and increased revenue in the domestic market. Thanks to higher sales and improved profitability, we achieved
an increase in the Group’s net profit of over PLN 19 million, which enabled us to achieve a profit of PLN 3.4 million.
The Group’s financial results for 2025 should be viewed within a broader market context. The ongoing global
diabetes epidemic – one of the world’s greatest health challenges, affecting as many as 11% of the adult population –
is driving growing demand for antidiabetic medicines. At the same time, technological advances, the growing
popularity of new therapies (particularly incretin-based medicines) and business decisions by the industry’s largest
companies are leading to a steady decline in the share of recombinant human insulin (RHI) in the global market. For
the BIOTON Group – one of the eight commercial manufacturers of RHI in the world – this presents both strategic
challenges and new business opportunities, as confirmed by the results achieved in 2025.
The 59.4% increase in revenue from total export sales, to over PLN 185.2 million, was made possible, among other
things, by actively seeking new business opportunities in the global market. The fulfilment of a contract secured in
2024 enabled us to increase export sales of insulin by 77%, to nearly PLN 171 million. The reduction in the global
supply of insulin by leading manufacturers – resulting from their focus on GLP-1 analogues – presents us with a real
opportunity to increase our market share. We are convinced that RHI will remain the primary antidiabetic drug in
many countries for many years to come, for both therapeutic and economic reasons. Seizing this opportunity through
global expansion, in both developing and developed markets, remains one of our key priorities.
In the Polish market, expansion in the insulin segment alone is no longer sufficient to maintain current revenue
levels. We estimate that in 2025 our market share increased by nearly 3 percentage points to 43.3%, yet market
sales in this segment fell by 8%, which is due to the growing popularity of alternative therapies and declining demand
for RHI.
However, the Group’s total sales revenue in Poland rose by 6% to PLN 97.4 million. This was made possible by the
consistent implementation of our product diversification strategy. Last year, we increased sales of oral antidiabetic
medicines, which we distribute, by 5.6%, whilst revenue from the sale of other products and services – including
other medicines and medical devices – doubled, exceeding PLN 13 million.
The BIOTON Group’s development strategy, adopted in 2024, represents a well-considered response to changes in
the global diabetes treatment market. We believe that its consistent implementation will enable us to return to a
sustainable growth trajectory.
Company name:
BIOTON Share
capital: PLN
1,717,284,000.00
(paid-up capital PLN 1,717,284,000.00)
Registered office and address
5 Starościńska Street
02-516 Warsaw
VAT No. PL5210082573
REGON 001384592
Correspondence address
Macierzysz, 12 Poznańska
Street 05-850 Ożarów
Mazowiecki
Tel. +48 22 721 40 00
www.bioton.pl
Registration Court
Registration Court in Warsaw, 13th Commercial
Division of the National Court Register,
KRS registration number 0000214072 BDO
number 000016736
One of our key operational objectives is to build a new business area by entering the insulin analogue and GLP-1
markets. As early as the second half of 2026, based on distribution agreements already in place, our product range in
Poland will be expanded to include a glargine-containing medicine and a liraglutide-containing product.
However, our ambitions extend beyond distribution. In the medium term, we plan to develop our own manufacturing
capabilities in the insulin analogue segment, based on our own API production technology. In 2025, we reached a
significant milestone – the production of glargine API on a laboratory scale. The next stages involve the
industrialisation of the process, the development of the finished dosage form and its registration as a biosimilar. This
is a multi-year process, linked to the expiry of patent protection, and its aim is to launch the product on local and
global markets before the end of the decade. The market we are targeting is extremely attractive. According to
expert estimates, the value of the European glargine market will exceed €1 billion within a few years. The prospects
for global growth in demand for glargine – linked both to therapeutic needs and to the greater availability of the drug
resulting from the expiry of patent protection for glargine U300 in 2028 – are exceptionally promising.
The project to launch glargine production under a CMO model at the Macierzysz site will play a key role in the
implementation of these plans. In February 2025, we signed an agreement with a global pharmaceutical company,
following which we commenced technology transfer and investments in the development of production capacity. We
are in the process of retrofitting the plant with, amongst other things, systems for drug dose preparation and
packaging, which will increase the plant’s efficiency, enabling us to expand further in the CMO/CDMO sector.
Expanding our operations in this area will allow us to utilise our production capacity more effectively and will become
an important source of revenue in the coming years.
At the same time, we plan to further expand the portfolio of products distributed in Poland. In the coming years, our
range will be expanded to include, amongst other things, SGLT2 inhibitor medicines. In the longer term, we also aim
to introduce oral medicines based on GLP-1 analogues to the Polish market. We are also expanding our range to
include other solutions dedicated to people with diabetes. From 2025, we will be offering CareSens Air – an
innovative continuous glucose monitoring (CGM) system that represents a true qualitative revolution in everyday
diabetes care. We firmly believe in an integrated, digital approach to diabetes diagnostics and are consistently
working to introduce further solutions that are part of this transformative change. With this in mind, we are
interested in introducing a point-of-care analyser to the Polish market, enabling the measurement of glycated
haemoglobin (HbA1c) – which is crucial for daily diabetes care – in specialist clinics, amongst other settings.
One of the Group’s most important long-term ambitions, which is set to transform the company, is to develop
expertise in the production of GLP-1 analogues. The development and market launch of biosimilar GLP-1 analogues,
used not only in the treatment of diabetes but also other chronic conditions, particularly obesity, would mark a new
chapter in our company’s history. We are now at the very beginning of the journey towards this goal, and achieving it
will require a considerable financial and organisational effort.
As we draw up our long-term plans, we do not forget about development in the RHI sector. The announced
withdrawal of the largest manufacturers from supplying recombinant human insulin to the EU market presents a
significant opportunity for us. In the context of the growing importance of drug safety in Europe, RHI can continue to
play a vital role – from both a medical and an economic perspective. Our current production capacity already allows
us to fully meet the European market’s demand for this medicine. Entering new EU markets, however, requires
overcoming administrative barriers, including potentially conducting costly clinical trials. We are working on
alternative registration pathways that will enable the successful launch of our products in further countries.
The BIOTON Group has been present in the healthcare market for 37 years, supporting patients with diabetes. We
believe that we have significant growth potential, and that the coming years will bring further business development
and an increase in the Company’s value for Shareholders.
We would like to take this opportunity to thank you for the trust you have placed in us.
We invite you to read the report.
Jeremy Launders Romuald Harwas
Chairman of the Board Member of the Management Board